Clinical trial NCT03638258
Conditions: Plaque Psoriasis
Sponsor: Arcutis Biotherapeutics, Inc.
Start date: 2018-09-21; Completion date: 2019-05-29
Enrollment: 331 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.

Detailed description:

Arms: arm 1: Roflumilast cream 0.3% topically applied QD for 12 weeks. arm 2: Roflumilast cream 0.15% topically applied QD for 12 weeks. arm 3: Vehicle cream matched to roflumilast cream (containing only excipients of active cream) applied QD for 12 weeks.
Interventions: intervention 1: Roflumilast Cream 0.3% intervention 2: Roflumilast Cream 0.15% intervention 3: Vehicle Cream
Intervention descriptions: intervention 1: Applied once daily for 12 weeks intervention 2: Applied once daily for 12 weeks intervention 3: Applied once daily for 12 weeks

Protocol documents:
SAP_002.pdf: 
 
 
Study 
Number: 
ARQ-151-201 
NCT #: 
NCT03638258 
Official 
Title: 
A Phase 2b 12-Week Parallel Group, Double 
Blind, Vehicle- 
Controlled Study of the Safety, Efficacy and 
Pharmacokinetics of 
ARQ-151 Cream 0.3% and ARQ-151 Cream 
0.15% 
Administered QD in Subjects with Chronic 
Plaque Psoriasis 
 
SAP Date: 
24-May-2019 
 


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STATISTICAL ANALYSIS PLAN 
Protocol Number: 
ARQ-151-201 
Study Title:  
A Phase 2b 12-Week Parallel Group, Double Blind, 
Vehicle-Controlled Study of the Safety, Efficacy, and 
Pharmacokinetics of ARQ-151 Cream 0.3% and 
ARQ-151 Cream 0.15% Administered QD in 
Subjects with Chronic Plaque Psoriasis 
Development Phase of Study: 
Phase 2b 
Sponsor: 
Arcutis, Inc. 
2945 Townsgate Road, Suite 110 
Westlake Village, CA 91361 
Sponsor Contact: 
David Berk, MD 
Vice President, Clinical Development 
Statistical Analysis Plan based on 
Protocol Version: 
Amendment 1, 12 November 2018 
Statistical Analysis Plan Date: 
24MAY2019 
Statistical Analysis Plan Version: 
Version 1 




 
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SAP Change History 
Only final versions will be documented in the Change History. 
Version Date 
Summary of Changes  
Author 
1 24MAY2019 Original document 
 
 
 


 
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TABLE OF CONTENTS 
1. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ....................................6 
2. 
INTRODUCTION .................................................................................................................7 
3. 
STUDY OBJECTIVES .........................................................................................................8 
4. 
STUDY DESIGN ...................................................................................................................8 
4.1 Overall Study Design ......................................................................................................8 
4.1.1 
Schedule of Visits and Assessments .................................................................8 
4.1.2 
Method of Assigning Subjects to Treatment Groups ........................................8 
4.1.3 
Blinding .............................................................................................................9 
5. 
EFFICACY AND SAFETY ENDPOINTS .........................................................................9 
5.1 Efficacy Endpoints ..........................................................................................................9 
5.1.1 
Primary Efficacy Endpoint ..............................................................................10 
5.1.2 
Secondary Efficacy Endpoints ........................................................................10 
5.1.3 
Additional Efficacy Endpoints ........................................................................11 
5.2 Safety Endpoints ...........................................................................................................11 
6. 
STATISTICAL AND ANALYTICAL PLANS ................................................................12 
6.1 General Methodology ...................................................................................................12 
6.1.1 
Statistical Analysis ..........................................................................................12 
6.1.2 
Baseline Definition ..........................................................................................12 
6.1.3 
Visit Windowing .............................................................................................13 
6.1.4 
Adjustments for Covariates .............................................................................13 
6.1.5 
Handling of Dropouts or Missing Data ...........................................................14 
6.1.6 
Interim Analyses and Data Monitoring ...........................................................14 
6.1.7 
Multicenter Studies ..........................................................................................14 
6.1.8 
Multiple Comparisons/Multiplicity .................................................................14 
6.1.9 
Use of an Efficacy Subset of Subjects .............................................................14 
6.1.10 Active-Control Studies Intended to Show Equivalence ..................................14 
6.1.11 Examination of Subgroups ..............................................................................15 
6.2 Disposition of Subjects .................................................................................................15 
6.3 Protocol Deviations .......................................................................................................15 
6.4 Data Sets Analyzed .......................................................................................................15 
6.4.1 
Intent-to-Treat Population ...............................................................................16 


 
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6.4.2 
Safety Population ............................................................................................16 
6.4.3 
Per-Protocol Population ..................................................................................16 
6.4.4 
Pharmacokinetic Population ............................................................................16 
6.5 Demographic and Other Baseline Characteristics ........................................................16 
6.6 Analysis of Efficacy ......................................................................................................17 
6.6.1 
Primary Efficacy Analysis ...............................................................................17 
6.6.2 
Secondary Efficacy Analysis ...........................................................................17 
6.6.3 
Exploratory Efficacy Analysis ........................................................................18 
6.7 Safety Evaluation ..........................................................................................................18 
6.7.1 
Extent of Exposure ..........................................................................................19 
6.7.2 
Adverse Events ................................................................................................19 
6.7.3 
Clinical Laboratory Evaluation .......................................................................20 
6.7.4 
Other Observations Related to Safety .............................................................20 
6.7.4.1 
Electrocardiogram Measurements ...............................................20 
6.7.4.2 
Vital Signs ....................................................................................20 
6.7.4.3 
Physical Examination...................................................................20 
6.7.4.4 
Medical History ...........................................................................21 
6.7.4.5 
Local Tolerance Assessments ......................................................21 
6.7.4.6 
Patient Health Questionnaire Depression Scale ...........................21 
6.7.4.7 
Columbia-Suicide Severity Rating Scale .....................................21 
6.7.4.8 
Prior and Concomitant Medications ............................................21 
6.8 Other Evaluations .........................................................................................................21 
6.8.1 
Pharmacokinetic Evaluation ............................................................................21 
7. 
DETERMINATION OF SAMPLE SIZE .........................................................................22 
8. 
CHANGES IN THE PLANNED ANALYSES..................................................................22 
9. 
REFERENCES ....................................................................................................................22 
10. INDEX OF PLANNED TABLES ......................................................................................23 
11. INDEX OF PLANNED LISTINGS .................................................................................157 
 
 


 
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1. LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
AE(s) 
Adverse Event(s) 
BSA 
Body Surface Area 
CRF(s) 
Case Report Form(s) 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
DLQI 
Dermatology Life Quality Index 
ECG 
Electrocardiogram 
IGA 
Investigator’s Global Assessment 
I-IGA 
Intertriginous IGA 
ITT 
Intent-to-Treat 
LOCF 
Last Observation Carried Forward 
MedDRA 
Medical Dictionary for Regulatory Activities 
mPASI 
Modified Psoriasis Area and Severity Index 
N 
Sample Size 
NRS 
Numerical Rating Score 
PHQ-8 
Patient Health Questionnaire Depression Scale 
PK 
Pharmacokinetic 
PP 
Per-Protocol 
PSD 
Patient Symptoms Diary 
QD 
Once a Day 
SAE(s) 
Serious Adverse Event(s) 
SAS® 
Statistical Analysis System (SAS® Institute Inc., Cary, NC) 
SD 
Standard Deviation 
TEAE(s) 
Treatment-Emergent Adverse Event(s) 
WHO 
World Health Organization 
WHO-DD 
World Health Organization Drug Dictionary 
WHO-ATC 
World Health Organization-Anatomical Therapeutic Chemical 
Classification System 
WI-NRS 
Worst Itch Numerical Rating Scale 
WPAI 
Work Productivity and Activity Impairment 
 
 


 
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2. INTRODUCTION 
Roflumilast is a phosphodiesterase 4 (PDE-4) inhibitor approved globally to reduce the risk of 
exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) associated 
with chronic bronchitis. Roflumilast and its active metabolite, roflumilast N-oxide, are high 
affinity selective inhibitors of PDE-4 (a major cyclic-3′,5′-adenosine monophosphate (cyclic 
AMP)-metabolizing enzyme), whose activity leads to accumulation of intracellular cyclic AMP. 
There are four different subtypes of PDE-4: PDE-4a, PDE-4b, PDE-4c, and PDE-4d, each with 
several isoforms (splicing variants). IC50 values of both roflumilast and roflumilast N-oxide for 
the different PDE-4 isoforms and subtypes are mostly sub-nanomolar and single digit nanomolar 
(Hatzelmann 2010). The PDE-4 family of enzymes are the most prevalent phosphodiesterases in 
immune cells and inhibition of PDE-4 subtypes has been associated with anti-inflammatory 
effects in many biological systems. 
Psoriasis is a chronic inflammatory skin disease characterized by raised, well-demarcated, 
erythematous oval plaques with adherent silvery scales. Numerous past reports have suggested a 
deficiency of cyclic AMP-dependent protein kinases in human psoriatic skin (Brion 1986). More 
recently, various cytokines produced by Th1 and Th17 cells have been shown to play a crucial 
role in the pathogenesis of psoriasis. It has been postulated that the anti-inflammatory effects of 
PDE-4 inhibitors may provide a beneficial therapeutic intervention in the treatment of chronic 
plaque psoriasis, and recently Otezla® (apremilast) a PDE-4 inhibitor has been approved for the 
oral treatment of chronic plaque psoriasis. 
The past 15 years have witnessed a transformation in the systemic treatment of moderate to 
severe psoriasis with the advent of biological therapies. However, for patients with milder forms 
of disease, best treated with topical options, the therapeutic landscape really has not changed in 
several decades. Topical steroids come in all shapes and forms, but the lower potency steroids 
are not effective and the higher potency steroids are beset with issues of local skin atrophy and 
the potential for hypothalamic-pituitary axis suppression when applied over larger body surface 
areas and for prolonged periods of time. Vitamin D has been the other staple of topical psoriasis 
treatment but it is irritating, not suitable for use on the face or intertriginous areas, and its 
efficacy is rather modest. Hence, there is substantial medical need for additional topical 
approaches in the treatment of psoriasis. Arcutis, Inc is developing a topical formulation of 
roflumilast for the treatment of chronic plaque psoriasis. 
 


 
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3. STUDY OBJECTIVES 
To assess the safety, pharmacokinetics and efficacy of ARQ-151 cream 0.3% and ARQ-151 
cream 0.15% vs. vehicle applied QD for 12 weeks to individuals treated with 2 to 20% 
(inclusive) Body Surface Area (BSA) of chronic plaque psoriasis. 
4. STUDY DESIGN 
4.1 
Overall Study Design 
This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream 0.3%, 
ARQ-151 cream 0.15% or vehicle cream QD is applied for 84 days to subjects with between 2% 
to 20% (inclusive) BSA of chronic plaque psoriasis.  
A total of up to approximately 300 subjects will be enrolled at approximately 30 study sites in 
the United States and Canada. Subjects will be adult (≥18 y/o) males or females with chronic 
plaque psoriasis. Subjects must have an Investigator’s Global Assessment (IGA) of disease 
severity of at least Mild (‘2’) at Baseline. Subjects with an IGA of ‘Mild’ (2) will be limited to 
20% of total enrollment. Subjects with an IGA of ‘Severe’ (4) will be limited to 15% of total 
enrollment. Subjects must have at least 2% and no more than 20% BSA of chronic plaque 
psoriasis. All psoriasis lesions on a subject will be treated including the face, trunk, genitals/skin 
folds, or limbs (excluding the scalp). The palms and soles will be treated but will not be counted 
towards any measurements of efficacy (IGA, BSA, Modified Psoriasis Area and Severity Index 
(mPASI)). For subjects with intertriginous area involvement, and with severity of the 
intertriginous area lesions at least ‘mild’ (IGA≥2) at Baseline, Intertriginous IGA (I-IGA) score 
will be recorded at weeks 4, 6, 8 and 12. The same IGA used for the primary endpoint (whole 
body) will also be used for I-IGA, but only intertriginous areas will be evaluated for I-IGA, not 
the rest of the body. 
4.1.1 
Schedule of Visits and Assessments 
The schedule of assessments can be found in Section 5 of the protocol. 
4.1.2 
Method of Assigning Subjects to Treatment Groups 
Assignment of drug or vehicle will be made at a 1:1:1 ratio according to a computer-generated 
randomization list. Randomization will take place at Baseline after the patient has been found to 
be fully eligible for participation. Kits containing tubes of study medication will be assigned to 
each subject using an internet-based randomization system (IWRS). A subject may receive more 
than one kit for the treatment period. 


 
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The kits and tubes are blinded and each kit is numbered with a unique kit number. 
4.1.3 
Blinding  
This is a double-blind study, therefore neither the subjects nor the Investigator, clinical team, and 
study sponsor will be aware of which treatment an individual has received. 
If the situation requires emergency unblinding this will be done by investigator using the study 
IWRS system after discussion with Medical Monitor and the Sponsor’s CMO. 
The treatment assignments for all enrolled subjects will be unblinded only after the conclusion of 
the study. Specifically, the blind will be broken only after all data are verified, entered into the 
database, and validated; subject evaluability assessments are performed and entered into the 
database; and the database is locked. 
5. EFFICACY AND SAFETY ENDPOINTS 
5.1 
Efficacy Endpoints 
mPASI is one of the measurements used for the severity of psoriasis. mPASI combines the 
assessment of the severity of lesions and the area affected into a single score in the range 0 (no 
disease) to 72 (maximal disease). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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5.1.1 
Primary Efficacy Endpoint 
The primary efficacy endpoint is as follows: 
• Success in Investigator Global Assessment (IGA) of disease severity, defined as an IGA 
of ‘Clear’ or ‘Almost Clear’ at Week 6. 
5.1.2 
Secondary Efficacy Endpoints 
The secondary efficacy endpoints are as follows: 
• IGA score of ‘clear’ or ‘almost clear’ at weeks 2, 4, 8, and 12. 
• Percent change from Baseline in mPASI at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Percent BSA affected at weeks 2, 4, 6, 8, and 12. 
• IGA score of ‘clear’ or ‘almost clear’ PLUS a 2-grade improvement from Baseline at 
weeks 2, 4, 6, 8 and 12. 
• For subjects with intertriginous area involvement, and with severity of the intertriginous 
lesions at least ‘mild’ (I-IGA≥2) at Baseline, ‘I-IGA’ score of ‘clear’ or ‘almost clear’ at 
weeks 2, 4, 6, 8 and 12. 
• Change from Baseline in Worst Itch Numerical Rating Scale (WI-NRS) pruritus score at 
weeks 2, 4, 6, 8, and 12. 
• In subjects with WI-NRS pruritus score ≥ 6 at Baseline, a 4-point reduction in WI-NRS 
pruritus score at 2, 4, 6, 8, and 12 weeks as compared to Baseline. 


 
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• Change from Baseline in Modified Psoriasis Area Severity Index-75 (mPASI-75) 
improvement at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Modified Psoriasis Area Severity Index-90 (mPASI-90) 
improvement at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Total Patient Symptoms Diary (PSD) at weeks 2, 4, 6, 8, and 
12. 
• Change from Baseline in Itch-related Sleep Loss score at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Dermatology Life Quality Index (DLQI) score at weeks 2, 4, 6, 
8, and 12. 
• Change from Baseline in responses to the questions of Total Patient Symptom Diary 
(PSD) at weeks 2, 4, 6, 8, and 12. 
Change from Baseline will be calculating by subtracting the score at Baseline from the post-
baseline score. Percent change from Baseline will be calculated by dividing change from 
Baseline by the Baseline score, multiplied by 100.  
5.1.3 
Additional Efficacy Endpoints 
The exploratory endpoints are as follows: 
• Change from Baseline in Fatigue Numerical Rating Score (NRS) score at weeks 2, 4, 6, 
8, and 12.  
• Change from Baseline in Work Productivity and Activity Impairment (WPAI) score at 
weeks 2, 4, 6, 8, and 12. 
Change from Baseline will be calculating by subtracting the score at Baseline from the post-
baseline score. 
5.2 
Safety Endpoints 
Safety will be evaluated through examination of data collected during physical examinations, 12-
lead Electrocardiograms (ECGs), local tolerability assessments, vital signs, counts and 
percentages of subjects who gain or lose >5% and >10% body weight, clinical laboratory 
parameters, Patient Health Questionnaire Depression Scale (PHQ-8), Columbia-Suicide Severity 
Rating Scale (C-SSRS) and adverse events (AEs) as outlined in the Schedule of Visits and 
Assessments. If deemed necessary, additional safety assessments will be performed at the 
discretion of the Principal Investigator. 


 
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6. STATISTICAL AND ANALYTICAL PLANS 
6.1 
General Methodology 
All statistical processing will be performed using SAS® (Version 9.4 or later) unless otherwise 
stated. No interim analyses are planned. Except where noted, all statistical tests will be two-sided 
and will be performed at the 0.05 level of significance. No adjustment will be made for 
multiplicity. 
Descriptive statistics will be used to provide an overview of the efficacy, safety, and 
pharmacokinetic results. For categorical parameters, the number and percentage of subjects in 
each category will be presented. The denominator for percentage will be based on the number of 
subjects appropriate for the purpose of analysis. For continuous parameters, descriptive statistics 
will include n (number of subjects), mean, standard deviation (SD), median, minimum and 
maximum. Appropriate inferential statistics will be used for the primary, secondary, and 
exploratory efficacy variables. 
The primary method of handling missing efficacy data will be a mixture of linear interpolation 
and last observation carried forward (LOCF).  
The efficacy analysis performed on the Intent-to-Treat (ITT) population is considered the 
primary analysis. The efficacy analysis performed on the Per-Protocol (PP) population is 
considered supportive analysis. 
The number of subjects in each analysis set will be summarized. Reasons for study withdrawal 
during the blinded study will be summarized using frequencies and percentages by treatment 
group. Reported AEs, medical history terms and prior and concomitant procedures and therapies 
will be classified on the basis of Medical Dictionary for Regulatory Activities (MedDRA) 
terminology. Prior and concomitant medications will be classified on the basis of World Health 
Organization Drug Dictionary (WHO-DD) terminology. 
6.1.1 
Statistical Analysis 
All analyses will be performed by QST using SAS® Version 9.4 or later. All summary tables 
and data listings will be prepared utilizing SAS® software. 
The standard operating procedures (SOPs) of QST will be followed in the creation and quality 
control of all data displays and analyses. 
6.1.2 
Baseline Definition 
Baseline is defined as the last non-missing assessment prior to first dose of study drug.  


 
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6.1.3 
Visit Windowing 
Data will be summarized based on nominal visit indications with the exception of data captured 
at early termination and unscheduled visits. Data from early termination and unscheduled visits 
will be summarized based on mapped visit values. The analysis windows for early termination 
and unscheduled visits are presented in the following table.  
 
Analysis Windows for Efficacy and Safety Assessments 
Scheduled Visit 
Target Study Day 
Window (Days) 
Week 2 
15 
8 to 22 
Week 4 
29 
23 to 36 
Week 6 
43 
37 to 50 
Week 8 
57 
51 to 71 
Week 12 
85 
72 to 99 
Week 16 
113 
100 to 127 
Data collected at early termination and unscheduled visits prior to study day 8 will not be 
analyzed, with the exception of those identified as baseline values. Data collected at visits after 
study day 127 will not be included in analyses.  
The definition for the study day included in each study window is defined as below: 
 
Study Day prior to Baseline Day 1 = Visit Date – Baseline Day 1 Date 
 
Study Day on or after Baseline Day 1 = Visit Date – Baseline Day 1 Date + 1 
If an assessment’s mapped visit is a visit at which the subject has data from a scheduled visit 
present, or if no analyses are planned for the assessment at the mapped visit, the data collected at 
the early termination or unscheduled visit will not be included in analyses.  
In the event of multiple values from unscheduled or early termination assessments within an 
analysis window, the value closest to the scheduled visit target study day will be used for 
analyses. If two values tie as closest to the time point (for example, one value is before and the 
other value is after the time point), then the later value will be selected.  
Data collected at all visits will be included in the data listings with visit presented as reported by 
the site. 
6.1.4 
Adjustments for Covariates 
The Baseline score will be used as a covariate for each endpoint analyzed. 


 
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6.1.5 
Handling of Dropouts or Missing Data 
The primary method of handling missing efficacy data will be a mixture of linear interpolation 
and LOCF. Linear interpolation will be used for all instances where subjects have observed 
values for at least one assessment both preceding and following the missing assessment. If an 
unscheduled assessment occurs between the preceding or following scheduled assessment and 
the missing assessment, the unscheduled assessment will be used in the linear interpolation. The 
actual study day of assessment will be used for the preceding and following assessments, and 
planned study day will be used for the missing assessment. IGA and I-IGA values imputed with 
linear interpolation will be rounded to the nearest integer. If the missing assessment is not 
followed by at least one observed assessment, the method of LOCF will be used. 
6.1.6 
Interim Analyses and Data Monitoring 
No interim analysis or data monitoring is planned for this study. 
6.1.7 
Multicenter Studies 
The clinical study will be conducted under a common protocol for each investigational site. 
Every effort will be made to promote consistency in study execution at each investigational site. 
Sites will be pooled for analyses. 
6.1.8 
Multiple Comparisons/Multiplicity 
No adjustments for multiple comparisons or multiplicity will be made. 
6.1.9 
Use of an Efficacy Subset of Subjects 
Subjects randomized to study drug who were at least 80% compliant with the study drug, did not 
miss more than three consecutive doses, and who do not have major protocol deviations will 
form the Per Protocol (PP) Population. The major protocol deviations will be defined at the time 
of evaluability evaluation, the time between the database soft lock and hard lock before 
unblinding. 
Excluding subjects who have major protocol deviations will decrease the variability in treatment 
response and will allow for a better determination of efficacy of ARQ-151 Cream 0.3% and 
ARQ-151 Cream 0.15%. 
6.1.10 
Active-Control Studies Intended to Show Equivalence 
Not applicable to this study. 


 
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6.1.11 
Examination of Subgroups 
Subset analyses will be conducted for the ITT population for the subgroups baseline IGA and 
baseline I-IGA. I-IGA will be dichotomized into presence or absence of I-IGA ≥ 2 at baseline. 
These analyses will contain only descriptive statistics of the primary efficacy endpoint. 
6.2 
Disposition of Subjects 
The number of subjects included in each analysis population (ITT, safety, PP, pharmacokinetic 
(PK)) will be summarized by treatment group. The number of subjects enrolled, completed, and 
discontinued (including the reasons for discontinuation) will be summarized for each treatment 
group. 
Subjects who are excluded from an analysis population will be summarized by the primary 
reason for exclusion. 
6.3 
Protocol Deviations 
Protocol deviations leading to exclusion from the PP population will be tabulated. In addition to 
protocol deviations leading to exclusion from the PP population, the protocol deviations listed 
below will be presented in a data listing. 
• Baseline PHQ-8 score greater than or equal to 15 
• Received incorrect treatment 
• Baseline mPASI less than 2 
• Baseline IGA of Clear or Almost Clear 
• Missed visit 
• Missed IGA at attended visit 
• Missed I-IGA at attended visit 
• Missed safety labs at attended visit  
6.4 
Data Sets Analyzed 
Subjects will be presented/summarized based on the primary reason for exclusion. The primary 
reason for exclusion for each population is the first inclusion condition a subject fails to meet 
based on the order listed below. 


 
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6.4.1 
Intent-to-Treat Population 
All randomized subjects will be included in the ITT population and analyzed according to the 
treatment group they were randomized. All efficacy analyses will be presented using the ITT 
population. 
6.4.2 
Safety Population 
All subjects in the ITT population who have at least one post-baseline safety assessment will be 
included in the safety population and analyzed according to the treatment group they received. In 
the event a subject receives more than one treatment, they will be analyzed based on the 
treatment they received for the majority of the study. All safety analyses will be performed using 
the safety population. 
6.4.3 
Per-Protocol Population 
All subjects in the safety population who were at least 80% compliant with study medication, did 
not miss more than 3 consecutive doses, and showed no other serious protocol violations will be 
included in the PP population and analyzed according to the treatment group they received. All 
efficacy analyses will be performed on the PP population. 
6.4.4 
Pharmacokinetic Population 
All subjects receiving the active drug with quantifiable plasma concentrations of roflumilast will 
be included in the PK population.  
6.5 
Demographic and Other Baseline Characteristics 
All summaries will be done on the ITT, PP, safety, and PK populations. 
Sex, race, and ethnicity will be summarized by counts and percentages. Age (years) will be 
summarized with descriptive statistics.  
Height, Weight, BSA, IGA, mPASI, WI-NRS, DLQI, Itch-Related Sleep Loss, and Total PSD 
will be summarized at baseline with descriptive statistics. 
Medical histories will be coded using the MedDRA dictionary and presented in a by-subject 
listing. 


 
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6.6 
Analysis of Efficacy 
6.6.1 
Primary Efficacy Analysis 
The primary efficacy endpoint is success in IGA, defined as an IGA of ‘Clear’ or ‘Almost Clear’ 
at Week 6. The primary efficacy endpoint will be analyzed with a logistic regression with a 
factor of treatment group and the respective Baseline IGA score as a covariate. Statistical 
comparison between the active treatment arms and vehicle arms will be facilitated by using 
contrasts. 
The primary efficacy analysis will be presented on both the ITT and PP populations. 
6.6.2 
Secondary Efficacy Analysis 
The secondary efficacy endpoints will include: 
• IGA score of ‘clear’ or ‘almost clear’ at weeks 2, 4, 8, and 12. 
• Percent change from Baseline in mPASI at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Percent BSA affected at weeks 2, 4, 6, 8, and 12. 
• IGA score of ‘clear’ or ‘almost clear’ PLUS a 2-grade improvement from Baseline at 
weeks 2, 4, 6, 8 and 12. 
• For subjects with intertriginous area involvement, and with severity of the 
intertriginous lesions at least ‘mild’ (I-IGA≥2) at Baseline, ‘I-IGA’ score of ‘clear’ or 
‘almost clear’ at weeks 2, 4, 6, 8 and 12. 
• For subjects with intertriginous area involvement, and with severity of the 
intertriginous lesions at least ‘mild’ (I-IGA≥2) at Baseline, ‘I-IGA’ score of ‘clear’ or 
‘almost clear’ and a 2-point improvement from Baseline at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in WI-NRS pruritus score at weeks 2, 4, 6, 8, and 12. 
• In subjects with WI-NRS pruritus score ≥ 6 at baseline, a 4-point reduction in WI-
NRS pruritus score at weeks 2, 4, 6, 8, and 12 as compared to Baseline. 
• Change from Baseline in Modified Psoriasis Area Severity Index-75 (mPASI-75) 
improvement at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Modified Psoriasis Area Severity Index-90 (mPASI-90) 
improvement at weeks 2, 4, 6, 8, and 12.  


 
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• Change from Baseline in Modified Psoriasis Area Severity Index-100 (mPASI-100) 
improvement at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Total PSD at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Itch-related Sleep Loss score at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in DLQI score at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in responses to the questions of PSD at weeks 2, 4, 6, 8, and 
12. 
Change from Baseline will be calculated by subtracting the score at Baseline from the post-
baseline score. Percent change from Baseline will be calculated by dividing change from 
Baseline by the Baseline score, multiplied by 100. 
The IGA, I-IGA, WI-NRS, and mPASI dichotomous endpoints will be analyzed with a logistic 
regression with a factor of treatment group and the respective Baseline score as a covariate. The 
remainder of the endpoints will be considered continuous and analyzed with an analysis of 
covariance with a factor of treatment group and the respective Baseline score as a covariate. 
Statistical comparisons between the active treatment arms and vehicle arm will be facilitated by 
using contrasts.  
The secondary efficacy analysis will be presented on both the ITT and PP populations. 
6.6.3 
Exploratory Efficacy Analysis 
There are two exploratory endpoints: 
• Change from Baseline in Fatigue NRS score at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in WPAI score at weeks 2, 4, 6, 8, and 12. 
Only descriptive statistics will be used to analyze these endpoints. Change from Baseline will be 
calculating by subtracting the score at Baseline from the post-baseline score. 
6.7 
Safety Evaluation 
The following analyses will be performed; however, no formal inferential statistics will be done 
on safety assessments. 
Descriptive statistics will be presented by visit and treatment group for quantitative safety data 
and frequency counts will be compiled for classification of qualitative safety data. Summaries of 
local tolerability will be presented by visit and treatment group. 


 
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6.7.1 
Extent of Exposure 
The extent of exposure to study drug in each treatment group will be summarized by total 
number of days of exposure, total number of applications, total amount of study drug used, 
number of missed applications, and number and percentage of subjects who are compliant. A 
subject will be considered compliant with the dosing regimen if the subject applied at least 80% 
of the expected number of applications while enrolled in the study and does not miss more than 3 
consecutive doses. 
Days of exposure = Date of last study application – Date of first study application + 1. 
The total number of applications is as follows: 
(Date of Last Application – Date of First Application + 1) – (Number of Days marked as missed 
dose on the Case Report Form (CRF)). 
The expected number of applications is as follows: 
Expected Date of Last Application – Date of Randomization + 1 
Where the Expected Date of Last Application is the date of the Week 12 visit or the date of the 
discontinuation visit for subjects who discontinue prior to Week 12.  
Compliance will be calculated as a percentage as 100 times the total number of applications 
divided by the expected number of applications. 
6.7.2 
Adverse Events 
All treatment-emergent AEs (TEAEs) occurring during the study will be recorded and classified 
on the basis of MedDRA terminology for the safety population. TEAEs are those AEs with an 
onset on or after the date of first study drug treatment. All AEs with incomplete onset date 
information will be considered treatment-emergent unless the available information indicates that 
this is not possible. All TEAEs will be summarized by treatment group, the number of subjects 
reporting TEAEs, system organ class, preferred term, severity, relationship, and seriousness. 
Each subject will be counted only once within a system organ class or a preferred term using the 
event with the greatest relationship and greatest severity. 
Comparisons between treatment groups will be made by tabulating the frequency of subjects 
with one or more TEAEs (classified into MedDRA terms) during the study.  
Serious AEs (SAEs) will be listed by subject. Treatment-emergent SAEs will be summarized by 
treatment group, severity, and relationship to study treatment.  


 
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All information pertaining to AEs noted during the study will be listed by subject, detailing the 
verbatim description given by the Investigator, preferred term, system organ class, start date, 
stop date, severity, action taken regarding study drug, corrective treatment, outcome, and drug 
relatedness. The event onset will also be shown relative (in number of days) to date of first 
application. In addition a listing of subjects who prematurely discontinue from the study due to 
AEs will also be provided. 
6.7.3 
Clinical Laboratory Evaluation 
Laboratory test results will be summarized by treatment group and visit as observed values and 
changes from Baseline using descriptive statistics. Additionally, shifts from Baseline to Week 4 
and Week 12 in laboratory test results based on normal ranges will be summarized with 
frequency counts and percentages.  
Individual laboratory test results, as well as abnormal laboratory results, will be presented in a 
by-subject listing. 
6.7.4 
Other Observations Related to Safety 
6.7.4.1 
Electrocardiogram Measurements 
Descriptive statistics of actual values and changes from baseline will be provided by treatment 
group and visit for the following ECG parameters: heart rate (HR), RR duration, QRS duration, 
PR duration, QT duration, QTc Interval, QTcB interval, QTcF interval. Investigator and 
cardiologist interpretation of the ECG will be summarized by counts and percentages. 
 
Individual ECG parameters, as well as interpretations, will be presented in a by-subject listing. 
6.7.4.2 
Vital Signs 
Descriptive statistics of actual values and changes from baseline will be provided by treatment 
group and visit for the following parameters: temperature, systolic blood pressure, diastolic 
blood pressure, heart rate, and weight. Additionally, counts and percentages of subjects who gain 
or lose > 5% body weight will be summarized by visit in a table.  
6.7.4.3 
Physical Examination 
Abnormal physical examination findings will recorded as AEs and included in the AE 
summaries.   


 
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6.7.4.4 
Medical History 
Medical history for all subjects will be presented in a by-subject listing.  
6.7.4.5 
Local Tolerance Assessments 
For the investigator’s assessment and subject local tolerability assessment of sensation following 
drug application, the numeric application site reaction scores will be summarized individually by 
using number and percentage of subjects by visit. In addition, a by-subject listing of investigator 
and subject assessments will be provided. 
6.7.4.6 
Patient Health Questionnaire Depression Scale 
The PHQ-8 will be analyzed by a shift in state of severity using the following scoring system: 
• None – Minimal depression (0 to 4) 
• Mild depression (5 to 9) 
• Moderate depression (10 to 14) 
• Moderately severe depression (15 to 19) 
• Severe depression (20 to 24) 
In addition, a by-subject listing of results will be provided. 
6.7.4.7 
Columbia-Suicide Severity Rating Scale  
The C-SSRS will be analyzed per the C-SSRS Scoring and Data Analysis Guide (Nilsson 2013).  
6.7.4.8 
Prior and Concomitant Medications 
Prior and concomitant medication information for all randomized subjects will be presented in a 
by-subject listing. Summary tables will be presented by World Health Organization-Anatomical 
Therapeutic Chemical Classification System (WHO-ATC) therapeutic category and product. 
6.8 
Other Evaluations 
6.8.1 
Pharmacokinetic Evaluation 
Plasma drug concentrations at pre-dose will be summarized using descriptive statistics, reporting 
n, mean, standard deviation, median, minimum, and maximum. 


 
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7. DETERMINATION OF SAMPLE SIZE 
The sample size was not powered based on data for the primary endpoint to provide statistical 
significance because of the absence of previous primary endpoint data. However, based on 
efficacy data from the Phase 1/2a study, this Phase 2b study is expected to provide reliable 
information regarding the efficacy and safety of the drug products. 
8. CHANGES IN THE PLANNED ANALYSES 
The Per-Protocol population was updated to exclude subjects with more than three consecutive 
missed doses in order to fully capture compliant subjects. 
A covariate of the respective Baseline score was added to the models used for analysis of the 
primary and secondary endpoints.  
A secondary efficacy analysis endpoint of ‘clear’ or ‘almost clear’ plus a 2-point improvement 
from Baseline for Intertriginous Investigator Global Assessment (I-IGA) at weeks 2, 4, 6, 8, and 
12 was added. 
 
A secondary efficacy analysis endpoint for change from Baseline in Modified Psoriasis Area 
Severity Index-100 (mPASI-100) at weeks 2, 4, 6, 8, and 12 was added. 
 
Week 2 was added to all secondary and exploratory efficacy endpoints. 
9. REFERENCES 
Brion DE, Raynaud F, Plet A, Laurent P, Leduc B, and Anderson W. Deficiency of cyclic 
AMP-dependent protein kinases in human psoriasis. Proc. Natl. Acad. Sci. 1986; 83:5272-5276. 
 
Hatzelmann A, Morcillo EJ, Lungarella G, Adnot S, Sanjar S, Beume R, et al. The preclinical 
pharmacology of roflumilast – a selective, oral phosphodiesterase 4 inhibitor in development for 
chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2010; 23:235–256. 
 
Nilsson M, Suryawanshi S, Gassmann-Mayer C, Dubrava S, McSorley P, and Jiang K. 
Columbia–Suicide Severity Rating Scale Scoring and Data Analysis Guide. Version 2. 2013 


 
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10. INDEX OF PLANNED TABLES 
Table 14.0.1: Summary of Subject Enrollment and Evaluability ..................................................29 
Table 14.0.2: Summary of Subject Completion/Discontinuation (Randomized Subjects) ...........30 
Table 14.1.1.1: Summary of Subject Demographics (Intent-to-Treat Population) ........................31 
Table 14.1.1.2: Summary of Subject Demographics (Per-Protocol Population) ...........................31 
Table 14.1.1.3: Summary of Subject Demographics (Safety Population) .....................................31 
Table 14.1.1.4: Summary of Subject Demographics (PK Population) ..........................................31 
Table 14.1.2.1: Summary of Subject Baseline Characteristics (Intent-to-Treat Population) ........32 
Table 14.1.2.2: Summary of Subject Baseline Characteristics (Per-Protocol Population) ............34 
Table 14.1.2.3: Summary of Subject Baseline Characteristics (Safety Population) ......................34 
Table 14.1.2.4: Summary of Subject Baseline Characteristics (PK Population) ...........................34 
Table 14.1.3: Summary of Medical History by MedDRA System Organ Class and Preferred 
Term (Safety Population) ...............................................................................................................35 
Table 14.1.4.1: Summary of Prior Medications by WHO-DD ATC Level 2 Term and Preferred 
Name  (Safety Population) .............................................................................................................36 
Table 14.1.4.2: Summary of Concomitant Medications by WHO-DD ATC Level 2 Term and 
Preferred Name  (Safety Population) .............................................................................................37 
Table 14.2.1.1: Analysis of Primary Efficacy Endpoint: Investigator Global Assessment (IGA) 
Score of ‘Clear’ or ‘Almost Clear’ at Week 6 (Intent-to-Treat Population) ..................................38 
Table 14.2.1.2: Analysis of Primary Efficacy Endpoint: Investigator Global Assessment (IGA) 
Score of ‘Clear’ or ‘Almost Clear’ at Week 6 (Per-Protocol Population) .....................................38 
Figure 14.2.1.1:  Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ by 
Visit (Intent-to-Treat Population) ..................................................................................................39 
Figure 14.2.1.2: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ by 
Visit (Per-Protocol Population)......................................................................................................39 
Table 14.2.2.1: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) 
Score of ‘Clear’ or ‘Almost Clear’  (Intent-to-Treat Population) ..................................................40 
Table 14.2.2.2: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) 
Score of ‘Clear’ or ‘Almost Clear’ (Per-Protocol Population) ......................................................40 
Table 14.2.3.1: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) 
Score of ‘Clear’ or ‘Almost Clear’ Plus a 2-Grade Improvement from Baseline (Intent-to-
Treat Population) ...........................................................................................................................41 


 
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Table 14.2.3.2: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) 
Score of ‘Clear’ or ‘Almost Clear’ Plus a 2-Grade Improvement from Baseline (Per-
Protocol Population) ......................................................................................................................41 
Figure 14.2.3.1:  Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ Plus 
a 2-Grade Improvement from Baseline by Visit (Intent-to-Treat Population) ..............................42 
Figure 14.2.3.2: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ Plus a 
2-Grade Improvement from Baseline by Visit (Per-Protocol Population) ....................................42 
Table 14.2.3.3: Summary of Proportion of Subjects Achieving an Investigator Global 
Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ Plus a 2-Grade Improvement from 
Baseline by Investigational Site (Intent-to-Treat Population) .......................................................43 
Table 14.2.4.1.1: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area 
Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline who Achieved a 
Score of ‘Clear’ or ‘Almost Clear’ (Intent-to-Treat Population: Subjects with I-IGA Severity of 
at Least ‘Mild’ at Baseline)............................................................................................................44 
Table 14.2.4.1.2: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area 
Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline who Achieved a 
Score of ‘Clear’ or ‘Almost Clear’ (Per-Protocol Population: Subjects with I-IGA Severity of at 
Least ‘Mild’ at Baseline) ...............................................................................................................45 
Figure 14.2.4.1.1:  Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) 
Severity of at Least ‘Mild’ at Baseline  who Achieved a Score of ‘Clear’ or ‘Almost Clear’  
(Intent-to-Treat Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) ..........46 
Figure 14.2.4.1.2: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) 
Severity of at Least ‘Mild’ at Baseline who Achieved a Score of ‘Clear’ or ‘Almost Clear’ (Per-
Protocol Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) .....................47 
Table 14.2.4.2.1: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area 
Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline who Achieved a 
Score of ‘Clear’ or ‘Almost Clear’ Plus a 2 Grade Improvement from Baseline (Intent-to-
Treat Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline)...........................48 
Table 14.2.4.2.2: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area 
Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline who Achieved a 
Score of ‘Clear’ or ‘Almost Clear’ Plus a 2 Grade Improvement from Baseline (Per-
Protocol Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) .....................49 
Figure 14.2.4.2.1:  Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) 
Severity of at Least ‘Mild’ at Baseline who Achieved a Score of ‘Clear’ or ‘Almost Clear’ Plus a 
2 Grade Improvement from Baseline (Intent-to-Treat Population: Subjects with I-IGA Severity 
of at Least ‘Mild’ at Baseline) .......................................................................................................50 
Figure 14.2.4.2.2: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) 
Severity of at Least ‘Mild’ at Baseline who Achieved a Score of ‘Clear’ or ‘Almost Clear’ Plus a 


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2 Grade Improvement from Baseline (Per-Protocol Population: Subjects with I-IGA Severity of 
at Least ‘Mild’ at Baseline)............................................................................................................51 
Table 14.2.5.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in 
Modified Psoriasis Area and Severity Index (mPASI) (Intent-to-Treat Population) ....................52 
Table 14.2.5.2: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in 
Modified Psoriasis Area and Severity Index (mPASI) (Per-Protocol Population) ........................57 
Figure 14.2.5.1:  Percent Change from Baseline in Modified Psoriasis Area and Severity Index 
(mPASI) (Intent-to-Treat Population)............................................................................................58 
Table 14.2.6.1: Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline (Intent-to-
Treat Population) ...........................................................................................................................59 
Table 14.2.6.1: Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline (Intent-to-
Treat Population) ...........................................................................................................................60 
Table 14.2.6.1: Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline (Intent-to-
Treat Population) ...........................................................................................................................61 
Table 14.2.6.2 Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline  (Per-
Protocol Population) ......................................................................................................................61 
Table 14.2.7.1: Dichotomized Percent Reductions in Modified Psoriasis Area and Severity Index 
(mPASI) Compared to Baseline (Intent-to-Treat Population) .......................................................62 
Table 14.2.7.2: Dichotomized Percent Reduction(s) in Modified Psoriasis Area and Severity 
Index (mPASI) Compared to Baseline (Per-Protocol Population) ................................................64 
Table 14.2.8.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in 
Body Surface Area (BSA) Affected (Intent-to-Treat Population) .................................................65 
Table 14.2.8.2: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in 
Body Surface Area (BSA) Affected (Per-Protocol Population) ....................................................70 
Table 14.2.9.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch 
Numerical Rating Scale (WI-NRS) Pruritus Score  (Intent-to-Treat Population) .........................71 
Table 14.2.9.2: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch 
Numerical Rating Scale (WI-NRS) Pruritus Score (Per-Protocol Population) .............................75 
Table 14.2.10.1.1: Analysis of Secondary Endpoint: Subjects with a Worst Itch Numerical 
Rating Scale (WI-NRS) Score ≥ 6 at Baseline and Achieved a 4 Point Reduction Compared to 
Baseline (Intent-to-Treat Population: Subjects with WI-NRS Score ≥ 6 at Baseline) ..................76 


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Table 14.2.10.1.2: Analysis of Secondary Endpoint: Subjects with a Worst Itch Numerical 
Rating Scale (WI-NRS) Score ≥ 6 at Baseline and Achieved a 4 Point Reduction Compared to 
Baseline (Per-Protocol Population: Subjects with WI-NRS Score ≥ 6 at Baseline) ......................77 
Table 14.2.10.2.1: Summary of Subjects with a Worst Itch Numerical Rating Scale (WI-NRS) 
Score ≥ 6 at Baseline and Achieved a 4 Point Reduction Compared to Baseline (Intent-to-
Treat Population: Subjects with WI-NRS Score ≥ 6 at Baseline) .................................................78 
Table 14.2.10.2.2: Summary of Subjects with a Worst Itch Numerical Rating Scale (WI-NRS) 
Score ≥ 6 at Baseline and Achieved a 4 Point Reduction Compared to Baseline (Per-
Protocol Population: Subjects with WI-NRS Score ≥ 6 at Baseline) ............................................78 
Table 14.2.11.1: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary 
(PSD) Score Compared to Baseline (Intent-to-Treat Population) .................................................79 
Table 14.2.11.2: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary 
(PSD) Score Compared to Baseline (Per-Protocol Population) .....................................................84 
Table 14.2.12.1: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom 
Diary (PSD) Responses Compared to Baseline (Intent-to-Treat Population) ...............................85 
Table 14.2.12.2: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom 
Diary (PSD) Responses Compared to Baseline (Per-Protocol Population) ...................................90 
Table 14.2.13.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-Related 
Sleep Loss Score (Intent-to-Treat Population) .................................................................91 
Table 14.2.13.2: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-
Related Sleep Loss Score (Per-Protocol Population) .....................................................................95 
Table 14.2.14.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in 
Dermatology Life Quality Index (DLQI) Score (Intent-to-Treat Population) ...............................96 
Table 14.2.14.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in 
Dermatology Life Quality Index (DLQI) Score (Intent-to-Treat Population) ...............................97 
Table 14.2.14.2: Analysis of Secondary Efficacy Endpoint: Change from Baseline in 
Dermatology Life Quality Index (DLQI) Score (Per-Protocol Population) ................................100 
Table 14.2.15.1: Summary of Exploratory Endpoint: Change from Baseline in Fatigue NRS 
Score (Intent-to-Treat Population) ...............................................................................................101 
Table 14.2.15.2: Summary of Exploratory Endpoint: Change from Baseline in Fatigue NRS 
Score (Per-Protocol Population) ..................................................................................................104 
Table 14.2.16.1: Summary of Exploratory Endpoint: Change from Baseline in Work Productivity 
and Activity Impairment (WPAI) Score (Intent-to-Treat Population) ........................................105 
Table 14.2.16.2: Summary of Exploratory Endpoint: Change from Baseline in Work Productivity 
and Activity Impairment (WPAI) Score  (Per-Protocol Population) ...........................................108 


 
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Table 14.2.17.1: Summary of Whole Body Investigator Global Assessment (IGA) (Intent-to-
Treat Population) .........................................................................................................................109 
Table 14.2.17.2: Summary of Whole Body Investigator Global Assessment (IGA) (Per-
Protocol Population) ....................................................................................................................114 
Table 14.2.18.1: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) 
(Intent-to-Treat Population) .........................................................................................................115 
Table 14.2.18.2: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) (Per-
Protocol Population) ....................................................................................................................120 
Table 14.3.0.1.1: Summary of Extent of Exposure (Safety Population) .....................................121 
Table 14.3.0.2.1: Summary of Pre-Dose Pharmacokinetic Concentrations  (PK Population) ....122 
Table 14.3.0.2.2: Summary of Additional Pharmacokinetic Concentrations  (PK Population) ..124 
Table 14.3.1.1: Summary of Local Tolerability  (Safety Population) .........................................125 
Figure 14.3.1.1: Subject Local Tolerability Sensation Following Drug Application (Safety 
Population) ...................................................................................................................................129 
Table 14.3.1.2.1: Number of Patients with Suicidal Ideation, Suicidal Behavior, and Self-
Injurious Behavior without Suicidal Intent Based on the Colombia-Suicide Severity Rating Scale 
(C-SSRS) During Treatment (Safety Population)........................................................................130 
Table 14.3.1.2.2: Number of Patients with Suicide-Related Treatment-Emergent Events Based on 
the Colombia-Suicide Severity Rating Scale (C-SSRS) During Treatment (Safety Population) 131 
Table 14.3.1.3.1: Summary of PHQ-8 Assessments by Treatment Group (Safety Population) ..132 
Table 14.3.1.3.2: Shift Summary of PHQ-8 Assessments by Treatment Group 
(Safety Population) ......................................................................................................................133 
Table 14.3.1.4.1: Overall Summary of Treatment-Emergent Adverse Event Characteristics 
(Safety Population) ......................................................................................................................136 
Table 14.3.1.4.2: Summary of Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (Safety Population) ............................................................................137 
Table 14.3.1.4.3: Summary of Treatment-Emergent Adverse Events Leading to Discontinuation 
of Study Drug by MedDRA System Organ Class and Preferred Term (Safety Population) .......138 
Table 14.3.1.4.4: Summary of Subjects Reporting Treatment-Emergent Adverse Events (TEAEs) 
by Severity (Safety Population) ...................................................................................................139 
Table 14.3.1.4.5: Summary of Subjects Reporting Treatment-Emergent Adverse Events (TEAEs) 
by Relationship to Study Drug (Safety Population) ....................................................................140 
Table 14.3.1.4.6: Summary of Treatment-Emergent Serious Adverse Event Characteristics 
(Safety Population) ......................................................................................................................141 


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Table 14.3.1.4.7: Summary of Subjects Reporting Serious Treatment-Emergent Adverse Events 
(TEAEs) by MedDRA System Organ Class and Preferred Term (Safety Population) ...............142 
Table 14.3.1.4.8: Summary of Subjects Reporting Serious Treatment-Emergent Adverse Events 
(TEAEs) by Severity (Safety Population)....................................................................................143 
Table 14.3.1.4.9: Summary of Subjects Reporting Serious Treatment-Emergent Adverse Events 
(TEAEs) by Relationship to Study Drug (Safety Population) .....................................................144 
Table 14.3.1.5.1.1: Summary of Chemistry Laboratory Results  (Safety Population) ................145 
Table 14.3.1.5.1.2: Summary of Hematology Laboratory Results (Safety Population) ..............146 
Table 14.3.1.5.1.3: Summary of Quantitative Urinalysis Laboratory Results (Safety Population)146 
Table 14.3.1.5.2.1: Shift Summary of Chemistry Laboratory Results (Safety Population) ........147 
Table 14.3.1.5.2.2: Shift Summary of Hematology Laboratory Results (Safety Population) .....147 
Table 14.3.1.5.2.3: Shift Summary of Quantitative Urinalysis Laboratory Results (Safety 
Population) ...................................................................................................................................147 
Table 14.3.1.6.1: Summary of Electrocardiogram (ECG) Parameters  (Safety Population) .......148 
Table 14.3.1.6.2: Shift Summary of Overall Electrocardiogram (ECG) Assessments 
(Safety Population) ......................................................................................................................150 
Table 14.3.1.7.1: Summary of Vital Signs  (Safety Population) .................................................151 
Table 14.3.1.7.2: Summary of Change in Body Weight Compared to Baseline 
(Safety Population) ......................................................................................................................155 


 
 
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Table 14.0.1: Summary of Subject Enrollment and Evaluability 
 
 
ARQ-151 Cream 0.3% 
  
ARQ-151 Cream 0.15% 
  
Vehicle Cream 
 
Number of Subjects in the ITT Population 
xx  
xx  
xx  
Number of Subjects Included from the Safety Population 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Subjects Excluded in the Safety Population 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Reason for Exclusion from the Safety Population  
   No Post-Baseline Safety Assessment 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Subjects Included from the PP Population 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Subjects Excluded in the PP Population 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Reason for Exclusion from the PP Population  
   Less than 80% Compliant 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
   Missed 3 or More Consecutive Doses 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
   Other Serious Protocol Violations 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Subjects Included from the PK Population 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Subjects Excluded in the PK Population 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
   No Evidence of Dosing with Study Drug 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
   Insufficient Plasma Concentrations 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
Note: ITT population includes all randomized subjects. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
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Table 14.0.2: Summary of Subject Completion/Discontinuation 
(Randomized Subjects) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Completed Study 
Yes 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
No 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Reason for Discontinuation 
Adverse Event 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Lost to Follow-Up 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Pregnancy 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Protocol Deviation 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Withdrawal by Subject 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Study Terminated by Sponsor 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Physician Decision 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Lack of Efficacy 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Other 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 
 
 


 
 
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Table 14.1.1.1: Summary of Subject Demographics 
(Intent-to-Treat Population) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Age (years) 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Sex 
N 
xx 
xx 
xx 
Male 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Female 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Ethnicity 
N 
xx 
xx 
xx 
Hispanic or Latino 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Not Hispanic or Latino 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Race 
N 
xx 
xx 
xx 
American Indian or Alaska Native 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Asian 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Black or African American 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Native Hawaiian or Other Pacific Islander 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
White 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Multiple/Other 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.1.1.1 for the following:  
Table 14.1.1.2: Summary of Subject Demographics (Per-Protocol Population) 
Table 14.1.1.3: Summary of Subject Demographics (Safety Population) 
Table 14.1.1.4: Summary of Subject Demographics (PK Population) 
 


 
 
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Table 14.1.2.1: Summary of Subject Baseline Characteristics 
(Intent-to-Treat Population) 
(Page 1 of 3) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Whole Body Investigator Global Assessment Score 
  N 
                           xx  
                           xx  
                           xx  
  0 – Clear  
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  1 – Almost Clear 
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  2 – Mild 
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  3 – Moderate  
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  4 – Severe    
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
Intertriginous Area Investigator Global Assessment Scorea 
  N 
                           xx  
                           xx  
                           xx  
  0 – Clear  
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  1 – Almost Clear 
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  2 – Mild 
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  3 – Moderate  
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  4 – Severe   
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
Itch-Related Sleep Loss Score 
 
 
 
  N 
              xx 
              xx 
              xx 
  Mean 
           xx.x 
           xx.x 
           xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a Collected for subjects with intertriginous involvement. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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Table 14.1.2.1: Summary of Subject Baseline Characteristics 
(Intent-to-Treat Population) 
(Page 2 of 3) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Body Surface Area (%) Affected by Psoriasis 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
mPASI 
n 
xx 
xx 
Xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
     xx.x 
      xx.x 
      xx.x 
  Min. to Max. 
                 xx to xx 
            
xx to xx                                      xx to xx 
WI-NRS Score 
n 
xx 
xx 
Xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
 
xx.x 
 
xx.x 
 
xx.x 
Min. to Max. 
 xx to xx 
 xx to xx 
 xx to xx 
 
 
 
Total Psoriasis Symptom Diary (PSD) Score  
 
 
 
n 
 
xx 
 
xx 
 
Xx 
Mean 
 
xx.x 
 
xx.x 
 
xx.x 
SD 
 
xx.xx 
 
xx.xx 
 
xx.xx 
Median 
 
xx.x 
 
xx.x 
 
xx.x 
Min. to Max. 
 xx to xx 
 xx to xx 
 xx to xx 
 
 
a Collected for subjects with intertriginous involvement. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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Table 14.1.2.1: Summary of Subject Baseline Characteristics 
(Intent-to-Treat Population) 
(Page 3 of 3) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Dermatology Life Quality Index (DLQI) Score 
 
 
 
n 
 
xx 
 
xx 
 
Xx 
Mean 
 
xx.x 
 
xx.x 
 
xx.x 
SD 
 
xx.xx 
 
xx.xx 
 
xx.xx 
Median 
 
xx.x 
 
xx.x 
 
xx.x 
Min. to Max. 
 xx to xx 
 xx to xx 
 xx to xx 
 
 
 
Height (cm) 
 
 
 
n 
 
xx 
 
xx 
 
Xx 
Mean 
 
xx.x 
 
xx.x 
 
xx.x 
SD 
 
xx.xx 
 
xx.xx 
 
xx.xx 
Median 
 
xx.x 
 
xx.x 
 
xx.x 
Min. to Max. 
 xx to xx 
 xx to xx 
 xx to xx 
 
 
 
Weight (kg) 
 
 
 
n 
 
xx 
 
xx 
 
Xx 
Mean 
 
xx.x 
 
xx.x 
 
xx.x 
SD 
 
xx.xx 
 
xx.xx 
 
xx.xx 
Median 
 
xx.x 
 
xx.x 
 
xx.x 
  Min. to Max. 
 xx to xx 
 xx to xx 
 xx to xx 
 
 
a Collected for subjects with intertriginous involvement. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.1.2.1 for the following:  
Table 14.1.2.2: Summary of Subject Baseline Characteristics (Per-Protocol Population) 
Table 14.1.2.3: Summary of Subject Baseline Characteristics (Safety Population) 
Table 14.1.2.4: Summary of Subject Baseline Characteristics (PK Population) 
 
 


 
 
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Table 14.1.3: Summary of Medical History by MedDRA System Organ Class and Preferred Term 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term  
 
ARQ-151 Cream 0.3% 
 
(N=xxx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xxx) 
 
 
Vehicle Cream 
 
(N=xxx) 
 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more medical histories that map to the MedDRA dictionary (Version 21.1). At each level      
   of summarization (System Organ Class or Preferred Term) subjects are counted once.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
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Table 14.1.4.1: Summary of Prior Medications by WHO-DD ATC Level 2 Term and Preferred Name 
 (Safety Population) 
(Page 1 of xx) 
  
ATC Level 2 Terma 
Preferred Name 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
ATC Level 2 Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
ATC Level 2 Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more prior medications that map to the WHO-DD (Version March 1, 2018). At each level of  
  summarization (ATC Level 2 Term or Preferred Name) subjects are counted once. 
Note: Table includes all medications used prior to date of first dose of study drug.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.1.4.2: Summary of Concomitant Medications by WHO-DD ATC Level 2 Term and Preferred Name 
 (Safety Population) 
(Page 1 of xx) 
  
ATC Level 2 Terma 
Preferred Name 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
ATC Level 2 Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
ATC Level 2 Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more concomitant medications that map to the WHO-DD (Version March 1, 2018). At each level of  
  summarization (ATC Level 2 Term or Preferred Name) subjects are counted once.  
Note: Table includes all medications used on or after date of first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
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Table 14.2.1.1: Analysis of Primary Efficacy Endpoint: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ at Week 6 
(Intent-to-Treat Population) 
  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
IGA Score of Clear or Almost Clear at Week 6 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream  
x.xxx 
x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline IGA score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.1.1 for the following:  
Table 14.2.1.2: Analysis of Primary Efficacy Endpoint: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ at Week 6 (Per-
Protocol Population) 
 
 
 
 
 
 
 
 
 
 


 
 
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Figure 14.2.1.1:  Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ by Visit 
(Intent-to-Treat Population) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_________________________________________________________________________________________________________________________________ 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
Repeat Figure 14.2.1.1 for the following:  
Figure 14.2.1.2: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ by Visit (Per-Protocol Population) 
 


 
 
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Table 14.2.2.1: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’  
(Intent-to-Treat Population) 
  
IGA Score of Clear or Almost Clear 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 4 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
Week 8 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 12 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline IGA score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.2.1 for the following:  
Table 14.2.2.2: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ (Per-Protocol Population) 
 
 
 
 
 


 
 
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Table 14.2.3.1: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) 
Score of ‘Clear’ or ‘Almost Clear’ Plus a 2-Grade Improvement from Baseline 
(Intent-to-Treat Population) 
  
IGA Score of Clear or Almost Clear  
Plus a 2-Grade Improvement from Baseline 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
Success 
                         xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                         xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                          x.xxx 
                         x.xxx 
Week 4 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 6 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 8 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 12 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline IGA score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
Repeat Table 14.2.3.1 for the following: 
Table 14.2.3.2: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ Plus a 2-Grade Improvement 
from Baseline (Per-Protocol Population) 
 
 


 
 
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Figure 14.2.3.1:  Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ Plus a 2-Grade Improvement from Baseline by Visit 
(Intent-to-Treat Population) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_________________________________________________________________________________________________________________________________ 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
Repeat Figure 14.2.3.1 for the following:  
Figure 14.2.3.2: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ Plus a 2-Grade Improvement from Baseline by Visit (Per-
Protocol Population) 
 


 
 
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Table 14.2.3.3: Summary of Proportion of Subjects Achieving an Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ 
Plus a 2-Grade Improvement from Baseline by Investigational Site 
(Intent-to-Treat Population) 
  
Investigational Site 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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Table 14.2.4.1.1: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least 
‘Mild’ at Baseline who Achieved a Score of ‘Clear’ or ‘Almost Clear’ 
(Intent-to-Treat Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) 
  
I-IGA Score of Clear or Almost Clear Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
Week 4 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 6 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 8 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 12 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                          x.xxx 
                          x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline I-IGA score. 
         Restricted to subjects with an I-IGA severity score of at least “Mild” at baseline. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Repeat Table 14.2.4.1.1 for the following:  
Table 14.2.4.1.2: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least 
‘Mild’ at Baseline who Achieved a Score of ‘Clear’ or ‘Almost Clear’ (Per-Protocol Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Figure 14.2.4.1.1:  Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline 
 who Achieved a Score of ‘Clear’ or ‘Almost Clear’  
(Intent-to-Treat Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_________________________________________________________________________________________________________________________________ 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Repeat Figure 14.2.4.1.1 for the following:  
Figure 14.2.4.1.2: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline who Achieved a Score of 
‘Clear’ or ‘Almost Clear’ (Per-Protocol Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.4.2.1: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least 
‘Mild’ at Baseline who Achieved a Score of ‘Clear’ or ‘Almost Clear’ Plus a 2 Grade Improvement from Baseline 
(Intent-to-Treat Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) 
  
I-IGA Score of Clear or Almost Clear Plus a 2 Grade 
Improvement from Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
Week 4 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 6 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 8 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 12 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                          x.xxx 
                          x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline I-IGA score. 
         Restricted to subjects with an I-IGA severity score of at least “Mild” at baseline. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Repeat Table 14.2.4.2.1 for the following:  
Table 14.2.4.2.2: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least 
‘Mild’ at Baseline who Achieved a Score of ‘Clear’ or ‘Almost Clear’ Plus a 2 Grade Improvement from Baseline (Per-Protocol Population: Subjects with I-IGA 
Severity of at Least ‘Mild’ at Baseline) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Figure 14.2.4.2.1:  Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline who Achieved a Score of 
‘Clear’ or ‘Almost Clear’ Plus a 2 Grade Improvement from Baseline 
(Intent-to-Treat Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_________________________________________________________________________________________________________________________________ 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Repeat Figure 14.2.4.2.1 for the following:  
Figure 14.2.4.2.2: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline who Achieved a Score of 
‘Clear’ or ‘Almost Clear’ Plus a 2 Grade Improvement from Baseline (Per-Protocol Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.5.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI) 
(Intent-to-Treat Population) 
(Page 1 of 6) 
  
mPASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline mPASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Table 14.2.5.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI)  
(Intent-to-Treat Population) 
(Page 2 of 6) 
  
mPASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline mPASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.5.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI) 
(Intent-to-Treat Population) 
(Page 3 of 6) 
  
mPASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline mPASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Table 14.2.5.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI) 
(Intent-to-Treat Population) 
(Page 4 of 6) 
  
mPASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline mPASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.5.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI) 
(Intent-to-Treat Population) 
(Page 5 of 6) 
  
mPASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline mPASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.5.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI) 
(Intent-to-Treat Population) 
(Page 6 of 6) 
  
mPASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline mPASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
Repeat Table 14.2.5.1 for the following:  
Table 14.2.5.2: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI) (Per-
Protocol Population) 
 
 


 
 
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CONFIDENTIAL 
 
Figure 14.2.5.1:  Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI) 
(Intent-to-Treat Population) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_________________________________________________________________________________________________________________________________ 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.6.1: Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 1 of  3) 
  
Reduction in mPASI Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
Week 4 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline mPASI score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.6.1: Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 2 of  3) 
  
Reduction in mPASI Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
Week 8 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline mPASI score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.6.1: Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 3 of  3) 
  
Reduction in mPASI Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline mPASI score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.6.1 for the following:  
Table 14.2.6.2 Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in Modified Psoriasis Area and Severity Index (mPASI) Compared 
to Baseline  (Per-Protocol Population) 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Table 14.2.7.1: Dichotomized Percent Reductions in Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 1 of 3) 
  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
75% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
  100% Reduction in mPASI Compared to Baseline 
   Success  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   Failure 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
Week 4 
75% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in mPASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.7.1: Dichotomized Percent Reductions in Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 2 of 3) 
  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
75% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in mPASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Week 8 
75% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in mPASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.2.7.1: Dichotomized Percent Reductions in Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 3 of 3) 
  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
75% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in mPASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Week 16 
 
 
 
75% Reduction in mPASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
90% Reduction in mPASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in mPASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
Repeat Table 14.2.7.1 for the following: 
Table 14.2.7.2: Dichotomized Percent Reduction(s) in Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline (Per-Protocol Population) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.8.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Body Surface Area (BSA) Affected 
(Intent-to-Treat Population) 
(Page 1 of 6) 
  
BSA 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline BSA score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.8.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Body Surface Area (BSA) Affected 
(Intent-to-Treat Population) 
(Page 2 of 6) 
  
BSA 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline BSA score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.8.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Body Surface Area (BSA) Affected 
(Intent-to-Treat Population) 
(Page 3 of 6) 
  
BSA 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline BSA score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.8.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Body Surface Area (BSA) Affected 
(Intent-to-Treat Population) 
(Page 4 of 6) 
  
BSA 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline BSA score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.8.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Body Surface Area (BSA) Affected 
(Intent-to-Treat Population) 
(Page 5 of 6) 
  
BSA 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline BSA score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.8.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Body Surface Area (BSA) Affected 
(Intent-to-Treat Population) 
(Page 6 of 6) 
  
BSA 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline BSA score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.8.1 for the following:  
Table 14.2.8.2: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Body Surface Area (BSA) Affected (Per-Protocol Population) 
 
 


 
 
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CONFIDENTIAL 
Table 14.2.9.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score  
(Intent-to-Treat Population) 
(Page 1 of 5) 
  
WI-NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.9.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score 
(Intent-to-Treat Population) 
(Page 2 of 5) 
  
WI-NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.9.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score 
(Intent-to-Treat Population) 
(Page 3 of 5) 
  
WI-NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.9.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score 
(Intent-to-Treat Population) 
(Page 4 of 5) 
  
WI-NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.9.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score 
(Intent-to-Treat Population) 
(Page 5 of 5) 
  
WI-NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.9.1 for the following:  
Table 14.2.9.2: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score (Per-
Protocol Population) 
 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.2.10.1.1: Analysis of Secondary Endpoint: Subjects with a Worst Itch Numerical Rating Scale (WI-NRS) Score ≥ 6 at Baseline and Achieved a 4 Point 
Reduction Compared to Baseline 
(Intent-to-Treat Population: Subjects with WI-NRS Score ≥ 6 at Baseline) 
  
4 Point Reduction in WI-NRS Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 4 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 6 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 8 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 12 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score. 
         Restricted to subjects with a baseline WI-NRS Score of 6 or greater.  
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Repeat Table 14.2.10.1.1 for the following:  
Table 14.2.10.1.2: Analysis of Secondary Endpoint: Subjects with a Worst Itch Numerical Rating Scale (WI-NRS) Score ≥ 6 at Baseline and Achieved a 4 Point 
Reduction Compared to Baseline (Per-Protocol Population: Subjects with WI-NRS Score ≥ 6 at Baseline) 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.10.2.1: Summary of Subjects with a Worst Itch Numerical Rating Scale (WI-NRS) Score ≥ 6 at Baseline and Achieved a 4 Point Reduction 
Compared to Baseline 
(Intent-to-Treat Population: Subjects with WI-NRS Score ≥ 6 at Baseline) 
  
4 Point Reduction in WI-NRS Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Week 4 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Week 6 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Week 8 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Week 12 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
        Restricted to subjects with a baseline WI-NRS Score of 6 or greater. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.10.2.1 for the following:  
Table 14.2.10.2.2: Summary of Subjects with a Worst Itch Numerical Rating Scale (WI-NRS) Score ≥ 6 at Baseline and Achieved a 4 Point Reduction Compared 
to Baseline (Per-Protocol Population: Subjects with WI-NRS Score ≥ 6 at Baseline) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.11.1: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary (PSD) Score Compared to Baseline 
(Intent-to-Treat Population) 
(Page 1 of 6) 
  
Total PSD Score 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.11.1: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary (PSD) Score Compared to Baseline 
(Intent-to-Treat Population) 
(Page 2 of 6) 
  
Total PSD Score 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.11.1: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary (PSD) Score Compared to Baseline 
(Intent-to-Treat Population) 
(Page 3 of 6) 
  
Total PSD Score 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.11.1: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary (PSD) Score Compared to Baseline 
(Intent-to-Treat Population) 
(Page 4 of 6) 
  
Total PSD Score 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.11.1: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary (PSD) Score Compared to Baseline 
(Intent-to-Treat Population) 
(Page 5 of 6) 
  
Total PSD Score 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.11.1: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary (PSD) Score Compared to Baseline 
(Intent-to-Treat Population) 
(Page 6 of 6) 
  
Total PSD Score 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.11.1 for the following:  
Table 14.2.11.2: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary (PSD) Score Compared to Baseline (Per-Protocol Population) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.12.1: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom Diary (PSD) Responses Compared to Baseline 
(Intent-to-Treat Population) 
(Page 1 of xx) 
  
PSD Responses to Individual Questions  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
<Question> 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD response. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
 
Table 14.2.12.1: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom Diary (PSD) Responses Compared to Baseline 
(Intent-to-Treat Population) 
(Page 2 of xx) 
  
PSD Responses to Individual Questions  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
<Question> 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD response. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.12.1: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom Diary (PSD) Responses Compared to Baseline 
(Intent-to-Treat Population) 
(Page 3 of xx) 
  
PSD Responses to Individual Questions  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
<Question> 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD response. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.12.1: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom Diary (PSD) Responses Compared to Baseline 
(Intent-to-Treat Population) 
(Page 4 of xx) 
  
PSD Responses to Individual Questions  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
<Question> 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD response. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.12.1: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom Diary (PSD) Responses Compared to Baseline 
(Intent-to-Treat Population) 
(Page 5 of xx) 
  
PSD Responses to Individual Questions  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
<Question> 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD response. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 90 of 202  
CONFIDENTIAL 
Table 14.2.12.1: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom Diary (PSD) Responses Compared to Baseline 
(Intent-to-Treat Population) 
(Page 6 of xx) 
  
PSD Responses to Individual Questions  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
<Question> 
Week 16 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD response. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.12.1 for the following:  
Table 14.2.12.2: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom Diary (PSD) Responses Compared to Baseline (Per-
Protocol Population) 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.13.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-Related Sleep Loss Score 
(Intent-to-Treat Population) 
(Page 1 of 5) 
  
Itch-Related Sleep Loss 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.13.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-Related Sleep Loss Score 
(Intent-to-Treat Population) 
(Page 2 of 5) 
  
Itch-Related Sleep Loss 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.13.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-Related Sleep Loss Score 
(Intent-to-Treat Population) 
(Page 3 of 5) 
  
Itch-Related Sleep Loss 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.13.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-Related Sleep Loss Score 
(Intent-to-Treat Population) 
(Page 4 of 5) 
  
Itch-Related Sleep Loss 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.13.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-Related Sleep Loss Score 
(Intent-to-Treat Population) 
(Page 5 of 5) 
  
Itch-Related Sleep Loss 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.13.1 for the following:  
Table 14.2.13.2: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-Related Sleep Loss Score (Per-Protocol Population) 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.14.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Dermatology Life Quality Index (DLQI) Score 
(Intent-to-Treat Population) 
(Page 1 of 5) 
  
DLQI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline DLQI score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.14.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Dermatology Life Quality Index (DLQI) Score 
(Intent-to-Treat Population) 
(Page 2 of 5) 
  
DLQI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline DLQI score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.14.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Dermatology Life Quality Index (DLQI) Score 
(Intent-to-Treat Population) 
(Page 3 of 5) 
  
DLQI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline DLQI score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.14.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Dermatology Life Quality Index (DLQI) Score 
(Intent-to-Treat Population) 
(Page 4 of 5) 
  
DLQI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline DLQI score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.14.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Dermatology Life Quality Index (DLQI) Score 
(Intent-to-Treat Population) 
(Page 5 of 5) 
  
DLQI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline DLQI score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
Repeat Table 14.2.14.1 for the following:  
Table 14.2.14.2: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Dermatology Life Quality Index (DLQI) Score (Per-Protocol Population) 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.15.1: Summary of Exploratory Endpoint: Change from Baseline in Fatigue NRS Score 
(Intent-to-Treat Population) 
(Page 1 of 3) 
  
NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.15.1: Summary of Exploratory Endpoint: Change from Baseline in Fatigue NRS Score 
(Intent-to-Treat Population) 
(Page 2 of 3) 
  
NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.15.1: Summary of Exploratory Endpoint: Change from Baseline in Fatigue NRS Score 
(Intent-to-Treat Population) 
(Page 3 of 3) 
  
NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
   Week 12 
       n 
xx 
xx 
xx 
       Mean 
xx.x 
xx.x 
xx.x 
       SD 
xx.xx 
xx.xx 
xx.xx 
       Median 
xx.x 
xx.x 
xx.x 
       Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
       Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 104 of 202  
CONFIDENTIAL 
Repeat Table 14.2.15.1 for the following:  
Table 14.2.15.2: Summary of Exploratory Endpoint: Change from Baseline in Fatigue NRS Score (Per-Protocol Population) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.16.1: Summary of Exploratory Endpoint: Change from Baseline in Work Productivity and Activity Impairment (WPAI) Score 
(Intent-to-Treat Population) 
(Page 1 of xx) 
  
<Score Type> 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 106 of 202  
CONFIDENTIAL 
Table 14.2.16.1: Summary of Exploratory Endpoint: Change from Baseline in Work Productivity and Activity Impairment (WPAI) Score 
(Intent-to-Treat Population) 
(Page 2 of xx) 
  
<Score Type> 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 107 of 202  
CONFIDENTIAL 
Table 14.2.16.1: Summary of Exploratory Endpoint: Change from Baseline in Work Productivity and Activity Impairment (WPAI) Score 
(Intent-to-Treat Population) 
(Page 3 of xx) 
  
<Score Type> 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
   Week 12 
       n 
xx 
xx 
xx 
       Mean 
xx.x 
xx.x 
xx.x 
       SD 
xx.xx 
xx.xx 
xx.xx 
       Median 
xx.x 
xx.x 
xx.x 
       Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
       Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 108 of 202  
CONFIDENTIAL 
Repeat Table 14.2.16.1 for the following:  
Table 14.2.16.2: Summary of Exploratory Endpoint: Change from Baseline in Work Productivity and Activity Impairment (WPAI) Score  (Per-
Protocol Population) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.17.1: Summary of Whole Body Investigator Global Assessment (IGA) 
(Intent-to-Treat Population) 
(Page 1 of 6) 
  
Whole Body Investigator Global Assessment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
               xx 
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Week 2 
n 
               xx  
               xx  
               xx  
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Score of Clear or Almost Clear 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baseline  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
        possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.17.1: Summary of Whole Body Investigator Global Assessment (IGA) 
(Intent-to-Treat Population) 
(Page 2 of 6) 
  
Whole Body Investigator Global Assessment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
               xx 
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baseline  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
        possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 111 of 202  
CONFIDENTIAL 
Table 14.2.17.1: Summary of Whole Body Investigator Global Assessment (IGA) 
(Intent-to-Treat Population) 
(Page 3 of 6) 
  
Whole Body Investigator Global Assessment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
n 
               xx 
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baseline  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
        possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
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Table 14.2.17.1: Summary of Whole Body Investigator Global Assessment (IGA) 
(Intent-to-Treat Population) 
(Page 4 of 6) 
  
Whole Body Investigator Global Assessment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
               xx 
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baseline  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
        possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
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Table 14.2.17.1: Summary of Whole Body Investigator Global Assessment (IGA) 
(Intent-to-Treat Population) 
(Page 5 of 6) 
  
Whole Body Investigator Global Assessment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
               xx 
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baseline  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
        possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 
 
 


 
 
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Table 14.2.17.1: Summary of Whole Body Investigator Global Assessment (IGA) 
(Intent-to-Treat Population) 
(Page 6 of 6) 
  
Whole Body Investigator Global Assessment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
n 
               xx 
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baseline  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
        possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.17.1 for the following:  
Table 14.2.17.2: Summary of Whole Body Investigator Global Assessment (IGA) (Per-Protocol Population) 
 
 


 
 
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Table 14.2.18.1: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) 
(Intent-to-Treat Population) 
(Page 1 of 6) 
  
Intertriginous Area Investigator Global Assessmenta 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
               xx 
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Week 2 
n 
               xx  
               xx  
               xx  
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Score of Clear or Almost Clearb 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baselineb  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
a Collected at baseline for subjects with intertriginous area involvement and collected post-baseline for subjects with a severity of at least mild at baseline. 
b Restricted to subjects with a severity of at least mild at baseline. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data was not imputed for Week 16. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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Table 14.2.18.1: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) 
(Intent-to-Treat Population) 
(Page 2 of 6) 
  
Intertriginous Area Investigator Global Assessmenta 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
   n 
               xx 
               xx 
               xx 
   0 – Clear  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   1 – Almost Clear 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   2 – Mild 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   3 – Moderate  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   4 – Severe   
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
 
Score of Clear or Almost Clearb 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baselineb  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
a Collected at baseline for subjects with intertriginous area involvement and collected post-baseline for subjects with a severity of at least mild at baseline. 
b Restricted to subjects with a severity of at least mild at baseline. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data was not imputed for Week 16. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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Table 14.2.18.1: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) 
(Intent-to-Treat Population) 
(Page 3 of 6) 
  
Intertriginous Area Investigator Global Assessmenta 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
   n 
               xx 
               xx 
               xx 
   0 – Clear  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   1 – Almost Clear 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   2 – Mild 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   3 – Moderate  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   4 – Severe   
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
 
Score of Clear or Almost Clearb 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baselineb  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
a Collected at baseline for subjects with intertriginous area involvement and collected post-baseline for subjects with a severity of at least mild at baseline. 
b Restricted to subjects with a severity of at least mild at baseline. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data was not imputed for Week 16. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.2.18.1: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) 
(Intent-to-Treat Population) 
(Page 4 of 6) 
  
Intertriginous Area Investigator Global Assessmenta 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
   n 
               xx 
               xx 
               xx 
   0 – Clear  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   1 – Almost Clear 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   2 – Mild 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   3 – Moderate  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   4 – Severe   
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
 
Score of Clear or Almost Clearb 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baselineb  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
a Collected at baseline for subjects with intertriginous area involvement and collected post-baseline for subjects with a severity of at least mild at baseline. 
b Restricted to subjects with a severity of at least mild at baseline. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data was not imputed for Week 16. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.2.18.1: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) 
(Intent-to-Treat Population) 
(Page 5 of 6) 
  
Intertriginous Area Investigator Global Assessmenta 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
   n 
               xx 
               xx 
               xx 
   0 – Clear  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   1 – Almost Clear 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   2 – Mild 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   3 – Moderate  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   4 – Severe   
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
 
Score of Clear or Almost Clearb 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baselineb  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
a Collected at baseline for subjects with intertriginous area involvement and collected post-baseline for subjects with a severity of at least mild at baseline. 
b Restricted to subjects with a severity of at least mild at baseline. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data was not imputed for Week 16. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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Table 14.2.18.1: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) 
(Intent-to-Treat Population) 
(Page 6 of 6) 
  
Intertriginous Area Investigator Global Assessmenta 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
   n 
               xx 
               xx 
               xx 
   0 – Clear  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   1 – Almost Clear 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   2 – Mild 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   3 – Moderate  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   4 – Severe   
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
 
Score of Clear or Almost Clearb 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baselineb  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
a Collected at baseline for subjects with intertriginous area involvement and collected post-baseline for subjects with a severity of at least mild at baseline. 
b Restricted to subjects with a severity of at least mild at baseline. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data was not imputed for Week 16. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.18.1 for the following:  
Table 14.2.18.2: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) (Per-Protocol Population) 
 
 
 
 
 


 
 
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Table 14.3.0.1.1: Summary of Extent of Exposure 
(Safety Population) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Number of Doses 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Amount of Drug Applied (g) 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Complianta 
n 
xx 
xx 
xx 
Yes 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
No 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a A subject is considered compliant with the dosing regimen if the subject applied at least 80% of the expected doses during the dosing period and did not miss   
   more than 3 consecutive doses.   
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
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Table 14.3.0.2.1: Summary of Pre-Dose Pharmacokinetic Concentrations 
 (PK Population) 
 (Page 1 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
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Table 14.3.0.2.1: Summary of Pre-Dose Pharmacokinetic Concentrations 
 (PK Population) 
 (Page 2 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 
 
 


 
 
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Table 14.3.0.2.2: Summary of Additional Pharmacokinetic Concentrations 
 (PK Population) 
 (Page 1 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
72 hr (3 days) 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
120 hr (5 days) 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
    168 hr (7 days) 
       n 
xx 
xx 
xx 
       Mean 
xx.x 
xx.x 
xx.x 
       SD 
xx.xx 
xx.xx 
xx.xx 
       Median 
xx.x 
xx.x 
xx.x 
       Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
    216 hr (9 days) 
       n 
xx 
xx 
xx 
       Mean 
xx.x 
xx.x 
xx.x 
       SD 
xx.xx 
xx.xx 
xx.xx 
       Median 
xx.x 
xx.x 
xx.x 
       Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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Table 14.3.1.1: Summary of Local Tolerability  
(Safety Population) 
(Page 1 of 4) 
  
Investigator Local Tolerability Dermal Response 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
  n 
xx  
xx  
xx  
  0 – No evidence of irritation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Minimal Erythema, Barely Perceptible 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite Erythema, Readily Visible;  
              
              
              
        Minimal edema or minimal papular response 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  3 – Erythema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  4 – Definite Edema 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  5 – Erythema, Edema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  6 – Vesicular Eruption 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  7 – Strong Reaction Spreading Beyond Application Site 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Subject Local Tolerability Sensation Following  
Drug Application 
Baseline 
 
 
 
  n 
xx  
xx  
xx  
  0 – No sensation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Slight warm, tingling sensation; not really bothersome 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite warm, tingling sensation that is somewhat        
        bothersome  
              
              
              
  3 – Hot, tingling/stinging sensation that has caused definite  
       discomfort 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.3.1.1: Summary of Local Tolerability  
(Safety Population) 
(Page 2 of 4) 
  
Investigator Local Tolerability Dermal Response 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
  n 
xx  
xx  
xx  
  0 – No evidence of irritation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Minimal Erythema, Barely Perceptible 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite Erythema, Readily Visible;  
              
              
              
        Minimal edema or minimal papular response 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  3 – Erythema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  4 – Definite Edema 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  5 – Erythema, Edema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  6 – Vesicular Eruption 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  7 – Strong Reaction Spreading Beyond Application Site 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Subject Local Tolerability Sensation Following  
Drug Application 
Week 4 
 
 
 
  n 
xx  
xx  
xx  
  0 – No sensation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Slight warm, tingling sensation; not really bothersome 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite warm, tingling sensation that is somewhat        
        bothersome  
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  3 – Hot, tingling/stinging sensation that has caused definite  
       discomfort 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.1: Summary of Local Tolerability  
(Safety Population) 
(Page 3 of 4) 
  
Investigator Local Tolerability Dermal Response 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
  n 
xx  
xx  
xx  
  0 – No evidence of irritation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Minimal Erythema, Barely Perceptible 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite Erythema, Readily Visible;  
              
              
              
        Minimal edema or minimal papular response 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  3 – Erythema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  4 – Definite Edema 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  5 – Erythema, Edema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  6 – Vesicular Eruption 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  7 – Strong Reaction Spreading Beyond Application Site 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Subject Local Tolerability Sensation Following  
Drug Application 
Week 8 
  n 
xx  
xx  
xx  
  0 – No sensation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Slight warm, tingling sensation; not really bothersome 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite warm, tingling sensation that is somewhat        
        bothersome  
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  3 – Hot, tingling/stinging sensation that has caused definite  
       discomfort 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.1: Summary of Local Tolerability  
(Safety Population) 
(Page 4 of 4) 
  
Investigator Local Tolerability Dermal Response 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
  n 
xx  
xx  
xx  
  0 – No evidence of irritation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Minimal Erythema, Barely Perceptible 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite Erythema, Readily Visible;  
              
              
              
        Minimal edema or minimal papular response 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  3 – Erythema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  4 – Definite Edema 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  5 – Erythema, Edema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  6 – Vesicular Eruption 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  7 – Strong Reaction Spreading Beyond Application Site 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Subject Local Tolerability Sensation Following  
Drug Application 
Week 12 
 
 
 
  n 
xx  
xx  
xx  
  0 – No sensation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Slight warm, tingling sensation; not really bothersome 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite warm, tingling sensation that is somewhat        
        bothersome  
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  3 – Hot, tingling/stinging sensation that has caused definite  
       discomfort 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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CONFIDENTIAL 
Figure 14.3.1.1: Subject Local Tolerability Sensation Following Drug Application 
(Safety Population) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_________________________________________________________________________________________________________________________________ 
Note: 0 (No sensation), 1 (Slight warm, tingling sensation; not really bothersome), 2 (Definite warm, tingling sensation that is somewhat bothersome), 
          3 (Hot, tingling/stinging sensation that has caused definite discomfort)          
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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Table 14.3.1.2.1: Number of Patients with Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior without Suicidal Intent Based on the Colombia-
Suicide Severity Rating Scale (C-SSRS) During Treatment 
(Safety Population) 
  
Events during treatment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Suicidal Ideation (1-5) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1) Wish to be dead 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2) Non-specific active suicidal thoughts 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3) Active suicidal ideation with any methods (not plan) 
without intent to act 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4) Active suicidal ideation with some intent to act, without 
specific plan 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
5) Active suicidal ideation with specific plan and intent 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Suicidal Behavior (6-10) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
6) Preparatory acts or behavior 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
7) Aborted attempt 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
8) Interrupted attempt 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
9) Non-fatal suicide attempt 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
10) Completed suicide 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Suicidal Ideation or Behavior (1-10) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Self-injurious behavior without suicidal intent 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.2.2: Number of Patients with Suicide-Related Treatment-Emergent Events Based on the Colombia-Suicide Severity Rating Scale (C-SSRS) During 
Treatment 
(Safety Population) 
 
Treatment-emergent (TE) Events  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
TE suicidal ideation (1-5) compared to recent history a 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
TE serious suicidal ideation (0-3 to 4-5) compared to 
recent history b 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Emergence of serious suicidal ideation (0 to 4-5) compared 
to recent historyc 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Improvement in suicidal ideation at endpoint compared with 
baselined 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Emergence of suicidal behavior (6-10) compared to all prior 
history e 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
a N=Number of enrolled patients with at least one post-baseline suicidal ideation score and whose maximum C-SSRS 
suicidal ideation score during the comparison period is non-missing and <5. 
b N=Number of enrolled patients with at least one post-baseline suicidal ideation score and whose maximum C-SSRS 
suicidal ideation score during the comparison period is 0-3. 
c N=Number of enrolled patients with at least one post-baseline suicidal ideation score and whose maximum C-SSRS 
suicidal ideation score during the comparison period is 0. 
d N=Number of enrolled patients whose suicidal ideation score is non-missing and >0 just prior to treatment. 
e N=number of enrolled patients with with at least one post-baseline C-SSRS assessment and who did not have suicidal 
behavior (6-10) prior to treatment. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.3.1: Summary of PHQ-8 Assessments by Treatment Group 
(Safety Population) 
 
PHQ-8 Assessment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
               xx 
None – Minimal Depression (0 to 4) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Mild Depression (5 to 9) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Moderate Depression (10 to 14) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Moderately Severe Depression (15 to 19) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Severe Depression (20 to 24) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Week 4 
n 
               xx  
               xx  
               xx  
None – Minimal Depression (0 to 4) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Mild Depression (5 to 9) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Moderate Depression (10 to 14) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Moderately Severe (15 to 19) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Severe Depression (20 to 24) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Week 8 
  n 
               xx  
               xx  
               xx  
  None – Minimal Depression (0 to 4) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Mild Depression (5 to 9) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Moderate Depression (10 to 14) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Moderately Severe (15 to 19) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Severe Depression (20 to 24) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
Week 12 
n 
               xx  
               xx  
               xx  
  None – Minimal Depression (0 to 4) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Mild Depression (5 to 9) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Moderate Depression (10 to 14) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Moderately Severe (15 to 19) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Severe Depression (20 to 24) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.3.2: Shift Summary of PHQ-8 Assessments by Treatment Group 
(Safety Population) 
(Page 1 of  3) 
 
PHQ-8 for (ARQ-151 Cream 0.3%) 
__________________________________________Week 4__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
__________________________________________Week 8__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
__________________________________________Week 12__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate   
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
 
 
Note: None = Minimal Depression (0 to 4); Mild = Mild Depression (5 to 9); Moderate = Moderate Depression (10 to 14);  
Moderately Severe = Moderately Severe Depression (15 to 19); Severe = Severe Depression (20 to 24). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.3.2: Shift Summary of PHQ-8 Assessments by Treatment Group 
(Safety Population) 
(Page 2 of  3) 
  
PHQ-8 for (ARQ-151 Cream 0.15%) 
__________________________________________Week 4__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
__________________________________________Week 8__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
__________________________________________Week 12__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
 
 
Note: None = Minimal Depression (0 to 4); Mild = Mild Depression (5 to 9); Moderate = Moderate Depression (10 to 14);  
Moderately Severe = Moderately Severe Depression (15 to 19); Severe = Severe Depression (20 to 24). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.3.2: Shift Summary of PHQ-8 Assessments by Treatment Group 
(Safety Population) 
(Page 3 of  3) 
  
PHQ-8 for (Vehicle Cream) 
__________________________________________Week 4__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
__________________________________________Week 8__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
__________________________________________Week 12__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
 
 
Note: None = Minimal Depression (0 to 4); Mild = Mild Depression (5 to 9); Moderate = Moderate Depression (10 to 14);  
Moderately Severe = Moderately Severe Depression (15 to 19); Severe = Severe Depression (20 to 24). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.3.1.4.1: Overall Summary of Treatment-Emergent Adverse Event Characteristics 
(Safety Population) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Subjects with any TEAE 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of TEAEs  
             xx   
                      xx   
                              xx   
Subjects with any Related TEAE 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Related TEAEs  
             xx   
                      xx   
                              xx   
Subjects with any Serious TEAE  
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Serious TEAEs  
             xx   
                      xx   
                              xx   
Subjects with any Related Serious TEAE  
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Related Serious TEAEs  
             xx   
                      xx   
                              xx   
Subjects who Died 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Subjects who Discontinued Study Drug due to TEAE 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Subjects who Discontinued Study due to TEAE 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Maximum Severity By Subject 
Grade 5 
            xx  (   xx.x%) 
            xx  (   xx.x%) 
            xx  (   xx.x%) 
Grade 4 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Grade 3 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Grade 2 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Grade 1 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
Maximum Relationship by Subject 
Likely 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Probably 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Possibly 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Unlikely 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Unrelated 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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Table 14.3.1.4.2: Summary of Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA dictionary (Version 21.1). At each level of summarization        
   (System Organ Class or Preferred Term) subjects are counted once. 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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Table 14.3.1.4.3: Summary of Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug by 
MedDRA System Organ Class and Preferred Term 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to the MedDRA dictionary (Version 21.1). At each level of summarization    
   (System Organ Class or Preferred Term) subjects are counted once. 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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Table 14.3.1.4.4: Summary of Subjects Reporting Treatment-Emergent Adverse Events (TEAEs) by Severity 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term 
 Severityb 
ARQ-151 Cream 0.3% 
_________(N=xx)___________ 
ARQ-151 Cream 0.15% 
_________(N=xx)___________ 
Vehicle Cream 
_________(N=xx)___________ 
Total 
Grade 5 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 4 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 3 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 2 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 1 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
System Organ Class 
Grade 5 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 4 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 3 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 2 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 1 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Preferred Term 
Grade 5 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 4 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 3 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 2 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 1 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to the MedDRA dictionary (Version 21.1). At each level of summarization   
   (System Organ Class or Preferred Term) subjects are counted once under the greatest reported severity. 
b  Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life Threatening; Grade 5 = Death. 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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Table 14.3.1.4.5: Summary of Subjects Reporting Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Drug 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term  
 Relationship 
ARQ-151 Cream 0.3% 
_________(N=xx)___________ 
ARQ-151 Cream 0.15% 
_________(N=xx)___________ 
Vehicle Cream 
_________(N=xx)___________ 
Total 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
System Organ Class 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Preferred Term 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Preferred Term 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to the MedDRA dictionary (Version 21.1). At each level of summarization  
   (System Organ Class or Preferred Term) subjects are counted once under the greatest reported relationship. 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.4.6: Summary of Treatment-Emergent Serious Adverse Event Characteristics 
(Safety Population) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Subjects with any Serious TEAE  
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Serious TEAEs  
             xx   
                      xx   
                              xx   
Subjects with any Related Serious TEAE  
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Related Serious TEAEs  
             xx   
                      xx   
                              xx   
Subjects who Died 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Subjects who Discontinued Study Drug due to TEAE 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Subjects who Discontinued Study due to TEAE 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Maximum Severity By Subject 
Grade 5 
            xx  (   xx.x%) 
            xx  (   xx.x%) 
            xx  (   xx.x%) 
Grade 4 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Grade 3 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Grade 2 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Grade 1 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
Maximum Relationship by Subject 
Likely 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Probably 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Possibly 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Unlikely 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Unrelated 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.4.7: Summary of Subjects Reporting Serious Treatment-Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to the MedDRA dictionary (Version 21.1). At each level of summarization  
   (System Organ Class or Preferred Term) subjects are counted once. 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.4.8: Summary of Subjects Reporting Serious Treatment-Emergent Adverse Events (TEAEs) by Severity 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term 
 Severityb 
ARQ-151 Cream 0.3% 
_________(N=xx)___________ 
ARQ-151 Cream 0.15% 
_________(N=xx)___________ 
Vehicle Cream 
_________(N=xx)___________ 
Total 
Grade 5 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 4 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 3 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 2 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 1 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
System Organ Class 
Grade 5 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 4 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 3 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 2 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 1 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Preferred Term 
Grade 5 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 4 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 3 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 2 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 1 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to the MedDRA dictionary (Version 21.1). At each level of summarization  
   (System Organ Class or Preferred Term) subjects are counted once under the greatest reported severity. 
b  Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life Threatening; Grade 5 = Death. 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.4.9: Summary of Subjects Reporting Serious Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Drug 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term  
 Relationship 
ARQ-151 Cream 0.3% 
_________(N=xx)___________ 
ARQ-151 Cream 0.15% 
_________(N=xx)___________ 
Vehicle Cream 
_________(N=xx)___________ 
Total 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
System Organ Class 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Preferred Term 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Preferred Term 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to the MedDRA dictionary (Version 21.1). At each level of summarization  
   (System Organ Class or Preferred Term) subjects are counted once under the greatest reported relationship. 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.5.1.1: Summary of Chemistry Laboratory Results 
 (Safety Population) 
(Page 1 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.5.1.1: Summary of Chemistry Laboratory Results 
 (Safety Population) 
(Page 2 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.3.1.5.1.1: Summary of Chemistry Laboratory Results 
For the following tables: 
Table 14.3.1.5.1.2: Summary of Hematology Laboratory Results (Safety Population) 
Table 14.3.1.5.1.3: Summary of Quantitative Urinalysis Laboratory Results (Safety Population) 
 
 
 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.5.2.1: Shift Summary of Chemistry Laboratory Results 
(Safety Population) 
(Page 1 of x) 
  
<Test name> (<units>) 
ARQ-151 Cream 0.3% 
                              (N=xx)  
ARQ-151 Cream 0.15% 
                              (N=xx)  
Vehicle Cream 
                              (N=xx)  
 
  
Week 4 
   
Week 4 
  
Week 4 
 
Baseline  
BNL 
  
WNL 
  
ANL 
  
BNL 
  
WNL 
  
ANL 
  
BNL 
  
WNL 
  
ANL 
 
BNL 
xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) 
WNL 
xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) 
ANL 
xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) 
  
Week 12 
   
Week 12 
  
Week 12 
 
Baseline  
BNL 
  
WNL 
  
ANL 
  
BNL 
  
WNL 
  
ANL 
  
BNL 
  
WNL 
  
ANL 
 
BNL 
xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) 
WNL 
xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) 
ANL 
xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) 
 
 
Note: BNL=Below Normal Limit, WNL=Within Normal Limit, ANL=Above Normal Limit. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.3.1.5.2.1: Shift Summary of Chemistry Laboratory Results 
For the following tables: 
Table 14.3.1.5.2.2: Shift Summary of Hematology Laboratory Results (Safety Population) 
Table 14.3.1.5.2.3: Shift Summary of Quantitative Urinalysis Laboratory Results (Safety Population) 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 148 of 202  
CONFIDENTIAL 
Table 14.3.1.6.1: Summary of Electrocardiogram (ECG) Parameters 
 (Safety Population) 
 (Page 1 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 149 of 202  
CONFIDENTIAL 
Table 14.3.1.6.1: Summary of Electrocardiogram (ECG) Parameters 
 (Safety Population) 
 (Page 2 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 150 of 202  
CONFIDENTIAL 
Table 14.3.1.6.2: Shift Summary of Overall Electrocardiogram (ECG) Assessments 
(Safety Population) 
(Page 1 of x) 
  
Overall ECG Assessment 
ARQ-151 Cream 0.3% 
                       (N=xx)  
ARQ-151 Cream 0.15% 
                      (N=xx)  
Vehicle Cream 
                      (N=xx)  
 
Week 4 
  
Week 4 
  
Week 4 
 
Baseline 
 
Normal 
  
Abnormal 
  
Normal 
  
Abnormal 
  
Normal 
  
Abnormal 
 
Normal 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Abnormal 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
Week 12 
  
Week 12 
  
Week 12 
 
Baseline 
 
Normal 
  
Abnormal 
  
Normal 
  
Abnormal 
  
Normal 
  
Abnormal 
 
Normal 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Abnormal 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 151 of 202  
CONFIDENTIAL 
Table 14.3.1.7.1: Summary of Vital Signs 
 (Safety Population) 
 (Page 1 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 152 of 202  
CONFIDENTIAL 
Table 14.3.1.7.1: Summary of Vital Signs 
 (Safety Population) 
 (Page 2 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 153 of 202  
CONFIDENTIAL 
Table 14.3.1.7.1: Summary of Vital Signs 
 (Safety Population) 
 (Page 3 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 154 of 202  
CONFIDENTIAL 
Table 14.3.1.7.1: Summary of Vital Signs 
 (Safety Population) 
 (Page 4 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 155 of 202  
CONFIDENTIAL 
Table 14.3.1.7.2: Summary of Change in Body Weight Compared to Baseline 
(Safety Population) 
(Page 1 of 2) 
  
Change in Body Weight Compared to Baselinea 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
Lost  >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Lost >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Maintained Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Gained >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Gained >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 6 
Lost  >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Lost >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Maintained Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Gained >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Gained >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 8 
Lost  >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Lost >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Maintained Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Gained >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Gained >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 12 
Lost  >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Lost >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Maintained Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Gained >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Gained >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Percentages may sum to over 100% due to the possibility of being included in more than one category. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 156 of 202  
CONFIDENTIAL 
 
Table 14.3.1.7.2: Summary of Change in Body Weight Compared to Baseline 
(Safety Population) 
(Page 2 of 2) 
  
Change in Body Weight Compared to Baselinea 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
Lost  >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Lost >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Maintained Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Gained >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Gained >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Percentages may sum to over 100% due to the possibility of being included in more than one category. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
  Page 157 of 202  
CONFIDENTIAL 
11. INDEX OF PLANNED LISTINGS
Listing 16.2.1.1: End of Study Information .................................................................................159 
Listing 16.2.1.2: Discontinued Subjects ......................................................................................160 
Listing 16.2.2.1: Inclusion/Exclusion Criteria Violations ...........................................................161 
Listing 16.2.2.2: Protocol Deviations ..........................................................................................162 
Listing 16.2.3: Analysis Populations ...........................................................................................163 
Listing 16.2.4.1: Subject Demographic Information ...................................................................164 
Listing 16.2.4.2.1: Unique Medical/Surgical History Coded to MedDRA System Organ Classes 
and Preferred Terms ............................................................................165 
Listing 16.2.4.2.2: Medical/Surgical History...............................................................................166 
Listing 16.2.4.3.1: Unique Medication Names Coded to WHO-DD ATC Level 2 Terms and 
Preferred Names ..................................................................................167 
Listing 16.2.4.3.2: Prior and Concomitant Medications ..............................................................168 
Listing 16.2.4.4.1: Unique Therapies and Procedures Coded to MedDRA System Organ Classes 
and Preferred Terms ............................................................................169 
Listing 16.2.4.4.2: Prior and Concomitant Therapies and Procedures ........................................170 
Listing 16.2.4.5: Physical Examination .......................................................................................171 
Listing 16.2.5.1: Study Visit Compliance ....................................................................................172 
Listing 16.2.5.2: Drug Accountability .........................................................................................173 
Listing 16.2.5.3: Study Drug Application ....................................................................................174 
Listing 16.2.5.4: Dosing Compliance ..........................................................................................175 
Listing 16.2.5.5: Dosing Deviations ............................................................................................176 
Listing 16.2.6.1: Investigator Global Assessment (IGA) ............................................................177 
Listing 16.2.6.2: Body Surface Area (BSA) Involved with Psoriasis .........................................178 
Listing 16.2.6.3: Modified Psoriasis Area and Severity Index (mPASI) .....................................179 
Listing 16.2.6.4: Numeric Rating Scale (NRS) Assessments/Sleep Loss ...................................180 
Listing 16.2.6.5.1: Dermatology Life Quality Index (DLQI) Questionnaire Descriptions .........181 
Listing 16.2.6.5.2: Dermatology Life Quality Index (DLQI) Questionnaire ...............................182 
Listing 16.2.6.6.1: Work Productivity and Activity Impairment (WPAI) Questionnaire 
Descriptions ........................................................................................183 
Listing 16.2.6.6.2: Work Productivity and Activity Impairment (WPAI) Questionnaire ...........184 
Listing 16.2.6.7: Columbia-Suicide Severity Rating Scale (C-SSRS) ........................................185 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
  Page 158 of 202  
CONFIDENTIAL 
Listing 16.2.6.8.1: Patient Health Questionnaire Depression Scale (PHQ-8) Question 
Descriptions ........................................................................................186 
Listing 16.2.6.8.2: Patient Health Questionnaire Depression Scale (PHQ-8) .............................187 
Listing 16.2.6.9.1: Psoriasis Symptom Diary (PSD) Questionnaire Descriptions.......................188 
Listing 16.2.6.9.2: Psoriasis Symptom Diary (PSD) Questionnaire ............................................189 
Listing 16.2.6.10: Photography Information................................................................................190 
Listing 16.2.7.1.1: Investigator Local Tolerability Assessment ..................................................191 
Listing 16.2.7.1.2: Subject Local Tolerability Assessment .........................................................192 
Listing 16.2.7.2.1: Unique Adverse Events Coded to MedDRA System Organ Classes and 
Preferred Terms ...................................................................................193 
Listing 16.2.7.2.2: Treatment-Emergent Adverse Events ............................................................194 
Listing 16.2.7.2.3: Serious Adverse Events .................................................................................195 
Listing 16.2.7.2.4: Subjects Who Permanently Discontinued Study Drug Due to Adverse Events196 
Listing 16.2.8.1: Urine Pregnancy Test Results ..........................................................................197 
Listing 16.2.8.2.1: Laboratory Test Results .................................................................................198 
Listing 16.2.8.2.2: Abnormal Laboratory Results .......................................................................199 
Listing 16.2.8.3: 12-lead Electrocardiogram Test Results ...........................................................200 
Listing 16.2.8.4: Vital Signs ........................................................................................................201 
Listing 16.2.8.5: Pharmacokinetics Blood Sample Collections ...................................................202 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 159 of 202  
CONFIDENTIAL 
Listing 16.2.1.1: End of Study Information 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
S: Subject
A: Age/Sex
F: Date of First Dose of Drug   Primary Reason for Study
E: Eval
L: Date of Last Dose of Drug    Completion/Discontinuation
Date of Completion/Discontinuation 
______________________________________________________________________________________________________________________________________ 
S: xxxxxx
F: xxxxxxxxxx
xxxxxxxxxx xx xxxxxxxxxxxxxxx
xxxxxxxxxx xxxx 
A: xxxx
L: xxxxxxxxxx
E: xxxxxxxxx
S: xxxxxx
F: xxxxxxxxxx
xxxxxxxxxx xx xxxxxxxxxxxxxxx
xxxxxxxxxx xxxx
A: xxxx    
L: xxxxxxxxxx
E: xxxxxxxxx
S: xxxxxx
F: xxxxxxxxxx
xxxxxxxxx xxxx xxxxxxxx xxxxx
xxxxxxxxxx xxxx
A: xxxx
  L: xxxxxxxxxx
E: xxxxxxxxx
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Note to programmer: concatenate ‘Describe’ text onto Primary Reason where applicable. 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 160 of 202  
CONFIDENTIAL 
Listing 16.2.1.2: Discontinued Subjects 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
S: Subject
A: Age/Sex
F: Date of First Dose of Drug   Primary Reason for Study
E: Eval
L: Date of Last Dose of Drug    Completion/Discontinuation
Date of Completion/Discontinuation 
______________________________________________________________________________________________________________________________________ 
S: xxxxxx
F: xxxxxxxxxx
xxxxxxxxxx xx xxxxxxxxxxxxxxx
xxxxxxxxxx xxxx 
A: xxxx
L: xxxxxxxxxx
E: xxxxxxxxx
S: xxxxxx
F: xxxxxxxxxx
xxxxxxxxxx xx xxxxxxxxxxxxxxx
xxxxxxxxxx xxxx
A: xxxx
L: xxxxxxxxxx
E: xxxxxxxxx
S: xxxxxx
F: xxxxxxxxxx
xxxxxxxxx xxxx xxxxxxxx xxxxx
xxxxxxxxxx xxxx
A: xxxx
L: xxxxxxxxxx 
E: xxxxxxxxx
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 161 of 202  
CONFIDENTIAL 
 
Listing 16.2.2.1: Inclusion/Exclusion Criteria Violations 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
                                Criterion    Criterion 
Subject   Age/Sex  Eval         Category     Identifier   Description 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx        x        xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx xxxxx  
                                                          xxxxxxxxxxx xxxxxx xxxxxxxx xxxxxxxxxx xx xxx xxxxxxxxx xxx xxxxxxxx xxxx 
                                   
                                xxxxxxxxx        x        xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx 
 
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx        x        xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx xxxxxxx                       
                                                          x xxxxxx xxxxxxxx xxxxxxxxxx xx xxx xxxxxxxxx xxx xxxxxxxx xxxxxx xxxxxxx x 
                                                          xxxxxxxxx xxxxx xxx 
 
                                xxxxxxxxx        xx       xxxxxxxx xxxx xxxxxx xxxx xxxxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxxxx xxx  
                                                          xxxxxxxx xxxxx xx xxxx xxxx xx xxx xx xxxx xxxx xxx xxxxx xxxxx 
 
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx        x        xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx  
                                               
                                xxxxxxxxx        xx       xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx xxxxxxxx 
                                                          xxx xxxxx xxxxxxxxx xxxx   
                                  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Criterion Category, and Criterion Identifier. 
 
 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 162 of 202  
CONFIDENTIAL 
Listing 16.2.2.2: Protocol Deviations 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
Subject   Age/Sex  Eval
Protocol Deviation 
______________________________________________________________________________________________________________________________________ 
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx 
xxxxxxxxxxx xxxxxx xxxxxxxx xxxxxxxxxx xx xxx 
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx x xxxxxx xxxxxxxx xxxxxxxxxx xx xxx 
xxxxxxxxx xxxxx xxx 
xxxxxxxx xxxx xxxxxx xxxx xxxxxxx  
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx 
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx x xxxxxx xxxxxxxx xxxxxxxxxx xx xxx 
xxxxxxxx xxxx xxxxxx xxxx xxxxxxx  
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 163 of 202  
CONFIDENTIAL 
Listing 16.2.3: Analysis Populations 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
Subject   Age/Sex     Population          Included           Reason(s) Excluded
______________________________________________________________________________________________________________________________________ 
xxxxxx    xxxx
Safety
xx
xxxxxxx x xxxxxx xxxxxxxxx 
Intent-to-Treat
xxx 
Per-Protocol
xxx 
Pharmacokinetic
xxx 
xxxxxx    xxxx
Safety
xxx 
Intent-to-Treat
xxx 
Per-Protocol
xxx 
Pharmacokinetic
xxx 
xxxxxx    xxxx
Safety
xxx 
Intent-to-Treat
xxx 
Per-Protocol
xx
  xxxxxxx xxxxxxx xxxxx 
Pharmacokinetic
xx
xxxxxxxxxxx xxxxxxxxx xxx xxxxxxxxxx xx xxxxxx x xxxxxxxxx 
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Listing sorted by Subject, and Population. 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 164 of 202  
CONFIDENTIAL 
Listing 16.2.4.1: Subject Demographic Information 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
P:  Did the Subject 
D: Date/Time of
C: Childbearing
Consent to Photography?
B: Date of Birth     Informed Consent     R: Race
Potential
D: Date of 
Subject  Eval       S: Sex
A: Age at Consent       E: Ethnicity
B: Birth Control Method    Photography Consent
______________________________________________________________________________________________________________________________________ 
xxxxxx   xxxxxxxx   B: xxxxxxxxxx     D: xxxx-xx-xxTxx:xx:xx  R: xxxxx xx xxxxxxx   C: xx
P: xxx 
S: xxxx
A: xx                   E: xxx xxxxxxxx xx    B:
D: xxxxxxxxxx 
xxxxxx   xxxxxxxx   B: xxxxxxxxxx     D: xxxx-xx-xxTxx:xx:xx  R: xxxxx
C: xxx
P: xx
S: xxxxxx
A: xx
E: xxx xxxxxxxx xx    B: xxxxxxxxxx xxxxxxxx  D:
xxxxxx   xxxxxxxx   B: xxxxxxxxxx     D: xxxx-xx-xxTxx:xx:xx  R: xxxxx
C: xxx                  P: xxx
S: xxxxxx
A: xx
E: xxx xxxxxxxx xx    B: xxxx xxxxxxxxxxxxxx  D: xxxxxxxxxx
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 165 of 202  
CONFIDENTIAL 
Listing 16.2.4.2.1: Unique Medical/Surgical History Coded to MedDRA System Organ Classes and Preferred Terms 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
MedDRA System Organ Class                     MedDRA Preferred Term                       Condition/Surgery Verbatim Term 
______________________________________________________________________________________________________________________________________ 
 
x xxx xxxxx                                   xxxx xxx xxxxx                              xxxx xxxxxxxxxx xx xxxxxx  
                                                                                         
                                                                                          xxxxx xxx xxxxxx xx 
                                                                                          
xxxx x xxxxxxxxx                              xxxxxxx xxxxxxxxxxxxx                       xxxx xxxxxx xxxxxxxxxx xx xxxxxx 
 
xxxx xxx xxxxx                                xxxx xxx xxxxx                              xxxx xxxxxxxx 
 
                                                                                          xxxxxx xxxxxxxxxx xx xxxxxx 
 
                                                                                          xxxxxx xxxxxxxxxx xx xxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                                                           
______________________________________________________________________________________________________________________________________ 
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
Listing sorted by System Organ Class, Preferred Term, and Verbatim Term. 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 166 of 202  
CONFIDENTIAL 
Listing 16.2.4.2.2: Medical/Surgical History 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________        
                                                                                                       
 
                                   Condition/Surgery            
P: MedDRA Preferred Term              S: Onset Date 
Subject    Age/Sex    Eval         Verbatim Term                  
S: MedDRA System Organ Class         
E: End Date 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx     xxxx       xxxxxxxx     xxxxxx xxxxxxx (xxxxxxxx xxxxx)  
P: xxxxxx xxxxxxxxxx               
S: xxxxxxxxxxx 
                                                                    
S: xxxxxxxxxxx xxxxxxx             
E: xxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
  
                                   xxxxxxxx xxxxxxxxxx              
P: xxxxxxx xxxxxxxx                  
S: xxxxxxxxxxx 
                                                                    
S: xxxxxx xxxxxxxxxxxxx               E: xxxxxxxxxxx 
 
 
 
 
 
 
  
 
                    
           
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
Listing sorted by Subject, Medical Condition/Surgery, Start Date, and End Date. 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 167 of 202  
CONFIDENTIAL 
Listing 16.2.4.3.1: Unique Medication Names Coded to WHO-DD ATC Level 2 Terms and Preferred Names 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
                                                                                                             I: Indication 
ATC Level 2 Term                 Preferred Name                         Medication Name                      R: Route 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx xxxxxx xx xxx             xxxxxxxxxx                             xxxxxxxxxx                           I: xxxxxxx xxxxxxxx 
                                                                                                             R: xxxx 
 
                                 xxxxxxx x                              xxxxxx                               I: xxxxxxx xxxxxxxx 
                                                                                                                xxxxxxxxxxxx 
                                                                                                             R: xxxx 
 
                                 xxxxxxxxx                              xxxxxxxxx                            I: xxxxxxx xxxxxxxx xxxx 
                                                                                                                xxxxx xxxxxxxx 
                                                                                                             R: xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: Preferred Name and ATC Level 2 Term map to the WHO-DD (Version March 1, 2018). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
Listing sorted by ATC Level 2 Term, Preferred Name, Medication Name, Indication, and Route. 
 
 
 
 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 168 of 202  
CONFIDENTIAL 
Listing 16.2.4.3.2: Prior and Concomitant Medications 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
M: Medication Name
D: Dose     
P: Preferred Name
F: Date of First Dose    U: Units
A: ATC Level 2 Term
S: Start Date (Day)¹     F: Frequency
Subject     Age/Sex    Eval
I: Indication
E: End Date (Day)¹       R: Route  
______________________________________________________________________________________________________________________________________ 
xxxxxx      xxxx       xxxxxxxxxx     M: xxxxxxxxxxxxx
F: xxxxxxxxxx
D: xx
P: xxxxxxxxxxxxx
S: xxxxxxxxxx
U: xx
A: xxxxxxxxxxxxx
E: xxxxxxxxxx
F: xxxx 
I: xxxxxxxx
R:xxxx 
M: xxxxxxxxxxxxx
F: xxxxxxxxxx
D: xxxxx
P: xxxxxxxxxxxxx
S: xxxxxxxxxx
U: xx
A: xxxxxxxxxxxxx
E: xxxxxxxxxx
F: xx 
I: xxxxxxxx
R:xxxx 
xxxxxx      xxxx       xxxxxxxxxx     M: xxxxxxxxxxxxx
F: xxxxxxxxxx
D: xxx
P: xxxxxxxxxxxxx
S: xxxxxxxxxx
U: xx
A: xxxxxxxxxxxxx
E: xxxxxxxxxx
F: xx 
I: xxxxxxxx
   R:xxxx 
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – date of first dose for dates prior to first dose. Otherwise, day is calculated as date – date of first    
  dose + 1 for dates on or after first dose. 
Note: Preferred Name and ATC Level 2 Term map to the WHO-DD (Version March 1, 2018). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Listing sorted by Subject, Start Date, End Date, Medication Name, Indication, and Route.  If ongoing, include ‘Ongoing’ in place of 
End Date. Concatenate Topical Area Treated onto route where applicable. 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 169 of 202  
CONFIDENTIAL 
Listing 16.2.4.4.1: Unique Therapies and Procedures Coded to MedDRA System Organ Classes and Preferred Terms 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
MedDRA System Organ Class                     MedDRA Preferred Term                       Procedure/Therapy Verbatim Term 
______________________________________________________________________________________________________________________________________ 
 
xxxx xxx xxxxx                                xxxx xxx xxxxx                              xxxx 
 
                                                                                          xxxxxx xxxxxxxxxx xx xxxxxx 
 
                                                                                          xxxxxx xxxxxxxxxx xx xxxxx 
 
 
xxxx xxx xxxxx                                xxxx xxx xxxxx                              xxxx 
 
                                                                                          xxxxxx xxxxxxxxxx xx xxxxxx 
 
                                                                                          xxxxxx xxxxxxxxxx xx xxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 
 
Listing sorted by MedDRA System Organ Class, MedDRA Preferred Term, and Procedure/Therapy Verbatim Term. 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 170 of 202  
CONFIDENTIAL 
 
Listing 16.2.4.4.2: Prior and Concomitant Therapies and Procedures 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
S: Subject 
A: Age/Sex                                        I: Indication            P: MedDRA Preferred Term              S: Start Date 
E: Eval       Procedure/Therapy Verbatim Term     A: Anatomical Area       S: MedDRA System Organ Class          E: End Date 
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx     xxxxxx xxxxxxx (xxxxxxxx xxxxx)     I: xxxxxxxxxx            P: xxxxxx xxxxxxxxxx               
S: xxxxxxxxxxx 
A: xxxx                                           A: xxxx                  S: xxxxxxxxxxx xxxxxxx             
E: xxxxxxxxxxx 
E: xxxxxxxx 
              xxxxxx xxxxxxx xxxxxxx              I: xxxxxxxxxx xxxxx      P: xxxxxx xxxxxxxxxx               
S: xxxxxxxxxxx 
                                                  A:                       S: xxxxxxxxxxx xxxxxxx             
E: xxxxxxxxxxx 
                
 
 
 
 
 
 
 
 
 
                
 
 
 
 
 
 
  
S: xxxxxx     xxxxxx xxxxxxxxxxxxxx               I: xxxxxxxxxx xxxxx      P: xxxxxx xxxxxxxxxx               
S: xxxxxxxxxxx 
A: xxxx                                           A: xxxx xxx xxxxx        S: xxxxxxxxxxx xxxxxxx             
E: xxxxxxxxxxx 
E: xxxxxxxx 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
                    
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Start Date, End Date, Procedure/Therapy, Indication. If ongoing, include ‘Ongoing’ in place of End Date. 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 171 of 202  
CONFIDENTIAL 
Listing 16.2.4.5: Physical Examination 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                 
                               
S: Subject          
                 
                                
A: Age/Sex                          
                                                                          Abnormal Finding                       
E: Eval         Visit             Date              Body System Assessed            Finding                     Specification  
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx       xxxxxxxxxxx       xxxxxxxxxx       Heart                            xxxxxxxxxx                 xxxxxxx xxxxx               
A: xxxx                                            Lungs                            xxxxx xxxxxxx 
E: xxxxxxxxx                                       Skin (Other than Psoriasis)      xxxxxxxx                            
                                                   <Other, specify>                 xxxx xxx xx                xxxxxxxxxxx xxx xxxxxx 
 
                xxxxxxxxxxx       xxxxxxxxxx       Heart                            xxxxxxxx                  
                                                   Lungs                            xxxxx xxxxxxx 
                                                   Skin (Other than Psoriasis)      xxxxxxxx                            
 
                xxxx xx           xxxxxxxxxx       Heart                            xxxxxxxx                  
                                                   Lungs                            xxxxx xxxxxxx 
                                                   Skin (Other than Psoriasis)      xxxxxxxx                            
 
S: xxxxxx       xxxxxxxxxxx       xxxxxxxxxx       Heart                            xxxxxxxxxx 
A: xxxx                                            Lungs                            xxxxxxxxx  xx              xxxxxx          
E: xxxxxxxxx                                       Skin (Other than Psoriasis)      xxxx xxxxxxxx 
 
                xxxxxxxxxxx       xxxxxxxxxx       Heart                            xxxxxx xxxxx                            
                                                   Lungs                            xxxxxxx                            
                                                   Skin (Other than Psoriasis)      xxxxxxxxxx     
                     
                xxxx xx           xxxxxxxxxx       Heart                            xxxxxxxx                  
                                                   Lungs                            xxxxx xxxxxxx 
                                                   Skin (Other than Psoriasis)      xxxxxxxx                            
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
Listing sorted by Subject, Visit, Date, Body System Assessed. 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 172 of 202  
CONFIDENTIAL 
 
Listing 16.2.5.1: Study Visit Compliance 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                                                         
                                                                                        Study          Within Visit     Days Out of   
Subject    Age/Sex    Eval          Visit                    Visit Date                 Day¹           Window           Window²     
______________________________________________________________________________________________________________________________________ 
 
xxxxxx     xxxx       xxxxxxxx      xxxxxxxxx                xxxxxxxxxx                 x              xxx 
                                    xxxxxxxx                 xxxxxxxxxx                 x              xxx 
                                    xxxx x                   xxxxxxxxxx                 xx             xxx              xxxx 
                          
xxxxxx     xxxx       xxxxxxxx      xxxxxxxxx                xxxxxxxxxx to xxxxxxxxxx   x              xxx 
                                    xxxxxxxx                 xxxxxxxxxx                 x              xxx 
                                    xxxx x                   xxxxxxxxxx                 xx             xxx 
                                    xxxx x                   xxxxxxxxxx                 xx             xxx 
 
xxxxxx     xxxx       xxxxxxxx      xxxxxxxxx                xxxxxxxxxx                 xx             xxx 
                                    xxxxxxxx                 xxxxxxxxxx                 x              xxx  
                                    xxxx x                   xxxxxxxxxx                 xx             xxx 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – baseline date for dates prior to baseline visit. Otherwise, day is calculated as  
  date – baseline date + 1 for dates on or after baseline visit. 
² Populated only for post baseline visits that are planned and out of window. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
Listing sorted by Subject, Visit, Visit Date. 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Listing 16.2.5.2: Drug Accountability 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
                                                  Date              Date                         Dispensed         Returned 
Subject    Age/Sex    Evaluable    Kit Number     Dispensed         Returned      Tube ID        Weight (g)        Weight (g) 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx     xxxx       xxxxxxxx     xxxxx          xxxxxxxxxx        xxxxxxxxxx      x            xx.x              xx.x  
                                                                                    x            xx.x              xx.x  
                                                                                    x            xx.x              xx.x  
                                                                                    x            xx.x              xx.x  
                                   xxxxx          xxxxxxxxxx        xxxxxxxxxx      x            xx.x              xx.x  
                                                                                    x            xx.x              xx.x  
                                                                                    x            xx.x              xx.x  
                                                                                    x            xx.x              xx.x  
                                   xxxxx          xxxxxxxxxx        xxxxxxxxxx      x            xx.x              xx.x  
                                                                                    x            xx.x              xx.x  
                                                                                    x            xx.x              xx.x  
                                                                                    x            xx.x              xx.x  
 
xxxxxx     xxxx       xxxxxxxx     xxxxx          xxxxxxxxxx        xxxxxxxxxx      x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
                                   xxxxx          xxxxxxxxxx        xxxxxxxxxx      x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
                                                                                    x            xx.x              xx.x 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Kit Number, Date Dispensed, Date Returned, and Tube ID.  
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 174 of 202  
CONFIDENTIAL 
Listing 16.2.5.3: Study Drug Application 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
                                                   Date/Time of Study     Study Drug           Pre-Dose     Post-Dose     Reason 
Subject    Age/Sex    Evaluable    Visit           Drug Application       Applied in Clinic?   Weight (g)   Weight (g)    Not Done 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx     xxxx       xxxxxxxx     xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x  
                                   xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x  
                                   xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x  
 
xxxxxx     xxxx       xxxxxxxx     xxxxx           xxxxxTxxxx                 xx                                         xxx xxx xxxxx 
                                   xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x  
                                   xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x  
 
xxxxxx     xxxx       xxxxxxxx     xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x  
                                   xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x  
                                   xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x  
 
xxxxxx     xxxx       xxxxxxxx     xxxxx           xxxxxTxxxx                 xx                                         xxx xxx xxxxx 
                                   xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x  
                                   xxxxx           xxxxxTxxxx                 xxx                xx.x          xx.x  
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Date/Time of Study Drug Application, Visit.  
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 175 of 202  
CONFIDENTIAL 
 
Listing 16.2.5.4: Dosing Compliance 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
S: Subject                              Number of    Calculated¹    Amount of     Maximum Number                                                       
A: Age/Sex     D: Date of First Dose     Days of      Number of    Study Drug       of Missed            Percent                    
E: Eval        R: Date of Last Dose      Exposure       Doses       Used (g)     Consecutive Doses      Compliant    Compliant?²     
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx      D: xxxxxxxxxxxx             xx            xx           xxxx              x                  xxx           xxx            
A: xxxx        R: xxxxxxxxxxxx 
E: xxxxxxxxx                     
 
S: xxxxxx      D: xxxxxxxxxxxx             xx            xx           xxxx              x                  xxx           xx                            
A: xxxx        R: xxxxxxxxxxxx  
E: xxxxxxxxx                     
 
S: xxxxxx      D: xxxxxxxxxxxx             xx            xx           xxxx                                 xxxx          xxx            
A: xxxx        R: xxxxxxxxxxxx   
E: xxxxxxxxx                     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
¹ The total number of doses was calculated from the date of first dose and the date of last known dose minus the missed doses plus     
  additional dose deviations. 
² A subject was considered compliant with the dosing regimen if the subject applied at least 80% of the expected doses during the  
  study drug application period and did not miss more than 3 consecutive doses. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 176 of 202  
CONFIDENTIAL 
Listing 16.2.5.5: Dosing Deviations 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
Subject     Age/Sex     Eval
Date of First Dose       Date of Dosing Deviation
Number of Doses Applied 
______________________________________________________________________________________________________________________________________ 
xxxxxx      xxxx
xxxxxxxxx     xxxxxxxxxx
xxxxxxxxxx
x 
xxxxxxxxxx
x 
xxxxxxxxxx
x 
xxxxxx      xxxx
xxxxxxxxx     xxxxxxxxxx
xxxxxxxxxx
x 
xxxxxxxxxx
x 
xxxxxx      xxxx
xxxxxxxxx     xxxxxxxxxx
xxxxxxxxxx
x 
xxxxxxxxxx
x 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Listing sorted by Subject, and Date of Dosing Deviation.  


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 177 of 202  
CONFIDENTIAL 
Listing 16.2.6.1: Investigator Global Assessment (IGA) 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________                 
                                                                                              
S: Subject                                         Whole Body            Does the Subject        Intertriginous  
A: Age/Sex                        Date of          Investigator Global   have Intertriginous     Investigator Global      Evaluator       
E: Eval         Visit             Assessment       Assessment Score      Area involvement?       Assessment Score         Initials 
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx       SCREENING         xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx             xxx  
A: xxxx 
E: xxxxxxxx 
                BASELINE          xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx             xxx 
                WEEK 2            xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx             xxx                         
                WEEK 4            xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx             xxx                
                WEEK 6            xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx             xxx                
                WEEK 8            xxxxxxxxxx       x x xxxxxxxx           xx                                               xxx  
                WEEK 12           xxxxxxxxxx       x x xxxxxxxx           xx                                               xxx 
                WEEK 16           xxxxxxxxxx       x x xxxxxxxx           xx                                               xxx               
 
S: xxxxxx       SCREENING         xxxxxxxxxx       x x xxxxxxxx           xx                                               x-x                         
A: xxxx 
E: xxxxxxxx 
                BASELINE          xxxxxxxxxx       x x xxxxxxxx           xx                                               x-x  
                WEEK 2            xxxxxxxxxx       x x xxxxxxxx           xx                                               x-x                         
                WEEK 4            xxxxxxxxxx       x x xxxxxxxx           xx                                               x-x               
                WEEK 6            xxxxxxxxxx       x x xxxxxxxx           xx                                               xxx               
                WEEK 8            xxxxxxxxxx       x x xxxxxxxx           xx                                               xxx   
                WEEK 12           xxxxxxxxxx       x x xxxxxxxx           xx                                               xxx 
                WEEK 16           xxxxxxxxxx       x x xxxxxxxx           xx                                               xxx            
                      
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Listing sorted by Subject, Visit, and Date of Assessment.  
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 178 of 202  
CONFIDENTIAL 
Listing 16.2.6.2: Body Surface Area (BSA) Involved with Psoriasis 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
Subject   Age/Sex  Eval        Visit             Date of Assessment              BSA¹ (%)                     Evaluator Initials 
______________________________________________________________________________________________________________________________________ 
   
xxxxxxxx  xxxx     xxxxxxxxx   xxxxxxx           xxxxxxxxxx                      xx.x                             xxx 
                               xxxxxxxxx         xxxxxxxxxx                      xx.x                             xxx 
                               xxxx x            xxxxxxxxxx                      xx.x                             xxx 
                               xxxx x            xxxxxxxxxx                      xx.x                             xxx 
                               xxxx x            xxxxxxxxxx                      xx.x                             xxx 
                               xxxx x            xxxxxxxxxx                      xx.x                             xxx 
                               xxxx xx           xxxxxxxxxx                      xx.x                             xxx 
 
 
xxxxxxxx  xxxx     xxxxxxxxx   xxxxxxx           xxxxxxxxxx                      xx.x                             xxx 
                               xxxxxxxxx         xxxxxxxxxx                      xx.x                             xxx 
                               xxxx x            xxxxxxxxxx                      xx.x                             xxx 
                               xxxx x            xxxxxxxxxx                      xx.x                             xxx 
                               xxxx x            xxxxxxxxxx                      xx.x                             xxx 
                               xxxx x            xxxxxxxxxx                      xx.x                             xxx 
                               xxxx xx           xxxxxxxxxx                      xx.x                             xxx 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
¹ Body Surface Area (BSA) involved with psoriasis (excluding the scalp, palms and soles). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit, Date of Assessment. 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 179 of 202  
CONFIDENTIAL 
 
Listing 16.2.6.3: Modified Psoriasis Area and Severity Index (mPASI) 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
                V: Visit                                                                                             
S: Subject      D: Date                                           
A: Age/Sex      E: Evaluator     Affected    Percent of       ___________________________Parameter Score___________________________    
E: Eval            Initials      Area        Skin Involved    Erythema (redness)    Induration (thickness)   Desquamation (scaling)      
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx       V: SCREENING     Arms        xx–xx            x - xxxxxxx xxxxxxxx  x - xxxxxxx xxxxxxxx     x - xxxxxxx xxxxxxxx                      
A: xxxx         D: xxxxxxxxxx                                                                                                                         
E: xxxxxxxxx    E: xxx       
                                 Head        xx-xx            x - xxxxxxx xxxxxxxx  x - xxxxxxx xxxxxxxx     x - xxxxxxx xxxxxxxx   
                                 Legs        xx-xx            x - xxxx              x - xxxx                 x 
                                 Trunk       x.x              x - xxxx              x - xxxx                 x 
 
                V: BASELINE      Arms        x.x              x                     x                        x                                         
                D: xxxxxxxxxx                                                                                                                          
                E: xxx       
                                 Head        x.x              x - xxxxxxx xxxxxxxx  x - xxxxxxx xxxxxxxx     x - xxxxxxx xxxxxxxx                      
                                 Legs        xx–xx            x - xxxx              x - xxxx                 x 
                                 Trunk       xx–xx            x - xxxx              x - xxxx                 x 
 
                V: WEEK 2        Arms        xx–xx            x                     x                        x                                         
                D: xxxxxxxxxx                                                                                                                          
                E: xxx       
                                 Head        xx–xx            x                     x                        x                                         
                                 Legs        xx–xx            x - xxxx              x - xxxx                 x - xxxx 
                                 Trunk       xx–xx            x - xxxx              x - xxxx                 x - xxxx 
 
                V: WEEK 6        Arms        xx–xx            x - xxxx              x - xxxx                 x                                        
                D: xxxxxxxxxx                                                                                                                         
                E: xxx       
                                 Head        xx–xx            x - xxxx              x                        x - xxxx                                  
                                 Legs        x.x              x - xxxx              x - xxxx                 x - xxxx 
                                 Trunk       xx–xx            x - xxxx              x - xxxx                 x - xxxx             
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME)  
 
Listing sorted by Subject, Visit, Date, and Affected Area. If < 10% of skin involved, present actual percent involved. 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 180 of 202  
CONFIDENTIAL 
 
Listing 16.2.6.4: Numeric Rating Scale (NRS) Assessments/Sleep Loss 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
                                                   Date of                                            Patient Reported 
Subject     Age/Sex   Eval        Visit            Assessment           Assessment                    Severity Score 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx      xxxx      xxxxxxxx    SCREENING        xxxxxxxxxx           xxxxxxxxxxx                   x - xx xxxxxxx 
                                                                        xxxxxxxxxxx  xx               xx - xxxxx xxxxxxxxxx xxxx      
                                                                        xxxxxxxxxxxxxxxxxxxxxxx       x 
 
                                  BASELINE         xxxxxxxxxx           xxxxxxxxxxx                   x   
                                                                        xxxxxxxxxxx  xx               x           
                                                                        xxxxxxxxxxxxxxxxxxxxxxx       x - xx xxxx-xxxxxxx xxxxx xxxx 
 
                                  WEEK 2           xxxxxxxxxx           xxxxxxxxxxx                   x   
                                                                        xxxxxxxxxxx  xx               x           
                                                                        xxxxxxxxxxxxxxxxxxxxxxx       x - xx xxxx-xxxxxxx xxxxx xxxx 
 
                                  WEEK 4           xxxxxxxxxx           xxxxxxxxxxx                   x - xx xxxx   
                                                                        xxxxxxxxxxx  xx               x           
                                                                        xxxxxxxxxxxxxxxxxxxxxxx       x - xx xxxx-xxxxxxx xxxxx xxxx 
 
                                  WEEK 6           xxxxxxxxxx           xxxxxxxxxxx                   x - xx xxxx   
                                                                        xxxxxxxxxxx  xx               x           
                                                                        xxxxxxxxxxxxxxxxxxxxxxx       x - xx xxxx-xxxxxxx xxxxx xxxx 
 
                                  WEEK 8           xxxxxxxxxx           xxxxxxxxxxx                   x - xx xxxx   
                                                                        xxxxxxxxxxx  xx               x           
                                                                        xxxxxxxxxxxxxxxxxxxxxxx       x - xx xxxx-xxxxxxx xxxxx xxxx 
 
                                  WEEK 12          xxxxxxxxxx           xxxxxxxxxxx                   x - xx xxxx   
                                                                        xxxxxxxxxxx  xx               x           
                                                                        xxxxxxxxxxxxxxxxxxxxxxx       x - xx xxxx-xxxxxxx xxxxx xxxx 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: Score is the patient-reported severity of this symptom at its highest intensity during the previous 24-hour period. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
Listing sorted by Subject, Visit, Date, and Assessment. 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 181 of 202  
CONFIDENTIAL 
 
Listing 16.2.6.5.1: Dermatology Life Quality Index (DLQI) Questionnaire Descriptions  
 
______________________________________________________________________________________________________________________________________ 
                 
Number   DLQI Question                                                                                           
______________________________________________________________________________________________________________________________________ 
 
    1   Over the last week, how itchy, sore, painful or stinging has your skin been? 
                                                                                                                           
     2   Over the last week, how embarrassed or self conscious have you been because of your skin? 
 
     3   Over the last week, how much has your skin interfered with you going shopping or looking after your home or garden? 
 
     4   Over the last week, how much has your skin influenced the clothes you wear? 
 
     5   Over the last week, how much has your skin affected any social or leisure activities? 
 
     6   Over the last week, how much has your skin made it difficult for you to do any sport? 
 
    7a   Over the last week, has your skin prevented you from working or studying? 
 
    7b   If "No", over the last week how much has your skin been a problem at work or studying? 
 
     8   Over the last week, how much has your skin created problems with your partner or any of your close friends or relatives? 
 
     9   Over the last week, how much has your skin caused any sexual difficulties? 
 
    10   Over the last week, how much of a problem has the treatment for your skin been, for example by making your home messy, or by 
         taking up time? 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Question Number. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 182 of 202  
CONFIDENTIAL 
 
Listing 16.2.6.5.2: Dermatology Life Quality Index (DLQI) Questionnaire  
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                  
                                                    Date of  
Subject    Age/Sex     Eval           Visit         Assessment        1    2    3    4    5    6    7a    7b    8    9    10    
______________________________________________________________________________________________________________________________________ 
 
xxxxxx     xxxx        xxxxxxxxx      xxxxxxxxx     xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x   
                                      xxxxxxxx      xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x      
                                      xxxx x        xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x      
                                      xxxx x        xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x               
                                      xxxx x        xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x                
                                      xxxx xx       xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x    
  
xxxxxx     xxxx        xxxxxxxxx      xxxxxxxxx     xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x   
                                      xxxxxxxx      xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x      
                                      xxxx x        xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x      
                                      xxxx x        xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x               
                                      xxxx x        xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x                
                                      xxxx xx       xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x    
 
xxxxxx     xxxx        xxxxxxxxx      xxxxxxxxx     xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x   
                                      xxxxxxxx      xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x      
                                      xxxx x        xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x      
                                      xxxx x        xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x               
                                      xxxx x        xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x                
                                      xxxx xx       xxxxxxxxxx        x    x    x    x    x    x     x     x    x    x     x    
           
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: Questions 1-6, 7b-10: 1 = Very much, 2 = A lot, 3 = A little, 4 = Not at all. 
      Question 7a: 1 = Yes, 0 = No.  
      NR = Not relevant. 
      ND = Not done. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit, and Date of assessment 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 183 of 202  
CONFIDENTIAL 
Listing 16.2.6.6.1: Work Productivity and Activity Impairment (WPAI) Questionnaire Descriptions 
 
______________________________________________________________________________________________________________________________________ 
                 
Number   WPAI Question                                                                                           
______________________________________________________________________________________________________________________________________ 
 
    1   Are you currently employed (working for pay)? 
                                                                                                                           
     2   During the past seven days, how many hours did you miss from work because of problems associated with your psoriasis?  
         Include hours you missed on sick days, times you went in late, left early, etc., because of your psoriasis. Do not include 
         time you missed to participate in this study.                          
 
     3   During the past seven days, how many hours did you miss from work because of any other reason, such as vacation, holidays, 
         time off to participate in this study?   
 
     4   During the past seven days, how many hours did you actually work? 
 
     5   During the past seven days, how much did your psoriasis affect your productivity while you were working? 
 
     6   During the past seven days, how much did your psoriasis affect your ability to do your regular daily activities, other than  
         work at a job? 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Question Number. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 184 of 202  
CONFIDENTIAL 
Listing 16.2.6.6.2: Work Productivity and Activity Impairment (WPAI) Questionnaire 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                  
S: Subject                                              
A: Age/Sex   V: Visit                              2. Psoriasis     3. Other      4. Hours   5. Productivity     6. Regular Activities 
E: Eval      D: Date of Assessment  1. Employed    Hours Missed    Hours Missed    Worked        Affected              Affected 
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx    V: xxxx                   xxx         xxx.x          xxx.x          xxx.x       x                   x   
A: xx xxxx   D: xxxxxxx                 
E: xx xx                             
 
             V: xxxx                   xxx         xxx.x          xxx.x          xxx.x       x                   x   
             D: xxxxxxx                 
 
 
S: xxxxxx    V: xxxx                   xxx         xxx.x          xxx.x          xxx.x       x                   x   
A: xx xxxx   D: xxxxxxx                 
E: xx xx             
             V: xxxx                   xxx         xxx.x          xxx.x          xxx.x       x                   x   
             D: xxxxxxx                 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: Questions 2 - 5 are answered conditionally based on the response to Question 1. 
      Questions 2 - 4 are reported in hours. 
      Question 5: Scaled (0 - Psoriasis had no effect on my) to (10 - Psoriasis completely prevented me from working). 
      Question 6: Scaled (0 - Psoriasis had no effect on my daily activities) to (10 - Psoriasis completely prevented me from doing my 
      daily activities). 
      ND = Not done. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit, and Date of assessment 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 185 of 202  
CONFIDENTIAL 
Listing 16.2.6.7: Columbia-Suicide Severity Rating Scale (C-SSRS) 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                 
S: Subject                          
A: Age/Sex     V: Visit         
E: Eval        D: Date          Question                                         Time Period       Response          
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx      V: SCREENING     xxxx xx xx xxxx                                  xxxxxxxx          xx 
A: xxxx        D: xxxxxxxxxx                                                     xxxx x xxxxxx     xxx xxxx 
E: xxxxxxxxx     
                                xxx xxxxxxx xxxxx xxxxxxxx xxxxxxx               xxxxxxxx          xxx                    
                                                                                                                      
                                                                                 xxxx x xxxxxx     xx                           
                                xxx xxxxxxx xxxxx xxxxxxxx xxxxxxx               xxxxxxxx          xx 
                                xxx xxxx xxxxxxxx xxxxx xx xxx                   xxxx x xxxxxx     xx 
                                xxxxxx xxxxxxx xxxxxxx xxxx xxxxx                xxxxxxxx          xx 
                                xx xxx xxxxxxx xxxxxxx xxxx                      xxxx x xxxxxx     xx 
                                xxxxxx xxxxxxx xxxxxxx xxxx xxxxx                xxxxxxxx          xxx                    
                                xxxx xxx xxxxxx                                  xxxx x xxxxxx     xx  
                                xxxx xxxxxx xxxxxxx                              xxxxxxxx          x                      
                                                                                                              
                                                                                 xxxx x xxxxxx     xxx xxxx 
                                xxx xxxx xxxxx xxxx xxxx xxxx xxxx               xxxxxxxx          x xxx xxxx 
                                                                                 xxxx x xxxxxx     xxx xxxx 
                                xxxx xx xxx xxxx xxxxx xxxxxxx                   xxxxxxxx          x x xxx xx xx 
                                xxx xxx xxxx xx xxxx xxxx                        xxxx x xxxxxx     xxx xxxx                             
                                xxxxxxx xxxxxxx                                  xxxxxxxx          xx 
                                                                                 xxxx x xxxxxx     xxx xxxx 
                                xxx xxxxxxx xxxxxx xx xxx xxxxxx                 xxxxxxxx          xx 
                                xxxxxxxxxxx xxxxxxxx                             xxxx x xxxxxx     xx 
                                xxxxxxxxx xxxxxxx                                xxxxxxxx          xxx xxxxx 
                                                                                 xxxx x xxxxxx     xxx xxxx 
 
               V: BASELINE      xxxx xx xx xxxx                                  xxxxx xxxx xxxxx  xx 
               D: xxxxxxxxxx  
                                                  
                                xxx xxxxxxx xxxxx xxxxxxxx xxxxxxx               xxxxx xxxx xxxxx  xx                                                  
                                xxx xxxxxxx xxxxx xxxxxxxx xxxxxxx               xxxxx xxxx xxxxx  xx 
                                xxx xxxx xxxxxxxx xxxxx xx xxx                              
                                                                 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit, Date, Question (in order in CRF), and Time Period (in order in CRF). All additional information 
(such as description, number of attempts) will be concatenated onto the response for the main question. 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 186 of 202  
CONFIDENTIAL 
Listing 16.2.6.8.1: Patient Health Questionnaire Depression Scale (PHQ-8) Question Descriptions  
 
______________________________________________________________________________________________________________________________________ 
                 
Number   PHQ-8 Question                                                                                           
______________________________________________________________________________________________________________________________________ 
 
    1   How often during the past 2 weeks were you bothered by: Little interest or pleasure in doing things? 
                                                                                                                           
     2   How often during the past 2 weeks were you bothered by: Feeling down, depressed, or hopeless?  
 
     3   How often during the past 2 weeks were you bothered by: Trouble falling or staying asleep, or sleeping too much? 
 
     4   How often during the past 2 weeks were you bothered by: Feeling tired or having little energy? 
 
     5   How often during the past 2 weeks were you bothered by: Poor appetite or overeating? 
 
     6   How often during the past 2 weeks were you bothered by: Feeling bad about yourself, or that you are a failure, or have let 
         yourself or your family down? 
 
     7   How often during the past 2 weeks were you bothered by: Trouble concentrating on things, such as reading the newspaper or 
         watching television? 
 
     8   How often during the past 2 weeks were you bothered by: Moving or speaking so slowly that other people could have 
         noticed. Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual? 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Question Number. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 187 of 202  
CONFIDENTIAL 
Listing 16.2.6.8.2: Patient Health Questionnaire Depression Scale (PHQ-8)  
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                  
                                                    Date of  
Subject    Age/Sex     Eval           Visit         Assessment        1      2      3      4      5      6      7      8    
______________________________________________________________________________________________________________________________________ 
 
xxxxxx     xxxx        xxxxxxxxx      xxxxxxxxx     xxxxxxxxxx        x      x      x      x      x      x      x      x    
                                      xxxxxxxx      xxxxxxxxxx        x      x      x      x      x      x      x      x       
                                      xxxx x        xxxxxxxxxx        x      x      x      x      x      x      x      x      
                                      xxxx x        xxxxxxxxxx        x      x      x      x      x      x      x      x      
                                      xxxx xx       xxxxxxxxxx        x      x      x      x      x      x      x      x     
            
xxxxxx     xxxx        xxxxxxxxx      xxxxxxxxx     xxxxxxxxxx        x      x      x      x      x      x      x      x    
                                      xxxxxxxx      xxxxxxxxxx        x      x      x      x      x      x      x      x       
                                      xxxx x        xxxxxxxxxx        x      x      x      x      x      x      x      x      
                                      xxxx x        xxxxxxxxxx        x      x      x      x      x      x      x      x      
                                      xxxx xx       xxxxxxxxxx        x      x      x      x      x      x      x      x     
 
xxxxxx     xxxx        xxxxxxxxx      xxxxxxxxx     xxxxxxxxxx        x      x      x      x      x      x      x      x    
                                      xxxxxxxx      xxxxxxxxxx        x      x      x      x      x      x      x      x       
                                      xxxx x        xxxxxxxxxx        x      x      x      x      x      x      x      x      
                                      xxxx x        xxxxxxxxxx        x      x      x      x      x      x      x      x      
                                      xxxx xx       xxxxxxxxxx        x      x      x      x      x      x      x      x     
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: For all Questions: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day, ND = Not Done. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
Listing sorted by Subject, Visit, and Date of Assessment. 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 188 of 202  
CONFIDENTIAL 
Listing 16.2.6.9.1: Psoriasis Symptom Diary (PSD) Questionnaire Descriptions  
 
______________________________________________________________________________________________________________________________________ 
                 
Number   PSD Question                                                                                           
______________________________________________________________________________________________________________________________________ 
 
    1   Overall, how severe was your psoriasis-related itching over the past 24 hours?     
                                                                                                                           
     2   Overall, how bothered were you by your psoriasis-related itching over the past 24 hours?   
 
     3   Overall, how severe was your psoriasis-related stinging over the past 24 hours? 
 
     4   Overall, how bothered were you by your psoriasis-related stinging over the past 24 hours? 
 
     5   Overall, how severe was your psoriasis-related burning over the past 24 hours? 
 
     6   Overall, how bothered were you by your psoriasis-related burning over the past 24 hours? 
 
     7   Overall, how severe was your psoriasis-affected skin cracking over the past 24 hours? 
 
     8   Overall, how bothered were you by your psoriasis-affected skin cracking over the past 24 hours? 
 
     9   Overall, how severe was your psoriasis-related pain over the past 24 hours? 
 
    10   Overall, how bothered were you by your psoriasis-related pain over the past 24 hours?  
                                                   
    11   Overall, how severe was your psoriasis scaling over the past 24 hours? 
 
    12   Overall, how bothered were you by your psoriasis scaling over the past 24 hours? 
 
    13   Overall, how noticeable did you think the colour of your psoriasis-affected skin was over the past 24 hours? 
 
    14   Overall, how much did you try to hide your psoriasis-affected skin over the past 24 hours? 
 
    15   Overall, how much did your psoriasis cause you to avoid activities with other people over the past 24 hours? 
 
    16   Overall, how embarrassed were you because of your psoriasis over the past 24 hours? 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Question Number. 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 189 of 202  
CONFIDENTIAL 
 
Listing 16.2.6.9.2: Psoriasis Symptom Diary (PSD) Questionnaire  
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                  
                                                    Date of  
Subject    Age/Sex     Eval           Visit         Assessment        1   2   3   4   5   6   7   8   9  10  11  12  13  14  15  16               
______________________________________________________________________________________________________________________________________ 
 
xxxxxx     xxxx        xxxxxxxxx      xxxxxxxxx     xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x 
                                      xxxxxxxx      xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x            
                                      xxxx x        xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x               
                                      xxxx x        xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x               
                                      xxxx x        xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x              
                                      xxxx xx       xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   
            
xxxxxx     xxxx        xxxxxxxxx      xxxxxxxxx     xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x 
                                      xxxxxxxx      xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x            
                                      xxxx x        xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x               
                                      xxxx x        xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x               
                                      xxxx x        xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x              
                                      xxxx xx       xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x              
 
xxxxxx     xxxx        xxxxxxxxx      xxxxxxxxx     xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x 
                                      xxxxxxxx      xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x            
                                      xxxx x        xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x               
                                      xxxx x        xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x               
                                      xxxx x        xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x              
                                      xxxx xx       xxxxxxxxxx        x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x              
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: Questions 1, 3, 5, 7, 9, 11: Scaled (0 - None) to (10 - As bad as you can imagine) 
      Questions 2, 4, 6, 8, 10, 12: Scaled (0 - Not bothered at all) to (10 - As bothered as you can imagine) 
      Question 13: Scaled (0 - Not at all noticeable) to (10 - As noticeable as you can imagine) 
      Question 14: Scaled (0 - Did not try to hide at all) to (10 - Totally avoided being seen by others) 
      Question 15: Scaled (0 - You did not avoid other people) to (10 - Avoided other people as much as you ever have) 
      Question 16: Scaled (0 - No embarrassment) to (10 - As embarrassed as you can imagine) 
      ND = Not done. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit, and Date of assessment 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 190 of 202  
CONFIDENTIAL 
Listing 16.2.6.10: Photography Information 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                  
Subject         Age/Sex          Eval            Visit                       Were Photographs Taken?        Date of Photograph 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx           xxxx            xxxxxxxxx       xxxxxxxx                            xxx                    xxxxxxxxxx 
                                                 xxxx x                              xxx                    xxxxxxxxxx 
                                                 xxxx x                              xxx                    xxxxxxxxxx 
                                                 xxxx x                              xxx                    xxxxxxxxxx 
                                                 xxxx xx                             xxx                    xxxxxxxxxx 
 
xxxxxx           xxxx            xxxxxxxxx       xxxxxxxx                            xxx                    xxxxxxxxxx 
                                                 xxxx x                              xxx                    xxxxxxxxxx 
                                                 xxxx x                              xx                     
                                                 xxxx x                              xxx                    xxxxxxxxxx 
                                                 xxxx xx                             xxx                    xxxxxxxxxx 
 
 
xxxxxx           xxxx            xxxxxxxxx       xxxxxxxx                            xxx                    xxxxxxxxxx 
                                                 xxxx x                              xx                    
                                                 xxxx x                              xxx                    xxxxxxxxxx 
                                                 xxxx x                              xxx                    xxxxxxxxxx 
                                                 xxxx xx                             xxx                    xxxxxxxxxx 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit, and Date of Photograph. 
 
 
 
 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 191 of 202  
CONFIDENTIAL 
Listing 16.2.7.1.1: Investigator Local Tolerability Assessment 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
 
S: Subject      V: Visit                                                                                             
A: Age/Sex      D: Date                                          Other Effects  Other Effects                  Locations where Other                   
E: Eval         E: Evaluator Initials  Dermal Response           Assessed?      Present                        Effects are Present 
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx       V: xxxxxxxx            xxxx  xxxxxxxx xxxxxxxx   xxx            xxxxxx xxxxxxxx                xxxx xxxxx 
A: xxxx         D: xxxxxxxxxx xxxx                                              xxxxxx xxxx xxxxxxxx           xxxx xxxxx xxxx xxxx                    
E: xxxxxxxxx    E: xxx 
               
                V: xxxxxxxx            xxxx  xxxxxxxx xxxxxxxx   xxx            xxxxxx xxx  xxxxxxxx           xxxx xxxxx xxxxxxx       
                D: xxxxxxxxxx xxxx     xxxxxxxxx xxxxxx                                         
                E: xxx  
  
                V: xxxxxxxx            xxxx  xxxxxxxx xxxxxxxx   xxx            xxxxxx xxx  xxxxxxxx           xxxx  
                D: xxxxxxxxxx xxxx     xxxxxxxxx xxxxxx                                         
                E: xxx  
 
                V: xxxxxxxx            xxxx  xxxxxxxx xxxxxxxx   xxx            xxxxxx xxx  xxxxxxxx           xxxx  
                D: xxxxxxxxxx xxxx     xxxxxxxxx xxxxxx                                         
                E: xxx  
 
 
S: xxxxxx       V: xxxxxxxx            xxxx  xxxxxxxx xxxxxxxx   xxx            xxxxxx xxxxxxxx                xxxx xxxxx 
A: xxxx         D: xxxxxxxxxx xxxx                                              xxxx xx xxxxx xxxx             xxxx                           
E: xxxxxxxxx    E: xxx                                                          xxxxxxx xxxx xxxxxxx           xxxx 
 
                V: xxxxxxxx            xxxx  xxxxxxxx xxxxxxxx   xxx            xxxxxx xxx  xxxxxxxx           xxxx  
                D: xxxxxxxxxx xxxx     xxxxxxxxx xxxxxx                                         
                E: xxx  
                                                                           
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
Listing sorted by Subject, Visit, and Date. 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 192 of 202  
CONFIDENTIAL 
Listing 16.2.7.1.2: Subject Local Tolerability Assessment 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                  
Subject       Age/Sex       Eval             Visit              Date of Assessment             Subject Reported Tolerability 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx        xxxx          xxxxxxxxx        xxxxxxxx           xxxxxxxxxx                     x xxxxxxxxxx 
                                             xxxx x             xxxxxxxxxx                     x xxxxxxxxxx 
                                             xxxx x             xxxxxxxxxx                     x xxxx 
                                             xxxx xx            xxxxxxxxxx                     x xxxx 
 
xxxxxx        xxxx          xxxxxxxxx        xxxxxxxx           xxxxxxxxxx                     x xxxx 
                                             xxxx x             xxxxxxxxxx                     x xxxx 
                                             xxxx x             xxxxxxxxxx                     x xxxx 
                                             xxxx xx            xxxxxxxxxx                     x xxxx 
 
xxxxxx        xxxx          xxxxxxxxx        xxxxxxxx           xxxxxxxxxx                     x xxxx 
                                             xxxx x             xxxxxxxxxx                     x xxxxxxx 
                                             xxxx x             xxxxxxxxxx                     x xxxx 
                                             xxxx xx            xxxxxxxxxx                     x xxxx 
 
xxxxxx        xxxx          xxxxxxxxx        xxxxxxxx           xxxxxxxxxx                     x xxxx 
                                             xxxx x             xxxxxxxxxx                     x xxxx 
                                             xxxx x             xxxxxxxxxx                     x xxxx 
                                             xxxx xx            xxxxxxxxxx                     x xxxx 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit, and Date of Assessment. 
 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 193 of 202  
CONFIDENTIAL 
Listing 16.2.7.2.1: Unique Adverse Events Coded to MedDRA System Organ Classes and Preferred Terms 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
MedDRA System Organ Class                      MedDRA Preferred Term                       Adverse Event 
______________________________________________________________________________________________________________________________________ 
 
xxxxx xxx xxxxxxxxx xxxxxx xxxxxxxxx           xxxxxxx                                     xxxxxx 
 
                                                                                           xxxxxx 
 
                                               xxxxxxxxxxxx                                xxxxxxxxxxxx 
 
xxx xxx xxxxxxxxx xxxxxxxxx                    xxxxxxx                                     xxxxxxx 
 
xxx xxxxxxxxx                                  xxxxxx xxxxxx xxxxxxx                       xxxxxxxxx xxxxxx xxxxxx 
 
xxxxxxxxxxxxxxxx xxxxxxxxx                     xxxxxxxxx xxxx                              xxxxxxxxx xxxx 
 
                                               xxxxxxxxx xxxxxxxxxxxx                      xxxxx xxxxxxxxx xxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by MedDRA System Organ Class, MedDRA Preferred Term, and Adverse Event. 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 194 of 202  
CONFIDENTIAL 
Listing 16.2.7.2.2: Treatment-Emergent Adverse Events 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                    
                                                                                                     S: Serious Event? 
                                                                         G: Grade2                    A: In Treatment Area?    
S: Subject         A: Adverse Event           F: Date of First Dose      R: Relationship to          T: Action Taken with     
A: Age/Sex         C: System Organ Class      S: Start Date (Day)¹          Study Drug                  Study Drug 
E: Eval            P: Preferred Term          E: End Date (Day)1          O: Outcome                  E: Action Taken to Treat Event  
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx          A: xxxxxxxxxxxxxxx         F: xxxxxxxxxx              G: xxxx                     S: xx 
A: xxxx            C: xxxxxxxxxxxxxxx         S: xxxxxxxxxx xxxx         R: xxxxxxxxxx               A: xxxx  
E: xxxxxxxxx       P: xxxxxxxxxxxxxxx         E: xxxxxxxxxx xxxx         O: xxxxxxxxxx               T: xxx 
                                                                                                     E: xxxxxxx 
 
S: xxxxxx          A: xxxxxxxxxxxxxxx         F: xxxxxxxxxx              G: xxxx                     S: xx 
A: xxxx            C: xxxxxxxxxxxxxxx         S: xxxxxxxxxx xxxx         R: xxxxxxxxxx               A: xxxx  
E: xxxxxxxxx       P: xxxxxxxxxxxxxxx         E: xxxxxxxxxx xxxx         O: xxxxxxxxxx               T: xxx 
                                                                                                     E: xxxxxxx 
 
S: xxxxxx          A: xxxxxxxxxxxxxxx         F: xxxxxxxxxx              G: xxxx                     S: xx 
A: xxxx            C: xxxxxxxxxxxxxxx         S: xxxxxxxxxx xxxx         R: xxxxxxxxxx               A: xx 
E: xxxxxxxxx       P: xxxxxxxxxxxxxxx         E: xxxxxxxxxx xxxx         O: xxxxxxxxxx               T: xxx 
                                                                                                     E: xxxxxxx 
 
 
 
 
 
 
 
 
  
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – date of first dose for dates prior to first dose.  Otherwise, day is calculated as 
  date – date of first dose + 1 for dates on or after first dose. 
2 Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life Threatening; Grade 5 = Death. 
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
Listing sorted by Subject, Start Date, End Date, and Adverse Event. 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 195 of 202  
CONFIDENTIAL 
Listing 16.2.7.2.3: Serious Adverse Events 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                    
                                                                                                     S: Serious Evemt? 
                                                                         G: Grade2                    A: In Treatment Area?    
S: Subject         A: Adverse Event           F: Date of First Dose      R: Relationship to          T: Action Taken with     
A: Age/Sex         C: System Organ Class      S: Start Date (Day)¹          Study Drug                  Study Drug 
E: Eval            P: Preferred Term          E: End Date (Day)1          O: Outcome                  E: Action Taken to Treat Event  
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx          A: xxxxxxxxxxxxxxx         F: xxxxxxxxxx              G: xxxx                     S: xxx 
A: xxxx            C: xxxxxxxxxxxxxxx         S: xxxxxxxxxx xxxx         R: xxxxxxxxxx               A: xxxx  
E: xxxxxxxxx       P: xxxxxxxxxxxxxxx         E: xxxxxxxxxx xxxx         O: xxxxxxxxxx               T: xxx 
                                                                                                     E: xxxxxxx 
 
S: xxxxxx          A: xxxxxxxxxxxxxxx         F: xxxxxxxxxx              G: xxxx                     S: xxx 
A: xxxx            C: xxxxxxxxxxxxxxx         S: xxxxxxxxxx xxxx         R: xxxxxxxxxx               A: xxxx  
E: xxxxxxxxx       P: xxxxxxxxxxxxxxx         E: xxxxxxxxxx xxxx         O: xxxxxxxxxx               T: xxx 
                                                                                                     E: xxxxxxx 
 
S: xxxxxx          A: xxxxxxxxxxxxxxx         F: xxxxxxxxxx              G: xxxx                     S: xxx 
A: xxxx            C: xxxxxxxxxxxxxxx         S: xxxxxxxxxx xxxx         R: xxxxxxxxxx               A: xx 
E: xxxxxxxxx       P: xxxxxxxxxxxxxxx         E: xxxxxxxxxx xxxx         O: xxxxxxxxxx               T: xxx 
                                                                                                     E: xxxxxxx 
 
 
 
 
 
 
 
 
  
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – date of first dose for dates prior to first dose.  Otherwise, day is calculated as 
  date – date of first dose + 1 for dates on or after first dose. 
2 Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life Threatening; Grade 5 = Death. 
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
Listing sorted by Subject, Start Date, End Date, and Adverse Event. 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 196 of 202  
CONFIDENTIAL 
Listing 16.2.7.2.4: Subjects Who Permanently Discontinued Study Drug Due to Adverse Events 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                
S: Subject            R: Primary Reason for Study          ______________________________Adverse Events_______________________________ 
A: Age/Sex               Completion/Discontinuation                                     G: Grade² 
E: Eval               S: Date of Study                     A: Adverse Event Description R: Relationship to 
F: Date of First Dose    Completion/Discontinuation (Day)¹ C: System Organ Class           Study Drug             S: Start Date (Day)¹ 
L: Date of Last Dose  V: Last Visit Attended               P: Preferred Term            A: Action Taken           E: End Date (Day)¹ 
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx             R: xxxxxxx xxxxx                     A: xxxxxxxx xxx              G: xxxxx x                S: xxxxxxxxxx xxxx 
A: xxxx               S: xxxxxxxxxx xxxx                   C: xxxxxxxxx xxxx            R: xxxxxxxxx              E: xxxxxxxxxx xxxx 
E: xxxxxxxxx          V: xxxx x                            P: xxxxxxxxx xxxxxxx xxxx    A: xxxxxxx xxxxxxxxx 
F: xxxxxxxxxx                                                 xxxxxxxxx                    xxxxxx 
L: xxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – date of first dose for dates prior to first dose.  Otherwise, day is calculated as 
  date – date of first dose + 1 for dates on or after first dose. 
2 Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life Threatening; Grade 5 = Death. 
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 
 


 
 
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Listing 16.2.8.1: Urine Pregnancy Test Results 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
Subject     Age/Sex     Eval          Visit                    Date                             Result 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx      xxxx        xxxxxxxx      xxxxxxxxx                xxxxxxxxxx                       xxxxxxxx 
                                      xxxxxxxx                 xxxxxxxxxx                       xxxxxxxx 
                                      xxxx x                   xxxxxxxxxx                       xxxxxxxx 
                                      xxxx x                   xxxxxxxxxx                       xxxxxxxx 
                                      xxxx xx                  xxxxxxxxxx                       xxxxxxxx 
 
xxxxxx      xxxx        xxxxxxxx      xxxxxxxxx                xxxxxxxxxx                       xxxxxxxx 
                                      xxxxxxxx                 xxxxxxxxxx                       xxxxxxxx 
                                      xxxx x                   xxxxxxxxxx                       xxxxxxxx 
                                      xxxx x                   xxxxxxxxxx                       xxxxxxxx 
                                      xxxx x                   xxxxxxxxxx                       xxxxxxxx 
                                      xxxx xx                  xxxxxxxxxx                       xxxxxxxx 
 
xxxxxx      xxxx        xxxxxxxx      xxxxxxxxx                xxxxxxxxxx                       xxxxxxxx 
                                      xxxxxxxx                 xxxxxxxxxx                       xxxxxxxx 
                                      xxxx x                   xxxxxxxxxx                       xxxxxxxx 
                                      xxxx x                   xxxxxxxxxx                       xxxxxxxx 
                                      xxxxxxxxx xx             xxxxxxxxxx                       xxxxxxxx 
                                      xxxx xx                  xxxxxxxxxx                       xxxxxxxx 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
Listing sorted by Subject, Visit, and Date. 
 
 
 
 
 


 
 
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Listing 16.2.8.2.1: Laboratory Test Results 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
    
S: Subject    V: Visit 
A: Age/Sex    D: Date/Time                                               Results      _______________Reference Range_______________    
E: Eval       C: Category              Laboratory Test                   (Units)       Normal Range             Indicator (CS¹)            
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx     V: xxxxxxxxx             xxxxxxxxxxxxxxxxxx                xx (xx)       x to xx                  xxxxxx xxxx    
A: xxxx       D: xxxx-xx-xxTxx:xx:xx 
E: xxxxxxxxx  C: xxxxxxxxxx   
 
                                       xxxxxxxxxxxxxxxxxx                xx (x)        xx to xx                 xxxxxx xxxx    
                                       xxxxxxxxxxxxxxxxxx                xx (x)        xx to xx                 xxxxxx xxxx    
                      
                   
                                       xxxxxxxxxxxxxxxxxx                xx (xx)       xx to xx                 xxxxxx xxxx            
                                       xxxxxxxxxxxxxxxxxx                xx xx (xx)    xx to xx                 xxxxxx xxxx    
                                       xxxxxxxxxxxxxxxxxx                xxx xxxxxx    xxxxx xxxx xxxx          xxxxxx xxxx    
 
                                       xxxxxxxxxxxxxxxxxx                xxxxxxxxx     xxxxxxxxx                xxxxxx xxxxx         
                                                                                                                    
                                                                                                                    
                                       xxxxxxxxxxxxxxxxxx                xx (xx)       x to xx                  xxxxxx xxxx    
               
                                                                         
 
 
 
 
______________________________________________________________________________________________________________________________________ 
¹ Clinically Significant per Investigator. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit, Date/Time, Category, and Lab Test. 
 
 
 
 
 


 
 
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Listing 16.2.8.2.2: Abnormal Laboratory Results 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
    
S: Subject    V: Visit 
A: Age/Sex    D: Date/Time                                               Results      _______________Reference Range_______________    
E: Eval       C: Category              Laboratory Test                   (Units)       Normal Range             Indicator (CS¹)            
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx     V: xxxxxxxxx             xxxxxxxxxxxxxxxxxx                xx (xx)       x to xx                  xxxxxx xxxx    
A: xxxx       D: xxxx-xx-xxTxx:xx:xx 
E: xxxxxxxxx  C: xxxxxxxxxx   
 
                                       xxxxxxxxxxxxxxxxxx                xx (x)        xx to xx                 xxxxxx xxxx    
                                       xxxxxxxxxxxxxxxxxx                xx (x)        xx to xx                 xxxxxx xxxx    
                      
                   
                                       xxxxxxxxxxxxxxxxxx                xx (xx)       xx to xx                 xxxxxx xxxx            
                                       xxxxxxxxxxxxxxxxxx                xx xx (xx)    xx to xx                 xxxxxx xxxx    
                                       xxxxxxxxxxxxxxxxxx                xxx xxxxxx    xxxxx xxxx xxxx          xxxxxx xxxx    
 
                                       xxxxxxxxxxxxxxxxxx                xxxxxxxxx     xxxxxxxxx                xxxxxx xxxxx         
                                                                                                                    
                                                                                                                    
                                       xxxxxxxxxxxxxxxxxx                xx (xx)       x to xx                  xxxxxx xxxx    
               
                                                                         
 
 
 
 
______________________________________________________________________________________________________________________________________ 
¹ Clinically Significant per Investigator. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit, Date/Time, Category, and Lab Test. 
 
 
 
 
 
 


 
 
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Listing 16.2.8.3: 12-lead Electrocardiogram Test Results 
Treatment Group 
(Page x of xx) 
 
_____________________________________________________________________________________________________________________________________ 
                                 
                                    V: Visit                                                                            
Subject      Age/Sex    Eval        D: Date/Time of ECG        Category      Evaluator        ECG Parameter    Result (Units)   
_____________________________________________________________________________________________________________________________________ 
 
xxxxxxxxx    xxxx       xxxxxxxx    V: xxxxxxxxx               xxxxxxxxxx    xxxxxxxxxxxx     xxxxxxxxxx       xxxx xxxxx xx              
                                    D: xxxx-xx-xxTxx:xx:xx                   xxxxxxxxxxxx     xxxxxxxxxx       xxxx xxxxx xx              
                                                                                              xxxxxxxxxx       xxxx xxxxx xx              
                                                                                              xxxxxxxxxx       xxxx xxxxx xx              
                                                                                              xxxxxxxxxx       xxxx xxxxx xx              
                                                                                              xxxxxxxxxx       xxxx xxxxx xx              
                                                                                              xxxxxxxxxx       xxxx xxxxx xx              
                                                                                              xxxxxxxxxx       xxxx xxxxx xx              
 
xxxxxxxxx    xxxx       xxxxxxxx    V: xxxxxxxxx               xxxxxxxxxx    xxxxxxxxxxxx     xxxxxxxxxx       xxxx xxxxx xx              
                                    D: xxxx-xx-xxTxx:xx:xx                   xxxxxxxxxxxx     xxxxxxxxxx       xxxx xxxxx xx              
                                                                                              xxxxxxxxxx       xxxx xxxxx xx              
                                                                                              xxxxxxxxxx       xxxx xxxxx xx              
                                                                                              xxxxxxxxxx       xxxx xxxxx xx              
                                                                                              xxxxxxxxxx       xxxx xxxxx xx              
                                                                                              xxxxxxxxxx       xxxx xxxxx xx              
                                                                                              xxxxxxxxxx       xxxx xxxxx xx              
 
 
 
 
 
 
 
                   
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit, Date/Time, Category, and ECG Parameter. 
 
 


 
 
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Listing 16.2.8.4: Vital Signs 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
Subject    Age/Sex    Eval         Visit            Date             Vital Sign                   Result          Units 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx     xxxx       xxxxxxxx     SCREENING        xxxxxxxxxx       Temperature                  xxxx            x 
                                                                     Heart Rate                   xx              xxxxxxxxx 
                                                                     Systolic Blood Pressure      xxx             xxxx 
                                                                     Diastolic Blood Pressure     xx              xxxx                                 
 
                                   BASELINE         xxxxxxxxxx       Temperature                  xxxx            x 
                                                                     Heart Rate                   xx              xxxxxxxxx 
                                                                     Systolic Blood Pressure      xxx             xxxx 
                                                                     Diastolic Blood Pressure     xx              xxxx 
                                                                     Height                       xx              xx 
                                                                     Weight                       xxx             xx 
 
                                   xxxx x           xxxxxxxxxx       Temperature                  xxxx            x 
                                                                     Heart Rate                   xx              xxxxxxxxx 
                                                                     Systolic Blood Pressure      xxx             xxxx 
                                                                     Diastolic Blood Pressure     xx              xxxx 
                                                                     Weight                       xxx             xx 
 
 
                                   xxxx x           xxxxxxxxxx       Temperature                  xxxx            x 
                                                                     Heart Rate                   xx              xxxxxxxxx 
                                                                     Systolic Blood Pressure      xxx             xxxx 
                                                                     Diastolic Blood Pressure     xx              xxxx 
                                                                     Weight                       xxx             xx 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit, Date, and Vital Sign (in the order displayed in the CRF). 
 
 


 
 
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Listing 16.2.8.5: Pharmacokinetics Blood Sample Collections 
Treatment Group 
(Page x of xx) 
 
_____________________________________________________________________________________________________________________________________ 
 
 S: Subject                   Date/Time                
 A: Age/Sex                   of Pre-Dose            Percent BSA          Additional PK                 Date/Time PK           
 E: Eval       Visit          PK Sample              Being Treated        Sample Collections¹           Sample Obtained          
_____________________________________________________________________________________________________________________________________ 
 
 S: xxxxxx     xxxxxxxxxx     xxxx-xx-xxTxx:xx:xx       xx.x%             72-Hour PK Sample             xxxx-xx-xxTxx:xx:xx                            
 A: xxxx                                                                    
 E: xxxxx                                                                  
                                                                          120-Hour PK Sample            xxxx-xx-xxTxx:xx:xx                            
                                                                          168-Hour PK Sample            xxxx-xx-xxTxx:xx:xx 
                                                                          216-Hour PK Sample            xxxx-xx-xxTxx:xx:xx 
 
 S: xxxxxx     xxxxxxxxxx     xxxx-xx-xxTxx:xx:xx       xx.x%              
 A: xxxx                                                                    
 E: xxxxx                                                                  
 
 S: xxxxxx     xxxxxxxxxx     xxxx-xx-xxTxx:xx:xx       xx.x%             72-Hour PK Sample             xxxx-xx-xxTxx:xx:xx                            
 A: xxxx                                                                    
 E: xxxxx                                                                  
                                                                          120-Hour PK Sample            xxxx-xx-xxTxx:xx:xx                            
                                                                          168-Hour PK Sample            xxxx-xx-xxTxx:xx:xx 
                                                                          216-Hour PK Sample            xxxx-xx-xxTxx:xx:xx 
                                                            
  
  
 
                                                              
                                         
 
 
 
 
_____________________________________________________________________________________________________________________________________ 
¹ Additional PK samples are collected on a conditional basis, date and time the PK sample was obtained is included in the listing. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit, Date/Time of Pre-Dose PK Sample, and Date/Time PK Sample Obtained.  
 
 


Statistical Analysis Plan 
Arcutis ARQ-151-201 
Version: 2 
Date: 11 JUN 2019 
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STATISTICAL ANALYSIS PLAN 
Protocol Number: 
ARQ-151-201 
Study Title:  
A Phase 2b 12-Week Parallel Group, Double Blind, 
Vehicle-Controlled Study of the Safety, Efficacy, and 
Pharmacokinetics of ARQ-151 Cream 0.3% and 
ARQ-151 Cream 0.15% Administered QD in 
Subjects with Chronic Plaque Psoriasis 
Development Phase of Study: 
Phase 2b 
Sponsor: 
Arcutis, Inc. 
2945 Townsgate Road, Suite 110 
Westlake Village, CA 91361 
Sponsor Contact: 
David Berk, MD 
Vice President, Clinical Development 
Statistical Analysis Plan based on 
Protocol Version: 
Amendment 1, 12 November 2018 
Statistical Analysis Plan Date: 
11JUN2019 
Statistical Analysis Plan Version: 
Version 2 




 
Statistical Analysis Plan 
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SAP Change History 
Only final versions will be documented in the Change History. 
Version Date 
Summary of Changes  
Author 
1 24MAY2019 Original document 
 
2 
11JUN2019 Added PASI to efficacy analysis 
 
 
 


 
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TABLE OF CONTENTS 
1. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ....................................6 
2. 
INTRODUCTION .................................................................................................................7 
3. 
STUDY OBJECTIVES .........................................................................................................8 
4. 
STUDY DESIGN ...................................................................................................................8 
4.1 Overall Study Design ......................................................................................................8 
4.1.1 
Schedule of Visits and Assessments .................................................................8 
4.1.2 
Method of Assigning Subjects to Treatment Groups ........................................8 
4.1.3 
Blinding .............................................................................................................9 
5. 
EFFICACY AND SAFETY ENDPOINTS .........................................................................9 
5.1 Efficacy Endpoints ..........................................................................................................9 
5.1.1 
Primary Efficacy Endpoint ..............................................................................10 
5.1.2 
Secondary Efficacy Endpoints ........................................................................10 
5.1.3 
Additional Efficacy Endpoints ........................................................................11 
5.2 Safety Endpoints ...........................................................................................................12 
6. 
STATISTICAL AND ANALYTICAL PLANS ................................................................12 
6.1 General Methodology ...................................................................................................12 
6.1.1 
Statistical Analysis ..........................................................................................13 
6.1.2 
Baseline Definition ..........................................................................................13 
6.1.3 
Visit Windowing .............................................................................................13 
6.1.4 
Adjustments for Covariates .............................................................................14 
6.1.5 
Handling of Dropouts or Missing Data ...........................................................14 
6.1.6 
Interim Analyses and Data Monitoring ...........................................................14 
6.1.7 
Multicenter Studies ..........................................................................................14 
6.1.8 
Multiple Comparisons/Multiplicity .................................................................14 
6.1.9 
Use of an Efficacy Subset of Subjects .............................................................15 
6.1.10 Active-Control Studies Intended to Show Equivalence ..................................15 
6.1.11 Examination of Subgroups ..............................................................................15 
6.2 Disposition of Subjects .................................................................................................15 
6.3 Protocol Deviations .......................................................................................................15 
6.4 Data Sets Analyzed .......................................................................................................16 
6.4.1 
Intent-to-Treat Population ...............................................................................16 


 
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6.4.2 
Safety Population ............................................................................................16 
6.4.3 
Per-Protocol Population ..................................................................................16 
6.4.4 
Pharmacokinetic Population ............................................................................16 
6.5 Demographic and Other Baseline Characteristics ........................................................17 
6.6 Analysis of Efficacy ......................................................................................................17 
6.6.1 
Primary Efficacy Analysis ...............................................................................17 
6.6.2 
Secondary Efficacy Analysis ...........................................................................17 
6.6.3 
Exploratory Efficacy Analysis ........................................................................19 
6.7 Safety Evaluation ..........................................................................................................19 
6.7.1 
Extent of Exposure ..........................................................................................19 
6.7.2 
Adverse Events ................................................................................................20 
6.7.3 
Clinical Laboratory Evaluation .......................................................................20 
6.7.4 
Other Observations Related to Safety .............................................................21 
6.7.4.1 
Electrocardiogram Measurements ...............................................21 
6.7.4.2 
Vital Signs ....................................................................................21 
6.7.4.3 
Physical Examination...................................................................21 
6.7.4.4 
Medical History ...........................................................................21 
6.7.4.5 
Local Tolerance Assessments ......................................................21 
6.7.4.6 
Patient Health Questionnaire Depression Scale ...........................21 
6.7.4.7 
Columbia-Suicide Severity Rating Scale .....................................22 
6.7.4.8 
Prior and Concomitant Medications ............................................22 
6.8 Other Evaluations .........................................................................................................22 
6.8.1 
Pharmacokinetic Evaluation ............................................................................22 
7. 
DETERMINATION OF SAMPLE SIZE .........................................................................22 
8. 
CHANGES IN THE PLANNED ANALYSES..................................................................22 
9. 
REFERENCES ....................................................................................................................23 
10. INDEX OF PLANNED TABLES ......................................................................................24 
11. INDEX OF PLANNED LISTINGS .................................................................................172 
 
 


 
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1. LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
AE(s) 
Adverse Event(s) 
BSA 
Body Surface Area 
CRF(s) 
Case Report Form(s) 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
DLQI 
Dermatology Life Quality Index 
ECG 
Electrocardiogram 
IGA 
Investigator’s Global Assessment 
I-IGA 
Intertriginous IGA 
ITT 
Intent-to-Treat 
LOCF 
Last Observation Carried Forward 
MedDRA 
Medical Dictionary for Regulatory Activities 
mPASI 
Modified Psoriasis Area and Severity Index 
N 
Sample Size 
NRS 
Numerical Rating Score 
PASI 
Psoriasis Area and Severity Index 
PHQ-8 
Patient Health Questionnaire Depression Scale 
PK 
Pharmacokinetic 
PP 
Per-Protocol 
PSD 
Patient Symptoms Diary 
QD 
Once a Day 
SAE(s) 
Serious Adverse Event(s) 
SAS® 
Statistical Analysis System (SAS® Institute Inc., Cary, NC) 
SD 
Standard Deviation 
TEAE(s) 
Treatment-Emergent Adverse Event(s) 
WHO 
World Health Organization 
WHO-DD 
World Health Organization Drug Dictionary 
WHO-ATC 
World Health Organization-Anatomical Therapeutic Chemical 
Classification System 
WI-NRS 
Worst Itch Numerical Rating Scale 
WPAI 
Work Productivity and Activity Impairment 
 
 


 
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2. INTRODUCTION 
Roflumilast is a phosphodiesterase 4 (PDE-4) inhibitor approved globally to reduce the risk of 
exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) associated 
with chronic bronchitis. Roflumilast and its active metabolite, roflumilast N-oxide, are high 
affinity selective inhibitors of PDE-4 (a major cyclic-3′,5′-adenosine monophosphate (cyclic 
AMP)-metabolizing enzyme), whose activity leads to accumulation of intracellular cyclic AMP. 
There are four different subtypes of PDE-4: PDE-4a, PDE-4b, PDE-4c, and PDE-4d, each with 
several isoforms (splicing variants). IC50 values of both roflumilast and roflumilast N-oxide for 
the different PDE-4 isoforms and subtypes are mostly sub-nanomolar and single digit nanomolar 
(Hatzelmann 2010). The PDE-4 family of enzymes are the most prevalent phosphodiesterases in 
immune cells and inhibition of PDE-4 subtypes has been associated with anti-inflammatory 
effects in many biological systems. 
Psoriasis is a chronic inflammatory skin disease characterized by raised, well-demarcated, 
erythematous oval plaques with adherent silvery scales. Numerous past reports have suggested a 
deficiency of cyclic AMP-dependent protein kinases in human psoriatic skin (Brion 1986). More 
recently, various cytokines produced by Th1 and Th17 cells have been shown to play a crucial 
role in the pathogenesis of psoriasis. It has been postulated that the anti-inflammatory effects of 
PDE-4 inhibitors may provide a beneficial therapeutic intervention in the treatment of chronic 
plaque psoriasis, and recently Otezla® (apremilast) a PDE-4 inhibitor has been approved for the 
oral treatment of chronic plaque psoriasis. 
The past 15 years have witnessed a transformation in the systemic treatment of moderate to 
severe psoriasis with the advent of biological therapies. However, for patients with milder forms 
of disease, best treated with topical options, the therapeutic landscape really has not changed in 
several decades. Topical steroids come in all shapes and forms, but the lower potency steroids 
are not effective and the higher potency steroids are beset with issues of local skin atrophy and 
the potential for hypothalamic-pituitary axis suppression when applied over larger body surface 
areas and for prolonged periods of time. Vitamin D has been the other staple of topical psoriasis 
treatment but it is irritating, not suitable for use on the face or intertriginous areas, and its 
efficacy is rather modest. Hence, there is substantial medical need for additional topical 
approaches in the treatment of psoriasis. Arcutis, Inc is developing a topical formulation of 
roflumilast for the treatment of chronic plaque psoriasis. 
 


 
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3. STUDY OBJECTIVES 
To assess the safety, pharmacokinetics and efficacy of ARQ-151 cream 0.3% and ARQ-151 
cream 0.15% vs. vehicle applied QD for 12 weeks to individuals treated with 2 to 20% 
(inclusive) Body Surface Area (BSA) of chronic plaque psoriasis. 
4. STUDY DESIGN 
4.1 
Overall Study Design 
This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream 0.3%, 
ARQ-151 cream 0.15% or vehicle cream QD is applied for 84 days to subjects with between 2% 
to 20% (inclusive) BSA of chronic plaque psoriasis.  
A total of up to approximately 300 subjects will be enrolled at approximately 30 study sites in 
the United States and Canada. Subjects will be adult (≥18 y/o) males or females with chronic 
plaque psoriasis. Subjects must have an Investigator’s Global Assessment (IGA) of disease 
severity of at least Mild (‘2’) at Baseline. Subjects with an IGA of ‘Mild’ (2) will be limited to 
20% of total enrollment. Subjects with an IGA of ‘Severe’ (4) will be limited to 15% of total 
enrollment. Subjects must have at least 2% and no more than 20% BSA of chronic plaque 
psoriasis. All psoriasis lesions on a subject will be treated including the face, trunk, genitals/skin 
folds, or limbs (excluding the scalp). The palms and soles will be treated but will not be counted 
towards any measurements of efficacy (IGA, BSA, Psoriasis Area and Severity Index (PASI), 
Modified PASI (mPASI)). For subjects with intertriginous area involvement, and with severity of 
the intertriginous area lesions at least ‘mild’ (IGA≥2) at Baseline, Intertriginous IGA (I-IGA) 
score will be recorded at weeks 4, 6, 8 and 12. The same IGA used for the primary endpoint 
(whole body) will also be used for I-IGA, but only intertriginous areas will be evaluated for I-
IGA, not the rest of the body. 
4.1.1 
Schedule of Visits and Assessments 
The schedule of assessments can be found in Section 5 of the protocol. 
4.1.2 
Method of Assigning Subjects to Treatment Groups 
Assignment of drug or vehicle will be made at a 1:1:1 ratio according to a computer-generated 
randomization list. Randomization will take place at Baseline after the patient has been found to 
be fully eligible for participation. Kits containing tubes of study medication will be assigned to 
each subject using an internet-based randomization system (IWRS). A subject may receive more 
than one kit for the treatment period. 


 
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The kits and tubes are blinded and each kit is numbered with a unique kit number. 
4.1.3 
Blinding  
This is a double-blind study, therefore neither the subjects nor the Investigator, clinical team, and 
study sponsor will be aware of which treatment an individual has received. 
If the situation requires emergency unblinding this will be done by investigator using the study 
IWRS system after discussion with Medical Monitor and the Sponsor’s CMO. 
The treatment assignments for all enrolled subjects will be unblinded only after the conclusion of 
the study. Specifically, the blind will be broken only after all data are verified, entered into the 
database, and validated; subject evaluability assessments are performed and entered into the 
database; and the database is locked. 
5. EFFICACY AND SAFETY ENDPOINTS 
5.1 
Efficacy Endpoints 
PASI is one of the measurements used for the severity of psoriasis. PASI combines the 
assessment of the severity of lesions and the area affected into a single score in the range 0 (no 
disease) to 72 (maximal disease). The body is divided into four sections (head (h) (10% of a 
person's skin); arms (a) (20%); trunk (t) (30%); legs (l) (40%)). Each of these areas is scored by 
itself, and then the four scores are combined into the final PASI. For each section, the percent of 
area (A) of skin involved is estimated and then transformed into a grade from 0 to 6 (A): 
 
0. 0% of involved area 
1. < 10% of involved area 
2. 10–29% of involved area 
3. 30–49% of involved area 
4. 50–69% of involved area 
5. 70–89% of involved area 
6. 90–100% of involved area 
Within each area, the severity is estimated by three clinical signs: erythema (‘E’; redness), 
induration (‘T’; thickness) and desquamation (‘S’; scaling). Severity parameters are measured on 
a scale of 0 to 4, from none to maximum severity possible. 
 
To calculate the PASI, the sum of the severity rating for the three main signs are multiplied 
with the numerical value of the area affected and with the various percentages of the four body 
areas. These values are then added to complete the formula as follows: 


 
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PASI = 0.1 (Eh + Th + Sh) Ah + 0.2 (Ea + Ta + Sa) Aa + 0.3 (Et + Tt + St) At + 
0.4 (El + Tl + Sl) Al 
 
In addition to PASI, an mPASI will also be used for the severity of psoriasis. The mPASI will be 
calculated the same as the PASI except for subjects with < 10% of an involved anatomical area. 
For subjects with < 10% of an involved anatomical area the mPASI will be calculated using the 
actual percentage of the anatomical area involved (e.g. 0.1 for 1%, 0.2 for 2%, 0.3 for 3%, … 0.9 
for 9%), corresponding to the actual percentage of that particular anatomical area of 
involvement. The resulting values will then be rounded to the nearest tenth prior to analysis. 
 
5.1.1 
Primary Efficacy Endpoint 
The primary efficacy endpoint is as follows: 
• Success in Investigator Global Assessment (IGA) of disease severity, defined as an IGA 
of ‘Clear’ or ‘Almost Clear’ at Week 6. 
5.1.2 
Secondary Efficacy Endpoints 
The secondary efficacy endpoints are as follows: 
• IGA score of ‘clear’ or ‘almost clear’ at weeks 2, 4, 8, and 12. 
• Percent change from Baseline in PASI at weeks 2, 4, 6, 8, and 12. 
• Percent change from Baseline in mPASI at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Percent BSA affected at weeks 2, 4, 6, 8, and 12. 
• IGA score of ‘clear’ or ‘almost clear’ PLUS a 2-grade improvement from Baseline at 
weeks 2, 4, 6, 8 and 12. 
• For subjects with intertriginous area involvement, and with severity of the intertriginous 
lesions at least ‘mild’ (I-IGA≥2) at Baseline, ‘I-IGA’ score of ‘clear’ or ‘almost clear’ at 
weeks 2, 4, 6, 8 and 12. 
• Change from Baseline in Worst Itch Numerical Rating Scale (WI-NRS) pruritus score at 
weeks 2, 4, 6, 8, and 12. 
• In subjects with WI-NRS pruritus score ≥ 6 at Baseline, a 4-point reduction in WI-NRS 
pruritus score at 2, 4, 6, 8, and 12 weeks as compared to Baseline. 


 
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• Change from Baseline in Psoriasis Area Severity Index-75 (PASI-75) improvement at 
weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Psoriasis Area Severity Index-90 (PASI-90) improvement at 
weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Psoriasis Area Severity Index-100 (PASI-100) improvement at 
weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Modified Psoriasis Area Severity Index-75 (mPASI-75) 
improvement at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Modified Psoriasis Area Severity Index-90 (mPASI-90) 
improvement at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Modified Psoriasis Area Severity Index-100 (mPASI-100) 
improvement at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Total Patient Symptoms Diary (PSD) at weeks 2, 4, 6, 8, and 
12. 
• Change from Baseline in Itch-related Sleep Loss score at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Dermatology Life Quality Index (DLQI) score at weeks 2, 4, 6, 
8, and 12. 
• Change from Baseline in responses to the questions of Total Patient Symptom Diary 
(PSD) at weeks 2, 4, 6, 8, and 12. 
Change from Baseline will be calculated by subtracting the score at Baseline from the post-
baseline score. Percent change from Baseline will be calculated by dividing change from 
Baseline by the Baseline score, multiplied by 100.  
5.1.3 
Additional Efficacy Endpoints 
The exploratory endpoints are as follows: 
• Change from Baseline in Fatigue Numerical Rating Score (NRS) score at weeks 2, 4, 6, 
8, and 12.  
• Change from Baseline in Work Productivity and Activity Impairment (WPAI) score at 
weeks 2, 4, 6, 8, and 12. 


 
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Change from Baseline will be calculating by subtracting the score at Baseline from the post-
baseline score. 
5.2 
Safety Endpoints 
Safety will be evaluated through examination of data collected during physical examinations, 12-
lead Electrocardiograms (ECGs), local tolerability assessments, vital signs, counts and 
percentages of subjects who gain or lose >5% and >10% body weight, clinical laboratory 
parameters, Patient Health Questionnaire Depression Scale (PHQ-8), Columbia-Suicide Severity 
Rating Scale (C-SSRS) and adverse events (AEs) as outlined in the Schedule of Visits and 
Assessments. If deemed necessary, additional safety assessments will be performed at the 
discretion of the Principal Investigator. 
6. STATISTICAL AND ANALYTICAL PLANS 
6.1 
General Methodology 
All statistical processing will be performed using SAS® (Version 9.4 or later) unless otherwise 
stated. No interim analyses are planned. Except where noted, all statistical tests will be two-sided 
and will be performed at the 0.05 level of significance. No adjustment will be made for 
multiplicity. 
Descriptive statistics will be used to provide an overview of the efficacy, safety, and 
pharmacokinetic results. For categorical parameters, the number and percentage of subjects in 
each category will be presented. The denominator for percentage will be based on the number of 
subjects appropriate for the purpose of analysis. For continuous parameters, descriptive statistics 
will include n (number of subjects), mean, standard deviation (SD), median, minimum and 
maximum. Appropriate inferential statistics will be used for the primary, secondary, and 
exploratory efficacy variables. 
The primary method of handling missing efficacy data will be a mixture of linear interpolation 
and last observation carried forward (LOCF).  
The efficacy analysis performed on the Intent-to-Treat (ITT) population is considered the 
primary analysis. The efficacy analysis performed on the Per-Protocol (PP) population is 
considered supportive analysis. 
The number of subjects in each analysis set will be summarized. Reasons for study withdrawal 
during the blinded study will be summarized using frequencies and percentages by treatment 
group. Reported AEs, medical history terms and prior and concomitant procedures and therapies 
will be classified on the basis of Medical Dictionary for Regulatory Activities (MedDRA) 


 
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terminology. Prior and concomitant medications will be classified on the basis of World Health 
Organization Drug Dictionary (WHO-DD) terminology. 
6.1.1 
Statistical Analysis 
All analyses will be performed by QST using SAS® Version 9.4 or later. All summary tables 
and data listings will be prepared utilizing SAS® software. 
The standard operating procedures (SOPs) of QST will be followed in the creation and quality 
control of all data displays and analyses. 
6.1.2 
Baseline Definition 
Baseline is defined as the last non-missing assessment prior to first dose of study drug.  
6.1.3 
Visit Windowing 
Data will be summarized based on nominal visit indications with the exception of data captured 
at early termination and unscheduled visits. Data from early termination and unscheduled visits 
will be summarized based on mapped visit values. The analysis windows for early termination 
and unscheduled visits are presented in the following table.  
 
Analysis Windows for Efficacy and Safety Assessments 
Scheduled Visit 
Target Study Day 
Window (Days) 
Week 2 
15 
8 to 22 
Week 4 
29 
23 to 36 
Week 6 
43 
37 to 50 
Week 8 
57 
51 to 71 
Week 12 
85 
72 to 99 
Week 16 
113 
100 to 127 
Data collected at early termination and unscheduled visits prior to study day 8 will not be 
analyzed, with the exception of those identified as baseline values. Data collected at visits after 
study day 127 will not be included in analyses.  
The definition for the study day included in each study window is defined as below: 
 
Study Day prior to Baseline Day 1 = Visit Date – Baseline Day 1 Date 
 
Study Day on or after Baseline Day 1 = Visit Date – Baseline Day 1 Date + 1 


 
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If an assessment’s mapped visit is a visit at which the subject has data from a scheduled visit 
present, or if no analyses are planned for the assessment at the mapped visit, the data collected at 
the early termination or unscheduled visit will not be included in analyses.  
In the event of multiple values from unscheduled or early termination assessments within an 
analysis window, the value closest to the scheduled visit target study day will be used for 
analyses. If two values tie as closest to the time point (for example, one value is before and the 
other value is after the time point), then the later value will be selected.  
Data collected at all visits will be included in the data listings with visit presented as reported by 
the site. 
6.1.4 
Adjustments for Covariates 
The Baseline score will be used as a covariate for each endpoint analyzed. 
6.1.5 
Handling of Dropouts or Missing Data 
The primary method of handling missing efficacy data will be a mixture of linear interpolation 
and LOCF. Linear interpolation will be used for all instances where subjects have observed 
values for at least one assessment both preceding and following the missing assessment. If an 
unscheduled assessment occurs between the preceding or following scheduled assessment and 
the missing assessment, the unscheduled assessment will be used in the linear interpolation. The 
actual study day of assessment will be used for the preceding and following assessments, and 
planned study day will be used for the missing assessment. IGA and I-IGA values imputed with 
linear interpolation will be rounded to the nearest integer. If the missing assessment is not 
followed by at least one observed assessment, the method of LOCF will be used. 
6.1.6 
Interim Analyses and Data Monitoring 
No interim analysis or data monitoring is planned for this study. 
6.1.7 
Multicenter Studies 
The clinical study will be conducted under a common protocol for each investigational site. 
Every effort will be made to promote consistency in study execution at each investigational site. 
Sites will be pooled for analyses. 
6.1.8 
Multiple Comparisons/Multiplicity 
No adjustments for multiple comparisons or multiplicity will be made. 


 
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6.1.9 
Use of an Efficacy Subset of Subjects 
Subjects randomized to study drug who were at least 80% compliant with the study drug, did not 
miss more than three consecutive doses, and who do not have major protocol deviations will 
form the Per Protocol (PP) Population. The major protocol deviations will be defined at the time 
of evaluability evaluation, the time between the database soft lock and hard lock before 
unblinding. 
Excluding subjects who have major protocol deviations will decrease the variability in treatment 
response and will allow for a better determination of efficacy of ARQ-151 Cream 0.3% and 
ARQ-151 Cream 0.15%. 
6.1.10 
Active-Control Studies Intended to Show Equivalence 
Not applicable to this study. 
6.1.11 
Examination of Subgroups 
Subset analyses will be conducted for the ITT population for the subgroups baseline IGA and 
baseline I-IGA. I-IGA will be dichotomized into presence or absence of I-IGA ≥ 2 at baseline. 
These analyses will contain only descriptive statistics of the primary efficacy endpoint. 
6.2 
Disposition of Subjects 
The number of subjects included in each analysis population (ITT, safety, PP, pharmacokinetic 
(PK)) will be summarized by treatment group. The number of subjects enrolled, completed, and 
discontinued (including the reasons for discontinuation) will be summarized for each treatment 
group. 
Subjects who are excluded from an analysis population will be summarized by the primary 
reason for exclusion. 
6.3 
Protocol Deviations 
Protocol deviations leading to exclusion from the PP population will be tabulated. In addition to 
protocol deviations leading to exclusion from the PP population, the protocol deviations listed 
below will be presented in a data listing. 
• Baseline PHQ-8 score greater than or equal to 15 
• Received incorrect treatment 
• 
 


 
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• Baseline IGA of Clear or Almost Clear 
• Missed visit 
• Missed IGA at attended visit 
• Missed I-IGA at attended visit 
• Missed safety labs at attended visit  
6.4 
Data Sets Analyzed 
Subjects will be presented/summarized based on the primary reason for exclusion. The primary 
reason for exclusion for each population is the first inclusion condition a subject fails to meet 
based on the order listed below. 
6.4.1 
Intent-to-Treat Population 
All randomized subjects will be included in the ITT population and analyzed according to the 
treatment group they were randomized. All efficacy analyses will be presented using the ITT 
population. 
6.4.2 
Safety Population 
All subjects in the ITT population who have at least one post-baseline safety assessment will be 
included in the safety population and analyzed according to the treatment group they received. In 
the event a subject receives more than one treatment, they will be analyzed based on the 
treatment they received for the majority of the study. All safety analyses will be performed using 
the safety population. 
6.4.3 
Per-Protocol Population 
All subjects in the safety population who were at least 80% compliant with study medication, did 
not miss more than 3 consecutive doses, and showed no other serious protocol violations will be 
included in the PP population and analyzed according to the treatment group they received. All 
efficacy analyses will be performed on the PP population. 
6.4.4 
Pharmacokinetic Population 
All subjects receiving the active drug with quantifiable plasma concentrations of roflumilast will 
be included in the PK population.  


 
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6.5 
Demographic and Other Baseline Characteristics 
All summaries will be done on the ITT, PP, safety, and PK populations. 
Sex, race, and ethnicity will be summarized by counts and percentages. Age (years) will be 
summarized with descriptive statistics.  
Height, Weight, BSA, IGA, mPASI, WI-NRS, DLQI, Itch-Related Sleep Loss, and Total PSD 
will be summarized at baseline with descriptive statistics. 
Medical histories will be coded using the MedDRA dictionary and presented in a by-subject 
listing. 
6.6 
Analysis of Efficacy 
6.6.1 
Primary Efficacy Analysis 
The primary efficacy endpoint is success in IGA, defined as an IGA of ‘Clear’ or ‘Almost Clear’ 
at Week 6. The primary efficacy endpoint will be analyzed with a logistic regression with a 
factor of treatment group and the respective Baseline IGA score as a covariate. Statistical 
comparison between the active treatment arms and vehicle arms will be facilitated by using 
contrasts. 
The primary efficacy analysis will be presented on both the ITT and PP populations. 
6.6.2 
Secondary Efficacy Analysis 
The secondary efficacy endpoints will include: 
• IGA score of ‘clear’ or ‘almost clear’ at weeks 2, 4, 8, and 12. 
• Percent change from Baseline in PASI at weeks 2, 4, 6, 8, and 12. 
• Percent change from Baseline in mPASI at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Percent BSA affected at weeks 2, 4, 6, 8, and 12. 
• IGA score of ‘clear’ or ‘almost clear’ PLUS a 2-grade improvement from Baseline at 
weeks 2, 4, 6, 8 and 12. 
• For subjects with intertriginous area involvement, and with severity of the 
intertriginous lesions at least ‘mild’ (I-IGA≥2) at Baseline, ‘I-IGA’ score of ‘clear’ or 
‘almost clear’ at weeks 2, 4, 6, 8 and 12. 


 
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• For subjects with intertriginous area involvement, and with severity of the 
intertriginous lesions at least ‘mild’ (I-IGA≥2) at Baseline, ‘I-IGA’ score of ‘clear’ or 
‘almost clear’ and a 2-point improvement from Baseline at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in WI-NRS pruritus score at weeks 2, 4, 6, 8, and 12. 
• In subjects with WI-NRS pruritus score ≥ 6 at baseline, a 4-point reduction in WI-
NRS pruritus score at weeks 2, 4, 6, 8, and 12 as compared to Baseline. 
• Change from Baseline in Psoriasis Area Severity Index-75 (PASI-75) improvement at 
weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Psoriasis Area Severity Index-90 (PASI-90) improvement at 
weeks 2, 4, 6, 8, and 12.  
• Change from Baseline in Psoriasis Area Severity Index-100 (PASI-100) improvement 
at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Modified Psoriasis Area Severity Index-75 (mPASI-75) 
improvement at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Modified Psoriasis Area Severity Index-90 (mPASI-90) 
improvement at weeks 2, 4, 6, 8, and 12.  
• Change from Baseline in Modified Psoriasis Area Severity Index-100 (mPASI-100) 
improvement at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Total PSD at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in Itch-related Sleep Loss score at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in DLQI score at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in responses to the questions of PSD at weeks 2, 4, 6, 8, and 
12. 
Change from Baseline will be calculated by subtracting the score at Baseline from the post-
baseline score. Percent change from Baseline will be calculated by dividing change from 
Baseline by the Baseline score, multiplied by 100. 
The IGA, I-IGA, WI-NRS, PASI, and mPASI dichotomous endpoints will be analyzed with a 
logistic regression with a factor of treatment group and the respective Baseline score as a 
covariate. The remainder of the endpoints will be considered continuous and analyzed with an 
analysis of covariance with a factor of treatment group and the respective Baseline score as a 


 
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covariate. Statistical comparisons between the active treatment arms and vehicle arm will be 
facilitated by using contrasts.  
The secondary efficacy analysis will be presented on both the ITT and PP populations. 
6.6.3 
Exploratory Efficacy Analysis 
There are two exploratory endpoints: 
• Change from Baseline in Fatigue NRS score at weeks 2, 4, 6, 8, and 12. 
• Change from Baseline in WPAI score at weeks 2, 4, 6, 8, and 12. 
Only descriptive statistics will be used to analyze these endpoints. Change from Baseline will be 
calculating by subtracting the score at Baseline from the post-baseline score. 
6.7 
Safety Evaluation 
The following analyses will be performed; however, no formal inferential statistics will be done 
on safety assessments. 
Descriptive statistics will be presented by visit and treatment group for quantitative safety data 
and frequency counts will be compiled for classification of qualitative safety data. Summaries of 
local tolerability will be presented by visit and treatment group. 
6.7.1 
Extent of Exposure 
The extent of exposure to study drug in each treatment group will be summarized by total 
number of days of exposure, total number of applications, total amount of study drug used, 
number of missed applications, and number and percentage of subjects who are compliant. A 
subject will be considered compliant with the dosing regimen if the subject applied at least 80% 
of the expected number of applications while enrolled in the study and does not miss more than 3 
consecutive doses. 
Days of exposure = Date of last study application – Date of first study application + 1. 
The total number of applications is as follows: 
(Date of Last Application – Date of First Application + 1) – (Number of Days marked as missed 
dose on the Case Report Form (CRF)) + (Number of Additional Doses indicated on CRF). 
The expected number of applications is as follows: 
Expected Date of Last Application – Date of Randomization + 1 


 
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Where the Expected Date of Last Application is the date of the Week 12 visit or the date of the 
discontinuation visit for subjects who discontinue prior to Week 12.  
Compliance will be calculated as a percentage as 100 times the total number of applications 
divided by the expected number of applications. 
6.7.2 
Adverse Events 
All treatment-emergent AEs (TEAEs) occurring during the study will be recorded and classified 
on the basis of MedDRA terminology for the safety population. TEAEs are those AEs with an 
onset on or after the date of first study drug treatment. All AEs with incomplete onset date 
information will be considered treatment-emergent unless the available information indicates that 
this is not possible. All TEAEs will be summarized by treatment group, the number of subjects 
reporting TEAEs, system organ class, preferred term, severity, relationship, and seriousness. 
Each subject will be counted only once within a system organ class or a preferred term using the 
event with the greatest relationship and greatest severity. 
Comparisons between treatment groups will be made by tabulating the frequency of subjects 
with one or more TEAEs (classified into MedDRA terms) during the study.  
Serious AEs (SAEs) will be listed by subject. Treatment-emergent SAEs will be summarized by 
treatment group, severity, and relationship to study treatment.  
All information pertaining to AEs noted during the study will be listed by subject, detailing the 
verbatim description given by the Investigator, preferred term, system organ class, start date, 
stop date, severity, action taken regarding study drug, corrective treatment, outcome, and drug 
relatedness. The event onset will also be shown relative (in number of days) to date of first 
application. In addition a listing of subjects who prematurely discontinue from the study due to 
AEs will also be provided. 
6.7.3 
Clinical Laboratory Evaluation 
Laboratory test results will be summarized by treatment group and visit as observed values and 
changes from Baseline using descriptive statistics. Additionally, shifts from Baseline to Week 4 
and Week 12 in laboratory test results based on normal ranges will be summarized with 
frequency counts and percentages.  
Individual laboratory test results, as well as abnormal laboratory results, will be presented in a 
by-subject listing. 


 
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6.7.4 
Other Observations Related to Safety 
6.7.4.1 
Electrocardiogram Measurements 
Descriptive statistics of actual values and changes from baseline will be provided by treatment 
group and visit for the following ECG parameters: heart rate (HR), RR duration, QRS duration, 
PR duration, QT duration, QTc Interval, QTcB interval, QTcF interval. Investigator and 
cardiologist interpretation of the ECG will be summarized by counts and percentages. 
 
Individual ECG parameters, as well as interpretations, will be presented in a by-subject listing. 
6.7.4.2 
Vital Signs 
Descriptive statistics of actual values and changes from baseline will be provided by treatment 
group and visit for the following parameters: temperature, systolic blood pressure, diastolic 
blood pressure, heart rate, and weight. Additionally, counts and percentages of subjects who gain 
or lose > 5% body weight will be summarized by visit in a table.  
6.7.4.3 
Physical Examination 
Abnormal physical examination findings will recorded as AEs and included in the AE 
summaries.   
6.7.4.4 
Medical History 
Medical history for all subjects will be presented in a by-subject listing.  
6.7.4.5 
Local Tolerance Assessments 
For the investigator’s assessment and subject local tolerability assessment of sensation following 
drug application, the numeric application site reaction scores will be summarized individually by 
using number and percentage of subjects by visit. In addition, a by-subject listing of investigator 
and subject assessments will be provided. 
6.7.4.6 
Patient Health Questionnaire Depression Scale 
The PHQ-8 will be analyzed by a shift in state of severity using the following scoring system: 
• None – Minimal depression (0 to 4) 
• Mild depression (5 to 9) 
• Moderate depression (10 to 14) 


 
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• Moderately severe depression (15 to 19) 
• Severe depression (20 to 24) 
In addition, a by-subject listing of results will be provided. 
6.7.4.7 
Columbia-Suicide Severity Rating Scale  
The C-SSRS will be analyzed per the C-SSRS Scoring and Data Analysis Guide (Nilsson 2013).  
6.7.4.8 
Prior and Concomitant Medications 
Prior and concomitant medication information for all randomized subjects will be presented in a 
by-subject listing. Summary tables will be presented by World Health Organization-Anatomical 
Therapeutic Chemical Classification System (WHO-ATC) therapeutic category and product. 
6.8 
Other Evaluations 
6.8.1 
Pharmacokinetic Evaluation 
Plasma drug concentrations at pre-dose will be summarized using descriptive statistics, reporting 
n, mean, standard deviation, median, minimum, and maximum. 
7. DETERMINATION OF SAMPLE SIZE 
The sample size was not powered based on data for the primary endpoint to provide statistical 
significance because of the absence of previous primary endpoint data. However, based on 
efficacy data from the Phase 1/2a study, this Phase 2b study is expected to provide reliable 
information regarding the efficacy and safety of the drug products. 
8. CHANGES IN THE PLANNED ANALYSES 
The Per-Protocol population was updated to exclude subjects with more than three consecutive 
missed doses in order to fully capture compliant subjects. 
A covariate of the respective Baseline score was added to the models used for analysis of the 
primary and secondary endpoints.  
A secondary efficacy analysis endpoint of ‘clear’ or ‘almost clear’ plus a 2-point improvement 
from Baseline for Intertriginous Investigator Global Assessment (I-IGA) at weeks 2, 4, 6, 8, and 
12 was added. 
 
A secondary efficacy analysis endpoint for change from Baseline in Modified Psoriasis Area 
Severity Index-100 (mPASI-100) at weeks 2, 4, 6, 8, and 12 was added. 


 
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Week 2 was added to all secondary and exploratory efficacy endpoints. 
 
An analysis of PASI was added for all planned mPASI analyses. 
9. REFERENCES 
Brion DE, Raynaud F, Plet A, Laurent P, Leduc B, and Anderson W. Deficiency of cyclic 
AMP-dependent protein kinases in human psoriasis. Proc. Natl. Acad. Sci. 1986; 83:5272-5276. 
 
Hatzelmann A, Morcillo EJ, Lungarella G, Adnot S, Sanjar S, Beume R, et al. The preclinical 
pharmacology of roflumilast – a selective, oral phosphodiesterase 4 inhibitor in development for 
chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2010; 23:235–256. 
 
Nilsson M, Suryawanshi S, Gassmann-Mayer C, Dubrava S, McSorley P, and Jiang K. 
Columbia–Suicide Severity Rating Scale Scoring and Data Analysis Guide. Version 2. 2013 


 
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10. INDEX OF PLANNED TABLES 
Table 14.0.1: Summary of Subject Enrollment and Evaluability ..................................................30 
Table 14.0.2: Summary of Subject Completion/Discontinuation (Randomized Subjects) ...........31 
Table 14.1.1.1: Summary of Subject Demographics (Intent-to-Treat Population) ........................32 
Table 14.1.1.2: Summary of Subject Demographics (Per-Protocol Population) ...........................32 
Table 14.1.1.3: Summary of Subject Demographics (Safety Population) .....................................32 
Table 14.1.1.4: Summary of Subject Demographics (PK Population) ..........................................32 
Table 14.1.2.1: Summary of Subject Baseline Characteristics (Intent-to-Treat Population) ........33 
Table 14.1.2.2: Summary of Subject Baseline Characteristics (Per-Protocol Population) ............36 
Table 14.1.2.3: Summary of Subject Baseline Characteristics (Safety Population) ......................36 
Table 14.1.2.4: Summary of Subject Baseline Characteristics (PK Population) ...........................36 
Table 14.1.3: Summary of Medical History by MedDRA System Organ Class and Preferred 
Term (Safety Population) ...............................................................................................................37 
Table 14.1.4.1: Summary of Prior Medications by WHO-DD ATC Level 2 Term and Preferred 
Name  (Safety Population) .............................................................................................................38 
Table 14.1.4.2: Summary of Concomitant Medications by WHO-DD ATC Level 2 Term and 
Preferred Name  (Safety Population) .............................................................................................39 
Table 14.2.1.1: Analysis of Primary Efficacy Endpoint: Investigator Global Assessment (IGA) 
Score of ‘Clear’ or ‘Almost Clear’ at Week 6 (Intent-to-Treat Population) ..................................40 
Table 14.2.1.2: Analysis of Primary Efficacy Endpoint: Investigator Global Assessment (IGA) 
Score of ‘Clear’ or ‘Almost Clear’ at Week 6 (Per-Protocol Population) .....................................40 
Figure 14.2.1.1:  Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ by 
Visit (Intent-to-Treat Population) ..................................................................................................41 
Figure 14.2.1.2: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ by 
Visit (Per-Protocol Population)......................................................................................................41 
Table 14.2.2.1: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) 
Score of ‘Clear’ or ‘Almost Clear’  (Intent-to-Treat Population) ..................................................42 
Table 14.2.2.2: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) 
Score of ‘Clear’ or ‘Almost Clear’ (Per-Protocol Population) ......................................................42 
Table 14.2.3.1: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) 
Score of ‘Clear’ or ‘Almost Clear’ Plus a 2-Grade Improvement from Baseline (Intent-to-
Treat Population) ...........................................................................................................................43 


 
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Table 14.2.3.2: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) 
Score of ‘Clear’ or ‘Almost Clear’ Plus a 2-Grade Improvement from Baseline (Per-
Protocol Population) ......................................................................................................................43 
Figure 14.2.3.1:  Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ Plus 
a 2-Grade Improvement from Baseline by Visit (Intent-to-Treat Population) ..............................44 
Figure 14.2.3.2: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ Plus a 
2-Grade Improvement from Baseline by Visit (Per-Protocol Population) ....................................44 
Table 14.2.3.3: Summary of Proportion of Subjects Achieving an Investigator Global 
Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ Plus a 2-Grade Improvement from 
Baseline by Investigational Site (Intent-to-Treat Population) .......................................................45 
Table 14.2.4.1.1: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area 
Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline who Achieved a 
Score of ‘Clear’ or ‘Almost Clear’ (Intent-to-Treat Population: Subjects with I-IGA Severity of 
at Least ‘Mild’ at Baseline)............................................................................................................46 
Table 14.2.4.1.2: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area 
Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline who Achieved a 
Score of ‘Clear’ or ‘Almost Clear’ (Per-Protocol Population: Subjects with I-IGA Severity of at 
Least ‘Mild’ at Baseline) ...............................................................................................................47 
Figure 14.2.4.1.1:  Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) 
Severity of at Least ‘Mild’ at Baseline  who Achieved a Score of ‘Clear’ or ‘Almost Clear’  
(Intent-to-Treat Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) ..........48 
Figure 14.2.4.1.2: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) 
Severity of at Least ‘Mild’ at Baseline who Achieved a Score of ‘Clear’ or ‘Almost Clear’ (Per-
Protocol Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) .....................49 
Table 14.2.4.2.1: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area 
Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline who Achieved a 
Score of ‘Clear’ or ‘Almost Clear’ Plus a 2 Grade Improvement from Baseline (Intent-to-
Treat Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline)...........................50 
Table 14.2.4.2.2: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area 
Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline who Achieved a 
Score of ‘Clear’ or ‘Almost Clear’ Plus a 2 Grade Improvement from Baseline (Per-
Protocol Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) .....................51 
Figure 14.2.4.2.1:  Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) 
Severity of at Least ‘Mild’ at Baseline who Achieved a Score of ‘Clear’ or ‘Almost Clear’ Plus a 
2 Grade Improvement from Baseline (Intent-to-Treat Population: Subjects with I-IGA Severity 
of at Least ‘Mild’ at Baseline) .......................................................................................................52 
 
 


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Figure 14.2.4.2.2: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) 
Severity of at Least ‘Mild’ at Baseline who Achieved a Score of ‘Clear’ or ‘Almost Clear’ Plus a 
2 Grade Improvement from Baseline (Per-Protocol Population: Subjects with I-IGA Severity of 
at Least ‘Mild’ at Baseline)............................................................................................................53 
Table 14.2.5.1.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in 
Psoriasis Area and Severity Index (PASI) (Intent-to-Treat Population) .......................................54 
Table 14.2.5.1.2: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in 
Psoriasis Area and Severity Index (PASI) (Per-Protocol Population) ...........................................59 
Figure 14.2.5.1.1:  Percent Change from Baseline in Psoriasis Area and Severity Index (PASI) 
(Intent-to-Treat Population) ...........................................................................................................60 
Table 14.2.5.2.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in 
Modified Psoriasis Area and Severity Index (mPASI) (Intent-to-Treat Population) ....................61 
Table 14.2.5.2.2: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in 
Modified Psoriasis Area and Severity Index (mPASI) (Per-Protocol Population) ........................66 
Figure 14.2.5.2.1:  Percent Change from Baseline in Modified Psoriasis Area and Severity Index 
(mPASI) (Intent-to-Treat Population)............................................................................................67 
Table 14.2.6.1.1: Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions 
in Psoriasis Area and Severity Index (PASI) Compared to Baseline (Intent-to-
Treat Population) ...........................................................................................................................68 
Table 14.2.6.1.2 Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Psoriasis Area and Severity Index (PASI) Compared to Baseline  (Per-Protocol Population) .....70 
Table 14.2.6.2.1: Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions 
in Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline (Intent-to-
Treat Population) ...........................................................................................................................71 
Table 14.2.6.2.2 Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline  (Per-
Protocol Population) ......................................................................................................................73 
Table 14.2.7.1.1: Dichotomized Percent Reductions in Psoriasis Area and Severity Index (PASI) 
Compared to Baseline (Intent-to-Treat Population) ......................................................................74 
Table 14.2.7.1.2: Dichotomized Percent Reduction(s) in Psoriasis Area and Severity Index 
(PASI) Compared to Baseline (Per-Protocol Population) .............................................................76 
Table 14.2.7.2.1: Dichotomized Percent Reductions in Modified Psoriasis Area and Severity 
Index (mPASI) Compared to Baseline (Intent-to-Treat Population) .............................................77 


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Table 14.2.7.2.2: Dichotomized Percent Reduction(s) in Modified Psoriasis Area and Severity 
Index (mPASI) Compared to Baseline (Per-Protocol Population) ................................................79 
Table 14.2.8.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in 
Body Surface Area (BSA) Affected (Intent-to-Treat Population) .................................................80 
Table 14.2.8.2: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in 
Body Surface Area (BSA) Affected (Per-Protocol Population) ....................................................85 
Table 14.2.9.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch 
Numerical Rating Scale (WI-NRS) Pruritus Score  (Intent-to-Treat Population) .........................86 
Table 14.2.9.2: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch 
Numerical Rating Scale (WI-NRS) Pruritus Score (Per-Protocol Population) .............................90 
Table 14.2.10.1.1: Analysis of Secondary Endpoint: Subjects with a Worst Itch Numerical 
Rating Scale (WI-NRS) Score ≥ 6 at Baseline and Achieved a 4 Point Reduction Compared to 
Baseline (Intent-to-Treat Population: Subjects with WI-NRS Score ≥ 6 at Baseline) ..................91 
Table 14.2.10.1.2: Analysis of Secondary Endpoint: Subjects with a Worst Itch Numerical 
Rating Scale (WI-NRS) Score ≥ 6 at Baseline and Achieved a 4 Point Reduction Compared to 
Baseline (Per-Protocol Population: Subjects with WI-NRS Score ≥ 6 at Baseline) ......................92 
Table 14.2.10.2.1: Summary of Subjects with a Worst Itch Numerical Rating Scale (WI-NRS) 
Score ≥ 6 at Baseline and Achieved a 4 Point Reduction Compared to Baseline (Intent-to-
Treat Population: Subjects with WI-NRS Score ≥ 6 at Baseline) .................................................93 
Table 14.2.10.2.2: Summary of Subjects with a Worst Itch Numerical Rating Scale (WI-NRS) 
Score ≥ 6 at Baseline and Achieved a 4 Point Reduction Compared to Baseline (Per-
Protocol Population: Subjects with WI-NRS Score ≥ 6 at Baseline) ............................................93 
Table 14.2.11.1: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary 
(PSD) Score Compared to Baseline (Intent-to-Treat Population) .................................................94 
Table 14.2.11.2: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary 
(PSD) Score Compared to Baseline (Per-Protocol Population) .....................................................99 
Table 14.2.12.1: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom 
Diary (PSD) Responses Compared to Baseline (Intent-to-Treat Population) .............................100 
Table 14.2.12.2: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom 
Diary (PSD) Responses Compared to Baseline (Per-Protocol Population) .................................105 
Table 14.2.13.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-
Related Sleep Loss Score (Intent-to-Treat Population) ...............................................................106 
Table 14.2.13.2: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-
Related Sleep Loss Score (Per-Protocol Population) ...................................................................110 
Table 14.2.14.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in 
Dermatology Life Quality Index (DLQI) Score (Intent-to-Treat Population) .............................111 


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Table 14.2.14.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in 
Dermatology Life Quality Index (DLQI) Score (Intent-to-Treat Population) .............................112 
Table 14.2.14.2: Analysis of Secondary Efficacy Endpoint: Change from Baseline in 
Dermatology Life Quality Index (DLQI) Score (Per-Protocol Population) ................................115 
Table 14.2.15.1: Summary of Exploratory Endpoint: Change from Baseline in Fatigue NRS 
Score (Intent-to-Treat Population) ...............................................................................................116 
Table 14.2.15.2: Summary of Exploratory Endpoint: Change from Baseline in Fatigue NRS 
Score (Per-Protocol Population) ..................................................................................................119 
Table 14.2.16.1: Summary of Exploratory Endpoint: Change from Baseline in Work Productivity 
and 
Activity 
Impairment 
(WPAI) 
Score 
(Intent-to-Treat 
Population) ........................................120 
Table 14.2.16.2: Summary of Exploratory Endpoint: Change from Baseline in Work Productivity 
and 
Activity 
Impairment 
(WPAI) 
Score 
 
(Per-Protocol 
Population) ...........................................123 
Table 14.2.17.1: Summary of Whole Body Investigator Global Assessment (IGA) (Intent-to-
Treat Population) .........................................................................................................................124 
Table 14.2.17.2: Summary of Whole Body Investigator Global Assessment (IGA) (Per-Protocol 
Population) ....................................................................................................................129 
Table 14.2.18.1: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) 
(Intent-to-Treat Population) .........................................................................................................130 
Table 14.2.18.2: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) (Per-
Protocol Population) ....................................................................................................................135 
Table 14.3.0.1.1: Summary of Extent of Exposure (Safety Population) .....................................136 
Table 14.3.0.2.1: Summary of Pre-Dose Pharmacokinetic Concentrations  (PK Population) ....137 
Table 14.3.0.2.2: Summary of Additional Pharmacokinetic Concentrations  (PK Population) ..139 
Table 14.3.1.1: Summary of Local Tolerability  (Safety Population) .........................................140 
Figure 14.3.1.1: Subject Local Tolerability Sensation Following Drug Application (Safety 
Population) ...................................................................................................................................144 
Table 14.3.1.2.1: Number of Patients with Suicidal Ideation, Suicidal Behavior, and Self-
Injurious Behavior without Suicidal Intent Based on the Colombia-Suicide Severity Rating Scale 
(C-SSRS) During Treatment (Safety Population)........................................................................145 
Table 14.3.1.2.2: Number of Patients with Suicide-Related Treatment-Emergent Events Based on 
the Colombia-Suicide Severity Rating Scale (C-SSRS) During Treatment (Safety Population) 146 
Table 14.3.1.3.1: Summary of PHQ-8 Assessments by Treatment Group (Safety Population) ..147 
Table 14.3.1.3.2: Shift Summary of PHQ-8 Assessments by Treatment Group 
(Safety Population) ......................................................................................................................148 


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Table 14.3.1.4.1: Overall Summary of Treatment-Emergent Adverse Event Characteristics 
(Safety Population) ......................................................................................................................151 
Table 14.3.1.4.2: Summary of Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (Safety Population) ............................................................................152 
Table 14.3.1.4.3: Summary of Treatment-Emergent Adverse Events Leading to Discontinuation 
of Study Drug by MedDRA System Organ Class and Preferred Term (Safety Population) .......153 
Table 14.3.1.4.4: Summary of Subjects Reporting Treatment-Emergent Adverse Events (TEAEs) 
by Severity (Safety Population) ...................................................................................................154 
Table 14.3.1.4.5: Summary of Subjects Reporting Treatment-Emergent Adverse Events (TEAEs) 
by Relationship to Study Drug (Safety Population) ....................................................................155 
Table 14.3.1.4.6: Summary of Treatment-Emergent Serious Adverse Event Characteristics 
(Safety Population) ......................................................................................................................156 
Table 14.3.1.4.7: Summary of Subjects Reporting Serious Treatment-Emergent Adverse Events 
(TEAEs) by MedDRA System Organ Class and Preferred Term (Safety Population) ...............157 
Table 14.3.1.4.8: Summary of Subjects Reporting Serious Treatment-Emergent Adverse Events 
(TEAEs) by Severity (Safety Population)....................................................................................158 
Table 14.3.1.4.9: Summary of Subjects Reporting Serious Treatment-Emergent Adverse Events 
(TEAEs) by Relationship to Study Drug (Safety Population) .....................................................159 
Table 14.3.1.5.1.1: Summary of Chemistry Laboratory Results  (Safety Population) ................160 
Table 14.3.1.5.1.2: Summary of Hematology Laboratory Results (Safety Population) ..............161 
Table 14.3.1.5.1.3: Summary of Quantitative Urinalysis Laboratory Results (Safety 
Population) ...................................................................................................................................161 
Table 14.3.1.5.2.1: Shift Summary of Chemistry Laboratory Results (Safety Population) ........162 
Table 14.3.1.5.2.2: Shift Summary of Hematology Laboratory Results (Safety Population) .....162 
Table 14.3.1.5.2.3: Shift Summary of Quantitative Urinalysis Laboratory Results (Safety 
Population) ...................................................................................................................................162 
Table 14.3.1.6.1: Summary of Electrocardiogram (ECG) Parameters  (Safety Population) .......163 
Table 14.3.1.6.2: Shift Summary of Overall Electrocardiogram (ECG) Assessments 
(Safety Population) ......................................................................................................................165 
Table 14.3.1.7.1: Summary of Vital Signs  (Safety Population) .................................................166 
Table 14.3.1.7.2: Summary of Change in Body Weight Compared to Baseline 
(Safety Population) ......................................................................................................................170 


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Table 14.0.1: Summary of Subject Enrollment and Evaluability 
ARQ-151 Cream 0.3% 
ARQ-151 Cream 0.15% 
Vehicle Cream 
Number of Subjects in the ITT Population 
xx 
xx 
xx 
Number of Subjects Included from the Safety Population 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Subjects Excluded in the Safety Population 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Reason for Exclusion from the Safety Population 
   No Post-Baseline Safety Assessment 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Subjects Included from the PP Population 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Subjects Excluded in the PP Population 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Reason for Exclusion from the PP Population 
   Less than 80% Compliant 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
   Missed 3 or More Consecutive Doses 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
   Other Serious Protocol Violations 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Subjects Included from the PK Population 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Subjects Excluded in the PK Population 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
   No Evidence of Dosing with Study Drug 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
   Insufficient Plasma Concentrations 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Note: ITT population includes all randomized subjects. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 


 
 
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Table 14.0.2: Summary of Subject Completion/Discontinuation 
(Randomized Subjects) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Completed Study 
Yes 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
No 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Reason for Discontinuation 
Adverse Event 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Lost to Follow-Up 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Pregnancy 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Protocol Deviation 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Withdrawal by Subject 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Study Terminated by Sponsor 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Physician Decision 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Lack of Efficacy 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Other 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 
 
 


 
 
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Table 14.1.1.1: Summary of Subject Demographics 
(Intent-to-Treat Population) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Age (years) 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Sex 
n 
xx 
xx 
xx 
Male 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Female 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Ethnicity 
n 
xx 
xx 
xx 
Hispanic or Latino 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Not Hispanic or Latino 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Race 
n 
xx 
xx 
xx 
American Indian or Alaska Native 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Asian 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Black or African American 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Native Hawaiian or Other Pacific Islander 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
White 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Multiple/Other 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.1.1.1 for the following:  
Table 14.1.1.2: Summary of Subject Demographics (Per-Protocol Population) 
Table 14.1.1.3: Summary of Subject Demographics (Safety Population) 
Table 14.1.1.4: Summary of Subject Demographics (PK Population) 
 


 
 
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Table 14.1.2.1: Summary of Subject Baseline Characteristics 
(Intent-to-Treat Population) 
(Page 1 of 3) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Whole Body Investigator Global Assessment Score 
 n 
                           xx  
                           xx  
                           xx  
  0 – Clear  
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  1 – Almost Clear 
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  2 – Mild 
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  3 – Moderate  
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  4 – Severe    
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
Intertriginous Area Investigator Global Assessment Scorea 
  n 
                           xx  
                           xx  
                           xx  
  0 – Clear  
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  1 – Almost Clear 
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  2 – Mild 
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  3 – Moderate  
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
  4 – Severe   
           xx (   xx.x%) 
           xx (   xx.x%) 
           xx (   xx.x%) 
Itch-Related Sleep Loss Score 
 
 
 
  n 
              xx 
              xx 
              xx 
  Mean 
           xx.x 
           xx.x 
           xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a Collected for subjects with intertriginous involvement. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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Table 14.1.2.1: Summary of Subject Baseline Characteristics 
(Intent-to-Treat Population) 
(Page 2 of 3) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Body Surface Area (%) Affected by Psoriasis 
N 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
PASI 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
     
xx.x 
      
xx.x 
      
xx.x 
  Min. to Max. 
                 xx to xx 
            
xx to xx                                      xx to xx 
mPASI 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
     xx.x 
      xx.x 
      xx.x 
  Min. to Max. 
                 xx to xx 
            
xx to xx                                      xx to xx 
WI-NRS Score 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
 
xx.x 
 
xx.x 
 
xx.x 
Min. to Max. 
 xx to xx 
 xx to xx 
 xx to xx 
 
 
a Collected for subjects with intertriginous involvement. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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Table 14.1.2.1: Summary of Subject Baseline Characteristics 
(Intent-to-Treat Population) 
(Page 3 of 3) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Total Psoriasis Symptom Diary (PSD) Score  
 
 
 
n 
 
xx 
 
xx 
 
xx 
Mean 
 
xx.x 
 
xx.x 
 
xx.x 
SD 
 
xx.xx 
 
xx.xx 
 
xx.xx 
Median 
 
xx.x 
 
xx.x 
 
xx.x 
Min. to Max. 
 xx to xx 
 xx to xx 
 xx to xx 
 
 
 
Dermatology Life Quality Index (DLQI) Score 
 
 
 
n 
 
xx 
 
xx 
 
Xx 
Mean 
 
xx.x 
 
xx.x 
 
xx.x 
SD 
 
xx.xx 
 
xx.xx 
 
xx.xx 
Median 
 
xx.x 
 
xx.x 
 
xx.x 
Min. to Max. 
 xx to xx 
 xx to xx 
 xx to xx 
 
 
 
Height (cm) 
 
 
 
n 
 
xx 
 
xx 
 
Xx 
Mean 
 
xx.x 
 
xx.x 
 
xx.x 
SD 
 
xx.xx 
 
xx.xx 
 
xx.xx 
Median 
 
xx.x 
 
xx.x 
 
xx.x 
Min. to Max. 
 xx to xx 
 xx to xx 
 xx to xx 
 
 
 
Weight (kg) 
 
 
 
n 
 
xx 
 
xx 
 
Xx 
Mean 
 
xx.x 
 
xx.x 
 
xx.x 
SD 
 
xx.xx 
 
xx.xx 
 
xx.xx 
Median 
 
xx.x 
 
xx.x 
 
xx.x 
  Min. to Max. 
 xx to xx 
 xx to xx 
 xx to xx 
 
 
a Collected for subjects with intertriginous involvement. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Repeat Table 14.1.2.1 for the following:  
Table 14.1.2.2: Summary of Subject Baseline Characteristics (Per-Protocol Population) 
Table 14.1.2.3: Summary of Subject Baseline Characteristics (Safety Population) 
Table 14.1.2.4: Summary of Subject Baseline Characteristics (PK Population) 
 
 
 
 
 


 
 
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Table 14.1.3: Summary of Medical History by MedDRA System Organ Class and Preferred Term 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term  
 
ARQ-151 Cream 0.3% 
 
(N=xxx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xxx) 
 
 
Vehicle Cream 
 
(N=xxx) 
 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more medical histories that map to the MedDRA dictionary (Version 21.1). At each level      
   of summarization (System Organ Class or Preferred Term) subjects are counted once.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
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Table 14.1.4.1: Summary of Prior Medications by WHO-DD ATC Level 2 Term and Preferred Name 
 (Safety Population) 
(Page 1 of xx) 
  
ATC Level 2 Terma 
Preferred Name 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
ATC Level 2 Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
ATC Level 2 Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more prior medications that map to the WHO-DD (Version March 1, 2018). At each level of  
  summarization (ATC Level 2 Term or Preferred Name) subjects are counted once. 
Note: Table includes all medications used prior to date of first dose of study drug.  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.1.4.2: Summary of Concomitant Medications by WHO-DD ATC Level 2 Term and Preferred Name 
 (Safety Population) 
(Page 1 of xx) 
  
ATC Level 2 Terma 
Preferred Name 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
ATC Level 2 Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
ATC Level 2 Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Name 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more concomitant medications that map to the WHO-DD (Version March 1, 2018). At each level of  
  summarization (ATC Level 2 Term or Preferred Name) subjects are counted once.  
Note: Table includes all medications used on or after date of first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
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Table 14.2.1.1: Analysis of Primary Efficacy Endpoint: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ at Week 6 
(Intent-to-Treat Population) 
  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
IGA Score of Clear or Almost Clear at Week 6 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream  
x.xxx 
x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline IGA score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.1.1 for the following:  
Table 14.2.1.2: Analysis of Primary Efficacy Endpoint: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ at Week 6 (Per-
Protocol Population) 
 
 
 
 
 
 
 
 
 
 


 
 
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Figure 14.2.1.1:  Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ by Visit 
(Intent-to-Treat Population) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_________________________________________________________________________________________________________________________________ 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
Repeat Figure 14.2.1.1 for the following:  
Figure 14.2.1.2: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ by Visit (Per-Protocol Population) 
 


 
 
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Table 14.2.2.1: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’  
(Intent-to-Treat Population) 
  
IGA Score of Clear or Almost Clear 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 4 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
Week 8 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 12 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline IGA score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.2.1 for the following:  
Table 14.2.2.2: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ (Per-Protocol Population) 
 
 
 
 
 


 
 
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Table 14.2.3.1: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) 
Score of ‘Clear’ or ‘Almost Clear’ Plus a 2-Grade Improvement from Baseline 
(Intent-to-Treat Population) 
  
IGA Score of Clear or Almost Clear  
Plus a 2-Grade Improvement from Baseline 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
Success 
                         xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                         xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                          x.xxx 
                         x.xxx 
Week 4 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 6 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 8 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 12 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline IGA score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
Repeat Table 14.2.3.1 for the following: 
Table 14.2.3.2: Analysis of Secondary Efficacy Endpoint: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ Plus a 2-Grade Improvement 
from Baseline (Per-Protocol Population) 
 
 


 
 
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Figure 14.2.3.1:  Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ Plus a 2-Grade Improvement from Baseline by Visit 
(Intent-to-Treat Population) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_________________________________________________________________________________________________________________________________ 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
Repeat Figure 14.2.3.1 for the following:  
Figure 14.2.3.2: Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ Plus a 2-Grade Improvement from Baseline by Visit (Per-
Protocol Population) 
 


 
 
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Table 14.2.3.3: Summary of Proportion of Subjects Achieving an Investigator Global Assessment (IGA) Score of ‘Clear’ or ‘Almost Clear’ 
Plus a 2-Grade Improvement from Baseline by Investigational Site 
(Intent-to-Treat Population) 
  
Investigational Site 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
xx/xx ( xx.x%) 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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Table 14.2.4.1.1: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least 
‘Mild’ at Baseline who Achieved a Score of ‘Clear’ or ‘Almost Clear’ 
(Intent-to-Treat Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) 
  
I-IGA Score of Clear or Almost Clear Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
Week 4 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 6 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 8 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 12 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                          x.xxx 
                          x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline I-IGA score. 
         Restricted to subjects with an I-IGA severity score of at least “Mild” at baseline. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Repeat Table 14.2.4.1.1 for the following:  
Table 14.2.4.1.2: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least 
‘Mild’ at Baseline who Achieved a Score of ‘Clear’ or ‘Almost Clear’ (Per-Protocol Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) 
 
 


 
 
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Figure 14.2.4.1.1:  Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline 
 who Achieved a Score of ‘Clear’ or ‘Almost Clear’  
(Intent-to-Treat Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_________________________________________________________________________________________________________________________________ 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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Repeat Figure 14.2.4.1.1 for the following:  
Figure 14.2.4.1.2: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline who Achieved a Score of 
‘Clear’ or ‘Almost Clear’ (Per-Protocol Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) 
 


 
 
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Table 14.2.4.2.1: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least 
‘Mild’ at Baseline who Achieved a Score of ‘Clear’ or ‘Almost Clear’ Plus a 2 Grade Improvement from Baseline 
(Intent-to-Treat Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) 
  
I-IGA Score of Clear or Almost Clear Plus a 2 Grade 
Improvement from Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
Week 4 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 6 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 8 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 12 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                          x.xxx 
                          x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline I-IGA score. 
         Restricted to subjects with an I-IGA severity score of at least “Mild” at baseline. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Repeat Table 14.2.4.2.1 for the following:  
Table 14.2.4.2.2: Analysis of Secondary Efficacy Endpoint: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least 
‘Mild’ at Baseline who Achieved a Score of ‘Clear’ or ‘Almost Clear’ Plus a 2 Grade Improvement from Baseline (Per-Protocol Population: Subjects with I-IGA 
Severity of at Least ‘Mild’ at Baseline) 
 
 


 
 
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Figure 14.2.4.2.1:  Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline who Achieved a Score of 
‘Clear’ or ‘Almost Clear’ Plus a 2 Grade Improvement from Baseline 
(Intent-to-Treat Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_________________________________________________________________________________________________________________________________ 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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Repeat Figure 14.2.4.2.1 for the following:  
Figure 14.2.4.2.2: Subjects with an Intertriginous Area Investigator Global Assessment (I-IGA) Severity of at Least ‘Mild’ at Baseline who Achieved a Score of 
‘Clear’ or ‘Almost Clear’ Plus a 2 Grade Improvement from Baseline (Per-Protocol Population: Subjects with I-IGA Severity of at Least ‘Mild’ at Baseline) 
 
 


 
 
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Table 14.2.5.1.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Psoriasis Area and Severity Index (PASI) 
(Intent-to-Treat Population) 
(Page 1 of 6) 
  
PASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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Table 14.2.5.1.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Psoriasis Area and Severity Index (PASI)  
(Intent-to-Treat Population) 
(Page 2 of 6) 
  
PASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
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Table 14.2.5.1.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Psoriasis Area and Severity Index (PASI) 
(Intent-to-Treat Population) 
(Page 3 of 6) 
  
PASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
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Table 14.2.5.1.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Psoriasis Area and Severity Index (PASI) 
(Intent-to-Treat Population) 
(Page 4 of 6) 
  
PASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.2.5.1.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Psoriasis Area and Severity Index (PASI) 
(Intent-to-Treat Population) 
(Page 5 of 6) 
  
PASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.5.1.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Psoriasis Area and Severity Index (PASI) 
(Intent-to-Treat Population) 
(Page 6 of 6) 
  
PASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
Repeat Table 14.2.5.1.1 for the following:  
Table 14.2.5.1.2: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Psoriasis Area and Severity Index (PASI) (Per-
Protocol Population) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
 
Figure 14.2.5.1.1:  Percent Change from Baseline in Psoriasis Area and Severity Index (PASI) 
(Intent-to-Treat Population) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_________________________________________________________________________________________________________________________________ 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.5.2.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI) 
(Intent-to-Treat Population) 
(Page 1 of 6) 
  
mPASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline mPASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
 
Table 14.2.5.2.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI)  
(Intent-to-Treat Population) 
(Page 2 of 6) 
  
mPASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline mPASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.5.2.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI) 
(Intent-to-Treat Population) 
(Page 3 of 6) 
  
mPASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline mPASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.5.2.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI) 
(Intent-to-Treat Population) 
(Page 4 of 6) 
  
mPASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline mPASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.5.2.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI) 
(Intent-to-Treat Population) 
(Page 5 of 6) 
  
mPASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline mPASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.5.2.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI) 
(Intent-to-Treat Population) 
(Page 6 of 6) 
  
mPASI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline mPASI score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally 
possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
Repeat Table 14.2.5.2.1 for the following:  
Table 14.2.5.2.2: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI) (Per-
Protocol Population) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
 
Figure 14.2.5.2.1:  Percent Change from Baseline in Modified Psoriasis Area and Severity Index (mPASI) 
(Intent-to-Treat Population) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_________________________________________________________________________________________________________________________________ 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 68 of 217  
CONFIDENTIAL 
Table 14.2.6.1.1: Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Psoriasis Area and Severity Index (PASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 1 of  3) 
  
Reduction in PASI Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
Week 4 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline PASI score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.6.1.1: Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Psoriasis Area and Severity Index (PASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 2 of  3) 
  
Reduction in PASI Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
Week 8 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline PASI score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.6.1.1: Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Psoriasis Area and Severity Index (PASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 3 of  3) 
  
Reduction in PASI Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline PASI score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.6.1.1 for the following:  
Table 14.2.6.1.2 Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in Psoriasis Area and Severity Index (PASI) Compared to 
Baseline  (Per-Protocol Population) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 71 of 217  
CONFIDENTIAL 
Table 14.2.6.2.1: Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 1 of  3) 
  
Reduction in mPASI Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
Week 4 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline mPASI score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 72 of 217  
CONFIDENTIAL 
Table 14.2.6.2.1: Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 2 of  3) 
  
Reduction in mPASI Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
Week 8 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline mPASI score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 73 of 217  
CONFIDENTIAL 
Table 14.2.6.2.1: Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in 
Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 3 of  3) 
  
Reduction in mPASI Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
75% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
90% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
100% Reduction 
Success 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
                        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
                         x.xxx 
                         x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline mPASI score. 
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.6.2.1 for the following:  
Table 14.2.6.2.2 Analysis of Secondary Efficacy Endpoints: Dichotomized Percent Reductions in Modified Psoriasis Area and Severity Index (mPASI) 
Compared to Baseline  (Per-Protocol Population) 
 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.2.7.1.1: Dichotomized Percent Reductions in Psoriasis Area and Severity Index (PASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 1 of 3) 
  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
75% Reduction in PASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in PASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
  100% Reduction in PASI Compared to Baseline 
   Success  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   Failure 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
Week 4 
75% Reduction in PASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in PASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in PASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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Table 14.2.7.1.1: Dichotomized Percent Reductions in Psoriasis Area and Severity Index (PASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 2 of 3) 
  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
75% Reduction in PASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in PASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in PASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Week 8 
75% Reduction in PASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in PASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in PASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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Table 14.2.7.1.1: Dichotomized Percent Reductions in Psoriasis Area and Severity Index (PASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 3 of 3) 
  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
75% Reduction in PASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in PASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in PASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Week 16 
 
 
 
75% Reduction in PASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
90% Reduction in PASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in PASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
Repeat Table 14.2.7.1.1 for the following: 
Table 14.2.7.1.2: Dichotomized Percent Reduction(s) in Psoriasis Area and Severity Index (PASI) Compared to Baseline (Per-Protocol Population) 
 
 


 
 
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Table 14.2.7.2.1: Dichotomized Percent Reductions in Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 1 of 3) 
  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
75% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
  100% Reduction in mPASI Compared to Baseline 
   Success  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   Failure 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
Week 4 
75% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in mPASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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Table 14.2.7.2.1: Dichotomized Percent Reductions in Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 2 of 3) 
  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
75% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in mPASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Week 8 
75% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in mPASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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Table 14.2.7.2.1: Dichotomized Percent Reductions in Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline 
(Intent-to-Treat Population) 
(Page 3 of 3) 
  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
75% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
90% Reduction in mPASI Compared to Baseline 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in mPASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Week 16 
 
 
 
75% Reduction in mPASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
90% Reduction in mPASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
100% Reduction in mPASI Compared to Baseline 
 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
Repeat Table 14.2.7.2.1 for the following: 
Table 14.2.7.2.2: Dichotomized Percent Reduction(s) in Modified Psoriasis Area and Severity Index (mPASI) Compared to Baseline (Per-Protocol Population) 
 


 
 
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CONFIDENTIAL 
Table 14.2.8.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Body Surface Area (BSA) Affected 
(Intent-to-Treat Population) 
(Page 1 of 6) 
  
BSA 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline BSA score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.2.8.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Body Surface Area (BSA) Affected 
(Intent-to-Treat Population) 
(Page 2 of 6) 
  
BSA 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline BSA score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.2.8.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Body Surface Area (BSA) Affected 
(Intent-to-Treat Population) 
(Page 3 of 6) 
  
BSA 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline BSA score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.8.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Body Surface Area (BSA) Affected 
(Intent-to-Treat Population) 
(Page 4 of 6) 
  
BSA 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline BSA score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.2.8.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Body Surface Area (BSA) Affected 
(Intent-to-Treat Population) 
(Page 5 of 6) 
  
BSA 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline BSA score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.2.8.1: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Body Surface Area (BSA) Affected 
(Intent-to-Treat Population) 
(Page 6 of 6) 
  
BSA 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Percent Change from Baseline 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline BSA score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data at Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.8.1 for the following:  
Table 14.2.8.2: Analysis of Secondary Efficacy Endpoint: Percent Change from Baseline in Body Surface Area (BSA) Affected (Per-Protocol Population) 
 
 


 
 
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CONFIDENTIAL 
Table 14.2.9.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score  
(Intent-to-Treat Population) 
(Page 1 of 5) 
  
WI-NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
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Table 14.2.9.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score 
(Intent-to-Treat Population) 
(Page 2 of 5) 
  
WI-NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.2.9.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score 
(Intent-to-Treat Population) 
(Page 3 of 5) 
  
WI-NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.2.9.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score 
(Intent-to-Treat Population) 
(Page 4 of 5) 
  
WI-NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
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Table 14.2.9.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score 
(Intent-to-Treat Population) 
(Page 5 of 5) 
  
WI-NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.9.1 for the following:  
Table 14.2.9.2: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score (Per-
Protocol Population) 
 
 
 
 


 
 
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Table 14.2.10.1.1: Analysis of Secondary Endpoint: Subjects with a Worst Itch Numerical Rating Scale (WI-NRS) Score ≥ 6 at Baseline and Achieved a 4 Point 
Reduction Compared to Baseline 
(Intent-to-Treat Population: Subjects with WI-NRS Score ≥ 6 at Baseline) 
  
4 Point Reduction in WI-NRS Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 4 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 6 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 8 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
Week 12 
Success 
        xx.x% 
                        xx.x% 
                           xx.x% 
Failure 
        xx.x% 
                        xx.x% 
                           xx.x% 
Contrast P-Value vs Vehicle Cream 
x.xxx 
x.xxx 
 
 
Note: P-values and estimates from a logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score. 
         Restricted to subjects with a baseline WI-NRS Score of 6 or greater.  
         Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Repeat Table 14.2.10.1.1 for the following:  
Table 14.2.10.1.2: Analysis of Secondary Endpoint: Subjects with a Worst Itch Numerical Rating Scale (WI-NRS) Score ≥ 6 at Baseline and Achieved a 4 Point 
Reduction Compared to Baseline (Per-Protocol Population: Subjects with WI-NRS Score ≥ 6 at Baseline) 
 
 
 
 


 
 
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Table 14.2.10.2.1: Summary of Subjects with a Worst Itch Numerical Rating Scale (WI-NRS) Score ≥ 6 at Baseline and Achieved a 4 Point Reduction 
Compared to Baseline 
(Intent-to-Treat Population: Subjects with WI-NRS Score ≥ 6 at Baseline) 
  
4 Point Reduction in WI-NRS Compared to Baseline 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 2 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Week 4 
 
 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Week 6 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Week 8 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Week 12 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
        Restricted to subjects with a baseline WI-NRS Score of 6 or greater. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.10.2.1 for the following:  
Table 14.2.10.2.2: Summary of Subjects with a Worst Itch Numerical Rating Scale (WI-NRS) Score ≥ 6 at Baseline and Achieved a 4 Point Reduction Compared 
to Baseline (Per-Protocol Population: Subjects with WI-NRS Score ≥ 6 at Baseline) 
 
 


 
 
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Table 14.2.11.1: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary (PSD) Score Compared to Baseline 
(Intent-to-Treat Population) 
(Page 1 of 6) 
  
Total PSD Score 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.2.11.1: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary (PSD) Score Compared to Baseline 
(Intent-to-Treat Population) 
(Page 2 of 6) 
  
Total PSD Score 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
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Table 14.2.11.1: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary (PSD) Score Compared to Baseline 
(Intent-to-Treat Population) 
(Page 3 of 6) 
  
Total PSD Score 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.2.11.1: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary (PSD) Score Compared to Baseline 
(Intent-to-Treat Population) 
(Page 4 of 6) 
  
Total PSD Score 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
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Table 14.2.11.1: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary (PSD) Score Compared to Baseline 
(Intent-to-Treat Population) 
(Page 5 of 6) 
  
Total PSD Score 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
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Table 14.2.11.1: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary (PSD) Score Compared to Baseline 
(Intent-to-Treat Population) 
(Page 6 of 6) 
  
Total PSD Score 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD score. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.11.1 for the following:  
Table 14.2.11.2: Analysis of Secondary Efficacy Endpoint: Total Psoriasis Symptom Diary (PSD) Score Compared to Baseline (Per-Protocol Population) 
 
 
 


 
 
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Table 14.2.12.1: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom Diary (PSD) Responses Compared to Baseline 
(Intent-to-Treat Population) 
(Page 1 of xx) 
  
PSD Responses to Individual Questions  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
<Question> 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD response. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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Table 14.2.12.1: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom Diary (PSD) Responses Compared to Baseline 
(Intent-to-Treat Population) 
(Page 2 of xx) 
  
PSD Responses to Individual Questions  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
<Question> 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD response. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.2.12.1: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom Diary (PSD) Responses Compared to Baseline 
(Intent-to-Treat Population) 
(Page 3 of xx) 
  
PSD Responses to Individual Questions  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
<Question> 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD response. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
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Table 14.2.12.1: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom Diary (PSD) Responses Compared to Baseline 
(Intent-to-Treat Population) 
(Page 4 of xx) 
  
PSD Responses to Individual Questions  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
<Question> 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD response. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Table 14.2.12.1: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom Diary (PSD) Responses Compared to Baseline 
(Intent-to-Treat Population) 
(Page 5 of xx) 
  
PSD Responses to Individual Questions  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
<Question> 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD response. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Table 14.2.12.1: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom Diary (PSD) Responses Compared to Baseline 
(Intent-to-Treat Population) 
(Page 6 of xx) 
  
PSD Responses to Individual Questions  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
<Question> 
Week 16 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline PSD response. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.12.1 for the following:  
Table 14.2.12.2: Analysis of Secondary Efficacy Endpoint: Improvement in Psoriasis Symptom Diary (PSD) Responses Compared to Baseline (Per-
Protocol Population) 
 
 
 
 


 
 
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Table 14.2.13.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-Related Sleep Loss Score 
(Intent-to-Treat Population) 
(Page 1 of 5) 
  
Itch-Related Sleep Loss 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.2.13.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-Related Sleep Loss Score 
(Intent-to-Treat Population) 
(Page 2 of 5) 
  
Itch-Related Sleep Loss 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.2.13.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-Related Sleep Loss Score 
(Intent-to-Treat Population) 
(Page 3 of 5) 
  
Itch-Related Sleep Loss 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Table 14.2.13.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-Related Sleep Loss Score 
(Intent-to-Treat Population) 
(Page 4 of 5) 
  
Itch-Related Sleep Loss 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Table 14.2.13.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-Related Sleep Loss Score 
(Intent-to-Treat Population) 
(Page 5 of 5) 
  
Itch-Related Sleep Loss 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.13.1 for the following:  
Table 14.2.13.2: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Itch-Related Sleep Loss Score (Per-Protocol Population) 
 
 
 
 
 
 
 


 
 
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Table 14.2.14.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Dermatology Life Quality Index (DLQI) Score 
(Intent-to-Treat Population) 
(Page 1 of 5) 
  
DLQI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline DLQI score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
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Table 14.2.14.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Dermatology Life Quality Index (DLQI) Score 
(Intent-to-Treat Population) 
(Page 2 of 5) 
  
DLQI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline DLQI score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.14.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Dermatology Life Quality Index (DLQI) Score 
(Intent-to-Treat Population) 
(Page 3 of 5) 
  
DLQI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline DLQI score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.2.14.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Dermatology Life Quality Index (DLQI) Score 
(Intent-to-Treat Population) 
(Page 4 of 5) 
  
DLQI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline DLQI score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.14.1: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Dermatology Life Quality Index (DLQI) Score 
(Intent-to-Treat Population) 
(Page 5 of 5) 
  
DLQI 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
LS Meana 
xx.x 
xx.x 
xx.x 
LS SDa 
xx.xx 
xx.xx 
xx.xx 
           Contrast P-Value vs Vehicle Creama 
x.xxx 
x.xxx 
 
 
a P-values and estimates from an ANCOVA with a factor of treatment group and a covariate of baseline DLQI score. 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
Repeat Table 14.2.14.1 for the following:  
Table 14.2.14.2: Analysis of Secondary Efficacy Endpoint: Change from Baseline in Dermatology Life Quality Index (DLQI) Score (Per-Protocol Population) 
 
 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.2.15.1: Summary of Exploratory Endpoint: Change from Baseline in Fatigue NRS Score 
(Intent-to-Treat Population) 
(Page 1 of 3) 
  
NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.15.1: Summary of Exploratory Endpoint: Change from Baseline in Fatigue NRS Score 
(Intent-to-Treat Population) 
(Page 2 of 3) 
  
NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.2.15.1: Summary of Exploratory Endpoint: Change from Baseline in Fatigue NRS Score 
(Intent-to-Treat Population) 
(Page 3 of 3) 
  
NRS 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
   Week 12 
       n 
xx 
xx 
xx 
       Mean 
xx.x 
xx.x 
xx.x 
       SD 
xx.xx 
xx.xx 
xx.xx 
       Median 
xx.x 
xx.x 
xx.x 
       Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
       Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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Repeat Table 14.2.15.1 for the following:  
Table 14.2.15.2: Summary of Exploratory Endpoint: Change from Baseline in Fatigue NRS Score (Per-Protocol Population) 
 
 


 
 
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Table 14.2.16.1: Summary of Exploratory Endpoint: Change from Baseline in Work Productivity and Activity Impairment (WPAI) Score 
(Intent-to-Treat Population) 
(Page 1 of xx) 
  
<Score Type> 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
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Table 14.2.16.1: Summary of Exploratory Endpoint: Change from Baseline in Work Productivity and Activity Impairment (WPAI) Score 
(Intent-to-Treat Population) 
(Page 2 of xx) 
  
<Score Type> 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Table 14.2.16.1: Summary of Exploratory Endpoint: Change from Baseline in Work Productivity and Activity Impairment (WPAI) Score 
(Intent-to-Treat Population) 
(Page 3 of xx) 
  
<Score Type> 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
   Week 12 
       n 
xx 
xx 
xx 
       Mean 
xx.x 
xx.x 
xx.x 
       SD 
xx.xx 
xx.xx 
xx.xx 
       Median 
xx.x 
xx.x 
xx.x 
       Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
       Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
Note: Missing data imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally possible. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Repeat Table 14.2.16.1 for the following:  
Table 14.2.16.2: Summary of Exploratory Endpoint: Change from Baseline in Work Productivity and Activity Impairment (WPAI) Score  (Per-
Protocol Population) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
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Table 14.2.17.1: Summary of Whole Body Investigator Global Assessment (IGA) 
(Intent-to-Treat Population) 
(Page 1 of 6) 
  
Whole Body Investigator Global Assessment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
               xx 
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Week 2 
n 
               xx  
               xx  
               xx  
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Score of Clear or Almost Clear 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baseline  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
        possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Table 14.2.17.1: Summary of Whole Body Investigator Global Assessment (IGA) 
(Intent-to-Treat Population) 
(Page 2 of 6) 
  
Whole Body Investigator Global Assessment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
               xx 
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baseline  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
        possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Table 14.2.17.1: Summary of Whole Body Investigator Global Assessment (IGA) 
(Intent-to-Treat Population) 
(Page 3 of 6) 
  
Whole Body Investigator Global Assessment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
n 
               xx 
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baseline  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
        possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
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Table 14.2.17.1: Summary of Whole Body Investigator Global Assessment (IGA) 
(Intent-to-Treat Population) 
(Page 4 of 6) 
  
Whole Body Investigator Global Assessment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
               xx 
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baseline  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
        possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Table 14.2.17.1: Summary of Whole Body Investigator Global Assessment (IGA) 
(Intent-to-Treat Population) 
(Page 5 of 6) 
  
Whole Body Investigator Global Assessment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
               xx 
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baseline  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
        possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 
 
 


 
 
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Table 14.2.17.1: Summary of Whole Body Investigator Global Assessment (IGA) 
(Intent-to-Treat Population) 
(Page 6 of 6) 
  
Whole Body Investigator Global Assessment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
n 
               xx 
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baseline  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
        possible. Missing data for Week 16 was not imputed. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.17.1 for the following:  
Table 14.2.17.2: Summary of Whole Body Investigator Global Assessment (IGA) (Per-Protocol Population) 
 
 


 
 
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Table 14.2.18.1: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) 
(Intent-to-Treat Population) 
(Page 1 of 6) 
  
Intertriginous Area Investigator Global Assessmenta 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
               xx 
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Week 2 
n 
               xx  
               xx  
               xx  
0 – Clear  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
1 – Almost Clear 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
2 – Mild 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
3 – Moderate  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
4 – Severe   
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Score of Clear or Almost Clearb 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baselineb  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
a Collected at baseline for subjects with intertriginous area involvement and collected post-baseline for subjects with a severity of at least mild at baseline. 
b Restricted to subjects with a severity of at least mild at baseline. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data was not imputed for Week 16. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Table 14.2.18.1: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) 
(Intent-to-Treat Population) 
(Page 2 of 6) 
  
Intertriginous Area Investigator Global Assessmenta 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
   n 
               xx 
               xx 
               xx 
   0 – Clear  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   1 – Almost Clear 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   2 – Mild 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   3 – Moderate  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   4 – Severe   
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
 
Score of Clear or Almost Clearb 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baselineb  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
a Collected at baseline for subjects with intertriginous area involvement and collected post-baseline for subjects with a severity of at least mild at baseline. 
b Restricted to subjects with a severity of at least mild at baseline. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data was not imputed for Week 16. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Table 14.2.18.1: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) 
(Intent-to-Treat Population) 
(Page 3 of 6) 
  
Intertriginous Area Investigator Global Assessmenta 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 6 
   n 
               xx 
               xx 
               xx 
   0 – Clear  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   1 – Almost Clear 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   2 – Mild 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   3 – Moderate  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   4 – Severe   
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
 
Score of Clear or Almost Clearb 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baselineb  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
a Collected at baseline for subjects with intertriginous area involvement and collected post-baseline for subjects with a severity of at least mild at baseline. 
b Restricted to subjects with a severity of at least mild at baseline. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data was not imputed for Week 16. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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Table 14.2.18.1: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) 
(Intent-to-Treat Population) 
(Page 4 of 6) 
  
Intertriginous Area Investigator Global Assessmenta 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
   n 
               xx 
               xx 
               xx 
   0 – Clear  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   1 – Almost Clear 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   2 – Mild 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   3 – Moderate  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   4 – Severe   
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
 
Score of Clear or Almost Clearb 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baselineb  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
a Collected at baseline for subjects with intertriginous area involvement and collected post-baseline for subjects with a severity of at least mild at baseline. 
b Restricted to subjects with a severity of at least mild at baseline. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data was not imputed for Week 16. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
 
Table 14.2.18.1: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) 
(Intent-to-Treat Population) 
(Page 5 of 6) 
  
Intertriginous Area Investigator Global Assessmenta 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
   n 
               xx 
               xx 
               xx 
   0 – Clear  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   1 – Almost Clear 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   2 – Mild 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   3 – Moderate  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   4 – Severe   
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
 
Score of Clear or Almost Clearb 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baselineb  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
a Collected at baseline for subjects with intertriginous area involvement and collected post-baseline for subjects with a severity of at least mild at baseline. 
b Restricted to subjects with a severity of at least mild at baseline. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data was not imputed for Week 16. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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Table 14.2.18.1: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) 
(Intent-to-Treat Population) 
(Page 6 of 6) 
  
Intertriginous Area Investigator Global Assessmenta 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
   n 
               xx 
               xx 
               xx 
   0 – Clear  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   1 – Almost Clear 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   2 – Mild 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   3 – Moderate  
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
   4 – Severe   
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
 
Score of Clear or Almost Clearb 
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
 
 
Score of Clear or Almost Clear and 
a 2-Grade Improvement  from Baselineb  
 
Success  
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
Failure 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
 
 
a Collected at baseline for subjects with intertriginous area involvement and collected post-baseline for subjects with a severity of at least mild at baseline. 
b Restricted to subjects with a severity of at least mild at baseline. 
Note: Missing data through Week 12 imputed using linear interpolation and last observation carried forward where linear interpolation is not computationally  
         possible. Missing data was not imputed for Week 16. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.2.18.1 for the following:  
Table 14.2.18.2: Summary of Intertriginous Area Investigator Global Assessment (I-IGA) (Per-Protocol Population) 
 
 
 
 
 


 
 
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Table 14.3.0.1.1: Summary of Extent of Exposure 
(Safety Population) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Number of Doses 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Amount of Drug Applied (g) 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Complianta 
n 
xx 
xx 
xx 
Yes 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
No 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a A subject is considered compliant with the dosing regimen if the subject applied at least 80% of the expected doses during the dosing period and did not miss   
   more than 3 consecutive doses.   
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
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Table 14.3.0.2.1: Summary of Pre-Dose Pharmacokinetic Concentrations 
 (PK Population) 
 (Page 1 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
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Table 14.3.0.2.1: Summary of Pre-Dose Pharmacokinetic Concentrations 
 (PK Population) 
 (Page 2 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 
 
 


 
 
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Table 14.3.0.2.2: Summary of Additional Pharmacokinetic Concentrations 
 (PK Population) 
 (Page 1 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
72 hr (3 days) 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
120 hr (5 days) 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
    168 hr (7 days) 
       n 
xx 
xx 
xx 
       Mean 
xx.x 
xx.x 
xx.x 
       SD 
xx.xx 
xx.xx 
xx.xx 
       Median 
xx.x 
xx.x 
xx.x 
       Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
    216 hr (9 days) 
       n 
xx 
xx 
xx 
       Mean 
xx.x 
xx.x 
xx.x 
       SD 
xx.xx 
xx.xx 
xx.xx 
       Median 
xx.x 
xx.x 
xx.x 
       Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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Table 14.3.1.1: Summary of Local Tolerability  
(Safety Population) 
(Page 1 of 4) 
  
Investigator Local Tolerability Dermal Response 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
  n 
xx  
xx  
xx  
  0 – No evidence of irritation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Minimal Erythema, Barely Perceptible 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite Erythema, Readily Visible;  
              
              
              
        Minimal edema or minimal papular response 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  3 – Erythema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  4 – Definite Edema 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  5 – Erythema, Edema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  6 – Vesicular Eruption 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  7 – Strong Reaction Spreading Beyond Application Site 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Subject Local Tolerability Sensation Following  
Drug Application 
Baseline 
 
 
 
  n 
xx  
xx  
xx  
  0 – No sensation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Slight warm, tingling sensation; not really bothersome 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite warm, tingling sensation that is somewhat        
        bothersome  
              
              
              
  3 – Hot, tingling/stinging sensation that has caused definite  
       discomfort 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.3.1.1: Summary of Local Tolerability  
(Safety Population) 
(Page 2 of 4) 
  
Investigator Local Tolerability Dermal Response 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
  n 
xx  
xx  
xx  
  0 – No evidence of irritation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Minimal Erythema, Barely Perceptible 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite Erythema, Readily Visible;  
              
              
              
        Minimal edema or minimal papular response 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  3 – Erythema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  4 – Definite Edema 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  5 – Erythema, Edema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  6 – Vesicular Eruption 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  7 – Strong Reaction Spreading Beyond Application Site 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Subject Local Tolerability Sensation Following  
Drug Application 
Week 4 
 
 
 
  n 
xx  
xx  
xx  
  0 – No sensation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Slight warm, tingling sensation; not really bothersome 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite warm, tingling sensation that is somewhat        
        bothersome  
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  3 – Hot, tingling/stinging sensation that has caused definite  
       discomfort 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.3.1.1: Summary of Local Tolerability  
(Safety Population) 
(Page 3 of 4) 
  
Investigator Local Tolerability Dermal Response 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
  n 
xx  
xx  
xx  
  0 – No evidence of irritation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Minimal Erythema, Barely Perceptible 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite Erythema, Readily Visible;  
              
              
              
        Minimal edema or minimal papular response 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  3 – Erythema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  4 – Definite Edema 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  5 – Erythema, Edema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  6 – Vesicular Eruption 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  7 – Strong Reaction Spreading Beyond Application Site 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Subject Local Tolerability Sensation Following  
Drug Application 
Week 8 
  n 
xx  
xx  
xx  
  0 – No sensation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Slight warm, tingling sensation; not really bothersome 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite warm, tingling sensation that is somewhat        
        bothersome  
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  3 – Hot, tingling/stinging sensation that has caused definite  
       discomfort 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.3.1.1: Summary of Local Tolerability  
(Safety Population) 
(Page 4 of 4) 
  
Investigator Local Tolerability Dermal Response 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
  n 
xx  
xx  
xx  
  0 – No evidence of irritation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Minimal Erythema, Barely Perceptible 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite Erythema, Readily Visible;  
              
              
              
        Minimal edema or minimal papular response 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  3 – Erythema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  4 – Definite Edema 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  5 – Erythema, Edema and Papules 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  6 – Vesicular Eruption 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  7 – Strong Reaction Spreading Beyond Application Site 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Subject Local Tolerability Sensation Following  
Drug Application 
Week 12 
 
 
 
  n 
xx  
xx  
xx  
  0 – No sensation 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  1 – Slight warm, tingling sensation; not really bothersome 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  2 – Definite warm, tingling sensation that is somewhat        
        bothersome  
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
  3 – Hot, tingling/stinging sensation that has caused definite  
       discomfort 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Figure 14.3.1.1: Subject Local Tolerability Sensation Following Drug Application 
(Safety Population) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_________________________________________________________________________________________________________________________________ 
Note: 0 (No sensation), 1 (Slight warm, tingling sensation; not really bothersome), 2 (Definite warm, tingling sensation that is somewhat bothersome), 
          3 (Hot, tingling/stinging sensation that has caused definite discomfort)          
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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Table 14.3.1.2.1: Number of Patients with Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior without Suicidal Intent Based on the Colombia-
Suicide Severity Rating Scale (C-SSRS) During Treatment 
(Safety Population) 
  
Events during treatment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Suicidal Ideation (1-5) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1) Wish to be dead 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2) Non-specific active suicidal thoughts 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3) Active suicidal ideation with any methods (not plan) 
without intent to act 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4) Active suicidal ideation with some intent to act, without 
specific plan 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
5) Active suicidal ideation with specific plan and intent 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Suicidal Behavior (6-10) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
6) Preparatory acts or behavior 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
7) Aborted attempt 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
8) Interrupted attempt 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
9) Non-fatal suicide attempt 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
10) Completed suicide 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Suicidal Ideation or Behavior (1-10) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Self-injurious behavior without suicidal intent 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 


 
 
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Table 14.3.1.2.2: Number of Patients with Suicide-Related Treatment-Emergent Events Based on the Colombia-Suicide Severity Rating Scale (C-SSRS) During 
Treatment 
(Safety Population) 
 
Treatment-emergent (TE) Events  
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
TE suicidal ideation (1-5) compared to recent history a 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
TE serious suicidal ideation (0-3 to 4-5) compared to 
recent history b 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Emergence of serious suicidal ideation (0 to 4-5) compared 
to recent historyc 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Improvement in suicidal ideation at endpoint compared with 
baselined 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Emergence of suicidal behavior (6-10) compared to all prior 
history e 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
a N=Number of enrolled patients with at least one post-baseline suicidal ideation score and whose maximum C-SSRS 
suicidal ideation score during the comparison period is non-missing and <5. 
b N=Number of enrolled patients with at least one post-baseline suicidal ideation score and whose maximum C-SSRS 
suicidal ideation score during the comparison period is 0-3. 
c N=Number of enrolled patients with at least one post-baseline suicidal ideation score and whose maximum C-SSRS 
suicidal ideation score during the comparison period is 0. 
d N=Number of enrolled patients whose suicidal ideation score is non-missing and >0 just prior to treatment. 
e N=number of enrolled patients with with at least one post-baseline C-SSRS assessment and who did not have suicidal 
behavior (6-10) prior to treatment. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 


 
 
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Table 14.3.1.3.1: Summary of PHQ-8 Assessments by Treatment Group 
(Safety Population) 
 
PHQ-8 Assessment 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
               xx 
None – Minimal Depression (0 to 4) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Mild Depression (5 to 9) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Moderate Depression (10 to 14) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Moderately Severe Depression (15 to 19) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Severe Depression (20 to 24) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Week 4 
n 
               xx  
               xx  
               xx  
None – Minimal Depression (0 to 4) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Mild Depression (5 to 9) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Moderate Depression (10 to 14) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Moderately Severe (15 to 19) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Severe Depression (20 to 24) 
xx (   xx.x%) 
xx (   xx.x%) 
xx (   xx.x%) 
Week 8 
  n 
               xx  
               xx  
               xx  
  None – Minimal Depression (0 to 4) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Mild Depression (5 to 9) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Moderate Depression (10 to 14) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Moderately Severe (15 to 19) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Severe Depression (20 to 24) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
Week 12 
n 
               xx  
               xx  
               xx  
  None – Minimal Depression (0 to 4) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Mild Depression (5 to 9) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Moderate Depression (10 to 14) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Moderately Severe (15 to 19) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
  Severe Depression (20 to 24) 
               xx (   xx.x%) 
               xx (   xx.x%) 
               xx (   xx.x%) 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.3.2: Shift Summary of PHQ-8 Assessments by Treatment Group 
(Safety Population) 
(Page 1 of  3) 
 
PHQ-8 for (ARQ-151 Cream 0.3%) 
__________________________________________Week 4__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
__________________________________________Week 8__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
__________________________________________Week 12__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate   
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
 
 
Note: None = Minimal Depression (0 to 4); Mild = Mild Depression (5 to 9); Moderate = Moderate Depression (10 to 14);  
Moderately Severe = Moderately Severe Depression (15 to 19); Severe = Severe Depression (20 to 24). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.3.2: Shift Summary of PHQ-8 Assessments by Treatment Group 
(Safety Population) 
(Page 2 of  3) 
  
PHQ-8 for (ARQ-151 Cream 0.15%) 
__________________________________________Week 4__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
__________________________________________Week 8__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
__________________________________________Week 12__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
 
 
Note: None = Minimal Depression (0 to 4); Mild = Mild Depression (5 to 9); Moderate = Moderate Depression (10 to 14);  
Moderately Severe = Moderately Severe Depression (15 to 19); Severe = Severe Depression (20 to 24). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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Table 14.3.1.3.2: Shift Summary of PHQ-8 Assessments by Treatment Group 
(Safety Population) 
(Page 3 of  3) 
  
PHQ-8 for (Vehicle Cream) 
__________________________________________Week 4__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
__________________________________________Week 8__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
__________________________________________Week 12__________________________________________ 
Baseline 
None 
Mild 
Moderate 
Moderately Severe 
Severe 
None 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Mild  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderate  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Moderately Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
Severe  
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
xx  (  xx.x%) 
 
 
Note: None = Minimal Depression (0 to 4); Mild = Mild Depression (5 to 9); Moderate = Moderate Depression (10 to 14);  
Moderately Severe = Moderately Severe Depression (15 to 19); Severe = Severe Depression (20 to 24). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.4.1: Overall Summary of Treatment-Emergent Adverse Event Characteristics 
(Safety Population) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Subjects with any TEAE 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of TEAEs  
             xx   
                      xx   
                              xx   
Subjects with any Related TEAE 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Related TEAEs  
             xx   
                      xx   
                              xx   
Subjects with any Serious TEAE  
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Serious TEAEs  
             xx   
                      xx   
                              xx   
Subjects with any Related Serious TEAE  
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Related Serious TEAEs  
             xx   
                      xx   
                              xx   
Subjects who Died 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Subjects who Discontinued Study Drug due to TEAE 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Subjects who Discontinued Study due to TEAE 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Maximum Severity By Subject 
Grade 5 
            xx  (   xx.x%) 
            xx  (   xx.x%) 
            xx  (   xx.x%) 
Grade 4 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Grade 3 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Grade 2 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Grade 1 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
Maximum Relationship by Subject 
Likely 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Probably 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Possibly 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Unlikely 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Unrelated 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.4.2: Summary of Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA dictionary (Version 21.1). At each level of summarization        
   (System Organ Class or Preferred Term) subjects are counted once. 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.4.3: Summary of Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug by 
MedDRA System Organ Class and Preferred Term 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to the MedDRA dictionary (Version 21.1). At each level of summarization    
   (System Organ Class or Preferred Term) subjects are counted once. 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.4.4: Summary of Subjects Reporting Treatment-Emergent Adverse Events (TEAEs) by Severity 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term 
 Severityb 
ARQ-151 Cream 0.3% 
_________(N=xx)___________ 
ARQ-151 Cream 0.15% 
_________(N=xx)___________ 
Vehicle Cream 
_________(N=xx)___________ 
Total 
Grade 5 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 4 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 3 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 2 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 1 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
System Organ Class 
Grade 5 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 4 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 3 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 2 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 1 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Preferred Term 
Grade 5 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 4 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 3 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 2 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 1 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to the MedDRA dictionary (Version 21.1). At each level of summarization   
   (System Organ Class or Preferred Term) subjects are counted once under the greatest reported severity. 
b  Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life Threatening; Grade 5 = Death. 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.4.5: Summary of Subjects Reporting Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Drug 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term  
 Relationship 
ARQ-151 Cream 0.3% 
_________(N=xx)___________ 
ARQ-151 Cream 0.15% 
_________(N=xx)___________ 
Vehicle Cream 
_________(N=xx)___________ 
Total 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
System Organ Class 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Preferred Term 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Preferred Term 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to the MedDRA dictionary (Version 21.1). At each level of summarization  
   (System Organ Class or Preferred Term) subjects are counted once under the greatest reported relationship. 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.4.6: Summary of Treatment-Emergent Serious Adverse Event Characteristics 
(Safety Population) 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Subjects with any Serious TEAE  
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Serious TEAEs  
             xx   
                      xx   
                              xx   
Subjects with any Related Serious TEAE  
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Related Serious TEAEs  
             xx   
                      xx   
                              xx   
Subjects who Died 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Subjects who Discontinued Study Drug due to TEAE 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Subjects who Discontinued Study due to TEAE 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Maximum Severity By Subject 
Grade 5 
            xx  (   xx.x%) 
            xx  (   xx.x%) 
            xx  (   xx.x%) 
Grade 4 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Grade 3 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Grade 2 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Grade 1 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
Maximum Relationship by Subject 
Likely 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Probably 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Possibly 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Unlikely 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Unrelated 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.4.7: Summary of Subjects Reporting Serious Treatment-Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term 
 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
System Organ Class 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Preferred Term 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to the MedDRA dictionary (Version 21.1). At each level of summarization  
   (System Organ Class or Preferred Term) subjects are counted once. 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.4.8: Summary of Subjects Reporting Serious Treatment-Emergent Adverse Events (TEAEs) by Severity 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term 
 Severityb 
ARQ-151 Cream 0.3% 
_________(N=xx)___________ 
ARQ-151 Cream 0.15% 
_________(N=xx)___________ 
Vehicle Cream 
_________(N=xx)___________ 
Total 
Grade 5 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 4 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 3 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 2 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 1 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
System Organ Class 
Grade 5 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 4 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 3 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 2 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 1 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Preferred Term 
Grade 5 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 4 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 3 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 2 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Grade 1 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to the MedDRA dictionary (Version 21.1). At each level of summarization  
   (System Organ Class or Preferred Term) subjects are counted once under the greatest reported severity. 
b  Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life Threatening; Grade 5 = Death. 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
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CONFIDENTIAL 
Table 14.3.1.4.9: Summary of Subjects Reporting Serious Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Drug 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa 
Preferred Term  
 Relationship 
ARQ-151 Cream 0.3% 
_________(N=xx)___________ 
ARQ-151 Cream 0.15% 
_________(N=xx)___________ 
Vehicle Cream 
_________(N=xx)___________ 
Total 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
System Organ Class 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Preferred Term 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
 
Preferred Term 
Likely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Probably 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Possibly 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unlikely 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
Unrelated 
xx  (   xx.x%) 
xx  (   xx.x%) 
xx  (   xx.x%) 
 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to the MedDRA dictionary (Version 21.1). At each level of summarization  
   (System Organ Class or Preferred Term) subjects are counted once under the greatest reported relationship. 
Note: Treatment-emergent adverse events are those with an onset after first dose of study drug. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.3.1.5.1.1: Summary of Chemistry Laboratory Results 
 (Safety Population) 
(Page 1 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.3.1.5.1.1: Summary of Chemistry Laboratory Results 
 (Safety Population) 
(Page 2 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.3.1.5.1.1: Summary of Chemistry Laboratory Results 
For the following tables: 
Table 14.3.1.5.1.2: Summary of Hematology Laboratory Results (Safety Population) 
Table 14.3.1.5.1.3: Summary of Quantitative Urinalysis Laboratory Results (Safety Population) 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.3.1.5.2.1: Shift Summary of Chemistry Laboratory Results 
(Safety Population) 
(Page 1 of x) 
  
<Test name> (<units>) 
ARQ-151 Cream 0.3% 
                              (N=xx)  
ARQ-151 Cream 0.15% 
                              (N=xx)  
 
Vehicle Cream 
                              (N=xx)  
 
 
  
Week 4 
   
Week 4 
  
Week 4 
 
Baseline  
BNL 
  
WNL 
  
ANL 
  
BNL 
  
WNL 
  
ANL 
  
BNL 
  
WNL 
  
ANL 
 
BNL 
xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) 
WNL 
xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) 
ANL 
xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) 
  
Week 12 
   
Week 12 
  
Week 12 
 
Baseline  
BNL 
  
WNL 
  
ANL 
  
BNL 
  
WNL 
  
ANL 
  
BNL 
  
WNL 
  
ANL 
 
BNL 
xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) 
WNL 
xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) 
ANL 
xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) xx ( xx.x%) 
 
 
Note: BNL=Below Normal Limit, WNL=Within Normal Limit, ANL=Above Normal Limit. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat Table 14.3.1.5.2.1: Shift Summary of Chemistry Laboratory Results 
For the following tables: 
Table 14.3.1.5.2.2: Shift Summary of Hematology Laboratory Results (Safety Population) 
Table 14.3.1.5.2.3: Shift Summary of Quantitative Urinalysis Laboratory Results (Safety Population) 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.3.1.6.1: Summary of Electrocardiogram (ECG) Parameters 
 (Safety Population) 
 (Page 1 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.3.1.6.1: Summary of Electrocardiogram (ECG) Parameters 
 (Safety Population) 
 (Page 2 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.3.1.6.2: Shift Summary of Overall Electrocardiogram (ECG) Assessments 
(Safety Population) 
(Page 1 of x) 
  
Overall ECG Assessment 
ARQ-151 Cream 0.3% 
                       (N=xx)  
ARQ-151 Cream 0.15% 
                      (N=xx)  
Vehicle Cream 
                      (N=xx)  
 
 
Week 4 
  
Week 4 
  
Week 4 
 
Baseline 
 
Normal 
  
Abnormal 
  
Normal 
  
Abnormal 
  
Normal 
  
Abnormal 
 
Normal 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Abnormal 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
Week 12 
  
Week 12 
  
Week 12 
 
Baseline 
 
Normal 
  
Abnormal 
  
Normal 
  
Abnormal 
  
Normal 
  
Abnormal 
 
Normal 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Abnormal 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.3.1.7.1: Summary of Vital Signs 
 (Safety Population) 
 (Page 1 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 2 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 167 of 217  
CONFIDENTIAL 
Table 14.3.1.7.1: Summary of Vital Signs 
 (Safety Population) 
 (Page 2 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 6 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.3.1.7.1: Summary of Vital Signs 
 (Safety Population) 
 (Page 3 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 8 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Week 12 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.3.1.7.1: Summary of Vital Signs 
 (Safety Population) 
 (Page 4 of xx) 
  
<Parameter> (<units>) 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Change from Baseline 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 
 
 
 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Table 14.3.1.7.2: Summary of Change in Body Weight Compared to Baseline 
(Safety Population) 
(Page 1 of 2) 
  
Change in Body Weight Compared to Baselinea 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 4 
Lost  >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Lost >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Maintained Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Gained >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Gained >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 6 
Lost  >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Lost >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Maintained Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Gained >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Gained >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 8 
Lost  >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Lost >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Maintained Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Gained >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Gained >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 12 
Lost  >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Lost >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Maintained Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Gained >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Gained >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Percentages may sum to over 100% due to the possibility of being included in more than one category. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 171 of 217  
CONFIDENTIAL 
 
Table 14.3.1.7.2: Summary of Change in Body Weight Compared to Baseline 
(Safety Population) 
(Page 2 of 2) 
  
Change in Body Weight Compared to Baselinea 
 
ARQ-151 Cream 0.3% 
 
(N=xx) 
 
 
ARQ-151 Cream 0.15% 
 
(N=xx) 
 
 
Vehicle Cream 
 
(N=xx) 
 
Week 16 
Lost  >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Lost >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Maintained Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Gained >5% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
     Gained >10% Body Weight 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Percentages may sum to over 100% due to the possibility of being included in more than one category. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
  Page 172 of 217  
CONFIDENTIAL 
11. INDEX OF PLANNED LISTINGS
Listing 16.2.1.1: End of Study Information .................................................................................174 
Listing 16.2.1.2: Discontinued Subjects ......................................................................................175 
Listing 16.2.2.1: Inclusion/Exclusion Criteria Violations ...........................................................176 
Listing 16.2.2.2: Protocol Deviations ..........................................................................................177 
Listing 16.2.3: Analysis Populations ...........................................................................................178 
Listing 16.2.4.1: Subject Demographic Information ...................................................................179 
Listing 16.2.4.2.1: Unique Medical/Surgical History Coded to MedDRA System Organ Classes 
and Preferred Terms ............................................................................180 
Listing 16.2.4.2.2: Medical/Surgical History...............................................................................181 
Listing 16.2.4.3.1: Unique Medication Names Coded to WHO-DD ATC Level 2 Terms and 
Preferred Names ..................................................................................182 
Listing 16.2.4.3.2: Prior and Concomitant Medications ..............................................................183 
Listing 16.2.4.4.1: Unique Therapies and Procedures Coded to MedDRA System Organ Classes 
and Preferred Terms ............................................................................184 
Listing 16.2.4.4.2: Prior and Concomitant Therapies and Procedures ........................................185 
Listing 16.2.4.5: Physical Examination .......................................................................................186 
Listing 16.2.5.1: Study Visit Compliance ....................................................................................187 
Listing 16.2.5.2: Drug Accountability .........................................................................................188 
Listing 16.2.5.3: Study Drug Application ....................................................................................189 
Listing 16.2.5.4: Dosing Compliance ..........................................................................................190 
Listing 16.2.5.5: Dosing Deviations ............................................................................................191 
Listing 16.2.6.1: Investigator Global Assessment (IGA) ............................................................192 
Listing 16.2.6.2: Body Surface Area (BSA) Involved with Psoriasis .........................................193 
Listing 16.2.6.3: Psoriasis Area and Severity Index (PASI)........................................................194 
Listing 16.2.6.4: Numeric Rating Scale (NRS) Assessments/Sleep Loss ...................................195 
Listing 16.2.6.5.1: Dermatology Life Quality Index (DLQI) Questionnaire Descriptions .........196 
Listing 16.2.6.5.2: Dermatology Life Quality Index (DLQI) Questionnaire ...............................197 
Listing 16.2.6.6.1: Work Productivity and Activity Impairment (WPAI) Questionnaire 
Descriptions ........................................................................................198 
Listing 16.2.6.6.2: Work Productivity and Activity Impairment (WPAI) Questionnaire ...........199 
Listing 16.2.6.7: Columbia-Suicide Severity Rating Scale (C-SSRS) ........................................200 


 
 
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  Page 173 of 217  
CONFIDENTIAL 
Listing 16.2.6.8.1: Patient Health Questionnaire Depression Scale (PHQ-8) Question 
Descriptions ........................................................................................201 
Listing 16.2.6.8.2: Patient Health Questionnaire Depression Scale (PHQ-8) .............................202 
Listing 16.2.6.9.1: Psoriasis Symptom Diary (PSD) Questionnaire Descriptions.......................203 
Listing 16.2.6.9.2: Psoriasis Symptom Diary (PSD) Questionnaire ............................................204 
Listing 16.2.6.10: Photography Information................................................................................205 
Listing 16.2.7.1.1: Investigator Local Tolerability Assessment ..................................................206 
Listing 16.2.7.1.2: Subject Local Tolerability Assessment .........................................................207 
Listing 16.2.7.2.1: Unique Adverse Events Coded to MedDRA System Organ Classes and 
Preferred Terms ...................................................................................208 
Listing 16.2.7.2.2: Treatment-Emergent Adverse Events ............................................................209 
Listing 16.2.7.2.3: Serious Adverse Events .................................................................................210 
Listing 16.2.7.2.4: Subjects Who Permanently Discontinued Study Drug Due to Adverse 
Events ..................................................................................................211 
Listing 16.2.8.1: Urine Pregnancy Test Results ..........................................................................212 
Listing 16.2.8.2.1: Laboratory Test Results .................................................................................213 
Listing 16.2.8.2.2: Abnormal Laboratory Results .......................................................................214 
Listing 16.2.8.3: 12-lead Electrocardiogram Test Results ...........................................................215 
Listing 16.2.8.4: Vital Signs ........................................................................................................216 
Listing 16.2.8.5: Pharmacokinetics Blood Sample Collections ...................................................217 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 174 of 217  
CONFIDENTIAL 
Listing 16.2.1.1: End of Study Information 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
S: Subject
A: Age/Sex
F: Date of First Dose of Drug   Primary Reason for Study
E: Eval
L: Date of Last Dose of Drug    Completion/Discontinuation
   Date of Completion/Discontinuation 
______________________________________________________________________________________________________________________________________ 
S: xxxxxx
F: xxxxxxxxxx
xxxxxxxxxx xx xxxxxxxxxxxxxxx 
xxxxxxxxxx xxxx 
A: xxxx
L: xxxxxxxxxx
E: xxxxxxxxx
S: xxxxxx
F: xxxxxxxxxx
xxxxxxxxxx xx xxxxxxxxxxxxxxx
xxxxxxxxxx xxxx      
A: xxxx
L: xxxxxxxxxx
E: xxxxxxxxx
S: xxxxxx
F: xxxxxxxxxx
xxxxxxxxx xxxx xxxxxxxx xxxxx
xxxxxxxxxx xxxx
A: xxxx
L: xxxxxxxxxx
E: xxxxxxxxx
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Note to programmer: concatenate ‘Describe’ text onto Primary Reason where applicable. 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Listing 16.2.1.2: Discontinued Subjects 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                    
                               
S: Subject                          
                 
                                
A: Age/Sex         F: Date of First Dose of Drug   Primary Reason for Study                           
E: Eval            L: Date of Last Dose of Drug    Completion/Discontinuation                Date of Completion/Discontinuation  
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx          F: xxxxxxxxxx                   xxxxxxxxxx xx xxxxxxxxxxxxxxx             xxxxxxxxxx xxxx  
A: xxxx            L: xxxxxxxxxx                                               
E: xxxxxxxxx                     
 
S: xxxxxx          F: xxxxxxxxxx                   xxxxxxxxxx xx xxxxxxxxxxxxxxx             xxxxxxxxxx xxxx           
A: xxxx            L: xxxxxxxxxx                                             
E: xxxxxxxxx                     
 
S: xxxxxx          F: xxxxxxxxxx                   xxxxxxxxx xxxx xxxxxxxx xxxxx             xxxxxxxxxx xxxx                               
A: xxxx            L: xxxxxxxxxx                                                    
E: xxxxxxxxx                     
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 176 of 217  
CONFIDENTIAL 
Listing 16.2.2.1: Inclusion/Exclusion Criteria Violations 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
Criterion    Criterion 
Subject   Age/Sex  Eval
Category     Identifier   Description 
______________________________________________________________________________________________________________________________________ 
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx
x
xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx xxxxx  
xxxxxxxxxxx xxxxxx xxxxxxxx xxxxxxxxxx xx xxx xxxxxxxxx xxx xxxxxxxx xxxx 
xxxxxxxxx
x
xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx 
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx
x        xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx xxxxxxx
x xxxxxx xxxxxxxx xxxxxxxxxx xx xxx xxxxxxxxx xxx xxxxxxxx xxxxxx xxxxxxx x 
xxxxxxxxx xxxxx xxx 
xxxxxxxxx        xx       xxxxxxxx xxxx xxxxxx xxxx xxxxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxxxx xxx 
xxxxxxxx xxxxx xx xxxx xxxx xx xxx xx xxxx xxxx xxx xxxxx xxxxx 
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx        x
xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx 
xxxxxxxxx
xx       xxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx xx x xxxxxxxx xx xxx xxxxxxxx 
xxx xxxxx xxxxxxxxx xxxx   
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Listing sorted by Subject, Criterion Category, and Criterion Identifier. 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 177 of 217  
CONFIDENTIAL 
Listing 16.2.2.2: Protocol Deviations 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
Subject   Age/Sex  Eval
Protocol Deviation 
______________________________________________________________________________________________________________________________________ 
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx 
xxxxxxxxxxx xxxxxx xxxxxxxx xxxxxxxxxx xx xxx 
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx x xxxxxx xxxxxxxx xxxxxxxxxx xx xxx 
xxxxxxxxx xxxxx xxx 
xxxxxxxx xxxx xxxxxx xxxx xxxxxxx  
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx xxxx xxxx x xxxxx xx x xxxxxxxxxx 
xxxxxx    xxxx     xxxxxxxxx    xxxxxxxxx x xxxxxx xxxxxxxx xxxxxxxxxx xx xxx 
xxxxxxxx xxxx xxxxxx xxxx xxxxxxx  
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 178 of 217  
CONFIDENTIAL 
Listing 16.2.3: Analysis Populations 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
Subject   Age/Sex     Population          Included           Reason(s) Excluded                                    
______________________________________________________________________________________________________________________________________ 
 
xxxxxx    xxxx        Safety                 xx              xxxxxxx x xxxxxx xxxxxxxxx 
                      Intent-to-Treat        xxx 
                      Per-Protocol           xxx 
                      Pharmacokinetic        xxx 
 
xxxxxx    xxxx        Safety                 xxx 
                      Intent-to-Treat        xxx 
                      Per-Protocol           xxx 
                      Pharmacokinetic        xxx 
 
xxxxxx    xxxx        Safety                 xxx 
                      Intent-to-Treat        xxx 
                      Per-Protocol           xx              xxxxxxx xxxxxxx xxxxx 
                      Pharmacokinetic        xx              xxxxxxxxxxx xxxxxxxxx xxx xxxxxxxxxx xx xxxxxx x xxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, and Population. 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Listing 16.2.4.1: Subject Demographic Information 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                        
                                                                                                            P:  Did the Subject  
                                      D: Date/Time of                               C: Childbearing            Consent to Photography?               
                    B: Date of Birth     Informed Consent     R: Race                  Potential            D: Date of 
Subject  Eval       S: Sex            A: Age at Consent       E: Ethnicity          B: Birth Control Method    Photography Consent          
______________________________________________________________________________________________________________________________________ 
 
xxxxxx   xxxxxxxx   B: xxxxxxxxxx     D: xxxx-xx-xxTxx:xx:xx  R: xxxxx xx xxxxxxx   C: xx                   P: xxx 
                    S: xxxx           A: xx                   E: xxx xxxxxxxx xx    B:                      D: xxxxxxxxxx  
                                                         
 
xxxxxx   xxxxxxxx   B: xxxxxxxxxx     D: xxxx-xx-xxTxx:xx:xx  R: xxxxx              C: xxx                  P: xx                           
                    S: xxxxxx         A: xx                   E: xxx xxxxxxxx xx    B: xxxxxxxxxx xxxxxxxx  D:                                
 
xxxxxx   xxxxxxxx   B: xxxxxxxxxx     D: xxxx-xx-xxTxx:xx:xx  R: xxxxx              C: xxx                  P: xxx                           
                    S: xxxxxx         A: xx                   E: xxx xxxxxxxx xx    B: xxxx xxxxxxxxxxxxxx  D: xxxxxxxxxx                              
                                                   
                                                   
                                                    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 180 of 217  
CONFIDENTIAL 
Listing 16.2.4.2.1: Unique Medical/Surgical History Coded to MedDRA System Organ Classes and Preferred Terms 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
MedDRA System Organ Class                     MedDRA Preferred Term                       Condition/Surgery Verbatim Term 
______________________________________________________________________________________________________________________________________ 
 
x xxx xxxxx                                   xxxx xxx xxxxx                              xxxx xxxxxxxxxx xx xxxxxx  
                                                                                         
                                                                                          xxxxx xxx xxxxxx xx 
                                                                                          
xxxx x xxxxxxxxx                              xxxxxxx xxxxxxxxxxxxx                       xxxx xxxxxx xxxxxxxxxx xx xxxxxx 
 
xxxx xxx xxxxx                                xxxx xxx xxxxx                              xxxx xxxxxxxx 
 
                                                                                          xxxxxx xxxxxxxxxx xx xxxxxx 
 
                                                                                          xxxxxx xxxxxxxxxx xx xxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                                                           
______________________________________________________________________________________________________________________________________ 
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
Listing sorted by System Organ Class, Preferred Term, and Verbatim Term. 
 
 
 
 
 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 181 of 217  
CONFIDENTIAL 
Listing 16.2.4.2.2: Medical/Surgical History 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________       
Condition/Surgery
P: MedDRA Preferred Term
S: Onset Date 
Subject    Age/Sex    Eval         Verbatim Term
S: MedDRA System Organ Class
E: End Date 
______________________________________________________________________________________________________________________________________ 
xxxxxx     xxxx       xxxxxxxx     xxxxxx xxxxxxx (xxxxxxxx xxxxx)  
P: xxxxxx xxxxxxxxxx
S: xxxxxxxxxxx 
S: xxxxxxxxxxx xxxxxxx
E: xxxxxxxxxxx 
xxxxxxxx xxxxxxxxxx
P: xxxxxxx xxxxxxxx
S: xxxxxxxxxxx 
S: xxxxxx xxxxxxxxxxxxx
E: xxxxxxxxxxx 
______________________________________________________________________________________________________________________________________ 
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Listing sorted by Subject, Medical Condition/Surgery, Start Date, and End Date. 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 182 of 217  
CONFIDENTIAL 
Listing 16.2.4.3.1: Unique Medication Names Coded to WHO-DD ATC Level 2 Terms and Preferred Names 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
I: Indication 
ATC Level 2 Term                 Preferred Name                         Medication Name                      R: Route 
______________________________________________________________________________________________________________________________________ 
xxxxxx xxxxxx xx xxx
    xxxxxxxxxx
xxxxxxxxxx
I: xxxxxxx xxxxxxxx 
R: xxxx 
xxxxxxx x
xxxxxx
I: xxxxxxx xxxxxxxx 
xxxxxxxxxxxx 
R: xxxx 
xxxxxxxxx
xxxxxxxxx
I: xxxxxxx xxxxxxxx xxxx 
xxxxx xxxxxxxx 
R: xxxx 
______________________________________________________________________________________________________________________________________ 
Note: Preferred Name and ATC Level 2 Term map to the WHO-DD (Version March 1, 2018). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Listing sorted by ATC Level 2 Term, Preferred Name, Medication Name, Indication, and Route. 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 183 of 217  
CONFIDENTIAL 
Listing 16.2.4.3.2: Prior and Concomitant Medications 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
M: Medication Name
D: Dose     
P: Preferred Name
F: Date of First Dose    U: Units
A: ATC Level 2 Term
S: Start Date (Day)¹     F: Frequency
Subject     Age/Sex    Eval
I: Indication
E: End Date (Day)¹       R: Route  
______________________________________________________________________________________________________________________________________ 
xxxxxx      xxxx       xxxxxxxxxx     M: xxxxxxxxxxxxx
F: xxxxxxxxxx
D: xx
P: xxxxxxxxxxxxx
S: xxxxxxxxxx
U: xx
A: xxxxxxxxxxxxx
E: xxxxxxxxxx
F: xxxx 
I: xxxxxxxx
R:xxxx 
M: xxxxxxxxxxxxx
F: xxxxxxxxxx
D: xxxxx
P: xxxxxxxxxxxxx
S: xxxxxxxxxx
U: xx
A: xxxxxxxxxxxxx
E: xxxxxxxxxx
F: xx 
I: xxxxxxxx
R:xxxx 
xxxxxx      xxxx       xxxxxxxxxx     M: xxxxxxxxxxxxx
F: xxxxxxxxxx
D: xxx
P: xxxxxxxxxxxxx
S: xxxxxxxxxx
U: xx
A: xxxxxxxxxxxxx
E: xxxxxxxxxx
F: xx 
I: xxxxxxxx
   R:xxxx 
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – date of first dose for dates prior to first dose. Otherwise, day is calculated as date – date of first    
  dose + 1 for dates on or after first dose. 
Note: Preferred Name and ATC Level 2 Term map to the WHO-DD (Version March 1, 2018). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Listing sorted by Subject, Start Date, End Date, Medication Name, Indication, and Route.  If ongoing, include ‘Ongoing’ in place of 
End Date. Concatenate Topical Area Treated onto route where applicable. 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 184 of 217  
CONFIDENTIAL 
Listing 16.2.4.4.1: Unique Therapies and Procedures Coded to MedDRA System Organ Classes and Preferred Terms 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
MedDRA System Organ Class
MedDRA Preferred Term
Procedure/Therapy Verbatim Term 
______________________________________________________________________________________________________________________________________ 
xxxx xxx xxxxx
xxxx xxx xxxxx
xxxx 
xxxxxx xxxxxxxxxx xx xxxxxx 
xxxxxx xxxxxxxxxx xx xxxxx 
xxxx xxx xxxxx    
xxxx xxx xxxxx
xxxx 
xxxxxx xxxxxxxxxx xx xxxxxx 
xxxxxx xxxxxxxxxx xx xxxxx 
______________________________________________________________________________________________________________________________________ 
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Listing sorted by MedDRA System Organ Class, MedDRA Preferred Term, and Procedure/Therapy Verbatim Term. 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 185 of 217  
CONFIDENTIAL 
 
Listing 16.2.4.4.2: Prior and Concomitant Therapies and Procedures 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
S: Subject 
A: Age/Sex                                        I: Indication            P: MedDRA Preferred Term              S: Start Date 
E: Eval       Procedure/Therapy Verbatim Term     A: Anatomical Area       S: MedDRA System Organ Class          E: End Date 
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx     xxxxxx xxxxxxx (xxxxxxxx xxxxx)     I: xxxxxxxxxx            P: xxxxxx xxxxxxxxxx               
S: xxxxxxxxxxx 
A: xxxx                                           A: xxxx                  S: xxxxxxxxxxx xxxxxxx             
E: xxxxxxxxxxx 
E: xxxxxxxx 
              xxxxxx xxxxxxx xxxxxxx              I: xxxxxxxxxx xxxxx      P: xxxxxx xxxxxxxxxx               
S: xxxxxxxxxxx 
                                                  A:                       S: xxxxxxxxxxx xxxxxxx             
E: xxxxxxxxxxx 
                
 
 
 
 
 
 
 
 
 
                
 
 
 
 
 
 
  
S: xxxxxx     xxxxxx xxxxxxxxxxxxxx               I: xxxxxxxxxx xxxxx      P: xxxxxx xxxxxxxxxx               
S: xxxxxxxxxxx 
A: xxxx                                           A: xxxx xxx xxxxx        S: xxxxxxxxxxx xxxxxxx             
E: xxxxxxxxxxx 
E: xxxxxxxx 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
                    
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: System Organ Class and Preferred Term map to the MedDRA dictionary (Version 21.1). 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Start Date, End Date, Procedure/Therapy, Indication. If ongoing, include ‘Ongoing’ in place of End Date. 
 
 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 186 of 217  
CONFIDENTIAL 
Listing 16.2.4.5: Physical Examination 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
S: Subject
A: Age/Sex                          
                                                                          Abnormal Finding
E: Eval         Visit             Date              Body System Assessed            Finding                     Specification  
______________________________________________________________________________________________________________________________________ 
S: xxxxxx       xxxxxxxxxxx       xxxxxxxxxx       Heart
xxxxxxxxxx
xxxxxxx xxxxx
A: xxxx
Lungs
xxxxx xxxxxxx 
E: xxxxxxxxx
Skin (Other than Psoriasis)      xxxxxxxx
<Other, specify>
xxxx xxx xx
xxxxxxxxxxx xxx xxxxxx 
xxxxxxxxxxx       xxxxxxxxxx       Heart    
xxxxxxxx
Lungs                            xxxxx xxxxxxx 
Skin (Other than Psoriasis)      xxxxxxxx
xxxx xx
xxxxxxxxxx       Heart
xxxxxxxx
Lungs                            xxxxx xxxxxxx 
Skin (Other than Psoriasis)      xxxxxxxx
S: xxxxxx       xxxxxxxxxxx       xxxxxxxxxx       Heart
xxxxxxxxxx 
A: xxxx
Lungs                            xxxxxxxxx  xx
xxxxxx
E: xxxxxxxxx
Skin (Other than Psoriasis)      xxxx xxxxxxxx 
xxxxxxxxxxx       xxxxxxxxxx       Heart
xxxxxx xxxxx
Lungs                            xxxxxxx
Skin (Other than Psoriasis)      xxxxxxxxxx    
xxxx xx
xxxxxxxxxx       Heart
xxxxxxxx
Lungs                            xxxxx xxxxxxx 
Skin (Other than Psoriasis)      xxxxxxxx
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Listing sorted by Subject, Visit, Date, Body System Assessed. 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 187 of 217  
CONFIDENTIAL 
 
Listing 16.2.5.1: Study Visit Compliance 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                                                         
                                                                                        Study          Within Visit     Days Out of   
Subject    Age/Sex    Eval          Visit                    Visit Date                 Day¹           Window           Window²     
______________________________________________________________________________________________________________________________________ 
 
xxxxxx     xxxx       xxxxxxxx      xxxxxxxxx                xxxxxxxxxx                 x              xxx 
                                    xxxxxxxx                 xxxxxxxxxx                 x              xxx 
                                    xxxx x                   xxxxxxxxxx                 xx             xxx              xxxx 
                          
xxxxxx     xxxx       xxxxxxxx      xxxxxxxxx                xxxxxxxxxx to xxxxxxxxxx   x              xxx 
                                    xxxxxxxx                 xxxxxxxxxx                 x              xxx 
                                    xxxx x                   xxxxxxxxxx                 xx             xxx 
                                    xxxx x                   xxxxxxxxxx                 xx             xxx 
 
xxxxxx     xxxx       xxxxxxxx      xxxxxxxxx                xxxxxxxxxx                 xx             xxx 
                                    xxxxxxxx                 xxxxxxxxxx                 x              xxx  
                                    xxxx x                   xxxxxxxxxx                 xx             xxx 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – baseline date for dates prior to baseline visit. Otherwise, day is calculated as  
  date – baseline date + 1 for dates on or after baseline visit. 
² Populated only for post baseline visits that are planned and out of window. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
Listing sorted by Subject, Visit, Visit Date. 
 
 


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 188 of 217  
CONFIDENTIAL 
Listing 16.2.5.2: Drug Accountability 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
Date
Date
Dispensed
Returned 
Subject    Age/Sex    Evaluable    Kit Number     Dispensed         Returned      Tube ID
Weight (g)
Weight (g) 
______________________________________________________________________________________________________________________________________ 
xxxxxx     xxxx       xxxxxxxx     xxxxx
xxxxxxxxxx
xxxxxxxxxx      x
xx.x
xx.x
x
xx.x
xx.x
x
xx.x
xx.x
x
xx.x
xx.x
xxxxx
xxxxxxxxxx
xxxxxxxxxx      x
xx.x
xx.x
x
xx.x
xx.x
x
xx.x
xx.x
x
xx.x
xx.x
xxxxx
xxxxxxxxxx
xxxxxxxxxx      x
xx.x
xx.x
x
xx.x
xx.x
x
xx.x
xx.x
x
xx.x
xx.x
xxxxxx     xxxx       xxxxxxxx     xxxxx
xxxxxxxxxx
xxxxxxxxxx      x
xx.x
xx.x
x    
xx.x
xx.x
x
xx.x
xx.x
x
xx.x
xx.x
xxxxx
xxxxxxxxxx
xxxxxxxxxx      x
xx.x
xx.x
x
xx.x
xx.x
x
xx.x
xx.x
x
xx.x
xx.x
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Listing sorted by Subject, Kit Number, Date Dispensed, Date Returned, and Tube ID.  


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 189 of 217  
CONFIDENTIAL 
Listing 16.2.5.3: Study Drug Application 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
Date/Time of Study     Study Drug           Pre-Dose     Post-Dose     Reason 
Subject    Age/Sex    Evaluable    Visit           Drug Application       Applied in Clinic?   Weight (g)   Weight (g)    Not Done 
______________________________________________________________________________________________________________________________________ 
xxxxxx     xxxx       xxxxxxxx     xxxxx
xxxxxTxxxx
xxx
xx.x
xx.x
xxxxx
xxxxxTxxxx
xxx
xx.x
xx.x
xxxxx
xxxxxTxxxx
xxx
xx.x
xx.x
xxxxxx     xxxx       xxxxxxxx     xxxxx           xxxxxTxxxx
xx
xxx xxx xxxxx 
xxxxx
xxxxxTxxxx
xxx
xx.x
xx.x
xxxxx
  xxxxxTxxxx
xxx
xx.x
xx.x
xxxxxx     xxxx       xxxxxxxx     xxxxx
xxxxxTxxxx
xxx
xx.x
xx.x
xxxxx
xxxxxTxxxx
xxx
xx.x
xx.x
xxxxx
xxxxxTxxxx
xxx
xx.x
xx.x
xxxxxx     xxxx       xxxxxxxx     xxxxx
xxxxxTxxxx
xx
xxx xxx xxxxx 
xxxxx
xxxxxTxxxx
xxx
xx.x
xx.x
xxxxx
xxxxxTxxxx
xxx
xx.x
xx.x
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Listing sorted by Subject, Date/Time of Study Drug Application, Visit.  


TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 190 of 217  
CONFIDENTIAL 
Listing 16.2.5.4: Dosing Compliance 
Treatment Group 
(Page xx of yy) 
______________________________________________________________________________________________________________________________________ 
S: Subject
Number of    Calculated¹    Amount of     Maximum Number
A: Age/Sex     D: Date of First Dose     Days of      Number of    Study Drug       of Missed            Percent
E: Eval
R: Date of Last Dose      Exposure       Doses       Used (g)     Consecutive Doses      Compliant    Compliant?²    
______________________________________________________________________________________________________________________________________ 
S: xxxxxx      D: xxxxxxxxxxxx
xx
xx
xxxx
x
xxx
xxx 
A: xxxx
R: xxxxxxxxxxxx 
E: xxxxxxxxx
S: xxxxxx      D: xxxxxxxxxxxx
xx
xx
xxxx
x
xxx
xx   
A: xxxx
R: xxxxxxxxxxxx 
E: xxxxxxxxx
S: xxxxxx      D: xxxxxxxxxxxx
xx
xx
xxxx
xxxx
xxx 
A: xxxx
R: xxxxxxxxxxxx  
E: xxxxxxxxx
______________________________________________________________________________________________________________________________________ 
¹ The total number of doses was calculated from the date of first dose and the date of last known dose minus the missed doses plus    
  additional dose deviations. 
² A subject was considered compliant with the dosing regimen if the subject applied at least 80% of the expected doses during the 
  study drug application period and did not miss more than 3 consecutive doses. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 191 of 217  
CONFIDENTIAL 
Listing 16.2.5.5: Dosing Deviations 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                             
Subject     Age/Sex     Eval          Date of First Dose       Date of Dosing Deviation             Number of Doses Applied 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx      xxxx        xxxxxxxxx     xxxxxxxxxx               xxxxxxxxxx                                     x 
                                                               xxxxxxxxxx                                     x 
                                                               xxxxxxxxxx                                     x 
 
xxxxxx      xxxx        xxxxxxxxx     xxxxxxxxxx               xxxxxxxxxx                                     x 
                                                               xxxxxxxxxx                                     x 
             
 
xxxxxx      xxxx        xxxxxxxxx     xxxxxxxxxx               xxxxxxxxxx                                     x 
                                                               xxxxxxxxxx                                     x 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
Listing sorted by Subject, and Date of Dosing Deviation.  
 
 


 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 192 of 217  
CONFIDENTIAL 
Listing 16.2.6.1: Investigator Global Assessment (IGA) 
Treatment Group 
(Page xx of yy) 
 
______________________________________________________________________________________________________________________________________                 
                                                                                              
S: Subject                                         Whole Body            Does the Subject        Intertriginous  
A: Age/Sex                        Date of          Investigator Global   have Intertriginous     Investigator Global      Evaluator       
E: Eval         Visit             Assessment       Assessment Score      Area involvement?       Assessment Score         Initials 
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx       SCREENING         xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx             xxx  
A: xxxx 
E: xxxxxxxx 
                BASELINE          xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx             xxx 
                WEEK 2            xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx             xxx                         
                WEEK 4            xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx             xxx                
                WEEK 6            xxxxxxxxxx       x x xxxxxxxx           xxx                     x x xxxxxxxx             xxx                
                WEEK 8            xxxxxxxxxx       x x xxxxxxxx           xx                                               xxx  
                WEEK 12           xxxxxxxxxx       x x xxxxxxxx           xx                                               xxx 
                WEEK 16           xxxxxxxxxx       x x xxxxxxxx           xx                                               xxx               
 
S: xxxxxx       SCREENING         xxxxxxxxxx       x x xxxxxxxx           xx                                               x-x                         
A: xxxx 
E: xxxxxxxx 
                BASELINE          xxxxxxxxxx       x x xxxxxxxx           xx                                               x-x  
                WEEK 2            xxxxxxxxxx       x x xxxxxxxx           xx                                               x-x                         
                WEEK 4            xxxxxxxxxx       x x xxxxxxxx           xx                                               x-x               
                WEEK 6            xxxxxxxxxx       x x xxxxxxxx           xx                                               xxx               
                WEEK 8            xxxxxxxxxx       x x xxxxxxxx           xx                                               xxx   
                WEEK 12           xxxxxxxxxx       x x xxxxxxxx           xx                                               xxx 
                WEEK 16           xxxxxxxxxx       x x xxxxxxxx           xx                                               xxx            
                      
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Listing sorted by Subject, Visit, and Date of Assessment.  
 

Prot_001.pdf: 
 
 
Study 
Number: 
ARQ-151-201 
NCT #: 
NCT03638258 
Official 
Title: 
A Phase 2b 12-Week Parallel Group, Double 
Blind, Vehicle- 
Controlled Study of the Safety, Efficacy and 
Pharmacokinetics of 
ARQ-151 Cream 0.3% and ARQ-151 Cream 
0.15% 
Administered QD in Subjects with Chronic 
Plaque Psoriasis 
 
Protocol 
Date: 
02-Aug-2018 
 


 
 
 
Protocol ARQ-151-201 
Amendment 1 
A Phase 2b 12-Week Parallel Group, Double Blind, Vehicle-
Controlled Study of the Safety, Efficacy and Pharmacokinetics of 
ARQ-151 
Cream 
0.3% 
and ARQ-151 
Cream 
0.15% 
Administered QD in Subjects with Chronic Plaque Psoriasis 
 
 
 
 
GCP Statement 
This study is to be performed in full compliance with the protocol, Good Clinical Practices 
(GCP), and applicable regulatory requirements. All required study documentation will be 
archived as required by regulatory authorities. 
 
Confidentiality Statement 
This document is confidential. It contains proprietary information of Arcutis, Inc. Any 
viewing or disclosure of such information that is not authorized in writing by Arcutis, Inc. is 
strictly prohibited. Such information may be used solely for the purpose of reviewing or 
performing this study. 




Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
 Page 3 of 83 
PROTOCOL REVISION HISTORY 
Version/Date 
Description 
ARQ-151-201 Version 1 
August 2, 2018 
Original protocol 
ARQ-151-201 Amendment 1.0 
November 8, 2018 
• 
Added protocol revision history section. 
• 
Added the Dermatology Life Quality Index (DLQI) to visits 
1 through 7. 
• 
Updated modified Intent to Treat (mITT) population to 
Intent to Treat (ITT) population.  
• 
Added footnote “b” in the Study Events Flowchart to clarify 
routine blood chemistries if Baseline is within 14 days of 
Screening, the Screening results may be utilized for 
Baseline. The other footnotes were updated accordingly.  
• 
Footnote “m” has been revised to include collection of the 
tube weight prior to the application and after the application. 
• 
Added footnote “r” to the Study Events Flowchart to update 
the duration of subject participation for the study.  Subjects 
who enroll into the open label extension study (ARQ-151-
202) will complete the study at Week 12; subjects that do 
not enroll into ARQ-151-202 will return at Week 16 to 
complete the study. 
• 
Revised Inclusion Criterion #8 to more completely define 
Females of Non-Child Bearing Potential to include those 
who are post-menopausal or surgically sterile.  
• 
Revised Exclusion Criterion #5 to clarify subjects with 
palmoplantar only involvement are to be excluded. 
• 
Clarified the optional PK draws will be applicable only to 
subjects who enter the 4-week follow up period. 
• 
Added text in Data Analysis section relevant to the PSD and 
addition of the DLQI; changed primary analysis population 
from mITT to ITT per FDA advice; rearranged order of 
subsections under Data Analysis to improve organization. 
• 
Editorial and administrative changes throughout the protocol 
to clarify language and formatting to improve readability. 
  
 


Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
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2 
ADDITIONAL KEY CONTACTS FOR THE STUDY 
Sponsor Contact for Serious Adverse 
Event Reporting 
 
 
 
 
 
 
Medical Monitor 
 
 
 
 
 
  
 
Managing CRO 
Cu-Tech, LLC 
333 US Highway 46 West 
Mountain Lakes, NJ 07046 
  
 
 
 
Certified Clinical Laboratory 
ACM Global Laboratories 
160 Elmgrove Park 
Rochester, NY 14624, USA  
 
 
Bioanalytical Laboratory 
Q Squared Solutions BioSciences, LLC 
19 Brown Road 
Ithaca, NY 14850 
 
 
 
Pharmacokinetic Analysis 
 
ADME Solutions, Inc. 
 
 
  


Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
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ADDITIONAL KEY CONTACTS FOR THE STUDY (Cont.) 
 
Data Management / Statistical 
Analysis 
 
QST Consultations, Ltd. 
11275 Edgewater Drive 
Allendale, MI 49401 
  
 


Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
 Page 6 of 83 
3 
TABLE OF CONTENTS 
1 
PRINCIPAL INVESTIGATOR AND SPONSOR – SIGNATORIES ............................. 2 
2 
ADDITIONAL KEY CONTACTS FOR THE STUDY .................................................... 4 
3 
TABLE OF CONTENTS ..................................................................................................... 6 
4 
SYNOPSIS ........................................................................................................................... 10 
5 
SCHEDULE OF VISITS AND ASSESSMENTS ............................................................ 15 
6 
ABBREVIATIONS ............................................................................................................. 17 
7 
BACKGROUND AND RATIONALE .............................................................................. 19 
7.1 
Introduction ................................................................................................................. 19 
7.2 
Preclinical Studies ....................................................................................................... 19 
7.2.1 Repeat-Dose Toxicity ............................................................................................... 20 
7.2.2 Oral (Systemic) Studies of Roflumilast and N-Oxide Metabolite ............................ 21 
7.2.3 Reproductive Toxicity .............................................................................................. 22 
7.2.4 Genotoxicity .............................................................................................................. 22 
7.2.5 Carcinogenicity ......................................................................................................... 22 
7.2.6 Special Toxicity:  Local Tolerance of Topical Formulation ..................................... 23 
7.2.7 Conclusions on Toxicity Findings ............................................................................ 23 
7.3 
Clinical Studies ............................................................................................................ 24 
7.3.1 Topical Roflumilast Cream ....................................................................................... 24 
7.3.2 Oral Roflumilast Tablet ............................................................................................ 26 
7.4 
Rationale for Development......................................................................................... 27 
7.4.1 Dose Selection .......................................................................................................... 27 
7.4.2 Risks and/or Benefits to Subjects ............................................................................. 28 
8 
STUDY ENDPOINTS AND OBJECTIVES ..................................................................... 29 
8.1 
Study Objectives.......................................................................................................... 29 
8.1.1 Primary Objectives.................................................................................................... 29 
8.2 
Efficacy Endpoints ...................................................................................................... 29 
8.2.1 Primary Endpoint ...................................................................................................... 29 
8.2.2 Secondary Endpoints ................................................................................................ 30 
8.2.3 Exploratory Endpoints .............................................................................................. 30 
9 
INVESTIGATIONAL PLAN ............................................................................................ 31 
9.1 
Overall Study Design and Plan .................................................................................. 31 
9.2 
Subject Participation .................................................................................................. 31 
9.2.1 Randomization .......................................................................................................... 32 
9.2.2 Numbering of Subjects ............................................................................................. 32 
9.3 
Selection of Study Population .................................................................................... 32 
9.3.1 Inclusion Criteria ...................................................................................................... 32 
9.3.2 Exclusion Criteria ..................................................................................................... 33 


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Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
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9.3.3 Removal of Subjects from the Study ........................................................................ 34 
9.4 
Study Restrictions ....................................................................................................... 35 
9.4.1 Prohibitions and Concomitant Therapy .................................................................... 35 
9.5 
Treatment .................................................................................................................... 36 
9.5.1 Drug Supplies, Packaging and Labeling ................................................................... 36 
9.5.2 Blinding..................................................................................................................... 36 
9.5.3 Treatment Administration ......................................................................................... 36 
9.5.4 Treatment Compliance .............................................................................................. 37 
10 STUDY PROCEDURES .................................................................................................... 38 
10.1 
Safety Assessments ...................................................................................................... 38 
10.1.1 
Screening............................................................................................................... 38 
10.1.2 
Physical Examination............................................................................................ 38 
10.1.3 
Vital Signs, Height and Weight ............................................................................ 38 
10.1.4 
12-Lead ECGs ....................................................................................................... 39 
10.1.5 
Laboratory Tests ................................................................................................... 39 
10.1.6 
Patient Health Questionnaire depression scale (PHQ-8) ...................................... 40 
10.1.7 
Columbia-Suicide Severity Rating Scale (C-SSRS) ............................................. 42 
10.1.8 
Local Tolerability Assessments ............................................................................ 42 
10.1.9 
Adverse Events ..................................................................................................... 43 
10.2 
Efficacy Evaluations ................................................................................................... 44 
10.2.1 
Investigator’s Global Assessment (IGA) .............................................................. 44 
10.2.2 
Modified Psoriasis Area and Severity Index (mPASI) ......................................... 45 
10.2.3 
Body Surface Area (BSA) .................................................................................... 46 
10.2.4 
Worst Itch Numerical Rating Scale (WI-NRS) .................................................... 46 
10.2.5 
Fatigue NRS .......................................................................................................... 46 
10.2.6 
Work Productivity and Activity Impairment (WPAI) .......................................... 47 
10.2.7 
Itch-Related Sleep Loss ........................................................................................ 47 
10.2.8 
Psoriasis Symptom Diary (PSD) ........................................................................... 47 
10.2.9 
Dermatology Life Quality Index (DLQI) ............................................................. 48 
10.2.10 Dermal Imaging .................................................................................................... 48 
10.3 
Pharmacokinetics Assessment ................................................................................... 48 
10.4 
Adverse Events ............................................................................................................ 48 
10.4.1 
Adverse Event Definition ..................................................................................... 48 
10.4.2 
Serious Adverse Event .......................................................................................... 49 
10.4.3 
Suspected Unexpected Serious Adverse Reaction (SUSAR) ............................... 50 
10.4.4 
Safety Review ....................................................................................................... 50 
10.4.5 
Adverse Event Reporting ...................................................................................... 50 
10.5 
Reporting Pregnancy .................................................................................................. 52 
10.6 
Treatment Stopping Rules ......................................................................................... 52 
10.6.1 
Emergency Unblinding ......................................................................................... 53 
11 DATA ANALYSIS .............................................................................................................. 53 


Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
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11.1 
Statistical Methods ...................................................................................................... 53 
11.1.1 
Determination of Sample Size .............................................................................. 54 
11.1.2 
Subjects to Analyze............................................................................................... 54 
11.1.3 
Interim Analysis .................................................................................................... 54 
11.1.4 
Background and Demographic Characteristics ..................................................... 54 
11.1.5 
Study Medication Compliance .............................................................................. 55 
11.2 
Efficacy Evaluation ..................................................................................................... 55 
11.2.1 
Primary Efficacy Endpoint ................................................................................... 55 
11.2.2 
Secondary Endpoints ............................................................................................ 55 
11.2.3 
Exploratory Endpoints .......................................................................................... 56 
11.3 
Safety Evaluation ........................................................................................................ 56 
11.3.1 
Adverse Events ..................................................................................................... 56 
11.3.2 
Local Tolerance Assessments ............................................................................... 57 
11.3.3 
Medical History and Physical Examinations ........................................................ 57 
11.3.4 
PHQ-8 ................................................................................................................... 57 
11.3.5 
C-SSRS ................................................................................................................. 58 
11.3.6 
Clinical Laboratory Results and Vital Signs/Weight Measurements ................... 58 
11.3.7 
Prior and Concomitant Medications ..................................................................... 58 
11.4 
Patient Reported Outcomes Analyses ....................................................................... 58 
11.4.1 
WI-NRS, Fatigue NRS, Itch-Related Sleep Loss ................................................. 58 
11.4.2 
Work Productivity and Activity Impairment (WPAI) Questionnaire ................... 58 
11.4.3 
Dermatology Life Quality Index (DLQI) ............................................................. 58 
11.4.4 
Psoriasis Symptom Diary (PSD) ........................................................................... 58 
11.5 
Pharmacokinetic Analysis .......................................................................................... 59 
12 STUDY ADMINISTRATION ........................................................................................... 59 
12.1 
Ethics ............................................................................................................................ 59 
12.1.1 
Ethics Review Board............................................................................................. 59 
12.1.2 
Ethical Conduct of the Study ................................................................................ 59 
12.1.3 
Subject Information and Consent.......................................................................... 60 
12.2 
Study Monitoring ........................................................................................................ 60 
12.3 
Data Quality Assurance .............................................................................................. 60 
12.3.1 
Verification of Blinding ........................................................................................ 60 
12.4 
Data Handling and Record Keeping ......................................................................... 61 
12.5 
Protocol Amendments and Deviations ...................................................................... 61 
12.6 
Report Format ............................................................................................................. 62 
12.7 
Publication Policy........................................................................................................ 62 
13 REFERENCES .................................................................................................................... 63 
14 APPENDICES ..................................................................................................................... 64 
 
 
 


Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
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LIST OF TABLES 
 
Table 1: Excluded Medications and Treatments ........................................................................... 35 
Table 2.: Laboratory Tests ............................................................................................................ 39 
 
 
LIST OF FIGURES 
 
Figure 1: TPSS x TPS Fitted Summary Statistics from MMRM (mITT Population) .................. 25 
 
 
LIST OF APPENDICES 
 
Appendix 1: Work Productivity and Activity Impairment Questionnaire (WPAI) ...................... 64 
Appendix 2: Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline/Screening 
Version .................................................................................................................... 66 
Appendix 3: Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version ........ 69 
Appendix 4: Psoriasis Symptom Diary (PSD) .............................................................................. 72 
Appendix 5: Dermatology Life Quality Index (DLQI)................................................................. 75 
Appendix 6: National Institute of Allergy and Infectious Diseases, Division of 
Microbiology and Infectious Diseases (DMID) Toxicity Table for Use in 
Trials Enrolling Healthy Adults (2014) Modified ................................................... 77 
 
 
 


Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
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4 
SYNOPSIS 
Compound: 
ARQ-151 cream 0.3% and ARQ-151 cream 0.15% 
IND 
135681 
Clinical Indication: 
Chronic Plaque Psoriasis 
Study Phase and 
Type: 
Phase 2b Parallel Group, Double Blind, Vehicle-Controlled Study  
Study Objectives: 
To assess the safety and efficacy of ARQ-151 cream 0.3% and ARQ-151 
cream 0.15% vs. vehicle administered QD for 84 days to individuals with 
2 - 20% BSA of chronic plaque psoriasis.  
Summary of Study 
Design: 
This is a parallel group, double blind, vehicle-controlled study in which 
ARQ-151 cream 0.3% or ARQ-151 cream 0.15% or vehicle cream is 
applied QD for 84 days to subjects with chronic plaque psoriasis involving 
between 2 and 20% BSA. 
Blinding: 
This study is double blind and vehicle controlled 
Countries:  
Canada and United States  
Number of sites: 
Approximately 30 sites  
Study Population: 
Subjects will be male and female adults (>18 y/o).  
Subjects will have 2% to 20% total BSA of chronic plaque psoriasis.  
Subjects will have a minimum IGA of ‘Mild’ (2) for study entry. 
Subjects with an IGA of ‘Mild’ (2) will be limited to 20% of total 
enrollment and subjects with IGA of ‘Severe” (4) will be limited to 15% of 
total enrollment. 
Main Inclusion 
Criteria 
1. Participants legally competent to sign and give informed consent 
2. Males and females ages 18 years and older  
3. Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as 
determined by the Investigator 
4. Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous 
areas involving 2% to 20% of BSA (excluding the scalp, palms and 
soles) 
5. An Investigator’s Global Assessment of disease severity (IGA) of at 
least Mild (‘2’) at Baseline   
6. A mPASI score of at least 2 (excluding the scalp, palms and soles) at 
Baseline  
7. Females of childbearing potential (FOCBP) must have a negative urine 
pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, 
sexually active FOCBP must agree to use at least one form of highly 
effective contraception throughout the trial.  Highly effective forms of 
contraception include: oral/implant/injectable/transdermal 
contraceptives, intrauterine device, and partner’s vasectomy.  If barrier 
methods are used (e.g., condom with spermicide, diaphragm with 
spermicide), then 2 forms of conception are required. The use of 
abstinence as a contraceptive measure is acceptable as long as this is a 


Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
 Page 11 of 83 
consistent part of a lifestyle choice and an acceptable backup method 
has been identified if the subject becomes sexually active. 
8. Females of non-childbearing potential should be post-menopausal with 
spontaneous amenorrhea for at least 12 months or have undergone 
surgical sterilization (permanent sterilization methods include 
hysterectomy, bilateral oophorectomy, hysteroscopic sterilization, 
bilateral tubal ligation or bilateral salpingectomy). 
Main Exclusion 
Criteria 
1. Subjects who cannot discontinue medication and treatments  prior to the 
Baseline visit and during the study according to Excluded Medications 
and Treatments (Table 1). 
2. Planned excessive exposure of treated area(s) to either natural or 
artificial sunlight, tanning bed or other LED. 
3. Subjects currently taking lithium or antimalarial drugs. 
4. Planned initiation or changes to concomitant medication that could, in 
the opinion of the Investigator, affect psoriasis vulgaris (e.g. beta 
blockers, ACE inhibitors).  
5. Current diagnosis of guttate, erythrodermic/exfoliative, palmoplantar 
only involvement, or pustular psoriasis.  
6. Subjects with any condition on the treatment area which, in the opinion 
of the Investigator, could confound efficacy measurements. 
7. Known allergies to excipients in ARQ-151 cream
 
 
 
  
8. Subjects who cannot discontinue the use of strong P-450 cytochrome 
inhibitors (e.g., indinavir, nelfinavir, ritonavir, clarithromycin, 
itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and 
telithromycin) for two weeks prior to the baseline visit and during the 
study period.  
9. Subjects who cannot discontinue the use of strong P-450 cytochrome 
inducers (e.g., efavirenz, nevirapine, glucocorticoids, barbiturates 
(including phenobarbital), phenytoin, and rifampin) for two weeks prior 
to the baseline visit and during the study period. 
10. Females who are pregnant, wishing to become pregnant during the 
study, or are breast-feeding. 
11. Previous treatment with ARQ-151. 
12. Subjects who have received oral roflumilast (Daliresp®, Daxas®) or 
other PDE4 inhibitors (apremilast)) within the past 4 weeks. 
13. Known or suspected:  
• 
severe renal insufficiency or severe hepatic disorders  
• 
hypersensitivity to component(s) of the investigational products  
• 
history of severe depression, suicidal ideation 
14. Subjects who are unable to communicate, read or understand the local 
language, or who display another condition, which in the Investigator’s 
opinion, makes them unsuitable for clinical study participation. 


Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
 Page 12 of 83 
Number of 
Subjects: 
Approximately 300 subjects; randomized 1:1:1 to ARQ-151 cream 0.3% 
QD : ARQ-151 cream 0.15% QD : vehicle QD 
Duration of 
Participation for 
Subjects: 
All subject will participate in Screening (up to 5 weeks) and Treatment 
phases (12 weeks).  
Upon completion of this study, participants may have the opportunity, 
subject to regulatory approval, to participate in an open-label extension 
study of up to 12 months, receiving the 0.3% concentration of drug product 
(ARQ-151-202). 
For subjects who enroll in ARQ-151-202, the week 12 visit will complete 
this study.  Subjects who do not enroll in ARQ-151-202 will return for a 
follow-up visit (4 weeks post-treatment completion). 
Study Products: 
• ARQ-151 drug product will be supplied as a 0.3% and 0.15% cream 
• Matching vehicle cream will contain only excipients of ARQ-151 cream 
Planned Dose 
Level: 
Subjects will receive ARQ-151 cream 0.3% QD or ARQ-151 cream 0.15% 
QD or matching vehicle cream QD applied to all psoriatic lesions up to and 
including an area of 20% BSA. Application will be all areas affected 
including the face and intertriginous/genital regions (except for the scalp).   
Safety Assessments: 
Safety will be monitored through application site assessments, safety labs, 
12-lead ECGs, PHQ-8, C-SSRS and AEs. 
Safety Analysis: 
The following analyses will be performed; however, no formal inferential 
statistics will be done on safety assessments. 
Descriptive statistics will be calculated for quantitative safety data and 
frequency counts will be compiled for classification of qualitative safety 
data.  
Descriptive statistics will be calculated for the PHQ-8. 
The C-SSRS will be analyzed per the Scoring and Data Analysis Guide 
from the Columbia Lighthouse Project.  
Adverse Events: 
A subject-by-subject treatment-emergent AE (TEAE) data listing, including 
verbatim term, preferred term, treatment, severity, and relationship to study 
drug, will be provided. 
The number of subjects experiencing AEs and number of AEs will be 
summarized by treatment using frequency counts. 
Medical History and Physical Examinations: 
Medical history will be listed by subject.  Physical examinations and 
12-lead ECGs will be performed at screening, Week 4 and end-of-study. 
Vital signs will be collected at all study visits.  
Clinical Laboratory Results: 
Routine blood chemistries will be obtained at screening, baseline, week 4 
and week 12.  If Baseline is within 14 days of Screening, the Screening 
results may be utilized.  Urine pregnancy tests will be obtained at screening, 
baseline, weeks 4, 8, and 12. 


Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
 Page 13 of 83 
Efficacy Analysis 
The Primary Efficacy Endpoint will be an IGA score of ‘clear’ or ‘almost 
clear’ at week 6. 
The secondary efficacy endpoints will include: 
• 
IGA score of ‘clear’ or ‘almost clear’ at weeks 4, 8 and 12.  
• 
Percent reduction in mPASI at weeks 4, 6, 8, and 12 as compared to 
Baseline. 
• 
Decrease in percent BSA affected at weeks 4, 6, 8, and 12 as 
compared to baseline. 
• 
IGA score of ‘clear’ or ‘almost clear’ PLUS a 2-grade improvement 
from Baseline at weeks 4, 6, 8 and 12. 
• 
For subjects with intertriginous area involvement, and with severity of 
the intertriginous lesions at least ‘mild’ (intertriginous IGA (I-IGA) 
≥2) at Baseline, ‘I-IGA’ score of ‘clear’ or ‘almost clear’ at weeks 4, 
6, 8 and 12. 
• 
Reduction in WI-NRS pruritus score at weeks 4, 6, 8, and 12 as 
compared to Baseline. 
• 
In subjects with WI-NRS pruritus score ≥ 6 at baseline, a 4-point 
reduction in WI-NRS pruritus score at weeks 4, 6, 8, and 12 as 
compared to Baseline. 
• 
Modified Psoriasis Area Severity Index-75 (mPASI-75; subjects who 
achieve a 75% reduction in mPASI from Baseline) improvement at 
weeks 4, 6, 8, and 12 as compared to Baseline. 
• 
Modified Psoriasis Area Severity Index-90 (mPASI-90; subjects who 
achieve a 90% reduction in mPASI from Baseline) improvement at 
weeks 4, 6, 8, and 12 as compared to Baseline. 
• 
Total PSD at weeks 4, 6, 8, and 12 as compared to Baseline. 
• 
Reduction in Itch-related Sleep Loss score at weeks 4, 6, 8, and 12 as 
compared to Baseline. 
• 
Reduction in Dermatology Life Quality Index (DLQI) score at weeks 
4, 6, 8, and 12 as compared to Baseline. 
• 
Responses to the questions of PSD analyzed as improvement at weeks 
4, 6, 8, and 12 as compared to Baseline. 
Exploratory Endpoints are as follows:  
• 
Reduction in Fatigue NRS score at weeks 4, 6, 8, and 12 as compared 
to Baseline. 
• 
Reduction in WPAI score at weeks 4, 6, 8, and 12 as compared to 
Baseline. 
 


Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
 Page 14 of 83 
Power and Sample 
Size 
Approximately 300 subjects are planned for this study.   
Approximately 100 subjects will receive ARQ-151 cream 0.3% QD; 
approximately 100 subjects will receive ARQ-151 cream 0.15% QD; 
approximately 100 subjects will receive matching vehicle cream QD. 
The randomization scheme will be 1:1:1 (ARQ-151 cream 0.3% QD : 
ARQ-151 cream 0.15% QD : matching vehicle QD. 
The sample size was not powered based on data for the primary endpoint 
to provide statistical significance because of the absence of previous 
primary endpoint data. However, based on efficacy data from the proof of 
concept study, this Phase 2b study is expected to provide reliable 
information regarding the efficacy and safety of the drug products. 
Pharmacokinetic 
Sample Collection:  
PK draws will be done on days 1 (baseline), 29 (week 4) and 85 
(week 12) pre-dose (trough) for all subjects.  
Approximately 30 subjects who enter the 4 week follow up period with 
greater than or equal to 5% BSA involvement will have the option to have 
additional PK draws at 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), 
and 216 hr (9 days) after the last dose of drug.   
For the 72 hour timepoint, the PK draw should be +/- 2 hours of the last 
study drug application.  The 5, 7 and 9 day draws should be completed in 
the morning before noon at the site.  
Statistical Analysis: 
Four analysis populations will be defined: 
• 
Safety population will include all subjects who are enrolled and 
received at least one confirmed dose of study medication; this 
population will be defined separately for each cohort. 
• 
Intent-to-Treatment (ITT) population will include all randomized 
subjects. 
• 
Per-Protocol (PP) Population will include all subjects who are in 
the safety population, were at least 80% compliant with study 
medication, and showed no other serious deviations from the 
study protocol. 
• 
PK population will include all subjects receiving the active drug 
with quantifiable plasma concentrations of roflumilast. 
Descriptive statistics will be presented for the endpoint data collected in 
the clinical trial. Missing efficacy data will be estimated by a mixture of 
linear interpolation and last observation carried forward for the cases were 
linear interpolation is not computationally possible. The week 6 ‘IGA 
success’ endpoint will be analyzed with a logistic regression.  Statistical 
comparison between the active treatment arms and vehicle arms will be 
facilitated by using contrasts. 


Protocol ARQ-151-201 
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Amendment 1.0  
 
November 8, 2018 
Confidential 
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5 
SCHEDULE OF VISITS AND ASSESSMENTS 
STUDY EVENTS FLOW CHART: 
 
Study Procedure 
Screen 
Baseline 
Day 1 
 
Wk 2  
Day 15 
 
Wk 4 
Day 29 
 
Wk 6 
Day 43 
 
Wk 8 
Day 57 
 
Wk 12 
Day 85  
 
Wk 16 
Day 113 
Visit 
1 
2 
3 
4 
5 
6 
7 
8 
Visit Window 
-35 
days 
 
+/- 3 
days 
+/- 5 
days 
+/- 5 
days 
+/- 5 
days 
+/- 7 days 
+/- 7 
days 
Informed consent 
X 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
Physical examinationa 
X 
X 
 
 
 
 
X 
 
I/E criteria 
X 
X 
 
 
 
 
 
 
Hematology, Serum 
Chemistries, and Urine 
Analysisb 
X 
X 
 
X 
 
 
 
X 
 
12-lead ECG 
X 
 
 
X 
 
 
X 
 
Vital signs, height, weightc 
X 
X 
X 
X 
X 
X 
X 
X 
IGAd, BSAd, mPASId 
X 
X 
X 
X 
X 
X 
X 
X 
Intertriginous area IGA 
(I-IGA)e 
 
X 
X 
X 
X 
X 
X 
X 
WI-NRSf, Fatigue NRSg, 
WPAIh, Itch-related sleep loss 
and DLQIi 
X 
X 
X 
X 
 
X 
X 
X 
 
Local Tolerability Assessmentsj 
 
X 
 
X 
 
X 
X 
 
C-SSRS, PHQ-8  
X 
X 
 
X 
 
X 
X 
 
PSD 
X 
X 
X 
X 
X 
X 
X 
X 
Optional Photographyk 
 
X 
 
X 
X 
X 
X 
 
Urine pregnancy testl 
X 
X 
 
X 
 
X 
X 
 
PK drawsm 
 
X 
 
X 
 
 
X 
 
IP application in clinicn 
 
X 
X 
X 
X 
X 
X 
 
Assign study medication kito 
 
X 
 
 
 
 
 
 
Dispense/review diary 
 
X 
X 
X 
X 
X 
X 
 
Weigh study medication tubesp 
 
X 
X 
X 
X 
X 
X 
 
Compliance calculationp 
 
X 
X 
X 
X 
X 
X 
 
Adverse event assessmentq 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
Study Exitr 
 
 
 
 
 
 
 
X 
a Limited physical examination: skin, lungs, and heart only 
b  To be collected at Screening, Baseline, Week 4 and Week 12. If Baseline is within 14 days of Screening, the Screening results 
may be utilized. 
c Height will be collected at Baseline only. Weight will be collected at baseline, week 4, 6, 8 and 12. Subject to void prior to 
weight being taken. Remove any jackets, outerwear and shoes. Remove any objects of significant weight (i.e. cell phones, 
wallet, key chains). A 5% weight loss should be reported to the medical monitor. 
d   IGA (based on whole body involvement) will be a 5-point scale ranging from clear (0) to severe (4). IGA should be 
completed prior to other physician assessments. Total BSA affected by psoriasis will be determined. mPASI will be 
determined by standard PASI methods for subjects with ≥ 10% BSA involvement; for subjects with < 10% BSA involvement 
the mPASI will be calculated using the actual percentage of the anatomical area involved (e.g. for 5% of an anatomical area 
involved 0.5 would be used for the calculation). PASI-75 and PASI-90 responses will be determined. 
 
 


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e  For subjects with intertriginous area involvement of at least ‘mild’ severity by IGA (IGA≥2) at Baseline (using the IGA scale 
but evaluating intertriginous areas ONLY and NOT whole body involvement), an IGA for the intertriginous region alone 
(I-IGA) will be recorded at weeks 2, 4, 6, 8, 12 and 14.  This ‘intertriginous area IGA’ should be done AFTER the 
‘standard whole body IGA’ (primary endpoint) in subjects who qualify. 
f   Subjects will complete WI-NRS pruritus assessment. 
g   Subjects will complete Fatigue NRS assessment. 
h   Subjects will complete WPAI (work impairment) assessment.  
i    Subjects will complete Itch-related sleep loss assessment and DLQI. 
j Tolerability assessments should be recorded prior to study drug application for Investigator assessment (Berger and Bowman 
skin irritation score) and 10-15 minutes post-drug application for subject ‘0-3’ burning/stinging assessment.  
k Photography will be performed at selected investigational sites.  Photography will be optional.  All efforts will be made to 
de-identify the subjects. 
l A urine pregnancy test will be administered to all females of child-bearing potential. A negative result is required for 
continued participation in the study, and results must be available prior to dispensing of study drug at each visit. 
m PK draws will be collected from all subjects at Days 1, 29 and 85. The draws will be pre-dose drug application in the clinic 
(i.e., trough levels). The tube weight will be collected prior to the application and after the application. Ensure study 
medication is not applied in the area where PK will be drawn. Approximately 30 subjects, continuing to the Week 16 visit, 
with greater than or equal to 5% BSA involvement, will have additional PK draws at 72 hr (3 days), 120 hr (5 days), 168 hr 
(7 days), and 216 hr (9 days) timepoints post the last treatment application. For the 72 hour timepoint, the PK draw should be 
+/- 2 hours of the last study drug application.  The 5, 7 and 9 day draws should be completed in the morning, before noon at 
the site. 
n   Subjects to apply assigned IP in clinic at every visit. The time of application will be documented.  
o Kits will be dispensed based on %BSA affected. See IP Handling Manual for details.   
p.  Each tube should be weighed and recorded at every visit. See IP Handling Manual for details. 
q Any emergent AEs will be followed in the clinic for up to one month at the Investigator’s discretion until resolved or 
otherwise judged as clinically stable. 
r    Subjects who enroll into the open label extension study (ARQ-151-202) will complete the study at Week 12; subjects that do 
not enroll into ARQ-151-202 will return at Week 16 to complete the study. 
 
 


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6 
 
ABBREVIATIONS 
AE 
Adverse Event 
AMP 
Adenosine Monophosphate 
AUC 
Area Under the Curve 
BSA 
Body Surface Area 
Cmax 
Maximum Concentration 
COPD 
Chronic Obstructive Pulmonary Disease 
CRF 
Case Report Form 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
CTCAE 
Common Terminology Criteria for Adverse Events 
DLQI 
Dermatology Life Quality Index 
DNA 
Deoxyribonucleic Acid 
ERB 
Ethics Review Board 
FDA 
U.S. Food and Drug Administration 
FOCBP 
Female of Child Bearing Potential 
GCP 
Good Clinical Practices 
HC 
Health Canada 
HCA 
Alpha-Hydroxycinnamaldehyde 
HPRT 
Hypoxanthine-guanine Phosphoribosyl Transferase 
IB 
Investigational Brochure 
IC50 
Half Maximal Inhibitory Concentration 
ICF 
Informed Consent Form 
ICH  
International Conference on Harmonisation 
IGA 
Investigator Global Assessment 
I-IGA 
Intertriginous IGA  
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
ITT 
Intent to Treat 
IWRS 
Interactive Web Response System  
LED 
Light Emitting Device 
µg 
Microgram 
MedDRA 
Medical Dictionary for Regulatory Activities 
mITT 
Modified Intent to Treat 
mL 
Milliliter 
MMRM 
Mixed effect Model Repeat Measurement  
mPASI 
Modified Psoriasis Area and Severity Index 
mPASI-75 
Modified Psoriasis Area and Severity Index-75; subjects who achieve a 75% reduction in 
mPASI from Baseline 
mPASI-90 
Modified Psoriasis Area and Severity Index-90; subjects who achieve a 90% reduction in 
mPASI from Baseline  


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MTD 
Maximum Tolerated Dose 
NCI 
National Cancer Institute 
NIH 
National Institutes of Health 
NOAEL 
No Observed Adverse Effect Level 
ng 
Nanogram 
NRS 
Numerical Rating Score  
PASI 
Psoriasis Area and Severity Index 
PDE-4 
Phosphodiesterase 4 
PHQ-8 
Patient Health Questionnaire depression scale 
PI 
Principal Investigator  
PK 
Pharmacokinetics 
PP 
Per Protocol  
PSD 
Psoriasis Symptoms Diary 
QD 
Once Daily ("quaque die") 
SAE 
Serious Adverse Event 
TEAE 
Treatment Emergent Adverse Event 
Th1 
Type 1 T Helper Cell 
Th17 
Type 17 T Helper Cell 
Tmax 
Time to reach maximum concentration 
V79 
Chinese hamster cell line 
WPAI 
Work Productivity and Activity Impairment Questionnaire 
WI-NRS 
Worst Itch – Numeric Rating Score 
 
 
 


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7 
BACKGROUND AND RATIONALE 
7.1 
Introduction 
Roflumilast is a phosphodiesterase 4 (PDE-4) inhibitor approved globally to reduce the risk of 
exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) associated 
with chronic bronchitis.  Roflumilast and its active metabolite, roflumilast N-oxide, are high 
affinity selective inhibitors of PDE-4 (a major cyclic-3′,5′-adenosine monophosphate 
(cyclic AMP)-metabolizing enzyme), whose activity leads to accumulation of intracellular cyclic 
AMP.  There are four different subtypes of PDE-4: PDE-4a, PDE-4b, PDE-4c, and PDE-4d, each 
with several isoforms (splicing variants).  IC50 values of both roflumilast and roflumilast N-oxide 
for the different PDE-4 isoforms and subtypes are mostly sub-nanomolar and single digit 
nanomolar (Hatzelmann 2010).  The PDE-4 family of enzymes are the most prevalent 
phosphodiesterases in immune cells and inhibition of PDE-4 subtypes has been associated with 
anti-inflammatory effects in many biological systems. 
 
Psoriasis is a chronic inflammatory skin disease characterized by raised, well-demarcated, 
erythematous oval plaques with adherent silvery scales.  Numerous past reports have suggested a 
deficiency of cyclic AMP-dependent protein kinases in human psoriatic skin (Brion 1986).  
More recently, various cytokines produced by Th1 and Th17 cells have been shown to play a 
crucial role in the pathogenesis of psoriasis.  It has been postulated that the anti-inflammatory 
effects of PDE-4 inhibitors may provide a beneficial therapeutic intervention in the treatment of 
chronic plaque psoriasis, and recently Otezla® (apremilast) a PDE-4 inhibitor has been approved 
for the oral treatment of chronic plaque psoriasis. 
 
The past 15 years have witnessed a transformation in the systemic treatment of moderate to 
severe psoriasis with the advent of biological therapies.  However, for patients with milder forms 
of disease, best treated with topical options, the therapeutic landscape really has not changed in 
several decades.  Topical steroids come in all shapes and forms, but the lower potency steroids 
are not effective and the higher potency steroids are beset with issues of local skin atrophy and 
the potential for hypothalamic-pituitary axis suppression when applied over larger body surface 
areas and for prolonged periods of time.  Vitamin D has been the other staple of topical psoriasis 
treatment but it is irritating, not suitable for use on the face or intertriginous areas, and its 
efficacy is rather modest.  Hence, there is substantial medical need for additional topical 
approaches in the treatment of psoriasis. The study sponsor is developing a topical formulation 
of roflumilast for the treatment of chronic plaque psoriasis.  Our Phase 2a results suggest that 
ARQ-151 may be a highly efficacious and well-tolerated topical treatment for psoriasis. 
7.2 
Preclinical Studies  
Roflumilast was initially developed as a 500 µg tablet for oral therapy in patients with COPD, 
and as such has been thoroughly evaluated in nonclinical studies.  The safety profile is 
well-established and the results of those studies are relevant to the dermal roflumilast (ARQ-151 
cream) development program.  Oral roflumilast (500 µg tablet) was approved by Health Canada 
as DAXAS® in December 2010 and by the US FDA as DALIRESP® in February 2011 for the 
treatment of COPD.  
 


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Based on the data from this study, the NOAEL in this strain of mice is the 20 mg/kg dose 
(2 mL/kg of a 1% w/w formulation). 
7.2.2 
Oral (Systemic) Studies of Roflumilast and N-Oxide Metabolite 
The repeat-dose toxicity studies of roflumilast has been evaluated in five animal species, with the 
longest duration being 6 months in mice, 6 months in rats, 3 months in hamsters, 12 months in 
dogs and 9-months in monkeys.  The N-oxide metabolite has been studied for 6 months in mice, 
1 month in rats and 12 months in dogs.  Below is a summary of the drug-related effects seen in 
these studies. 
 
Dose-related changes in rodent olfactory mucosa consisted of disorganization and degeneration 
accompanied by basal cell hyperplasia and inflammatory changes of Bowman’s capsule and 
submucosa.  The rat was the most sensitive species (NOAEL of 0.8 mg/kg/day), while mice and 
hamsters were less sensitive (NOAEL of 4 mg/kg/day).  No equivalent changes were observed in 
the olfactory mucosa of dogs and monkeys, despite high systemic exposures to roflumilast and 
roflumilast N-oxide.  Nasal mucosa lesions in the olfactory region are attributed to a rodent-
specific metabolite.  Humans do not have the corresponding olfactory-specific enzyme. 
 
Gastrointestinal effects in rats (erosion, ulceration and/or inflammation) were seen primarily in 
the 4-week studies with roflumilast and roflumilast N-oxide at the highest doses.  
Gastrointestinal effects seen in monkeys (inflammation in the pyloric region) were minimal and 
transient as they occurred after one month of treatment, but were absent after 9 months of dosing.  
In relation to the approved 500 µg dose, the safety margins (plasma AUC of free drug fraction) 
for any potential gastrointestinal effects are 3.7- and 7.4-fold for rats, and 15- and 9.3-fold for 
monkeys, for roflumilast and roflumilast N-oxide, respectively.  For mice, hamsters and dogs, 
the safety margins at the highest dose tested are 628-, 22- and 47-fold for roflumilast and 249-, 
56- and 3.8-fold for roflumilast N-oxide, respectively. While these margins based on AUC may 
be somewhat less with topical administration if exposure to roflumilast and roflumilast N-oxide 
is increased with topical administration at high BSAs, gastrointestinal effects are likely to be 
Cmax-mediated and thus should be mitigated by a lower, and slower ascent to, Cmax that occurs 
with topical administration. 
 
Epididymal spermiogenic granuloma as well as tubular dilation and degeneration of the testes 
were observed in rats treated with roflumilast and roflumilast N-oxide at doses >0.8 mg/kg/day 
or >1.2 mg/kg/day, respectively.  No drug-related changes in the testis or epididymis were noted 
in the other species. 
 
Cardiac lesions such as focal hemorrhages, hemosiderin deposits and lympho-histiocytic cell 
infiltration in the right atria/auricles were found in repeat dose toxicity with roflumilast and 
roflumilast N-oxide in dogs.  In a 6-month study in mice, peri-arteritis was seen in 1-2/40 mice at 
doses > 12 mg/kg/day.  In a 1-month study in monkeys, myocarditis was seen in 1/3 monkeys at 
0.25 mg/kg/day, but was not seen in a subsequent 9-month study at 0.5 mg/kg/day. The effects 
seen in the latter two species are not considered treatment related. 
 


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Decreased food consumption, reduced body weight gain and adrenal hypertrophy (in mice 
accompanied by a premature involution of the juxtamedullary x-zone) occurred in mice, rats and 
hamsters at high doses of roflumilast that produced exposure ratios exceeding 9- to 650-fold the 
human plasma levels of unbound roflumilast and roflumilast N-oxide compared to the 500 µg 
oral dose.. 
7.2.3 
Reproductive Toxicity 
 
Roflumilast was not teratogenic in rats and rabbits following oral administration up to the highest 
doses of 1.8 mg/kg/day in rats and 0.8 mg/kg/day in rabbits.  Administered at the same doses, 
roflumilast has been shown to induce mild retardation of embryo-fetal development (incomplete 
ossification) in the rat, but not in the rabbit.  Exposure of pregnant rats to unbound roflumilast 
and roflumilast N-oxide was 1.7 and 10.8 times higher, respectively, than exposure of women at 
the 500 µg oral roflumilast dose.  In one of three rat studies on fertility and embryo-fetal 
development, post-implantation losses were observed at oral doses of 0.8 mg/kg/day.  Post-
implantation losses were not seen in rabbits up to doses of 0.8 mg/kg/day.  Rat and rabbit fetuses 
were exposed to roflumilast and the permeability of the placental barrier for drug-related 
material increased with the progression of pregnancy.  Prolongation of gestation was seen in 
mice due to a potential tocolytic effect. 
 
There was no effect on female fertility up to the highest roflumilast dose of 1.5 mg/kg/day in 
rats.  Slight reduction in male fertility was seen in conjunction with epididymal toxicity in rats 
dosed with 1.8 mg/kg/day.  This finding is not considered relevant to humans. 
7.2.4 
Genotoxicity 
 
Roflumilast tested positive in an in vivo mouse micronucleus test, but negative in the following 
assays: Ames test for bacterial gene mutation, in vitro chromosome aberration assay in human 
lymphocytes, in vitro HPRT test with V79 cells, in vitro micronucleus test with V79 cells, DNA 
adduct formation assay in rat nasal mucosa, liver and testes, and in vivo mouse bone marrow 
chromosome aberration assay.  Roflumilast N-oxide was negative in the Ames test and the in 
vitro micronucleus test with V79 cells.  
7.2.5 
Carcinogenicity 
In a 2-year carcinogenicity study in mice, roflumilast was administered by gavage at doses up to 
18 mg/kg/day in males and 12 mg/kg/day in females.  No compound-related tumors occurred.  
In the two 2-year carcinogenicity studies in hamsters, roflumilast was administered by gavage at 
doses up to 16 mg/kg/day.  Nasal neoplasms (undifferentiated carcinomas of the olfactory 
epithelium and adenocarcinoma of Bowman’s gland) were observed at the high doses of 
roflumilast.  No other treatment-related neoplastic findings were observed.  Overall, the tumor-
free level in the animals was 4 mg/kg/day.  The significance of this finding to humans is 
unknown.  


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7.2.6 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
  
 
 
 
 
  
7.2.7 
Conclusions on Toxicity Findings 
 
Oral roflumilast is approved globally for COPD, and its safety profile is well-
established.  An extensive systemic toxicity program that evaluated both roflumilast and its 
active N-oxide metabolite in multiple species via the oral route of administration was conducted 
to support registration.   
 
The previously-conducted systemic toxicity program included studies to evaluate reproductive 
toxicity, genotoxicity and carcinogenicity, and the results of those studies are included in the 
labeling for oral roflumilast.  
 
 
 
 
 
 
 
  


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7.3 
Clinical Studies 
7.3.1 
Topical Roflumilast Cream 
 
This will be the second study of topical ARQ-151 cream in the human population. 
 
ARQ-151 cream 0.5% and 0.15% have been studied in a Phase 2a study (protocol # 
ARQ-151-101; NCT03392168) in patients with mild to moderate chronic plaque psoriasis in the 
United States and Canada.  The study included two cohorts.  Cohort 1 was a single dose study to 
25 cm2 of psoriatic plaque(s) in 8 psoriasis subjects.  Cohort 1 subjects were then enrolled, if 
they met entry criteria, into Cohort 2 of the study. Cohort 2 was a parallel group, double blind, 
vehicle-controlled study in which ARQ-151 cream 0.5%, ARQ-151 cream 0.15% or vehicle 
cream was applied QD for 28 days to 89 subjects with at least 0.5% BSA of chronic plaque 
psoriasis; area for application was not to exceed 5.0% BSA. Cohort 2 subjects had at least one 
target plaque of psoriasis of at least 9 cm2 Target Plaque Area (TPA) in size and with a Target 
Plaque Severity Score (TPSS) ≥ 4. However, all body psoriasis plaques were treated except for 
the face, scalp, intertriginous areas and palms/soles.  Only safety and pharmacokinetics were 
evaluated for the single dose Cohort 1 subjects.  
 
In the parallel group assessment (Cohort 2), the Primary Efficacy Endpoint was:  
 
• Difference in mean percent change from baseline at week 4 in the product of 
TPSS x TPA between each dose concentration level of ARQ-151 cream and vehicle 
control.  This was assessed as a sum of up to 3 target plaques per subject. 
 
Efficacy and safety results of ARQ-151-101 are as follows: 
 
• Figure 1 shows evaluation of the primary efficacy endpoint at Weeks 1, 2, 3 and 4, with 
p values and standard error bars: 
 


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Day 28 pharmacokinetic results of ARQ-151-101 are as follows: 
 
 
 
 
 
 
 
 
7.3.2 
Oral Roflumilast Tablet 
 
Oral roflumilast (DALIRESP®, DAXAS®, a 500 µg tablet) has been approved globally for the 
treatment of COPD and has been evaluated in nine Phase III/IV randomized double-blind clinical 
trials (Wedzicha 2016).  Overall, the safety of oral roflumilast has been well established in its 
targeted population of mostly middle- and upper-aged individuals who currently smoke 
cigarettes or have smoked them extensively in the past.  Adverse events (AEs) reported with 
roflumilast tablets have been consistent with those expected for oral PDE-4 inhibitors.  
In a pooled analysis of safety data from 6-month and 1-year clinical trials (N=8630), the most 
common AEs were diarrhea, weight loss and nausea.  Other AEs reported more frequently with 
roflumilast treatment than with placebo were back pain, influenza, insomnia and decreased 
appetite (Michalski 2012, Wedzicha 2016). 
 
In addition to the self-reported cases of weight loss in the 6-month and 1-year oral trials, 
clinically significant weight loss was also reported in two prospective studies that evaluated 
weight (Michalski 2012). 
 
 
 


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Psychiatric-related AEs were also greater in patients treated with roflumilast tablets (5.9%) 
compared to those treated with placebo (3.3%).  The most common psychiatric-related AEs were 
insomnia, depression and anxiety.  A small number of cases of completed suicide and suicide 
ideation have been reported in patients taking oral roflumilast in clinicals trials and also during 
post-marketing experience (Michalski 2012).   
 
The only contraindication to oral roflumilast, other than hypersensitivity to components of the 
product, is in patients with moderate to severe liver impairment (Child-Pugh B or C), 
where systemic levels of roflumilast may become highly elevated. 
7.4 
Rationale for Development 
In 2016, Snape and colleagues performed a Phase 1 randomized clinical trial to assess the effect 
on skin inﬁltrate thickness and tolerability of topical phosphodiesterase inhibitors, including 
roflumilast, in the treatment of psoriasis vulgaris using a modiﬁed psoriasis plaque test.  
The products evaluated were the active comparators calcipotriol 0.005% and betamethasone 
valerate 0.1% (both in their marketed cream formulations), and investigational cream 
formulations of roﬂumilast 0.5%, TAK-084 0.5% and 5%.  A vehicle cream was used as a 
control (the vehicle cream and roflumilast formulations in this study were different from the 
ARQ-151 cream formulation).  Each treatment was applied daily to different test sites located on 
a single psoriasis plaque of an individual for 3 weeks.  Fifteen patients with psoriasis were 
studied.  The primary endpoint of mean change from baseline in skin inﬁltrate thickness after 
3 weeks of treatment showed statistically signiﬁcant improvements for all treatments: 
betamethasone valerate (-286.9 μm), the selective PDE-4 inhibitors roﬂumilast 0.5% 
(-237.1 μm), TAK-084 0.5% (-153.6 μm), TAK-084 5% (-216.7 μm) and calcipotriol 0.005% 
(-187.7 μm) when compared with vehicle cream control (all p < 0.001) (Snape 2016).  
 
 
   
7.4.1 
Dose Selection 
 
 
 
 
 
 
 


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7.4.2 
Risks and/or Benefits to Subjects 
 
Based on the Phase 2a study results, subjects randomized to active treatment groups are likely to 
see an improvement in their psoriasis with ARQ-151 cream at both the 0.3% and 0.15% dose 
levels.  Subjects randomized to the vehicle arm may also see some improvement as the 
excipients in the vehicle appeared to have some benefit, likely because of a moisturizing effect 
on the subject’s psoriatic plaques.  
 
The safety monitoring practices employed in this protocol (i.e., physical examinations, vital 
signs/weight, 12-lead ECGs, local skin toleration assessments, hematology, serum chemistry, 
urinalysis, PHQ-8, C-SSRS and AE questioning) are adequate to protect the subjects’ safety and 
should detect expected AEs. 
 
Oral roflumilast has now been used for almost a decade in the treatment of COPD exacerbations 
and its safety record has been well-documented.  The known adverse effects of oral treatment in 
the COPD population (nausea, diarrhea, weight loss, psychiatric AEs; see Section 7.3.2) are 
monitorable, the current protocol is designed to detect these adverse events and others should 
they occur, and provides guidance for management, as necessary, to ensure patient safety. 
 


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8 
STUDY ENDPOINTS AND OBJECTIVES 
8.1 
Study Objectives 
8.1.1 
Primary Objectives 
 
To assess the safety, pharmacokinetics and efficacy of ARQ-151 cream 0.3% and ARQ-151 
cream 0.15% vs. vehicle applied QD for 12 weeks to individuals treated with 2 to 20% 
(inclusive) BSA of chronic plaque psoriasis. 
8.2 
Efficacy Endpoints 
8.2.1 
Primary Endpoint 
 
The parallel groups will have analyses for safety, pharmacokinetics, and efficacy. 
 
The Primary Efficacy Endpoint will be:  
 
• IGA score of ‘clear’ or ‘almost clear’ at Week 6.  
Investigator Global Assessment of Disease (IGA) 
 
Scale Grade 
Description 
0 
Clear  
Plaque thickening = no elevation or thickening over normal skin 
Scaling = no evidence of scaling 
Erythema = none (no residual red coloration but post-inflammatory 
hyperpigmentation may be present) 
1 
Almost 
Clear 
Plaque thickening = none or possible thickening but difficult to ascertain 
if there is a slight elevation above normal skin level 
Scaling = none or residual surface drying and scaling 
Erythema = light pink coloration 
2 
Mild  
Plaque thickening = slight but definite elevation 
Scaling = fine scales partially or mostly covering the lesions 
Erythema = light red coloration 
3 
Moderate 
Plaque thickening = moderate elevation with rounded or sloped edges 
Scaling = most lesions at least partially covered 
Erythema = definite red coloration 
4 
Severe 
Plaque thickening = marked or very marked elevation typically with hard 
or sharp edges 
Scaling = non-tenacious or thick tenacious scale, covering most or all of 
lesions 
Erythema = very bright red coloration; extreme red coloration; deep red 
coloration  
This IGA (whole body) will be the first efficacy endpoint measured at clinic visits and prior 
to the application of any Investigational Product. 


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8.2.2 
Secondary Endpoints 
 
The secondary efficacy endpoints will include: 
 
• IGA score of ‘clear’ or ‘almost clear’ at weeks 4, 8 and 12. 
• Percent reduction in mPASI at weeks 4, 6, 8, and 12 as compared to Baseline. 
• Decrease in Percent BSA affected at weeks 4, 6, 8, and 12 as compared to Baseline. 
• IGA score of ‘clear’ or ‘almost clear’ PLUS a 2-grade improvement from Baseline at 
weeks 4, 6, 8 and 12. 
• For subjects with intertriginous area involvement, and with severity of the intertriginous 
lesions at least ‘mild’ (I-IGA≥2) at Baseline, ‘I-IGA’ score of ‘clear’ or ‘almost clear’ at 
weeks 4, 6, 8 and 12. 
• Reduction in WI-NRS pruritus score at weeks 4, 6, 8, and 12 as compared to Baseline. 
• In subjects with WI-NRS pruritus score ≥ 6 at baseline, a 4-point reduction in WI-NRS 
pruritus score at 4, 6, 8, and 12 weeks as compared to Baseline. 
• Modified Psoriasis Area Severity Index-75 (mPASI-75) improvement at weeks 4, 6, 8, 
and 12 as compared to Baseline. 
• Modified Psoriasis Area Severity Index-90 (mPASI-90) improvement at weeks 4, 6, 8, 
and 12 as compared to Baseline. 
• Total PSD at weeks 4, 6, 8, and 12 as compared to Baseline 
• Reduction in Itch-related Sleep Loss score at weeks 4, 6, 8, and 12 as compared to 
Baseline. 
• Reduction in Dermatology Life Quality Index (DLQI) score at weeks 4, 6, 8, and 12 as 
compared to Baseline. 
• Responses to the questions of PSD analyzed as improvement at weeks 4, 6, 8, and 12 as 
compared to Baseline. 
8.2.3 
Exploratory Endpoints 
 
Exploratory Endpoints are as follows:  
 
• Reduction in Fatigue NRS score at weeks 4, 6, 8, and 12 as compared to Baseline. 
• Reduction in WPAI score at weeks 4, 6, 8, and 12 as compared to Baseline. 
 
 
 


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9 
INVESTIGATIONAL PLAN 
9.1 
Overall Study Design and Plan 
This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream 0.3%, 
ARQ-151 cream 0.15% or vehicle cream QD is applied for 84 days to subjects with between 2% 
to 20% (inclusive) BSA of chronic plaque psoriasis. 
 
A total of up to approximately 300 subjects will be enrolled at approximately 30 study sites in 
the United States and Canada.  Subjects will be adult (≥18 y/o) males or females with chronic 
plaque psoriasis. Subjects must have an Investigator’s Global Assessment of disease severity 
(IGA) of at least Mild (‘2’) at Baseline.  Subjects with an IGA of ‘Mild’ (2) will be limited to 
20% of total enrollment. Subjects with an IGA of ‘Severe’ (4) will be limited to 15% of total 
enrollment. Subjects must have at least 2% and no more than 20% Body Surface Area (BSA) of 
chronic plaque psoriasis. All psoriasis lesions on a subject will be treated including the face, 
trunk, genitals/skin folds, or limbs (excluding the scalp).  The palms and soles will be treated but 
will not be counted towards any measurements of efficacy (IGA, BSA, mPASI).  For subjects 
with intertriginous area involvement, and with severity of the intertriginous area lesions at least 
‘mild’ (IGA≥2) at Baseline, ‘I-IGA’ score will be recorded at weeks 4, 6, 8 and 12.  The same 
IGA used for the primary endpoint (whole body) will also be used for ‘intertriginous area lesion 
IGA score’ (I-IGA) ), but only intertriginous areas will be evaluated for I-IGA, not the rest of the 
body.   
9.2 
Subject Participation 
Subject participation involves a minimum of seven clinic visits:eight clinic visits including 
Screening, Baseline and five visits at Week 2, Week 4, Week 6, Week 8 and Week 12 of 
treatment and a week 14 follow-up visit (2 weeks after last dose).  The interval between the 
Screening and Baseline visits could be up to 35 days, therefore the anticipated maximum 
duration of subject participation is ~19 weeks. 
 
Upon completion of this study, participants may have the opportunity, subject to regulatory 
approval, to participate in an open-label extension study of up to 12 months, receiving the 0.3% 
concentration of drug product. The week 12 visit will be the Day 1 visit for ARQ-151-202. 
 
For subjects who do not enter ARQ-151-202 there will be a minimum of eight clinic visits: 
Screening, Baseline, five visits at Week 2, Week 4, Week 6, Week 8 and Week 12 of treatment, 
and a week 16 follow-up visit (4 weeks after last dose).  The interval between the Screening and 
Baseline visits could be up to 35 days, therefore the anticipated maximum duration of subject 
participation is ~21 weeks. 
 
 


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9.2.1 
Randomization 
Subjects will apply ARQ-151 cream 0.3% QD or ARQ-151 cream 0.15% QD or vehicle cream 
QD to psoriatic plaques of 2% BSA up to a maximum application area of 20% BSA.   
 
Assignment of drug or vehicle will be made at a 1:1:1 ratio according to a computer-generated 
randomization list.   
 
Randomization will take place at Baseline after the patient has been found to be fully eligible for 
participation.  Kits containing tubes of study medication will be assigned to each subject using an 
internet-based randomization system (IWRS). A subject may receive more than one kit for the 
treatment period.  
 
The kits and tubes are blinded and each kit is numbered with a unique kit number.  
9.2.2 
Numbering of Subjects 
All screened subjects will be identified by a unique five-digit subject ID number.  The first two 
digits correspond to the site number (assigned by the Sponsor), the next three digits correspond 
to the sequential order in which the subject is screened for the study (e.g., Subject ID 10001: 
Site 10, first subject screened 001 for that site). Site number 10 will be the first site in the study. 
 
The clinical site is responsible for maintaining a current log of subject ID number assignments 
and the kit number assigned to that subject.  The subject ID number is required to be entered on 
all clinical study documentation (e.g., case report forms, labeling of clinical materials and sample 
containers, investigational product accountability logs, etc.).  
9.3 
Selection of Study Population 
9.3.1 
Inclusion Criteria 
 
Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the 
study: 
1. Participants legally competent to sign and give informed consent 
2. Males and females ages 18 years and older (inclusive) 
3. Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the 
Investigator 
4. Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas involving 2-20% 
(inclusive) of BSA (excluding the scalp, palms and soles). 
5. An Investigator’s Global Assessment of disease severity (IGA) of at least Mild (‘2’) at 
Baseline.   
6. A mPASI score of at least 2 (excluding the scalp, palms and soles) at Baseline.  


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7. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at 
Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to 
use at least one form of highly effective contraception throughout the trial.  Highly effective 
forms of contraception include: oral/implant/injectable/transdermal contraceptives, 
intrauterine device, and partner’s vasectomy.  If barrier methods are used (e.g., condom with 
spermicide, diaphragm with spermicide), then 2 forms of conception are required. The use of 
abstinence as a contraceptive measure is acceptable as long as this is a consistent part of a 
lifestyle choice and a backup method has been identified if the subject becomes sexually 
active. 
8. Females of non-childbearing potential should be post-menopausal with spontaneous 
amenorrhea for at least 12 months or have undergone surgical sterilization (permanent 
sterilization methods include hysterectomy, bilateral oophorectomy, hysteroscopic 
sterilization, bilateral tubal ligation or bilateral salpingectomy). 
9. In good health as judged by the Investigator, based on medical history, physical examination, 
serum chemistry labs, hematology values, and urinalysis. 
10. Subjects agree not to have prolonged sun exposure during the course of the study.  
Tanning bed use or use of other LEDs is not allowed. 
11. Subjects are considered reliable and capable of adhering to the Protocol and visit schedule, 
according to the judgment of the Investigator. 
9.3.2 
Exclusion Criteria 
 
1. Subjects who cannot discontinue medications and treatments prior to the Baseline visit and 
during the study according to Excluded Medications and Treatments (Table 1). 
2. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, 
tanning bed or other LED.   
3. Subjects currently taking lithium or antimalarial drugs. 
4. Planned initiation or changes to concomitant medication that could, in the opinion of the 
Investigator, affect psoriasis vulgaris (e.g. beta blockers, ACE inhibitors). 
5. Current diagnosis of guttate, erythrodermic/exfoliative, palmoplantar only involvement, or 
pustular psoriasis.  
6. Subjects with any condition on the treatment area which, in the opinion of the Investigator, 
could confound efficacy measurements. 
7. Known allergies to excipients in ARQ-151 cream
 
 
  
8. Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors 
e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, 
saquinavir, suboxone and telithromycin for two weeks prior to the baseline visit and during 
the study period.   


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9. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, 
nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, and rifampin 
for two weeks prior to the baseline visit and during the study period.   
10. Subjects who have received oral roflumilast (Daxas®, Daliresp®) within the past 4 weeks.  
11. Known or suspected:  
• severe renal insufficiency or severe hepatic disorders  
• hypersensitivity to component(s) of the investigational products  
• history of severe depression, suicidal ideation 
 
12. Females who are pregnant, wishing to become pregnant during the study, or are breast-
feeding. 
13. Previous treatment with ARQ-151. 
14. Subjects with any serious medical condition or laboratory abnormality that would prevent 
study participation or place the subject at significant risk, as determined by the Investigator. 
15. Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of 
study medication. 
16. History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or 
anaphylactoid reaction) to PDE-4 inhibitors. 
17. Current or a history of cancer within 5 years with the exception of fully treated skin basal cell 
carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix. 
18. Subjects with active infection that required oral or intravenous administration of antibiotics, 
antifungal or antiviral agents within 7 days of Baseline/Day 1. 
19. Subjects who are unable to communicate, read or understand the local language, or who 
display another condition, which in the Investigator’s opinion, makes them unsuitable for 
clinical study participation. 
9.3.3 
Removal of Subjects from the Study 
 
Subject participation in this trial may be discontinued for any of the following reasons: 
1. Occurrence of any medical condition or circumstance that, in the opinion of the Investigator, 
exposes the subject to substantial risk and/or does not allow the subject to adhere to the 
requirements of the Protocol. 
2. Occurrence of a treatment-emergent adverse event (TEAE) or considerable worsening of an 
AE that, in the opinion of the investigator in consultation with the Medical Monitor and 
Sponsor, represents an unacceptable risk to the subject if he/she continues in the study.  
The investigator must follow the subject until the AE resolves or satisfactorily stabilizes. 
3. Pregnancy. 
4. Subject's decision to withdraw. 


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5. Weight loss of >5% if not dieting and after consultation with the Sponsor, at the 
Investigator’s discretion. 
6. C-SSRS indicative of suicidal ideation or a PHQ-8 score ≥15, after consultation with a 
mental health professional, the Sponsor, and at the Investigator’s discretion. 
7. Requirement for use of prohibited concomitant medication after consultation with the 
Sponsor and Medical Monitor. 
8. Subject’s repeated failure to comply with protocol requirements or study related procedures. 
9. The subject interrupts trial study drug application for more than 50% of scheduled doses. 
10. Termination of the study by the Sponsor, FDA, or other regulatory authorities. 
9.4 
Study Restrictions 
9.4.1 
Prohibitions and Concomitant Therapy 
 
Prohibited medications and products are detailed in Table 1.   
Table 1: Excluded Medications and Treatments 
 
Excluded Medications and treatments 
Wash out period prior to Day 1 
• Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris within the 
following time periods prior to randomization 
etanercept 
4 weeks 
adalimumab, infliximab 
8 weeks 
All other biologics 
12 weeks 
• Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris 
Oral corticosteroids, retinoids, apremilast, methotrexate, 
cyclosporine and other systemic immunosuppressants 
4 weeks 
Topical anti-psoriasis medications (e.g., topical corticosteroids, 
vitamin D analogs, prescription shampoos) (except for emollients) 
2 weeks 
PUVA phototherapy 
4 weeks 
UVB  
2 weeks  
Systemic retinoids 
12 weeks 
Investigational drugs 
12 weeks (biologics); 
5 half-lives (orals);  
2 weeks (topical) 
Notes:   
(1) Eye drop and nasal corticosteroid preparations are allowed.  Inhaled corticosteroid preparations are allowed 
if used for a stable condition and at a stable dose for > 28 days before screening, and are continued at the 
same dose throughout the study. 
(2) Non-medicated emollients, moisturizers and sunscreens will be allowed as used normally by the subjects. 
These can be applied to non-treated areas as needed and should not be used within 12 hours of a  study visit. 
(3) Study medication should be applied at least 20 minutes before going to bed. No emollients or moisturizers 
should be applied on treated areas.   
(4) A tar-containing or dandruff shampoo (zinc pyrithione or selenium sulfide) is allowed for treatment of the 
scalp. 


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Generally, the addition of new medications, including nonprescription medications, during the 
course of the study is discouraged.  However, the short-term use of a medication may be 
authorized by the Investigator.  The Investigator must make the decision to authorize the use of 
any such a medication only after consideration of the clinical situation, the potential for masking 
symptoms of a more significant underlying event, and whether the use of the medication will 
compromise the outcome or validity of the clinical investigation.  If medication is required, 
the name, strength, frequency, duration of use, and reason for use will be recorded in source 
documents and transcribed to Case Report Forms.  Medications which have been used 
chronically by subjects, in particular statins and anti-hypertensives, are allowed for use during 
the study, except as prohibited in ‘Exclusions’ (Table 1).  
9.5 
Treatment 
9.5.1 
Drug Supplies, Packaging and Labeling 
 
ARQ-151 cream or vehicle cream will be in 45 gram squeeze tubes.  The tubes will be packaged 
in kits, each containing 4 tubes of investigational product. The number of kits dispensed to a 
subject will be based on the BSA involvement of psoriasis.  It is anticipated that the maximum 
number of kits dispensed to a subject will be four. The kits and tubes will be labeled in a blinded 
manner.  The kit(s) dispensed to a subject will be labeled with a unique number. 
 
The Sponsor will supply sufficient quantities of the study drug (ARQ-151 cream 0.3%, 
ARQ-151 cream 0.15%, and matching vehicle cream) to each site to allow for completion of this 
study. 
 
Records will be made of the receipt and dispensing of the study drugs supplied. At the 
conclusion of the study, any unused study drugs will be returned to the Sponsor or designee, or 
destroyed, as per Sponsor instructions. 
9.5.2 
Blinding 
This is a double-blind study, therefore neither the subjects nor the Investigator and clinical 
personnel will be aware of which treatment an individual has received. 
9.5.3 
Treatment Administration 
 
At the randomization visit (Baseline visit), the study staff will demonstrate to the subject how to 
apply ARQ-151 cream or vehicle cream using the first tube from the kit that is assigned to the 
subject at randomization.   Study site staff will be trained to ensure a unit dose (a pea size unit of 
ARQ-151 vehicle cream will cover approximately 1% BSA) is properly squeezed from the tube 
and applied to psoriatic lesion(s) as a thin film and rubbed in using the index and middle finger, 
rubbing in thoroughly but gently, until the ‘white’ has disappeared.  The subject will then 
practice squeezing a similar amount onto their index and middle finger and apply a thin film to 
other psoriatic areas to be treated.  The study staff will confirm that the subject’s application 
technique is correct.  
 


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Re-training will be conducted at subsequent visits (weeks 2, 4, 6 and 8) as needed (i.e., if the 
returned tube(s) weighs substantially different than the expected weight). 
Subjects will be instructed to apply study medication once daily.  All subjects should apply 
medication each evening (except on clinic visit days) at least 15 minutes after showering or 
bathing (if they take an evening shower/bath) and then not wash areas where ARQ-151 cream or 
vehicle has been applied until at least 4 hours after study drug application and preferably not 
until the following morning.  Study medication should be applied at least 20 minutes before 
going to bed.   
 
Subjects should continue to apply study medication to all treatment areas identified by the 
investigator at Baseline using a Body Diagram even if that area has cleared during the treatment 
period. New plaques that develop during the study should be treated as well. 
 
Each study medication tube will be weighed prior to dispensing at the baseline visit or 
subsequent visits. Study medication tubes must be returned by subjects at each study visit, both 
empty and full, and will be weighed. If the subject’s actual use is substantially different than the 
expected use for the subject’s BSA (see IP Manual), the subject will be retrained on the study 
drug application technique. 
9.5.4 
Treatment Compliance  
Study medication tubes will be weighed at each follow-up clinic visit.   
Subjects will complete a daily diary recording the date and time of each dose applied, any missed 
doses, and a comment section should the subjects have a comment, e.g., record potential AEs. 
Site personnel will review the diaries and use the information to question the subject regarding 
compliance and AEs and then record appropriate information in source documents and complete 
Case Report Forms (CRFs).  If a subject misses a dose, they should be instructed to return to the 
protocol study medication administration schedule (i.e. if subject forgets a dose they should wait 
until that evening and apply as usual).   
A subject will be considered compliant with the dosing regiment if the subject applies at least 
80% of the expected applications during the study drug application period and does not miss 
more than 3 consecutive doses.  
Compliance will be assessed by review of the dosing diary. Weight of study medication applied 
will be measured for reporting purposes.  
If the diary shows less than 80% of expected use, the subject is using too little study drug and 
retraining must be conducted and documented.  
Compliance will be documented in source and in eCRF. 


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10 STUDY PROCEDURES 
10.1 Safety Assessments 
The Schedule of Visits and Assessments (Section 5) summarizes the clinical procedures to be 
performed at each visit. Individual clinical procedures are described in detail below. Additional 
evaluations/testing may be deemed necessary by the PI and/or the Sponsor for reasons related to 
subject safety. 
This study assesses the safety and efficacy of ARQ-151 cream. Safety will be determined by 
evaluating physical examinations, 12-lead ECGs, local tolerability assessments, vital 
signs/weight, clinical laboratory parameters, PHQ-8, C-SSRS and AEs as outlined in the 
Schedule of Visits and Assessments (Section 5). If deemed necessary, additional safety 
assessments will be performed at the discretion of the PI. 
10.1.1 
Screening 
Within 35 days prior to the first dosing, subjects will be provided details of study requirements 
and sign an informed consent.  Medical history and demographic data including sex, age, race, 
ethnicity, body weight (kg), and height (cm) will be recorded. Each subject will undergo 
psoriatic plaque assessments, a physical examination, vital sign measurements (blood pressure, 
heart rate, and temperature), PHQ-8, C-SSRS, and laboratory tests: hematology, chemistry, 
urinalysis and a pregnancy test for female subjects of child bearing potential. 
All screened subjects will receive a screening number and be entered into the electronic subject 
tracking system. 
10.1.2 
Physical Examination 
 
Physical examinations will be performed as follows: 
 
Screening, Baseline and Week 12.   
The physical exam will be limited to skin, lungs and heart only. 
10.1.3 
Vital Signs, Height and Weight 
 
Vital signs will be collected at timepoints noted below: 
 
Blood pressure, heart rate, and temperature will be measured at Screening, Baseline, Weeks 2, 4, 
6, 8, 12 and 16 (if applicable).  
 
Height will be collected at Baseline only.  
 
 
 


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Weight will be collected at Baseline, Weeks 4, 6, 8 and 12. Subject to void prior to weight being 
taken and remove any jackets, outerwear and shoes. Remove any objects of significant weight 
(i.e. cell phones, wallet, key chains). A 5% weight loss should be reported to the medical 
monitor. 
10.1.4 
12-Lead ECGs 
 
12-lead ECGs will be performed as follows: 
 
Screening, Week 4 and 12. 
 
ECGs will be performed on subjects after 5 minutes in the supine position. All ECG tracings and 
readouts will be reviewed by the central reader at the ECG laboratory. 
10.1.5 
Laboratory Tests 
All tests listed below will be performed as follows: 
Screening, Baseline, Weeks 4 and 12.    
All tests listed in Table 2 below will be performed according to the Study Events Flow Chart 
unless otherwise noted. The collection of specimens will be in a non-fasting state. In addition, 
laboratory safety tests may be performed at various unscheduled time points, if deemed 
necessary by the Investigator. 
Table 2.: Laboratory Tests 
 
Hematology 
 
Serum Chemistry 
• 
Hemoglobin 
• 
Hematocrit  
• 
Total and differential leukocyte count 
• 
Red blood cell count with indices and 
morphology 
• 
Platelet count 
 
• 
Blood Urea Nitrogen 
• 
Bilirubin (total and direct) 
• 
Alkaline phosphatase 
• 
Aspartate aminotransferase 
• 
Alanine aminotransferase 
• 
Albumin 
• 
Sodium 
• 
Potassium 
• 
Chloride 
• 
Glucose 
• 
Creatinine  
 
 


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Laboratory Tests, continued 
 
Urinalysis 
 
Additional Tests 
• 
pH 
• 
Specific gravity 
• 
Protein* 
• 
Glucose 
• 
Ketones 
• 
Bilirubin 
• 
Blood* 
• 
Nitrite* 
• 
Urobilinogen 
• 
Leukocyte esterase* 
 
• 
Urine pregnancy test** 
(for females of child bearing potential only) 
* If urinalysis is positive for protein, blood, nitrite and/or leukocyte esterase, a microscopic examination (for red blood cells, 
white blood cells, bacteria, casts, and epithelial cells) will be performed. 
** At screening, baseline, Weeks 4, 8 and 12 for FOCBP only  
10.1.6 
Patient Health Questionnaire depression scale (PHQ-8)  
 
The 8 item PHQ-8 Assessment will be performed as follows: 
 
Screening, Baseline, Weeks 4, 8, and 12 
 
Subjects will complete PHQ-8 questionnaire. 
 
A subject with a PHQ-8 score of ‘15’ or above should be referred promptly to a mental health 
care professional and, if currently applying study drug, consideration be given to discontinuation 
from study drug.   
 


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The PHQ-8 
 
 
 
PHQ-8 score is the sum of the responses for the 8 questions. 
 
Five severity categories of depression are defined as follows:  
• None – Minimal depression (0 to 4)  
• Mild depression (5 to 9)  
• Moderate depression (10 to 14)  
• Moderately severe depression (15 to 19)  
• Severe depression (20 to 24) 
 


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10.1.7 
Columbia-Suicide Severity Rating Scale (C-SSRS)  
 
C-SSRS Assessments will be performed as follows: 
 
Screening, Baseline, Weeks 4, 8, and 12. 
 
The administration schedule of the C-SSRS will be: 
 
• 
The Baseline-Screening version (Appendix 2) will be used at Screening to provide a pre-
treatment assessment baseline.  
o If a subject has a score greater than 0 in suicidal ideation, this is important and 
may indicate the need for mental health intervention. The investigator should give 
consideration to not enrolling the subject in the study.  
• 
On all subsequent visits, the Since Last Visit version (Appendix 3) will be used. 
o Any score greater than 0 in the suicidal ideation score is important and may 
indicate the need for mental health intervention and consideration be given to 
discontinuation from study drug. This should result in prompt referral to a mental 
health professional and/or possibly the emergency room. The Medical Monitor 
should be contacted.  
 
The trained administrator will conduct the C-SSRS.  The C-SSRS administrator will be trained 
via the C-SSRS training video. A training certificate for the administer(s) will be on file in the 
trial master file at the site. 
 
The Investigator must review the completed C-SSRS.  A qualified mental health care provider 
must be available, immediately if needed, to refer the subject for further evaluation. 
10.1.8 
Local Tolerability Assessments  
The Investigator Local Tolerability Assessment will be performed as follows: 
Baseline, Weeks 4, 8 and 12 
Application site reactions will be graded at the timepoints outlined in the Schedule of Visits and 
Assessments (Section 5).  Irritation reactions are graded using the scale detailed in the following 
section (Berger-1982).  Reactions at the site of product application, which may occur post-
Baseline, should be differentiated from the preexisting inflammation associated with the 
subject’s psoriasis.   
 
The investigator assessments will be conducted by the investigator prior to study drug 
application in the clinic.  
 


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Dermal Response 
0 = no evidence of irritation 
1 = minimal erythema, barely perceptible 
2 = definite erythema, readily visible; minimal edema or minimal papular response 
3 = erythema and papules 
4 = definite edema 
5 = erythema, edema and papules 
6 = vesicular eruption 
7 = strong reaction spreading beyond application site 
Other Effects 
 
A = slight glazed appearance 
 
B = marked glazing 
 
C = glazing with peeling and cracking 
 
D = glazing with fissures 
 
E = film of dried serous exudates  
 
F = small petechial erosions and/or scabs 
G = no other effects 
 
The Subject Local Tolerability Assessment will be performed as follows: 
Baseline, Weeks 4, 8 and 12 
This assessment will be administered by the site 10 to 15 minutes after study drug application in 
the clinic at Baseline and at Weeks 4, 8 and 12.  
Grade 
Sensation Following Drug Application 
0 (none) 
No sensation 
1 (mild)  
Slight warm, tingling sensation; not really bothersome 
2 (moderate) 
Definite warm, tingling sensation that is somewhat 
bothersome 
3 (severe) 
Hot, tingling/stinging sensation that has caused definite 
discomfort  
 
10.1.9 
Adverse Events  
 
Adverse events (AEs) will be collected beginning at informed consent and assessed as follows: 
Screening, Baseline, Weeks 2, 4, 6, 8, 12 and 16 (if applicable) 
Any treatment emergent AEs will be followed in the clinic for up to one month at the 
Investigator’s discretion until resolved or otherwise judged as clinically stable. 
For further details on Adverse Events please see Section 10.4. 


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10.2 Efficacy Evaluations  
10.2.1 
Investigator’s Global Assessment (IGA) 
 
Investigator’s Global Assessments (‘whole body’ and ‘intertriginous area’) will be performed at 
the following study visits. The IGA should be completed prior to other physician assessments. 
 
Screening, Baseline, Weeks 2, 4, 6, 8, 12 and 16 (if applicable) 
 
The IGA is a static evaluation of qualitative overall psoriasis severity. This global assessment 
scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). Each grade 
is defined by a distinct and clinically relevant morphologic description that minimizes inter-
observer variability.  
 
Note: Palms and soles will be treated in this study with study medication, but will not be counted 
towards IGA, mPASI, or BSA assessments. 
 
Every effort should be made for the same Evaluator to complete the IGA for the subject at 
every study visit. 
 
Investigator Global Assessment of Disease (IGA) 
 
Scale 
Grade 
Description 
0 
Clear  
Plaque thickening = no elevation or thickening over normal skin 
Scaling = no evidence of scaling 
Erythema = none (no residual red coloration but post-inflammatory 
hyperpigmentation may be present) 
1 
Almost 
Clear 
Plaque thickening = none or possible thickening but difficult to ascertain 
if there is a slight elevation above normal skin level 
Scaling = none or residual surface drying and scaling 
Erythema = light pink coloration 
2 
Mild  
Plaque thickening = slight but definite elevation 
Scaling = fine scales partially or mostly covering the lesions 
Erythema = light red coloration 
3 
Moderate 
Plaque thickening = moderate elevation with rounded or sloped edges 
Scaling = most lesions at least partially covered 
Erythema = definite red coloration 
4 
Severe 
Plaque thickening = marked or very marked elevation typically with hard 
or sharp edges 
Scaling = non-tenacious or thick tenacious scale, covering most or all of 
lesions 
Erythema = very bright red coloration; extreme red coloration; deep red 
coloration  
 
The standard ‘whole body’ IGA shown above will be recorded for every subject in the 
study. 
 


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For subjects with intertriginous area involvement of at least ‘mild’ severity by IGA (I-IGA≥2) at 
Baseline (using the IGA scale shown above but evaluating intertriginous areas ONLY and NOT 
whole body involvement), an IGA for the intertriginous region alone (I-IGA) will be recorded at 
weeks 2, 4, 6, 8, 12 and 16 (if applicable).   
This ‘intertriginous area IGA’ (I-IGA) should be done AFTER the ‘standard whole body 
IGA’ (primary endpoint) in subjects who qualify.  
10.2.2 
Modified Psoriasis Area and Severity Index (mPASI) 
mPASI Assessments will be performed as follows: 
Screening, Baseline, Weeks 2, 4, 6, 8, 12 and 16 (if applicable) 
Every effort should be made for the same Evaluator to complete the mPASI for the subject 
at every study visit. 
 
Modified Psoriasis Area and Severity Index (mPASI) is used for the measurement of severity of 
psoriasis.  
 
mPASI combines the assessment of the severity of lesions and the area affected into a single 
score in the range 0 (no disease) to 72 (maximal disease). 
The body is divided into four sections (head (h) (10% of a person's skin); arms (a) (20%); trunk 
(t) (30%); legs (l) (40%)). Each of these areas is scored by itself, and then the four scores are 
combined into the final mPASI. For each section, the percent of area (A) of skin involved is 
estimated and then transformed into a grade from 0 to 6 (A): 
 
0. 0% of involved area 
1. < 10% of involved area - see below for Modified PASI (mPASI) for this grade 
2. 10–29% of involved area 
3. 30–49% of involved area 
4. 50–69% of involved area 
5. 70–89% of involved area 
6. 90–100% of involved area 
 
mPASI: for subjects with < 10% of an involved anatomic area, the mPASI will be calculated 
using the actual percentage of the anatomical area involved (e.g. 0.1 for 1%, 0.2 for 2%, 0.3 for 
3%, … 0.9 for 9%), corresponding to the actual percentage of that particular anatomical area of 
involvement.  
 
Note: Palms and soles may be treated with study medication in this study, but will not be 
counted towards IGA, mPASI, or BSA assessments. 
 
Within each area, the severity is estimated by three clinical signs: erythema (‘E’; redness), 
induration (‘T’; thickness) and desquamation (‘S’; scaling). Severity parameters are measured on 
a scale of 0 to 4, from none to maximum severity possible. 


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To calculate the mPASI, the sum of the severity rating for the three main signs are multiplied 
with the numerical value of the area affected and with the various percentages of the four body 
areas. These values are then added to complete the formula as follows: 
 
PASI = 0.1 (Eh + Th + Sh) Ah + 0.2 (Ea + Ta + Sa) Aa + 0.3 (Et + Tt + St) At + 
0.4 (El + Tl + Sl) Al 
10.2.3 
Body Surface Area (BSA) 
BSA Assessments will be performed as follows: 
Screening, Baseline, Weeks 2, 4, 6, 8, 12 and 16 (if applicable)  
The BSA affected by psoriasis will be determined by the subject’s hand method, where the 
subject’s hand (including fingers) surface area is assumed to equal 1% of body surface area 
(BSA).   
 
Note: Palms and soles will be treated with study medication, but will not be counted towards 
IGA, mPASI, or BSA assessments. 
10.2.4 
Worst Itch Numerical Rating Scale (WI-NRS)  
WI-NRS Assessments will be performed as follows: 
Screening, Baseline, Weeks 2, 4, 6, 8 and 12 
 
The WI-NRS has been developed as a simple, single item to assess the patient-reported severity 
of this symptom at its highest intensity during the previous 24-hour period. (Naegeli). The 
WI-NRS will be determined by asking the subject’s assessment of worst itch over the past 
24 hours. The scale is from ‘0 to 10’ (“no itch” to “worst imaginable itch”). Subjects will 
complete the WI-NRS pruritus assessment. 
 
 
 
10.2.5 
Fatigue NRS 
 
Fatigue NRS Assessments will be performed as follows: 
 
Screening, Baseline, Weeks 2, 4, 6, 8 and 12 
 
 
 


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Subjects will complete circle the number on the Fatigue NRS assessment that best fits their 
fatigue severity. Fatigue severity will be measured using a unidimensional 11-point numeric 
rating scale (NRS) with anchors of 0 (No Fatigue) and 10 (Fatigue as bad as it can be) for the 
intensity during the previous 24-hour period. The words ‘no fatigue’ and ‘Fatigue as bad as it can 
be’ corresponding to the anchors 0 and 10, respectively, will be placed under the NRS scale.   
No
Fatigue as 
     fatigue
bad as it can be 
10.2.6 
Work Productivity and Activity Impairment (WPAI) 
WPAI Assessments will be completed at the following: 
Screening, Baseline, Weeks 2, 4, 6, 8 and 12 
Subjects will complete the WPAI questionnaire.  Please see Appendix 1 for the WPAI. 
10.2.7 
Itch-Related Sleep Loss  
Itch-Related Sleep Loss Assessments will be performed as follows: 
Screening, Baseline, Weeks 2, 4, 6, 8 and 12  
Subjects will complete the itch-related sleep loss numerical rating scale (NRS) assessment. Itch-
related sleep loss severity will be measured using a unidimensional rating scale (NRS) with 
anchors at 0 (no itch-related sleep loss) and 10 (itch-related sleep loss as bad as it could be) for 
the intensity during the previous 24-hour period. The words ‘no itch-related sleep loss’ and 
‘itch-related sleep loss as bad as it could be’ correspond to the anchors or 0 and 10, respectively, 
and will be placed on the NRS scale.  
      No itch-related
Sleep loss 
 sleep loss
as bad as it can be 
10.2.8 
Psoriasis Symptom Diary (PSD) 
The PSD will be completed as follows: 
Screening, Baseline, Weeks 2, 4, 6, 8, 12 and 16 (if applicable) 
Subjects will complete the PSD. See Appendix 4 for the PSD.  


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10.2.9 
Dermatology Life Quality Index (DLQI)  
 
The DLQI will be completed as follows: 
 
Screening, Baseline, Weeks 2, 4, 6, 8 and 12  
 
Subjects will complete the DLQI. See Appendix 5 for the DLQI. 
10.2.10 Dermal Imaging 
 
Optional photography will be performed at selected centers only at Baseline, Weeks 4, 6, 8 
and 12. 
10.3 Pharmacokinetics Assessment 
PK draws will be performed as follows for all subjects at all sites: 
 
Baseline, Weeks 4 and 12 
Plasma PK assessments will be performed on all subjects.  
 
PK draws will be collected while the subject is having serum chemistries drawn. The draws will 
be pre-dose drug application in the clinic. The tube weight will be collected prior to the 
application and after the application. Ensure study medication is not applied in the area where 
PK will be drawn. 
 
Approximately 30 subjects, continuing to the Week 16 visit, with greater than or equal to 5% 
BSA at the Baseline visit, will have the option to participate in additional PK draws at 72 hours 
(3 days), 120 hours (5 days), 168 hours (7 days) and 216 hours (9 days) post the last treatment 
application.  For the 72 hour timepoint, the PK draw should be +/- 2 hours of the last study drug 
application.  The 5, 7 and 9 day draws should be completed in the morning, before noon at the 
site. 
10.4 Adverse Events 
10.4.1 
Adverse Event Definition 
An AE means any untoward medical occurrence associated with the use of a drug in humans, 
whether or not considered drug related. An AE can therefore be any unfavorable and unintended 
sign (including an abnormal laboratory finding), symptom, or disease temporally associated with 
the use of a medicinal (investigational) product, whether or not related to the medicinal 
(investigational) product.  
AEs will be collected following informed consent of the subject through subject study 
completion.  
A treatment emergent adverse event (TEAE) is defined as an AE that started post application of 
study medication at the Baseline visit through study completion.  


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Application site reactions will be considered adverse events if they require intervention, 
suspension or discontinuation of study drug.  
10.4.2 
Serious Adverse Event 
The definitions and reporting requirements of Health Canada/the Food and Drug Administration 
(FDA)/ICH Guidelines for Clinical Safety Data Management, Definitions and Standards for 
Expedited Reporting, Topic E2A will be adhered to. If any AEs are serious, as defined by ICH 
Guidelines for Clinical Safety, required procedures will be followed. All SAEs will be reported 
to the Sponsor via fax or e-mail within 24 hours of becoming aware of the event, whether or not 
the serious events are deemed drug-related. All serious event reporting will adhere to ICH E6: 
Guideline for Good Clinical Practice and ICH E2A: Clinical Safety Data Management: 
Definitions and Standards for Expedited Reporting.:  The ERB/IRB will be notified of the Alert 
Reports as per HC, FDA, ICH and the IRB/ERB’s policies and procedures. 
An SAE is any AE that in the view of either the PI or Sponsor, results in any of the following 
outcomes:  Death, a life-threatening AE, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions, or a congenital anomaly/birth defect.  Important medical events 
that may not result in death, be life-threatening, or require hospitalization may be considered 
serious when, based upon appropriate medical judgment, they may jeopardize the subject and 
may require medical or surgical intervention to prevent one of the outcomes listed in the above 
definition. Examples of such medical events include allergic bronchospasm requiring intensive 
treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalization, or the development of drug dependency or drug abuse.  
 
Life-threatening is defined as an AE that in the view of the PI or Sponsor, places the subject at 
immediate risk of death. It does not include an AE that, had it occurred in a more severe form, 
might have caused death. 
Hospitalization does not include the following: 
• Rehabilitation facilities, hospice facilities or respite care (e.g. caregiver relief) 
• Nursing homes or skilled nursing facilities 
• Emergency room visits 
• Same day surgeries (as outpatient/same day/ambulatory procedures) 
• <24 hour admissions for observation or evaluation 
 
Hospitalization or prolongation of hospitalization in the absence of a precipitating, clinical AE is 
not in itself an SAE.  Examples include: 
• Admission for treatment of a preexisting condition that did not worsen 
• Hospitalizations for cosmetic elective surgery, social, and/or convenience admissions 
• Pre-planned treatments or surgical procedures should be noted in the baseline 
documentation for the individual subject. 


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• Diagnostic and therapeutic procedures, such as surgery, should not be reported as AEs; 
however, the medical condition for which the procedure was performed should be 
reported if it occurs during the reporting period and meets the definition of an AE.  
For example, an acute appendicitis that begins during the AE reporting period should be 
reported as an AE, and the resulting appendectomy should be recorded as treatment of the 
AE. 
 
Unexpected is defined as an AE that is not listed in the IB or is not listed at the specificity or 
severity that has been observed; or is not consistent with the risk information described in the 
general investigational plan or elsewhere in the current IND/CTA. 
If a SAE occurs to a subject on this study, contact the Sponsor personnel listed in Section 2 
within one business day of knowledge of event.  
10.4.3 
Suspected Unexpected Serious Adverse Reaction (SUSAR) 
 
This is defined as a serious adverse reaction, the nature or severity of which is not consistent with 
the known study treatment information. A serious event or reaction is not defined as a SUSAR 
when: ‘it is serious but expected’ or it does not fit the definition of an SAE, whether expected or 
not.  
10.4.4 
Safety Review 
 
At each follow-up visit, subjects will be queried with an open-ended question such as: 
‘How have you been feeling since your last visit?’  Additionally, the study staff will review 
subject diaries and, if it appears that a potential AE was recorded, study staff will query the 
subject and determine if an AE occurred.   
 
AEs (whether serious or non-serious) and clinically significant abnormal laboratory test value(s) 
will be evaluated by the PI and treated and/or followed up for up to one month after end of 
treatment until the symptoms or value(s) return to normal, or acceptable levels, as judged by the 
PI. 
 
Where appropriate, medical test(s) and/or examination(s) will be performed to document 
resolution of event(s). Outcome may be classified as resolved, improved, unchanged, worse, fatal 
or unknown (lost to follow-up). 
10.4.5 
Adverse Event Reporting 
 
The PI will review each event and assess its relationship to drug treatment (unrelated, unlikely, 
possibly, probably, likely). Each sign or symptom reported will be graded on the NIH NCI 
CTCAE toxicity grading scale 5-point severity scale (Grade 1, 2, 3, 4 and 5). The date and time 
of onset, time relationship to drug dosing, duration, and outcome (resolved, improved, 
unchanged, worse, fatal, or unknown/lost to follow-up) of each event will be noted. 
 
The relationship of each AE to the study drug will be assessed using the following definitions: 


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Unrelated 
• The AE must clearly be caused by the subject’s clinical state, or the study 
procedure/conditions. 
• Definitely not related to drug. 
• Temporal sequence of an AE onset relative to administration of drug not 
reasonable. 
• Another obvious cause of an AE. 
Unlikely 
• Time sequence is unreasonable. 
• There is another more likely cause for an AE. 
Possibly 
• Corresponds to what is known about the drug. 
• Time sequence is reasonable. 
• Could have been due to another equally, likely cause. 
Probably 
• Is a known effect of the drug. 
• Time sequence from taking drug is reasonable. 
• Ceases on stopping the drug. 
• Cannot be reasonably explained by the known characteristics of the 
subject’s clinical state. 
Likely 
• Is a known effect of the drug (e.g., listed in Physicians' Desk Reference, 
Compendium of Pharmaceuticals and Specialties, IB). 
• Time sequence from taking drug is reasonable. 
• Event stops upon stopping drug, event returns upon restarting drug. 
 
The following CTCAE toxicity grading scale 5-point severity scale definitions for rating 
maximum severity will be used: 
Grade 1 
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated. 
Grade 2 
Moderate; minimal, local or noninvasive intervention indicated; limiting age-
appropriate instrumental activities of daily living.* 
Grade 3 
Severe or medically significant but not immediately life-threatening; 
Hospitalization or prolongation of hospitalization indicated; disabling; limiting 
self-care activities of daily living.** 
Note: An experience may be severe but may not be serious, e.g., severe 
headache). 
Grade 4 
Life-threatening consequences; urgent intervention indicated. 
Grade 5 
Death related to AE. 
Note:  A semi-colon indicates ‘or’ within the description of the grade. 
*Instrumental activities of daily living refer to preparing meals, shopping for groceries or clothes, using the 
telephone, managing money, etc. 
**Self-care activities of daily living refer to bathing, dressing and undressing, feeding self, using the toilet, 
taking medications, and not bedridden. 


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AEs will be coded using the most current MedDRA® version available at the start of the study 
(e.g., 21.0 or higher). 
10.5 Reporting Pregnancy 
During the study, all subjects should be instructed to contact the investigator immediately if they 
suspect they might be pregnant (e.g., missed or late menstrual period).  If pregnancy is 
confirmed, the subject will be withdrawn from the study and followed until the pregnancy comes 
to term.   
The investigator is responsible for reporting all available pregnancy information on the 
pregnancy report within 24 hours of becoming aware of the event, although pregnancy itself is 
not considered an AE.  Study treatment must be discontinued immediately in the event of a 
pregnancy.  The subject should be referred to an obstetrician/gynecologist experienced in 
reproductive toxicity for further evaluation and counseling. Monitoring of the subject should 
continue until the conclusion of the pregnancy.  Follow-up information detailing the outcome of 
the pregnancy and the health of the newborn should be reported as it becomes available.   
Partner pregnancies of a male subject do not need to be reported. 
Any pregnancy complication or premature terminations including miscarriage, spontaneous 
abortion or elective termination of a pregnancy for medical reasons will be reported as an SAE, 
as described in Section 10.4.2. Should the pregnancy result in a congenital abnormality or birth 
defect, a separate SAE report must be submitted.  Furthermore, all neonatal deaths that occur 
within 30 days of the birth should be reported as SAEs, without regard to causality.  In addition, 
any infant death that occurs after the 30-day reporting period that the investigator suspects is 
related to the in-utero exposure to the study treatment should also be reported.  
10.6 Treatment Stopping Rules 
If a subject has non-cutaneous adverse events of concern, clinically significant laboratory values 
or any condition that the investigator determines could possibly be related to the study drug, 
the Investigator should immediately contact the Medical Monitor to discuss if the subject should 
be discontinued from the study.   
 
Treatment for any individual subject will be discontinued if the subject:  
• 
Experiences a serious adverse event (SAE) or a clinically significant non-serious AE 
which in the opinion of the Principal Investigator or Medical Monitor warrants 
discontinuation from the study for that subject’s well-being. 
• 
A severe (Grade 3) laboratory abnormality (confirmed by repeat sample and considered 
related to study drug).  
o See Appendix 6 for details. 
Dosing of study drug for an individual subject may be suspended for safety concerns other than 
those described above, at the discretion of the investigator if he/she feels the subject’s safety may 
be threatened. 


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A subject with a PHQ-8 score of ‘15’ or above should be referred promptly to a mental health 
care professional and consideration be given to discontinuation from study drug.   
A subject that is experiencing suicidal ideation and behavior should be referred immediately to a 
qualified mental health care provider and consideration given to discontinuation from study drug. 
As noted above, study treatment must be discontinued immediately in the event of a female 
subject’s pregnancy.   
Treatment should be interrupted: 
• If a subject develops an application site reaction with the clinical appearance of an 
‘irritation reaction’, and with a severity of a Dermal Response Score of 5 (erythema, 
edema and papules) or greater on the scale of Berger and Bowman, treatment should be 
interrupted for up to one week and may then be resumed if the reaction has, in the 
opinion of the Investigator, adequately resolved.   
 
Treatment should be discontinued: 
• 
If the reaction reoccurs, treatment should be discontinued permanently, and the subject 
followed until the reaction resolves.  Given the excellent local toleration in the Phase 1/2a 
study, such reactions are possible, but unlikely. 
10.6.1 
Emergency Unblinding 
 
If the situation requires emergency unblinding this will be done by investigator using the study  
IWRS system after discussion with Medial Monitor and the Sponsor’s CMO.  
11 DATA ANALYSIS 
Data will be handled and processed according to the Contract Research Organization’s Standard 
Operating Procedures, which are written based on the principles of GCP. 
11.1 Statistical Methods 
The methodology presented below is a summary of the more detailed analysis plan that will be 
presented in the Statistical Analysis Plan (SAP).  The SAP will be finalized before the database 
is locked and unblinded.  Any changes to the methods described in the final SAP will be 
described and justified in the clinical study report.  
All statistical processing will be performed using SAS® (Version 9.4) unless otherwise stated. 
No interim efficacy analyses are planned. 
Descriptive statistics will be used to provide an overview of the efficacy, safety and 
pharmacokinetic results.  For categorical parameters, the number and percentage of subjects in 
each category will be presented. The denominator for percentage will be based on the number of 
subjects appropriate for the purpose of analysis.  For continuous parameters, descriptive statistics 


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will include n (number of subjects), mean, standard deviation (SD), median, minimum, 
and maximum. 
Missing efficacy data will be estimated by a mixture of linear interpolation and last observation 
carried forward for the cases were linear interpolation is not computationally possible. 
P-values of less than 0.05 will be considered statistically significant based on a two-sided test 
unless otherwise specified. No adjustment will be made for multiplicity. 
11.1.1 
Determination of Sample Size 
A sample size of approximately 300 subjects are planned for the study.  
Approximately 100 subjects will receive ARQ-151 cream 0.3% QD; approximately 100 subjects 
will receive ARQ-151 cream 0.15% QD; and approximately 100 subjects will receive matching 
vehicle cream QD.  The randomization scheme will be 1:1:1 (ARQ-151 cream 0.3% QD: 
ARQ-151 cream 0.15% QD: matching vehicle QD). 
The sample size was not powered based on data for the primary endpoint to provide statistical 
significance because of the absence of previous primary endpoint data. However, based on 
efficacy data from the Phase 1/2a study, this Phase 2b study is expected to provide reliable 
information regarding the efficacy and safety of the drug products. 
11.1.2 
Subjects to Analyze 
Safety population will include all subjects who are enrolled and received at least one confirmed 
dose of study medication. This population will be defined separately for each cohort. 
The Intent-to-Treatment (ITT) population will include all randomized subjects. 
Per-Protocol (PP) Population will include all subjects who are in the safety population, were at 
least 80% compliant with study medication application, and showed no other serious deviations 
from the study protocol. 
The PK population will include all subjects receiving the active drug with sufficient plasma 
concentrations of roflumilast to define a profile, as determined by the pharmacokineticist. 
This population will be defined separately for each cohort. 
11.1.3 
Interim Analysis 
No interim efficacy analyses are planned. 
11.1.4 
Background and Demographic Characteristics 
Descriptive statistics will be used to summarize demographic characteristics (age, sex, and race) 
and background characteristics for the enrolled subjects.  Past/coexistent medical history 
information and physical examination observations and vital signs information for all 
randomized subjects will be presented in a by-subject listing.   


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11.1.5 
Study Medication Compliance 
The number of study drug applications by each subject based on diary data will be summarized 
using summary statistics (mean, standard deviation [SD], median, minimum, and maximum), 
and categorically.  
The amount of study medication used by each subject based on tube weight will be summarized 
by treatment using summary statistics (mean, SD, median, minimum, and maximum), 
and categorically.   
11.2 Efficacy Evaluation 
11.2.1 
Primary Efficacy Endpoint 
 
The primary efficacy variable in this study is success in Investigator Global Assessment (IGA) of 
disease severity, defined as an IGA of ‘Clear’ or ‘Almost Clear’ at Week 6. 
 
The primary endpoint will be analyzed with a logistic regression with a factor of treatment 
group. Statistical comparison between the active treatment arms and vehicle arms will be 
facilitated by using contrasts. 
11.2.2 
Secondary Endpoints 
 
The secondary efficacy endpoints will include: 
• 
IGA score of ‘clear’ or ‘almost clear’ at weeks 4, 8 and 12.  
• Percent reduction in mPASI at weeks 4, 8, and 12 as compared to Baseline. 
• Decrease in Percent BSA affected at weeks 4, 6, 8, and 12 as compared to baseline. 
• IGA score of ‘clear’ or ‘almost clear’ PLUS a 2-grade improvement from Baseline at 
weeks 4, 6, 8 and 12. 
• For subjects with intertriginous area involvement, and with severity of the 
intertriginous lesions at least ‘mild’ (I-IGA≥2) at Baseline, ‘I-IGA’ score of ‘clear’ or 
‘almost clear’ at weeks 4, 6, 8 and 12. 
• Reduction in WI-NRS pruritus score at weeks 4, 6, 8, and 12 as compared to 
Baseline. 
• In subjects with WI-NRS pruritus score ≥ 6 at baseline, a 4-point reduction in WI-
NRS pruritus score at 4, 6, 8, and 12 weeks as compared to Baseline. 
• Modified Psoriasis Area Severity Index-75 (mPASI-75) improvement at weeks 4, 6, 
8, and 12 as compared to Baseline. 
• Modified Psoriasis Area Severity Index-90 (mPASI-90) improvement at weeks 4, 6, 
8, and 12 as compared to Baseline. 
• Total PSD at weeks 4, 6, 8, and 12 as compared to Baseline. 


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• Reduction in Itch-related Sleep Loss score at weeks 4, 6, 8, and 12 as compared to 
Baseline. 
• Reduction in Dermatology Life Quality Index (DLQI) score at weeks 4, 6, 8, and 12 
as compared to Baseline. 
• Responses to the questions of PSD analyzed as improvement at weeks 4, 6, 8, and 12 
as compared to Baseline. 
The dichotomized IGA analyses will be analyzed with logistic regression similar to the primary 
endpoint. The remainder of the endpoints will be considered continuous and analyzed with an 
analysis of variance with a factor of treatment group. Statistical comparison between the active 
treatment arms and vehicle arms will be facilitated by using contrasts.  
mPASI will be analyzed for all subjects with the modification that, for subjects with < 10% of an 
involved anatomic area, the actual percentage of the anatomical area involved is used rather than 
a ‘0’ or ‘1’ (e.g. for 5% area involved, 0.5 would be used for the calculation).   
11.2.3 
Exploratory Endpoints 
 
Exploratory Endpoints are as follows:  
• Reduction in Fatigue NRS score at weeks 4, 6, 8, and 12 as compared to Baseline. 
• Reduction in WPAI score at weeks 4, 6, 8, and 12 as compared to Baseline. 
Only descriptive statistics will be used to analyze these endpoints. 
11.3 Safety Evaluation 
The following analyses will be performed; however, no formal inferential statistics will be done 
on safety assessments. 
Descriptive statistics will be presented by visit and treatment group for quantitative safety data 
and frequency counts will be compiled for classification of qualitative safety data. Sumaries of 
local tolerability will be presented by visit and treatment group. 
11.3.1 
Adverse Events 
All treatment-emergent AEs occurring during the study will be recorded and classified on the 
basis of MedDRA terminology for the safety population. Treatment-emergent AEs are those AEs 
with an onset on or after the date of study treatment. All treatment-emergent AEs will be 
summarized by treatment group, the number of subjects reporting treatment-emergent AEs, 
system organ class, preferred term, severity, relationship, and seriousness. 
Comparisons between treatment groups will be made by tabulating the frequency of subjects 
with one or more treatment-emergent AEs (classified into MedDRA terms) during the study.  


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Serious adverse events (SAEs) will be listed by subject. SAEs will be summarized by treatment 
group, severity, and relationship to study treatment. Each subject will be counted only once 
within a system organ class or a preferred term using the event with the greatest relationship and 
greatest severity. 
All information pertaining to AEs noted during the study will be listed by subject, detailing the 
verbatim description given by the Investigator, preferred term, system organ class, start date, 
stop date, severity, action taken regarding study drug, corrective treatment, outcome, and drug 
relatedness. The event onset will also be shown relative (in number of days) to date of first 
application. In addition, a list of subjects who prematurely discontinue from the study due to 
adverse events will also be provided. 
A subject-by-subject treatment-emergent AE (TEAE) data listing, including verbatim term, 
preferred term, treatment, severity, and relationship to study drug, will be provided.  
Medical history will be listed by subject. Physical examinations and 12-lead ECGs will be 
performed at screening, baseline and end-of-study which will be listed by subject. 
Vital signs will be tabulated by visit and treatment group. 
ECGs will be tabulated by visit and treatment group. 
Routine blood chemistries will be obtained throughout the study and the results summarized by 
parameter, visit and treatment group. 
11.3.2 
Local Tolerance Assessments 
For the Investigator’s assessment the numeric application site reaction scores will be summarized 
individually by using number and percentage of subjects by visit.   
11.3.3 
Medical History and Physical Examinations 
Medical history for all subjects will be presented in a by-subject listing.  
Physical examination findings for all subjects will be presented in a by-subject listing.  
Changes in physical examinations will be described in the text of the final report. 
11.3.4 
PHQ-8 
Data will be analyzed by a shift in state of severity using the following scoring system: 
• None – Minimal depression (0 to 4) 
• Mild depression (5 to 9) 
• Moderate depression (10 to 14) 
• Moderately severe depression (15 to 19) 
• Severe depression (20 to 24) 


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11.3.5 
C-SSRS 
The C-SSRS will be analyzed per the Columbia–Suicide Severity Rating Scale Scoring and Data 
Analysis Guide. 
11.3.6 
Clinical Laboratory Results and Vital Signs/Weight Measurements 
All clinical laboratory results and vital signs measurements and their change from baseline 
(pre-dose), will be summarized along with time point of collection. 
A shift table describing out-of-normal range shifts will be provided for clinical laboratory results.  
A shift table will identify subjects who gain or lose >5% body weight over the course of the 
study. 
11.3.7 
Prior and Concomitant Medications 
Prior and concomitant medication information for all randomized subjects will be presented in a 
by-subject listing.  Summary tables will be presented by World Health Organization-Anatomical 
Therapeutic Chemical Classification System (WHO-ATC) therapeutic category and product. 
11.4 Patient Reported Outcomes Analyses 
11.4.1 
WI-NRS, Fatigue NRS, Itch-Related Sleep Loss  
The NRS scales will be analyzed for change from baseline in itch severity (WI-NRS), fatigue  
NRS, and itch-related sleep loss.  
11.4.2 
Work Productivity and Activity Impairment (WPAI) Questionnaire 
The WPAI yields four types of scores:   
1.  Absenteeism (work time missed) 
2.  Presenteeism (impairment at work / reduced on-the-job effectiveness) 
3.  Work productivity loss (overall work impairment / absenteeism plus presenteeism) 
4.  Activity Impairment  
11.4.3 
Dermatology Life Quality Index (DLQI) 
The DLQI will be analyzed by evaluation of the reduction in total score at weeks 4, 6, 8, and 12 
as compared to Baseline. 
11.4.4 
Psoriasis Symptom Diary (PSD) 
The PSD will be analyzed as the improvement in responses to the questions of PSD weeks 4, 6, 
8, and 12 as compared to Baseline.  


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11.5 Pharmacokinetic Analysis 
Plasma drug concentrations at pre-dose will be summarized using descriptive statistics, reporting 
n, mean, standard deviation, median, minimum, and maximum. 
 
For all subjects, blood samples for the determination of roflumilast and its N-oxide metabolite 
will be collected at scheduled time points as delineated in the Schedule of Visits and 
Assessments (Section 5).   
A manual for blood sampling, collection, processing, and sample shipment will be provided in a 
separate document.  
12 STUDY ADMINISTRATION 
12.1 Ethics 
12.1.1 
Ethics Review Board  
Before enrollment of patients into the study, the current protocol and ICF will be reviewed and 
approved by an appropriate IRB or IEC, as required by FDA (21 CFR § 56), Health Canada, 
and ICH GCP regulations.  A letter documenting the IRB or IEC approval must be received by 
the Sponsor before the initiation of the study at a clinical site. Amendments to the protocol will 
be subject to the same requirements as the original protocol.  
The Investigator, Sponsor, or designee will submit a progress report at least once yearly to the 
IRB or IEC. However, the frequency of these reports will depend on IRB or IEC requirements. 
As soon as possible after completion or termination of the study, the Investigator will submit a 
final report to the IRB or IEC per the IRB or IEC requirements, and in compliance with FDA and 
Health Canada regulations and ICH GCP guidelines. 
The Investigator, the Sponsor, or designee shall promptly notify the IRB or IEC of any SAEs, 
SUSARs, or any other information that may affect the safe use of the study drug(s) during the 
study, per the IRB or IEC local requirements, and in compliance with FDA and Health Canada 
regulations and ICH GCP guidelines. 
12.1.2 
Ethical Conduct of the Study 
 
This research will be carried out in accordance with the protocol, the principles of the Tri-
Council Policy Statement (TCPS), the ethical principles set forth in the Declaration of Helsinki, 
and the ICH harmonized tripartite guideline regarding GCP (E6 Consolidated Guidance, 
April 1996). 
 
 


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12.1.3 
Subject Information and Consent 
 
The purpose of the study, the procedures to be carried out and the potential hazards will be 
described to the subjects in non-technical terms. Subjects will be required to read, sign and date 
an ICF summarizing the discussion prior to screening and will be assured that they may 
withdraw from the study at any time without jeopardizing their medical care. 
Subjects will be given a signed copy of their ICF. 
12.2 Study Monitoring 
Prior to the initiation of the clinical investigation, Sponsor representatives or designees will visit 
the clinical site where the investigation is to be conducted.  Sponsor representatives shall ensure 
that the Investigator understands the investigational status of the investigational product, all 
requirements of the investigation to be undertaken, and all of his/her responsibilities as an 
Investigator.  Sponsor representatives will also visit the clinical site at appropriate intervals as 
required to ensure compliance with the protocol and to verify the accuracy and completeness of 
data reported on the CRFs.  The Study Director or designees shall be available for consultation 
with the Investigator and serve as liaisons between the clinical site and the Sponsor. 
The Sponsor or authorized designees may inspect all documents and records required to be 
maintained by the Investigator, including but not limited to medical records (office, clinic, 
or hospital) and investigational product dispensation logs for the subjects in this clinical 
investigation.  The Investigator must permit access to such records.  The Investigator must 
obtain, as part of informed consent, permission for an authorized representative of the Sponsor, 
or regulatory authorities, to review, in confidence, any records identifying subjects. 
12.3 Data Quality Assurance 
In order to ensure the collection of accurate, consistent, complete, and reliable data during this 
clinical investigation, Sponsor representatives or designees may conduct audits of participating 
sites at appropriate intervals throughout the study.  The results of these periodic site audits may 
be subject to review by independent auditors at completion of the clinical investigation.   
The Clinical Study Report will be audited by the QST’s Research’s Quality Assurance (QA) 
department and the QA audit certificate will be included in the study report. 
All clinical data will undergo a 100% quality control check prior to clinical database lock. Edit 
checks are then performed for appropriate databases as a validation routine using SAS® to check 
for missing data, data inconsistencies, data ranges etc. Corrections are made prior to database 
lock. 
12.3.1 
Verification of Blinding 
The treatment assignments for all enrolled subjects will be unblinded only after the conclusion of 
the study. Specifically, the blind will be broken only after all data are verified, entered into the 
database, and validated; subject evaluability assessments are performed and entered into the 
database; and the database is locked. 


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12.4 Data Handling and Record Keeping 
During the clinical study, the Investigator will maintain adequate records, including medical 
records, records detailing the progress of the study for each subject, laboratory reports, signed 
informed consent forms, investigational product disposition records, correspondence with the 
ERB/IRB and Study Monitor/Sponsor, AE reports, and information regarding subject 
discontinuation and completion of the clinical investigation. 
 
All required study data will be recorded on eCRFs.  Any change of data will be recorded on the 
audit trail and a reason for the change will be entered.  
 
The principal investigator must retain all documentation relating to the study for a period of at 
least 2 years after the last marketing application approval or, if not approved, 2 years following 
the discontinuance of the test article for investigation.  If this requirement differs from any local 
regulations, the local regulations will take precedence unless the local retention policy is less 
than 2 years.   
12.5 Protocol Amendments and Deviations  
No change or amendment to this protocol may be made by the investigator or Sponsor after the 
protocol has been agreed to and signed by all parties unless such change(s) or amendment(s) has 
(have) been agreed upon by the investigator and Sponsor.  Any change agreed upon will be 
recorded in writing, and the written amendment will be signed by the investigator and Sponsor.  
Institutional review board approval is required prior to the implementation of an amendment, 
unless overriding safety reasons warrant immediate action, in which case the IRB(s) will be 
promptly notified. 
 
No deviation from the protocol will be made except to protect the life or physical well-being of a 
subject in an emergency.  Except in such emergencies, prior approval of the Sponsor, and the 
IRB, is required before deviations from the planned protocol.  All protocol deviations that occur 
during the study will be documented and reported to Sponsor and to the IRB(s), if applicable, 
according to regulations.  Further details about the documentation, evaluation, and follow-up of 
protocol deviations are detailed in this study’s clinical monitoring plan.  
 
No waivers to inclusion/exclusion criteria will be granted; subjects need to meet all criteria, 
exactly as specified, to be enrolled.  Additionally, prospective deviations from the protocol or 
investigational plan are not permitted except to protect the life or physical well-being of a subject 
in an emergency.  Deviations that occur unintentionally or are the result of action by the subject 
must be documented and reported to the IRB(s), if applicable, according to regulations.  Further 
details about the documentation, evaluation, and follow-up of protocol deviations are detailed in 
this study’s clinical monitoring plan. 
 
 


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12.6 Report Format 
According to the ICH Harmonized Tripartite Guideline (Organization of the Common Technical 
Document for the Registration of Pharmaceuticals for Human Use M4 and the ICH M2 Expert 
Working Group), the final report will be written according to the ICH E3 Guideline (Structure 
and Content of Clinical Study Reports).  
12.7 Publication Policy 
The Sponsor is supportive of publishing clinical trial findings.  The process of coordinating 
publication efforts is detailed in the Clinical Trial Agreement. 
 


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13 REFERENCES 
Berger, RS, Bowman JP. A reappraisal of the 21-day Cumulative Irritation Test in man.  
J. Toxicol Ot & Ocular Toxicol 1982:1(2);109-115. 
Bethke, TD, Lahu, G.  High absolute bioavailability of the new oral phosphodiesterase-4 
inhibitor roflumilast.  Int. J Clin Pharmacol Ther.  2011; 49:51-57. 
Brion DE, Raynaud F, Plet A, Laurent P, Leduc B, and Anderson W.  Deficiency of cyclic 
AMP-dependent protein kinases in human psoriasis.  Proc. Natl. Acad. Sci.  1986; 83:5272-5276. 
DALIRESP (roflumilast) tablets [package insert]. AstraZeneca Pharmaceuticals LP, Wilmington, 
DE USA; 2017. 
DAXAS (roflumilast) film-coated tablets [product monograph]. AstraZeneca Canada, Inc., 
Mississauga, Ontario Canada; 2017. 
Hatzelmann A, Morcillo EJ, Lungarella G, Adnot S, Sanjar S, Beume R, et al. The preclinical 
pharmacology of roflumilast – a selective, oral phosphodiesterase 4 inhibitor in development for 
chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2010; 23:235–256. 
Investigator’s Brochure, Edition 2.1, October 2018 
Michalski, J. M., Golden, G., Ikari, J. and Rennard, S. I. (2012), PDE4: A Novel Target in the 
Treatment of Chronic Obstructive Pulmonary Disease. Clinical Pharmacology & Therapeutics, 
91: 134–142 
Naegeli AN, Flood E, Tucker J, Devlen J, Edson-Heredia E. The Worst Itch Numeric Rating 
Scale for patients with moderate to severe plaque psoriasis or psoriatic arthritis. Int J 
Dermatol. 2015;54(6):715–22. 
Snape SD, Wigger-Alberti W, Goehring, UM.  A phase I randomized trial to assess the effect on 
skin inﬁltrate thickness and tolerability of topical phosphodiesterase inhibitors in the treatment of 
psoriasis vulgaris using a modiﬁed psoriasis plaque test.  Br J Dermatol.  2016; 175:479-486. 
Tang-Liu DD, Matsumoto RM, Usansky JI. Clinical pharmacokinetics and drug metabolism of 
tazarotene: a novel topical treatment for acne and psoriasis. Clin Pharmacokinet. 1999; 
37:273-287. 
Wedzicha, JA, Calverley, PMA, Klaus, FR.  Roflumilast: a review of its use in the treatment of 
COPD.  International Journal of Chronic Obstructive Pulmonary Disease (2016) 11:81-90. 


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14 APPENDICES 
Appendix 1: Work Productivity and Activity Impairment Questionnaire (WPAI) 
 
Work Productivity and Activity Impairment Questionnaire: 
Specific Health Problem V2.0 (WPAI:SHP) 
 
The following questions ask about the effect of your psoriasis on your ability to work and 
perform regular activities.  Please fill in the blanks or circle a number, as indicated. 
 
1.  Are you currently employed (working for pay)?  
_____ NO ___ YES 
  If NO, check “NO” and skip to question 6. 
The next questions are about the past seven days, not including today. 
 
 
2. During the past seven days, how many hours did you miss from work because of 
problems associated with your psoriasis?  Include hours you missed on sick days, 
times you went in late, left early, etc., because of your psoriasis.  Do not include time 
you missed to participate in this study. 
 
_____ HOURS 
 
 
3. During the past seven days, how many hours did you miss from work because of 
any other reason, such as vacation, holidays, time off to participate in this study? 
 
_____HOURS 
 
 
4. During the past seven days, how many hours did you actually work? 
 
_____HOURS  (If “0”, skip to question 6.) 
 
 
5. During the past seven days, how much did your psoriasis affect your productivity 
while you were working?   
Think about days you were limited in the amount or kind of work you could do, days 
you accomplished less than you would like, or days you could not do your work as 
carefully as usual.  If psoriasis affected your work only a little, choose a low number.  
Choose a high number if psoriasis affected your work a great deal.   
Consider only how much psoriasis affected  
productivity while you were working. 


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Psoriasis had 
no effect on my 
work 
 
 
 
 
 
 
 
 
 
 
 
Psoriasis 
completely 
prevented me 
from working 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
CIRCLE A NUMBER 
 
6. During the past seven days, how much did your psoriasis affect your ability to do 
your regular daily activities, other than work at a job?   
 
By regular activities, we mean the usual activities you do, such as work around the 
house, shopping, childcare, exercising, studying, etc.  Think about times you were 
limited in the amount or kind of activities you could do and times you accomplished 
less than you would like.  If psoriasis affected your activities only a little, choose a 
low number.  Choose a high number if psoriasis affected your activities a great deal.   
 
Consider only how much psoriasis affected your ability  
to do your regular daily activities, other than work at a job. 
Psoriasis had 
no effect on my 
daily activities 
 
 
 
 
 
 
 
 
 
 
 
Psoriasis 
completely 
prevented me 
from doing my 
daily activities 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
                           
CIRCLE A NUMBER 
 
WPAI:SHP  V2.0 (US English)      
  
 


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Appendix 2: Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline/Screening Version 
 


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Appendix 3: Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version 
 


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Appendix 4: Psoriasis Symptom Diary (PSD) 
 
  
 
 Psoriasis Symptom Diary (PSD) 
 
 
 
 
 
 1 Overall, how severe was 
your psoriasis-related 
itching over the past 
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
 No itching 
Itching as bad as you  
can imagine 
 
  
 
 2 Overall, how bothered  
were you by your psoriasis-
related itching over the 
past 24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Not bothered  
at all 
As bothered as you  
can imagine 
 
  
 
 3 Overall, how severe was 
your psoriasis-related 
stinging over the past 
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
No stinging 
Stinging as bad as you  
can imagine 
 
  
 
 4 Overall, how bothered  
were you by your psoriasis-
related stinging over the 
past 24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Not bothered  
at all 
As bothered as you  
can imagine 
 
  
 
 5 Overall, how severe was 
your psoriasis-related 
burning over the past 
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
No burning 
Burning as bad as you  
can imagine 
 
 
 
 
 
 
 
 
 
 
 


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 6 Overall, how bothered  
were you by your psoriasis-
related burning over the 
past 24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Not bothered  
at all 
As bothered as you  
can imagine 
 
  
 
 7 Overall, how severe was 
your psoriasis-affected skin 
cracking over the past 
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
 No pain 
Pain as bad as you  
can imagine 
 
  
 
 8 Overall, how bothered  
were you by your psoriasis-
affected skin cracking over 
the past 24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Not bothered  
at all 
As bothered as you  
can imagine 
 
  
 
 9 Overall, how severe was 
your psoriasis-related pain 
over the past 24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
No pain 
Pain as bad as you  
can imagine 
 
  
 
 10 Overall, how bothered  
were you by your psoriasis-
related pain over the past 
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Not bothered  
at all 
As bothered as you  
can imagine 
 
  
 
 11 Overall, how severe was 
your psoriasis scaling over 
the past 24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
No scaling  
Scaling as bad as you  
can imagine 
 
 
 
 
 
 
 
 
 


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 12 Overall, how bothered were 
you by your psoriasis 
scaling over the past 
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Not bothered  
at all 
As bothered as you  
can imagine 
 
  
 
 13 Overall, how noticeable did 
you think the colour of your 
psoriasis-affected skin was 
over the past 24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Not at all  
noticeable 
As noticeable as you  
can imagine 
 
  
 
 14 Overall, how much did you 
try to hide your psoriasis-
affected skin over the past 
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Did not try to  
hide at all 
Totally avoided being seen 
by others 
 
  
 
 15 Overall, how much did  
your psoriasis cause you  
to avoid activities with other 
people over the past  
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
You did not avoid  
other people  
Avoided other people as 
much as you ever have 
 
  
 
 16 Overall, how embarrassed 
were you because of your 
psoriasis over the past  
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
No embarrassment 
As embarrassed as you  
can imagine 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
© Novartis 2018 
 
 
 


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Appendix 5: Dermatology Life Quality Index (DLQI) 
 
 
 
 
DERMATOLOGY LIFE QUALITY INDEX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 DLQI 
Site No:  
 
 
 
 
Date: 
 
 
 
 
 
Score: 
Name:  
 
 
 
 
 
 
 
 
 
 
 
Address: 
 
 
 
 
Diagnosis: 
 
 
 
 
 
 
The aim of this questionnaire is to measure how much your skin problem has affected your life OVER 
THE LAST WEEK.  Please tick ; one box for each question. 
 
 
1. 
Over the last week, how itchy, sore,  
 
 
 
Very much 
 
 
painful or stinging has your skin   
 
 
 
A lot 
 
 
 
been?   
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
2. 
Over the last week, how embarrassed 
 
 
 
Very much 
 
 
or self conscious have you been because   
 
 
A lot 
 
 
 
of your skin? 
 
  
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
3. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin interfered with you going 
 
  
 
 
A lot 
 
 
 
shopping or looking after your home or   
 
 
A little  
 
 
garden?        
 
 
 
 
 
 
Not at all 
 
 
Not relevant  
 
4. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin influenced the clothes  
 
 
 
 
A lot 
 
 
 
you wear? 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
Not relevant  
 
5. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin affected any social or  
 
 
 
 
A lot 
 
 
 
leisure activities? 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant  
 
6. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin made it difficult for   
 
 
 
 
A lot 
 
 
 
you to do any sport? 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant  
 
7. 
Over the last week, has your skin prevented 
 
 
Yes 
 
 
 
you from working or studying?  
 
 
 
No 
 
 
 
 
 
 
 
 
 
 
 
Not relevant  
 
 


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If "No", over the last week how much has   
 
 
A lot 
 
 
 
your skin been a problem at  
 
 
 
 
A little  
 
 
work or studying? 
 
 
 
 
 
Not at all 
 
 
8. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin created problems with your   
 
 
 
A lot 
 
 
 
partner or any of your close friends 
 
 
 
A little  
 
 
or relatives?  
 
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant  
 
9. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin caused any sexual   
 
 
 
 
A lot 
 
 
 
difficulties? 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant  
 
10. 
Over the last week, how much of a  
 
 
 
Very much 
 
 
problem has the treatment for your 
 
 
 
A lot 
 
 
 
skin been, for example by making  
 
 
 
A little  
 
 
your home messy, or by taking up time?   
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant  
 
 
Please check you have answered EVERY question. Thank you.  
 
 
 
¤AY Finlay, GK Khan, April 1992 www.dermatology.org.uk, this must not be copied without the permission of the authors. 
 
 


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Appendix 6: National Institute of Allergy and Infectious Diseases, Division of Microbiology 
and Infectious Diseases (DMID) Toxicity Table for Use in Trials Enrolling 
Healthy Adults (2014) Modified 
 
ABBREVIATIONS USED IN FOLLOWING TABLES:  
 
Abbreviation/Ter
m 
Definition/Explanation 
 
Abbreviation/Ter
m 
Definition/Explanation 
ALT 
alanine aminotransferase 
 
LO 
Low 
aPTT 
activated partial 
thromboplastin time 
mEq 
Milliequivalent 
AST 
aspartate aminotransferase 
mmHg 
millimeter of mercury 
AV block 
atrioventricular block 
Ms 
Millisecond 
bpm 
beats per minute 
N 
Normal 
BUN 
blood urea nitrogen 
PT 
prothrombin time 
CK 
creatine kinase 
PTT 
partial thromboplastin time 
CPK 
creatine phosphokinase 
QTc 
QT-interval corrected for 
heart rate 
FEV1 
forced expiratory volume in 1 
second 
QTcB 
Bazett’s corrected QT 
interval 
g 
Gram 
QTcF 
Fridericia’s corrected QT 
interval 
HI 
High 
RBC 
red blood cell 
HPF 
high power field 
Rx 
Therapy 
IU 
international unit 
S 
Second 
IV 
Intravenous 
U 
Unit 
K/CUMM 
x103/mm3 
ULN 
upper limit of normal 
LLN 
lower limit of normal 
 
 
 
ESTIMATING SEVERITY GRADE 
 
For abnormalities NOT found elsewhere in the Toxicity Tables use the scale below to estimate 
grade of severity: 
GRADE 1 
Mild: 
Transient or mild discomfort (<48 hours); no medical 
intervention/therapy required 
GRADE 2 
Moderate: 
Mild to moderate limitation in activity - some assistance may be 
needed; no or minimal medical intervention/therapy required 
GRADE 3 
Severe:  
Marked limitation in activity, some assistance usually required; 
medical intervention/therapy required hospitalizations possible. 
LABORATORY RANGES 
 
Where discrepancies in the ULN and LLN of laboratory ranges occur between those included in 
this document and those of the laboratory that performs the assays, the values provided by the 
laboratory will be used for assignment of severity grade.  
 


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CLINICAL ADVERSE EVENTS 
Cardiovascular 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Arrhythmia 
 
Asymptomatic, transient signs, no Rx 
required  
Recurrent/persistent; symptomatic 
Rx required  
Hemorrhage, blood loss  
Estimated blood loss ≤100 mL  
Estimated blood loss >100 mL, no 
transfusion required 
Transfusion required 
QTcF (Fridericia’s correction) 
a or QTcB (Bazett’s 
correction) 
Asymptomatic, QTc interval 450-479 
ms, OR  
Increase in interval<30 ms above 
baseline 
Asymptomatic, QTc interval 480-499 
ms, OR  
Increase in interval 30-59 ms above 
baseline 
Asymptomatic, QTc interval ≥500 
ms, OR  
Increase in interval ≥60 ms above 
baseline 
PR interval (prolonged) 
PR interval 0.20-0.25 s 
PR interval >0.25 s 
Type II 2nd degree AV block OR 
Ventricular pause >3.0 s 
Respiratory 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Cough 
Transient-no treatment  
Persistent cough  
Interferes with daily activities 
Bronchospasm, acute 
Transient wheeze; no treatment;  
  
Requires treatment; normalizes with 
bronchodilator and   
FEV1 < 80% predicted before 
bronchodilator  
Minimal  normalization with 
bronchodilator and FEV1 <80% 
predicted after bronchodilator 
Dyspnea  
Does not interfere with usual and social 
activities 
Interferes with usual and social 
activities, no treatment 
Prevents daily and usual social 
activity or requires treatment 
Nasal discharge (rhinitis 
infective per CTCAE 4.0) 
- 
Localized; local intervention indicated 
(e.g. topical antibiotic, antifungal, or 
antiviral) 
- 
Pharyngitis (CTCAE 4.0) 
- 
Localized; local intervention indicated 
(e.g. topical antibiotic, antifungal, or 
antiviral) 
IV antibiotic, antifungal, or antiviral 
intervention indicated; radiologic or 
operative intervention indicated 
Pneumonitis (rales or rhonchi) 
(CTCAE 4.0) 
Asymptomatic; clinical or diagnostic 
observations only; intervention not 
indicated 
Symptomatic; medical intervention 
indicated; limiting instrumental ADL 
Severe symptoms; limiting self-care 
ADL; oxygen indicated 
Lung infection (CTCAE 4.0) 
- 
Moderate symptoms; oral intervention 
indicated (e.g. antibiotic, antifungal, 
antiviral) 
IV antibiotic, antifungal, or antiviral 
intervention indicated; radiologic, 
endoscopic, or operative intervention 
indicated 
a Inclusion dependent upon protocol requirements 


Protocol ARQ-151-201 
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Amendment 1.0  
 
November 8, 2018 
Confidential 
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Gastrointestinal 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Nausea  
No interference with activity 
Some interference with activity 
Prevents daily activities 
Vomiting  
No interference with activity or 
1-2 episodes/24 hours 
Some interference with activity or 
>2 episodes/24 hours 
Prevents daily activity or requires 
IV hydration 
Diarrhea  
2-3 loose or watery stools or  
<400 g/24 hours 
4-5 loose or watery stools or  
400-800 g/24 hours 
6 or more loose or watery stools or 
>800 g/24 hours or requires 
IV hydration 
Urinary Tract 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Urinary tract infection 
(CTCAE 4.0) 
- 
Localized; local intervention indicated 
(e.g., oral or topical antibiotic, 
antifungal, antiviral) 
IV antibiotic, antifungal, or antiviral 
intervention indicated; radiologic or 
operative intervention indicated 
Reactogenicity 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Local reactions 
Pain 
Does not interfere with activity 
Repeated use of non-narcotic pain 
reliever >24 hours or interferes with 
activity 
Any use of narcotic pain reliever or 
prevents daily activity 
Tenderness 
Discomfort only to touch 
Discomfort with movement 
Significant discomfort at rest 
Erythema/redness a 
2.5-5 cm 
5.1-10 cm 
>10 cm 
Induration/swelling b 
2.5-5 cm and does not interfere with 
activity 
5.1-10 cm or interferes with activity 
>10 cm or prevents daily activity 
Systemic reactions 
Allergic reaction  
Pruritus without rash  
Localized urticaria  
Generalized urticaria; angioedema or 
anaphylaxis  
Headache  
No interference with activity 
Repeated use of non-narcotic pain 
reliever >24 hours or some 
interference with activity 
Significant; any use of narcotic pain 
reliever or prevents daily activity 
Fatigue  
No interference with activity 
Some interference with activity 
Significant; prevents daily activity 
Myalgia 
No interference with activity 
Some interference with activity 
Significant; prevents daily activity 


Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
 Page 80 of 83 
All other conditions 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Illness or clinical adverse 
event (as defined according to 
applicable regulations) 
No interference with activity 
Some interference with activity not 
requiring medical intervention 
Prevents daily activity and requires 
medical intervention 
a  In addition to grading the measured local reaction at the greatest single diameter, the measurement should be recorded as a continuous variable. 
b  Induration/swelling should be evaluated and graded using the functional scale as well as the actual measurement. 
 
LABORATORY AND VITAL SIGNS TOXICITY GRADING (Some laboratory values have been modified to be consistent with the normal ranges of 
the ACM laboratory used in the present study) 
 
Blood, Serum, or Plasma Chemistries a 
LO/HI/N b 
Mild  
(Grade 1) c 
Moderate  
(Grade 2) 
Severe  
(Grade 3) 
Sodium (mEq/L or mmol/L) 
LO 
131-<LLN  
130  
<130 
HI 
>ULN-148 
149-150 
>150 
Potassium (mEq/L or mmol/L)  
LO 
<LLN-3.2 
<3.2-3.1 
<3.1 
HI 
>ULN-5.6 
>5.6-5.7 
>5.7 
Glucose (mg/dL) 
LO mmol/L 
<LLN-3.0 
<3.0-2.2 
<2.2 
HI mmol/L 
>ULN-8.9 
>8.9-13.9 
>13.9 
Blood urea nitrogen  
HI mmol/L 
>8.9-17.8 
>17.8-35.5 
>35.5 
Creatinine  
N 
115-151 (µmol/L) 
152-177 (µmol/L) 
> 177 (µmol/L) 
Calcium  (CTCAE 4.0) 
LO mmol/L 
<LLN-2.0 
<2.0-1.75 
<1.75 
HI mmol/L 
>ULN-2.9 
>2.9-3.1 
>3.1 
Magnesium  (CTCAE 4.0) 
LO mmol/L 
<LLN-0.5 
<0.5-0.4 
<0.4 
Phosphorous  (CTCAE 4.0) 
LO mmol/L 
<LLN-0.8 
<0.8-0.6 
<0.6 
Creatine kinase (CPK or CK) (CTCAE 4.0) 
HI 
>ULN-2.5xULN 
>2.5xULN-5xULN 
>5xULN 


Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
 Page 81 of 83 
Blood, Serum, or Plasma Chemistries a 
LO/HI/N b 
Mild  
(Grade 1) c 
Moderate  
(Grade 2) 
Severe  
(Grade 3) 
Albumin  
LO g/L 
<30-28 
<28-25 
<25 
Total protein  
LO g/L 
<LLN-52 
<52-50 
<50 
Alkaline phosphatase (U/L) (CTCAE 4.0) 
HI 
>ULN-2.5xULN 
>2.5xULN-5xULN 
>5xULN 
AST (U/L) (CTCAE 4.0) 
HI 
>ULN-3xULN 
>3xULN-5xULN 
>5xULN 
ALT (U/L) (CTCAE 4.0) 
HI 
>ULN-3xULN 
>3xULN-5xULN 
>5xULN 
Bilirubin, serum total (mmol/L) (CTCAE 4.0) 
HI mmol/L 
>ULN-1.5xULN 
>1.5xULN-3xULN 
>3xULN 
Bilirubin, serum total (mg/dL) when ALT ≥105 (Hy’s 
law) 
HI 
1.3-1.5 
1.6-2.0  
>2.0  
Bilirubin, serum direct (mmol/L) (CTCAE 4.0) 
HI mmol/L 
>ULN-1.5xULN 
>1.5xULN-3xULN 
>3xULN 
Amylase (U/L) (CTCAE 4.0) 
HI 
>ULN-1.5xULN 
>1.5xULN-2xULN 
>2xULN 
Lipase (U/L) (CTCAE 4.0)  
HI 
>ULN-1.5xULN 
>1.5xULN-2xULN 
>2xULN 
Uric acid (mg/dL/mmol/L) (CTCAE 4.0) 
HI 
>ULN – 10 mg/dL 
(0.59 mmol/L) without 
physiologic 
consequences 
- 
>ULN – 10 mg/dL 
(0.59 mmol/L) with 
physiologic 
consequences 
a   Depending upon the laboratory used, references ranges, eligibility ranges and grading may be split out by sex and/or age. 
b   Low, High, Not Graded (N). 
c   If initial boundary of grade 1 has gap from reference range or eligibility range, calculations based on the New England Journal of Medicine (NEJM) reference 
ranges. 
 
 


Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
 Page 82 of 83 
Hematology 
LO/HI/N a 
Mild 
(Grade 1) b 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Hemoglobin (women) (g/dL) 
Hemoglobin (men) (g/dL) 
LO 
10.8-11.3 
9.2-10.7 
<9.2  
LO 
12.0-12.5 
10.0-11.9 
<10.0 
White blood cell count (K/CUMM) 
HI 
11.00-15.00 
15.00-20.00 
>20.00 
LO 
2.50-3.50 
1.50-2.49 
<1.50 
Lymphocytes (K/CUMM) 
LO 
0.76-0.90  
0.50-0.75 
<0.5 
Neutrophils (K/CUMM) 
LO 
1.50-1.95  
1.00-1.49 
<1.00 
Eosinophils (K/CUMM) 
HI 
0.58-0.74  
0.75-1.50 
>1.50 
Platelets (K/CUMM) 
LO 
120-130 
100-120 
<100 
Coagulation 
 
 
 
 
Prothrombin time (PT, seconds) 
HI 
> ULN-14.4 
14.5-15.7 
>15.7 
Partial thromboplastin time  
(PTT or aPTT, seconds) 
HI 
>ULN-42.1 
42.2-50.0 
>50.0 
Fibrinogen (mg/dL) (CTCAE 4.0) 
HI 
>ULN-500 
501-600 
>600 
LO 
<LLN-0.75xLLN 
<0.75xLLN-0.5xLLN 
<0.5xLLN 
Urine  
 
 
 
 
Protein (dipstick) 
HI 
1+ 
2+ 
>2+ 
Glucose (dipstick) 
HI 
1+ 
2+ 
>2+ 
Blood (microscopic) - red blood cells per high power field 
(RBC/HPF) 
HI 
5-10 for males 
9-10 for females  
11-50  
>50 and/or gross blood 
a  Low, High, Not Graded. 
b  If initial boundary of grade 1 has gap from reference range or eligibility range, calculations based on the New England Journal of Medicine (NEJM) reference 
ranges. 
 
 
 


Protocol ARQ-151-201 
Arcutis, Inc. 
Amendment 1.0  
 
November 8, 2018 
Confidential 
 Page 83 of 83 
Vital Signs 
LO/HI/N a 
Mild 
(Grade 1 ) b 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Fever (°C) c 
HI 
38.0-38.4 
38.5-38.9 
>38.9 
Fever (°F)  
HI 
100.4-101.1 
101.2-102.0 
>102.1  
Tachycardia - beats per minute 
HI 
101-115 
116-130 
>130 or ventricular 
dysrhythmias 
Bradycardia - beats per minute 
LO 
40-45  
35-40 
<35 
Hypertension (systolic) - mm Hg d 
HI 
141-150 
151-160 
>160 
Hypertension (diastolic) - mm Hg 
HI 
91-95 
96-100 
>100 
Hypotension (systolic) - mm Hg 
LO 
85-89 
80-84 
<80 
Tachypnea - breaths per minute 
HI 
23-25 
26-30 
>30 
a  Low, High, Not Graded. 
b  If initial boundary of grade 1 has gap from reference range or eligibility range, calculations based on the New England Journal of Medicine (NEJM) reference 
ranges. 
c  Oral temperature; no recent hot or cold beverages or smoking. A protocol should select either °C or °F for inclusion. 
d  Assuming subject is awake, resting, and supine; for adverse events, 3 measurements on the same arm with concordant results.