Clinical trial NCT04128007
Conditions: Plaque Psoriasis
Sponsor: Arcutis Biotherapeutics, Inc.
Start date: 2020-01-13; Completion date: 2020-09-25
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of ARQ-154 foam vs placebo applied once a day for 56 days by subjects with scalp and body psoriasis

Detailed description:
This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily x 8 weeks to adolescent and adult subjects with scalp and body psoriasis

Arms: arm 1: active arm 2: placebo
Interventions: intervention 1: Roflumilast foam 0.3% intervention 2: Vehicle foam
Intervention descriptions: intervention 1: experimental intervention 2: experimental

Protocol documents:
SAP_002.pdf: 
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 1 of 172
   Statistical Analysis Plan
Sponsor
Arcutis Biotherapeutics, Inc.
Protocol Title:
A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-
Controlled Study of the Safety and Efficacy of ARQ-154 Foam 
0.3% Administered QD in Adolescents and Adults with Scalp and 
Body Psoriasis
Protocol Number:
ARQ-154-204
Premier Research PCN:
ARCU210101
Document Version:
Final 2.0
Document Date: 
09-Dec-2020
Approvals
Role
Signatures
Date (dd-Mmm-yyyy)
Lead 
Biostatistician
Print Name: 
Sign Name:
Premier Senior 
Reviewer
Print Name: 
Sign Name:
Arcutis 
Biotherapeutics, 
Inc. Representative
Print Name: 
Sign Name:
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Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 2 of 172
Document History
Version
Date
Section
Description of Change/Purpose
1.0
12-Nov-2020
N/A
N/A
2.0
04-Dec-2020
8.1
Text from this section describing the primary 
endpoint analysis (including sensitivity analysis) 
was accidentally removed when accepting 
changes from the redlined version of SAP draft 
v0.3. This text was not in redline, so the deletion 
was unexpected and therefore not noticed once 
the draft was upversioned to final v1.0. The 
exact text from draft v0.3 was copied back into 
the SAP; no other changes were made to the 
SAP.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 3 of 172
Table of Contents
Approvals........................................................................................................................................ 1
Document History........................................................................................................................... 2
Table of Contents............................................................................................................................ 3
List of Tables .................................................................................................................................. 5
List of Figures................................................................................................................................. 5
1.
Overview............................................................................................................................. 6
2.
Study Objectives and Endpoints......................................................................................... 6
2.1.
Study Objectives ........................................................................................................... 6
2.1.1. Primary Objective ......................................................................................................... 6
2.2.
Study Endpoints............................................................................................................ 6
2.2.1. Safety Endpoints........................................................................................................... 6
2.2.2. Efficacy Endpoints........................................................................................................ 7
3.
Overall Study Design and Plan........................................................................................... 8
3.1.
Overall Design .............................................................................................................. 8
3.2.
Sample Size and Power................................................................................................. 8
3.3.
Study Population........................................................................................................... 9
3.4.
Treatments Administered.............................................................................................. 9
3.5.
Method of Assigning Subjects to Treatment Groups.................................................... 9
3.6.
Blinding and Unblinding............................................................................................... 9
3.7.
Schedule of Events........................................................................................................ 9
4.
Statistical Analysis and Reporting.................................................................................... 11
4.1.
Introduction................................................................................................................. 11
4.2.
Interim Analysis and Data Monitoring ....................................................................... 11
5.
Analysis Populations......................................................................................................... 12
6.
General Issues for Statistical Analysis.............................................................................. 12
6.1.
Statistical Definitions and Algorithms........................................................................ 12
6.1.1. Baseline....................................................................................................................... 12
6.1.2. Adjustments for Covariates......................................................................................... 13
6.1.3. Multiple Comparisons................................................................................................. 13
6.1.4. Handling of Dropouts or Missing Data....................................................................... 15
6.1.5. Analysis Visit Windows ............................................................................................. 17
6.1.6. Pooling of Sites........................................................................................................... 18
6.1.7. Derived Variables ....................................................................................................... 18
6.1.8. Data Adjustments/Handling/Conventions .................................................................. 21
6.2.
Special Handling for COVID-19 Disruptions............................................................. 22
7.
Study Subjects and Demographics.................................................................................... 23


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 4 of 172
7.1.
Disposition of Subjects and Withdrawals................................................................... 23
7.2.
Protocol Deviations..................................................................................................... 23
7.3.
Demographics and Other Baseline Characteristics..................................................... 23
7.4.
Exposure and Compliance .......................................................................................... 24
8.
Efficacy Analysis.............................................................................................................. 24
8.1.
Primary Efficacy Analysis .......................................................................................... 24
8.1.1. Scalp Investigator Global Assessment (S-IGA) ......................................................... 24
8.2.
Secondary Efficacy Analysis ...................................................................................... 26
8.2.1. Body Investigator Global Assessment (B-IGA) ......................................................... 27
8.2.2. Psoriasis Scalp Severity Index (PSSI) ........................................................................ 27
8.2.3. Scalp Itch – Numeric Rating Scale (SI-NRS)............................................................. 28
8.2.4. Psoriasis Symptoms Diary (PSD) ............................................................................... 28
8.3.
Exploratory Efficacy Analysis.................................................................................... 28
9.
Safety and Tolerability Analysis....................................................................................... 29
9.1.
Adverse Events ........................................................................................................... 29
9.1.1. Adverse Events Leading to Withdrawal ..................................................................... 30
9.1.2. Deaths and Serious Adverse Events ........................................................................... 30
9.2.
Local Tolerability Assessments.................................................................................. 30
9.3.
Clinical Laboratory Evaluations ................................................................................. 30
9.4.
Vital Signs................................................................................................................... 30
9.5.
PHQ-8 and Modified PHQ-A ..................................................................................... 31
9.6.
C-SSRS ....................................................................................................................... 31
9.7.
Physical Examination.................................................................................................. 31
9.8.
Concomitant Medication............................................................................................. 31
10.
Changes from Planned Analysis ....................................................................................... 32
11.
Other Planned Analysis..................................................................................................... 33
11.1.
Pharmacokinetic Analysis........................................................................................... 33
12.
References......................................................................................................................... 33
13.
Tables, Listings, and Figures ............................................................................................ 34
13.1.
Planned Table Descriptions ........................................................................................ 34
13.1.1. Demographic Data ...................................................................................................... 34
13.1.2. Efficacy Data .............................................................................................................. 34
13.1.3. Safety Data.................................................................................................................. 40
13.2.
Planned Listing Descriptions...................................................................................... 42
14.
Table, Listing, and Figure Shells ...................................................................................... 44
14.1.
Standard Layout for all Tables, Listings, and Figures................................................ 44
14.2.
Planned Table Shells................................................................................................... 46


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 5 of 172
Appendix 1: Premier Research Library of Abbreviations .......................................................... 170
List of Tables
Table 1: Schedule of Events ......................................................................................................... 10
Table 2: Analysis Visit Windows ................................................................................................. 17
Table 3: S-IGA.............................................................................................................................. 24
Table 4: Demographic Data Summary Tables.............................................................................. 34
Table 5: Efficacy Data Summary Tables...................................................................................... 34
Table 6: Safety Data Summary Tables ......................................................................................... 40
Table 7: Planned Listings.............................................................................................................. 42
List of Figures
Figure 1: Primary and Secondary Endpoint Testing..................................................................... 14
Figure 2: Standardized Layout...................................................................................................... 45
Figure 3: Planned Table Shells ..................................................................................................... 47


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 6 of 172
1.
Overview
This statistical analysis plan (SAP) describes the planned analysis and reporting for Arcutis 
Biotherapeutics, Inc. protocol number ARQ-154-204 (A Phase 2b, 8-Week, Parallel Group, 
Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% 
Administered QD in Adolescents and Adults with Scalp and Body Psoriasis), dated 13-Jan-2020
Amendment Version 1.0. Reference materials for this statistical plan include the protocol and the 
accompanying sample data collection documents. Operational aspects related to collection and 
timing of planned clinical assessments are not repeated in this SAP unless relevant to the planned 
analysis.
The structure and content of this SAP provides sufficient detail to meet the requirements 
identified by the Food and Drug Administration (FDA), European Medicines Agency (EMA), 
and International Conference on Harmonization (ICH) of Technical Requirements for 
Registration of Pharmaceuticals for Human Use: Guidance on Statistical Principles in Clinical 
Trials1. All work planned and reported for this SAP will follow internationally accepted 
guidelines, published by the American Statistical Association3 and the Royal Statistical Society1, 
for statistical practice.
The planned analyses identified in this SAP may be included in clinical study reports (CSRs), 
regulatory submissions, or future manuscripts. Also, post-hoc exploratory analyses not 
necessarily identified in this SAP may be performed to further examine study data. Any post-hoc 
or unplanned, exploratory analysis performed will be clearly identified as such in the final CSR.
The statistical plan described hereafter is an a priori plan. It will be submitted to file prior to any 
unblinded inferential or descriptive analysis of data pertaining to Arcutis Biotherapeutics, Inc.’s 
study ARQ-154-204. Any amendments to this plan that occur after unblinding for an interim 
analysis will be performed by a study statistician who remains blinded to treatment codes and 
outcomes.
ARQ-154 foam 0.3% will be described as “roflumilast foam 0.3%” throughout this document 
and the tables, listings, and figures (TLFs).
2.
Study Objectives and Endpoints
2.1.
Study Objectives
2.1.1. Primary Objective
The primary objective is to assess the safety and efficacy of roflumilast foam 0.3% vs vehicle 
administered daily (QD) x 8 weeks in adolescents and adults with scalp and body plaque 
psoriasis.
2.2.
Study Endpoints
2.2.1. Safety Endpoints
The safety endpoints of this study include the following:
x
Local tolerability assessments


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
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x
Clinical laboratory parameters
x
Adverse events (AEs)
x
Columbia-Suicide Severity Rating Scale (C-SSRS)
x
Patient Health Questionnaire depression scale (PHQ-8)
x
Modified PHQ-Adolescents (PHQ-A)
x
Vital signs
x
Physical examinations
2.2.2. Efficacy Endpoints
2.2.2.1.
Primary Efficacy Endpoint
The primary efficacy endpoint of this study is Scalp-Investigator Global Assessment (S-IGA)
Success at Week 8, defined as achievement of an S-IGA score of “Clear” or “Almost Clear” plus 
a 2-grade improvement from baseline.
2.2.2.2.
Secondary Efficacy Endpoints
The secondary efficacy endpoints of this study include the following:
x
Body-IGA (B-IGA) Success at Week 8, defined as achievement of B-IGA score of 
“Clear” or “Almost Clear” plus a 2-grade improvement from baseline
x
Psoriasis Scalp Severity Index (PSSI)-75 (subjects who achieve a 75% reduction in PSSI 
from Baseline) at Week 8
x
For subjects with baseline Scalp Itch - Numeric Rating Scale (SI-NRS) score 4, 
achievement of 4-point improvement from baseline in SI-NRS at Week 8
x
For subjects with baseline SI-NRS score 4, achievement of 4-point improvement from 
baseline in SI-NRS at Week 4
x
For subjects with baseline SI-NRS score 4, achievement of 4-point improvement from 
baseline in SI-NRS at Week 2
x
Time to success in PSSI-50
x
Change and percent change from baseline in total Psoriasis Symptoms Diary (PSD) score 
at Week 8
x
Change and percent change from baseline in total PSD score at Week 4
x
PSSI-90 (subjects who achieve a 90% reduction in PSSI from Baseline) at Week 8
2.2.2.3.
Exploratory Efficacy Endpoints
The exploratory efficacy endpoints of this study include the following:
x
Psoriasis Area Severity Index (PASI)-75 (subjects who achieve a 75% reduction in PASI 
from Baseline) at Week 8
x
Time to success in PASI-50 
x
Change and percent change from baseline modified PASI (mPASI) at Weeks 2, 4, 8, 
and 9
x
For subjects with baseline Worst Itch - Numeric Rating Scale (WI-NRS) score 4, 
achievement of 4-point improvement from baseline in WI-NRS at Weeks 2, 4, and 8
x
Change and percent change from baseline in Dermatology Life Quality Index (DLQI)/ 
Children’s DLQI (CDLQI) total scores at Weeks 2, 4, and 8


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 8 of 172
x
Change and percent change from baseline in % BSA affected by disease at Weeks 2, 4, 
and 8
The exploratory endpoints below are not defined in the protocol explicitly but are based on other 
efficacy assessments collected:
x
Change and percent change from baseline in SI-NRS at Weeks 2, 4, and 8
x
Change and percent change from baseline in PASI at Weeks 2, 4, 8, and 9
x
PASI-90 (subjects who achieve a 90% reduction in PASI from Baseline), PASI-75
(subjects who achieve a 75% reduction in PASI from Baseline), and PASI-50 (subjects 
who achieve a 50% reduction in PASI from Baseline) at Weeks 2, 4, 8, and 9
x
Change and percent change from baseline in WI-NRS at Weeks 2, 4, and 8
3.
Overall Study Design and Plan
3.1.
Overall Design
This is a parallel group, double blind, vehicle-controlled study in which roflumilast foam 0.3% 
or vehicle foam is applied QD x 8 weeks to adolescent and adults with scalp and body psoriasis 
of at least mild severity (S-IGA and B-IGA with a score of at least “2”), involving up to 25% 
body surface area (BSA) (scalp and body, not including palms/soles). 
Approximately 300 subjects will be enrolled. After having met all inclusion criteria, and none of 
the exclusion criteria, subjects will be randomized in a 2:1 ratio to roflumilast foam 0.3% QD or 
vehicle foam QD, which will be applied to all psoriasis lesions (including the scalp, face, trunk, and 
intertriginous areas; palms and soles will be treated but will not be counted towards any 
measurements of efficacy). Screening will be for up to 4 weeks followed by an 8-week Treatment 
Phase, with a Follow-up Visit 1 week after last dose. The anticipated maximum duration of subject 
participation is approximately 13 weeks.
Subjects will have to apply the study drug once a day in the evening, with the exception of Day 0, 
Week 2 (Visit 3), and Week 4 (Visit 4), when the study drug is applied at the study site in the 
morning. Participants have to record the date and time each dose has been applied with details 
including missed doses and any additional comments. 
3.2.
Sample Size and Power
There are approximately 300 subjects planned for this study. Approximately 200 subjects will 
receive roflumilast foam 0.3% QD; approximately 100 subjects will receive vehicle foam QD. 
The sample size was selected to provide an adequate number of subjects to compare the efficacy
of roflumilast treatment to vehicle and to provide an adequate number of subjects needed for a 
safety database.
This sample size provides 96% power at the Į=0.05 level to detect a 22.4% difference between 
treatment groups for S-IGA Success at Week 8 using a 2-sided Chi-squared test. The results from  
a recent phase 2b study (ARQ-151-201) of roflumilast cream compared to vehicle treatment 
were used to estimate the treatment difference, and it is assumed that the S-IGA response in the 
present study are similar to IGA responses seen with roflumilast cream. Specifically, in the phase 
2b trial, 32.2% of subjects reported IGA success in the roflumilast cream 0.3% group and 9.8% 
of subjects reported IGA success in the vehicle group.
The number of subjects to be enrolled will also provide sufficient power for most secondary 


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 9 of 172
endpoints.
3.3.
Study Population
Study population consists of male and female subjects aged 12 years or older with no more than 
25% BSA of scalp and body psoriasis. Subjects should have a minimum S-IGA of at least 
“Moderate” (3) and B-IGA of “Mild” (2) at Baseline. Note that the original protocol allowed 
subjects having an S-IGA of “Mild” (2) to be enrolled, and some subjects were enrolled and 
treated with an S-IGA of “Mild” before the amendment under which this SAP operates was put 
into effect (i.e., Amendment Version 1.0, dated 13-Jan-2020).
3.4.
Treatments Administered
Subjects who meet the eligibility criteria will be randomized to 1 of the 2 following treatment 
groups in a 2:1 ratio (active:vehicle):
x
Roflumilast foam 0.3% QD
x
Matching vehicle foam QD.
3.5.
Method of Assigning Subjects to Treatment Groups
Subjects will be randomized and assigned to active drug or vehicle will be made at a 2:1 ratio 
according to a computer-generated randomization list. Randomization will be stratified by 
country, baseline S-IGA (S-IGA=2 vs. S-IGA 3), and baseline B-IGA (B-IGA=2 vs. B-IGA
3).
3.6.
Blinding and Unblinding
This is a double-blind study; therefore, neither the subjects nor the investigator, clinical 
personnel, or sponsor will be aware of which treatment a subject has received. Emergency 
unblinding will be done using the study internet-based randomization system (interactive web-
response system; IWRS) system in consultation with the medical monitor and the sponsor’s chief 
medical officer (CMO).  
3.7.
Schedule of Events
A detailed schedule of events for the study is provided in Table 1.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
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Table 1: Schedule of Events
Study Procedure
Screen
Baseline
Day 0
Wk 2
Day 14
Wk 4
Day 28
Wk 8
Day 56
Wk 9
Day 63
Visit
1
2
3
4
5
6
Visit Window
-4 weeks
+/- 3 days
+/- 5 days
+/- 5 days
+/- 5 days
Informed consent/assent
X
Medical history
X
Physical examinationa
X
X
X
I/E criteria
X
X
Randomization
X
Hematology, Serum 
Chemistries, and Urine 
Analysis 
X
X
X
X
Vital signs, heightb, 
weightb
X
X
X
X
X
X
S-IGAc, B-IGAc, PSSIc, 
BSAc, PASI/mPASI
X
X
X
X
X
X
Scalp Itch NRS, WI-NRS 
pruritus, DLQI, CDLQI, 
PSDd
X
X
X
X
X
Application Site Reaction 
Assessment/Local 
tolerabilitye
X
X
X
C-SSRS, PHQ-8/PHQ-Af
X
X
X
X
Medical Photographyg
X
X
X
X
Pregnancy testh
X
X
X
X
PK drawsi
X
X
X
IP/vehicle application in 
clinicj
X
X
X
Dispense IP kitk
X
X
X
Dispense/review diary
X
X
X
X
Weigh IP kitl
X
X
X
X
Compliance calculationm
X
X
X
X
Adverse event
assessmentn
X
X
X
X
X
X
Concomitant medications
X
X
X
X
X
X
Footnote:
a Limited physical examination: skin, lungs, and heart only
b Height will be collected at Baseline and Week 8. Weight will be collected at all study visits. 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% unintentional weight loss should be reported to the medical monitor.
c   S-IGA will be a 5-point scale ranging from clear (0) to severe (4) and is evaluated for the scalp only. B-IGA will use the same 
scale as S-IGA, but will evaluate the entire body (except the scalp, palms, and soles).  PSSI is scored on a 0-72 scale and 
evaluates the scalp only.  Total BSA and scalp BSA affected by psoriasis will be determined (except the palms and soles).  
PASI/mPASI assessment should exclude palms and soles.  S-IGA and B-IGA should be completed prior to other physician 
assessments.
d. Subjects will complete the WI-NRS pruritus, Scalp Itch-NRS, DLQI, CDLQI (for adolescents) and PSD questionnaires.
e.  Local Tolerability Assessments:  the Investigator local tolerability assessment of skin irritation (Berger and Bowman skin 
irritation score) should be performed prior to the investigational product application at Day 0, Weeks 4 and 8. Note for 


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
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investigator tolerability assessments: 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. Subjects will 
perform the local tolerability 10-15 minutes post-IP application at Day 0 and Week 4, and recall assessment at Week 8 for the 
subject’s ‘0-3’ burning/stinging assessment.  
f Adolescents and adults will complete the C-SSRS.  Adults will complete the PHQ-8.  Adolescents will complete a modified 
version of the PHQ-A (PHQ-9 modified for Adolescents).
g At selected sites, medical photography will be obtained for target lesions.  All efforts will be made to de-identify the subjects. 
Subjects who are unwilling to participate in the medical photography will be allowed to opt out of this procedure.
h A pregnancy test will be administered to all females of child-bearing potential. A serum pregnancy test will be performed at 
the Screening visit only. A urine pregnancy test will be performed at Day 0, Week 4, and Week 8. A negative result is 
required for continued participation in the study, and results must be available prior to dispensing of the IP at each visit.
i
PK draws will be collected at Days 0, Weeks 4 and 8 pre-dose (within 1 hour) for all subjects.  Serial PK will be obtained in a 
subset of approximately 15 subjects on Days 0 and 28 at 1, 2, 4, 6 (all + 20 min), and 24 hours (+ 2 hours) post-dose
j   Subjects to apply assigned IP in clinic at Day 0, Weeks 2 and 4. 
k Kits will be dispensed based on %BSA affected. See IP Handling Manual for details.  
l.  The entire kit should be weighed and recorded at every visit. See IP Handling Manual for details.
m Compliance calculation is described in the IP Handling Manual
n 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.
4.
Statistical Analysis and Reporting
4.1.
Introduction
Data processing, tabulation of descriptive statistics, calculation of inferential statistics, and 
graphical representations, will be performed primarily using SAS (release 9.4 or higher). If the 
use of other software is warranted for analyses conducted by Premier Research, the final 
statistical methodology report will detail what software was used for what purposes.
Continuous (quantitative) variable summaries will include the number of subjects (n) with 
nonmissing values, mean, standard deviation (SD), median, minimum, and maximum.
Categorical (qualitative) variable summaries will include the frequency and percentage of 
subjects who are in the particular category or each possible value. In general, the denominator 
for the percentage calculation will be based upon the total number of subjects in the study 
population for the treatment group, unless otherwise specified. 
Unless otherwise indicated, all statistical tests will be conducted at the familywise Į=0.05
significance level using 2-tailed tests, and P values will be reported. Corresponding 95%
confidence intervals (CIs) will be presented for statistical tests. Details for splitting the 
familywise Į to control for multiple comparisons will be discussed in Section 6.1.3.
4.2.
Interim Analysis and Data Monitoring
No interim efficacy analyses are planned.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
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5.
Analysis Populations
The following analysis populations are planned for this study:
x
Safety Population (SAF): The Safety population will include all subjects who are 
enrolled and received at least 1 confirmed dose of investigational product (IP). This 
population will be used for all safety analyses.
x
Intent-To-Treat Population (ITT): The ITT population will include all randomized 
subjects. This population will be the primary analysis population for the analysis of 
efficacy endpoints, along with subject disposition.
x
Modified Intent-To-Treat Population (mITT): The mITT population includes all 
randomized subjects with the exception of subjects who missed the Week 8 S-IGA 
assessment specifically due to novel coronavirus disease-19 (COVID-19) disruptions. 
This population will be the sensitivity analysis population for the analysis of primary and 
secondary efficacy endpoints.
x
Scalp Pruritus ITT Population (SPRU4-ITT): The SPRU4-ITT population is a subset 
of the ITT population and includes subjects with SI-NRS score 4 at baseline. This 
population will be used for the analysis of achievement of a 4-point reduction in SI-NRS 
score as compared to baseline for this subset of ITT subjects.
x
Scalp Pruritus mITT Population (SPRU4-mITT): The SPRU4-mITT population is a 
subset of the mITT population and includes subjects with SI-NRS score 4 at baseline. 
This population will be used for the analysis of achievement of a 4-point reduction in 
SI-NRS score as compared to baseline for this subset of mITT subjects.
x
Pruritus ITT Population (PRU4-ITT): The PRU4-ITT population is a subset of the ITT 
population and includes subjects with WI-NRS score 4 at baseline. This population will 
be used for the analysis of achievement of a 4-point reduction in WI-NRS score as 
compared to baseline for this subset of ITT subjects.
x
Pruritus mITT Population (PRU4-mITT): The PRU4-mITT population is a subset of 
the mITT population and includes subjects with WI-NRS score 4 at baseline. This 
population will be used for the analysis of achievement of a 4-point reduction in WI-NRS 
score as compared to baseline for this subset of mITT subjects.
x
Pharmacokinetic Population (PK): 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 used for 
analyses of PK parameters.
6.
General Issues for Statistical Analysis
6.1.
Statistical Definitions and Algorithms
6.1.1. Baseline
For most efficacy assessments (i.e., S-IGA, B-IGA, PSSI, PASI/mPASI, and % BSA) and all 
safety assessments except PHQ-8/PHQ-A, the last observation recorded before the first 
application of study drug will be used as the baseline observation for all calculations of change 


Statistical Analysis Plan, 
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PCN Number ARCU210101
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from baseline. For other efficacy and safety assessments with a 24-hour or greater recall period 
(i.e., SI-NRS, WI-NRS, PSD, DLQI/CDLQI, and PHQ-8/PHQ-A), for the previously-named 
assessments where time is missing (and therefore we are assuming that the assessment was 
collected before first dose of study drug as per the protocol), or for subject local tolerability 
(which is expected to be post-dose), the last observation recorded on or before the day of first 
application of study drug will be used as the baseline observation for all calculations of change 
from baseline. 
For assessments that are collected both before and after application of study drug at the Baseline 
Day 0 visit, the last observation recorded before the first dose of study will be used as the 
baseline observation. For assessments collected only after application of study drug, no baseline 
will be defined (except for subject local tolerability). If the tolerability assessments are not done 
as per protocol Section 5.1.8, those records will be excluded from the analysis.
6.1.2. Adjustments for Covariates
Subgroup analyses may be generated for the baseline covariates.
6.1.3. Multiple Comparisons
To control for multiple comparisons among the secondary endpoints, the following testing plan 
will be used, as outlined in Figure 1.
Upon demonstration of statistical significance for S-IGA Success at Week 8, the secondary 
endpoint of B-IGA Success at Week 8 will be tested hierarchically at the 5% significance level.  
If the test for B-IGA Success at Week 8 is significant, the Į of 0.05 will be split to test 2 families 
of secondary endpoints. The first family comprise the PSSI-75, which will be tested at the Į =
0.03 level. If the test of PSSI-75 is statistically significant, then Į = 0.03 will be used with a 
Holm testing procedure to test the 4 endpoints of time to success in PSSI-50, change from 
baseline in Total PSD score at Week 8, change from baseline in Total PSD score at Week 4, and 
PSSI-90 at Week 8. The remaining Į = 0.02 will be used to test the second family, comprising 
the SI-NRS at Week 8, the SI-NRS at Week 4, and the SI-NRS at Week 2. The tests within this 
second family will be hierarchical, beginning with the endpoint at Week 8, followed by Week 4 
and Week 2.  


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
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Figure 1: Primary and Secondary Endpoint Testing
1° Endpoint: S-IGA Success at Week 8 at Į = 0.05
2° Endpoint: B-IGA Success at Week 8 at Į = 0.05
If IGA EPs are met, partition Į as follow:
0.03 for testing of Endpoint Family 2 and Family 3
Į = 0.03
PSSI-75 at Week 8 at 
Į = 0.03
Using the Holm procedure:
x
Time to success in PSSI-50
x
CFB in Total PSD score at Week 8
x
SI-IGA Clear at Week 8
x
PSSI-90 at Week 8
Į = 0.03
0.02 for sequential testing of SI-NRS
SI-NRS Success at 
Week 8 at Į = 0.02
Į = 0.02
Į = 0.02
SI-NRS Success at Week 4
SI-NRS Success at Week 2
Sequentially at Į = 0.02
Achievement of IGA success is a score of “clear” or “almost clear” plus a 2-grade improvement from baseline.
SI-WRS Success is a 4-point reduction in SI-NRS among subjects with SI-NRS  4 at baseline.
B-IGA = Body-Investigator Global Assessment; EP = endpoint; CFB = change from baseline; PSSI = Psoriasis Scalp Severity 
Index; S-IGA = Scalp-Investigator Global Assessment; SI-NRS = Scalp Itch - Numeric Rating Scale. 


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
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6.1.4. Handling of Dropouts or Missing Data
6.1.4.1.
Imputation of Missing Data
Any subject who prematurely withdraws from the study will have their last available data 
assigned to an analysis window as described in Section 6.1.5. 
For the primary efficacy endpoint of S-IGA score, the primary analysis will impute missing 
values using a regression-based multiple imputation model. This is a three step process. 
1. The first step is to understand the pattern of missingness. In order to perform the multiple 
imputation, a monotone missing pattern has to be achieved. For example, if there exists 
values for baseline and Week 8 visits, but missing values for the Week 2 or 4 visits, 
Markov-Chain Monte-Carlo (MCMC) method will be used to impute the small amount of 
missing data that may be missing at the intermediate visits that is required to make the 
missing data pattern monotone before applying the multiple imputation algorithm. This 
method uses a non-informative Jeffreys prior to derive the posterior mode from the 
expectation-maximization (EM) algorithm as the starting values for the MCMC method. 
MCMC method will use seed of 34978264. The S-IGA score will be treated as a 
continuous variable for this step. To avoid values that could not be observed in practice, 
imputed values will be constrained to be integers in the range of 0 to 4. 
a.
The table below will determine the number of datasets to be imputed in this step.  
Determine the proportion of datapoints with non-monotone pattern across all 
visits and subjects which could be derived as a percentage of number of 
nonmonotone data points/total number of expected data points. 
This can be determined as 
௡௨௠௕௘௥௢௙௡௢௡௠௢௡௧௢௡௘௩௜௦௜௧௦
௧௢௧௔௟௡௨௠௕௘௥௢௙௩௜௦௜௧௦௔௖௥௢௦௦௔௟௟௦௨௕௝௘௖௧௦כ 100
Non-monotone 
Missing Data
Number of 
Imputed Datasets
 2%
1
> 2% to  5%
3
> 5%
10
2. Once the monotone pattern is achieved, the next step is to implement the imputation 
algorithm. For this, the Predictive Mean Matching method (PMM) will be used. This 
method is particularly helpful if the normality assumption is violated. For subjects with 
complete data up to a particular visit, a PMM model will be fit that includes the outcome 
at that visit as the dependent variable and as independent variables, S-IGA score 
outcomes at previous visits, treatment group, and country using a seed of 51192215. This 
process will be repeated 25 times, resulting in a total of 25 to 250 complete analysis 


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datasets, depending on the number of imputed monotone datasets that are required. The 
seed may be changed after unblinding in case of any issues with the imputation process, 
and it will be documented in the CSR if any change is required.
3. For each completed dataset, compute the necessary derived variables. The dichotomous 
success rate (clear or almost clear with at least a 2-point change from baseline) will be 
derived. The results obtained will be analyzed using the Cochran-Mantel-Haenszel 
(CMH) analysis for each of the complete analysis data sets stratified by baseline S-IGA 
score category, baseline B-IGA score category, and country. The results will be 
combined into one multiple imputation inference (odds ratio, associated CI, and P value) 
using PROC MIANALYZE as illustrated4.
This approach to imputation should be superior to other strategies such as carrying forward the 
last available observation, which may yield unrealistic imputed values. Also, the use of multiple 
imputation avoids the problem of artificially increasing power through data imputation 
associated with single-imputation methods because it accounts for the uncertainty associated 
with the imputation. Other missing data will not be imputed, with the exception of incomplete 
dates as described in Section 6.1.8. For responder analyses, missing data will be treated as a 
nonresponse with the exception of S-IGA. Only observed data will be summarized using 
descriptive statistics.
The SAS pseudo code for the multiple imputation process is listed below:
Step 1:
proc mi data=example seed=34978264 nimpute=XX round=1 out=example_1;
  mcmc impute=monotone;
  var <baseline score> ………… <visit8 score>;
run;
Step 2:
proc mi data=example_1 seed=51192215 nimpute=XX  out=example_2;
  class <treatment> <country>;
  monotone regpmm(<baseline score> ………… <visit8 score>);
  var <treatment> <country> <baseline score> ………… <visit8 score>;
run;
XX will be the determined based on the proportion of missing data across visits.
Step 3: This step involves running CMH test stratified by baseline S-IGA score category, baseline 
B-IGA score category, and country on each completed dataset and combining the results using 
PROC MIANALYZE.
proc freq data=example noprint;
by <imputationnumber> <visit> ;
tables <country> * <BL S-IGA cat> * <BL B-IGA cat> * <treatment> *
         <outcome> / cmh alpha=0.05;
output out=example_stat cmh;
run;


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In order to apply PROC MIANALYZE, normalizing transformations have to be applied to odds 
ratio. P values are obtained using Wilson Hilferty transformation as illustrated4.
6.1.4.2.
Tipping Point Analysis
As a sensitivity analysis to the multiple imputation analysis as described in Section 6.1.4.1 for 
the S-IGA primary endpoint, a tipping point analysis will be performed in order to determine the 
inflection point at which the inference under the MNAR assumption changes substantially. This 
will be used to check the robustness of the imputation.
The sensitivity analysis will be performed by using a specified sequence of shift parameters, 
which will adjust the imputed values for observations in the active treatment group. The range of 
shift parameters to be included in this analysis are -1.5 to 1.5 by 0.2. Once the likely point of the 
shift is determined, the analysis will be rerun using an expanded range around the suspected 
tipping point, with greater precision (i.e., to 2 decimal places, by 0.01). Thus, the value at which 
the results of the analysis are shifted from significant (i.e., Į  0.05) to non-significant (i.e., Į > 
0.05) will be determined. 
Step 1 of the analysis will be the same as for the multiple imputation analysis as described in 
Section 6.1.4.1. However, Step 2 of the analysis is where the shift parameters will be applied. 
Step 3 will be similar to the multiple imputation analysis described in Section 6.1.4.1, however, 
the BY statement in PROC FREQ will also include the shift parameter (i.e., by <shift 
parameter> <imputation number> <shift parameter> <visit>); this will also be included 
in the PROC MIANALYZE steps. Pseudo-code for Step 2 is as follows:
proc mi data=example_1 seed=51192215 nimpute=XX  out=example_2;
  class <treatment> <country> ;
  monotone regpmm(<baseline score> ………… <visit8 score>);
  var <treatment> <country> <baseline score> ………… <visit8 score>;
  mnar adjust( <visit2 score> / shift=YY adjustobs=(treatment = ‘Vehicle’) );
  mnar adjust( <visit4 score> / shift=YY adjustobs=(treatment = ‘Vehicle’) );
  mnar adjust( <visit8 score> / shift=YY adjustobs=(treatment = ‘Vehicle’) );
run;
XX will be the determined based on the proportion of missing data across visits.
YY will encompass the range of shift parameters as pre-specified above.
6.1.5. Analysis Visit Windows
Visits will be analyzed as scheduled. Unscheduled, early termination, and/or repeated 
measurements will only be included if a scheduled measurement is not available and the 
unscheduled, early termination, or repeated measurement falls within the analysis visit windows 
as described in Table 2. The windows follow the Schedule of Events in Table 1. 
Unscheduled/repeated measurements will be listed.
Table 2: Analysis Visit Windows
Visit Name
Visit Number Target Start Day
Lower Limit
Upper Limit
Week 2
3
14
2
22
Week 4
4
28
23
42


Statistical Analysis Plan, 
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Visit Name
Visit Number Target Start Day
Lower Limit
Upper Limit
Week 8
5
56
43
61
Week 9
6
63
62
--
6.1.6. Pooling of Sites
Not applicable.
6.1.7. Derived Variables
x
S-IGA success = S-IGA of “Clear” or “Almost Clear” plus a 2-grade improvement from 
baseline.
x
B-IGA success = B-IGA of “Clear” or “Almost Clear” plus a 2-grade improvement from 
baseline.
x
SI-NRS 4-point reduction = achievement of a 4-point reduction in SI-NRS pruritus score 
at Weeks 2, 4, and 8 compared to baseline, calculated only for subjects with an SI-NRS
pruritus score of   4 at baseline.
x
WI-NRS 4-point reduction = achievement of a 4-point reduction in WI-NRS pruritus 
score at Weeks 2, 4, and 8 compared to baseline, calculated only for subjects with a 
WI-NRS pruritus score of   4 at baseline.
x
PSSI = (erythema score + induration + desquamation) × extent of scalp affected (range 
0 to 72). Erythema, induration, and desquamation are scored on a scale of 0 to 4, where 0 = 
absent and 4 = severest possible; extent of scale affected is scored on a scale of 0 to 6, 
where 0 = 0% of involved area and 6 = 90-100% of involved area.
x
PSSI-50 = achievement of a 50% reduction in PSSI from baseline
x
PSSI-75 = achievement of a 75% reduction in PSSI from baseline
x
PSSI-90 = achievement of a 90% reduction in PSSI from baseline
x
PSSI-100 = achievement of a 100% reduction in PSSI from baseline
x
Time to PSSI-50 (days) = date of first PSSI-50 achievement – Day 1 date + 1. Subjects 
not achieving PSSI-50 will be censored at day of study discontinuation or date lost to 
follow-up, whichever is later. Due COVID-19-related site closures, some discontinuation 
visits occurred much later than Week 9, so time to PSSI-50 may be after Week 9.
x
Time to PSSI-75 (days) = date of first PSSI-75 achievement – Day 1 date + 1. Subjects 
not achieving PSSI-75 will be censored at day of study discontinuation or date lost to 
follow-up, whichever is later. Due COVID-19-related site closures, some discontinuation 
visits occurred much later than Week 9, so time to PSSI-75 may be after Week 9.


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
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x
Time to PSSI-90 (days) = date of first PSSI-90 achievement – Day 1 date + 1. Subjects 
not achieving PSSI-90 will be censored at day of study discontinuation or date lost to 
follow-up, whichever is later. Due COVID-19-related site closures, some discontinuation 
visits occurred much later than Week 9, so time to PSSI-90 may be after Week 9.
x
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)
where E, T, and S are erythema, thickness, and scaling, respectively, scored on a 
scale of 0 to 4, A is estimated area of skin involved, graded on a scale of 0 to 6, and 
h, a, t, and l are head, arms, trunk, and legs, respectively (range for total score 0 to 
72). If any of the component scores are missing, the PASI cannot be calculated.
x
PASI-50 = achievement of a 50% reduction in PASI from baseline
x
PASI-75 = achievement of a 75% reduction in PASI from baseline
x
PASI-90 = achievement of a 90% reduction in PASI from baseline
x
Time to PASI-50 = date of first PASI-50 achievement – Day 1 date + 1. Subjects not 
achieving PASI-50 will be censored at day of study discontinuation or date lost to follow-
up, whichever is later. Due COVID-19-related site closures, some discontinuation visits 
occurred much later than Week 9, so for purposes of this calculation, the upper limit for 
time to PASI-50 will be capped at Day 68 (Week 9).
x
mPASI = (0.1×[Eh + Th + Sh]×pAh) + (0.2×[Ea + Ta + Sa]×pAa) + (0.3×[Et + Tt + St]×pAt) 
+ (0.4×[El + Tl + Sl]×pAl)
where E, T, and S are erythema, thickness, and scaling, respectively, scored on a 
scale of 0 to 4, pA is estimated area of skin involved as an actual percentage (i.e., 
percentage in the eCRF/10) if the percent involvement is <10% OR as graded on a 
scale of 0 to 6, and h, a, t, and l are head, arms, trunk, and legs, respectively (range 
for total score 0 to 72). If any of the component scores are missing, the mPASI 
cannot be calculated.
x
DLQI Score = sum of the 10 questions (individual questions scored as Very much=3, A 
lot=2, A little=1, Not at all=0, with Not relevant recoded to 0; Question 7: Yes=3, No=0, 
with Not relevant recoded to 0; range for score 0 to 30). If 1 item is missing, that item is 
scored as 0. If 2 or more items are missing, the score should not be calculated.
x
CDLQI Score = sum of the 10 questions (individual questions scored as Very much=3, 
Quite a lot=2, Only a little=1, Not at all=0; Question 7: if the last week was school time, 
the question was scored as Very much=3, Quite a lot=2, Only a little=1, Not at all=0, with 
Prevented school recoded to 3, and if the last week was vacation, the standard responses 
apply; range for score 0 to 30). If 1 item is missing, that item is scored as 0. If 2 or more 
items are missing, the score should not be calculated.


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x
PSD Total score = sum of the 16 questions (individual questions scored 0 to 10, where 
higher scores indicate more severe symptoms; range for total score 0 to 160). If 1 or more 
items are missing, the score is not calculated. 
x
Compliance = number of applications divided by the expected number of IP applications 
for each subject. Compliance will be calculated using drug accountability data over the 
entire treatment period for each subject, up to treatment completion or discontinuation.
x
Number of expected IP applications = 56 for subjects who complete the study or 
number of days between first and last application of IP (last treatment date - first 
treatment date + 1) for subjects who discontinue early from the study.
x
Number of IP applications = number of expected IP applications – missed IP 
applications as collected in the electronic case report form (eCRF).
x
Weight of IP (g) = returned can weight – dispensed can weight.
x
Body mass index (BMI) (kg/m2) = [weight (kg) / height (cm) / height (cm)] x 10,000.
x
BMI Categories
•
Underweight: BMI < 18.5
•
Normal:          18.5  BMI  24.9
•
Overweight:   25.0  BMI  29.9
•
Obese:            BMI  30.0  
x
Change from baseline = value at current time point – value at baseline. 
x
Treatment emergent AE (TEAE) = any AE with an onset date/time after the first 
application of IP.
x
PHQ-8 = sum of the 8 questions (individual questions scored as Not at all=0, Several 
days=1, More than half the days=2, and Nearly every day=3; range for score 0 to 24). If 
more than 1 item is missing, the score should not be calculated.  If 1 item is missing, the 
score is calculated as (sum of answered items*8)/number of answered items.
x
PHQ-A = sum of the 8 questions (individual questions scored as Not at all=0, Several 
days=1, More than half the days=2, and Nearly every day=3, (range for score 0 to 24). If 1 
item is missing, the score should not be calculated.  If 1 item is missing, the score is 
calculated as (sum of answered items*8)/number of answered items.
x
C-SSRS Suicidal Ideation = A “yes” answer at any time during treatment to any 1 of the 
5 suicidal ideation questions (Categories 1-5: Wish to be Dead, Nonspecific Active 
Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent 


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to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, and Active 
Suicidal Ideation with Specific Plan and Intent).
x
C-SSRS Suicidal Behavior = A “yes” answer at any time during treatment to any 1 of the 
5 suicidal behavior questions (Categories 6-10: Preparatory Acts or Behavior, Aborted 
Attempt, Interrupted Attempt, Actual Attempt (nonfatal), Completed Suicide).
x
C-SSRS Suicidal Ideation or Behavior = A “yes” answer at any time during treatment to 
any 1 of the 10 suicidal ideation and behavior questions (Categories 1-10) on the C-SSRS.
x
Completion of Study = Completion of the primary efficacy assessment (S-IGA) at 
Week 8. This may differ than what was recorded in the eCRF.
6.1.8. Data Adjustments/Handling/Conventions
All collected data will be presented in Clinical Data Interchange Standards Consortium (CDISC)
datasets. Data not subject to analysis according to this plan will not appear in any tables or graphs 
but will be included only in the CDISC datasets.
All P values will be displayed in 4 decimals and rounded using standard scientific notation (e.g., 
0.XXXX). If a P value less than 0.0001 occurs it will be shown in tables as <0.0001; similarly, if 
a P value greater than 0.9999 occurs it will be shown in tables as >0.9999.
Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA)
version 23.0 thesaurus.
A treatment-related AE is any AE with a relationship to the study drug of possibly, probably, 
likely, or missing.
For partial AE and medication start dates:
x
If the year is unknown, then do not impute the date but assign a missing value.
x
If the year is known, but the month or month and day is unknown, then:
o
If the year matches the year of first dose date and the end date (if present) is after 
first dose date, then impute as the month and day of the first dose date.
o
Otherwise, assign 01 January.
x
If the year and month are known, but the day is unknown, then:
o
If the month and year match the month and year of the first dose date, then impute 
as the day of the first dose date.
o
Otherwise, assign 01.
For partial AE and medication end dates:
x
If the year is unknown, then do not impute the date but assign as missing value.
x
If the year is known, but the month or month and day is unknown, then:


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o
If the year matches the year of the last date of the study (date of last contact if 
subject lost to follow-up; date of completion or early termination otherwise), then 
impute as the month and day of the last date of the study.
o
Otherwise, assign 31 December.
x
If the year and month are known, but the day is unknown, then:
o
If the month and year match the month and year of the last date of the study, then 
impute as the day of the last date of the study.
o
Otherwise, assign the last day of the month.
These conventions will be applied to AE and medication onset dates and times with the 
following precaution: if the missing date and time reflect the date and time of onset of an AE, the 
modified date and time will be constructed to match the first documented date/time post drug 
administration while preserving the order in which the AE was reported in the eCRF.
In cases where variables for questionnaires were derived in the eCRF (e.g., total scores) and a 
derivation is indicated in Section 6.1.7, the results as derived by statistics (as opposed to the 
results derived in the eCRF) will be used in analysis.
6.2.
Special Handling for COVID-19 Disruptions
In some cases, study visits will have to be delayed/not performed as a result of COVID-19 
disruptions (e.g., sites were closed or subjects were under stay-at-home orders). Where possible, 
study sites may collect post-baseline data from subjects remotely by telephone, traditional mail, 
and/or email; this will be clearly documented in the source. If possible, sites should adhere to the 
protocol visit window for remote data collection.
Investigator assessments and subject questionnaires normally completed directly in the electronic 
patient reported outcomes (ePRO) tablet during on-site visits should be completed on the 
appropriate paper source documents. The following assessments/questionnaires are approved to 
be collected via telemedicine/remotely:
x
WI-NRS/SI-NRS
x
DLQI/CDLQI
x
C-SSRS
x
PHQ-8/PHQ-A
x
Subject Local Tolerability
x
PSD
The following assessments cannot be completed via telemedicine/remotely:
x
S-IGA/B-IGA
x
BSA
x
Investigator Local Tolerability
x
PASI/mPASI
x
PSSI
x
Subject Weight


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
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Study visits and procedures must be followed per protocol whenever possible. Any specific 
changes in study conduct that deviate from the protocol should be communicated to the 
institutional review board and Sponsor. All protocol deviations which occurred as a result of 
COVID-19 disruptions (e.g., visits out of window, missed assessments, etc.) will be 
differentiated from other protocol deviations. 
Subjects who were affected by COVID-19 disruptions by either missing their Week 8 visit or 
being discontinued before having a Week 8 visit due to COVID-19 related disruptions will be 
excluded from the mITT population, as described in Section 5.
7.
Study Subjects and Demographics
7.1.
Disposition of Subjects and Withdrawals
Disposition will include tabulations of the number of subjects randomized into each treatment 
group, the number of subjects who received treatment, subjects completing study, tabulated 
reasons for discontinuation from the study, including whether or not the subject did not complete 
the study due to COVID-19 disruption and reasons, and number of subjects in each analysis 
population. Disposition will be summarized for all subjects who were entered into database by 
treatment group and overall.
7.2.
Protocol Deviations
The number of subjects with major protocol deviations and/or eligibility deviations will be 
summarized in categories by treatment group and overall for subjects in Safety population.
7.3.
Demographics and Other Baseline Characteristics
Summary statistics for age, age category (12-17, 18), gender (including child-bearing 
potential), race, ethnicity, height, weight, percent BSA, BMI, and baseline disease characteristics 
(S-IGA, B-IGA, PSSI, SI-NRS, PSD total score, PASI, mPASI, WI-NRS, DLQI, and CDLQI) 
will be presented by treatment group and overall.   
A summary of treatment history, including history of response, intolerance, or contraindication 
to topical corticosteroids and/or topical vitamin D derivatives, and psoriasis involvement on 
knees and/or elbows and genitalia will be provided.
For the continuous variables, the number of nonmissing values and the mean, SD, minimum, 
median and maximum will be tabulated. 
For ordinal variables such as the S-IGA, B-IGA, SI-NRS, and WI-NRS, summary statistics 
including the mean, median, and range of the ordinal variable will be presented, as well as 
frequency counts of each level of the ordinal variable.  
For the categorical variables, the counts and proportions of each value will be tabulated.   
These analyses will be conducted for the ITT, mITT, and Safety populations, except for 
treatment history summary, which will only be summarized on the Safety population.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
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7.4.
Exposure and Compliance
The number of IP applications by each subject based on diary data will be summarized using 
descriptive statistics appropriate for continuous variables. 
The amount of IP each subject used based on can weight will be summarized descriptively by 
treatment group using continuous methods.  
A subject will be considered compliant with the dosing regimen if the subject applies at least 
80% of the expected applications during the IP application period and does not miss more than 
3 consecutive doses.
Investigational product application compliance will be calculated based on number of 
applications divided by the expected number of IP applications. Compliance will be summarized 
descriptively by treatment group using the following categories:
>100%
80% - 100%
<80%
8.
Efficacy Analysis
The order of testing for the primary and secondary endpoints is discussed in Section 6.1.3. 
Exploratory endpoints are not included in the testing strategy.
8.1.
Primary Efficacy Analysis
8.1.1. Scalp Investigator Global Assessment (S-IGA)
The S-IGA is an ordinal scale with 5 severity grades which is reported only in integers. 
Table 3 illustrates the description of each severity grade. 
Table 3: S-IGA
Score
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


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
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Score
Grade
Description
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
For this study, the primary estimand is the odds of achieving S-IGA success at 8 weeks; that is, 
the ratio of the odds of achieving S-IGA success at 8 weeks roflumilast foam 0.3% relative to the 
odds of success at 8 weeks of using a matching vehicle cream. In the course of the 8-week 
randomized treatment period, subjects may be exposed to possible known or unknown 
intercurrent events that could possibly impact the estimand, such as treatment discontinuation 
due to a specific adverse effect or perhaps a lack of effect. The “Treatment Policy Strategy” has 
been adopted for handling all known or unknown intercurrent events in this study. To this end, 
the ITT principle will serve as the analytical basis for interpreting the estimand. In other words, 
the odds ratio of achieving S-IGA success for roflumilast foam 0.3% relative to vehicle at 8 
weeks will be evaluated regardless of the occurrence of any such intercurrent event. This 
estimand shall be estimated using the CMH approach. This approach produces an estimate that is 
the combined odds ratio resulting from adjusting for the possible effects of 3 classification 
factors: country, baseline S-IGA category (2 vs. 3) and baseline B-IGA category (2 vs. 3).
Categorical Data Analysis
The primary efficacy endpoint is success in S-IGA of disease severity, defined as an S-IGA of
“Clear” or “Almost Clear” plus a 2-grade improvement from baseline at Week 8.
The primary endpoint will be analyzed using a CMH test stratified by country, baseline S-IGA 
category, and baseline B-IGA category. Statistical significance will be concluded at the 5% 
significance level (2-sided) or less, as discussed in Section 6.1.3. Odds ratios and 95% CIs for the 
odds ratios will be provided. Additionally, the 95% Wilson CIs for proportion of successes in 
each treatment group will be presented.
For the primary analysis, missing S-IGA scores will be imputed using multiple imputation as 
described in Section 6.1.4.1. These imputations will result in a minimum of 25 to a maximum of 
250 complete analysis datasets, depending on the number of imputed monotone datasets 
required. The CMH analyses will be performed separately for each of the complete analysis data 
sets, and the results will be combined into one multiple imputation inference (estimated treatment 
effect and associated CI and P value). As a sensitivity analysis, the above described CMH test 
will be performed on the nonimputed data.
Sensitivity analyses of the primary endpoint will also be performed using the original 
(nonimputed) dataset. These will include a repeated measures logistic regression model (GEE) 
with S-IGA success as the dependent variable and treatment, country, visit, and baseline S-IGA 
score as the independent variables.


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
PCN Number ARCU210101
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Achievement of a score of clear will also be analyzed using the CMH test, on nonimputed data.
A tipping point analysis will be performed as described in Section 6.1.4.2. For the tipping point 
analysis, a figure will be provided that displays the P values in the analysis plotted against the 
range of shift parameters; included in this figure will be the shift parameters and P values for the 
range of shift parameters to provide information on where the analysis tips from significant to 
non-significant.
Subgroup Analyses – Observed Data
For the primary endpoint of IGA success (S-IGA of “Clear” or “Almost Clear” plus a 2-grade 
improvement from baseline at Week 8), the CMH analysis will be performed on the following
subgroups, using observed data:
x
Topical Corticosteroids – Naïve Subjects 
x
Topical Vitamin D Derivatives – Naïve Subjects
x
Psoriasis involvement on the knee and/or elbow 
x
Subjects who achieved both S-IGA and B-IGA success at Week 8
x
By Study Site
Subgroup Analyses – Multiple Imputation Data
For the primary endpoint of IGA success (S-IGA of “Clear” or “Almost Clear” plus a 2-grade 
improvement from baseline at Week 8), the CMH analysis will be performed on the following
subgroups, using multiple imputation data:
x
Baseline S-IGA = 3
x
Baseline S-IGA = 4
x
Age Category = 12-17 years
x
Age Category = 18 years
x
Subjects who achieved both S-IGA and B-IGA success at Week 8
Continuous Data Analysis
Analysis of change from baseline in S-IGA scores at Weeks 2, 4, 8, and 9 will be performed 
using descriptive summaries (mean, median, inter-quartile range) by treatment group and study 
visit. These descriptive statistics will also be presented based on the multiple imputation data.
All Analyses
All other missing data for all other analyses and summaries will remain missing and will not be 
imputed. All weeks will be included in these analyses, although only Week 8 using the ITT 
population will be included in the testing strategy.
The primary efficacy analysis will be based on ITT population, and all of the above analyses will 
be repeated for the mITT population.  
8.2.
Secondary Efficacy Analysis
All secondary efficacy analyses will be performed using the ITT and mITT populations, unless 
otherwise specified.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
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8.2.1. Body Investigator Global Assessment (B-IGA)
The scale, grade, and description for the B-IGA is identical to the S-IGA, as discussed in 
Section 8.1.
Achievement of a B-IGA score of “clear” or “almost clear” PLUS a 2-grade improvement from 
baseline at Weeks 2, 4, 8, and 9 will be analyzed similar to the primary efficacy endpoint using 
CMH test stratified by country, baseline S-IGA category, and baseline B-IGA category, with the 
exception that missing data will not be replaced (i.e., observed data). Odds ratios and 95% CIs of 
the odds ratios will be provided. Additionally, the 95% Wilson CIs for proportion of successes in 
each treatment group will be presented. In addition, the number and percentage of subjects in 
each category will be summarized by treatment and visit. Only the Week 8 results using the ITT 
population will be included in the testing strategy.
Analysis of change from baseline in B-IGA scores at Weeks 2, 4, 8, and 9 will be performed 
using descriptive summaries (mean, median, inter-quartile range) by treatment group and study 
visit.
8.2.2. Psoriasis Scalp Severity Index (PSSI)
The PSSI is used to measure the severity of psoriasis, combining the assessment of the severity 
of scalp lesions and the area of scalp affected into a single score ranging from 0 (no disease) to 
72 (maximal disease). The PSSI score will be analyzed as follows:
x
Change and percent change from baseline to Weeks 2, 4, 8, and 9 in the PSSI will be 
analyzed using descriptive summaries and an analysis of covariance (ANCOVA) with 
terms for country, baseline S-IGA category, and baseline B-IGA category, and baseline 
PSSI score as a covariate. Statistical comparisons between the treatment groups will be 
obtained using contrasts. The least-squares (LS) means, standard errors, 95% CIs, and P
values will be presented.
x
Frequencies and percentages of subjects achieving PSSI-50, PSSI-75, PSSI-90, and PSSI-
100 will be presented by study week and treatment group. Additionally, these endpoints 
will be analyzed similar to the primary efficacy endpoint using a CMH test stratified by 
country, baseline S-IGA category, and baseline B-IGA category, on observed data. Only 
the PSSI-75 and PSSI-90 at Week 8 using the ITT population will be included in the 
testing strategy. Odds ratios and 95% CIs of the odds ratios will be provided. 
Additionally, the 95% Wilson CIs for proportion of successes in each treatment group 
will be presented.
x
Time to achieving PSSI-50, PSSI-75, and PSSI-90 will be summarized using Kaplan-
Meier methods and the difference between treatment groups evaluated using the log-rank 
statistic, and 95% CIs of the median for each treatment group will be presented. In 
addition, a Cox proportional hazards model that includes the stratification factors will be 
run and the hazard ratio and associated 95% Wald CIs will be presented. Time to 
achieving PSSI-50 using the ITT population will also be included in the testing strategy.
Time to achieving PSSI-75 or PSSI-90 using the ITT population will not be included in 
the testing strategy, but will be considered as a supportive analysis.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
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8.2.3. Scalp Itch – Numeric Rating Scale (SI-NRS)
The SI-NRS scale ranges from 0 to 10 with 0 being “no scalp itch” and 10 equaling “worst scalp 
itch imaginable.” This will be determined by asking the subject’s assessment of worst scalp itch 
over the past 24 hours. The SI-NRS will be analyzed as follows:
x
Change and percent change from baseline to Weeks 2, 4, and 8 in SI-NRS will be 
analyzed using descriptive summaries and an ANCOVA with terms for country, baseline 
S-IGA category, and baseline B-IGA category, and baseline SI-NRS score as a covariate. 
Statistical comparisons between the treatment groups will be obtained using contrasts.
The LS means, standard errors, 95% CIs, and P values will be presented.
x
In subjects with a baseline SI-NRS score 4, achievement of a 4-point improvement 
from baseline in SI-NRS score at Weeks 2, 4, and 8 will be analyzed using CMH tests 
stratified by country, baseline S-IGA category, and baseline B-IGA similar to the primary
analysis above, with the exception that missing data will not be replaced. Odds ratios and 
95% CIs of the odds ratios will be provided. Additionally, the 95% Wilson CIs for 
proportion of successes in each treatment group will be presented. This will be 
summarized using SPRU-ITT and SPRU-mITT populations.
8.2.4. Psoriasis Symptoms Diary (PSD)
The PSD assesses the severity of symptoms or how bothersome are the symptoms of psoriasis. 
The PSD will be analyzed as follows:
x
Change and percent change from baseline to Weeks 2, 4, and 8 in the PSD individual 
item and total scores will be analyzed using descriptive statistics and an ANCOVA (total 
score only) with terms for country, baseline S-IGA category, and baseline B-IGA 
category, and baseline PSD score as a covariate. Statistical comparisons between the 
treatment groups will be obtained using contrasts. The LS means, standard errors, 95% 
CIs, and P values will be presented. Only change from baseline in PSD total score at 
Weeks 4 and 8 using the ITT population will be included in the testing strategy.
8.3.
Exploratory Efficacy Analysis
Exploratory efficacy analysis will be performed for subjects belonging to ITT and mITT 
populations.
The exploratory endpoints include:
x
Achievement of success in PASI-90, PASI-75, and PASI-50 at Weeks 2, 4, 8, and 9
x
Time to success in PASI-50
x
Change and percent change from baseline in PASI/mPASI at Weeks 2, 4, 8, and 9
x
Change and percent change from baseline in WI-NRS at Weeks 2, 4, and 8
x
For subjects with baseline WI-NRS score 4, achievement of 4-point improvement from 
baseline in WI-NRS at Weeks 2, 4, and 8 (summarized on the PRU4-ITT and PRU4-
mITT populations)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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x
Change and percent change from baseline in DLQI/CDLQI total scores at Weeks 2, 4, 
and 8
x
Change and percent change from baseline in % BSA affected by disease at Weeks 2, 4, 8, 
and 9
Time to success in PASI-50 and change and percent change from baseline for all relevant 
exploratory endpoints will be summarized descriptively; additionally, all endpoints will be 
analyzed using an ANCOVA with terms for country, baseline S-IGA category, and baseline 
B-IGA category, and baseline assessment score as a covariate. Statistical comparisons between 
the treatment groups will be obtained using contrasts. The LS means, standard errors, 95% CIs, 
and P values will be presented. Achievement of success in PASI-50, PASI-75, and PASI-90; 
achievement of success in mPASI-50, mPASI-75, and mPASI-90; and improvement in WI-NRS 
will be presented using proportions. Odds ratios and 95% CIs of the odds ratios will be provided.
Additionally, the 95% Wilson CIs for proportion of successes in each treatment group will be 
presented.
For efficacy analysis purposes, the data that is collected by the ePRO will be used for % BSA 
affected by disease summarization.
9.
Safety and Tolerability Analysis
Safety will be evaluated from reported AEs, physical examinations, local tolerability assessments, 
changes in clinical laboratory values, changes in vital signs/weight, C-SSRS, PHQ-8, and modified 
PHQ-A results. No inferential statistical tests will be performed.
All safety analyses will be performed on the Safety population.
9.1.
Adverse Events
All AEs, TEAEs, and SAEs will be coded using the MedDRA dictionary version 23.0.
A TEAE is defined as an AE that started post application of IP at the Baseline visit through study 
completion. An overall summary of TEAEs will be provided; this will present number and 
percent of subjects who reported at least 1 of the following: TEAE (including all TEAEs, TEAEs 
by maximum severity, and TEAEs by greatest relationship), SAE, discontinued the study due to 
a TEAE, or a TEAE resulting in death.
The number and percent of subjects reporting TEAEs, grouped by MedDRA system organ class
(SOC) and preferred term, will be tabulated by severity or greatest relationship to study IP and 
treatment group. In the case of multiple occurrences of the same TEAE within the same subject, 
each subject will only be counted once for each preferred term. Additionally, the number and 
percent of subjects reporting related TEAEs will be summarized by MedDRA preferred term and 
treatment group.
In the summaries showing severity and relationship to study medication the event with the 
maximum severity (mild < moderate < severe) or strongest relationship (not related < related) 
will be reported. If a particular event is missing the severity and/or relationship, then the 
strongest possible severity or relationship will be assumed for analysis (severity = severe, 
relationship = likely).


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
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In the AE data listings, all AEs will be displayed. Any AEs that are treatment emergent will be 
flagged.
9.1.1. Adverse Events Leading to Withdrawal
A summary of incidence rates (frequencies and percentages) of TEAEs leading to withdrawal of 
study drug by treatment group, SOC, and preferred term will be prepared for the Safety 
population. Additionally, this table will be repeated for TEAEs leading to withdrawal from the 
study. No inferential statistical tests will be performed.
A data listing of AEs leading to withdrawal of study drug will also be provided, displaying 
details of the event(s) captured on the eCRF.
9.1.2. Deaths and Serious Adverse Events
Any deaths that occur during the study will be listed.
Serious adverse events (SAEs) will be listed and tabulated by SOC and preferred term and 
presented by treatment group, severity, and relationship to study treatment.  
9.2.
Local Tolerability Assessments
The investigator’s assessment of the application site reaction will be summarized by study visit 
using both categorical methods (number and percentage of subjects with each score) as well as 
continuous methods (e.g., mean, median). Categorical summaries will be provided for dermal 
response as well as other effects. No inferential statistical tests will be performed.
The subject’s assessment of the application site reaction will be summarized similarly.
9.3.
Clinical Laboratory Evaluations
Laboratory test results will be summarized descriptively by treatment and study visit as both 
observed values and change from baseline values for continuous hematology, chemistry, and 
urinalysis results. Categorical urinalysis results will be summarized using frequencies by study 
visit and treatment.
The number of subjects with clinical laboratory values below, within, or above the normal range 
by study visit and in relation to baseline will be tabulated for each clinical laboratory analyte by 
treatment group (shift table).
Abnormal results will be flagged in the listings. In addition, pregnancy test results and hormonal 
laboratory results will be listed.
9.4.
Vital Signs
Descriptive summaries of observed values and changes from baseline will be calculated for 
systolic blood pressure, diastolic blood pressure, heart rate, height, weight, BMI, and oral body 
temperature by treatment group and visit.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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The number of subjects who gain or lose 5% of their baseline body weight during the course of 
the study, as well as subjects who gain or lose 10% of their baseline body weight over the 
course of the study, will be summarized by treatment group. This summary will be repeated by
intentionality of weight loss (intentional or unintentional, as captured on the eCRF).
Shift tables for subjects who shift from their baseline BMI category as defined in Section 6.1.7
(underweight, normal, overweight, obese) to a different BMI category throughout the course of 
the study will be provided by treatment group and visit. This summary will be repeated by 
intentionality of weight loss (intentional or unintentional, as captured on the eCRF).
9.5.
PHQ-8 and Modified PHQ-A
Data for PHQ-8 and modified PHQ-A will be classified using each subject’s total score at a time 
point into a category based on the following scoring system: 
x
None – Minimal depression (0 to 4)
x
Mild depression (5 to 9)
x
Moderate depression (10 to 14)
x
Moderately severe depression (15 to 19)
x
Severe depression (20 to 24)
Shift tables showing the category of severity at each visit by treatment group will be presented.
9.6.
C-SSRS
The C-SSRS is a questionnaire that prospectively assesses Suicidal Ideation and Suicidal 
Behavior. At the Screening study visit, “Baseline/Screening” version of the C-SSRS will be 
used. This version assesses Suicidal Ideation and Suicidal Behavior during the subject’s lifetime 
and during the past 6 months. For the Screening visit, “lifetime” experience of the subject with 
Suicidal Ideation and Suicidal Behavior will be summarized. From Baseline visit, the “Since 
Last Visit” version will be used.
Suicidality data collected on the C-SSRS will be listed for all subjects. Tables will include results 
from the Suicidal Ideation and Suicidal Behavior sections of the C-SSRS. Frequencies and 
percentages of subjects with a response of “Yes” at any point on the Suicidal Ideation and 
Suicidal Behavior items will be summarized by study visit and treatment group. 
9.7.
Physical Examination
The number and percentage of subjects with normal and abnormal findings in the physical 
examination will be displayed at each study visit and treatment group.
9.8.
Concomitant Medication
Prior and concomitant medications will be summarized descriptively by treatment, Anatomical 
Therapeutic Chemical (ATC) Class Level 4, and Preferred Term using counts and percentages.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Prior medications will be presented separately from concomitant medications. Medications that 
started before the first application of IP will be considered prior medications whether or not they 
were stopped prior to the first application of study drug. Any medications continuing or starting 
after the first application of study drug will be considered to be concomitant. If a medication 
starts before the first application of study drug and continues after the first application of study 
drug it will be considered both prior and concomitant.
Medications will be coded using World Health Organization (WHO) Drug Global B3, version 
September 2019.
10.
Changes from Planned Analysis
The following analysis populations have been added:
x
The mITT population has been added to handle situations where a subject was unable to 
attend the Week 8 visit or discontinued from the study before the Week 8 visit due to 
COVID-19 disruptions;
x
The SPRU4-ITT and SPRU4-mITT populations have been added to facilitate SI-NRS 
analysis on the ITT and mITT populations, respectively; and
x
The PRU4-ITT and PRU4-mITT populations have been added to facilitate WI-NRS 
analysis on the ITT and mITT populations, respectively. 
These populations are not included in the protocol. 
The PP population and associated analyses have been removed at the request of the Sponsor, as 
they were considered to be uninformative. 
Additional exploratory endpoints have been added in the SAP which are not specified in the 
protocol. They are:
x
Change and percent change from baseline in SI-NRS at Weeks 2, 4, and 8
x
Change and percent change from baseline in PASI at Weeks 2, 4, 8, and 9
x
Change and percent change from baseline in WI-NRS at Weeks 2, 4, and 8
Additionally, odds ratios and 95% CIs of odds ratios for comparisons between treatment groups,
and 95% Wilson CIs for proportion of successes in each treatment group for binary outcomes 
will be provided.
Additional efficacy analyses have been added in the SAP which are not specified in the protocol, 
as requested by the Sponsor. They are:
x
Analysis of S-IGA success based on the following subgroups (both ITT and mITT 
populations, observed data only):
o
Topical corticosteroids – naïve subjects
o
Topical vitamin D derivatives – naïve subjects
o
Subjects with psoriasis involvement on the knee and/or elbow
o
Subjects who achieved S-IGA and B-IGA success at Week 8
o
By study site
x
Analysis of S-IGA score of clear (included in the fixed-sequence testing strategy)
x
Analysis of S-IGA success based on the following subgroups (both ITT and mITT 


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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populations, multiple imputation data only):
o
Baseline S-IGA = 3
o
Baseline S-IGA = 4
o
Age Category: 12-17 years
o
Age Category: 18 years
o
Subjects who achieved S-IGA and B-IGA success at Week 8
x
Achievement of success in PSSI-100
x
Time to achievement of PSSI-75 and PSSI-90
x
Achievement of success in mPASI-50, mPASI-75, and mPASI-90
Additional safety analyses have been added in the SAP which are not specified in the protocol, 
as requested by the Sponsor. They are:
x
Incidence of TEAEs leading to study discontinuation by SOC and preferred term
x
Incidence of related TEAEs by preferred term
x
Summarization of weight loss categories by intentionality of weight lose
x
Shift tables for BMI categories
11.
Other Planned Analysis
11.1.
Pharmacokinetic Analysis
All PK collection information from the eCRF will be presented in a listing. Concentration data 
and PK parameters will be summarized by timepoint (concentrations data) and treatment group 
using summary statistics. In addition, PK concentration and parameter listings will be presented.
12.
References
1. US Federal Register. (1998) International Conference on Harmonization; Guidance on 
Statistical Principles for Clinical Trials. Department of Health and Human Services: Food 
and Drug Administration [Docket No. 97D-0174]. Federal Register Volume 63, Number 179, 
pages 49583-49598. September 16, 1998.
2. ASA. (2016) Ethical Guidelines for Statistical Practice. Prepared by the Committee on 
Professional Ethics, April 2016. http://www.amstat.org/about/ethicalguidelines.cfm
3. RSS. (2014) The Royal Statistical Society: Code of Conduct, 2014. 
http://www.rss.org.uk/Images/PDF/join-us/RSS-Code-of-Conduct-2014.pdf.
4. Ratitch, B., Lipkovich, I., & O’Kelly, M. (2013). Combining Analysis Results from Multiply 
Imputed Categorical Data. 
PharmaSUG. https://www.pharmasug.org/proceedings/2013/SP/PharmaSUG-2013-SP03.pdf


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 34 of 172
13.
Tables, Listings, and Figures
All TLFs will have a header showing the sponsor company name and protocol and a footer 
showing the version of SAS, the file name and path, and the source of the data (e.g., listing 
number).
13.1.
Planned Table Descriptions
The following are planned summary tables for protocol number ARQ-154-204. The table 
numbers and page numbers are place holders only and will be determined when the tables are 
produced.
13.1.1. Demographic Data 
Table 4: Demographic Data Summary Tables
Number
Population
Title
Table 14.1.1
All 
Randomized
Summary of Subject Disposition 
Table 14.1.2.1
Safety
Summary of Demographics and Baseline Characteristics 
Table 14.1.2.2
ITT
Summary of Demographics and Baseline Characteristics 
Table 14.1.2.3
mITT
Summary of Demographics and Baseline Characteristics 
Table 14.1.3
Safety
Previous Treatment History of Scalp and Body Psoriasis
Table 14.1.4
Safety
Summary of Protocol Deviations
Table 14.1.5
Safety
Summary of Prior Medications by ATC Class Level 4 and Preferred Term
Table 14.1.6
Safety
Summary of Study Drug Exposure and Compliance 
13.1.2. Efficacy Data 
Table 5: Efficacy Data Summary Tables
Number
Population
Title
Table 14.2.1.1
ITT
Summary and Change from Baseline in Scalp Investigator Global Assessment 
(S-IGA) Grades by Study Visit – Observed Data
Table 14.2.1.2
mITT
Summary and Change from Baseline in Scalp Investigator Global Assessment 
(S-IGA) Grades by Study Visit – Observed Data
Table 14.2.1.3
ITT
Summary and Change from Baseline in Scalp Investigator Global Assessment 
(S-IGA) Grades by Study Visit – Multiple Imputation
Table 14.2.1.4
mITT
Summary and Change from Baseline in Scalp Investigator Global Assessment 
(S-IGA) Grades by Study Visit – Multiple Imputation


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 35 of 172
Number
Population
Title
Table 14.2.1.5.1
ITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Observed Data
Categorical Results
Table 14.2.1.5.2
ITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Observed Data
Categorical Results
Topical Corticosteroids – Naïve Subjects
Table 14.2.1.5.3
ITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Observed Data
Categorical Results 
Topical Vitamin D Derivatives – Naïve Subjects
Table 14.2.1.5.4
ITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Observed Data
Categorical Results
Subjects with Psoriasis Involvement on the Knee and/or Elbow
Table 14.2.1.5.5
ITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Observed Data
Categorical Results
Subjects who Achieved S-IGA and B-IGA Success at Week 8
Table 14.2.1.5.6
ITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit and Study Site – Observed Data
Categorical Results
Table 14.2.1.6.1
mITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Observed Data
Categorical Results
Table 14.2.1.6.2
mITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Observed Data
Categorical Results
Topical Corticosteroids – Naïve Subjects
Table 14.2.1.6.3
mITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Observed Data
Categorical Results 
Topical Vitamin D Derivatives – Naïve Subjects
Table 14.2.1.6.4
mITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Observed Data
Categorical Results
Subjects with Psoriasis Involvement on the Knee and/or Elbow


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 36 of 172
Number
Population
Title
Table 14.2.1.6.5
mITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Observed Data
Categorical Results
Subjects who Achieved S-IGA and B-IGA Success at Week 8
Table 14.2.1.6.6
mITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit and Study Site – Observed Data
Categorical Results
Table 14.2.1.7.1
ITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Multiple Imputation
Categorical Results
Table 14.2.1.7.2
ITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Multiple Imputation
Categorical Results
Baseline S-IGA = 3
Table 14.2.1.7.3
ITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Multiple Imputation
Categorical Results
Baseline S-IGA = 4
Table 14.2.1.7.4
ITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Multiple Imputation
Categorical Results
Age Category = 12-17 Years
Table 14.2.1.7.5
ITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Multiple Imputation
Categorical Results
Age Category = 18 Years
Table 14.2.1.7.6
ITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Multiple Imputation
Categorical Results
Subjects who Achieved S-IGA and B-IGA Success at Week 8
Table 14.2.1.8.1
mITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Multiple Imputation
Categorical Results
Table 14.2.1.8.2
mITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Multiple Imputation
Categorical Results
Baseline S-IGA = 3


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 37 of 172
Number
Population
Title
Table 14.2.1.8.3
mITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Multiple Imputation
Categorical Results
Baseline S-IGA = 4
Table 14.2.1.8.4
mITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Multiple Imputation
Categorical Results
Age Category = 12-17 Years
Table 14.2.1.8.5
mITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Multiple Imputation
Categorical Results
Age Category = 18 Years
Table 14.2.1.8.6
mITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Multiple Imputation
Categorical Results
Subjects who Achieved S-IGA and B-IGA Success at Week 8
Table 14.2.1.9
ITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Observed Data
Tabulation of Fitted Point Estimates from Generalized Estimating Equations for 
Binary Response
Table 14.2.1.10
mITT
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success 
by Study Visit – Observed Data 
Tabulation of Fitted Point Estimates from Generalized Estimating Equations for 
Binary Response
Table 14.2.1.11
ITT
Summary of Scalp Investigator Global Assessment (S-IGA) – Score of Clear –
Observed Data
Table 14.2.1.12
mITT
Summary of Scalp Investigator Global Assessment (S-IGA) – Score of Clear –
Observed Data
Figure 14.2.1.11
ITT
Plot of Scalp Investigator Global Assessment (S-IGA) Tipping Point Analysis
P Values vs Shift Parameters
Figure 14.2.1.12
mITT
Plot of Scalp Investigator Global Assessment (S-IGA) Tipping Point Analysis
P Values vs Shift Parameters
Table 14.2.2.1
ITT
Summary and Change from Baseline in Body Investigator Global Assessment 
(B-IGA) Grades by Study Visit 
Table 14.2.2.2
mITT
Summary and Change from Baseline in Body Investigator Global Assessment 
(B-IGA) Grades by Study Visit 
Table 14.2.2.3
ITT
Summary of Body Investigator Global Assessment (B-IGA) Grades and Success 
by Study Visit 
Categorical Results


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 38 of 172
Number
Population
Title
Table 14.2.2.4
mITT
Summary of Body Investigator Global Assessment (B-IGA) Grades and Success 
by Study Visit
Categorical Results
Table 14.2.3.1
ITT
Summary and Change from Baseline in PSSI Scores by Study Visit
Table 14.2.3.2
mITT
Summary and Change from Baseline in PSSI Scores by Study Visit
Table 14.2.3.3
ITT
Summary of Achievement of PSSI-50, PSSI-75, PSSI-90, and PSSI-100 by 
Study Visit
Table 14.2.3.4
mITT
Summary of Achievement of PSSI-50, PSSI-75, PSSI-90, and PSSI-100 by 
Study Visit
Table 14.2.3.5
ITT
Time to Achievement of PSSI-50, PSSI-75, and PSSI-90
Table 14.2.3.6
mITT
Time to Achievement of PSSI-50, PSSI-75, and PSSI-90
Table 14.2.3.7
ITT
Summary of  PSSI Scores by Study Visit – ANCOVA
Table 14.2.3.8
mITT
Summary of  PSSI Scores by Study Visit – ANCOVA
Table 14.2.4.1
ITT
Summary and Change from Baseline in Scalp Itch – Numeric Rating Scale (SI-
NRS) Pruritus Score by Study Visit 
Table 14.2.4.2
mITT
Summary and Change from Baseline in Scalp Itch – Numeric Rating Scale (SI-
NRS) Pruritus Score by Study Visit 
Table 14.2.4.3
SPRU4-ITT
Scalp Itch – Numeric Rating Scale (SI-NRS) Pruritus Score Success by Study 
Visit 
Table 14.2.4.4
SPRU4-mITT Scalp Itch – Numeric Rating Scale (SI-NRS) Pruritus Score Success by Study 
Visit 
Table 14.2.4.5
ITT
Summary of Scalp Itch – Numeric Rating Scale (SI-NRS) Pruritus Score by 
Study Visit – ANCOVA
Table 14.2.4.6
mITT
Summary of Scalp Itch – Numeric Rating Scale (SI-NRS) Pruritus Score by 
Study Visit – ANCOVA
Table 14.2.5.1
ITT
Summary and Change from Baseline in Psoriasis Symptom Diary (PSD) Total 
and Individual Item Scores by Study Visit 
Table 14.2.5.2
mITT
Summary and Change from Baseline in Psoriasis Symptom Diary (PSD) Total 
and Individual Item Scores by Study Visit
Table 14.2.5.3
ITT
Summary of Psoriasis Symptom Diary (PSD) Total Scores by Study Visit –
ANCOVA  
Table 14.2.5.4
mITT
Summary of Psoriasis Symptom Diary (PSD) Total Scores by Study Visit –
ANCOVA  
Table 14.2.6.1
ITT
Summary and Change from Baseline in PASI/mPASI by Study Visit 
Table 14.2.6.2
mITT
Summary and Change from Baseline in PASI/mPASI by Study Visit 
Table 14.2.6.3
ITT
Summary of PASI/mPASI by Study Visit – ANCOVA  
Table 14.2.6.4
mITT
Summary of PASI/mPASI by Study Visit – ANCOVA  


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 39 of 172
Number
Population
Title
Table 14.2.6.5
ITT
Summary of Achievement of PASI-50, PASI-75, and PASI-90 by Study Visit
Table 14.2.6.6
mITT
Summary of Achievement of PASI-50, PASI-75, and PASI-90 by Study Visit
Table 14.2.6.7
ITT
Time to Achievement of PASI-50
Table 14.2.6.8
mITT
Time to Achievement of PASI-50
Table 14.2.6.9
ITT
Summary of Achievement of mPASI-50, mPASI-75, and mPASI-90 by Study 
Visit
Table 14.2.6.10
mITT
Summary of Achievement of mPASI-50, mPASI-75, and mPASI-90 by Study 
Visit
Table 14.2.7.1
ITT
Summary and Change from Baseline in Worst Itch – Numeric Rating Scale 
(WI-NRS) by Study Visit
Table 14.2.7.2
mITT
Summary and Change from Baseline in Worst Itch – Numeric Rating Scale 
(WI-NRS) by Study Visit
Table 14.2.7.3
ITT
Summary of Worst Itch – Numeric Rating Scale (WI-NRS) by Study Visit –
ANCOVA 
Table 14.2.7.4
mITT
Summary of Worst Itch – Numeric Rating Scale (WI-NRS) by Study Visit –
ANCOVA 
Table 14.2.7.5
PRU4-ITT
Worst Itch – Numeric Rating Scale (WI-NRS) Pruritus Score Success by Study 
Visit 
Table 14.2.7.6
PRU4-mITT
Worst Itch – Numeric Rating Scale (WI-NRS) Pruritus Score Success by Study 
Visit 
Table 14.2.8.1
ITT
Summary and Change from Baseline in Dermatology Life Quality Index 
(DLQI)/Children’s DLQI (CDLQI) by Study Visit
Table 14.2.8.2
mITT
Summary and Change from Baseline in Dermatology Life Quality Index 
(DLQI)/Children’s DLQI (CDLQI) by Study Visit
Table 14.2.8.3
ITT
Summary of Dermatology Life Quality Index (DLQI)/Children’s DLQI 
(CDLQI) by Study Visit – ANCOVA 
Table 14.2.8.4
mITT
Summary of Dermatology Life Quality Index (DLQI)/Children’s DLQI 
(CDLQI) by Study Visit – ANCOVA 
Table 14.2.9.1
ITT
Summary and Change from Baseline in % Body Surface Area (BSA) Affected 
by Disease by Study Visit 
Table 14.2.9.2
mITT
Summary and Change from Baseline in % Body Surface Area (BSA) Affected 
by Disease by Study Visit 
Table 14.2.9.3
ITT
Summary of % Body Surface Area (BSA) Affected by Disease by Study Visit –
ANCOVA
Table 14.2.9.4
mITT
Summary of % Body Surface Area (BSA) Affected by Disease by Study Visit –
ANCOVA


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 40 of 172
13.1.3. Safety Data 
Table 6: Safety Data Summary Tables
Number
Population Title
14.3.1 Displays of Adverse Events
Table 14.3.1.1
Safety
Summary of Treatment Emergent Adverse Events 
Table 14.3.1.2
Safety
Incidence of Treatment Emergent Adverse Events by System Organ Class and 
Preferred Term
Table 14.3.1.3
Safety
Incidence of Treatment Emergent Adverse Events by System Organ Class, Preferred 
Term, and Maximum Severity
Table 14.3.1.4
Safety
Incidence of Treatment Emergent Adverse Events by System Organ Class, Preferred 
Term, and Relationship to Study Drug
Table 14.3.1.5
Safety
Incidence of Treatment Emergent Adverse Events Leading to Study Drug 
Discontinuation by System Organ Class and Preferred Term
Table 14.3.1.6
Safety
Incidence of Treatment Emergent Adverse Events Leading to Study Discontinuation 
by System Organ Class and Preferred Term
Table 14.3.1.7
Safety
Incidence of Related Treatment Emergent Adverse Events by Preferred Term 
14.3.2 Summary of Deaths, Other Serious and Significant Adverse Events
Table 14.3.2.1
Safety
Incidence of Serious Adverse Events by System Organ Class and Preferred Term
Table 14.3.2.2
Safety
Incidence of Serious Adverse Events by System Organ Class, Preferred Term, and 
Relationship to Study Drug
Table 14.3.2.3
Safety
Incidence of Serious Adverse Events by System Organ Class, Preferred Term, and 
Maximum Severity
14.3.3 Narratives of Deaths, Other Serious and Certain Other Significant Adverse Events
Table 14.3.3.1
Safety
Listing of Adverse Events Leading to Study Drug Discontinuation
Table 14.3.3.2
Safety
Listing of Serious Adverse Events
Table 14.3.3.3
Safety
Listing of Deaths
14.3.4 Abnormal Laboratory Value 
NA
14.3.5 Laboratory Data Summary Tables
Table 
14.3.5.1.1
Safety
Summary of Serum Chemistry Laboratory Results by Study Visit
Table 
14.3.5.1.2
Safety
Shift from Baseline in Clinical Chemistry Laboratory Results by Study Visit
Table 
14.3.5.2.1
Safety
Summary of Hematology Laboratory Results by Study Visit
Table 
14.3.5.2.2
Safety
Shift from Baseline in Hematology Laboratory Results by Study Visit


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 41 of 172
Number
Population Title
Table 
14.3.5.3.1
Safety
Summary of Quantitative Urinalysis Laboratory Results by Study Visit
Table 
14.3.5.3.2
Safety
Shift from Baseline in Quantitative and Qualitative Urinalysis Laboratory Results by 
Study Visit
Table 
14.3.5.3.3
Safety
Summary of Qualitative Urinalysis Laboratory Results by Study Visit
14.3.6 Other Safety Data Summary Tables
Table 14.3.6.1
Safety
Shift from Baseline in Patient Health Questionnaire (PHQ-8)/Modified PHQ-
Adolescents by Study Visit
Table 
14.3.6.2.1
Safety
Summary of Investigator Local Tolerability Assessment by Study Visit
Table 
14.3.6.2.2
Safety
Summary of Investigator Local Tolerability Assessment (Dermal Response) by Study 
Visit
Categorical Results
Table 
14.3.6.2.3
Safety
Summary of Investigator Local Tolerability Assessment (Other Effects) by Study 
Visit
Categorical Results
Table 
14.3.6.3.1
Safety
Summary of Subject Local Tolerability Assessment by Study Visit
Table 
14.3.6.3.2
Safety
Summary of Subject Local Tolerability Assessment by Study Visit
Categorical Results
Table 
14.3.6.4.1
Safety
Summary of Vital Signs by Study Visit
Table 
14.3.6.4.2
Safety
Shift from Baseline in Weight by Study Visit
Table 
14.3.6.4.3
Safety
Shift from Baseline in Weight by Study Visit and Weight Loss Intentional/Non-
Intentional Categories
Table 
14.3.6.4.4
Safety
Shift from Baseline in BMI Categories by Study Visit
Table 
14.3.6.4.5
Safety
Shift from Baseline in BMI Categories by Study Visit and Weight Loss 
Intentional/Non-Intentional Categories
Table 14.3.6.5
Safety
Summary of Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation and 
Suicidal Behavior by Study Visit
Table 14.3.6.6
Safety
Summary of Physical Examination by Study Visit
Table 14.3.6.7
Safety
Summary of Concomitant Medications by ATC Class Level 4 and Preferred Term
14.4 Pharmacokinetic and Pharmacodynamic Summary Tables
14.4.1.1
PK
Summary of Pharmacokinetic Results by Study Visit and Time Point
14.4.1.2
PK
Summary of Pharmacokinetic Parameters by Study Visit


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 42 of 172
13.2.
Planned Listing Descriptions
The following are planned data and patient/subject data listings for protocol number ARQ-154-
204.
In general, one listing will be produced per eCRF domain. All listings will be sorted by 
treatment, site, and subject number. All calculated variables will be included in the listings.
Screen failures will only be presented in Listing 16.2.2.1.
In all listings a blank line will be placed between each subject. Within a data listing, if an item 
appears line after line (e.g., repetition of subject number), then only the first occurrence will be 
displayed.
In data listings, the information for one subject will be kept on one page if at all possible, rather 
than splitting a subject’s information across pages.
Table 7: Planned Listings
Number
Population
Title
16.2.1 Subject Discontinuations/Completions
Listing 16.2.1.1
All Subjects
Subject Disposition
Listing 16.2.1.2
All Subjects
Subject Visits
16.2.2 Protocol Deviations
Listing 16.2.2.1
All Subjects
Inclusion and Exclusion Criteria Not Met
Listing 16.2.2.2
All Subjects
Protocol Deviations
16.2.3 Subjects Excluded from the Efficacy Analyses
Listing 16.2.3.1
All Subjects
Subject Randomization
Listing 16.2.3.2
All Subjects
Analysis Populations
16.2.4 Demographic Data and Other Baseline Characteristics
Listing 16.2.4.1.1
All Subjects
Subject Demographics
Listing 16.2.4.1.2
All Subjects
Baseline Characteristics
Listing 16.2.4.2
All Subjects
Medical History
16.2.5 Compliance and/or Drug Concentration Data
Listing 16.2.5.1
All Subjects
Study Drug Application at the Study Site
Listing 16.2.5.2
All Subjects
Cans
Listing 16.2.5.3
All Subjects
Diary Dispensation
Listing 16.2.5.4
All Subjects
Compliance (CRF)
Listing 16.2.5.5
All Subjects
Missed Doses
Listing 16.2.5.6
PK
Pharmacokinetic Blood Collection
Listing 16.2.5.7
PK
Pharmacokinetic Calculated Parameters


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 43 of 172
Number
Population
Title
16.2.6 Individual Efficacy Response Data
Listing 16.2.6.1
All Subjects
Scalp Investigator Global Assessment (S-IGA)
Listing 16.2.6.2
All Subjects
Body Investigator Global Assessment (B-IGA)
Listing 16.2.6.3
All Subjects
Psoriasis Scalp Severity Index (PSSI)
Listing 16.2.6.4
All Subjects
Scalp Itch – Numeric Rating Scale (SI-NRS)
Listing 16.2.6.5
All Subjects
Psoriasis Symptoms Diary (PSD)
Listing 16.2.6.6
All Subjects
Psoriasis Area Severity Index (PASI)/Modified PASI (mPASI)
Listing 16.2.6.7
All Subjects
Worst Itch – Numeric Rating Scale (WI-NRS)
Listing 16.2.6.8
All Subjects
Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI)
Listing 16.2.6.9
All Subjects
Body Surface Area (BSA) (excluding Palms and Soles) 
16.2.7 Adverse Event Listings (by Subject)
Listing 16.2.7.1
All Subjects
Adverse Events
16.2.8 Laboratory Values (by Subject)
Listing 16.2.8.1.1
All Subjects
Clinical Laboratory Data: Clinical Chemistry
Listing 16.2.8.1.2
All Subjects
Clinical Laboratory Data: Hematology
Listing 16.2.8.1.3
All Subjects
Clinical Laboratory Data: Urinalysis
Listing 16.2.8.1.4
All Subjects
Clinical Laboratory Data: Serum and Urine Pregnancy Test
16.2.9 Other Clinical Observations and Measurements (by Subject)
Listing 16.2.9.1
All Subjects
Investigator Local Tolerability Assessments
Listing 16.2.9.2
All Subjects
Subject Local Tolerability Assessments
Listing 16.2.9.3.1
All Subjects
Vital Signs
Listing 16.2.9.3.2
All Subjects
Vital Signs - Weight
Listing 16.2.9.4
All Subjects
Physical Examination
Listing 16.2.9.5
All Subjects
Medical Photography
Listing 16.2.9.6
All Subjects
Prior and Concomitant Medications
Listing 16.2.9.7
All Subjects
Patient Health Questionnaire (PHQ-8)/Modified PHQ-Adolescents 
(PHQ-A)
Listing 16.2.9.8
All Subjects
Columbia-Suicide Severity Rating Scale (C-SSRS)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 44 of 172
14.
Table, Listing, and Figure Shells
14.1.
Standard Layout for all Tables, Listings, and Figures
The following standard layout will be applied to all TLFs in support of this study. Note that 
programming notes may be added if appropriate after each TLF shell.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 45 of 172
Figure 2: Standardized Layout
Arcutis Biotherapeutics, Inc.
Page X of Y
Protocol: ARQ-154-204
<Version>
<Table, Listing, Figure> xx.x.x
<Title of Table Listing or Figure>
<Study Population and if applicable subgroup Description>
____________________________________________________________________________________________________________
Body of Table, Listing or Figure
___________________________________________________________________________________________________________
<Note: If directly Applicable>
Footnote 1 <if applicable>  Recommendation is to keep footnotes to a minimum
Footnote 2 <if applicable>
Footnote n <if applicable>
Footnote n+1 <pgm path and name>,  <date>


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 46 of 172
14.2.
Planned Table Shells
See Figure 3 below.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 47 of 172
Figure 3: Planned Table Shells


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 48 of 172
Table 14.1.1
Summary of Subject Disposition
All Randomized Subjects
Status
Roflumilast Foam 0.3%
(N=XX)
Vehicle 
(N=XX)
Overall
(N=XX)
Study Populations:
   ITT Population [1]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Safety Population [2]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%) 
   mITT Population [3]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   SPRU4-ITT Population [4]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   SPRU4-mITT Population [4]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   PRU4-ITT Population [5]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   PRU4-mITT Population [5]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   PK Population [6]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: COVID-19 = novel coronavirus disease-19; eCRF = electronic case report form; ITT = Intent-to-treat; IP = investigational product; mITT = 
modified intent-to-treat; PI = principal investigator; PK = pharmacokinetic; PRU4 = Subjects with WI-NRS Pruritus Score 4 at Baseline; S-IGA = scalp 
investigator global assessment; SI-NRS = Scalp Itch – Numeric Rating Scale; SPRU4 = Subjects with SI-NRS Pruritus Score 4 at Baseline; WI-NRS = 
Worst Itch – Numeric Rating Scale.
Note: Percentages are n/Number of subjects randomized within planned treatment and overall*100.
[1] The ITT population includes all randomized subjects.
[2] The Safety population includes all subjects who are enrolled and received at least 1 confirmed dose of IP.
[3] The mITT population includes all randomized subjects with the exception of subjects who missed the Week 8 disease assessment specifically due to 
COVID-19 disruptions.[4] The SPRU4-ITT and SPRU4-mITT populations are subsets of the ITT and mITT populations, respectively, and include subjects 
with SI-NRS pruritus score  4 at Baseline. These populations will be used for the analyses of achievement of a 4-point reduction in SI-NRS pruritus score as 
compared to Baseline.
[5] The PRU4-ITT and PRU4-mITT populations are subsets of the ITT and mITT populations, respectively, and include subjects with WI-NRS pruritus score 
 4 at Baseline. These populations will be used for the analyses of achievement of a 4-point reduction in WI-NRS pruritus score as compared to Baseline.
[6] The PK population includes all subjects receiving the active drug with sufficient plasma concentrations of roflumilast to define a profile, as determined by 
the pharmacokineticist.
[7] Based on completion of the S-IGA assessment at the Week 8 visit; if a subject is marked as not completing the study in the eCRF but completed the 
S-IGA assessment at the Week 8 visit before discontinuation, that subject will be considered as a completer for purposes of this summary, and reason for 
discontinuation is not summarized.
Reference Listings: 16.2.1.1, 16.2.3


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 49 of 172
Table 14.1.1 (cont.)
Summary of Subject Disposition
All Randomized Subjects
Status
Roflumilast Foam 0.3%
(N=XX)
Vehicle 
(N=XX)
Overall
(N=XX)
Completed Study [7]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Ongoing in Study
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Prematurely Discontinued from Study [7]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Reason for Discontinuation:
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Withdrawal by Subject
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Sponsor’s Decision
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      PI’s Decision
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Non-Compliance
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Protocol Violation
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Lost to Follow-up
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Adverse Event
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Death
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Pregnancy
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Other
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Programming note: only display reason for discontinuation if COMPLFL=N, regardless of ADSL.DCREAS.
Abbreviations: COVID-19 = novel coronavirus disease-19; eCRF = electronic case report form; ITT = Intent-to-treat; IP = investigational product; mITT = 
modified intent-to-treat; PI = principal investigator; PK = pharmacokinetic; PRU4 = Subjects with WI-NRS Pruritus Score 4 at Baseline; S-IGA = scalp 
investigator global assessment; SI-NRS = Scalp Itch – Numeric Rating Scale; SPRU4 = Subjects with SI-NRS Pruritus Score 4 at Baseline; WI-NRS = 
Worst Itch – Numeric Rating Scale.
Note: Percentages are n/Number of subjects randomized within planned treatment and overall*100.
[1] The ITT population includes all randomized subjects.
[2] The Safety population includes all subjects who are enrolled and received at least 1 confirmed dose of IP.
[3] The mITT population includes all randomized subjects with the exception of subjects who missed the Week 8 disease assessment specifically due to 
COVID-19 disruptions.[4] The SPRU4-ITT and SPRU4-mITT populations are subsets of the ITT and mITT populations, respectively, and include subjects 
with SI-NRS pruritus score  4 at Baseline. These populations will be used for the analyses of achievement of a 4-point reduction in SI-NRS pruritus score as 
compared to Baseline.
[5] The PRU4-ITT and PRU4-mITT populations are subsets of the ITT and mITT populations, respectively, and include subjects with WI-NRS pruritus score 
 4 at Baseline. These populations will be used for the analyses of achievement of a 4-point reduction in WI-NRS pruritus score as compared to Baseline.
[6] The PK population includes all subjects receiving the active drug with sufficient plasma concentrations of roflumilast to define a profile, as determined by 
the pharmacokineticist.
[7] Based on completion of the S-IGA assessment at the Week 8 visit; if a subject is marked as not completing the study in the eCRF but completed the 
S-IGA assessment at the Week 8 visit before discontinuation, that subject will be considered as a completer for purposes of this summary, and reason for 
discontinuation is not summarized.
Reference Listings: 16.2.1.1, 16.2.3


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 50 of 172
Table 14.1.1 (cont.)
Summary of Subject Disposition
All Randomized Subjects
Status
Roflumilast Foam 0.3%
(N=XX)
Vehicle 
(N=XX)
Overall
(N=XX)
Prematurely Discontinued from the Study Due to 
COVID-19 Disruption
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    Reason for Discontinuation:
        XXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
        XXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
        XXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
        XXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: COVID-19 = novel coronavirus disease-19; eCRF = electronic case report form; ITT = Intent-to-treat; IP = investigational product; mITT = 
modified intent-to-treat; PI = principal investigator; PK = Pharmacokinetic; PRU4 = Subjects with WI-NRS Pruritus Score 4 at Baseline; S-IGA = scalp 
investigator global assessment; SI-NRS = Scalp Itch – Numeric Rating Scale; SPRU4 = Subjects with SI-NRS Pruritus Score 4 at Baseline; WI-NRS = 
Worst Itch – Numeric Rating Scale.
Note: Percentages are n/Number of subjects randomized within planned treatment and overall*100.
[1] The ITT population includes all randomized subjects.
[2] The Safety population includes all subjects who are enrolled and received at least 1 confirmed dose of IP.
[3] The mITT population includes all randomized subjects with the exception of subjects who missed the Week 8 disease assessment specifically due to 
COVID-19 disruptions.[4] The SPRU4-ITT and SPRU4-mITT populations are subsets of the ITT and mITT populations, respectively, and include subjects 
with SI-NRS pruritus score  4 at Baseline. These populations will be used for the analyses of achievement of a 4-point reduction in SI-NRS pruritus score as 
compared to Baseline.
[5] The PRU4-ITT and PRU4-mITT populations are subsets of the ITT and mITT populations, respectively, and include subjects with WI-NRS pruritus score 
 4 at Baseline. These populations will be used for the analyses of achievement of a 4-point reduction in WI-NRS pruritus score as compared to Baseline.
[6] The PK population includes all subjects receiving the active drug with sufficient plasma concentrations of roflumilast to define a profile, as determined by 
the pharmacokineticist.
[7] Based on completion of the S-IGA assessment at the Week 8 visit; if a subject is marked as not completing the study in the eCRF but completed the 
S-IGA assessment at the Week 8 visit before discontinuation, that subject will be considered as a completer for purposes of this summary, and reason for 
discontinuation is not summarized.
Reference Listings: 16.2.1.1, 16.2.3
Programming note: “Ongoing in Study” row will be removed once the database has hardlocked and all subjects have completed the study. For COVID-19 Disruption, list only the 
reasons for discontinuation as populated in the database.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 51 of 172
Table 14.1.2.1
Summary of Demographics and Baseline Characteristics 
Safety Population
Variable
   Statistic or Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Age (years)
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Age Category
   12-17 years
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   18 years
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Gender
   Male
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Female
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Child-Bearing Potential? [1]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Yes
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    No
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Ethnicity
   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
   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%)
   Other
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   More than One Race
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: S-IGA = scalp investigator global assessment; B-IGA = body investigator global assessment; PSSI = Psoriasis Scalp Severity 
Index; SI-NRS = Scalp Itch – Numeric Rating Scale; PSD = Psoriasis Symptoms Diary; PASI = Psoriasis Area Severity Index; mPASI = modified 
PASI; WI-NRS = Worst Itch – Numeric Rating Scale; DLQI = Dermatology Life Quality Index; CDLQI = Children’s DLQI.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100.
[1] Only captured for female subjects; percentages are based on the number of female subjects in the Safety population.
[2] The SI-NRS was determined by asking the subject’s assessment of worst itch of scalp over the past 24 hours. The scale is from 0 to 10, 
which ranges from “no scalp itch” to “worst scalp itch imaginable”.
[3] The WI-NRS was determined by asking the subject’s assessment of worst itch over the past 24 hours. The scale is from 0 to 10, which 
ranges from “no itch” to “worst imaginable itch”.
Reference Listings: 16.2.4.1.1, 16.2.4.1.2, 16.2.6.1, 16.2.6.2, 16.2.6.3, 16.2.6.4, 16.2.6.5, 16.2.6.7, 16.2.9.4.1, 16.2.9.4.2


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 52 of 172
Table 14.1.2 (cont.)
Demographics and Baseline Characteristics
Safety Population
Variable
   Statistic or Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Height (cm)
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Weight (kg)
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Body Mass Index (kg/m2)
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Body Surface Area (%) Affected by Disease
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Abbreviations: S-IGA = scalp investigator global assessment; B-IGA = body investigator global assessment; PSSI = Psoriasis Scalp Severity Index; 
SI-NRS = Scalp Itch – Numeric Rating Scale; PSD = Psoriasis Symptoms Diary; PASI = Psoriasis Area Severity Index; mPASI = modified PASI; 
WI-NRS = Worst Itch – Numeric Rating Scale; DLQI = Dermatology Life Quality Index; CDLQI = Children’s DLQI.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100.
[1] Only captured for female subjects; percentages are based on the number of female subjects in the Safety population.
[2] The SI-NRS was determined by asking the subject’s assessment of worst itch of scalp over the past 24 hours. The scale is from 0 to 10, which 
ranges from “no scalp itch” to “worst scalp itch imaginable”.
[3] The WI-NRS was determined by asking the subject’s assessment of worst itch over the past 24 hours. The scale is from 0 to 10, which ranges 
from “no itch” to “worst imaginable itch”.
Reference Listings: 16.2.4.1.1, 16.2.4.1.2, 16.2.6.1, 16.2.6.2, 16.2.6.3, 16.2.6.4, 16.2.6.5, 16.2.6.6, 16.2.6.7, 16.2.6.8, 16.2.9.3.1, 16.2.9.3.2


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 53 of 172
Table 14.1.2.1 (cont.)
Demographics and Baseline Characteristics
Safety Population
Variable
   Statistic or Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline S-IGA
   Clear 
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Almost Clear
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Mild
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Moderate
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Severe
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Baseline S-IGA - Numeric
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Baseline B-IGA
   Clear 
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Almost Clear
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Mild
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Moderate
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Severe
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Baseline B-IGA - Numeric
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Abbreviations: S-IGA = scalp investigator global assessment; B-IGA = body investigator global assessment; PSSI = Psoriasis Scalp Severity 
Index; SI-NRS = Scalp Itch – Numeric Rating Scale; PSD = Psoriasis Symptoms Diary; PASI = Psoriasis Area Severity Index; mPASI = modified 
PASI; WI-NRS = Worst Itch – Numeric Rating Scale; DLQI = Dermatology Life Quality Index; CDLQI = Children’s DLQI.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100.
[1] Only captured for female subjects; percentages are based on the number of female subjects in the Safety population.
[2] The SI-NRS was determined by asking the subject’s assessment of worst itch of scalp over the past 24 hours. The scale is from 0 to 10, which
ranges from “no scalp itch” to “worst scalp itch imaginable”.
[3] The WI-NRS was determined by asking the subject’s assessment of worst itch over the past 24 hours. The scale is from 0 to 10, which ranges 
from “no itch” to “worst imaginable itch”.
Reference Listings: 16.2.4.1.1, 16.2.4.1.2, 16.2.6.1, 16.2.6.2, 16.2.6.3, 16.2.6.4, 16.2.6.5, 16.2.6.6, 16.2.6.7, 16.2.6.8, 16.2.9.3.1, 16.2.9.3.2


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 54 of 172
Table 14.1.2.1 (cont.)
Demographics and Baseline Characteristics
Safety Population
Variable
   Statistic or Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline PSSI - Numeric
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Baseline SI-NRS - Numeric [2]
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Baseline SI-NRS [2]
   0
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   4
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   5
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   6
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   7
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   8
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   9
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   10
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: S-IGA = scalp investigator global assessment; B-IGA = body investigator global assessment; PSSI = Psoriasis Scalp Severity 
Index; SI-NRS = Scalp Itch – Numeric Rating Scale; PSD = Psoriasis Symptoms Diary; PASI = Psoriasis Area Severity Index; mPASI = modified 
PASI; WI-NRS = Worst Itch – Numeric Rating Scale; DLQI = Dermatology Life Quality Index; CDLQI = Children’s DLQI.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100.
[1] Only captured for female subjects; percentages are based on the number of female subjects in the Safety population.
[2] The SI-NRS was determined by asking the subject’s assessment of worst itch of scalp over the past 24 hours. The scale is from 0 to 10, which 
ranges from “no scalp itch” to “worst scalp itch imaginable”.
[3] The WI-NRS was determined by asking the subject’s assessment of worst itch over the past 24 hours. The scale is from 0 to 10, which ranges 
from “no itch” to “worst imaginable itch”.
Reference Listings: 16.2.4.1.1, 16.2.4.1.2, 16.2.6.1, 16.2.6.2, 16.2.6.3, 16.2.6.4, 16.2.6.5, 16.2.6.6, 16.2.6.7, 16.2.6.8, 16.2.9.3.1, 16.2.9.3.2


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 55 of 172
Table 14.1.2.1 (cont.)
Demographics and Baseline Characteristics
Safety Population
Variable
   Statistic or Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline PSD Total Score
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Baseline PASI
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Baseline mPASI
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Abbreviations: S-IGA = scalp investigator global assessment; B-IGA = body investigator global assessment; PSSI = Psoriasis Scalp Severity 
Index; SI-NRS = Scalp Itch – Numeric Rating Scale; PSD = Psoriasis Symptoms Diary; PASI = Psoriasis Area Severity Index; mPASI = 
modified PASI; WI-NRS = Worst Itch – Numeric Rating Scale; DLQI = Dermatology Life Quality Index; CDLQI = Children’s DLQI.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100.
[1] Only captured for female subjects; percentages are based on the number of female subjects in the Safety population.
[2] The SI-NRS was determined by asking the subject’s assessment of worst itch of scalp over the past 24 hours. The scale is from 0 to 10, 
which ranges from “no scalp itch” to “worst scalp itch imaginable”.
[3] The WI-NRS was determined by asking the subject’s assessment of worst itch over the past 24 hours. The scale is from 0 to 10, which 
ranges from “no itch” to “worst imaginable itch”.
Reference Listings: 16.2.4.1.1, 16.2.4.1.2, 16.2.6.1, 16.2.6.2, 16.2.6.3, 16.2.6.4, 16.2.6.5, 16.2.6.6, 16.2.6.7, 16.2.6.8, 16.2.9.3.1, 16.2.9.3.2


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 56 of 172
Table 14.1.2.1 (cont.)
Demographics and Baseline Characteristics
Safety Population
Variable
   Statistic or Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline WI-NRS - Numeric [3]
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Baseline WI-NRS [3]
   0
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   4
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   5
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   6
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   7
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   8
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   9
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   10
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: S-IGA = scalp investigator global assessment; B-IGA = body investigator global assessment; PSSI = Psoriasis Scalp Severity 
Index; SI-NRS = Scalp Itch – Numeric Rating Scale; PSD = Psoriasis Symptoms Diary; PASI = Psoriasis Area Severity Index; mPASI = 
modified PASI; WI-NRS = Worst Itch – Numeric Rating Scale; DLQI = Dermatology Life Quality Index; CDLQI = Children’s DLQI.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100.
[1] Only captured for female subjects; percentages are based on the number of female subjects in the Safety population.
[2] The SI-NRS was determined by asking the subject’s assessment of worst itch of scalp over the past 24 hours. The scale is from 0 to 10, 
which ranges from “no scalp itch” to “worst scalp itch imaginable”.
[3] The WI-NRS was determined by asking the subject’s assessment of worst itch over the past 24 hours. The scale is from 0 to 10, which 
ranges from “no itch” to “worst imaginable itch”.
Reference Listings: 16.2.4.1.1, 16.2.4.1.2, 16.2.6.1, 16.2.6.2, 16.2.6.3, 16.2.6.4, 16.2.6.5, 16.2.6.6, 16.2.6.7, 16.2.6.8, 16.2.9.3.1, 16.2.9.3.2


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 57 of 172
Table 14.1.2.1 (cont.)
Demographics and Baseline Characteristics
Safety Population
Variable
   Statistic or Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline DLQI
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Baseline CDLQI
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Abbreviations: S-IGA = scalp investigator global assessment; B-IGA = body investigator global assessment; PSSI = Psoriasis Scalp Severity 
Index; SI-NRS = Scalp Itch – Numeric Rating Scale; PSD = Psoriasis Symptoms Diary; PASI = Psoriasis Area Severity Index; mPASI = modified 
PASI; WI-NRS = Worst Itch – Numeric Rating Scale; DLQI = Dermatology Life Quality Index; CDLQI = Children’s DLQI.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100.
[1] Only captured for female subjects; percentages are based on the number of female subjects in the Safety population.
[2] The SI-NRS was determined by asking the subject’s assessment of worst itch of scalp over the past 24 hours. The scale is from 0 to 10, which 
ranges from “no scalp itch” to “worst scalp itch imaginable”.
[3] The WI-NRS was determined by asking the subject’s assessment of worst itch over the past 24 hours. The scale is from 0 to 10, which ranges 
from “no itch” to “worst imaginable itch”.
Reference Listings: 16.2.4.1.1, 16.2.4.1.2, 16.2.6.1, 16.2.6.2, 16.2.6.3, 16.2.6.4, 16.2.6.5, 16.2.6.6, 16.2.6.7, 16.2.6.8, 16.2.9.3.1, 16.2.9.3.2


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 58 of 172
Table 14.1.2.2
Summary of Demographics and Baseline Characteristics 
ITT Population
(Same shell as Table 14.1.2.1; subjects are summarized by planned treatment, not treatment received;
Update Note: footnote as Percentages are n/Number of subjects in the ITT population within planned treatment and overall*100.)
Table 14.1.2.3
Summary of Demographics and Baseline Characteristics 
mITT Population
(Same shell as Table 14.1.2.1; subjects are summarized by planned treatment, not treatment received;
Update Note: footnote as Percentages are n/Number of subjects in the mITT population within planned treatment and overall*100.)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 59 of 172
Table 14.1.3
Previous Treatment History of Scalp and Body Psoriasis
Safety Population
Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle 
(N=XX)
Overall
(N=XX)
Inadequate Response, Intolerance or 
Contraindication to 
   Topical Corticosteroids
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Topical Vitamin D Derivatives
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Missing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Subject has Psoriasis Involvement on
   Knees and/or Elbow
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Genitalia
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Missing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Subjects with a 
response of “Yes” are summarized.
Reference Listing: 16.2.4.2
Programming note: Only display Missing rows if a subject does not have an answer to the questions on the CRF regarding previous treatment and/or psoriasis involvement.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 60 of 172
Table 14.1.4
Summary of Protocol Deviations 
Safety Population
Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle 
(N=XX)
Overall
(N=XX)
Subjects with Any Protocol Deviations
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Subjects with Major Protocol Deviations
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   XXXXXXXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   XXXXXXXXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   XXXXXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Only major protocol 
deviations are presented. Subjects with any protocol deviations row can include counts from major and minor deviations. Subjects with 
one or more deviations within a type of protocol deviation were counted only once. Protocol Deviations were collected throughout the 
study.
Reference Listing: 16.2.2.2
Programming note: the structure of this table may change depending on the information in the protocol deviations file.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Page 61 of 172
Table 14.1.5
Summary of Prior Medications by ATC Class Level 4 and Preferred Term
Safety Population
ATC Class Level 4
   Preferred Term 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Subjects with at least 1 Prior Medication
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
ATC Class 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
ATC Class 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: ATC = Anatomic Therapeutic Chemical; PT = preferred term; WHO-DDE = World Health Organization-Drug Dictionary 
Enhanced.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Medications were coded 
using WHO-DDE Global B3 version September 2019. Prior medications are all medications that were started before the application of study
drug. Medications are displayed by alphabetical order of ATC Level 4 classification, then descending frequency of PT within ATC, and then 
alphabetically by PT. Subjects were counted only once for each ATC and PT.
Reference Listing: 16.2.9.6
Programming note: ATC & PT text should be presented as is from the dataset.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
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Table 14.1.6
Summary of Study Drug Exposure and Compliance 
Safety Population
Variable
   Statistic / Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Total Number of IP Applications
   n
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
Total Weight of IP Applied (g) [1]
   n
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
Compliance [2]
   >100%
XX (XX.X%)
XX (XX.X%)
    80% - 100%
XX (XX.X%)
XX (XX.X%)
   < 80%
XX (XX.X%)
XX (XX.X%)
> 3 Consecutive Missed Doses
XX (XX.X%)
XX (XX.X%)
Compliant [3]
XX (XX.X%)
XX (XX.X%)
Abbreviation: IP = investigational product.
Note: n is the number of subjects in the Safety Population. Percentages are n/Number of subjects in the Safety 
Population within treatment received*100.
[1] Total weight of IP is determined by subtracting returned can weight from the dispensed can weight.
[2] Compliance is calculated based on number of applications divided by the expected number of IP applications 
for each subject*100.
[3] A subject is considered compliant if the subject applies at least 80% of the expected applications during the IP 
application period and does not miss more than 3 consecutive doses.
Reference Listings: 16.2.5.1, 16.2.5.2, 16.2.5.4


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 63 of 172
Table 14.2.1.1
Summary and Change from Baseline in Scalp Investigator Global Assessment (S-IGA) Grades by Study Visit – Observed Data
ITT Population
Roflumilast Foam 0.3%
Vehicle 
Study Visit
(N=XX)
(N=XX)
   Statistic
Observed
Change
Observed
Change
Baseline 
   n
XX
XX
   Mean (SD)
XX.X (X.XX)
XX.X (X.XX)
   Median
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
   Q1, Q3
XX.X
XX.X
Week 2
   n
XX
XX
XX
XX
   Mean (SD)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
   Median
XX.X
XX.X
XX.Xs
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
XX, XX
   Q1, Q3
XX.X
XX.X
XX.X
XX.X
   
Repeat for Week 4, Week 8, Week 9. 
Abbreviation: S-IGA = scalp investigator global assessment.
Note: Subjects are summarized by planned treatment. S-IGA is a static qualitative evaluation of overall psoriasis severity involving an ordinal scale with 5 
severity grades (reported only in integers of 0 to 4) where 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe. Baseline is the last non-missing 
measurement taken before the first application of study drug. Change from baseline is calculated as result – baseline result. 
Reference Listing: 16.2.6.1


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 64 of 172
Table 14.2.1.2
Summary and Change from Baseline in Scalp Investigator Global Assessment (S-IGA) Grades by Study Visit – Observed Data
mITT Population
(Same shell as Table 14.2.1.1)
Table 14.2.1.3
Summary and Change from Baseline in Scalp Investigator Global Assessment (S-IGA) Grades by Study Visit – Multiple Imputation
ITT Population
(Same shell as Table 14.2.1.1; add “B-IGA = body investigator global assessment” to abbreviations in alphabetical order; Programming note: update “Note:” portion of 
footnote to add in the following text just after “Note:”:  Separate multiple imputation steps were used for monotone and non-monotone missing data. For monotone missing 
pattern, a predictive mean matching model was used to impute missing value for a subject at particular visit having baseline S-IGA score, treatment group, and country as independent 
variables and study visit as dependent variable. For non-monotone missing IGA values, Markov-Chain Monte Carlo (MCMC) method was used to impute the data at intermediate visits 
to make the missing data pattern into monotone before applying the predictive mean matching multiple imputation algorithm. )
Table 14.2.1.4
Summary and Change from Baseline in Scalp Investigator Global Assessment (S-IGA) Grades by Study Visit – Multiple Imputation
mITT Population
(Same shell as Table 14.2.1.1; add “B-IGA = body investigator global assessment” to abbreviations in alphabetical order; Programming note: update “Note:” portion of 
footnote to add in the following text just after “Note:”:  Separate multiple imputation steps were used for monotone and non-monotone missing data. For monotone missing 
pattern, a predictive mean matching model was used to impute missing value for a subject at particular visit having baseline S-IGA score, treatment group, and country as independent 
variables and study visit as dependent variable. For non-monotone missing IGA values, Markov-Chain Monte Carlo (MCMC) method was used to impute the data at intermediate visits 
to make the missing data pattern into monotone before applying the predictive mean matching multiple imputation algorithm.)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 65 of 172
Table 14.2.1.5.1
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Observed Data
Categorical Results
ITT Population
Study Visit
   Category/Statistic 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Baseline
XX
XX
   0 = Clear
XX (XX.X%)
XX (XX.X%)
   1 = Almost Clear
XX (XX.X%)
XX (XX.X%)
   2 = Mild
XX (XX.X%)
XX (XX.X%)
   3 = Moderate
XX (XX.X%)
XX (XX.X%)
   4 = Severe
XX (XX.X%)
XX (XX.X%)
Week 2
XX
XX
   0 = Clear
XX (XX.X%)
XX (XX.X%)
   1 = Almost Clear
XX (XX.X%)
XX (XX.X%)
   2 = Mild
XX (XX.X%)
XX (XX.X%)
   3 = Moderate
XX (XX.X%)
XX (XX.X%)
   4 = Severe
XX (XX.X%)
XX (XX.X%)
   S-IGA Success [1]
      Yes 
XX (XX.X%)
XX (XX.X%)
         95% CI [2]
(X.XX, X.XX)
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (95% CI) [3] 
X.XX (X.XX, X.XX)
      P value [3]
X.XXXX
Repeat for all Week 4, Week 8, and Week 9.
Abbreviations: B-IGA = body investigator global assessment; CI = confidence interval; S-IGA = scalp 
investigator global assessment.
Note: Percentages are n/Number of subjects in the ITT population within planned treatment at each 
visit*100. Baseline is the last non-missing measurement taken before the first application of study drug.
[1] S-IGA Success (“Yes”) is defined as an S-IGA score of “Clear” or “Almost Clear” plus a 2-grade 
improvement from baseline; “No” otherwise.
[2] 95% CIs for “Yes” are obtained using Wilson method.
[3] The odds ratio, 95% CI, and P value are obtained from Cochran Mantel Haenszel test (stratified by 
country, baseline S-IGA category, and baseline B-IGA category) comparing roflumilast foam 0.3% to vehicle.
Reference Listings: 16.2.6.1, 16.2.6.2


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 66 of 172
Table 14.2.1.5.2
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Observed Data
Categorical Results
ITT Population - Topical Corticosteroids - Naïve Subjects
(Same shell as Table 14.2.1.5.1; add 16.2.4.2 to reference listings; change “Percentages” footnote to be “Percentages are n/Number of subjects in the ITT population that 
are topical corticosteroids – naïve subjects within planned treatment at each visit*100.”)
Table 14.2.1.5.3
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Observed Data
Categorical Results
ITT Population - Topical Vitamin D Derivative - Naïve Subjects
(Same shell as Table 14.2.1.5.1; add 16.2.4.2 to reference listings; change “Percentages” footnote to be “Percentages are n/Number of subjects in the ITT population that 
are topical vitamin D derivative – naïve subjects within planned treatment at each visit*100.”)
Table 14.2.1.5.4
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Observed Data
Categorical Results
ITT Population - Subjects with Psoriasis Involvement on the Knee and/or Elbow
(Same shell as Table 14.2.1.5.1; add 16.2.4.2 to reference listings; change “Percentages” footnote to be “Percentages are n/Number of subjects in the ITT population that 
have psoriasis involvement on the knee and/or elbow within planned treatment at each visit*100.”)
Table 14.2.1.5.5
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Observed Data
Categorical Results
ITT Population - Subjects who Achieved S-IGA and B-IGA Success at Week 8
(Same shell as Table 14.2.1.5.1; change “Percentages” footnote to be “Percentages are n/Number of subjects in the ITT population that achieved both S-IGA and B-IGA 
success at Week 8 within planned treatment at each visit*100.”)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 67 of 172
Table 14.2.1.5.6
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Observed Data
Categorical Results
ITT Population – by Study Site
Study Site: SITENAM (Site SITEID)
Study Visit
   Category/Statistic 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Baseline
XX
XX
   0 = Clear
XX (XX.X%)
XX (XX.X%)
   1 = Almost Clear
XX (XX.X%)
XX (XX.X%)
   2 = Mild
XX (XX.X%)
XX (XX.X%)
   3 = Moderate
XX (XX.X%)
XX (XX.X%)
   4 = Severe
XX (XX.X%)
XX (XX.X%)
Week 2
XX
XX
   0 = Clear
XX (XX.X%)
XX (XX.X%)
   1 = Almost Clear
XX (XX.X%)
XX (XX.X%)
   2 = Mild
XX (XX.X%)
XX (XX.X%)
   3 = Moderate
XX (XX.X%)
XX (XX.X%)
   4 = Severe
XX (XX.X%)
XX (XX.X%)
   S-IGA Success [1]
      Yes 
XX (XX.X%)
XX (XX.X%)
         95% CI [2]
(X.XX, X.XX)
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (95% CI) [3] 
X.XX (X.XX, X.XX)
      P value [3]
X.XXXX
Repeat for all Week 4, Week 8, and Week 9.
Abbreviations: B-IGA = body investigator global assessment; CI = confidence interval; S-IGA = scalp investigator global assessment.
Note: Percentages are n/Number of subjects in the ITT population within planned treatment and study site at each visit*100. Baseline is the 
last non-missing measurement taken before the first application of study drug.
[1] S-IGA Success (“Yes”) is defined as an S-IGA score of “Clear” or “Almost Clear” plus a 2-grade improvement from baseline; “No” 
otherwise.
[2] 95% CIs for “Yes” are obtained using Wilson method.
[3] The odds ratio, 95% CI, and P value are obtained from Cochran Mantel Haenszel test (stratified by country, baseline S-IGA category, and 
baseline B-IGA category) comparing roflumilast foam 0.3% to vehicle.
Reference Listings: 16.2.6.1, 16.2.6.2
Programming note: sort by ADSL.SITEID. Format study site as shown (e.g., “Study Site Name (Site 01)”).


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
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Table 14.2.1.6.1
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Observed Data
Categorical Results
mITT Population
(Same shell as Table 14.2.1.5)
Table 14.2.1.6.2
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Observed Data
Categorical Results
mITT Population - Topical Corticosteroids - Naïve Subjects
(Same shell as Table 14.2.1.5.2; add 16.2.4.2 to reference listings; change “Percentages” footnote to be “Percentages are n/Number of subjects in the mITT population 
that are topical corticosteroids – naïve subjects within planned treatment at each visit*100.”)
Table 14.2.1.6.3
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Observed Data
Categorical Results
mITT Population - Topical Vitamin D Derivative - Naïve Subjects
(Same shell as Table 14.2.1.5.3; add 16.2.4.2 to reference listings; change “Percentages” footnote to be “Percentages are n/Number of subjects in the mITT population 
that are topical vitamin D derivative – naïve subjects within planned treatment at each visit*100.”)
Table 14.2.1.6.4
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Observed Data
Categorical Results
mITT Population - Subjects with Psoriasis Involvement on the Knee and/or Elbow
(Same shell as Table 14.2.1.5.4; add 16.2.4.2 to reference listings; change “Percentages” footnote to be “Percentages are n/Number of subjects in the mITT that have 
psoriasis involvement on the knee and/or elbow within planned treatment at each visit*100.”)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Page 69 of 172
Table 14.2.1.6.5
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Observed Data
Categorical Results
mITT Population - Subjects who Achieved S-IGA and B-IGA Success at Week 8
(Same shell as Table 14.2.1.5.1; change “Percentages” footnote to be “Percentages are n/Number of subjects in the mITT population that achieved both S-IGA and B-IGA 
success at Week 8 within planned treatment at each visit*100.”)
Table 14.2.1.6.6
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Observed Data
Categorical Results
mITT Population – by Study Site
(Same shell as Table 14.2.1.5.6; )


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
PCN Number ARCU210101
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Table 14.2.1.7.1
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Multiple Imputation
Categorical Results
ITT Population
(Same shell as Table 14.2.1.5.1; add “B-IGA = body investigator global assessment” to abbreviations in alphabetical order; update “Note:” portion of footnote to add in the 
following text just after “Note:”:  Separate multiple imputation steps were used for monotone and non-monotone missing data. For monotone missing pattern, a predictive mean 
matching model was used to impute missing value for a subject at particular visit having baseline S-IGA score, treatment group, and country as independent variables and study visit 
as dependent variable. For non-monotone missing IGA values, Markov-Chain Monte Carlo (MCMC) method was used to impute the data at intermediate visits to make the missing 
data pattern into monotone before applying the predictive mean matching multiple imputation algorithm.)
Table 14.2.1.7.2
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Multiple Imputation
Categorical Results
ITT Population – Baseline S-IGA = 3
(Same shell as Table 14.2.1.7.1; change “Percentages” footnote to be “Percentages are n/Number of subjects in the ITT population that have a baseline S-IGA score of 3
within planned treatment at each visit*100.”)
Table 14.2.1.7.3
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Multiple Imputation
Categorical Results
ITT Population – Baseline S-IGA = 4
(Same shell as Table 14.2.1.7.1; change “Percentages” footnote to be “Percentages are n/Number of subjects in the ITT population that have a baseline S-IGA score of 4
within planned treatment at each visit*100.”)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
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Table 14.2.1.7.4
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Multiple Imputation
Categorical Results
ITT Population – Age Category = 12-17 Years
(Same shell as Table 14.2.1.7.1; change “Percentages” footnote to be “Percentages are n/Number of subjects in the ITT population that are between 12 and 17 years of 
age, inclusive, within planned treatment at each visit*100.”)
Table 14.2.1.7.5
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Multiple Imputation
Categorical Results
ITT Population – Age Category = 18 Years
(Same shell as Table 14.2.1.7.1; change “Percentages” footnote to be “Percentages are n/Number of subjects in the ITT population that are aged 18 years or older within 
planned treatment at each visit*100.”)
Table 14.2.1.7.6
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Multiple Imputation
Categorical Results
ITT Population – Subjects who Achieved S-IGA and B-IGA Success at Week 8
(Same shell as Table 14.2.1.7.1; change “Percentages” footnote to be “Percentages are n/Number of subjects in the ITT population that achieved both S-IGA and B-IGA 
success at Week 8 within planned treatment at each visit*100.”)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.2.1.8.1
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Multiple Imputation
Categorical Results
mITT Population
(Same shell as Table 14.2.1.7.1)
Table 14.2.1.8.2
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Multiple Imputation
Categorical Results
mITT Population – Baseline S-IGA = 3
(Same shell as Table 14.2.1.7.1; change “Percentages” footnote to be “Percentages are n/Number of subjects in the mITT population that have a baseline S-IGA score of 3
within planned treatment at each visit*100.”)
Table 14.2.1.8.3
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Multiple Imputation
Categorical Results
mITT Population – Baseline S-IGA = 4
(Same shell as Table 14.2.1.7.1; change “Percentages” footnote to be “Percentages are n/Number of subjects in the mITT population that have a baseline S-IGA score of 4
within planned treatment at each visit*100.”)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.2.1.8.4
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Multiple Imputation
Categorical Results
mITT Population – Age Category = 12-17 Years
(Same shell as Table 14.2.1.7.1; change “Percentages” footnote to be “Percentages are n/Number of subjects in the mITT population that are between 12 and 17 years of 
age, inclusive, within planned treatment at each visit*100.”)
Table 14.2.1.8.5
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Multiple Imputation
Categorical Results
mITT Population – Age Category = 18 Years
(Same shell as Table 14.2.1.7.1; change “Percentages” footnote to be “Percentages are n/Number of subjects in the mITT population that are aged 18 years or older within 
planned treatment at each visit*100.”)
Table 14.2.1.8.6
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Multiple Imputation
Categorical Results
mITT Population – Subjects who Achieved S-IGA and B-IGA Success at Week 8
(Same shell as Table 14.2.1.7.1; change “Percentages” footnote to be “Percentages are n/Number of subjects in the mITT population that achieved both S-IGA and B-IGA 
success at Week 8 within planned treatment at each visit*100.”)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.2.1.9
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Observed Data
Tabulation of Fitted Point Estimates from Generalized Estimating Equations for Binary Response
ITT Population
Study Visit 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Treatment Difference 
(Roflumilast Foam 0.3% vs Vehicle) [3]
n [1]
Responder [2]
n [1]
Responder [2]
Odds Ratio
95% CI for OR
P value
Week 2
XX
XX.X %
XX
XX.X %
X.XX
(XX.XX, XX.XX)
X.XXXX
Week 4
XX
XX.X %
XX
XX.X %
X.XX
(XX.XX, XX.XX)
X.XXXX
Week 8
XX
XX.X %
XX
XX.X %
X.XX
(XX.XX, XX.XX)
X.XXXX
Week 9
XX
XX.X %
XX
XX.X %
X.XX
(XX.XX, XX.XX)
X.XXXX
Abbreviations: CI = Confidence interval; OR = odds ratio; S-IGA = scalp investigator global assessment.
Note: Percentages are n/Number of subjects in the ITT population within planned treatment at each visit*100. Baseline is the last non-missing measurement taken before 
the first application of study drug.
[1] Number of subjects at each visit.
[2] Number of subjects with an S-IGA score of “Clear” or “Almost Clear” plus a 2-grade improvement from baseline.
[3] Estimates for odds ratio, 95% CI for odds ratio, and P value are from a generalized estimating equations for binary response model, with S-IGA success as the 
dependent variable and treatment, country, visit, and baseline S-IGA score as the independent variables. An unstructured correlation matrix was used to model the within 
subject correlation. In case of convergence issues, other covariance structures will be used including Toeplitz, compound symmetry or Autoregressive (1) (AR[1]) covariance 
structure will be used, following this sequence until convergence is achieved. The odds ratio is the estimate of the odds of having S-IGA response for subjects treated with 
roflumilast foam 0.3% relative to that for subjects treated with vehicle.
Reference Listing: 16.2.6.1


Statistical Analysis Plan, 
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Table 14.2.1.10
Summary of Scalp Investigator Global Assessment (S-IGA) Grades and Success by Study Visit – Observed Data
Tabulation of Fitted Point Estimates from Generalized Estimating Equations for Binary Response
mITT Population
(Programming note: Same as table shell 14.2.1.9)


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
PCN Number ARCU210101
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Table 14.2.1.11
Summary of Scalp Investigator Global Assessment (S-IGA) – Score of Clear – Observed Data
ITT Population
Study Visit
   Category/Statistic 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Week 2
XX
XX
   S-IGA Clear [1]
      Yes 
XX (XX.X%)
XX (XX.X%)
        95% CI [2]
(X.XX, X.XX)
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (95% CI) [3] 
X.XX (X.XX, X.XX)
      P value [3]
X.XXXX
Repeat for all Week 4, Week 8, and Week 9.
Abbreviations: CI = confidence interval; S-IGA = scalp investigator global assessment.
Note: Percentages are n/Number of subjects in the ITT population within planned treatment at each 
visit*100. Baseline is the last non-missing measurement taken before the first application of study drug.
[1] S-IGA Clear (“Yes”) is defined as an S-IGA score of “Clear”; “No” otherwise.
[2] 95% CIs for “Yes” are obtained using Wilson method.
[3] The odds ratio, 95% CI, and P value are obtained from Cochran Mantel Haenszel test (stratified by 
country, baseline S-IGA category, and baseline B-IGA category) comparing roflumilast foam 0.3% to vehicle.
Reference Listing: 16.2.6.1


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
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Table 14.2.1.12
Summary of Scalp Investigator Global Assessment (S-IGA) – Score of Clear – Observed Data
mITT Population
(Same as table shell 14.2.1.11)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Figure 14.2.1.13
Plot of Scalp Investigator Global Assessment (S-IGA) Tipping Point Analysis
P Values vs Shift Parameters
ITT Population
Shift Parameter
P value
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
0.0585
X.XX
0.0513
X.XX
0.0448
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
X.XX
X.XXXX
Abbreviation: MNAR = missing not at random.
Note: A tipping point analysis was performed in order to determine the inflection point at which the inference under the MNAR assumption for multiple imputation 
changes substantially and is used to check the robustness of the imputation. Shift parameters from -1.5 to 1.5 by 0.2 were initially used to determine approximately 
where results of the analysis are shifted from significant (i.e., P  0.05) to non-significant (i.e., P > 0.05). Once this was determined, the range around the 
approximate inflection point was expanded to include values with greater precision (i.e., to 2 decimal places, by 0.01); this expanded range of shift parameters and P 
values are presented here. If this tipping point value is considered clinically implausible, then there is evidence of efficacy with respect to the primary endpoint 
despite missing data.
-2
-1
0
1
2
Shift Parameter
0.0
0.1
0.2
0.3
0.4
P-value


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
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Figure 14.2.1.14
Plot of Scalp Investigator Global Assessment (S-IGA) Tipping Point Analysis
P Values vs Shift Parameters
mITT Population
(Programming note: Same as figure shell 14.2.1.13)
Table 14.2.2.1
Summary and Change from Baseline in Body Investigator Global Assessment (B-IGA) Grades by Study Visit
ITT Population
(Programming note: Same as table shell 14.2.1.1; update reference listing to Reference Listing: 16.2.6.2; Update any instances of S-IGA to B-IGA)
Table 14.2.2.2
Summary and Change from Baseline in Body Investigator Global Assessment (B-IGA) Grades by Study Visit
mITT Population
(Programming note: Same as table shell 14.2.1.1; update reference listing to Reference Listing: 16.2.6.2; Update any instances of S-IGA to B-IGA)
Table 14.2.2.3
Summary of Body Investigator Global Assessment (B-IGA) Grades and Success by Study Visit
Categorical Results 
ITT Population
(Programming note: Same as table 14.2.1.5; update reference listing to Reference Listings: 16.2.6.1, 16.2.6.2; Update any instances of S-IGA to B-IGA)
Table 14.2.2.4
Summary of Body Investigator Global Assessment (B-IGA) Grades and Success by Study Visit
Categorical Results 
mITT Population
(Programming note: Same as table 14.2.1.5; update reference listing to Reference Listing: 16.2.6.2; Update any instances of S-IGA to B-IGA)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.2.3.1
Summary and Change from Baseline in PSSI Scores by Study Visit 
ITT Population
Roflumilast Foam 0.3%
Vehicle 
(N=XX)
Study Visit
(N=XX)
   Statistic
Observed
Change
% Change
Observed
Change
% Change
Baseline 
   n
XX
XX
   Mean (SD)
XX.X (X.XX)
XX.X (X.XX)
   Median
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
   Q1, Q3
XX.X
XX.X
Week 2
   n
XX
XX
XX
XX
XX
XX
   Mean (SD)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
   Median
XX.X
XX.X
XX.X
XX.Xs
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
XX, XX
XX, XX
XX, XX
   Q1, Q3
XX.X
XX.X
XX.X
XX.X
XX.X
XX.X
Repeat for Week 4, Week 8, Week 9. 
Abbreviation: PSSI = Psoriasis Scalp Severity Index.
Note: Subjects are summarized by planned treatment. PSSI total score is calculated as (erythema score + induration + desquamation) × extent of scalp affected. The score ranges 
from 0 to 72. Erythema, induration, and desquamation are scored on a scale of 0 to 4, where 0 = absent and 4 = severest possible; extent of scale affected is scored on a scale of 
0 to 6, where 0 = 0% of involved area and 6 = 90-100% of involved area. Baseline is the last non-missing measurement taken before the first application of study drug. Change 
from baseline is calculated as result – baseline result. Percent change from baseline is calculated as (change from baseline/baseline)*100.
Reference Listing: 16.2.6.3


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
PCN Number ARCU210101
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Table 14.2.3.2
Summary and Change from Baseline in PSSI Scores by Study Visit
mITT Population
(Programming note: Same as table 14.2.3.1)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.2.3.3
Summary of Achievement of PSSI-50, PSSI-75, PSSI-90, and PSSI-100 by Study Visit
ITT Population
Study Visit
   Category/Statistic 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Week 2
XX
XX
   PSSI-50 [1]
      Yes 
XX (XX.X%)
XX (XX.X%)
        95% CI [5]
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (95% CI) [6] 
X.XX (X.XX, X.XX)
      P value [6]
X.XXXX
   PSSI-75 [2]
      Yes 
XX (XX.X%)
XX (XX.X%)
        95% CI [5]
(X.XX, X.XX)
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (95% CI) [6] 
X.XX (X.XX, X.XX)
X.XX (X.XX, X.XX)
      P value [6]
X.XXXX
Continue for PSSI-90 [3] and PSSI-100 [4]; Repeat for Week 4, Week 8, and Week 9.
Abbreviations: B-IGA = body investigator global assessment; CI = confidence interval; S-IGA = scalp investigator global assessment; 
PSSI = Psoriasis Scalp Severity Index.
Note: Percentages are n/Number of subjects in the ITT population within planned treatment at each visit*100. Baseline is the last non-
missing measurement taken before the first application of study drug.
[1] PSSI-50 is populated with “Yes” when there is an achievement of a 50% reduction in PSSI total score from baseline; “No” otherwise.
[2] PSSI-75 is populated with “Yes” when there is an achievement of a 75% reduction in PSSI total score from baseline; “No” otherwise.
[3] PSSI-90 is populated with “Yes” when there is an achievement of a 90% reduction in PSSI total score from baseline; “No” otherwise.
[4] PSSI-100 is populated with “Yes” when there is an achievement of a 100% reduction in PSSI total score from baseline; “No” otherwise.
[5] 95% CI for “Yes” are obtained using Wilson method.
[6] The odds ratio, 95% CI, and P value are obtained from Cochran Mantel Haenszel test (stratified by country, baseline S-IGA score 
category, and baseline B-IGA score category) comparing roflumilast foam 0.3% to vehicle.
Reference Listings: 16.2.6.1, 16.2.6.2, 16.2.6.3


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
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Table 14.2.3.4
Summary of Achievement of PSSI-50, PSSI-75, PSSI-90, and PSSI-100 by Study Visit
mITT Population
(Programming note: Same as table 14.2.3.3.)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
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PCN Number ARCU210101
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Table 14.2.3.5
Time to Achievement of PSSI-50, PSSI-75, and PSSI-90
ITT Population
Variable
   Statistic
Roflumilast Foam 0.3%
(N=XXX)
Vehicle
(N=XXX)
Time to Achieve PSSI-50 (Days) [1]
   n
XXX
XXX
   Events/Censors [2]
XX/XX
XX/XX
   Mean (SD)
X.X (X.XX)
X.X (X.XX)
   Median
X.X
X.X
   Min, Max
X, XX
X, XX
Kaplan-Meier Estimate of Time to Achieve PSSI-50 (Days)
   Median (95% CI)
X.X (X.X, X.X)
X.X (X.X, X.X)
   P value [3]
X.XXXX
Cox Proportional Hazards Model [4]
   Hazard Ratio
X.XXX
   (95% Wald CI for Hazard Ratio)
(X.XXX, X.XXX)
Repeat for “Time to Achieve PSSI-75 (Days) [5]” and “Time to Achieve PSSI-90 (Days) [6]”
Abbreviations: CI = confidence interval; NE = not estimable; PSSI = Psoriasis Scalp Severity Index; SD = standard 
deviation.
Note: Subjects are summarized by planned treatment. Censored values are not included in the descriptive statistics. Only 
subjects who achieved PSSI-50, PSSI-75, or PSSI-90 are included in the relevant descriptive statistics.
[1] PSSI-50 is achievement of 50% reduction in PSSI from baseline. Time to PSSI-50 is calculated as date of PSSI-50 
achievement - Day 1 date + 1. 
[2] Subjects who did not achieve PSSI-50, PSSI-75, or PSSI-90 were censored at day of discontinuation or date lost to 
follow-up, whichever is earlier.
[3] P value was obtained from the log rank test where roflumilast foam 0.3% was compared to vehicle.
[4] The hazard ratio and 95% Wald CI are obtained from a Cox Proportional Hazards model with country, baseline S-IGA 
score category, and baseline B-IGA score category as factors in the model, comparing roflumilast foam 0.3% to vehicle.
[5] PSSI-75 is achievement of 75% reduction in PSSI from baseline. Time to PSSI-75 is calculated as date of PSSI-75
achievement - Day 1 date + 1.
[6] PSSI-90 is achievement of 90% reduction in PSSI from baseline. Time to PSSI-90 is calculated as date of PSSI-90 
achievement - Day 1 date + 1.
Reference Listing: 16.2.6.3


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 85 of 172
Table 14.2.3.6
Time to Achievement of PSSI-50, PSSI-75, and PSSI-90
mITT Population
(Programming note: Same as table 14.2.3.6.)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 86 of 172
Table 14.2.3.7
Summary of PSSI Scores by Study Visit – ANCOVA
ITT Population
Study Visit
   Category  
       Statistic [1]
Roflumilast Foam 0.3%
(N=XX)
Vehicle 
(N=XX)
Week 2
   Change from Baseline
      n
XX
XX
      LS Mean Change from Baseline (SE)
X.XX (X.XXX)
X.XX (X.XXX)
        (95% CI for LS Mean Change from Baseline)
(X.XX, X.XX)
(X.XX, X.XX)
      P value for LS Mean Change from Baseline) [2]
X.XXXX
      LS Mean Difference from Vehicle (SE)
(X.XX, X.XX)
        (95% CI for Difference from Vehicle)
X.XX (X.XXX)
     P value for Difference from Vehicle [3]
X.XXXX
Continue for Percent Change from Baseline. Repeat for Week 4, Week 8, Week 9.
   
Abbreviations: ANCOVA = analysis of covariance; B-IGA = body investigator global assessment; CI = confidence interval; LS = least-squares; 
PSSI = Psoriasis Scalp Severity Index; S-IGA = scalp investigator global assessment; SE = standard error.
Note: Subjects are summarized by planned treatment. PSSI total score is calculated as (erythema score + induration + desquamation) × extent of 
scalp affected. The score ranges from 0 to 72. Erythema, induration, and desquamation are scored on a scale of 0 to 4, where 0 = absent and 4 = 
severest possible; extent of scale affected is scored on a scale of 0 to 6, where 0 = 0% of involved area and 6 = 90-100% of involved area.
[1] Estimates for LS means (change/percent change from baseline and difference from vehicle [i.e., change/percent change from baseline for 
roflumilast foam 0.3% minus change from baseline for vehicle]) and accompanying 95% CIs, and P values are from an ANCOVA with country, 
baseline S-IGA score category, baseline B-IGA score category, and baseline PSSI score as independent variables. Baseline is the last non-
missing measurement taken before the first application of study drug. Percent change from baseline is calculated as (result – baseline result)*100.
[2] P value for testing change/percent change from baseline is zero.
[3] P value for testing difference (roflumilast foam 0.3% minus vehicle) in change/percent change from baseline from is zero.
Reference Listings: 16.2.6.1, 16.2.6.2, 16.2.6.5


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Page 87 of 172
Table 14.2.3.8
Summary of PSSI Scores by Study Visit – ANCOVA
mITT Population
(Programming note: Same as table 14.2.3.7.)
Table 14.2.4.1
Summary and Change from Baseline in Scalp Itch – Numeric Rating Scale (SI-NRS) Pruritus Score by Study Visit
ITT Population
(Programming note: Same as table 14.2.3.1. Update abbreviation row to display “SI-NRS = Scalp Itch – Numeric Rating Scale”. Change reference listing to Reference 
Listing: 16.2.6.4. Update the footnotes as “Note: Subjects are summarized by planned treatment. The SI-NRS will be determined by asking the subject’s assessment of worst itch of 
scalp over the past 24 hours. The scale is from 0 to 10, which ranges from “no scalp itch” to “worst scalp itch imaginable”. Baseline is the last non-missing measurement taken on or
before the day of first application of study drug. Change from baseline is calculated as result – baseline result. Percent change from baseline is calculated as (change from
baseline/baseline)*100.”)
Table 14.2.4.2
Summary and Change from Baseline in Scalp Itch – Numeric Rating Scale (SI-NRS) Pruritus Score by Study Visit
mITT Population
(Programming note: Same as table 14.2.4.1.)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 88 of 172
Table 14.2.4.3
Scalp Itch – Numeric Rating Scale (SI-NRS) Pruritus Score Success by Study Visit 
ITT Population, Subjects with SI-NRS Pruritus Score 4 at Baseline (SPRU4-ITT Population)
Study Visit/
   Category/Statistic 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Week 2
XX
XX
   SI-NRS Success [1]
      Yes 
XX (XX.X%)
XX (XX.X%)
        95% CI [2]
(X.XX, X.XX)
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (95% CI) [3] 
X.XX (X.XX, X.XX)
      P value [3]
X.XXXX
Repeat for all Week 4, Week 8, and Week 9.
Abbreviations: B-IGA = body investigator global assessment; CI = confidence interval; S-IGA = scalp investigator global assessment; SI-
NRS = Scalp Itch – Numeric Rating Scale.
Note: Percentages are n/Number of subjects in the SPRU4-ITT population within planned treatment at each visit*100. Baseline is the last 
non-missing measurement taken on or before the day first application of study drug.
[1] SI-NRS success (“Yes”) is defined as an achievement of a 4-point improvement from baseline score of 4; “No” otherwise.
[2] 95% CIs for “Yes” are obtained using Wilson method.
[3] The odds ratio, 95% CI, and P value are obtained from Cochran Mantel Haenszel test (stratified by country, baseline S-IGA score 
category, and baseline B-IGA score category) comparing roflumilast foam 0.3% to vehicle.
Reference Listings: 16.2.6.1, 16.2.6.2, 16.2.6.4


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 89 of 172
Table 14.2.4.4
Scalp Itch – Numeric Rating Scale (SI-NRS) Pruritus Score Success by Study Visit 
mITT Population, Subjects with SI-NRS Pruritus Score 4 at Baseline (SPRU4-mITT Population)
(Programming note: Same as table 14.2.4.3. Change “Note:” to be “Note: Percentages are n/Number of subjects in the SPRU4-mITT population within planned treatment at each 
visit*100.”)
Table 14.2.4.5
Summary of Scalp Itch – Numeric Rating Scale (SI-NRS) Pruritus Score by Study Visit – ANCOVA
ITT Population
(Programming note: Same as table 14.2.3.7. Update [1] as to use “SI-NRS score” instead of “PSSI score”. Update abbreviation row to display “SI-NRS = Scalp Itch –
Numeric Rating Scale”Change reference listing to Reference Listings: 16.2.6.1, 16.2.6.2, 16.2.6.4. Update the Note as “Note: Subjects are summarized by planned treatment. The 
SI-NRS will be determined by asking the subject’s assessment of worst itch of scalp over the past 24 hours. The scale is from 0 to 10, which ranges from “no scalp itch” to “worst scalp 
itch imaginable”. Baseline is the last non-missing measurement taken on or before the day of first application of study drug. Percent change from baseline is calculated as (result –
baseline result)*100.”)
Table 14.2.4.6
Summary of Scalp Itch – Numeric Rating Scale (SI-NRS) Pruritus Score by Study Visit – ANCOVA
mITT Population
(Programming note: Same as table 14.2.4.5.)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 90 of 172
Table 14.2.5.1
Summary and Change from Baseline in Psoriasis Symptom Diary (PSD) Total and Individual Item Scores by Study Visit
ITT Population 
(Programming note: Same as table 14.2.3.1, except add header rows at the top for
“Item: Total Score”,
“Item: How severe was your psoriasis-related itching?”,
“Item: How bothered were you by your psoriasis-related itching?”, 
“Item: How severe was your psoriasis-related stinging?”, 
“Item: How bothered were you by your psoriasis-related stinging?”, 
“Item: How severe was your psoriasis-related burning?”, 
“Item: How bothered were you by your psoriasis-related burning?”, 
“Item: How severe was your psoriasis-affected skin cracking?”, 
“Item: How bothered were you by your psoriasis-affected skin cracking?”, 
“Item: How severe was your psoriasis-related pain?”, 
“Item: How bothered were you by your psoriasis-related pain?”, 
“Item: How severe was your psoriasis scaling?”, 
“Item: How bothered were you by your psoriasis scaling?”, 
“Item: How noticeable did you think the color of your psoriasis-affected skin was?”, 
“Item: How much did you try to hide your psoriasis affected skin?”, 
“Item: How much did your psoriasis cause you to avoid activities with other people?”, 
“Item: How embarrassed were you because of your psoriasis?”
Change abbreviation from PSSI to PSD = Psoriasis Symptom Diary. Change reference listings to Reference Listing: 16.2.6.5. Update footnoteas “The PSD total score is 
calculated as sum of the 16 questions (individual questions scored 0 to 10, where higher scores indicate more severe symptoms). The total score ranges from 0 to 160. If 1 or more 
items are missing, the total score was not calculated. Baseline is the last non-missing measurement taken on or before the day first application of study drug. Change from baseline is 
calculated as result – baseline result. Percent change from baseline is calculated as (change from baseline/baseline)*100.”)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 91 of 172
Table 14.2.5.2
Summary and Change from Baseline in Psoriasis Symptom Diary (PSD) Total and Individual Item Scores by Study Visit
mITT Population 
(Programming note: Same as table 14.2.5.1.)
Table 14.2.5.3
Summary of Psoriasis Symptom Diary (PSD) Total Scores by Study Visit – ANCOVA
ITT Population
(Programming note: Same as table 14.2.3.7. Update [1] as to use “PSD total score” instead of “PSSI score”. Change abbreviation from PSSI to PSD = Psoriasis Symptom 
Diary. Change reference listings to Reference Listings: 16.2.6.1, 16.2.6.2, 16.2.6.5. Update the Note as “Note: Subjects are summarized by planned treatment. Baseline is the last 
non-missing measurement taken before the first application of study drug. PSD total score is calculated as sum of the 16 questions (individual questions scored 0 to 10, where higher 
scores indicate more severe symptoms). The score ranges from 0 to 160. If 1 or more items are missing, the score is not calculated.”)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 92 of 172
Table 14.2.5.4
Summary of Psoriasis Symptom Diary (PSD) Total Scores by Study Visit – ANCOVA
mITT Population
(Programming note: Same as table 14.2.5.3.)
Table 14.2.6.1
Summary and Change from Baseline in PASI/mPASI by Study Visit
ITT Population
(Programming note: Same as table 14.2.3.1, except add header rows at the top for “Scale: PASI” or “Scale: mPASI”. Add Abbreviations “PASI = Psoriasis Area Severity 
Index” and “mPASI = modified PASI” in alphabetical order. Change reference listing to Reference Listings: 16.2.6.1, 16.2.6.2, 16.2.6.6. Update [1] as ”PASI is calculated as 
(0.1×[Eh + Th + Sh]×Ah) + (0.2×[Ea + Ta + Sa]×Aa) + (0.3×[Et + Tt + St]×At) + (0.4×[El + Tl + Sl]×Al), where E, T, and S are erythema, thickness, and scaling, respectively, scored on 
a scale of 0 to 4, A is estimated area of skin involved, graded on a scale of 0 to 6, and h, e, t, and l are head, arms, trunk, and legs respectively. The total score ranges from 0 to 72. 
mPASI is calculated similar to PASI except that for subjects with < 10% of any particular involved anatomic area, the mPASI will be calculated using the actual percentage of the 
anatomical area involved rather than the 0 to 6 estimated area score (e.g., 0.1 for 1%, 0.2 for 2%, 0.3 for 3%, … 0.9 for 9%). Lower scores indicate improvement. Change from 
baseline is calculated as result – baseline result. Percent change from baseline is calculated as (change from baseline/baseline)*100.”)
Table 14.2.6.2
Summary and Change from Baseline in PASI/mPASI by Study Visit
mITT Population
(Programming note: Same as table 14.2.6.1)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 93 of 172
Table 14.2.6.3
Summary of PASI/mPASI by Study Visit – ANCOVA
ITT Population
(Programming note: Same as table 14.2.5.3, except add header rows at the top for “Scale: PASI” or “Scale: mPASI”. Replace instances of PSD with PASI/mPASI. Add the 
following to Abbreviations “PASI = Psoriasis Area Severity Index” and “mPASI = modified Psoriasis Area Severity Index” in alphabetical order. Change reference listings 
to Reference Listings: 16.2.6.1, 16.2.6.2, 16.2.6.6. Replace PSD Total Score text in the note footnote with ”PASI is calculated as (0.1×[Eh + Th + Sh]×Ah) + (0.2×[Ea + Ta + Sa]×Aa) + 
(0.3×[Et + Tt + St]×At) + (0.4×[El + Tl + Sl]×Al), where E, T, and S are erythema, thickness, and scaling, respectively, scored on a scale of 0 to 4, A is estimated area of skin involved, 
graded on a scale of 0 to 6, and h, e, t, and l are head, arms, trunk, and legs respectively. The total score ranges from 0 to 72. mPASI is calculated similar to PASI except that for 
subjects with < 10% of any particular involved anatomic area, the mPASI will be calculated using the actual percentage of the anatomical area involved rather than the 0 to 6 estimated 
area score (e.g., 0.1 for 1%, 0.2 for 2%, 0.3 for 3%, …, 0.9 for 9%). Lower scores indicate improvement.”)
Table 14.2.6.4
Summary of PASI/mPASI by Study Visit – ANCOVA
mITT Population
(Programming note: Same as table 14.2.6.3.)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 94 of 172
Table 14.2.6.5
Summary of Achievement of PASI-50, PASI-75, and PASI-90 by Study Visit
ITT Population
Study Visit
   Category/Statistic 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Week 2
XX
XX
   PASI-50 [1]
      Yes 
XX (XX.X%)
XX (XX.X%)
        95% CI [4]
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (95% CI) [5] 
X.XX (X.XX, X.XX)
      P value [5]
X.XXXX
   PASI-75 [2]
      Yes 
XX (XX.X%)
XX (XX.X%)
        95% CI [4]
(X.XX, X.XX)
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (95% CI) [5] 
X.XX (X.XX, X.XX)
X.XX (X.XX, X.XX)
      P value [5]
X.XXXX
   PASI-90 [3]
      Yes 
XX (XX.X%)
XX (XX.X%)
        95% CI [4]
(X.XX, X.XX)
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (95% CI) [5] 
X.XX (X.XX, X.XX)
X.XX (X.XX, X.XX)
      P value [5]
X.XXXX
Repeat for Week 4, Week 8, and Week 9.
Abbreviations: B-IGA = body investigator global assessment; CI = confidence interval; S-IGA = scalp investigator global assessment; PASI 
= Psoriasis Area Severity Index.
Note: Percentages are n/Number of subjects in the ITT population within planned treatment at each visit*100. Baseline is the last non-
missing measurement taken before the first application of study drug.
[1] PASI-50 is populated with “Yes” when there is an achievement of a 50% reduction in PASI total score from baseline; “No” otherwise.
[2] PASI-75 is populated with “Yes” when there is an achievement of a 75% reduction in PASI total score from baseline; “No” otherwise.
[3] PASI-90 is populated with “Yes” when there is an achievement of a 90% reduction in PASI total score from baseline; “No” otherwise.
[4] 95% CIs for “Yes” are obtained using Wilson method.
[5] The odds ratio, 95% CI, and P value are obtained from Cochran Mantel Haenszel test (stratified by country, baseline S-IGA score 
category, and baseline B-IGA score category) comparing roflumilast foam 0.3% to vehicle.
Reference Listings: 16.2.6.1, 16.2.6.2, 16.2.6.6


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.2.6.6
Summary of Achievement of PASI-50, PASI-75, and PASI-90 by Study Visit
mITT Population
(Programming note: Same as table 14.2.6.5)
Table 14.2.6.7
Time to Achievement of PASI-50
ITT Population
(Programming note: Same as table 14.2.3.5. Replace instances of PSSI-50 with PASI-50 and update the abbreviations accordingly. Change the reference listings to 
16.2.6.1, 16.2.6.2, 16.2.6.6)
Table 14.2.6.8
Time to Achievement of PASI-50
mITT Population
(Programming note: Same as table 14.2.3.5. Replace instances of PSSI-50 with PASI-50 and update the abbreviations accordingly. Change the reference listings to 
16.2.6.1, 16.2.6.2, 16.2.6.6)
Table 14.2.6.9
Summary of Achievement of mPASI-50, mPASI-75, and mPASI-90 by Study Visit
ITT Population
(Same shell as Table 14.2.6.5; change all instances of PASI to mPASI)
Table 14.2.6.10
Summary of Achievement of mPASI-50, mPASI-75, and mPASI-90 by Study Visit
mITT Population
(Same shell as Table 14.2.6.5; change all instances of PASI to mPASI)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 96 of 172
Table 14.2.7.1
Summary and Change from Baseline in Worst Itch – Numeric Rating Scale (WI-NRS) by Study Visit 
ITT Population
(Programming note: Same as table 14.2.3.1. Change reference listing to Reference Listing: 16.2.6.7. Update abbreviation row to display “WI-NRS = Worst Itch – Numeric 
Rating Scale”. Update footnote as follows: “Note: Subjects are summarized by planned treatment. 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, which ranges from “no itch” to “worst imaginable itch”. Baseline is the last non-missing measurement taken on or before the day of 
first application of study drug. Change from baseline is calculated as result – baseline result. Percent change from baseline is calculated as (change from baseline/baseline)*100.”)
Table 14.2.7.2
Summary and Change from Baseline in Worst Itch – Numeric Rating Scale (WI-NRS) by Study Visit 
mITT Population
(Programming note: Same as table 14.2.7.1)
Table 14.2.7.3
Summary of Worst Itch – Numeric Rating Scale (WI-NRS) by Study Visit – ANCOVA 
ITT Population
(Programming note: Same as table 14.2.3.7; Replace instances of PSD with WI-NRS in [1]. Change reference listings to Reference Listings: 16.2.6.1, 16.2.6.2, 16.2.6.7. 
Update abbreviation row to display “WI-NRS = Worst Itch – Numeric Rating Scale”. Update the baseline definition to read, “Baseline is the last non-missing measurement 
taken on or before the day first application of study drug.” Replace PSD Total Score text in the note footnote with ”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, which ranges from “no itch” to “worst imaginable itch”. Lower scores indicate improvement.”)
Table 14.2.7.4
Summary of Worst Itch – Numeric Rating Scale (WI-NRS) by Study Visit – ANCOVA 
mITT Population
(Programming note: Same as table 14.2.7.3)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 97 of 172
Table 14.2.7.5
Worst Itch – Numeric Rating Scale (WI-NRS) Pruritus Score Success by Study Visit 
ITT Population, Subjects with WI-NRS Pruritus Score 4 at Baseline (PRU4-ITT Population)
(Programming note: Same as table 14.2.4.3, except replace all instances of SI-NRS with WI-NRS. Update abbreviation row to display “WI-NRS = Worst Itch – Numeric 
Rating Scale”. Change reference listings to Reference Listings: 16.2.6.1, 16.2.6.2, 16.2.6.7.)
Table 14.2.7.6
Worst Itch – Numeric Rating Scale (WI-NRS) Pruritus Score Success by Study Visit 
mITT Population, Subjects with WI-NRS Pruritus Score 4 at Baseline (PRU4-mITT Population)
(Programming note: Same as table 14.2.7.5.)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 98 of 172
Table 14.2.8.1
Summary and Change from Baseline in Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI) by Study Visit 
ITT Population
(Programming note: Same as table 14.2.3.1, except add header rows at the top for “Scale: DLQI” and “Scale: “CDLQI”. Add “DLQI = Dermatology Life Quality Index” and 
“CDLQI = Children’s DLQI” to abbreviations in alphabetical order. Change reference listing to Reference Listing: 16.2.6.8. Update footnotes as “Note: Subjects are 
summarized by planned treatment. The DLQI/CDLQI score is calculated as sum of all the 10 questions at each visit and ranges between 0-30. The individual questions are scored as 
“Very much” or “Yes”= 3, “A lot” = 2, “A Little” = 1, “Not at all” or “Not Relevant” = 0. If 1 item is missing, it is scored as 0 for that item. If 2 or more items are missing, the score should 
not be calculated. Baseline is the last non-missing measurement taken on or before the day of first application of study drug. Change from baseline is calculated as result – baseline 
result. Percent change from baseline is calculated as (change from baseline/baseline)*100.”)
Table 14.2.8.2
Summary and Change from Baseline in Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI) by Study Visit 
mITT Population
(Programming note: Same as table 14.2.8.1)
Table 14.2.8.3
Summary of Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI) by Study Visit – ANCOVA 
ITT Population
(Programming note: Same as table 14.2.3.7, except add header rows at the top for “Scale: DLQI” and “Scale: “CDLQI”. Add “DLQI = Dermatology Life Quality Index” and 
“CDLQI = Children’s DLQI” to abbreviations in alphabetical order. Change reference listings to Reference Listings: 16.2.6.1, 16.2.6.2, 16.2.6.8. Replace instances of PSD 
with DLQI/CDLQI in [1]. Replace PSD Total Score text in the note footnote with ”The DLQI/CDLQI score is calculated as sum of all the 10 questions at each visit and ranges 
between 0-30. The individual questions are scored as “Very much” or “Yes”= 3, “A lot” = 2, “A Little” = 1, “Not at all” or “Not Relevant” = 0. If 1 item is missing, it is scored as 0 for that 
item. If 2 or more items are missing, the score should not be calculated. Lower scores indicate improvement. Baseline is the last non-missing measurement taken on or before the day
first application of study drug. Change from baseline is calculated as result – baseline result. Percent change from baseline is calculated as (change from baseline/baseline)*100.”)
Table 14.2.8.4
Summary of Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI) by Study Visit – ANCOVA 
mITT Population
(Programming note: Same as table 14.2.8.4)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 99 of 172
Table 14.2.9.1
Summary and Change from Baseline in % Body Surface Area (BSA) Affected by Disease by Study Visit
ITT Population
(Programming note: Same as table 14.2.3.1. Add “BSA = body surface area” to abbreviations in alphabetical order. Change reference listing to Reference Listing: 16.2.6.9. 
Update footnotes as “Note: Subjects are summarized by planned treatment. Baseline is the last non-missing measurement taken before the first application of study drug. Change 
from baseline is calculated as result – baseline result. Percent change from baseline is calculated as (change from baseline/baseline)*100.”)
Table 14.2.9.2
Summary and Change from Baseline in % Body Surface Area (BSA) Affected by Disease by Study Visit
mITT Population
(Programming note: Same as table 14.2.9.2)
Table 14.2.9.3
Summary of % Body Surface Area (BSA) Affected by Disease by Study Visit – ANCOVA 
ITT Population
(Programming note: Same as table 14.2.3.7. Add “BSA = body surface area” and “ePRO = electronic patient reported outcomes” to abbreviations in alphabetical order. 
Change reference listings to Reference Listings: 16.2.6.1, 16.2.6.2, 16.2.6.9. Replace instances of PSD with BSA in [1]. Replace PSD Total Score text in the note footnote 
with ”BSA collected on the ePRO tablet will be used for summarization.”)
Table 14.2.9.4
Summary of % Body Surface Area (BSA) Affected by Disease by Study Visit – ANCOVA 
mITT Population
(Programming note: Same as table 14.2.9.3)


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
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Table 14.3.1.1
Summary of Treatment Emergent Adverse Events
Safety Population
Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Subjects with at least 1 TEAE
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Maximum Severity of TEAE [1]
      Grade 1 (Mild)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 2 (Moderate)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 3 (Severe)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 4 (Life-threatening consequences)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 5 (Death related to AE)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Subjects with a Related TEAE [2]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Subjects with a TEAE Leading to Discontinuation of Study Drug
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Subjects with an SAE
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Subjects with a Grade 5 TEAE [3]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events; IP = investigational product; SAE = serious adverse 
event; TEAE = treatment emergent adverse event.
Note: Percentages are n/Number of subjects in the Safety population within treatment received*100. A TEAE is defined as an AE that started post 
application of IP at the baseline visit through study completion.
[1] Severity grades are reported according to the CTCAE version 4.0. Subjects are counted only once at the worst severity. If a severity designation is 
missing, it will be considered as severe.
[2] AEs with a relationship of possibly, probably, likely, or missing were considered related.
[3] A Grade 5 TEAE is a TEAE leading to death.
Reference Listing: 16.2.7.1


Statistical Analysis Plan, 
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Table 14.3.1.2
Incidence of Treatment Emergent Adverse Events by System Organ Class and Preferred Term
Safety Population
System Organ Class
   Preferred Term
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Subjects with at least 1 TEAE
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
System Organ Class 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
System Organ Class 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: AE = adverse event; IP = investigational product; MedDRA = Medical Dictionary for Regulatory Activities; TEAE = treatment 
emergent adverse event.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. AEs were coded using 
MedDRA version 23.0. A TEAE is defined as an AE that started post application of IP at the baseline visit through study completion. Subjects 
are counted once for each system organ class (SOC) and once for each preferred term (PT). AEs are displayed alphabetically by SOC, then 
by descending frequency of PT within SOC, and then alphabetically by PT.
Reference Listing: 16.2.7.1
Programming note: SOC & PT text should be presented as is from the dataset.


Statistical Analysis Plan, 
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Table 14.3.1.3
Incidence of Treatment Emergent Adverse Events by System Organ Class, Preferred Term, and Maximum Severity
Safety Population
System Organ Class   
   Preferred Term
      Maximum Severity [1]
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Subjects with at least 1 TEAE
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 1 (Mild)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 2 (Moderate)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 3 (Severe)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 4 (Life-threatening consequences)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 5 (Death related to AE)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
System Organ Class 1
   Any Event (Total)
      Grade 1 (Mild)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 2 (Moderate)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 3 (Severe)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 4 (Life-threatening consequences)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 5 (Death related to AE)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
      Grade 1 (Mild)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 2 (Moderate)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
…
Abbreviations: AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events; IP = investigational product; MedDRA = Medical 
Dictionary for Regulatory Activities; TEAE = treatment emergent adverse event.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. AEs were coded using MedDRA 
version 23.0. A TEAE is defined as an AE that started post application of IP at the baseline visit through study completion. Subjects are counted 
once for each system organ class (SOC) and once for each preferred term (PT) at the maximum severity. 
[1] Severity grades are reported according to the CTCAE version 4.0. The severity shown is the greatest severity reported for a particular subject 
(Grade 5 [Death related to AE] > Grade 4 [Life-threatening consequences] > Grade 3 [Severe] > Grade 2 [Moderate] > Grade 1 [Mild]). AEs with a 
missing severity were counted as Severe. AEs are displayed alphabetically by SOC, then by descending frequency of PT within SOC, and then 
alphabetically by PT.
Reference Listing: 16.2.7.1
Programming note: SOC & PT text should be presented as is from the dataset.


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
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AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.3.1.4
Incidence of Treatment Emergent Adverse Events by System Organ Class, Preferred Term, and Relationship to Study Drug
Safety Population
System Organ Class
   Preferred Term
      Relationship [1]
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Subjects with at least 1 TEAE
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Related
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Not Related
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
System Organ Class 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Related
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Not Related
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Related
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Not Related
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: AE = adverse event; IP = investigational product; MedDRA = Medical Dictionary for Regulatory Activities; TEAE = 
treatment emergent adverse event.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. AEs were coded using 
MedDRA version 23.0. A TEAE is defined as an AE that started post application of IP at the baseline visit through study completion. 
Subjects are counted once for each system organ class (SOC) and once for each preferred term (PT) at the greatest relationship 
category. The relationship shown is the greatest relationship reported for a particular subject (Related > Not Related). AEs with a 
missing relationship were counted as Related. AEs are displayed alphabetically by SOC, then by descending frequency of PT within 
SOC, and then alphabetically by PT.
[1] Related = Probably Related, Possibly Related, Likely Related, and Missing; Not Related = Unrelated and Unlikely Related.
Reference Listing: 16.2.7.1
Programming note: SOC & PT text should be presented as is from the dataset.


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
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AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.3.1.5
Incidence of Treatment Emergent Adverse Events Leading to Study Drug Discontinuation by System Organ Class and Preferred Term
Safety Population
(Same shell as Table 14.3.1.2)
Table 14.3.1.6
Incidence of Treatment Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term
Safety Population
(Same shell as Table 14.3.1.2)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.3.1.7
Incidence of Related Treatment Emergent Adverse Events by Preferred Term
Safety Population
Preferred Term
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Subjects with at least 1 Related TEAE
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Preferred Term 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Preferred Term 3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Preferred Term 4
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Preferred Term 5
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Preferred Term 6
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Preferred Term 7
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Preferred Term 8
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Preferred Term 9
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Preferred Term 10
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Preferred Term 11
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
…
Abbreviations: AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events; IP = investigational product; MedDRA = Medical 
Dictionary for Regulatory Activities; TEAE = treatment emergent adverse event.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. AEs were coded using MedDRA 
version 23.0. A TEAE is defined as an AE that started post application of IP at the baseline visit through study completion. Related TEAEs are AE 
marked Probably Related, Possibly Related, Likely Related, or missing. Subjects are counted once for each once for each preferred term (PT). 
AEs are displayed by descending frequency of PT, and then alphabetically by PT in case of ties.
Programming note: PT text should be presented as is from the dataset.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.3.2.1
Incidence of Serious Adverse Events by System Organ Class and Preferred Term
Safety Population
(Same shell as Table 14.3.1.2; first-row text is “Subjects with at least 1 SAE”; add SAE = serious adverse event)
Table 14.3.2.2
Incidence of Serious Adverse Events by System Organ Class, Preferred Term, and Relationship to Study Drug
Safety Population
(Same shell as Table 14.3.1.4; first-row text is “Subjects with at least 1 SAE”; add SAE = serious adverse event)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Page 107 of 172
Table 14.3.2.3
Incidence of Serious Adverse Events by System Organ Class, Preferred Term, and Maximum Severity
Safety Population
(Same shell as Table 14.3.1.3; first-row text is “Subjects with at least 1 SAE”; add SAE = serious adverse event)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.3.3.1
Listing of Adverse Events Leading to Study Drug Discontinuation
Safety Population
Subject 
ID
Treatment 
Received
System Organ Class/
   Preferred Term/
      Verbatim Term
Start Date/Time (Study Day)/
   End Date/Time (Study Day)
CTCAE Toxicity Grade/
   Relationship
Outcome/
  Study Drug Action Taken/
    Other Action Taken
Serious?/
  Criteria Met
XXXXX
XXXXXXXX
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXXXXX
      XXXXXXXXXXXXX
DDMONYYYY/hh:mm (X)/
   DDMONYYYY/hh:mm (X)
XXXXXXXXX/
   XXXXXXXXXX
XXXXXXXXX/
   XXXXXXXXXXXX/
      XXXXXXXXXX
XX
XXXXX
XXXXXXXX
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXXXXX
      XXXXXXXXXXXXX
DDMONYYYY/hh:mm (X)/
   DDMONYYYY/hh:mm (X)
XXXXXXXXX/
   XXXXXXXXXX
XXXXXXXXX/
   XXXXXXXXXXXX/
      XXXXXXXXXX
XX
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXXXXX
      XXXXXXXXXXXXX
DDMONYYYY/hh:mm (X)/
   DDMONYYYY/hh:mm (X)
XXXXXXXXX/
   XXXXXXXXXX
XXXXXXXXX/
   XXXXXXXXXXXX/
      XXXXXXXXXX
XXX/
   XXXXXXXXX
Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events; MedDRA = Medical Dictionary for Regulatory Activities.
Note: Study day is calculated relative to the date of first application of study drug. AEs were coded using MedDRA version 23.0. Severity grades are reported according to the CTCAE 
version 4.0.
Programming note: If time missing, display “- -:- -”. “Other Action Taken” will be either None, Concomitant Medication, Non-drug Therapy, Hospitalization or Prolongation of 
Hospitalization, Discontinued Study or Other; if specify text is needed, concatenate “Concomitant Medication:” or “Other:” with the text. If Serious? is Yes, concatenate all serious 
criteria marked as Yes with a semicolon. If no events meet the criteria for display, present “No events are reported.” SOC & PT text should presented as is from the dataset.


Statistical Analysis Plan, 
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Table 14.3.3.2
Listing of Serious Adverse Events
Safety Population
(Same shell as Table 14.3.3.1)
Table 14.3.3.3
Listing of Deaths
Safety Population
(Same shell as Table 14.3.3.1)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
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Table 14.3.5.1.1
Summary of Clinical Chemistry Laboratory Results by Study Visit
Safety Population
Parameter: XXXXXXX (unit)
Study Visit
   Statistic
Roflumilast Foam 0.3% 
(N=XX)
Vehicle 
(N=XX)
Overall
(N=XX)
Observed
Change
Observed
Change
Observed 
Change
Baseline
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Week 4
   n
XX
XX
XX
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
XX, XX
XX, XX
XX, XX
Repeat for Week 8. Continue for other parameters. Sort alphabetically by parameter.
Note: Subjects are summarized by treatment received and overall. Baseline is the last non-missing measurement taken before the first application of study drug. 
Reference Listing: 16.2.8.1.1


Statistical Analysis Plan, 
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Table 14.3.5.1.2
Shift from Baseline in Clinical Chemistry Laboratory Results by Study Visit 
Safety Population
Parameter: XXXXXXX (unit)
Baseline Grade
Post-
Baseline
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Study Visit
Grade
Missing
Low
Normal
High
Total
Missing
Low
Normal
High
Total
Week 4
Missing
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%)
XX (XX.X%)
Low
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%)
XX (XX.X%)
Normal
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%)
XX (XX.X%)
High
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%)
XX (XX.X%)
Total
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%)
XX (XX.X%)
Week 8
Missing
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%)
XX (XX.X%)
Low
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%)
XX (XX.X%)
Normal
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%)
XX (XX.X%)
High
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%)
XX (XX.X%)
Total
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%)
XX (XX.X%)
Repeat for Overall. Repeat all for clinical chemistry parameters (excluding serum HCG results).
Note: Percentages are n/Number of subjects in the Safety population within treatment received*100. Baseline is the last non-missing measurement taken before the first application of study 
drug.
Reference Listing: 16.2.8.1.1


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
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Table 14.3.5.2.1
Summary of Hematology Laboratory Results by Study Visit 
Safety Population
(Same shell as Table 14.3.5.1.1; Reference Listing: 16.2.8.1.2)
Table 14.3.5.2.2
Shift from Baseline in Hematology Laboratory Results by Study Visit 
Safety Population
(Same shell as Table 14.3.5.1.2; Reference Listing: 16.2.8.1.2)
Table 14.3.5.3.1
Summary of Quantitative Urinalysis Laboratory Results by Study Visit 
Safety Population
(Same shell as Table 14.3.5.1.1; Reference Listing: 16.2.8.1.3)
Table 14.3.5.3.2
Shift from Baseline in Quantitative and Qualitative Urinalysis Laboratory Results by Study Visit 
Safety Population
(Same shell as Table 14.3.5.1.2; Reference Listing: 16.2.8.1.3)


Statistical Analysis Plan, 
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Table 14.3.5.3.3
Summary of Qualitative Urinalysis Laboratory Results by Study Visit 
Safety Population
Study Visit
   Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline
   XXXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   XXXXXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 4
   XXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   XXXXXXXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   XXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 8
   XXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   XXXXXXXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   XXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Baseline is the last non-
missing measurement taken before the first application of study drug.
Reference Listing: 16.2.8.1.3


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
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Table 14.3.6.1
Shift from Baseline in Patient Health Questionnaire (PHQ-8)/Modified PHQ-Adolescents by Study Visit
Safety Population
Scale: PHQ-8
Baseline Category
Roflumilast Foam 0.3% (N=XX)
Study Visit
   Category [1]
Missing
None
Mild
Moderate
Moderately 
Severe
Severe
Total
Week 4
   Missing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   None
XX (XX.X%)
XX (XX.X%)
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%)
XX (XX.X%)
XX (XX.X%)
   Moderate
XX (XX.X%)
XX (XX.X%)
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%)
XX (XX.X%)
XX (XX.X%)
   Severe
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Total
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 8
   Missing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   None
XX (XX.X%)
XX (XX.X%)
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%)
XX (XX.X%)
XX (XX.X%)
   Moderate
XX (XX.X%)
XX (XX.X%)
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%)
XX (XX.X%)
XX (XX.X%)
   Severe
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Total
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Repeat for Vehicle and Overall. Repeat for Scale: PHQ-A
Abbreviations: PHQ-8 = patient health questionnaire (8 questions); PHQ-A = patient health questionnaire - adolescents.
Note: Percentages are n/Number of subjects in the Safety population within scale (PHQ-8 or PHQ-A) and treatment received and overall*100. Baseline is the last non-missing 
measurement taken on or before the day of first application of study drug. The PHQ total score is calculated as sum of the 8 questions (individual questions scored as Not at 
all=0, Several days=1, More than half the days=2, and Nearly every day=3). The total score ranges from 0 to 24. If more than 1 item is missing the score was not calculated. If 
1 item is missing the score is calculated as (sum of answered items*8)/number of answered items. The PHQ-8 was filled out by adults and the modified PHQ-A was filled out 
by adolescents.
[1] If the total score ranges from 0 to 4, it is classified as None – Minimal Depression; 5 – 9 classified as Mild; 10 – 14 classified as Moderate; 15-19 classified as Moderately 
Severe; 20 – 24 classified as Severe Depression.
Reference Listing: 16.2.9.7


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Table 14.3.6.2.1
Summary of Investigator Local Tolerability Assessment (Dermal Response) by Study Visit 
Safety Population
(Same shell as Table 14.3.5.1.1; Reference Listing: 16.2.9.1; Repeat for Week 4, Week 8; Add this line at the end in note footnote – “Lower scores indicate no evidence of 
irritation while higher scores indicate worsening reaction. These assessments should be done prior to the IP application in the study site. Subjects not meeting this 
condition on baseline visit are completely removed from the table summary.”)


Statistical Analysis Plan, 
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Table 14.3.6.2.2
Summary of Investigator Local Tolerability Assessment (Dermal Response) by Study Visit 
Categorical Results
Safety Population
Study Visit
   Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline
    0 = No evidence of irritation
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    1 = Minimal erythema
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    2 = Definite erythema
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
Week 4
    0 = No evidence of irritation
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    1 = Minimal erythema
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    2 = Definite erythema
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%)
Repeat for Week 8
Abbreviation: IP = investigational product.
Note: Percentages are n/Number of subjects in the Safety Population within treatment received and overall*100. Baseline is the last 
non-missing measurement taken before the first application of study drug. These assessments should be done prior to the IP 
application in the study site. Subjects not meeting this condition on baseline visit are completely removed from the table summary.
Reference Listing: 16.2.9.1


Statistical Analysis Plan, 
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Table 14.3.6.2.3
Summary of Investigator Local Tolerability Assessment (Other Effects) by Study Visit 
Categorical Results
Safety Population
Study Visit
   Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline
   A = Slight glazed appearance
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   B = Marked glazing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   C = Glazing with peeling and cracking
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   D = Glazing with fissures
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   E = Film of dried serous exudates 
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   F = Small petechial erosions and/or scabs
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   G = No other effects
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 4
   A = Slight glazed appearance
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   B = Marked glazing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   C = Glazing with peeling and cracking
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   D = Glazing with fissures
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   E = Film of dried serous exudates 
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   F = Small petechial erosions and/or scabs
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   G = No other effects
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Repeat for Week 8
Abbreviation: IP = investigational product.
Note: Percentages are n/Number of subjects in the Safety Population within treatment received and overall*100. Baseline is the last 
non-missing measurement taken before the first application of study drug. These assessments should be done 10 - 15 minutes after 
the application of IP in the study site. Subjects not meeting this condition on baseline visit are completely removed from the table 
summary.
Reference Listing: 16.2.9.1


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
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Table 14.3.6.3.1
Summary of Subject Local Tolerability Assessment by Study Visit 
Safety Population
(Same shell as Table 14.3.5.1.1; Reference Listing: 16.2.9.2; Repeat for Week 4, Week 8; add "IP = investigational product” to abbreviations; Add this line at the end in note 
footnote – “Lower scores indicate no sensation while higher scores indicate worsening/severe sensation. These assessments should be done 10 - 15 minutes after the 
application of IP in the study site. Subjects not meeting this condition on baseline visit are completely removed from the table summary.” Change baseline definition to 
“Baseline for subject local tolerability assessment is the last non-missing measurement taken on the day of first application of study drug.”)


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
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Table 14.3.6.3.2
Summary of Subject Local Tolerability Assessment by Study Visit 
Categorical Results
Safety Population
Study Visit
   Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline
    0 = None (no sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    1 = Mild (slight warm, tingling sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    2 = Moderate (definite warm, tingling sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    3 = Severe (hot, tingling/stinging sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 4
    0 = None (no sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    1 = Mild (slight warm, tingling sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    2 = Moderate (definite warm, tingling sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    3 = Severe (hot, tingling/stinging sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Repeat for Week 8
Abbreviation: IP = investigational product.
Note: Percentages are n/Number of subjects in the Safety Population within treatment received and overall*100. Baseline for subject 
local tolerability assessment is the last non-missing measurement taken on the day of first application of study drug. These
assessments should be done 10 - 15 minutes after the application of IP in the study site. Subjects not meeting this condition on 
baseline visit are completely removed from the table summary.
Reference Listing: 16.2.9.2


Statistical Analysis Plan, 
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Table 14.3.6.4.1
Summary of Vital Signs by Study Visit
Safety Population
(Same shell as Table 14.3.5.1.1; visits include Baseline, Week 2, Week 4, Week 8, Week 9; parameters include Temperature (°C), Heart Rate (bpm), Systolic Blood Pressure 
(mmHg), Diastolic Blood Pressure (mmHg), Height (cm), Weight (kg), and BMI (kg/m2) [1], where [1] goes to “[1] Body Mass Index (BMI) = weight (kg) / [height (m)]2.”; 
Reference Listings: 16.2.9.3.1, 16.2.9.4.2)


Statistical Analysis Plan, 
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Table 14.3.6.4.2
Shift from Baseline in Weight by Study Visit 
Safety Population
Study Visit
   Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Week 2
   Weight Loss  10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Weight Gain  10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Weight Loss  5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Weight Gain  5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 4
   Weight Loss  10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Weight Gain  10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Weight Loss  5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Weight Gain  5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 8
   Weight Loss  10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Weight Gain  10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Weight Loss  5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Weight Gain  5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Continue for Week 9
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Baseline is the last non-
missing measurement taken before the first application of study drug.
Reference Listing: 16.2.9.3.2


Statistical Analysis Plan, 
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Table 14.3.6.4.3
Shift from Baseline in Weight by Study Visit and Weight Loss Intentional/Non-Intentional Categories
Safety Population
(Same shell as Table 14.3.6.4.2, except will be presented by the following categories as headers in the by-line: “Weight Loss: Intentional” and “Weight Loss: Not 
Intentional or Missing”).


Statistical Analysis Plan, 
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Table 14.3.6.4.4
Shift from Baseline in BMI Categories by Study Visit
Safety Population
Baseline Category
Post-Baseline
Roflumilast Foam 0.3% (N=XX)
Study Visit
Category [1]
Missing
Underweight
Normal
Overweight
Obese
Total
Week 2
Missing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Underweight
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Normal
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Overweight
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Obese
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Total
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 4
Missing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Underweight
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Normal
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Overweight
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Obese
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Total
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Repeat for Vehicle and Overall. Repeat all for Week 8. 
Abbreviation: BMI = body mass index.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Baseline is the last non-missing measurement taken 
before the first application of study drug. BMI is derived as (weight in kg)/[(height in cm/100)2]. 
[1] If BMI is below 18.5 then it is categorized as underweight; if BMI ranges between 18.5 – 24.9 then it is categorized as Normal; if BMI ranges between 25.0 – 29.9 
then it is categorized as overweight; if BMI is  30.0 then it is categorized as obese.
Reference Listings: 16.2.9.4.1, 16.2.9.4.2


Statistical Analysis Plan, 
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Table 14.3.6.4.5
Shift from Baseline in Weight by Study Visit and Weight Loss Intentional/Non-Intentional Categories
Safety Population
(Same shell as Table 14.3.6.4.5, except will be presented by the following categories as headers in the by-line: “Weight Loss: Intentional” and “Weight Loss: Not 
Intentional or Missing”).


Statistical Analysis Plan, 
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Protocol Number ARQ-154-204
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Table 14.3.6.5
Summary of Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation and Suicidal Behavior by Study Visit
Safety Population
Study Visit
   C-SSRS Section
Roflumilast Foam 0.3%
Vehicle
Overall
      C-SSRS Item
(N=XX)
(N=XX)
(N=XX)
Screening
   Suicidal Ideation
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Wish to be Dead
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Non-Specific Active Suicidal Thoughts
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Active Suicidal Ideation with Any Methods
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Active Suicidal Ideation with Some Intent
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Active Suicidal Ideation with Specific Plan
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Suicidal Behavior
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Actual Attempt
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Interrupted Attempt
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Aborted Attempt
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Preparatory Acts or Behavior
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Suicidal Ideation or Behavior
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Subject Engaged in Non-Suicidal Self-Injurious Behavior  
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Repeat for Baseline Day 0, Week 4, Week 8; Add Suicide row for all visits except Screening.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. The number and percent of subjects who experience the 
event at least once during treatment are summarized. Subjects are counted once for each C-SSRS section and once for each C-SSRS item answered “Yes” during treatment 
period. “Baseline/Screening” version was used for Screening visit and “Since Last Visit” was used for all other visits.
Reference Listing: 16.2.9.8


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Table 14.3.6.6
Summary of Physical Examination by Study Visit
Safety Population
Study Visit
   Body System
      Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle 
(N=XX)
Overall
(N=XX)
Screening
   Skin
      Normal
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Abnormal (NCS)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Abnormal (CS)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Missing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Total
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Lungs
      Normal
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Abnormal (NCS)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Abnormal (CS)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Missing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Total
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Heart
      Normal
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Abnormal (NCS)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Abnormal (CS)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Missing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Total
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
                                      Repeat for Baseline, Week 8
Abbreviations: CS = clinically significant; NCS = not clinically significant.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Baseline is the last non-missing 
measurement taken before the first application of study drug.
Reference Listing: 16.2.9.4


Statistical Analysis Plan, 
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Page 127 of 172
Table 14.3.6.7
Summary of Concomitant Medications by ATC Class Level 4 and Preferred Term
Safety Population
ATC Class Level 4
   Preferred Term
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Subjects with at least 1 Concomitant Medication
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
ATC Class 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
ATC Class 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: ATC = Anatomic Therapeutic Chemical; PT = preferred term; WHO-DDE = World Health Organization-Drug Dictionary 
Enhanced.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Medications were coded 
using WHO-DDE Global B3 version September 2019. Concomitant medications are all medications that were continuing or starting after 
first application of study drug. Medications are displayed by alphabetical order of ATC Level 4 classification, then descending frequency of 
PT within ATC, and then alphabetically by PT. Subjects were counted only once for each ATC and PT.
Reference Listing: 16.2.9.6
Programming note: ATC & PT text should be presented as is from dataset.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 128 of 172
Table 14.4.1.1
Summary of Pharmacokinetic Concentration Results by Study Visit and Time Point
PK Population
Study Visit
   Time Point
      Statistic
Roflumilast Foam 0.3%
(N=XX)
Baseline Day 0
   Predose
       n
XX
       Mean (SD)
XX.X (XX.XX)
       Median 
XX.X
       Min, Max
XX, XX
   1 hour postdose
       n
XX
       Mean (SD)
XX.X (XX.XX)
       Median 
XX.X
       Min, Max
XX, XX
   2 hours postdose
       n
XX
       Mean (SD)
XX.X (XX.XX)
       Median 
XX.X
       Min, Max
XX, XX
Programming note: Repeat for Baseline: 4 hours postdose, 6 hours 
postdose, and 24 hours postdose; Week 4: Predose, 1 hour postdose, 2 
hours postdose, 4 hours postdose, 6 hours postdose, and 24 hours 
postdose; Week 8: Predose.
Note: Subjects are summarized by treatment received. Results at the predose 
time point that occurred after dosing are excluded from this summary.
Reference Listing: 16.2.5.6


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
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Page 129 of 172
Table 14.4.1.2
Summary of Pharmacokinetic Parameters by Study Visit
PK Population
Parameter: XXXXXXXX
Study Visit
    Statistic
Roflumilast Foam 0.3%
(N=XX)
Baseline Day 0
    n
XX
    Mean (SD)
XX.X (XX.XX)
    Median 
XX.X
    Min, Max
XX, XX
Week 4
     n
XX
     Mean (SD)
XX.X (XX.XX)
     Median 
XX.X
     Min, Max
XX, XX
Week 8
     n
XX
     Mean (SD)
XX.X (XX.XX)
     Median 
XX.X
     Min, Max
XX, XX
Programming note: Continue for all parameters.
Note: Subjects are summarized by treatment received.
Reference Listing: 16.2.5.7


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 130 of 172
14.3. Planned Listing Shells
Listing 16.2.1.1
Subject Disposition
All Subjects
Randomized
Did Subject
Complete Study? [1]
Date of 
Completion/
Early Termination
Date of Last Study 
Visit
Reason for Early
Cause of Death/
Early Termination Due
Subject ID
Treatment
eCRF
Derived
(Study Day)
(Study Day)
Termination [2]
   Date of Death
to COVID-19 Disruption
XXXXXX
XXXXXX
Yes
Yes
DDMMMYYYY 
(XX)
DDMMMYYYY (XX)
XXXXXX
XXXXXX
Yes
Yes
DDMMMYYYY 
(XX)
DDMMMYYYY (XX)
XXXXXX
XXXXXX
Yes
Yes
DDMMMYYYY
(XX)
DDMMMYYYY (XX)
XXXXXX
XXXXXX
No
Yes
DDMMMYYYY 
(XX)
DDMMMYYYY (X)
XXXXXXXXXX: 
XXXXXXXXX
XXXXXX
XXXXXX
No
Yes
DDMMMYYYY 
(XX)
DDMMMYYYY (XX)
XXXXXX
XXXXXX/    
   DDMMMYYYY
XXX
Abbreviations: COVID-19 = novel coronavirus disease-19; eCRF = electronic case report form.
Note: Study day is calculated relative to the date of first application of study drug.
[1] The derived completion status is based on a subject completing the Week 8 visit; this is what is used in the subject disposition summary. The eCRF completion status is based on what 
was recorded in the eCRF. 
[2] Based on the eCRF.
Programming Note: If reason for early termination is Other, concatenate the specify text as follows: “Other: XXXXXXXXX”. If reason for early termination is lost to follow-up, 
concatenate with date of last contact as follows: “Lost to follow-up; date of last contact: DDMMMYYYY”. 


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 131 of 172
Listing 16.2.1.2
Subject Visits
All Subjects
Subject ID
Treatment 
Received
Was Visit 
Performed?
Visit
Visit Date
(Study Day)
If Visit not Performed, 
COVID-19 Disruption 
Contributed to Missed Visit
XXXXXX
XXXXXX
Yes
XXXXXXX
DDMMMYYYY (XX)
Yes
XXXXXX
DDMMMYYYY (XX)
Yes
XXXXXXXXX
DDMMMYYYY (XX)
No
XXXXXXX
Yes
XXXXXX
XXXXXX
Yes
XXXXXXX
DDMMMYYYY (XX)
Yes
XXXXXX
DDMMMYYYY (XX)
Abbreviation: COVID-19 = novel coronavirus disease-19.
Note: Study day is calculated relative to the date of first application of study drug.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 132 of 172
Listing 16.2.2.1
Inclusion and Exclusion Criteria
All Subjects
Subject ID
Was Subject 
Rescreened?
Subject Screen 
Failed
due to COVID-19 
Disruption
Randomized 
Treatment
Date/Time (Study Day) of:
All Inclusion
Criteria Met? 
[1]
Any Exclusion
Criteria Met? 
[2]
Screening
     Informed Consent
If Adolescent, 
Date of Written 
Assent
XXXXXX
XX
XXXXXX
DDMMMYYYY 
(-X)
DDMMMYYYY/hh:m
m
(-X) 
Yes
No
DDMMMYYYY
XXXXXX
XX
XX
DDMMMYYYY 
No: 05, 13
No
XXXXXX
XX
XX
DDMMMYYYY 
DDMMMYYYY/hh:m
m
No: 02
No
XXXXXX
XXX
XXXXXX
DDMMMYYYY 
(-X)
DDMMMYYYY 
(-X)
Yes
Yes: 02
XXXXXX
XX
XXXXXX
DDMMMYYYY
(-X) 
DDMMMYYYY
(-X) 
Yes
No
XXXXXX
XX
XXXXXX
DDMMMYYYY 
(-X)
DDMMMYYYY 
(-X)
Yes
No
Abbreviation: COVID-19 = novel coronavirus disease-19.
Note: Study day is calculated relative to the date of first application of study drug. If a subject is a rescreen, the latest date of screening and informed consent are presented.
[1] 02 = Males and females ages 12 years and older (inclusive) at the time of consent or assent (for adolescents); 05 = A Psoriasis Scalp Severity Index (PSSI) score of at 
least 6 at Baseline; 13 = Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.
[2] 02 = Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
Programming note: If more than 1 inclusion or exclusion criterion number exists, concatenate with a comma as shown above. Decode any relevant criteria in the footnotes as shown 
in the example. If no criteria are present for a column, remove the [1] and/or [2] from the column header. Time is only collected for informed consent. If time is missing, display as 
shown in the shell. If subject rescreens, populate the latest date of screening and informed consent.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 133 of 172
Listing 16.2.2.2
Protocol Deviations
All Subjects
Subject ID
Treatment 
Received
Date of Protocol 
Violation Collection 
(Study Day)
Event Type
Violation 
Level
Description
COVID-19 
Related
COVID-19 
Infection
Action/Resolution
XXXXXX
XXXXXX
DDMONYYYY (XX) XXXXXXXXXXX
Minor
XXXXXXX
DDMONYYYY (XX) XXXXXXXXXXXXXX
Major
XXXXXXXXXXXXXXX
XXXXXX
XXXXXX
DDMONYYYY (XX) XXXXXXXXXXXX
XXXXX
XXXXXXXXXXXXXXXXXXX
DDMONYYYY (XX) XXXXXXXXXXXXXXXX
XXXXX
XXXXXXXXXXX
XXX
XXX
XXXXXX
XXXXXX
DDMONYYYY (XX) XXXXXXXXXXXX
XXXXX
XXXXXXXXXXXXXXXXXXXX
XX
XX
Abbreviation: COVID-19 = novel coronavirus disease-19.
Note: Study day is calculated relative to the date of first application of study drug.
Programming note: the structure of this listing may change depending on the information in the protocol deviations file.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 134 of 172
Listing 16.2.3.1
Subject Randomization
All Subjects
Subject 
ID
Treatment 
Received
Randomization
Randomized
Treatment
Date/Time
Number
Stratification ID
XXXXXX
XXXXXX
XXXXX
DDMMMYYY/
hh:mm
XXXX
XXXX
XXXXXX
XXXXXXX
XXXXX
DDMMMYYY/
hh:mm
XXXX
XXXX
XXXXXX


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 135 of 172
Listing 16.2.3.2
Analysis Populations
All Subjects
Subject 
ID
Treatment 
Received
Safety
[1]
ITT
[2]
mITT
[3]
SPRU4-ITT
[4]
SPRU4-mITT
[4]
PRU4-ITT
[5]
PRU4-mITT
[5]
PK
[6]
Primary Reason(s) for Exclusion [7]
XXXXXX
XXXXXX
Yes
Yes
No
Yes
XXX
XXX
XXX
XXX
Subject missed Week 8 disease assessment
specifically due to COVID-19 disruptions.
XXXXXX
XXXXXXX
Yes
Yes
Yes
Yes
XXX
XXX
XXX
XXX
XXXXXX
No
Yes
No
No
XXX
XXX
XXX
XXX
Subject did not receive at least 1 dose of IP.
Abbreviations: COVID-19 = novel coronavirus disease-19; ITT = intent-to-treat; IP = investigational product; mITT = modified intent-to-treat; NA = not applicable; PK = pharmacokinetic; 
PRU4 = Subjects with WI-NRS Pruritus Score 4 at Baseline; SI-NRS = Scalp Itch – Numeric Rating Scale; SPRU4 = Subjects with SI-NRS Pruritus Score 4 at Baseline; WI-NRS = 
Worst Itch – Numeric Rating Scale.
[1] The Safety Population includes all subjects who are enrolled and received at least 1 confirmed dose of IP.
[2] The ITT Population includes all subjects who are randomized. 
[3] The mITT population includes all randomized subjects with the exception of subjects who missed the Week 8 S-IGA assessment specifically due to COVID-19 disruptions.
[4] The SPRU4-ITT and SPRU4-mITT populations are subsets of the ITT and mITT populations, respectively, and include subjects with SI-NRS pruritus score  4 at Baseline. These
populations will be used for the analyses of achievement of a 4-point reduction in SI-NRS pruritus score as compared to Baseline.
[5] The PRU4-ITT and PRU4-mITT populations are subsets of the ITT and mITT populations, respectively, and include subjects with WI-NRS pruritus score  4 at Baseline. These
populations will be used for the analyses of achievement of a 4-point reduction in WI-NRS pruritus score as compared to Baseline.
[6] The PK population includes all subjects receiving the active drug with sufficient plasma concentrations of roflumilast to define a profile, as determined by the pharmacokineticist.
[7] Applies to the Safety, ITT, and mITT populations only.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 136 of 172
Listing 16.2.4.1.1
Subject Demographics 
All Subjects
Child-Bearing
Potential? If 
Yes, Specify 
Contraception
Year of
Birth
Age
(years) 
[1]
Photography 
Consent Obtained/
  Date of Consent
PK Consent 
Obtained/
  Date of Consent
Subject 
ID
Treatment 
Received
Sex
Ethnicity
Race
XXXXXX
XXXXXX
XXXX
No
YYYY
XX
XXXXXXX
XXXXXXX
Yes/
  DDMMMYYYY
Yes/
  DDMMMYYYY
XXXXXX
XXXXXX
XXXXXX
No
YYYY
XX
XXXXXXX
XXXXXX
Yes/
  DDMMMYYYY
Yes/
  DDMMMYYYY
XXXXXX
XXXXXX
XXXX
YYYY
XX
XXXXXXX
XXXXXX
No
No
XXXXXX
XXXXXX
XXXX
YYYY
XX
XXXXXXX
XXXXX
Yes/
  DDMMMYYYY
Yes/
  DDMMMYYYY
XXXXXX
XXXXXX
XXXXXX
No
YYYY
XX
XXXXXXX
XXXXXX
Yes/
  DDMMMYYYY
Yes/
  DDMMMYYYY
XXXXXX
XXXXXX
XXXXX
Yes: 
XXXXXXX
YYYY
XX
XXXXXX
XXXXXX
XXX
XXX
Abbreviation: PK = pharmacokinetic.
[1] Age at Screening.
Programming Note: If subject has multiple races, concatenate them. If child-bearing potential is Yes, concatenate type of contraception with “:” as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 137 of 172
Listing 16.2.4.1.2
Baseline Characteristics
All Subjects
Height 
(cm)
Weight
(kg)
BSA
(%)
S-IGA [1]
B-IGA [1]
SI-NRS [2]
WI-NRS [2]
Subject ID
Treatment 
Received
XXXXXX
XXXXXX
XX.X
XX.X
XX.X
X = XXXXX
X = XXXXX
XX
XX
XXXXXX
XXXXXX
XX.X
XX.X
XX.X
X = XXXXX *
X = XXXXX *
XX
XX
XXXXXX
XXXXXX
XX.X
XX.X
XX.X
X = XXXXX
X = XXXXX
XX
XX
XXXXXX
XXXXXX
XX.X
XX.X
XX.X
X = XXXXX
X = XXXXX
XX
XX
XXXXXX
XXXXXX
XX.X
XX.X
XX.X
X = XXXXX
X = XXXXX
XX
XX
XXXXXX
XXXXXX
XX.X
XX.X
XX.X
X = XXXXX
X = XXXXX
XX
XX
Abbreviations: B-IGA = body investigator global assessment; BSA = body surface area; S-IGA = scalp investigator global assessment; SI-NRS = Scalp Itch –
Numeric Rating Scale; WI-NRS = Worst Itch – Numeric Rating Scale.
Note: Weight and % BSA affected by disease are the values at Screening. Height was collected at Baseline Day 0. 
[1] For S-IGA and B-IGA, baseline is the last non-missing measurement taken before the first application of study drug. * = Screening visit was used as 
baseline.
[2] For SI-NRS and WI-NRS, baseline is the last non-missing measurement taken on or before the day of first application of study drug.
Programming Note: For S-IGA and B-IGA scores, if VISIT is not Baseline Day 0 for the record where ABLFL=Y, then add a * to the end of the concatenated numeric + text 
result, as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 138 of 172
Listing 16.2.4.2
Medical History
All Subjects
Subject 
ID
Treatment 
Received
Subject History of Psoriasis 
Involvement 
Type of History
Other Medical History Conditions
System Organ Class/
  Preferred Term/
      Verbatim Term
Start Date (Study Day)/
    End Date (Study Day)
XXXXXX
XXXXXX
Knees/Elbow: Yes/
Genitalia: No
Topical Corticosteroids: Yes/
Topical Vitamin D Derivatives: No
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXXXXX
      XXXXXXXXXXXXX
DDMMMYYYY (X)/
   DDMMMYYYY (X)
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXXXXX
      XXXXXXXXXXXXX
DDMMMYYYY (X)/
   DDMMMYYYY (X)
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXXXXX
      XXXXXXXXXXXXX
DDMMMYYYY (X)/
   DDMMMYYYY (X)
XXXXXX
XXXXXX
Knees/Elbow: Yes/
Genitalia: No
Topical Corticosteroids: Yes/
Topical Vitamin D Derivatives: No
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXXXXX
       XXXXXXXXXXXXX
DDMMMYYYY (X)/
   Ongoing
Abbreviation: MedDRA = Medical Dictionary for Regulatory Activities.
Note: Study day is calculated relative to the date of first application of study drug. Medical history was coded using MedDRA version 23.0. Only subjects 
with medical history recorded are listed.
Programming note: SOC & PT text should be presented as is from the dataset. 


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 139 of 172
Listing 16.2.5.1
Study Drug Application at the Study Site
All Subjects
Subject 
ID
Treatment 
Received
Was Study 
Drug 
Application 
Performed at 
Study Site?
Study 
Visit
Date/Time of
Application
(Study Day)
Pre-Application 
Can Weight (g) 
Measurement 
Post-Application 
Can Weight (g) 
Measurement
Applied 
Dose
(g)
Reason Pre- and/or 
Post-Application 
Can Weight 
Measurement not 
Performed
Kit Number/
   Can ID
XXXX
XXXXXX
Yes
XXXXXX
DDMMMYYYY/HH:MM (X)
XX
XX
XX
XXXX/
   XX
XXXXXX
DDMMMYYYY/HH:MM (XX)
XX.X
XX.X
XX.X
XXXX/
   XX
XXXXXX
DDMMMYYYY/HH:MM (XX)
XX
XX
XX
XXXX/
   XX
No: XXXXXX
XXXXXX
XXXX
XXXXXX
Yes
XXXXXX
DDMMMYYYY/HH:MM (X)
XX
XX
XX
XXXX/
   XX
XXXXXX
DDMMMYYYY/HH:MM (XX)
XX
XX
XX.X
XXXX/
   XX
XXXXXX
DDMMMYYYY/HH:MM (XX)
XX
Not Done
XXXXXXXXXXXXX
XXXX/
   XX
Note: Study day is calculated relative to the date of first application of study drug.
Programming note: For Pre & Post-Application Can Weight Measurement columns, if the weight measurement is not performed, set the value to be “Not Done”. If drug not 
administered, concatenate reason (COVID-19 Disruption or other specify text) as shown in shell.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 140 of 172
Listing 16.2.5.2
Cans
All Subjects
Subject ID
Treatment 
Received
Kit Number/
   Can ID
Can Dispensed?
Reason if No
Date Dispensed 
(Study Day)
Dispense 
Weight (g)
Can Returned?
Reason if No
Date Returned
(Study Day)
Return
Weight (g)
XXXXX
XXXXXX
XXXXX/
   XX
Yes
DDMMMYYYY (X)
XX.X
Yes
DDMMMYYYY (X)
XX.X
XXXXX/
   XX
Yes
DDMMMYYYY (X)
XX.X
Yes
DDMMMYYYY (X)
XX.X
XXXXX/
   XX
Yes
DDMMMYYYY (X)
ND
Yes
DDMMMYYYY (X)
ND
XXXXX
XXXXXX
XXXXX
No: XXXXX
No: XXXXX
Abbreviation: ND = not done.
Note: Study day is calculated relative to the date of first application of study drug.
Programming note: within subject, sort by dispense date, return date, kit number and CAN ID.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 141 of 172
Listing 16.2.5.3
Diary Dispensation 
All Subjects
Subject ID
Treatment 
Received
Diary 
Dispensation
Visit
Diary 
Dispensed?
Date Dispensed 
(Study Day)
Diary 
Returned
Visit
Diary Returned
and Reviewed?
Reason Diary 
not Returned
Date Returned 
(Study Day)
XXXXX
XXXXXX
XXXXXX
Yes
DDMMMYYYY (X)
XXXXXX
Yes
DDMMMYYYY (X)
XXXXXX
Yes
DDMMMYYYY (X)
XXXXXX
Yes
DDMMMYYYY (X)
XXXXXX
Yes
DDMMMYYYY (X)
XXXXXX
No
XXXXXXXXXX
XXXXX
XXXXXX
XXXXX
No
XXXXXX
No
XXXXXXXXX
Note: Study day is calculated relative to the date of first application of study drug.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 142 of 172
Listing 16.2.5.4
Compliance (CRF)
All Subjects
Subject ID
Treatment 
Received
Study
Visit
Subject Compliant with 
Medication?
Date of Compliance 
Check (Study Day)
Compliance [1]
Overall 
Compliance [2]
Was Subject Retrained if not 
Compliant with Medication
XXXXXX
XXXXXX
XXXXXX
XXX
DDMMMYYYY (X)
XX.X %
XX.X %
XXXXXX
XXX
DDMMMYYYY (X)
XX.X %
XXXXXX
XXX
DDMMMYYYY (X)
XX.X %
XXXXXX
XXXXXX
XXXXXX
XXX
DDMMMYYYY (X)
XX.X %
XX.X%
XXXXXX
XXX
DDMMMYYYY (X)
XX.X %
XXXXXX
XX
XXX
Abbreviations: IP = investigational product; CRF = case report form.
Note: Study day is calculated relative to the date of first application of study drug. 
[1] This data comes from CRF page, unless otherwise specified. 
[2] Overall compliance was calculated based on number of applications divided by the expected number of IP applications for each subject. Number of expected IP 
applications was calculated as number of days between first and last application of IP (last treatment date - first treatment date + 1). Number of IP applications was
calculated as number of expected IP applications - missed IP applications as collected in the CRF.
Programming note: Populate overall compliance only for the first visit.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 143 of 172
Listing 16.2.5.5
Missed Doses
All Subjects
Subject ID
Treatment 
Received
Study
Visit
Date of Missed Dose
(Study Day)
Missed Dose due to 
COVID-19
Disruption?
Reason for Missed Dose
XXXXXX
XXXXXX
XXXXXX
DDMMMYYYY (X)
No
XXXXXXXXXXXXXX
XXXXXX
DDMMMYYYY (X)
No
XXXXXXXXXXXXXX
XXXXXX
XXXXXX
XXXXXX
DDMMMYYYY (X)
Yes
XXXXXXXXXXXXXX
XXXXXX
XXXXXX
XXXXXX
DDMMMYYYY (X)
No
XXXXXXXXXXXXXX
XXXXXX
DDMMMYYYY (X)
No
XXXXXXXXXXXXXX
Abbreviation: COVID-19 = novel coronavirus disease-19.
Note: Study day is calculated relative to the date of first application of study drug.
Programming note: Only subjects with missed doses should be presented in this listing.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 144 of 172
Listing 16.2.5.6
Pharmacokinetic Blood Collection
All Consenting Subjects with Pharmacokinetic Data Collected
Subject 
ID
Treatment 
Received
PK Sample Collected 
at this Visit? Reason 
if No
Study Visit
PK Sample 
Collected 
Pre-Dose
PK Collection 
Time Point
Date/Time of 
Assessment
(Study Day)
Accession
Number
BSA Treated at 
the Time of PK 
Sample Collection
Roflumilast 
Concentration 
(unit)
XXXXXX
XXXXXX
XXX
XXXXXX
XXX
XXXXX
DDMMMYYY/
HH:MM (X)
XXXXX
XX.X %
XX.X
XXXXXX
XXX
XXXXX
DDMMMYYY/
HH:MM (X)
XXXXX
XX %
XX.X
XXXXXX
XXX
XXXXX
DDMMMYYY/
HH:MM (X)
XXXXX
XX %
XX.X
No: XXXXXXXX
XXXXXX
XX
XXXXX
Abbreviation: BLQ = Below the limit of quantification; BSA = body surface area; PK = pharmacokinetic.
Note: Study day is calculated relative to the date of first application of study drug.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 145 of 172
Listing 16.2.5.7
Pharmacokinetic Calculated Parameters
PK Population
Subject 
ID
Treatment 
Received
Study Visit
AUC0-t
(unit)
AUCtau
(unit)
Tmax
(unit)
Tlag
(unit)
Tlast
(unit)
Cmax
(unit)
Cmin
(unit)
XXXXX
XXXXXX
XXXXXX
XX
XX
XX
XX
XX
XX
XX
XXXXXX
XX
XX
XX
XX
XX
XX
XX
XXXXXX
XX
XX
XX
XX
XX
XX
XX
XXXXXX
XX
XX
XX
XX
XX
XX
XX
Abbreviation: PK = pharmacokinetic.
Programming note: The above parameters are expected. However the final parameters provided by the pharmacokineticist will be listed and may be different than 
shown.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 146 of 172
Listing 16.2.6.1
Scalp Investigator Global Assessment (S-IGA) 
All Subjects
Subject 
ID
Randomized 
Treatment
Was Assessment 
Completed? Reason 
if No
If Yes, Telemedicine 
or Delay in 
Assessment 
Collection [1]
Study Visit
Date/Time of
Assessment 
(Study Day)
Result
Text Result
Change 
from 
Baseline
S-IGA 
Success 
[2]
XXXXXX
XXXXXX
Yes
No
XXXXXXX
DDMMMYYYY/hh:mm
(X)
X
XXXXXXXXXX
Yes
Yes: Delay in 
Assessment 
Collection
XXXXXXX
DDMMMYYYY/hh:mm
(X)
X
XXXXXXXXXX
X
Yes
No: COVID-19 
Disruption
XXXXXXX
Yes
No
XXXXXXX
DDMMMYYYY/hh:mm
(X)
X
XXXXXXXXXX
X
Yes
XXXXXX
XXXXXX
Yes
Yes: Assessment 
Completed via 
Telemedicine
XXXXXXX
DDMMMYYYY/hh:mm
(X)
X
XXXXXXXXXX
No: XXXXXXXX
XXXXXXX
DDMMMYYYY/hh:mm
(X)
Abbreviations: COVID-19 = novel coronavirus disease-19; S-IGA = scalp investigator global assessment.
Note: Study day is calculated relative to the date of first application of study drug. Baseline is the last non-missing measurement taken before the first application of study drug. Change from 
baseline is calculated as Result – Baseline.
[1] Due to COVID-19 disruption.
[2] S-IGA Success (“Yes”) is defined as an S-IGA score of “Clear” or “Almost Clear” plus a 2-grade improvement from baseline at Weeks 2, 4, 8, and 9; “No” otherwise.
Programming note:  Concatenate reason not done (COVID-19 Disruption or other specify text) as shown in the shell. For the “If Yes, Telemedicine or Delay in Assessment Collection” column, do 
the following: if the answer to both questions (was assessment completed via telemedicine or was delayed) is No, display “No”; if the answer to only was assessment completed via telemedicine is 
yes, set to “Yes: Assessment Completed via Telemedicine”; if the answer to only did COVID-19 disruption cause/contribute to delay, set to “Yes: Delay in Assessment Collection”; if both are yes, 
set to “Yes: Assessment Completed via Telemedicine; Delay in Assessment Collection”.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 147 of 172
Listing 16.2.6.2
Body Investigator Global Assessment (B-IGA) 
All Subjects
Programming note: Same as shell 16.2.6.1. Update any instances of S-IGA to B-IGA.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 148 of 172
Listing 16.2.6.3
Psoriasis Scalp Severity Index (PSSI)
All Subjects
Subject 
ID
Randomized 
Treatment
Was 
Assessment 
Completed? 
Reason if No
If Yes, 
Telemedicine or 
Delay in 
Assessment 
Collection [1]
Study
Visit
Date/Time of
Assessment 
(Study Day)
Test
Numeric 
Result
Text Result
Change 
from 
Baseline
PSSI-50 [3]/
PSSI-75 [4]/
PSSI-90 [5]
XXXXXX
XXXXXX
Yes
No
XXXX
DDMMMYYYY/hh:mm
(X)
Erythema
2
XXXX
Induration
2
XXXXX
Desquamation
2
XXXX
Sum of Severity 
Rating
6
Extent of Scalp 
Affected
2
PSSI Total Score [3]
12
Yes
Yes: Delay in 
Assessment 
Collection
XXXX
DDMMMYYYY/hh:mm
(X)
Erythema
2
XXXXX
XX
Induration
3
XXXXX
XX
Desquamation
2
XXXX
XX
Sum of Severity 
Rating
7
XX
Extent of Scalp 
Affected
2
XX
PSSI Total Score [2]
14
XX
XX/XX/XX
Abbreviations: COVID-19 = novel coronavirus disease-19; PSSI = Psoriasis Scalp Severity Index.
Note: Study day is calculated relative to the date of first application of study drug. Baseline is the last non-missing measurement taken before the first application of study drug. Change from 
baseline is calculated as Result – Baseline. 
[1] Due to COVID-19 disruption.
[2] PSSI total score is calculated as (erythema score + induration + desquamation) × extent of scalp affected. The score ranges from 0 to 72. Erythema, induration, and desquamation are 
scored on a scale of 0 to 4, where 0 = absent and 4 = severest possible; extent of scale affected is scored on a scale of 0 to 6, where 0 = 0% of involved area and 6 = 90-100% of involved area.
[3] PSSI-50 is populated with “Yes” when there is an achievement of a 50% reduction in PSSI total score from baseline. 
[4] PSSI-75 is populated with “Yes” when there is an achievement of a 75% reduction in PSSI total score from baseline.
[5] PSSI-90 is populated with “Yes” when there is an achievement of a 90% reduction in PSSI total score from baseline.
Programming note:  Concatenate reason not done (COVID-19 Disruption or other specify text) as shown in the shell for Listing 16.2.6.1. For the “If Yes, Telemedicine or Delay in Assessment 
Collection” column, do the following: if the answer to both questions (was assessment completed via telemedicine or was delayed) is No, display “No”; if the answer to only was assessment 
completed via telemedicine is yes, set to “Yes: Assessment Completed via Telemedicine”; if the answer to only did COVID-19 disruption cause/contribute to delay, set to “Yes: Delay in 
Assessment Collection”; if both are yes, set to “Yes: Assessment Completed via Telemedicine; Delay in Assessment Collection”.
Only populate PSSI-50, PSSI-75, and PSSI-90 on PSSI Total Score row.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 149 of 172
Listing 16.2.6.4
Scalp Itch – Numeric Rating Scale (SI-NRS) 
All Subjects
Subject ID
Randomized 
Treatment
Was Assessment
Completed?
Reason if No
If Yes, Telemedicine or 
Delay in Assessment 
Collection [1]
Study Visit
Date/Time of
Assessment 
(Study Day)
Result
Change from 
Baseline
SI-NRS
Success 
(baseline  4) 
[2]
XXXXXX
XXXXXX
Yes
No
XXXXXXX
DDMMMYYYY/hh:mm (X)
9
Yes
No
XXXXXXX
DDMMMYYYY/hh:mm (X)
X
X
Yes
Yes
No
XXXXXXX
DDMMMYYYY/hh:mm (X)
X
X
Yes
Yes
Yes: Delay in 
Assessment Collection
XXXXXXX
DDMMMYYYY/hh:mm (X)
X
X
Yes
Yes
No
XXXXXXX
DDMMMYYYY/hh:mm (X)
X
X
Yes
XXXXXX
XXXXXX
Yes
No
XXXXXXX
DDMMMYYYY/hh:mm (X)
X
No: XXXXXX
XXXXXXX
DDMMMYYYY/hh:mm (X)
Abbreviations: COVID-19 = novel coronavirus disease-19; SI-NRS = Scalp Itch – Numeric Rating Scale.
Note: Study day is calculated relative to the date of first application of study drug. Subjects rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst 
itch imaginable). Higher score indicates greater itch intensity. Baseline is the last non-missing measurement taken on or before the day of first application of study drug. Change 
from baseline is calculated as Result – Baseline.
[1] Due to COVID-19 disruption.
[2] SI-NRS Success is defined as achievement of a 4-point reduction in SI-NRS pruritus score at Weeks 2, 4, 8, and 9 compared to baseline, calculated only for subjects with a 
pruritus score of  4 at baseline.
Programming note:  Concatenate reason not done (COVID-19 Disruption or other specify text) as shown in the shell for Listing 16.2.6.1. For the “If Yes, Telemedicine or Delay in 
Assessment Collection” column, do the following: if the answer to both questions (was assessment completed via telemedicine or was delayed) is No, display “No”; if the answer to 
only was assessment completed via telemedicine is yes, set to “Yes: Assessment Completed via Telemedicine”; if the answer to only did COVID-19 disruption cause/contribute to 
delay, set to “Yes: Delay in Assessment Collection”; if both are yes, set to “Yes: Assessment Completed via Telemedicine; Delay in Assessment Collection”.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 150 of 172
Listing 16.2.6.5
Psoriasis Symptoms Diary (PSD) 
All Subjects
Subject 
ID
Randomized 
Treatment
Assessment 
Completed? 
Reason if No
If Yes, 
Telemedicine or 
Delay in 
Assessment 
Collection [1]
Study 
Visit
Date of Assessment
(Study Day)
Question [2]
Result
Change from 
Baseline
XXXX
XXXXXX
Yes
No
XXXXX
DDMMMYYYY (XX)
How severe was your psoriasis-related itching?
1
How bothered were you by your psoriasis-related itching?
2
How severe was your psoriasis-related stinging?
3
How bothered were you by your psoriasis-related stinging?
4
How severe was your psoriasis-related burning?
5
how bothered were you by your psoriasis-related
burning?
1
How severe was your psoriasis-affected skin cracking?
2
How bothered were you by your psoriasis-affected
skin cracking?
3
How severe was your psoriasis-related pain?
4
How bothered were you by your psoriasis-related
pain?
5
How severe was your psoriasis scaling?
1
How bothered were you by your psoriasis scaling?
2
How noticeable did you think the color of your
psoriasis-affected skin was?
3
How much did you try to hide your psoriasis affected
Skin?
5
How much did your psoriasis cause you to avoid activities 
with other people?
4
How embarrassed were you because of your psoriasis?
8
Total Score [3]
XX
Abbreviations: COVID-19 = novel coronavirus disease-19; PSD = Psoriasis Symptoms Diary.
Note: Study day is calculated relative to the date of first application of study drug. Subjects rate the severity of symptoms or how bothersome the symptoms are on an 11-point scale ranging from 
0 to 10. Higher score indicates more severe symptoms. Baseline is the last non-missing measurement taken on or before the day of first application of study drug. Change from baseline is 
calculated as Result – Baseline.
[1] Due to COVID-19 disruption.
[2] These questions are based on the psoriasis symptoms over the past 24 hours.
[3] Total score is calculated as sum of all 16 questions. The total score ranges from 0 to 160. If 1 or more items are missing, the score is not calculated. 
Programming note:  Concatenate reason not done (COVID-19 Disruption or other specify text) as shown in the shell for Listing 16.2.6.1. For the “If Yes, Telemedicine or Delay in 
Assessment Collection” column, do the following: if the answer to both questions (was assessment completed via telemedicine or was delayed) is No, display “No”; if the answer to 
only was assessment completed via telemedicine is yes, set to “Yes: Assessment Completed via Telemedicine”; if the answer to only did COVID-19 disruption cause/contribute to 
delay, set to “Yes: Delay in Assessment Collection”; if both are yes, set to “Yes: Assessment Completed via Telemedicine; Delay in Assessment Collection”.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 151 of 172
Listing 16.2.6.6
Psoriasis Area Severity Index (PASI)/Modified PASI (mPASI) 
All Subjects
Subject 
ID
Randomized 
Treatment
Was 
Assessment 
Completed? 
Reason if No
If Yes, 
Telemedicine or 
Delay in 
Assessment 
Collection [1]
Study
Visit
Date/Time of
Assessment 
(Study Day)
Area
Test
Numeric 
Result
Text Result
Change 
from 
Baseline
XXXXXX
XXXXXX
Yes
No
XXXX
DDMMMYYYY/
hh:mm (X)
Head
Erythema
2
XXXX
Induration
2
XXXXX
Desquamation
2
XXXX
% Area Affected
XX.X
Area Lesion score
Degree of Involvement
Head PASI Score 
Arm
Erythema
2
XXXXX
Induration
2
XXXX
Desquamation
2
XXXXX
% Area Affected
XX.X
Area Lesion score
Degree of Involvement
Arm PASI Score 
Repeat the same for Trunk, Legs
All
PASI Total Score [2]
XX
mPASI Total Score [3]
XX
Abbreviations: COVID-19 = novel coronavirus disease-19; mPASI = modified Psoriasis Area Severity Index; PASI = Psoriasis Area Severity Index.
Note: Study day is calculated relative to the date of first application of study drug. Baseline is the last non-missing measurement taken before the first application of study drug. Change 
from baseline is calculated as Result – Baseline. 
[1] Due to COVID-19 disruption.
[2] PASI total score is calculated as (0.1×[Eh + Th + Sh]×Ah) + (0.2×[Ea + Ta + Sa]×Aa) + (0.3×[Et + Tt + St]×At) + (0.4×[El + Tl + Sl]×Al) where E, T, and S are erythema, thickness, 
and scaling, respectively, scored on a scale of 0 to 4, A is estimated area of skin involved, graded on a scale of 0 to 6, and h, e, t, and l are head, arms, trunk, and legs, respectively. 
The range of total score is 0 to 72.
[3] mPASI total score is calculated same as PASI above, except that for subjects with < 10% of any particular involved anatomic area, the mPASI will be calculated using the actual 
percentage of the anatomical area involved rather than the 0 to 6 estimated area score (e.g., 0.1 for 1%, 0.2 for 2%, 0.3 for 3%, … 0.9 for 9%).  
Programming note:  Concatenate reason not done (COVID-19 Disruption or other specify text) as shown in the shell for Listing 16.2.6.1. For the “If Yes, Telemedicine or Delay in 
Assessment Collection” column, do the following: if the answer to both questions (was assessment completed via telemedicine or was delayed) is No, display “No”; if the answer to 
only was assessment completed via telemedicine is yes, set to “Yes: Assessment Completed via Telemedicine”; if the answer to only did COVID-19 disruption cause/contribute to 
delay, set to “Yes: Delay in Assessment Collection”; if both are yes, set to “Yes: Assessment Completed via Telemedicine; Delay in Assessment Collection”.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 152 of 172
Listing 16.2.6.7
Worst Itch – Numeric Rating Scale (WI-NRS) 
All Subjects
Subject ID
Randomized 
Treatment
Was Assessment
Completed?
Reason if No
If Yes, Telemedicine 
or Delay in 
Assessment 
Collection [1]
Study Visit
Date/Time of
Assessment (Study Day)
Result
Change from 
Baseline
XXXXXX
XXXXXX
Yes
No
XXXXXXX
DDMMMYYYY/hh:mm (X)
X
Yes
No
XXXXXXX
DDMMMYYYY/hh:mm (X)
X
X
Yes
Yes: Delay in 
Assessment 
Collection
XXXXXXX
DDMMMYYYY/hh:mm (X)
X
X
Yes
No
XXXXXXX
DDMMMYYYY/hh:mm (X)
X
X
XXXXXX
XXXXXX
Yes
Yes: Assessment 
Completed via 
Telemedicine
XXXXXXX
DDMMMYYYY/hh:mm (X)
X
No: XXXXXX
XXXXXXX
DDMMMYYYY/hh:mm (X)
Abbreviations: COVID-19 = novel coronavirus disease-19; WI-NRS = Worst Itch – Numeric Rating Scale.
Note: Study day is calculated relative to the date of first application of study drug. Subjects rate the intensity of their itch on an 11-point scale ranging from 0 (no 
itch) to 10 (worst itch imaginable). Higher score indicates greater itch intensity. Baseline is the last non-missing measurement taken on or before the day of first 
application of study drug. Change from baseline is calculated as Result – Baseline.
[1] Due to COVID-19 disruption.
Programming note:  Concatenate reason not done (COVID-19 Disruption or other specify text) as shown in the shell for Listing 16.2.6.1. For the “If Yes, 
Telemedicine or Delay in Assessment Collection” column, do the following: if the answer to both questions (was assessment completed via telemedicine or was 
delayed) is No, display “No”; if the answer to only was assessment completed via telemedicine is yes, set to “Yes: Assessment Completed via Telemedicine”; if 
the answer to only did COVID-19 disruption cause/contribute to delay, set to “Yes: Delay in Assessment Collection”; if both are yes, set to “Yes: Assessment 
Completed via Telemedicine; Delay in Assessment Collection”.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 153 of 172
Listing 16.2.6.8
Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI) 
All Subjects
Form Name: DLQI
Subject 
ID
Randomized
Treatment 
Study 
Visit
Assessment 
Completed?
Reason if No
If Yes, 
Telemedicine 
or Delay in 
Assessment 
Collection [1]
Date/Time of 
Assessment
(Study Day)
Question
Numeric 
Result
Text 
Result
Change 
from 
Baseline
XXXX
XXXXXX
XXXXX
Yes
No
DDMMMYYYY/
hh:mm (XX)
1. Over the last week, how itchy, sore, painful 
or stinging has your skin been?
0
Not at all
2. Over the last week, how embarrassed or self 
conscious have you been because of your 
skin?
3
Very much
3. Over the last week, how much has your skin 
interfered with you going shopping or looking 
after your home or garden?
3
Very much
4. Over the last week, how much has your skin 
influenced the clothes you wear?
3
Very much
5. Over the last week, how much has your skin 
affected any social or leisure activities?
2
A lot
6. Over the last week, how much has your skin 
made it difficult for you to do any sport?
1
A little
7. Over the last week, has your skin prevented 
you from working or studying? If "No", over the 
last week how much has your skin been a 
problem at work or studying?
3
Yes
8. Over the last week, how much has your skin 
created problems with your partner or any of 
your close friends or relatives?
0
Not 
relevant
9. Over the last week, how much has your skin 
caused any sexual difficulties?
0
Not 
relevant
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?
3
Very much
DLQI Total Score [2]
18
Programming note: Continue for other visits. If form name=CDLQI, then refer to Protocol Appendix 7 for Questions. Replace DLQI total Score with CDLQI Total Score [1] in 
the body of listing. Footnote will remain as is.
Abbreviations: COVID-19 = novel coronavirus disease-19; DLQI = Dermatology Life Quality Index; CDLQI = Children’s Dermatology Life Quality Index.
Note: Study day is calculated relative to the date of the first application of study drug. Baseline is the last non-missing measurement taken on or before the day of first application of 
study drug. Change from baseline is calculated as Result – Baseline.
[1] Due to COVID-19 disruption.
[2] The DLQI total score ranges between 0-30 and calculated as sum of all the 10 questions at each visit, where "Not relevant" was recoded to 0 before calculation of this score. If 1 item 
is missing, it is scored as 0 for that item. If 2 or more items are missing, the score was not calculated. The CDLQI total score is calculated similar to DLQI total score. 


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 154 of 172
Programming note:  Concatenate reason not done (COVID-19 Disruption or other specify text) as shown in the shell for Listing 16.2.6.1. For the “If Yes, Telemedicine or Delay in 
Assessment Collection” column, do the following: if the answer to both questions (was assessment completed via telemedicine or was delayed) is No, display “No”; if the answer to 
only was assessment completed via telemedicine is yes, set to “Yes: Assessment Completed via Telemedicine”; if the answer to only did COVID-19 disruption cause/contribute to 
delay, set to “Yes: Delay in Assessment Collection”; if both are yes, set to “Yes: Assessment Completed via Telemedicine; Delay in Assessment Collection”.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 155 of 172
Listing 16.2.6.9
Body Surface Area (BSA) (excluding Palms and Soles)
All Subjects 
Subject ID
Randomized
Treatment
Assessment 
Performed?
If Assessment 
Performed, did 
COVID-19 
disruption cause 
or contribute to a 
delay in BSA 
Collection?
If Assessment 
Not Performed, 
did COVID-19 
disruption cause 
or contribute to 
missed BSA 
Collection?
Study Visit
Date/Time of 
Assessment
(Study Day)
Test
Result
XXXXXX
XXXXXX
XXX
XX
XXXXXX
DDMMMYYYY/hh:mm
(XX)
Coverage Area (Head)
XX %
Coverage Area (Lower Limbs)
XX %
Coverage Area (Upper Limbs)
XX.X %
Coverage Area (Trunk)
XX.X %
BSA Result [1]
XX.X %
BSA CRF [2]
XX.X %
XX
XX
XXXXXX
XXX
XXX
XXXXXX
DDMMMYYYY (XX)
Coverage Area (Head)
XX %
Coverage Area (Lower Limbs)
XX %
Coverage Area (Upper Limbs)
XX.X %
Coverage Area (Trunk)
XX.X %
BSA Result [1]
XX.X %
BSA CRF [2]
XX.X %
Abbreviations: BSA = body surface area; COVID-19 = novel coronavirus disease-19; CRF = case report form; ePRO = electronic patient report outcome.
Note: Study day is calculated relative to the date of first application of study drug. 
[1] BSA result is calculated as sum of coverage areas of head, lower limbs, upper limbs and trunk. This is derived in the ePRO.
[2] BSA captured in the CRF data.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 156 of 172
Listing 16.2.7.1
Adverse Events
All Subjects
Subject 
ID
Treatment 
Received
TEAE?
System Organ Class/
   Preferred Term/
      Verbatim Term
Start Date/Time (Study Day)/
   End Date/Time (Study Day)
CTCAE Toxicity Grade/
   Relationship
Outcome/
   Action Taken/
      Other Action Taken
Serious?/
  Criteria Met
AE Lead to Study 
D/C?
XXXXX
XXXXXX
XXX
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXX
  XXXXXXXXXX
DDMMMYYYY/hh:mm (X)/
   DDMMMYYYY/ hh:mm (X)
XXXXXXXXX/
   XXXXXXXXXX
XXXXXXXXX/
   XXXXXXXXXX/
       XXXXXXXXXX  
XX
XX
XXXXX
XXXXXX
XXX
XXXXXXXXXXXXXX/
   XXXXXXXXXXXX
  XXXXXXXXXXXXX
DDMMMYYYY/ hh:mm (X)/
   DDMONYYYY/ hh:mm (X)
XXXXXXXXX/
   XXXXXXXXXX
XXXXXXXXX/
   XXXXXXXXXX/
       XXXXXXXXXX  
XX
XX
XX
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXX
      XXXXXXXXXXXXX
DDMONYYYY/ hh:mm (X)/
   Ongoing
XXXXXXXXX/
   XXXXXXXXXX
XXXXXXXXX/
   XXXXXXXXXX/
      XXXXXXXXXX   
XXX/
   XXXXXXX
XXX
Abbreviations: AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events; D/C = discontinuation; IP = investigational product; MedDRA = Medical 
Dictionary for Regulatory Activities; TEAE = treatment emergent adverse event.
Note: Study day is calculated relative to the date of first application of study drug. AEs were coded using MedDRA version 23.0. All AEs that occur after the date/time of first 
application of IP will be considered TEAEs. Severity grades are reported according to the CTCAE version 4.0.
Programming note: If time missing, display “- -:- -”. If Serious? is Yes, concatenate all serious criteria marked as Yes with a semicolon. “Other Action Taken” will be either None, 
Concomitant Medication, Non-drug Therapy, Hospitalization or Prolongation of Hospitalization, Discontinued Study or Other; if specify text is needed, concatenate  “Other:” with the 
text. If no events meet the criteria for display, present “No events are reported.” SOC & PT text should be presented as is from the dataset.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 157 of 172
Listing 16.2.8.1.1
Clinical Laboratory Data: Clinical Chemistry
All Subjects
Subject
ID
Study
Visit
Date/Time of
Assessment
(Study Day)
Standard
Results
Reference
Range
[1]
Treatment
Received
Parameter (unit)
Reference 
Range
Flag
Result 
Interpretation; 
Specify CS 
Finding
Accession
Number
Comments/
Reason not Done
XXXXX
XXXXX
Alanine 
Aminotransferase (U/L)
XXXXX
DDMMMYYYY/hh:mm
(X)
XX
XX – YY
High
Normal
XXXXX
XXXXX
DDMMMYYYY/hh:mm
(X)
XX
XX – YY
Abnormal, NCS
XXXX
XXXXX
DDMMMYYYY/hh:mm
(X)
XX
XX – YY
Low
Normal
XXXXX
XXXXX
DDMMMYYYY/hh:mm
(X)
XX
XX – YY
Normal
XXXXX
XXXXX
DDMMMYYYY/hh:mm
(X)
XX
XX – YY
Abnormal, CS; 
XXXXXXX
XXXXX
Alkaline 
Phosphatase (U/L)
XXXXX
DDMMMYYYY (X)
XX
XX – YY
Low
XXXXX
XXXXX
XXXXX
DDMMMYYYY/hh:mm/
hh:mm (X)
XX
XX – YY
XXXXX
XXXXX
XXXXX
ND
XXXXXXX
XXXXX
DDMMMYYYY/hh:mm
(X)
XX
XX – YY
High
XXXXXX
XXXXX
Abbreviations: CS = clinically significant; NCS = not clinically significant; ND = not done.
Note: Study day is calculated relative to the date of first application of study drug. Time of assessment was provided by the central laboratory (ACM).
[1] Reference range is used to identify potentially clinically significant laboratory values.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 158 of 172
Listing 16.2.8.1.2
Clinical Laboratory Data: Hematology
All Subjects
(Same shell as Listing 16.2.8.1.1)
Listing 16.2.8.1.3
Clinical Laboratory Data: Urinalysis
All Subjects
(Same shell as Listing 16.2.8.1.1)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 159 of 172
Listing 16.2.8.1.4
Clinical Laboratory Data: Serum and Urine Pregnancy Test
Female Subjects
Subject ID
Treatment 
Received
Was Pregnancy 
Test Performed? 
Reason if No
Study Visit
Type of Test
Date/Time Performed
(Study Day)
Result
XXXXX
XXXXXX
Yes
XXXXXX
Serum
DDMMMYYYY/hh:mm (XX) XXXXXXXX
Urine
DDMMMYYYY/hh:mm (XX) XXXXXXXXX
XXXXXX
Urine
DDMMMYYYY/hh:mm (XX) XXXXXXXXX
XXXXX
XXXXXX
Yes
XXXXXX
Serum
DDMMMYYYY/hh:mm (XX)
XXXXXXXX
Urine
DDMMMYYYY/hh:mm (XX)
XXXXXXXXX
No: XXXXXXXXXX
XXXXXX
Urine
Note: Study day is calculated relative to the date of first application of study drug. Time of assessment for serum pregnancy test was provided by the central 
laboratory (ACM).
Programming note: If time is missing, display it as --:--.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 160 of 172
Listing 16.2.9.1
Investigator Local Tolerability Assessments 
All Subjects
Subject 
ID
Treatment 
Received
Tolerability
Assessment 
Performed? Reason if 
No
If Yes, Telemedicine 
or Delay in 
Assessment 
Collection [1]
Study Visit
Date/Time of 
Assessment (Study 
Day)
Dermal Response
Other Effects
XXXXXX
XXXXXX
Yes
No
XXXXXX
DDMMMYYYY/hh:mm
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
Yes
Yes: Delay in 
Assessment 
Collection
XXXXXX
DDMMMYYYY/hh:mm
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
Yes
No
XXXXXX
DDMMMYYYY/hh:mm
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
XXXXXX
XXXXXX
Yes
No
XXXXXX
DDMMMYYYY/hh:mm
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
Yes
No
XXXXXX
DDMMMYYYY/hh:mm
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
Yes
Yes: Assessment 
Completed via 
Telemedicine
XXXXXX
DDMMMYYYY/hh:mm
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
XXXXXX
XXXXXX
Yes
No
XXXXXX
DDMMMYYYY/hh:mm
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
Yes
No
XXXXXX
DDMMMYYYY/hh:mm
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
No: COVID-19 
Disruption
XXXXXX
Abbreviations: COVID-19 = novel coronavirus disease-19; IP = investigational product.
Note: Study day is calculated relative to the date of the first application of study drug. This assessment will be conducted by the investigator prior to the 
application of IP in the study site.
[1] Due to COVID-19 disruption.
Programming note:  Concatenate reason not done (COVID-19 Disruption or other specify text) as shown in the shell. For the “If Yes, Telemedicine or Delay in 
Assessment Collection” column, do the following: if the answer to both questions (was assessment completed via telemedicine or was delayed) is No, display 
“No”; if the answer to only was assessment completed via telemedicine is yes, set to “Yes: Assessment Completed via Telemedicine”; if the answer to only did 
COVID-19 disruption cause/contribute to delay, set to “Yes: Delay in Assessment Collection”; if both are yes, set to “Yes: Assessment Completed via 
Telemedicine; Delay in Assessment Collection”.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 161 of 172
Listing 16.2.9.2
Subject Local Tolerability Assessments 
All Subjects
Subject 
ID
Treatment 
Received
Tolerability
Assessment 
Performed? 
Reason if No
If Yes, 
Telemedicine or 
Delay in 
Assessment 
Collection [1]
Study Visit
Date/Time of 
Assessment (Study 
Day)
Grade
Sensation Following the Application of IP
XXXXXX
XXXXXX
Yes
No
XXXXXX
DDMMMYYYY/hh:mm
(XX)
0 = None
No sensation
Yes
Yes: Delay in 
Assessment 
Collection
XXXXXX
DDMMMYYYY/hh:mm
(XX)
1 = Mild
Slight warm, tingling sensation; not really 
bothersome
Yes
No
XXXXXX
DDMMMYYYY/hh:mm
(XX)
2 = Moderate
Definite warm, tingling sensation that is 
somewhat bothersome
XXXXXX
XXXXXX
Yes
No
XXXXXX
DDMMMYYYY/hh:mm
(XX)
0 = None
No sensation
Yes
Yes: Assessment 
Completed via 
Telemedicine
XXXXXX
DDMMMYYYY/hh:mm
(XX)
3 = Severe
Hot tingling/stinging sensation that has 
caused definite discomfort
No: COVID-19 
Disruption
XXXXXX
Abbreviations: COVID-19 = novel coronavirus disease-19; IP = investigational product.
Note: Study day is calculated relative to the date of the first application of study drug. This assessment will be performed at baseline visit 10 to 15 minutes after the application of 
IP in the study site.
[1] Due to COVID-19 disruption.
Programming note:  Concatenate reason not done (COVID-19 Disruption or other specify text) as shown in the shell. For the “If Yes, Telemedicine or Delay in Assessment 
Collection” column, do the following: if the answer to both questions (was assessment completed via telemedicine or was delayed) is No, display “No”; if the answer to only was 
assessment completed via telemedicine is yes, set to “Yes: Assessment Completed via Telemedicine”; if the answer to only did COVID-19 disruption cause/contribute to delay, set 
to “Yes: Delay in Assessment Collection”; if both are yes, set to “Yes: Assessment Completed via Telemedicine; Delay in Assessment Collection”.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 162 of 172
Listing 16.2.9.3.1
Vital Signs
All Subjects
Subject 
ID
Treatment 
Received
Vital Signs 
Collected? 
Reason if No
Study 
Visit
Date of 
Assessment
(Study Day)
Temp
(°C)
Heart 
Rate
(bpm)
Position
Blood
Pressure (mmHg)
Height
(cm)
BMI
(kg/m2)
Abnormal Findings/         
   Clinically Significant/
Systolic
Diastolic
      Description of Finding
XXXXX
XXXXXX
Yes
XXXXX
DDMMMYYYY 
(X)
XX.X
XX
XXXX
XX
XX
XXX
XX.X
XX
Yes
XXXXX
DDMMMYYYY 
(X)
XX.X
XX
XXXXX
XX
XX
XX.X
No: XXXXXX
XXXXX
Yes
XXXXX
DDMMMYYYY 
(X)
XX.X
XX
XXXXX
XX
XX
XXX
XX.X
XXX/
  XXX/
     XXXXXXX
Abbreviation: BMI = body mass index; Temp = temperature.
Note: Study day is calculated relative to the date of first application of study drug.
[1] BMI is derived as (weight in kg)/[(height in cm/100)2]. Weight is collected at all visits. For visits up to Week 4, Baseline Day 0 height is used for BMI derivation. Week 8 and 
Week 9 BMI is derived using Week 8 height.
Programming note:  Concatenate reason not done as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 163 of 172
Listing 16.2.9.3.2
Vital Signs - Weight
All Subjects
Subject
ID
Treatment 
Received
Vital Signs 
Collected?
Reason if No
Study 
Visit
Date of 
Assessment
(Study Day)
Weight
(kg)
Percent 
Change in 
Weight 
Since 
Baseline
Was Weight 
Loss 
Intentional?
Weight Loss 
due to 
Complications 
Associated with 
COVID-19
Underlying Reason 
for Weight Loss
Abnormal Findings/
   Clinically Significant/
      Description of Finding
XXXXX
XXXXXX
Yes
XXXXX
DDMMMYYYY 
(X)
XXX
XX
Yes
No
Weight loss was a 
result of dieting
XX
Yes
XXXXX
DDMMMYYYY 
(X)
XXX
XX
Yes
No 
Other: XXXXX
XXXXX
XXXXXX
No: 
XXXXXXXX
XXXXX
XXX/
  XXX/
     XXXXXXX
Abbreviation: COVID-19 = novel coronavirus disease-19.
Note: Study day is calculated relative to the date of first application of study drug.
Programming note: Concatenate reason not done as shown in the shell. If reason for weight loss is “Other”, concatenate reason as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 164 of 172
Listing 16.2.9.4
Physical Examination
All Subjects
Physical 
Examination 
Date of
Subject ID
Treatment 
Received
Performed? 
Reason if No
Study Visit
Assessment 
(Study Day)
Body System
Result
Abnormal Findings
Clinically Significant?
XXXXXX
XXXXXXX
Yes
XXXXXXX
DDMMMYYYY
(-X)
Skin
Normal
Lungs
Abnormal
XXXXXXXX
No
Heart
Normal
Yes
XXXXXXX
DDMMMYYYY
(-X)
Skin
Normal
Lungs
Abnormal
XXXXXXXX
No
Heart
Normal
No: XXXXXXX
XXXXXXX
Note: Study day is calculated relative to the date of first application of study drug.
Programming note:  Concatenate reason not done as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 165 of 172
Listing 16.2.9.5
Medical Photography
All Subjects 
Subject ID
Treatment 
Received
Photography 
Performed?
Reason if No
If Yes, Delay in 
Assessment 
Collection [1]
Study Visit
Date of Assessment
(Study Day)
XXXXXX
XXXXXX
Yes
No
XXXXXX
DDMMMYYYY (XX)
Yes
No
XXXXXX
DDMMMYYYY (XX)
Yes
Yes: Delay in 
Assessment 
Collection
XXXXXX
DDMMMYYYY (XX)
Yes
No
XXXXXX
DDMMMYYYY (XX)
No: XXXXXX
XXXXXX
Abbreviation: COVID-19 = novel coronavirus disease-19.
Note: Study day is calculated relative to the date of first application of study drug.
[1] Due to COVID-19 disruption.
Programming note:  Concatenate reason not done (COVID-19 Disruption or other specify text) as shown in the shell. For the 
“If Yes, Delay in Assessment Collection” column, do the following: if the answer to did COVID-19 disruption cause/contribute to 
delay, set to “Yes: Delay in Assessment Collection”.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 166 of 172
Listing 16.2.9.6
Prior and Concomitant Medications
All Subjects
Subject 
ID
Country
Treatment 
Received
Prior/
Concomitant
[1]
Indication 
ATC Class (Level 4)/
  Preferred Term/
     Verbatim Term
Start Date (Study Day)/
  End Date (Study Day)
Dose (unit)
Route/
  Frequency
XXXXX
XXX
XXXXXX
Prior
XXXXXXXX
XXXXXXXXXXXXXXXXX/
   XXXXXXXXXXXXXX/
      XXXXXXXXXXXXX
DDMMMYYYY (X)/
   DDMMMYYYY (X)
XXX (XXX)
XXXXXXXX/
   XXXXXXX
  
Both
XXXXXXXX
XXXXXXXXX/
   XXXXXXXXXXXXXXX/
      XXXXXXXXXXX
DDMMMYYYY (X)/
   Ongoing
XXX (XXX)
XXXXXXXX/
   XXXXXXX
Concomitant
XXXXXXX
XXXXXXXXX/
   XXXXXXXXXXXXXX/
      XXXXXXXXXXXXX
DDMMMYYYY (X)/
   DDMMMYYYY (X)
XXX (XXX)
  
XXXXXXXX/
   XXXXXXX
Abbreviation: ATC = anatomic therapeutic chemical; NA = Not applicable; WHO-DDE = World Health Organization-Drug Dictionary Enhanced.
Note: Study day is calculated relative to the date of first application of study drug. Medications were coded using WHO-DDE Global B3 version September 2019.
[1] Prior indicates medication that was started and stopped prior to dosing of study drug. Concomitant indicates medication that started during the treatment period. Both 
indicates medication that was started prior to dosing of study drug and continued during the treatment period.
Programming note: If Dose unit, Route or Frequency is Other, display other specify text only (ie, do not display “Other: XXXXXX” but just “XXXXXX “). Sort by subject, start date, end 
date, ATC level 4 & PT. ATC & PT text should be presented as is from the dataset. 


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 167 of 172
Listing 16.2.9.7
Patient Health Questionnaire (PHQ-8)/Modified PHQ-Adolescents (PHQ-A) 
All Subjects 
Subject 
ID
Treatment 
Received
Assessment 
Completed?
Reason If No
If Yes, Telemedicine 
or Delay in 
Assessment 
Collection [1]
Study 
Visit
Date/Time of 
Assessment
(Study Day)
Form 
Name
[2]
Result
Text Result
Question [3]
XXXXX
XXXXX
Yes
Yes: Delay in 
Assessment 
Collection
XXXXX
DDMMMYYYY/
hh:mm (XX)
PHQ-8
1. Little interest or pleasure in doing things
0
Not at all
2. Feeling down, depressed, or hopeless
1
Several days
3. Trouble falling or staying asleep, or sleeping 
too much
2
More than half the 
days
4. Feeling tired or having little energy
3
Nearly every day
5. Poor appetite or overeating
0
Not at all
6. Feeling bad about yourself, or that you are a 
failure, or have let yourself or your family down
1
Several days
7. Trouble concentrating on things, such as 
reading the newspaper or watching television
2
More than half the 
days
8. 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
3
Nearly every day
CRF-Calculated Total Score
XX
Total Score [4]
12
Moderate depression
No: XXXXX
XXXXX
DDMMMYYYY/
hh:mm (XX)
Abbreviations: COVID-19 = novel coronavirus disease-19; CRF = case report form; PHQ-8 = patient health questionnaire-8 questions; PHQ-A = patient health questionnaire-adolescents.
Note: Study day is calculated relative to the date of the first application of study drug.
[1] Due to COVID-19 disruption.
[2] Form name will be PHQ-8 for adults and Modified PHQ-A for adolescents.
[3] These questions are based on the “Over the last 2 weeks, how often have you been bothered by any of the following problems?” prompt. 
[4] The total score is calculated as sum of all the 8 questions. If more than 1 item is missing the total score should not be calculated.  If 1 item is missing, the total score is calculated as (sum of 
answered items*8)/number of answered items. If total score ranges between 0-4, it is categorized as None – Minimal depression; 5-9 = Mild depression; 10-14 = Moderate depression; 15-19 = 
Moderately severe depression; 20-24 = Severe depression.
Programming note:  Concatenate reason not done (COVID-19 Disruption or other specify text) as shown in the shell. For the “If Yes, Telemedicine or Delay in Assessment Collection” column, 
do the following: if the answer to both questions (was assessment completed via telemedicine or was delayed) is No, display “No”; if the answer to only was assessment completed via 
telemedicine is yes, set to “Yes: Assessment Completed via Telemedicine”; if the answer to only did COVID-19 disruption cause/contribute to delay, set to “Yes: Delay in Assessment Collection”; 
if both are yes, set to “Yes: Assessment Completed via Telemedicine; Delay in Assessment Collection”.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 168 of 172
Listing 16.2.9.8
Columbia-Suicide Severity Rating Scale (C-SSRS) 
All Subjects 
Subject
ID
Treatment 
Received
Study Visit
Date/Time of
Assessment 
(Study Day)
Reference
Period
Telemedicine 
or Delay in 
Assessment 
Collection [1]
Category
Assessment
Result
XXXXXX
XXXXXX
XXXXXX
DDMMMYYYY/
hh:mm (XX)
Baseline/
Screening
Yes: Delay in 
Assessment 
Collection
Suicidal 
Ideation
1. Wish to be dead
XX
If yes, describe:
2. Non-Specific Active 
Suicidal Thoughts
XX
If yes, describe:
3. Active Suicidal Ideation 
with Any Methods (not 
Plan) without Intent to Act
XX
If yes, describe:
4. Active Suicidal Ideation 
with Some Intent to Act, 
without Specific Plan
XX
If yes, describe:
5. Active Suicidal Ideation 
with Specific Plan and 
Intent
XX
If yes, describe:
Intensity of 
Ideation
Most Severe Ideation Type 
# (1-5)
X
Description of Ideation
XXXXXXXXXXX
XXXX
Frequency
1 = Less than 
once a week
Duration
1 = Fleeting –
few seconds or 
minutes
Controllability
1 = Easily able to 
control thoughts
Programming note: Reference period will be either Baseline/Screening or Since Last Visit. Display the results following the order of C-SSRS questionnaire 
for all categories.
Abbreviations: COVID-19 = novel coronavirus disease-19; C-SSRS = Columbia-Suicide Severity Rating Scale.
Note: Study day is calculated relative to the date of first application of study drug. Assessments that are marked as Not Done are not included in the listing.
[1] Due to COVID-19 disruption.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 169 of 172
Programming note: For the “Telemedicine or Delay in Assessment Collection” column, do the following: if the answer to both questions (was assessment completed via telemedicine 
or was delayed) is No, display “No”; if the answer to only was assessment completed via telemedicine is yes, set to “Yes: Assessment Completed via Telemedicine”; if the answer to 
only did COVID-19 disruption cause/contribute to delay, set to “Yes: Delay in Assessment Collection”; if both are yes, set to “Yes: Assessment Completed via Telemedicine; Delay in 
Assessment Collection”.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 170 of 172
Appendix 1: Premier Research Library of Abbreviations
Abbreviation
Definition
AE
adverse event
ANCOVA
analysis of covariance
ATC
anatomical therapeutic chemical
B-IGA
body investigator global assessment
BMI
body mass index
BSA
body surface area
CDISC
Clinical Data Interchange Standards Consortium
CDLQI
Children’s Dermatology Life Quality Index
CI
confidence interval
CMH
Cochran-Mantel-Haenszel
COVID-19
novel coronavirus disease-19
CRF
case report form
CS
clinically significant
C-SSRS
Columbia Suicide Severity Rating Scale
DBP
diastolic blood pressure
DLQI
Dermatology Life Quality Index
eCRF
electronic case report form
ePRO
electronic patient report outcomes
FDA
Food and Drug Administration


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 171 of 172
Abbreviation
Definition
HR
heart rate
ICH
International Council for Harmonisation 
ITT
intent-to-treat
LS
least-squares
MedDRA
Medical Dictionary for Regulatory Activities
mPASI
Modified Psoriasis Scalp Severity Index
NA
not applicable
NCS
nonclinically significant
PASI
Psoriasis Scalp Severity Index
PD
protocol deviation
PE
physical examination
PHQ-A
Modified PHQ-9 for Adolescents
PHQ-8
Patient Health Questionnaire depression scale
PK
pharmacokinetic
PP
per-protocol
PSD
Psoriasis Symptoms Diary
PSSI
Psoriasis Scalp Severity Index
RR
respiratory rate 
SAE
serious adverse event
SAP
statistical analysis plan
SAS® 
a software system used for data analysis


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-204
PCN Number ARCU210101
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 2.0    |    09-Dec-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 172 of 172
Abbreviation
Definition
SBP
systolic blood pressure
SD
standard deviation
S-IGA
scalp investigator global assessment
SI-NRS
scalp itch – numeric rating scale
SOC
system organ class
TEAE
treatment emergent adverse event
TLFs
tables, listings, and figures
WHO
World Health Organization
WHO-DD
world health organization drug dictionary
WI-NRS
worst itch – numeric rating scale

Prot_000.pdf: 




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SUMMARY OF CHANGES 
The following sections have been changed in Amendment 2 of the ARQ-154-204 protocol. 
Section 
Summary of Changes 
Title Page 
Updated medical monitor contact information 
1.1 Synopsis 
Updated to align with changes made within the body of the 
protocol. 
1.3 Schedule of Visits and 
Assessments  
Footnote i: added pharmacokinetic collection windows 
4.2 Number of Subjects 
Revised description of subjects to enroll with S-IGA of at 
least Moderate (3) at Baseline.  
4.4.1 Inclusion Criteria 
Inclusion 3: revised S-IGA criteria from Mild (‘2’) to at 
least Moderate (‘3) as subjects with mild scalp psoriasis 
frequently benefit from treatment with medicated shampoos 
(e.g. coal tar, keratolytics, antifungals, zinc pyrithione, etc.) 
and may not represent the main target population for 
treatment with ARQ-154 foam. 
Inclusion 4: specified the inclusion criteria for scalp 
psoriasis involvement is applicable to the Baseline visit. 
Inclusion 10: updated criteria to align with the Investigator 
Brochure and allow acceptable effective contraception 
methods for FOCBP. 
4.4.2 Exclusion Criteria 
Exclusion 10: removed hypersensitivity to components of 
the investigational product to reduce redundancy from 
exclusion 7. 
5.3 Pharmacokinetics 
Assessment 
Added pharmacokinetic collection windows 
6.3.3 Exploratory Endpoints 
New section added to describe Exploratory Endpoints to 
align with all efficacy assessments planned for the study. 
Editorial changes made throughout to improve accuracy or readability. 
 
 
 




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5.1.3 
Physical Examination............................................................................................ 40 
5.1.4 
Vital Signs, Height and Weight ............................................................................ 40 
5.1.5 
Laboratory Tests ................................................................................................... 40 
5.1.6 
Patient Health Questionnaire Depression Scale (PHQ-8) ..................................... 41 
5.1.7 
Patient Health Questionnaire Depression Scale (Modified PHQ-A) .................... 42 
5.1.8 
Columbia-Suicide Severity Rating Scale (C-SSRS) ............................................. 42 
5.1.9 
Local Tolerability Assessments ............................................................................ 43 
5.1.10 
Adverse Events ..................................................................................................... 44 
5.2 
Efficacy Evaluations .................................................................................................. 45 
5.2.1 
Scalp (S-IGA) and Body/Non-scalp (B-IGA) Investigator’s Global Assessment 45 
5.2.2 
Psoriasis Scalp Severity Index (PSSI) .................................................................. 46 
5.2.3 
Psoriasis Area and Severity Index (PASI) and Modified Psoriasis Area and 
Severity Index (mPASI) ....................................................................................... 47 
5.2.4 
Body Surface Area (BSA) .................................................................................... 48 
5.2.5 
Worst Itch Numerical Rating Scale (WI-NRS) .................................................... 49 
5.2.6 
Scalp Itch Numerical Rating Scale ....................................................................... 49 
5.2.7 
Psoriasis Symptom Diary (PSD) ........................................................................... 50 
5.2.8 
Dermatology Life Quality Index (DLQI) and Children’s Dermatology Life 
Quality Index (CDLQI) ........................................................................................ 50 
5.2.9 
Dermal Imaging .................................................................................................... 50 
5.3 
Pharmacokinetics Assessment .................................................................................. 50 
5.4 
Final Study Visit ......................................................................................................... 51 
5.5 
Early Termination Visit ............................................................................................. 51 
5.6 
Unscheduled Visit ....................................................................................................... 51 
5.7 
Adverse Events ........................................................................................................... 51 
5.7.1 
Adverse Event Definition ..................................................................................... 51 
5.7.2 
Serious Adverse Event .......................................................................................... 51 
5.7.3 
Suspected Unexpected Serious Adverse Reaction (SUSAR) ............................... 53 
5.7.4 
Safety Review ....................................................................................................... 53 
5.7.5 
Adverse Event Reporting ...................................................................................... 53 
5.8 
Reporting Pregnancy ................................................................................................. 55 
5.9 
Treatment Stopping Rules ......................................................................................... 55 
5.9.1 
Emergency Unblinding ......................................................................................... 56 
6 
DATA ANALYSIS .............................................................................................................. 56 
6.1 
Statistical Methods ..................................................................................................... 56 
6.1.1 
Determination of Sample Size .............................................................................. 57 
6.1.2 
Subjects to Analyze ............................................................................................... 57 
6.1.3 
Interim Analysis .................................................................................................... 57 
6.1.4 
Background and Demographic Characteristics ..................................................... 58 
6.1.5 
Study Disposition .................................................................................................. 58 
6.1.6 
Protocol Deviations and Eligibility Deviations .................................................... 58 
6.1.7 
Investigational Product Compliance ..................................................................... 58 


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6.2 
Study Objective .......................................................................................................... 58 
6.2.1 
Primary Objective ................................................................................................. 58 
6.3 
Efficacy Evaluation .................................................................................................... 58 
6.3.1 
Primary Efficacy Endpoint ................................................................................... 58 
6.3.2 
Secondary Endpoints ............................................................................................ 59 
6.3.3 
Exploratory Endpoints .......................................................................................... 61 
6.4 
Safety Evaluation ....................................................................................................... 61 
6.4.1 
Adverse Events ..................................................................................................... 61 
6.4.2 
Local Tolerance Assessments ............................................................................... 62 
6.4.3 
Medical History and Physical Examinations ........................................................ 62 
6.4.4 
PHQ-8 and Modified PHQ-A ............................................................................... 62 
6.4.5 
C-SSRS ................................................................................................................. 62 
6.4.6 
Clinical Laboratory Results and Vital Signs/Weight Measurements ................... 62 
6.4.7 
Prior and Concomitant Medications ..................................................................... 62 
6.5 
Patient Reported Outcomes Analyses ...................................................................... 63 
6.5.1 
Scalp Itch-NRS ..................................................................................................... 63 
6.5.2 
Dermatology Life Quality Index (DLQI) and Children’s Dermatology Life 
Quality Index (CDLQI) ........................................................................................ 63 
6.5.3 
Psoriasis Symptom Diary (PSD) ........................................................................... 63 
6.6 
Pharmacokinetic Analysis ......................................................................................... 63 
7 
STUDY ADMINISTRATION............................................................................................ 63 
7.1 
Ethics ........................................................................................................................... 63 
7.1.1 
Ethics Review Board ............................................................................................. 63 
7.1.2 
Ethical Conduct of the Study ................................................................................ 64 
7.1.3 
Subject Information and Consent/Assent .............................................................. 64 
7.2 
Study Completion and Termination ......................................................................... 64 
7.2.1 
Study Completion ................................................................................................. 64 
7.2.2 
Study Termination ................................................................................................ 65 
7.3 
Study Monitoring ....................................................................................................... 65 
7.4 
Data Quality Assurance ............................................................................................. 65 
7.4.1 
Verification of Blinding ........................................................................................ 66 
7.5 
Data Handling and Record Keeping ........................................................................ 66 
7.6 
Protocol Amendments and Deviations ..................................................................... 66 
7.7 
Confidentiality and Privacy ...................................................................................... 67 
7.8 
Conflict of Interest ..................................................................................................... 67 
7.9 
Report Format ............................................................................................................ 67 
7.10 
Publication Policy ....................................................................................................... 67 
8 
REFERENCES .................................................................................................................... 68 
9 
APPENDICES ..................................................................................................................... 70 


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LIST OF TABLES 
Table 1: 
Excluded Medications and Treatments ................................................................... 36 
Table 2: 
Laboratory Tests ...................................................................................................... 41 
 
 
LIST OF FIGURES 
Figure 1: 
ARQ-151-201: Achievement of IGA Success (IGA=0/1 plus 2-grade 
improvement) (ITT) ................................................................................................ 26 
Figure 2: 
ARQ-151-201: Achievement of Intertriginous-IGA (I-IGA) Success 
(I-IGA=0 or 1 plus 2-grade improvement) (ITT) .................................................... 27 
Figure 3: 
Primary and Secondary Endpoint Testing ............................................................... 60 
 
 
LIST OF APPENDICES 
Appendix 1: Patient Health Questionnaire Depression Scale (PHQ-8) ....................................... 70 
Appendix 2: Patient Health Questionnaire Depression Scale (Modified PHQ-A) ...................... 71 
Appendix 3: Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline/Screening 
Version .................................................................................................................... 72 
Appendix 4: Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version ....... 75 
Appendix 5: Psoriasis Symptom Diary (PSD) ............................................................................. 78 
Appendix 6: Dermatology Life Quality Index (DLQI) ................................................................ 81 
Appendix 7: Children’s Dermatology Life Quality Index (CDLQI) ........................................... 83 
Appendix 8: 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 ................................................... 85 
 
 
 


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1 
PROTOCOL SUMMARY 
1.1 
Synopsis 
Protocol Title: 
A Phase 2b, 8-Week, Parallel Group, Double 
Blind, Vehicle-Controlled Study of the Safety and 
Efficacy of ARQ-154 Foam 0.3% Administered 
QD in Adolescents and Adults with Scalp and 
Body Psoriasis 
Investigational Product: 
ARQ-154 foam investigational product (IP) will 
be supplied at a concentration of 0.3%. 
Matching vehicle foam will contain only 
excipients of ARQ-154 foam. 
IND: 
142047 
Clinical Indication: 
Scalp and Body Plaque Psoriasis 
Study Design: 
This is a parallel group, double blind, 
vehicle-controlled study in which ARQ-154 foam 
0.3% or vehicle foam is applied QD x 8 weeks to 
scalp and body psoriasis of adolescents and 
adults.  Total body surface area (BSA) affected 
and treated will not exceed 25% (not including 
palms/soles). 
Study Objectives: 
To assess the safety and efficacy of ARQ-154 
foam 0.3% vs vehicle administered QD x 8 weeks 
in adolescents and adults with scalp and body 
plaque psoriasis. 
Study Sites:  
Multicenter study with approximately 40-45 sites  
Study Population: 
Subjects will be male and female adolescents and 
adults (>12 y/o). Subjects will have psoriatic 
scalp involvement with a minimum Scalp-IGA 
(S-IGA) of ‘Moderate’ (3) for study entry. 
Subjects must also have psoriasis elsewhere on 
the body, with a minimum body (i.e., non-scalp)-
IGA (B-IGA) of ‘Mild’ (2) for study entry.   
The total BSA affected with psoriasis 
(scalp + rest of body) should not exceed 25% 
BSA (not including palms/soles). 


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Inclusion Criteria: 
1. Participants legally competent to read, write, 
and sign and give informed consent, or, in the 
case of adolescents, assent with consent of a 
parent(s) or legal guardian, as required by 
local laws. 
2. Males and females ages 12 years and older 
(inclusive) at the time of consent or assent 
(for adolescents). 
3. Scalp psoriasis with an Investigator Global 
Assessment of Scalp disease severity (S-IGA) 
of at least Moderate (‘3’) at Baseline. 
4. Extent of scalp psoriasis involving ≥10% of 
the total scalp at Baseline. 
5. A Psoriasis Scalp Severity Index (PSSI) score 
of at least 6 at Baseline. 
6. An IGA of body (i.e., non-scalp) psoriasis 
(B-IGA) of at least Mild (‘2’) at Baseline. 
7. A PASI score of at least 2 (excluding the 
palms and soles) at Baseline. 
8. Clinical diagnosis of psoriasis vulgaris of at 
least 6 months duration as determined by the 
Investigator.  Stable disease for the past 
4 weeks. 
9. Psoriasis involvement on scalp and non-scalp 
areas totaling <25% BSA (not including 
palms/soles). 
10. Females of childbearing potential (FOCBP) 
must have a negative serum pregnancy test at 
Screening (Visit 1) and a negative urine 
Baseline (Visit 2). In addition, sexually active 
FOCBP must agree to use at least one form of 
an acceptable effective contraception 
throughout the trial.  Acceptable effective 
forms of contraception may include: combine 
estrogen and progesterone containing 
hormonal contraception associated with 
inhibition of ovulation (oral, intravaginal, 
transdermal); progesterone only contraception 
associated with inhibition of ovulation 
(oral, injectable, implantable); intrauterine 
device, intrauterine hormone releasing 
system, bilateral tubal occlusion, and partner's 
vasectomy.  If barrier methods are used 
(e.g., condom with spermicide, diaphragm 


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with spermicide), then 2 forms of conception 
are required. The use of abstinence as a 
contraceptive measure is acceptable as long as 
this is the preferred and usual lifestyle choice 
of the subject and a backup method has been 
identified if the subject becomes sexually 
active. 
11. Females of non-childbearing potential should 
either be pre-menarchal, or 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). 
12. In good health as judged by the Investigator, 
based on medical history, physical 
examination, vital signs, serum chemistry 
labs, hematology values, and urinalysis. 
13. Subjects are considered reliable and capable 
of adhering to the Protocol and visit schedule, 
according to the Investigator judgment. 
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 non-plaque forms of 
psoriasis (e.g., guttate, erythrodermic/ 
exfoliative, palmoplantar only involvement, 
or pustular psoriasis). Current diagnosis of 
drug-induced psoriasis.   
6. Subjects with any condition on the treatment 
area which, in the opinion of the Investigator, 
could confound efficacy measurements. 




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significant risk, as determined by the 
Investigator. 
16. Subjects with a history of chronic alcohol or 
drug abuse within 6 months of initiation of 
the investigational product. 
17. Subjects with a history of a major surgery 
within 4 weeks prior to Baseline (Visit 2) or 
has a major surgery planned during the 
study. 
18. 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.  
Subjects unable to apply product to the scalp 
(and/or psoriasis elsewhere) due to physical 
limitations. 
19. 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. 
20. Subjects with active infection that required 
oral or intravenous administration of 
antibiotics, antifungals, or antiviral agents 
within 7 days of Baseline/Day 0. 
21. Subjects who are family members of the 
clinical study site, clinical study staff, or 
sponsor, or family members residing in the 
same household of enrolled subjects. 
Number of Subjects: 
Approximately 300 subjects; randomized 2:1 to 
ARQ-154 foam 0.3% : vehicle foam  
Duration of Participation for Subjects: Screening (up to 4 weeks) + Treatment phase 
(8 weeks) and follow-up (1 week post-treatment 
completion) for a total of 13 weeks 
Key Assessments: 
Safety will be monitored through application site 
assessments, safety labs, and AEs. Safety will 
also be monitored by C-SSRS, and either PHQ-8 
(in adults) or a modified version of the PHQ-A 
(in adolescents) assessments. 
Efficacy assessments will include IGA, S-IGA, 
B IGA, PSSI, BSA, PASI/mPASI, WI-NRS, 
Scalp Pruritis NRS, PSD, and DLQI/CDLQI  


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Pharmacokinetic (PK) samples will be collected 
on Day 0, Weeks 4 and 8 pre-dose (trough) for all 
subjects. Serial PK will be obtained in a subset of 
approximately 15 subjects on Days 0 and 28 
(at 1, 2, 4, 6, and 24 hours post-dosing). Refer to 
the Schedule of Visits and Assessments 
(Section 1.3) for detailed schedules of the study 
assessments. 
Study Endpoints: 
 
 
The primary efficacy endpoint is S-IGA Success 
at Week 8, defined as achievement of Scalp-IGA 
(S-IGA) score of ‘Clear’ or ‘Almost Clear’ PLUS 
a 2-grade improvement from Baseline. 
 
The secondary endpoints will include: 
• B-IGA Success at Week 8, defined as 
Achievement of Body-IGA (B-IGA) score 
of ‘Clear’ or ‘Almost Clear’ PLUS a 
2-grade improvement from Baseline 
• PSSI-75 (subjects who achieve a 75% 
reduction in PSSI from Baseline) at 
Week 8 
• For subjects with Baseline Scalp Itch NRS 
score ≥4, achievement of ≥4-point 
improvement from Baseline in Scalp Itch 
NRS at Week 8 
• For subjects with Baseline Scalp Itch NRS 
score ≥4, achievement of ≥4-point 
improvement from Baseline in Scalp Itch 
NRS at Week 4 
• For subjects with Baseline Scalp Itch NRS 
score ≥4, achievement of ≥4-point 
improvement from Baseline in Scalp Itch 
NRS at Week 2 
• For subjects with Baseline Scalp Itch NRS 
score ≥4, achievement of ≥4-point 
improvement from Baseline in Scalp Itch 
NRS at Week 2 
• Time to success in PSSI-50 
• Change from Baseline in total PSD score at 
Week 8  
• Change from Baseline in total PSD score at 
Week 4 


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• PSSI-90 (subjects who achieve a 90% 
reduction in PSSI from Baseline) at 
Week 8 
 
The exploratory endpoints will include: 
• PASI-75 (subjects who achieve a 
75% reduction in PASI from Baseline) at 
Week 8 
• Time to success in PASI-50 
• Changes from Baseline in the mPASI 
• For subjects with Baseline WI-NRS score 
≥4, achievement of ≥4-point improvement 
from Baseline in WI-NRS at Weeks 8, 4, 
and 2 
• Change from Baseline in DLQI/CDLQI at 
Weeks 8, 4, and 2 
• Change from Baseline in % BSA affected 
by disease at Weeks 8, 4, and 2. 
Statistical Considerations: 
There are approximately 300 subjects planned for 
this study.  Approximately 200 subjects will 
receive ARQ-154 foam 0.3% QD; approximately 
100 subjects will receive vehicle foam QD.  
The sample size was selected to provide an 
adequate number of subjects to compare the 
efficacy of ARQ-154 treatment to vehicle and to 
provide an adequate number of subjects needed 
for a safety database.  
This sample size provides 96% power at the 
α=0.05 level to detect a 22.4% difference between 
treatment groups for the primary endpoint of 
S-IGA success using a 2-sided Chi-squared test.  
The results from a recent phase 2b study 
(ARQ-151-201) of ARQ-151 compared to vehicle 
treatment were used to estimate the treatment 
difference with the assumption that that both 
S-IGA response in the present study are similar to 
IGA responses seen with ARQ-151.  Specifically, 
in the phase 2b trial, 32.2% of subjects reported 
IGA success in the ARQ-151 0.3% group and 
9.8% of subjects reported IGA success in the 
vehicle group.   
Descriptive statistics will be presented for 
endpoint and safety data collected in the clinical 
trial. This includes the number and percentage of 


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subjects for binary endpoints/categorical data, and 
mean, SD, median, minimum, and maximum for 
continuous data.   
The primary endpoint of ‘S-IGA success at 
Week 8’ will be analyzed using a Cochran-
Mantel-Haenszel test stratified by country, 
baseline S-IGA (2 vs. 3), and baseline B-IGA 
(2 vs. 3). The analysis will be performed on the 
Intention-to-Treat (ITT) population and missing 
data will be imputed using multiple imputation.   
Continuous secondary and exploratory endpoints 
will be analyzed using Analysis of Covariance 
with treatment and stratification factors as 
independent variables.  The ITT population will 
be used, and missing data will be imputed using 
multiple imputation.  Binary secondary and 
exploratory endpoints will be analyzed similarly 
to the primary endpoint. Time-to-event endpoints 
will be analyzed using the Kaplan-Meier 
estimator. Treatment group comparisons will be 
performed using the log-rank statistic.  To control 
for multiple comparisons among the secondary 
endpoints, the following testing plan will be used: 
Upon demonstration of statistical significance for 
S-IGA Success at Week 8, the secondary 
endpoint of B-IGA Success at Week 8 will be 
tested hierarchically at the 5% significance level.  
If the test for B-IGA Success at Week 8 is 
significant, the α of 0.05 will be split to test 2 
families of secondary endpoints.  The first family 
will be comprised of the PSSI-75, which will be 
tested at α = 0.03 level.  If the test of PSSI-75 is 
statistically significant, the α=0.03 will be used 
with a Holm testing procedure to test the 
4-endpoints of time to success in PSSI-50, CFB 
in Total PSD score at Week 8, CFB in Total PSD 
score at Week 4, and PSSI-90 at Week 8.  The 
remaining α = 0.02 will be used to test the second 
family, comprised of the Scalp WI-NRS at 
Week 8, the Scalp WI-NRS at Week 4, and the 
Scalp WI-NRS at Week 2.  The tests within this 
second family will be hierarchical, beginning 
with the endpoint at Week 8, followed by Week 4 
and Week 2. 


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Descriptive statistics will be provided for 
exploratory endpoints.   
All subjects who are randomized and receive at 
least one confirmed dose of investigational 
product will be included in the safety population.  
Adverse events (AEs) will be summarized by 
preferred term, system organ class, and treatment 
group for all treatment-emergent AEs, serious 
AEs, related AEs, AEs leading to withdrawal 
from investigational product. 
Safety laboratory parameters and vital signs will 
be summarized at each visit using descriptive 
statistics or frequencies and percentages, as 
appropriate. Changes from baseline in laboratory 
values and vital signs will also be summarized by 
visit. In addition, changes from baseline in weight 
and laboratory values will be summarized using 
shift tables.  
Descriptive statistics will be calculated for the 
PHQ-8 (adults) or Modified PHQ-A 
(adolescents). The C-SSRS will be analyzed per 
the Scoring and Data Analysis Guide from the 
Columbia Lighthouse Project. 
 
 


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1.2 
Study Schema 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening (Visit 1) 
Baseline (Visit 2) 
Randomization and Treatment Day 0 
ARQ-154 
0.3% 
Vehicle Foam 
 8-Week Treatment Period (Visits 3, 4, & 5) 
Follow Up Period / Visit 6 
A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the 
Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Adolescents and 
Adults with Scalp and Body Psoriasis 
 
Approximately 300 adolescent and adult subjects with scalp and body psoriasis 
will be randomized 2:1 to receive either: 
• 
ARQ-154 foam 0.3%, or  
• 
Vehicle foam 


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1.3 
Schedule of Visits and Assessments 
Study Procedure 
Screen 
Baseline 
Day 0 
Wk 2 
Day 14 
Wk 4 
Day 28 
Wk 8 
Day 56 
Wk 9 
Day 63 
Visit 
1 
2 
3 
4 
5 
6 
Visit Window 
-4 weeks 
 
+/- 3 days 
+/- 5 days 
+/- 5 days 
+/- 5 days 
Informed consent/assent 
X 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
Physical examinationa 
X 
X 
 
 
X 
 
I/E criteria 
X 
X 
 
 
 
 
Randomization 
 
X 
 
 
 
 
Hematology, Serum 
Chemistries, and Urine 
Analysis  
X 
X 
 
X 
X 
 
Vital signs, heightb, 
weightb 
X 
X 
X 
X 
X 
X 
S-IGAc, B-IGAc, PSSIc, 
BSAc, PASI/mPASI 
X 
X 
X 
X 
X 
X 
Scalp Itch NRS, WI-NRS 
pruritus, DLQI, CDLQI, 
PSDd 
X 
X 
X 
X 
X 
 
Application Site Reaction 
Assessment/Local 
tolerabilitye 
 
X 
 
X 
X 
 
C-SSRS, PHQ-8/PHQ-Af 
X 
X 
 
X 
X 
 
Medical Photographyg 
 
X 
X 
X 
X 
 
Pregnancy testh 
X 
X 
 
X 
X 
 
PK drawsi 
 
X 
 
X 
X 
 
IP/vehicle application in 
clinicj 
 
X 
X 
X 
 
 
Dispense IP kitk 
 
X 
X 
X 
 
 
Dispense/review diary 
 
X 
X 
X 
X 
 
Weigh IP kitl 
 
X 
X 
X 
X 
 
Compliance calculationm 
 
X 
X 
X 
X 
 
Adverse event 
assessmentn 
X 
X 
X 
X 
X 
X 
Concomitant medications 
X 
X 
X 
X 
X 
X 
 
 
 


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Footnotes from above table: 
a Limited physical examination: skin, lungs, and heart only 
b Height will be collected at Baseline and Week 8. Weight will be collected at all study visits. 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% unintentional weight loss should be reported to the medical monitor. 
c   S-IGA will be a 5-point scale ranging from clear (0) to severe (4) and is evaluated for the scalp only. B-IGA will use the same 
scale as S-IGA, but will evaluate the entire body (except the scalp, palms, and soles).  PSSI is scored on a 0-72 scale and 
evaluates the scalp only.  Total BSA and scalp BSA affected by psoriasis will be determined (except the palms and soles).  
PASI/mPASI assessment should exclude palms and soles.  S-IGA and B-IGA should be completed prior to other physician 
assessments. 
d   Subjects will complete the WI-NRS pruritus, Scalp Itch-NRS, DLQI, CDLQI (for adolescents) and PSD questionnaires. 
e   Local Tolerability Assessments:  the Investigator local tolerability assessment of skin irritation (Berger and Bowman skin 
irritation score) should be performed prior to the investigational product application at Day 0, Weeks 4 and 8.  Note for 
investigator tolerability assessments: 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. Subjects will 
perform the local tolerability 10-15 minutes post-IP application at Day 0 and Week 4, and recall assessment at Week 8 for the 
subject’s ‘0-3’ burning/stinging assessment.   
f Adolescents and adults will complete the C-SSRS.  Adults will complete the PHQ-8.  Adolescents will complete a modified 
version of the PHQ-A (PHQ-9 modified for Adolescents). 
g At selected sites, medical photography will be obtained for target lesions.  All efforts will be made to de-identify the subjects. 
Subjects who are unwilling to participate in the medical photography will be allowed to opt out of this procedure. 
h A pregnancy test will be administered to all females of child-bearing potential. A serum pregnancy test will be performed at 
the Screening visit only. A urine pregnancy test will be performed at Day 0, Week 4, and Week 8. A negative result is 
required for continued participation in the study, and results must be available prior to dispensing of the IP at each visit. 
i PK draws will be collected at Days 0, Weeks 4 and 8 pre-dose (within 1 hour) for all subjects.  Serial PK will be obtained in a 
subset of approximately 15 subjects on Days 0 and 28 at 1, 2, 4, 6 (all + 20 min), and 24 hours (+ 2 hours) post-dose 
j   Subjects to apply assigned IP in clinic at Day 0, Weeks 2 and 4.  
k Kits will be dispensed based on %BSA affected. See IP Handling Manual for details.   
l   The entire kit should be weighed and recorded at every visit. See IP Handling Manual for details. 
m Compliance calculation is described in the IP Handling Manual 
n 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. 
 
 


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2 
ABBREVIATIONS 
Abbreviation 
Definition 
AE 
Adverse Event 
AMP 
Adenosine Monophosphate 
AUC 
Area Under the Curve 
BSA 
Body Surface Area 
B-IGA 
Body Investigator Global Assessment 
Cmax 
Maximum Concentration 
CDLQI 
Children’s Dermatology Life Quality Index 
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 
IB 
Investigational Brochure 
IC50 
Half Maximal Inhibitory Concentration 
ICF 
Informed Consent Form 
ICH  
International Conference on Harmonisation 
IGA 
Investigator Global Assessment 
I-IGA 
Intertriginous Investigator Global Assessment  
IND 
Investigational New Drug 
IP 
Investigational Product 
IRB 
Institutional Review Board 
ITT 
Intent to Treat 
IWRS 
Interactive Web Response System  
LED 
Light Emitting Device 
g 
Microgram 
MedDRA 
Medical Dictionary for Regulatory Activities 


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Abbreviation 
Definition 
mITT 
Modified Intent to Treat 
mL 
Milliliter 
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  
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 
PASI-75 
Psoriasis Area and Severity Index-75; subjects who achieve a 75% 
reduction in PASI from Baseline 
PASI-90 
Psoriasis Area and Severity Index-90; subjects who achieve a 90% 
reduction in PASI from Baseline  
PDE-4 
Phosphodiesterase 4 
PHQ-A 
Modified PHQ-9 for Adolescents 
PHQ-8 
Patient Health Questionnaire depression scale 
PI 
Principal Investigator  
PK 
Pharmacokinetics 
PP 
Per Protocol  
PSSI 
Psoriasis Scalp Severity Index 
PSD 
Psoriasis Symptoms Diary 
QD 
Once Daily ("quaque die") 
SAE 
Serious Adverse Event 
S-IGA 
Scalp Investigator Global Assessment 
SI-NRS 
Scalp Itch – Numeric Rating Score 
TEAE 
Treatment Emergent Adverse Event 
Th1 
Type 1 T Helper Cell 
Th17 
Type 17 T Helper Cell 
Tmax 
Time to reach maximum concentration 
WI-NRS 
Worst Itch – Numeric Rating Score 
 
 


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3 
BACKGROUND AND RATIONALE 
3.1 
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 scalp is a common area of psoriasis involvement, and often the first area on the body to be 
affected.  The scalp is considered an underdiagnosed, undertreated, and difficult to manage area 
for psoriasis.  Scalp psoriasis may be associated with pruritus, pain, flaking, and hair loss, and 
may disproportionately impact quality of life relative to psoriasis elsewhere.  Treatment of scalp 
psoriasis is often limited to topical therapy, unless there are sufficient additional non-scalp 
psoriasis to merit systemic treatment.  Intralesional therapy represents another approach.  Current 
treatment options for scalp psoriasis include topical steroids, vitamin D derivatives, 
tar preparations, and salicylic acid products, but considerable unmet need remains for safe and 
effective products (Blakely 2016, Schlager 2016, Wang 2017, Merola 2018, Kivelevitch 2018).  
Given the scalp is a hair-bearing site, choice of formulation is critical, and foams are a favored 
option. 
 
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 has not significantly 
changed in several decades.  Similarly, topical treatment options for the scalp have also not 
significantly 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 




















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4 
INVESTIGATIONAL PLAN 
4.1 
Overall Study Design and Plan 
This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam 0.3% or 
vehicle foam is applied QD x 8 weeks to adolescent and adults with scalp and body psoriasis of 
at least mild severity, involving up to 25% BSA (scalp and body, not including palms/soles). 
4.2 
Number of Subjects 
A total of up to approximately 300 subjects will be enrolled at approximately 40-45 study sites in 
the North America, Australia, and Europe. Additional study sites may be added or removed as 
necessary.  Subjects will be adolescent and adult males or females with scalp and body psoriasis.  
Subjects must have a Scalp – Investigator’s Global Assessment of disease severity (S-IGA) of at 
least Moderate (‘3’) at Baseline.  Subjects must have a Body (i.e., non-scalp) – Investigator’s 
Global Assessment of disease severity (B-IGA) of at least Mild (‘2’) at Baseline.  Subjects must 
have no more than 25% BSA of psoriasis (excluding palms/soles).  All psoriasis lesions on a 
subject will be treated including the scalp, face, trunk, and intertriginous areas.  The palms and 
soles will be treated but will not be counted towards any measurements of efficacy (IGA, BSA, 
PASI/mPASI). 
4.3 
Subject Participation 
There will be a minimum of 6 clinic visits, including Screening, Baseline, Week 2, Week 4, and 
Week 8, of treatment, as well as a Week 9 follow-up visit (1 week after last dose).  Since the 
interval between the Screening and Baseline visits may be up to 4 weeks, the anticipated 
maximum duration of subject participation is approximately 13 weeks. 
4.3.1 
Randomization 
Assignment of active drug or vehicle will be made at a 2:1 ratio according to a computer-
generated randomization list, stratified by country, Baseline S-IGA (S-IGA=2 vs. S-IGA≥3), 
and Baseline B-IGA (B-IGA=2 vs. B-IGA≥3).   
Randomization will take place at Baseline after the subject has been found to be fully eligible for 
participation.  Kits containing IP 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. 
Subjects will be trained by the study site staff to apply ARQ-154 foam 0.3% QD or vehicle foam 
QD to lesions of scalp and body psoriasis up to a maximum application area of 25% BSA. 
 
The kits and foam cans are blinded and each kit is numbered with a unique kit number. 
4.3.2 
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. 


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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.).  
4.4 
Selection of Study Population 
4.4.1 
Inclusion Criteria 
Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the 
study: 
1. Participants legally competent to read, write, and sign and give informed consent, or, in the 
case of adolescents, assent with consent of a parent(s) or legal guardian, as required by local 
laws. 
2. Males and females ages 12 years and older (inclusive) at the time of consent or assent 
(for adolescents)  
3. Scalp psoriasis with an Investigator Global Assessment of Scalp disease severity (S-IGA) of 
at least Moderate (‘3’) at Baseline  
4. Extent of scalp psoriasis involving ≥10% of the total scalp at Baseline  
5. A Psoriasis Scalp Severity Index (PSSI) score of at least 6 at Baseline. 
6. An IGA of body (i.e., non-scalp) psoriasis (B-IGA) of at least Mild (‘2’) at Baseline 
7. A PASI score of at least 2 (excluding the palms, and soles) at Baseline 
8. Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the 
Investigator.  Stable disease for the past 4 weeks. 
9. Psoriasis involvement on scalp and non-scalp areas totaling <25% BSA (not including 
palms/soles) 
10. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at 
Screening (Visit 1) and a negative urine Baseline (Visit 2). In addition, sexually active 
FOCBP must agree to use at least one form of an acceptable effective contraception 
throughout the trial.  Acceptable effective forms of contraception may include: combine 
estrogen and progesterone containing hormonal contraception associated with inhibition of 
ovulation (oral, intravaginal, transdermal); progesterone only contraception associated with 
inhibition of ovulation (oral, injectable, implantable); intrauterine device, intrauterine 
hormone releasing system, bilateral tubal occlusion, 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 the preferred and usual lifestyle choice of the subject and a backup method has 
been identified if the subject becomes sexually active. 
11. Females of non-childbearing potential should either be pre-menarchal, or 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). 




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13. Previous treatment with ARQ-151 or ARQ-154. 
14. Subjects who have received oral roflumilast (Daxas®, Daliresp®) or other PDE-4 inhibitors 
(apremilast) within the past 4 weeks. 
15. 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. 
16. Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of the 
investigational product. 
17. Subjects with a history of a major surgery within 4 weeks prior to Baseline (Visit 2) or has a 
major surgery planned during the study. 
18. 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. Subjects unable to apply product to the scalp (and/or psoriasis 
elsewhere) due to physical limitations. 
19. 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. 
20. Subjects with active infection that required oral or intravenous administration of antibiotics, 
antifungal, or antiviral agents within 7 days of Baseline/Day 0.  
21. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, 
or family members residing in the same household of enrolled subjects. 
4.4.3 
Removal of Subjects from Investigational Product 
A subject may discontinue from receiving the IP 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 from administration of the IP. 
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 or modified PHQ-A 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 (see Table 1) after consultation 
with the Sponsor and Medical Monitor. 
8. Subject’s repeated failure to comply with protocol requirements or study related procedures. 


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9. The subject interrupts trial IP application for more than 50% of scheduled doses. 
4.4.4 
Removal of Subjects from the Study 
A subject may be removed from study participation for any of the following reasons: 
1. Subject’s decision to withdraw from the study. 
2. Subject is lost to follow up. 
3. Termination of the study by the Sponsor, FDA, or other regulatory authorities. 
4.5 
Study Restrictions 
4.5.1 
Prohibitions and Concomitant Therapy 
Prohibited medications and products are detailed in Table 1. 
 
Table 1: 
Excluded Medications and Treatments 
Excluded Medications and Treatments 
Washout Period Prior to Day 0 
Etanercept 
4 weeks 
Adalimumab, infliximab 
8 weeks 
All other biologics 
12 weeks 
Oral corticosteroids, retinoids, apremilast, roflumilast, methotrexate, 
cyclosporine, fumarates, and other systemic immunosuppressants 
4 weeks 
Medicated shampoos (eg, coal tar, keratolytics, antifungals, zinc 
pyrithione, selenium sulfide, corticosteroids, medical devices) 
2 weeks 
Topical medications used on the scalp for conditions besides psoriasis, 
eg, use of topical minoxidil for androgenetic alopecia 
4 weeks 
Topical anti-psoriasis medications (e.g., topical corticosteroids, 
vitamin D analogs, prescription shampoos) (except for emollients) 
2 weeks 
PUVA or UVB phototherapy 
4 weeks 
Investigational drugs 
12 weeks (biologics); 
5 half-lives (orals);  
2 weeks (topical) 
Antihistamines – if prescribed for pruritus associated with psoriasis 
2 weeks 
Notes:   
(1) Eye drop, ear, 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) No emollients or moisturizers should be applied on treated areas.   
 


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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). 
 
Only non-medicated shampoos are permitted.  Medicated shampoos (eg, coal tar, keratolytics 
including salicylic acid, antifungals, zinc pyrithione, selenium sulfide, corticosteroids, medical 
devices) are prohibited.  Subjects should not use other hair products for at least an hour before or 
after application of investigational product. 
4.6 
Treatment 
4.6.1 
Investigational Product Supplies, Packaging and Labeling 
ARQ-154 foam 0.3% or vehicle foam will be provided in a dispense can containing 
approximately 60 grams of foam.  The cans will be packaged in kits, each containing two cans. 
The number of kits dispensed to a subject will be based on the BSA involvement.  It is 
anticipated that the maximum number of kits dispensed to a subject will be four. The kits and 
pumps 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 IP (ARQ-154 foam 0.3%, and matching 
vehicle foam) to each site to allow for completion of this study. 
 
Records will be made of the receipt and dispensing of the IP supplied. At the conclusion of the 
study, any unused IP will be returned to the Sponsor or designee, or destroyed, as per Sponsor 
instructions. 
 
Refer to the most current version of the IP Handling Manual for details on the accountability, 
storage, and management of ARQ-154 and matching vehicle. 
4.6.2 
Blinding 
This is a double-blind study, therefore neither the subjects nor the Investigator, Sponsor and 
clinical personnel will be aware of which treatment an individual has received. 


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4.6.3 
Treatment Administration 
At the randomization visit (Baseline visit), the study staff will demonstrate to the subject how to 
apply ARQ-154 foam or vehicle foam using the first can from the kit that is assigned to the 
subject at randomization.  Study site staff will be trained to ensure a proper amount is dispensed 
from the can and applied to psoriasis lesions as a thin layer and rubbed in thoroughly but gently, 
until the foam has disappeared.  For scalp lesions, special attention should be given to 
ensuring adequate IP is applied to scalp skin and not rubbed off on hair. The subject will 
then practice dispensing a similar amount of IP onto their finger and applying to lesion(s).  
The study staff will confirm that the subject’s application technique is correct.  
 
IP will be applied QD in the evening (except at Baseline, Week 2, and 4, in which case IP will be 
applied in the AM at the study site) to areas of lesions of psoriasis.  IP will be applied at least 
20 minutes before going to bed.   
 
For Scalp Lesions: IP will be applied QD, when the skin and hair on the scalp is dry.  Subjects 
should part hair where there are lesions and use fingers to rub IP into scalp skin. As the IP is 
applied, the subject should move any hair away to ensure that sufficient foam is actually applied 
directly to the affected skin on the scalp. Subjects should not use other hair products for at least 
an hour before or after application.  Subjects should maintain treatment of areas with the IP for 
the duration of the study regardless of whether treatable areas of psoriasis clear.  Any new 
psoriasis lesions that develop during the treatment period should be treated, whether on the scalp 
or the body. 
 
For Body/Non-Scalp Lesions: IP should be applied QD to affected areas as a thin layer and 
rubbed in thoroughly but gently until the foam has disappeared.  Subjects should maintain 
treatment of areas with IP for the duration of the study regardless of whether treatable areas of 
psoriasis clear.  Any new psoriasis lesions that develop during the treatment period should be 
treated, whether on the scalp or the body. 
 
Re-training will be conducted at subsequent visits (Weeks 2 and 4) as needed (i.e., if the returned 
can(s) weighs substantially different than the expected weight). 
Subjects should not wash areas (or otherwise expose to water, e.g. swimming) where ARQ-154 
foam or vehicle has been applied until at least 4 hours after IP application and preferably not 
until the following morning.   
 
Subjects should continue to apply IP to all treatment areas identified by the investigator at 
Baseline using a Body and Scalp Diagram even if that area has cleared during the treatment 
period. New plaques that develop during the study should be treated as well. 
 
Each IP can will be weighed prior to dispensing at the Baseline visit or subsequent visits. IP cans 
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 Handling Manual), the subject will be retrained on the IP application technique. 


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4.6.4 
Treatment Compliance 
Weight of the IP applied will be measured for reporting purposes. IP cans will be weighed at 
each follow-up clinic visit. The weight of the IP can will be collected prior to the IP application 
and after the IP application at Baseline, Weeks 2, and 4. Weight of the IP applied, and the IP 
cans will be recorded in the source notes and in the eCRF.  
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 at each clinic visit 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 IP 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 regimen if the subject applies at least 
80% of the expected applications during the IP application period and does not miss more than 
3 consecutive doses.  
Compliance will be assessed by review of the dosing diary. If the diary shows less than 80% of 
expected use, the subject is using too little IP and retraining must be conducted and documented.  
Compliance will be documented in source and in eCRF. 
5 
STUDY PROCEDURES 
5.1 
Safety Assessments 
The Schedule of Visits and Assessments (Section 1.3) 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-154 foam 0.3%. Safety will be determined by 
evaluating physical examinations, local tolerability assessments, vital signs/weight, clinical 
laboratory parameters, PHQ-8 (adults)/modified PHQ-A (adolescents), C-SSRS and AEs as 
outlined in the Schedule of Visits and Assessments (Section 1.3). If deemed necessary, additional 
safety assessments will be performed at the discretion of the Investigator. 
5.1.1 
Screening 
Within 4 weeks prior to the first dosing (Baseline visit), 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 (adults)/modified PHQ-A (adolescents), 
C-SSRS, and laboratory tests: hematology, chemistry, urinalysis and serum (Screening) and 
urine (Baseline) pregnancy tests for female subjects of child bearing potential. 


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All screened subjects will receive a screening number and be entered into the electronic subject 
tracking system. Subjects may be re-screened one time, the original assigned Subject ID will be 
used for re-screening. 
5.1.2 
Baseline 
Randomization will take place at the Baseline visit (Day 0) after the subject has been found to be 
fully eligible for participation. The subject is considered enrolled into the study once 
randomization occurs and the subject has been assigned to one of the treatment groups. 
 
If the Baseline visit occurs within 14 days of Screening, the Screening lab results may be 
utilized. 
5.1.3 
Physical Examination 
Physical examinations will be performed according to the Schedule of Visits and Assessments 
(Section 1.3): 
 
Screening, Baseline and Week 8. 
The physical exam will be limited to skin, lungs and heart only. System driven physical 
examination will be conducted in case of symptoms and adverse events. 
5.1.4 
Vital Signs, Height and Weight 
Vital signs will be collected according to the Schedule of Visits and Assessments (Section 1.3): 
 
Blood pressure, heart rate, and temperature will be measured at Screening, Baseline, Weeks 2, 4, 
8, and 9.  
 
Height will be collected at Baseline and Week 8. 
 
Weight will be collected at Screening, Baseline, Weeks 2, 4, 8, and 9. 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. Blood pressure will be collected while the subject is sitting/resting for at 
least 5 minutes. 
5.1.5 
Laboratory Tests 
All tests listed below will be performed as follows: 
Screening, Baseline, Weeks 4 and 8. 
All tests listed in Table 2 below will be performed according to the Schedule of Visits and 
Assessments (Section 1.3) 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. 


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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  
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) 
• 
Serum pregnancy test (hCG)*** 
* 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 Baseline, Weeks 4, and 8, for FOCBP only  
*** At Screening, for FOCBP only 
5.1.6 
Patient Health Questionnaire Depression Scale (PHQ-8) 
The 8 item PHQ-8 Assessment (see Appendix 1) will be performed in adult subjects as follows: 
 
Screening, Baseline, Weeks 4, and 8. 
 
Only adult 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 IP, consideration be given to discontinuation from 
the IP. 
 
PHQ-8 score is the sum of the responses for the 8 questions. 
 


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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) 
5.1.7 
Patient Health Questionnaire Depression Scale (Modified PHQ-A) 
The 8 item Modified PHQ-A Assessment (see Appendix 2) will be performed in adolescent 
subjects as follows: 
 
Screening, Baseline, Weeks 4, and 8 
 
Only adolescent subjects will complete PHQ-A questionnaire. 
 
A subject with a Modified PHQ-A score of ‘15’ or above should be referred promptly to a 
mental health care professional and, if currently applying IP, consideration be given to 
discontinuation from the IP. 
 
Modified PHQ-A 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) 
5.1.8 
Columbia-Suicide Severity Rating Scale (C-SSRS) 
C-SSRS Assessments will be performed as follows: 
 
Screening, Baseline, Weeks 4, and 8. 
 


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The administration schedule of the C-SSRS will be: 
• The Baseline-Screening version (Appendix 3) will be used at Screening to provide a pre-
treatment assessment baseline.  
• On all subsequent visits, the Since Last Visit version (Appendix 4) will be used. 
• If a subject has a score greater than 0 in suicidal ideation at Screening or Baseline, this is 
important and may indicate the need for mental health intervention. The investigator 
should not enroll the subject in the study.  
• 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 
the IP. 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. 
5.1.9 
Local Tolerability Assessments 
The Investigator Local Tolerability Assessment will be an overall assessment of local tolerability 
and performed as follows: 
Baseline, Weeks 4, and 8  
Application site reactions will be graded at the timepoints outlined in the Schedule of Visits and 
Assessments (Section 1.3).  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 IP application in the 
clinic for applicable visits.  
 
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 


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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 an overall assessment of local tolerability and 
performed as follows: 
 
Baseline, Weeks 4, and 8 
 
The assessment will be administered by the site 10 to 15 minutes after IP application in the clinic 
at Baseline and Week 4, and a recall assessment at Week 8. 
 
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  
5.1.10 
Adverse Events 
Adverse events (AEs) will be collected beginning at informed consent and assessed at the 
following visits and throughout the study: 
Screening, Baseline, Weeks 2, 4, 8, and 9 
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 5.7. 


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5.2 
Efficacy Evaluations 
5.2.1 
Scalp (S-IGA) and Body/Non-scalp (B-IGA) Investigator’s Global Assessment 
Investigator’s Global Assessments (‘scalp’ and ‘body’) will be performed at the following study 
visits according to the Schedule of Visits and Assessments (Section 1.3). The IGAs should be 
completed prior to other physician assessments.  The ‘scalp’ and ‘body’ IGAs are the same 
instrument applied to different areas of the body. 
 
Screening, Baseline, Weeks 2, 4, 8, and 9 
 
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 the IP, but will not be counted towards 
B-IGA, PASI/mPASI, or BSA assessments. 
 
Every effort must be made for the same Evaluator to complete the S-IGA and B-IGA for 
the subject at every study visit. 
 
Scalp - Investigator Global Assessment of Disease (S-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  


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The S-IGA (scalp IGA) will be the first efficacy assessment performed at clinic visits.  
As with other efficacy assessments, the S-IGA should be performed prior to the application 
of any Investigational Product. 
Body - Investigator Global Assessment of Disease (B-IGA, i.e. non-scalp) 
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 B-IGA (Body-IGA) will be the second efficacy assessment performed at clinic visits 
(after the S-IGA).  As with other efficacy assessments, the B-IGA should be performed 
prior to the application of any Investigational Product.  In assessing B-IGA, the scalp, 
palms, and soles should not be considered. 
5.2.2 
Psoriasis Scalp Severity Index (PSSI) 
PSSI assessments will be performed at the following study visits according to the Schedule of 
Visits and Assessments (Section 1.3): 
Screening, Baseline, Weeks 2, 4, 8, and 9 
Every effort must be made for the same Evaluator to complete the PSSI for the subject at 
every study visit. 
 
The PSSI is used for the measurement of severity of psoriasis.  
 
PSSI combines the assessment of the severity of scalp lesions and the area of scalp affected into 
a single score in the range 0 (no disease) to 72 (maximal disease). 
 


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The extent of scalp affected is scored based on the following: 
 
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 
 
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: 
 
0. absent 
1. slight 
2. moderate 
3. severe 
4. severest possible 
 
To calculate the PSSI, the sum of the severity rating for the three main signs are multiplied with 
the numerical value of the area affected: 
 
PSSI = Sum of scores for erythema, induration and desquamation x involved area (range 0–72) 
5.2.3 
Psoriasis Area and Severity Index (PASI) and Modified Psoriasis Area and 
Severity Index (mPASI) 
Assessments will be performed as single assessments at each timepoint, from which both PASI’s 
and mPASI’s will be calculated. 
PASI/mPASI assessments will be performed at the following study visits according to the 
Schedule of Visits and Assessments (Section 1.3): 
Screening, Baseline, Weeks 2, 4, 8, and 9 
Every effort must be made for the same Evaluator to complete the PASI/mPASI for the 
subject at every study visit. 
 
Psoriasis Area and Severity Index (PASI)/Modified Psoriasis Area and Severity Index (mPASI) 
is used for the measurement of severity of psoriasis.  
 


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PASI/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 PASI/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 
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 the IP in this study, but will not be counted towards 
IGA, PASI/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. 
 
To calculate the PASI/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 
5.2.4 
Body Surface Area (BSA) 
BSA Assessments will be performed at the following study visits according to the Schedule of 
Visits and Assessments (Section 1.3): 


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Screening, Baseline, Weeks 2, 4, 8, and 9 
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 the IP but will not be counted towards B-IGA, 
PASI/mPASI, or BSA assessments. 
5.2.5 
Worst Itch Numerical Rating Scale (WI-NRS) 
WI-NRS Assessments will be performed at the following study visits according to the Schedule 
of Visits and Assessments (Section 1.3):  
Screening, Baseline, Weeks 2, 4, and 8. 
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 2015). 
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. 
 
 
5.2.6 
Scalp Itch Numerical Rating Scale 
Scalp Itch-NRS Assessment will be performed at the following study visits according to the 
Schedule of Visits and Assessments (Section 1.3): 
Screening, Baseline, Weeks 2, 4, and 8  
 
The Scalp Itch-NRS is a single-item scale to assess the patient-reported severity of their 
symptom at the highest intensity of scalp itching over the past 24 hours. Scalp Itch-NRS will be 
determined by asking the subject’s assessment of worst itching of the scalp over the past 
24 hours. The scale is from ‘0’ to ‘10’ (‘no scalp itch’ to ‘worst scalp itch imaginable’). Subjects 
will complete the Scalp Itch-NRS assessment (Wang 2019). 
 
 


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5.2.7 
Psoriasis Symptom Diary (PSD) 
The PSD will be performed at the following study visits according to the Schedule of Visits and 
Assessments (Section 1.3): 
 
Screening, Baseline, Weeks 2, 4, and 8 
 
Only adult subjects will complete the PSD. See Appendix 5 for the PSD.  
5.2.8 
Dermatology Life Quality Index (DLQI) and Children’s Dermatology Life Quality 
Index (CDLQI) 
The DLQI (ages 17+ years) and CDLQI (ages 12-16 years) will be performed at the following 
study visits according to the Schedule of Visits and Assessments (Section 1.3): Screening, 
Baseline, Weeks 2, 4, and 8. 
 
Subjects/caregivers will complete the DLQI/CDLQI. See Appendix 6 for the DLQI and 
Appendix 7 for CDLQI. Adolescent subjects 16 years of age at the time of consent will complete 
the CDLQI throughout the study. 
5.2.9 
Dermal Imaging 
At selected sites, medical photography will be performed at Baseline, Weeks 2, 4, and 8 for 
possible use in presentations and disease-related publications. Photography should be focused on 
single lesions or specific body sections (e.g. arm) without capturing identifiable scars, tattoos, 
etc. Body or half body photos should only be taken if necessary. All efforts will be made to 
de-identify the subjects. Subjects who are unwilling to participate in the medical photography 
will be allowed to opt out of this procedure and documented on the informed consent. Refer to 
the current photography manual for instructions and requirements on how to conduct 
photography. 
5.3 
Pharmacokinetics Assessment 
PK draws will be performed as follows for all subjects at all sites: 
 
Baseline, Weeks 4, and 8 
PK draws will be collected while the subject is having serum chemistries drawn. The draws will 
be pre-dose (within 1 hour) IP application in the clinic. Ensure IP is not applied in the area where 
PK will be drawn. 
 
Serial PK will be obtained in a subset of approximately 15 subjects on Days 0 and 28 at 1, 2, 4, 6 
(all + 20 min), and 24 hours (+ 2 hours) post-dose 


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5.4 
Final Study Visit 
The approximate final study visit will occur at Week 9. The procedures performed during these 
visits are described in the Schedule of Visits and Assessments (Section 1.3). A 5-day scheduling 
window is allowed for this visit. Adverse events will be recorded as reported by the participant 
or followed to resolution as outlined in Section 5.1.10. 
5.5 
Early Termination Visit 
If a subject is withdrawn or wishes to exit the study, a termination visit will be scheduled. This 
visit should include the procedures and assessments that would be performed at the Week 9 visit 
(Day 63). 
5.6 
Unscheduled Visit 
Unscheduled visits may be necessary to repeat testing following abnormal laboratory results, for 
follow-up of AEs, or for any other reason, as warranted in the judgment of the Investigator. 
5.7 
Adverse Events 
5.7.1 
Adverse Event Definition 
An AE means any untoward medical occurrence associated with the use of a drug in humans, 
whether or not considered IP 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 
IP at the Baseline visit through study completion.  
Application site reactions will be considered adverse events if they require intervention, 
suspension or discontinuation of the IP.  
5.7.2 
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 SAEs are deemed IP-related. Refer to the Safety Reporting 
Instructions for details on how to submit the SAE Report. All serious event reporting will adhere 
to ICH E6: Guideline for Good Clinical Practice and ICH E2A: Clinical Safety Data 


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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. 
• 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. 


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If a SAE occurs to a subject on this study, contact the Medical Monitor within one business day 
of knowledge of event.  
5.7.3 
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.  
5.7.4 
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 Investigator 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 Investigator. 
 
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). 
5.7.5 
Adverse Event Reporting 
The Investigator will review each event and assess its relationship to IP 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 IP dosing, duration, and outcome (resolved, improved, 
unchanged, worse, fatal, or unknown/lost to follow-up) of each event will be noted. 
 


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The relationship of each AE to the IP will be assessed using the following definitions: 
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. 
AEs will be coded using the most current MedDRA® version available at the start of the study 
(e.g., 21.0 or higher). 


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5.8 
Reporting Pregnancy 
During study participation, all female 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, Investigational Product must be discontinued immediately, the subject 
should be referred to an obstetrician experienced in reproductive toxicity for evaluation and 
counseling, and the subject should be followed until the conclusion of the pregnancy.  Subject 
may be required to sign a separate informed consent form to obtain pregnancy follow-up 
information, per local requirements or consent to their pregnancy medical data being collected 
within the main study consent form. 
The Investigator is responsible for reporting all available pregnancy information on the 
pregnancy report and submitting to the Medical Monitor within 24 hours of becoming aware of 
the event, although pregnancy itself is not considered an AE.  Monitoring of the subject should 
continue until the conclusion of the pregnancy if the female subject has agreed on providing 
these medical data.  Follow-up information detailing the outcome of the pregnancy and the 
health of the newborn should be reported as it becomes available. Any pregnancy complication 
must be reported as a SAE. In addition, any pregnancy resulting in a congenital abnormality or 
birth defect of the newborn, or neonatal death occurring within 30 days of the birth must be 
reported as a SAE, regardless of causality. Any infant death that occurs after the 30 day reporting 
period that the Investigator suspects is related to the Investigational Product must also be 
reported as a SAE. 
Partner pregnancies of a male subject do not need to be reported. 
5.9 
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 IP, 
the Investigator should immediately contact the Medical Monitor to discuss if the subject should 
be discontinued from the IP.   
 
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 IP for that subject’s well-being. 
• A severe (Grade 3) laboratory abnormality (confirmed by repeat sample and considered 
related to IP).  
o See Appendix 8 for details. 
Dosing of IP 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. 
A subject with a PHQ-8 or modified PHQ-A score of ‘15’ or above should be referred promptly 
to a mental health care professional and consideration be given to discontinuation from IP.   


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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 IP. 
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 
and 2b studies, such reactions are possible, but unlikely. 
5.9.1 
Emergency Unblinding 
Treatment assignment should remain blinded unless the knowledge is necessary to determine 
emergency medical care, as determined by the Investigator. Emergency unblinding will be done 
using the study IWRS system in consultation with the Medical Monitor and the Sponsor. 
Blinding of study treatment is critical to the integrity of this clinical trial and therefore, if a 
subject’s treatment assignment is disclosed to the Investigator, the subject will have the IP 
discontinued.  
6 
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. 
6.1 
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. 
6.1.1 
Determination of Sample Size 
There are approximately 300 subjects planned for this study.  Approximately 200 subjects will 
receive ARQ-154 foam 0.3% QD; approximately 100 subjects will receive vehicle foam QD.  
The sample size was selected to provide an adequate number of subjects to compare the efficacy 
of ARQ-154 treatment to vehicle and to provide an adequate number of subjects needed for a 
safety database.  
This sample size provides 96% power at the α=0.05 level to detect a 22.4% difference between 
treatment groups for S-IGA Success at Week 8 using a 2-sided Chi-squared test.  The results 
from a recent phase 2b study (ARQ-151-201) of ARQ-151 compared to vehicle treatment were 
used to estimate the treatment difference and it is assumed that the S-IGA response in the present 
study are similar to IGA responses seen with ARQ-151.  Specifically, in the phase 2b trial, 
32.2% of subjects reported IGA success in the ARQ-151 0.3% group and 9.8% of subjects 
reported IGA success in the vehicle group. 
The number of subjects to be enrolled will also provide sufficient power for most secondary 
endpoints. 
6.1.2 
Subjects to Analyze 
Safety population will include all subjects who are enrolled and received at least one confirmed 
dose of IP. This population will be used for all safety analyses. 
The Intention-to-Treat (ITT) population will include all randomized subjects. This population 
will be the primary analysis population for the analysis of efficacy endpoints. 
Per-Protocol (PP) Population will include all subjects who are in the safety population, were at 
least 80% compliant with IP application, and showed no other serious deviations from the study 
protocol. This population will be used as a sensitivity analysis of primary and secondary efficacy 
endpoints. 
The Pruritis population is a subset of the ITT population and includes subjects with Scalp Itch 
NRS score ≥ 4 at Baseline.  This population will be used for the analysis of achievement of a 
4-point reduction in Scalp Itch NRS pruritus score as compared to Baseline. 
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 used for analyses of PK parameters. 
6.1.3 
Interim Analysis 
No interim efficacy analyses are planned. 


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6.1.4 
Background and Demographic Characteristics 
Demographics, baseline disease characteristics, Baseline height, weight, and BSA will be 
summarized descriptively for all randomized subjects. 
6.1.5 
Study Disposition 
Number of subjects randomized, receiving IP, completing study, and withdrawing prematurely 
(with reason for withdrawal) will be summarized by treatment group. 
6.1.6 
Protocol Deviations and Eligibility Deviations 
The number of subjects with important protocol deviations and/or eligibility deviations will be 
summarized by category and by treatment group. 
6.1.7 
Investigational Product Compliance 
The number of IP applications by each subject based on diary data will be summarized using 
descriptive statistics.  
The amount of IP used by each subject based on can weight will be summarized by treatment 
using summary statistics (mean, SD, median, minimum, and maximum), and categorically. 
IP compliance will be calculated based on number of applications divided by the expected 
number (amount) of IP for each subject.  Compliance will be summarized descriptively by 
treatment group. 
6.2 
Study Objective 
6.2.1 
Primary Objective 
To assess the safety and efficacy of ARQ-154 foam 0.3% vs vehicle administered QD x 8 weeks 
in adolescents and adults with scalp and body plaque psoriasis. 
6.3 
Efficacy Evaluation 
6.3.1 
Primary Efficacy Endpoint 
The primary efficacy endpoint is S-IGA Success at Week 8, defined as achievement of an S-IGA 
score of ‘Clear’ or ‘Almost Clear’ plus a 2-grade improvement from Baseline.   
 
The primary endpoint will be analyzed using a Cochran-Mantel-Haenszel test stratified by 
country, baseline S-IGA (2 vs. 3), and baseline B-IGA (2 vs. 3).  Missing S-IGA and B-IGA 
scores will be imputed using multiple imputation.  Sensitivity analyses of the primary endpoint 
may be conducted in by study site or groups of study sites. 


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6.3.2 
Secondary Endpoints 
The Secondary Efficacy Endpoints will include: 
• 
B-IGA Success at Week 8, defined as achievement of Body-IGA (B-IGA) score of 
‘Clear’ or ‘Almost Clear’ plus a 2-grade improvement from baseline 
• PSSI-75 (subjects who achieve a 75% reduction in PSSI from Baseline) at Week 8 
• For subjects with Baseline Scalp Itch NRS score ≥4, achievement of ≥4-point 
improvement from Baseline in Scalp Itch NRS at Week 8 
• For subjects with Baseline Scalp Itch NRS score ≥4, achievement of ≥4-point 
improvement from Baseline in Scalp Itch NRS at Week 4 
• For subjects with Baseline Scalp Itch NRS score ≥4, achievement of ≥4-point 
improvement from Baseline in Scalp Itch NRS at Week 2 
• Time to PSSI-50  
• Change from Baseline in total PSD score at Week 8 
• Change from Baseline in total PSD score at Week 4 
• PSSI-90 (subjects who achieve a 90% reduction in PSSI from Baseline) at Week 8 
 
To control for multiple comparisons among the secondary endpoints, the following testing plan 
will be used: 
 
Upon demonstration of statistical significance for S-IGA Success at Week 8, the secondary 
endpoint of B-IGA Success at Week 8 will be tested hierarchically at the 5% significance level.   
 
If the test for B-IGA Success at Week 8 is significant, the α of 0.05 will be split to test 2 families 
of secondary endpoints.  The first family will be comprised of the PSSI-75, which will be tested 
at the α = 0.03 level.  If the test of PSSI-75 is statistically significant, then α = 0.03 will be used 
with a Holm testing procedure to test the 4 endpoints of time to success in PSSI-50, CFB in Total 
PSD score at Week 8, CFB in Total PSD score at Week 4, and PSSI-90 at Week 8.  The 
remaining α = 0.02 will be used to test the second family, comprised of the Scalp WI-NRS at 
Week 8, the Scalp WI-NRS at Week 4, and the Scalp WI-NRS at Week 2.  The tests within this 
second family will be hierarchical, beginning with the endpoint at Week 8, followed by Week 4 
and Week 2.  . 
 


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Figure 3: 
Primary and Secondary Endpoint Testing 
 
 
The binary secondary endpoints will be analyzed using a Cochran-Mantel-Haenszel test stratified 
by country, baseline S-IGA, and baseline B-IGA similar to the primary endpoint.  
 
The continuous secondary endpoints will be analyzed using an analysis of covariance with 
treatment, the stratification factors including country, baseline S-IGA, and baseline B-IGA, 
and baseline value as independent variables. Statistical comparison between the active treatment 
arm and vehicle arm will be facilitated by using contrasts. 
 
Time-to-event endpoints will be analyzed using the Kaplan-Meier estimator. Treatment group 
comparisons will be performed using the log-rank statistic. 
 
Sensitivity analyses of secondary endpoints may be conducted in by study site or groups of study 
sites. 


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6.3.3 
Exploratory Endpoints 
 
The Exploratory Endpoints will include: 
• PASI-75 (subjects who achieve a 75% reduction in PASI from Baseline) at Week 8 
• Time to success in PASI-50 
• Changes from Baseline in the mPASI 
• For subjects with Baseline WI-NRS score ≥4, achievement of ≥4-point improvement 
from Baseline in WI-NRS at Weeks 8, 4, and 2 
• Change from Baseline in DLQI/CDLQI at Weeks 8, 4, and 2 
• Change from Baseline in % BSA affected by disease at Weeks 8, 4, and 2 
 
The analysis of all exploratory endpoints will be descriptive statistics. 
6.4 
Safety Evaluation 
Descriptive statistics will be calculated for safety data and 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. 
6.4.1 
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. 
 
Serious adverse events (SAEs) will be listed by subject.  SAEs will be summarized by treatment 
group, severity, and relationship to study treatment. 
 
For AEs, 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 IP, corrective treatment, outcome, and IP 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 IP due to adverse events 
will also be provided. 


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6.4.2 
Local Tolerance Assessments 
For the Investigator’s and Subject’s assessment, the numeric application site reaction scores will 
be summarized individually by using number and percentage of subjects by visit, as well as 
mean/median scores.   
6.4.3 
Medical History and Physical Examinations 
Clinically significant changes observed during physical examination will be captured as adverse 
events and included in AE tabulations. 
6.4.4 
PHQ-8 and Modified PHQ-A 
Data for PHQ-8 and Modified PHQ-A 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) 
6.4.5 
C-SSRS 
The C-SSRS will be analyzed per the Columbia–Suicide Severity Rating Scale Scoring and 
Data Analysis Guide. 
6.4.6 
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 from Baseline will be provided for clinical 
laboratory results.  
 
Shift tables will identify subjects who gain or lose >5% body weight over the course of the 
study, as well as subjects who gain or lose >10% body weight over the course of the study. 
6.4.7 
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. 


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6.5 
Patient Reported Outcomes Analyses 
6.5.1 
Scalp Itch-NRS 
Change from baseline in scalp itch severity will be analyzed by treatment group and over time 
using the Scalp Itch-NRS scale. For subjects with Scalp Itch-NRS pruritus score ≥ 6 at baseline, 
the proportion of subjects with a 4-point reduction in Scalp Itch-NRS pruritus score at Week 8 as 
compared to Baseline will be calculated by treatment group and analyzed using a Cochran-
Mantel-Haenszel test stratified by country baseline S-IGA, and baseline B-IGA (see secondary 
endpoints). 
6.5.2 
Dermatology Life Quality Index (DLQI) and Children’s Dermatology Life Quality 
Index (CDLQI) 
Both the DLQI and CDLQI will be analyzed by evaluation of the reduction in total score at 
Weeks 2, 4, and 8 as compared to Baseline. 
6.5.3 
Psoriasis Symptom Diary (PSD) 
The PSD will be analyzed as the improvement in responses to the questions of PSD Weeks 2, 4, 
and 8 as compared to Baseline.  
6.6 
Pharmacokinetic Analysis 
Plasma drug concentrations at pre-dose will be summarized using descriptive statistics. 
 
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 1.3).   
A manual for blood sampling, collection, processing, and sample shipment will be provided in a 
separate document.  
7 
STUDY ADMINISTRATION 
7.1 
Ethics 
7.1.1 
Ethics Review Board 
Before enrollment of patients into the study, the current protocol, ICF, and any accompanying 
material to be provided to the subjects will be reviewed and approved by an appropriate IRB or 
IEC, as required by ICH GCP and other local/regional regulatory requirements.  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. 


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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 local and 
regional regulatory requirements. 
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 IP during the study, per the 
IRB or IEC local requirements, and in compliance with local and regional regulatory 
requirements and ICH GCP guidelines. 
7.1.2 
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, the ICH Harmonized tripartite Guideline regarding GCP (E6 (R2), Nov 2016) and the 
applicable regulations of the country(ies) in which the trial is conducted. 
7.1.3 
Subject Information and Consent/Assent 
The Investigator is responsible for obtaining written informed consent from each individual 
participating in this study and/or parent(s)/legal guardian(s), after adequate explanation 
(in non-technical terms) of the purpose of the study, the procedures to be carried out and the 
potential hazards before undertaking any study-related procedures. Subject and/or parent(s)/legal 
guardian(s) must provide their written informed consent prior to enrollment in a clinical trial and 
before any protocol-specified procedures are performed. The investigator must use the most 
current approved consent form for documenting written informed consent. Subjects and/or 
parent(s)/ legal guardian(s) will be assured that they may withdraw from the study at any time 
without jeopardizing subject’s medical care. Each informed consent will be read, appropriately 
signed and dated by the subject and/or parent(s)/legal guardian(s), the investigator conducting 
the consent discussion, and by an impartial witness if required by local requirements.   
 
Adolescents will provide written assent and their parent(s) or legal guardian(s) will provide 
consent, as required by local laws. 
Subjects and/or parent(s)/legal guardian(s) will be given a signed copy of their Consent/Assent. 
7.2 
Study Completion and Termination 
7.2.1 
Study Completion 
The study is considered completed with the last visit of the last subject participating in the study. 
The final data from the investigational site will be sent to the Sponsor (or designee) after 
completion of the final subject visit at that site, in the time frame specified in the Clinical Trial 
Agreement. 


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7.2.2 
Study Termination 
The Sponsor reserves the right to close the investigational site or terminate the study at any time 
for any reason at the sole discretion of the Sponsor. Investigational sites will be closed upon 
study completion. An investigational site is considered closed when all required documents and 
study supplies have been collected and a site closure visit has been performed. The investigator 
may initiate site closure at any time, provided there is reasonable cause and sufficient notice is 
given in advance of the intended termination. 
 
Reasons for the early closure of an investigational site by the Sponsor or investigator may 
include but are not limited to: 
• 
Failure of the investigator to comply with the protocol, the Sponsor’s procedures, 
or GCP guidelines. 
• 
Inadequate recruitment of subjects by the investigator. 
• 
Discontinuation of further IP development. 
7.3 
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 or designees 
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 or designees 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. 
7.4 
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 Premier Research’s Quality Assurance (QA) 
department and the QA audit certificate will be included in the study report. 


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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 to check for 
missing data, data inconsistencies, data ranges etc. Corrections are made prior to database lock. 
7.4.1 
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. 
7.5 
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. 
7.6 
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.  
 


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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. 
7.7 
Confidentiality and Privacy 
The investigator must assure that subjects’ confidentiality will be strictly maintained and that 
their identities are protected from unauthorized parties. Only an identification code and any other 
unique identifier(s) as allowed by local law (such as date of birth) will be recorded on any form 
or biological sample submitted to the Sponsor. 
 
The investigator agrees that all information received from Arcutis Inc., including but not limited 
to the investigator brochure, this protocol, CRF/eCRF, the IP, and any other study information, 
remain the sole and exclusive property of Arcutis Inc. during the conduct of the study and 
thereafter. This information is not to be disclosed to any third party (except employees or agents 
directly involved in the conduct of the study or as required by law) without prior written consent 
from Arcutis Inc. The investigator further agrees to take all reasonable precautions to prevent the 
disclosure by any employee or agent of the study site to any third party or otherwise into the 
public domain. 
7.8 
Conflict of Interest 
All study investigators will provide documentation of their financial interest or arrangements 
with Arcutis Inc., or proprietary interests in the IP under study. This documentation must be 
provided prior to the investigator’s participation in the study. All investigators with reported 
conflict of interest will be required to have such conflicts managed in a way that is appropriate to 
their participation in the design and conduct of this study. 
7.9 
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).  
7.10 Publication Policy 
The Sponsor is supportive of publishing clinical trial findings.  Any form of publication that is 
derived from this study must be submitted to Arcutis, Inc. for review and approval. The process 
of coordinating publication efforts is detailed in the Clinical Trial Agreement. 


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8 
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. 
Blakely K, Gooderham M. Management of scalp psoriasis: current perspectives. Psoriasis 
(Auckl). 2016; 6:33-40. Published 2016 Mar 29. Doi: 10.2147/PTT.S85330  
Brion DE, Raynaud F, Plet A, Laurent P, et al.  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, 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 1.0, September 2019 
Kivelevitch D, Frieder J, Watson I, et al. Pharmacotherapeutic approaches for treating psoriasis 
in difficult-to-treat areas. Expert Opin Pharmacother. 2018;19(6):561-575. 
Merola JF, Qureshi A, Husni ME. Underdiagnosed and undertreated psoriasis: Nuances of 
treating psoriasis affecting the scalp, face, intertriginous areas, genitals, hands, feet, and nails. 
Dermatol Ther. 2018;31(3):e12589. 
Michalski JM., Golden G., Ikari J., et al. PDE4: A Novel Target in the Treatment of Chronic 
Obstructive Pulmonary Disease. Clinical Pharmacology & Therapeutics. 2012;91:134-142. 
Naegeli AN, Flood E, Tucker J, et al. 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. 
Schlager JG, Rosumeck S, Werner RN, et al. Topical treatments for scalp psoriasis: summary of 
a Cochrane Systematic Review. Br. J. Dermatol. 2016;176(3):604-614. 
Wang TS, Tsai TF. Managing Scalp Psoriasis: An Evidence-Based Review. Am J Clin Dermatol. 
2017;18(1):17-43. 


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Wang Y, Coyne K, Sofen H, et al. Qualitative analysis and reproducibility assessment of the 
Scalp Itch Numeric Rating Scale among patients with moderate to severe plaque psoriasis of the 
scalp. Journal of Dermatological Treatment. 2019. DOI: 10.1080/09546634.2019.1577546 
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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9 
APPENDICES 
Appendix 1: Patient Health Questionnaire Depression Scale (PHQ-8) 
 
 
  
  
 


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Appendix 2: Patient Health Questionnaire Depression Scale (Modified PHQ-A) 
 
 
 
 


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Appendix 3: Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline/Screening 
Version 
 
 
COLUMBIA-SUICIDE SEVERITY 
RATING SCALE 
(C-SSRS)  
Baseline/Screening Version 
Version 1/14/09 
 
  
Posner, K.; Brent, D.; Lucas, C.; Gould, M.; Stanley, B.; Brown, G.; Fisher, P.; Zelazny, J.; 
Burke, A.; Oquendo, M.; Mann, J.  
 
Disclaimer: 
This scale is intended to be used by individuals who have received training in its administration. The questions contained in 
the Columbia-Suicide Severity Rating Scale are suggested probes. Ultimately, the determination of the presence of suicidal 
ideation or behavior depends on the judgment of the individual administering the scale. 
 
 
Definitions of behavioral suicidal events in this scale are based on those used in The Columbia Suicide History Form, 
developed by John Mann, MD and Maria Oquendo, MD, Conte Center for the Neuroscience of Mental Disorders 
(CCNMD), New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032. (Oquendo M. A., 
Halberstam B. & Mann J. J., Risk factors for suicidal behavior: utility and limitations of research instruments. In M.B. First 
[Ed.] Standardized Evaluation in Clinical Practice, pp. 103 -130, 2003.) 
For reprints of the C-SSRS contact Kelly Posner, Ph.D., New York State Psychiatric Institute, 1051 Riverside Drive, New 
York, New York, 10032; inquiries and training requirements contact posnerk@nyspi.columbia.edu 
© 2008 The Research Foundation for Mental Hygiene, Inc. 


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SUICIDAL IDEATION 
Ask questions 1 and 2.  If both are negative, proceed to “Suicidal Behavior” section. If the answer to 
question 2 is “yes”, ask questions 3, 4 and 5.  If the answer to question 1 and/or 2 is “yes”, complete 
“Intensity of Ideation” section below. 
Lifetime: Time 
He/She Felt 
Most Suicidal 
Past 
 
Months 
1.  Wish to be Dead  
Subject endorses thoughts about a wish to be dead or not alive anymore, or wish to fall asleep and not wake up   
Have you wished you were dead or wished you could go to sleep and not wake up?  
 
If yes, describe: 
 
Yes       No 
□    □ 
 
Yes     No 
□   □ 
2.  Non-Specific Active Suicidal Thoughts 
General non-specific thoughts of wanting to end one’s life/commit suicide (e g , “I’ve thought about killing myself”) without thoughts 
of ways to kill oneself/associated methods, intent, or plan during the assessment period   
Have you actually had any thoughts of killing yourself? 
 
If yes, describe: 
 
    Yes       No 
   □    □ 
 
Yes     No 
□   □ 
3.  Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act 
Subject endorses thoughts of suicide and has thought of at least one method during the assessment period  This is different than a 
specific plan with time, place or method details worked out (e g   thought of method to kill self but not a specific plan)   Includes person 
who would say, “I thought about taking an overdose but I never made a specific plan as to when, where or how I would actually do 
it…and I would never go through with it.” 
Have you been thinking about how you might do this? 
 
If yes, describe: 
 
 
    Yes      No 
 □    □ 
 
Yes     No 
□   □ 
4.  Active Suicidal Ideation with Some Intent to Act, without Specific Plan 
Active suicidal thoughts of killing oneself and subject reports having some intent to act on such thoughts, as opposed to “I have the 
thoughts but I definitely will not do anything about them.” 
Have you had these thoughts and had some intention of acting on them?  
 
If yes, describe: 
 
 
   Yes      No 
□    □ 
 
Yes     No 
□   □ 
5.  Active Suicidal Ideation with Specific Plan and Intent 
Thoughts of killing oneself with details of plan fully or partially worked out and subject has some intent to carry it out  
Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan? 
   
If yes, describe: 
 
 
   Yes       No 
 □    □ 
 
Yes     No 
□   □ 
INTENSITY OF IDEATION 
The following features should be rated with respect to the most severe type of ideation (i.e., 1-5 from above, with 1 being 
the least severe and 5 being the most severe).  Ask about time he/she was feeling the most suicidal.  
                                   
Lifetime -           Most Severe Ideation:  _______                  ________________________________________ 
                                                                       Type # (1-5)                                                 Description of  Ideation 
 
Past X Months - Most Severe Ideation:  _______                   ________________________________________ 
                                                                      Type # (1-5)                                                 Description of  Ideation 
Most  
Severe 
Most 
Severe 
Frequency 
How many times have you had these thoughts?  
(1) Less than once a week    (2) Once a week   (3)  2-5 times in week    (4) Daily or almost daily    (5) Many times each day 
 
 
____ 
 
 
____ 
Duration 
When you have the thoughts how long do they last? 
(1) Fleeting - few seconds or minutes                                                 (4) 4-8 hours/most of day 
(2) Less than 1 hour/some of the time                                                 (5) More than 8 hours/persistent or continuous 
(3) 1-4 hours/a lot of time 
____ 
____ 
Controllability 
Could/can you stop thinking about killing yourself or wanting to die if you want to? 
(1) Easily able to control thoughts                                                      (4) Can control thoughts  with a lot of difficulty 
(2) Can control thoughts with little difficulty                                     (5) Unable to control thoughts 
(3) Can control thoughts with some difficulty                                    (0) Does not attempt to control thoughts 
____ 
____ 
Deterrents 
Are there things - anyone or anything (e.g., family, religion, pain of death) - that stopped you from wanting to 
die or acting on thoughts of committing suicide? 
(1) Deterrents definitely stopped you from attempting suicide            (4) Deterrents most likely did not stop you  
(2) Deterrents probably stopped you                                                    (5) Deterrents definitely did not stop you  
(3) Uncertain that deterrents stopped you                                             (0) Does not apply 
____ 
____ 
Reasons for Ideation 
What sort of reasons did you have for thinking about wanting to die or killing yourself?  Was it to end the pain 
or stop the way you were feeling (in other words you couldn’t go on living with this pain or how you were 
feeling) or was it to get attention, revenge or a reaction from others? Or both? 
(1) Completely to get attention, revenge or a reaction from others       (4) Mostly to end or stop the pain (you couldn’t go on 
(2) Mostly to get attention, revenge or a reaction from others                     living with the pain or how you were feeling) 
(3) Equally to get attention, revenge or a reaction from others               (5) Completely to end or stop the pain (you couldn’t go on  
       and to end/stop the pain                                                                         living with the pain or  how you were feeling) 
                                                                                                                 (0)  Does not apply 
 
 
____ 
 
 
 
 
© 2008 Research Foundation for Mental Hygiene, Inc. 
 
        C-SSRS—Baseline/Screening (Version 1/14/09)    
 
 
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SUICIDAL BEHAVIOR 
(Check all that apply, so long as these are separate events; must ask about all types) 
 
Lifetime 
Past 
 
Years 
Actual Attempt:  
A potentially self-injurious act committed with at least some wish to die, as a result of act. Behavior was in part thought of as method to kill 
oneself  Intent does not have to be 100%   If there is any intent/desire to die associated with the act, then it can be considered an actual suicide 
attempt  There does not have to be any injury or harm, just the potential for injury or harm  If person pulls trigger while gun is in 
mouth but gun is broken so no injury results, this is considered an attempt    
Inferring Intent: Even if an individual denies intent/wish to die, it may be inferred clinically from the behavior or circumstances  For example, a 
highly lethal act that is clearly not an accident so no other intent but suicide can be inferred (e g , gunshot to head, jumping from window of a 
high floor/story)  Also, if someone denies intent to die, but they thought that what they did could be lethal, intent may be inferred   
Have you made a suicide attempt? 
Have you done anything to harm yourself? 
Have you done anything dangerous where you could have died? 
What did you do? 
Did you______ as a way to end your life?  
Did you want to die (even a little) when you_____?  
Were you trying to end your life when you _____? 
Or Did you think it was possible you could have died from_____? 
Or did you do it purely for other reasons / without ANY intention of killing yourself (like to relieve stress, feel better,  
get sympathy, or get something else to happen)?  (Self-Injurious Behavior without suicidal intent) 
If yes, describe: 
 
Has subject engaged in Non-Suicidal Self-Injurious Behavior? 
Yes     No 
□   □ 
 
 
 
 
 
 
 
Total # of 
Attempts 
 
 
 
 
 
 
 
 
 
Yes     No 
□   □ 
Yes     No 
□   □ 
 
 
 
 
 
 
Total # of 
Attempts 
 
 
 
 
 
 
 
 
 
Yes     No 
□   □ 
Interrupted Attempt:   
When the person is interrupted (by an outside circumstance) from starting the potentially self-injurious act (if not for that, actual attempt would 
have occurred). 
Overdose: Person has pills in hand but is stopped from ingesting   Once they ingest any pills, this becomes an attempt rather than an interrupted 
attempt  Shooting: Person has gun pointed toward self, gun is taken away by someone else, or is somehow prevented from pulling trigger  Once 
they pull the trigger, even if the gun fails to fire, it is an attempt  Jumping: Person is poised to jump, is grabbed and taken down from ledge  
Hanging: Person has noose around neck but has not yet started to hang - is stopped from doing so  
Has there been a time when you started to do something to end your life but someone or something stopped you before 
you actually did anything? 
If yes, describe: 
 
Yes      No 
□   □ 
 
 
 
Total # of 
interrupted 
 
 
 
Yes     No 
□   □ 
 
 
Total # of 
interrupted 
 
 
 
Aborted Attempt:   
When person begins to take steps toward making a suicide attempt, but stops themselves before they actually have engaged in any self-
destructive behavior  Examples are similar to interrupted attempts, except that the individual stops him/herself, instead of being stopped by 
something else  
Has there been a time when you started to do something to try to end your life but you stopped yourself before you 
actually did anything? 
If yes, describe: 
 
Yes      No 
□   □ 
 
 
Total # of 
aborted 
 
 
Yes     No 
□   □ 
 
Total # of 
aborted 
 
 
Preparatory Acts or Behavior: 
Acts or preparation towards imminently making a suicide attempt  This can include anything beyond a verbalization or thought, such as 
assembling a specific method (e g , buying pills, purchasing a gun) or preparing for one’s death by suicide (e g , giving things away, writing a 
suicide note)   
Have you taken any steps towards making a suicide attempt or preparing to kill yourself (such as collecting pills, 
getting a gun, giving valuables away or writing a suicide note)? 
If yes, describe: 
 
 
 
Yes      No 
□   □ 
 
 
Yes     No 
□   □ 
Suicidal Behavior: 
Suicidal behavior was present during the assessment period? 
Yes      No 
□   □ 
Yes     No 
□   □ 
Answer for Actual Attempts Only 
Most Recent 
Attempt 
Date: 
Most Lethal        
Attempt 
Date: 
Initial/First 
Attempt 
Date: 
Actual Lethality/Medical Damage:   
0   No physical damage or very minor physical damage (e g , surface scratches)  
1   Minor physical damage (e g , lethargic speech; first-degree burns; mild bleeding; sprains)  
2   Moderate physical damage; medical attention needed (e g , conscious but sleepy, somewhat responsive; second-degree 
burns; bleeding of major vessel)  
3   Moderately severe physical damage; medical hospitalization and likely intensive care required (e g , comatose with reflexes 
intact; third-degree burns less than 20% of body; extensive blood loss but can recover; major fractures)  
4   Severe physical damage; medical hospitalization with intensive care required (e g , comatose without reflexes; third-degree 
burns over 20% of body; extensive blood loss with unstable vital signs; major damage to a vital area)  
5   Death 
 
Enter Code 
 
 
 
______ 
 
 
 
 
Enter Code 
 
 
 
______ 
 
 
 
 
Enter Code 
 
 
 
______ 
 
 
 
Potential Lethality: Only Answer if Actual Lethality=0 
Likely lethality of actual attempt if no medical damage (the following examples, while having no actual medical damage, had 
potential for very serious lethality: put gun in mouth and pulled the trigger but gun fails to fire so no medical damage; laying 
on train tracks with oncoming train but pulled away before run over)  
 
0 = Behavior not likely to result in injury 
1 = Behavior likely to result in injury but not likely to cause death 
2 = Behavior likely to result in death despite available medical care 
 
Enter Code 
 
 
 
______ 
 
 
Enter Code 
 
 
 
______ 
 
 
Enter Code 
 
 
 
______ 
 
© 2008 Research Foundation for Mental Hygiene, Inc. 
 
        C-SSRS—Baseline/Screening (Version 1/14/09)    
 
 
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Appendix 4: Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version 
 
 
 
 
 
 
 
 
 
 
COLUMBIA-SUICIDE SEVERITY 
RATING SCALE 
(C-SSRS) 
Since Last Visit 
Version 1/14/09 
 
Posner, K.; Brent, D.; Lucas, C.; Gould, M.; Stanley, B.; Brown, G.; Fisher, P.; Zelazny, J.; 
Burke, A.; Oquendo, M.; Mann, J.  
 
 
Disclaimer: 
This scale is intended to be used by individuals who have received training in its administration. The questions contained 
in the Columbia-Suicide Severity Rating Scale are suggested probes. Ultimately, the determination of the presence of 
suicidal ideation or behavior depends on the judgment of the individual administering the scale. 
 
 
Definitions of behavioral suicidal events in this scale are based on those used in The Columbia Suicide History 
Form, developed by John Mann, MD and Maria Oquendo, MD, Conte Center for the Neuroscience of Mental Disorders 
(CCNMD), New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032. (Oquendo M. A., 
Halberstam B. & Mann J. J., Risk factors for suicidal behavior: utility and limitations of research instruments. In M.B. First 
[Ed.] Standardized Evaluation in Clinical Practice, pp. 103 -130, 2003.) 
 
For reprints of the C-SSRS contact Kelly Posner, Ph.D., New York State Psychiatric Institute, 1051 Riverside Drive, New 
York, New York, 10032; inquiries and training requirements contact posnerk@nyspi.columbia.edu 
 
© 2008 The Research Foundation for Mental Hygiene, Inc. 


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10 April 2020 
 
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 Page 76 of 91 
 
 
SUICIDAL IDEATION 
Ask questions 1 and 2.  If both are negative, proceed to “Suicidal Behavior” section. If the answer to question 2 is “yes”, 
ask questions 3, 4 and 5.  If the answer to question 1 and/or 2 is “yes”, complete “Intensity of Ideation” section below. 
 
Since Last 
Visit 
1.  Wish to be Dead  
Subject endorses thoughts about a wish to be dead or not alive anymore, or wish to fall asleep and not wake up   
Have you wished you were dead or wished you could go to sleep and not wake up?  
 
If yes, describe: 
 
 
Yes       No 
 □    □ 
2.  Non-Specific Active Suicidal Thoughts 
General, non-specific thoughts of wanting to end one’s life/commit suicide (e g , “I’ve thought about killing myself”) without thoughts of ways to kill 
oneself/associated methods, intent, or plan during the assessment period   
Have you actually had any thoughts of killing yourself? 
 
If yes, describe: 
 
 Yes      No 
 □    □ 
3.  Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act 
Subject endorses thoughts of suicide and has thought of at least one method during the assessment period  This is different than a specific plan with time, 
place or method details worked out (e g , thought of method to kill self but not a specific plan)   Includes person who would say, “I thought about taking an 
overdose but I never made a specific plan as to when, where or how I would actually do it…and I would never go through with it.” 
Have you been thinking about how you might do this? 
 
If yes, describe: 
 
 Yes      No 
 □    □ 
4.  Active Suicidal Ideation with Some Intent to Act, without Specific Plan 
Active suicidal thoughts of killing oneself and subject reports having some intent to act on such thoughts, as opposed to “I have the thoughts but I 
definitely will not do anything about them.” 
Have you had these thoughts and had some intention of acting on them?  
 
If yes, describe: 
 
 
Yes       No 
 □    □ 
5.  Active Suicidal Ideation with Specific Plan and Intent 
Thoughts of killing oneself with details of plan fully or partially worked out and subject has some intent to carry it out  
Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan? 
   
If yes, describe: 
 
 
 Yes      No 
 □    □ 
INTENSITY OF IDEATION 
The following features should be rated with respect to the most severe type of ideation (i.e., 1-5 from above, with 1 being the least severe 
and 5 being the most severe).  
                                             
Most Severe Ideation:             _____                      _________________________________________________ 
                                               
                                                                                                           Type # (1-5)                                         Description of  Ideation 
Most 
Severe 
Frequency 
How many times have you had these thoughts?  
(1) Less than once a week    (2) Once a week   (3)  2-5 times in week    (4) Daily or almost daily    (5) Many times each day 
 
____ 
Duration 
When you have the thoughts, how long do they last? 
(1) Fleeting - few seconds or minutes                                                 (4) 4-8 hours/most of day 
(2) Less than 1 hour/some of the time                                                 (5) More than 8 hours/persistent or continuous 
(3) 1-4 hours/a lot of time                                                                    
____ 
Controllability 
Could/can you stop thinking about killing yourself or wanting to die if you want to? 
(1) Easily able to control thoughts                                                      (4) Can control thoughts with a lot of difficulty 
(2) Can control thoughts with little difficulty                                     (5) Unable to control thoughts 
(3) Can control thoughts with some difficulty                                    (0) Does not attempt to control thoughts 
____ 
Deterrents 
Are there things - anyone or anything (e.g., family, religion, pain of death) - that stopped you from wanting to die or acting on 
thoughts of committing suicide? 
(1) Deterrents definitely stopped you from attempting suicide            (4) Deterrents most likely did not stop you  
(2) Deterrents probably stopped you                                                    (5) Deterrents definitely did not stop you  
(3) Uncertain that deterrents stopped you                                             (0) Does not apply 
____ 
Reasons for Ideation 
What sort of reasons did you have for thinking about wanting to die or killing yourself?  Was it to end the pain or stop the way 
you were feeling (in other words you couldn’t go on living with this pain or how you were feeling) or was it to get attention, 
revenge or a reaction from others? Or both? 
(1) Completely to get attention, revenge or a reaction from others       (4) Mostly to end or stop the pain (you couldn’t go on 
(2) Mostly to get attention, revenge or a reaction from others                     living with the pain or how you were feeling) 
(3) Equally to get attention, revenge or a reaction from others               (5) Completely to end or stop the pain (you couldn’t go on  
       and to end/stop the pain                                                                         living with the pain or  how you were feeling) 
                                                                                                                 (0)  Does not apply 
 
 
 
 
____ 
© 2008 Research Foundation for Mental Hygiene, Inc. 
 
        C-SSRS—Since Last Visit (Version 1/14/09)    
 
 
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SUICIDAL BEHAVIOR 
(Check all that apply, so long as these are separate events; must ask about all types) 
Since Last 
Visit 
Actual Attempt:  
A potentially self-injurious act committed with at least some wish to die, as a result of act. Behavior was in part thought of as method to kill oneself  Intent 
does not have to be 100%   If there is any intent/desire to die associated with the act, then it can be considered an actual suicide attempt  There does not 
have to be any injury or harm, just the potential for injury or harm  If person pulls trigger while gun is in mouth but gun is broken so no injury results, 
this is considered an attempt    
Inferring Intent: Even if an individual denies intent/wish to die, it may be inferred clinically from the behavior or circumstances  For example, a highly 
lethal act that is clearly not an accident so no other intent but suicide can be inferred (e g , gunshot to head, jumping from window of a high floor/story)  
Also, if someone denies intent to die, but they thought that what they did could be lethal, intent may be inferred   
Have you made a suicide attempt? 
Have you done anything to harm yourself? 
 
Have you done anything dangerous where you could have died? 
What did you do? 
Did you______ as a way to end your life?  
Did you want to die (even a little) when you_____?  
Were you trying to end your life when you _____? 
Or did you think it was possible you could have died from_____? 
Or did you do it purely for other reasons / without ANY intention of killing yourself (like to relieve stress, feel better, get 
sympathy, or get something else to happen)?  (Self-Injurious Behavior without suicidal intent) 
If yes, describe: 
 
 
Has subject engaged in Non-Suicidal Self-Injurious Behavior? 
 
Yes      No 
□   □ 
 
 
 
 
 
 
 
Total # of 
Attempts 
 
 
 
 
 
 
 
 
 
Yes     No 
□   □ 
Interrupted Attempt:   
When the person is interrupted (by an outside circumstance) from starting the potentially self-injurious act (if not for that, actual attempt would have 
occurred). 
Overdose: Person has pills in hand but is stopped from ingesting   Once they ingest any pills, this becomes an attempt rather than an interrupted attempt  
Shooting: Person has gun pointed toward self, gun is taken away by someone else, or is somehow prevented from pulling trigger  Once they pull the trigger, 
even if the gun fails to fire, it is an attempt  Jumping: Person is poised to jump, is grabbed and taken down from ledge  Hanging: Person has noose around 
neck but has not yet started to hang - is stopped from doing so  
Has there been a time when you started to do something to end your life but someone or something stopped you before you 
actually did anything? 
If yes, describe: 
 
Yes      No 
□   □ 
 
 
Total # of 
interrupted 
 
 
Aborted Attempt:   
When person begins to take steps toward making a suicide attempt, but stops themselves before they actually have engaged in any self-destructive behavior  
Examples are similar to interrupted attempts, except that the individual stops him/herself, instead of being stopped by something else  
Has there been a time when you started to do something to try to end your life but you stopped yourself before you 
actually did anything? 
If yes, describe: 
 
 
Yes      No 
□   □ 
 
Total # of 
aborted 
 
 
Preparatory Acts or Behavior: 
Acts or preparation towards imminently making a suicide attempt  This can include anything beyond a verbalization or thought, such as assembling a 
specific method (e g , buying pills, purchasing a gun) or preparing for one’s death by suicide (e g , giving things away, writing a suicide note)   
Have you taken any steps towards making a suicide attempt or preparing to kill yourself (such as collecting pills, getting a gun, 
giving valuables away or writing a suicide note)? 
If yes, describe: 
 
 
Yes      No 
□   □ 
Suicidal Behavior: 
Suicidal behavior was present during the assessment period? 
Yes      No 
□   □ 
Suicide: 
   Yes    No 
□   □ 
Answer for Actual Attempts Only 
Most Lethal 
Attempt 
Date: 
Actual Lethality/Medical Damage:   
0   No physical damage or very minor physical damage (e g , surface scratches)  
1   Minor physical damage (e g , lethargic speech; first-degree burns; mild bleeding; sprains)  
2   Moderate physical damage; medical attention needed (e g , conscious but sleepy, somewhat responsive; second-degree burns; bleeding of major vessel)  
3   Moderately severe physical damage; medical hospitalization and likely intensive care required (e g , comatose with reflexes intact; third-degree burns 
less than 20% of body; extensive blood loss but can recover; major fractures)  
4   Severe physical damage; medical hospitalization with intensive care required (e g , comatose without reflexes; third-degree burns over 20% of body; 
extensive blood loss with unstable vital signs; major damage to a vital area)  
5   Death 
 
Enter Code 
 
 
 
______ 
Potential Lethality: Only Answer if Actual Lethality=0 
Likely lethality of actual attempt if no medical damage (the following examples, while having no actual medical damage, had potential for very serious 
lethality: put gun in mouth and pulled the trigger but gun fails to fire so no medical damage; laying on train tracks with oncoming train but pulled away 
before run over)  
 
0 = Behavior not likely to result in injury 
1 = Behavior likely to result in injury but not likely to cause death 
2 = Behavior likely to result in death despite available medical care  
 
Enter Code 
 
 
 
______ 
© 2008 Research Foundation for Mental Hygiene, Inc. 
 
        C-SSRS—Since Last Visit (Version 1/14/09)    
 
 
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Appendix 5: 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 
 
 
 
 
 
 
 
 
 
 
 


Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 79 of 91 
  
 
 
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 
 
 
 
 
 
 
 
 
 


Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 80 of 91 
  
 
 
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 color 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 
 
 


Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 81 of 91 
Appendix 6: 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 
 
 
 
 
If "No", over the last week how much has   
 
 
A lot 
 
 
 
your skin been a problem at  
 
 
 
 
A little  
 


Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 82 of 91 
 
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. 
 
 
 


Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 83 of 91 
Appendix 7: Children’s Dermatology Life Quality Index (CDLQI) 
 
CHILDREN'S DERMATOLOGY LIFE QUALITY INDEX 
 
Subject Number:  
 
Diagnosis: 
 
 
 
 
 
CDLQI  
Age: 
 
 
 
Date: 
 
 
 
 
 
 
SCORE: 
 
The aim of this questionnaire is to measure how much your skin problem has 
affected you OVER THE LAST WEEK.  Please tick ✓ one box for each question. 
 
1. 
Over the last week, how itchy, "scratchy",  
 
 
              Very much 
□ 
 
sore or painful has your skin been? 
 
  
 
              Quite a lot 
□ 
 
 
  
 
 
 
 
 
 
 
Only a little 
□ 
 
 
 
 
 
 
 
 
 
 
Not at all 
□ 
 
2. 
Over the last week, how embarrassed 
 
 
 
             Very much 
□ 
 
or self conscious, upset or sad have you  
 
 
 
             Quite a lot 
□ 
 
been because of your skin? 
 
  
 
 
 
Only a little 
□ 
 
 
 
 
 
 
 
 
 
 
Not at all 
□ 
 
3. 
Over the last week, how much has your  
 
 
 
             Very much 
□ 
 
skin affected your friendships? 
  
 
 
 
             Quite a lot 
□ 
 
 
 
 
 
 
 
 
 
 
Only a little 
□ 
 
 
 
 
 
 
 
 
 
 
Not at all 
□ 
 
4. 
Over the last week, how much have you changed 
 
 
             Very much 
□ 
 
or worn different or special clothes/shoes  
 
 
             Quite a lot 
□ 
 
because of your skin? 
 
 
 
 
 
             Only a little 
□ 
 
 
 
 
 
 
 
 
 
 
Not at all 
□ 
 
5. 
Over the last week, how much has your  
 
 
 
            Very much 
□ 
 
skin trouble affected going out, playing, 
 
 
 
             Quite a lot 
□ 
 
or doing hobbies? 
 
 
 
 
 
 
Only a little 
□ 
 
 
 
 
 
 
 
 
 
 
Not at all 
□ 
 
6. 
Over the last week, how much have you 
  
 
 
          
Very much 
□ 
 
avoided swimming or other sports because  
 
                           Quite a lot 
□ 
 
of your skin trouble? 
 
 
 
 
 
 
Only a little 
□ 
 
 
 
 
 
 
 
 
 
 
Not at all 
□ 
 
7. 
Last week, 
 
  
If school time: Over the  
           
Prevented school □ 
             
last week, how much did  
               Very much 
□ 
 
school time?   
 
            your skin problem affect your 
             Quite a lot 
□ 
 
 
 
 
 
school work? 
 
 
 
Only a little 
□ 
 
   OR 
 
 
 
 
 
 
 
 
Not at all 
□ 
 
 
was it 
 
 
   
If holiday time: How much 
 
Very much 
□ 
 
holiday time?  
   
               over the last week, has your 
 
Quite a lot 
□ 
 
 
 
 
 
skin problem interfered with 
 
Only a little 
□ 
 
 
 
 
 
your enjoyment of the holiday? 
              Not at all 
□ 
 
 
 
was it 


Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 84 of 91 
8. 
Over the last week, how much trouble  
 
 
 
             Very much 
□ 
 
have you had because of your skin with 
 
 
 
             Quite a lot 
□ 
 
other people calling you names, teasing, 
 
 
 
            Only a little 
□ 
 
bullying, asking questions or avoiding you? 
 
 
             Not at all 
□ 
 
9. 
Over the last week, how much has your sleep  
 
 
             Very much 
□ 
 
been affected by your skin problem? 
 
 
 
              Quite a lot 
□ 
 
 
 
 
 
 
 
 
 
 
Only a little 
□ 
 
 
 
 
 
 
 
 
 
 
Not at all 
□ 
 
10. 
Over the last week, how much of a   
 
 
 
              Very much 
□ 
 
problem has the treatment for your  
 
 
 
              Quite a lot 
□ 
 
skin been? 
 
 
 
 
 
 
 
Only a little 
□ 
 
 
 
 
 
 
 
 
  
 
Not at all 
□ 
Please check that you have answered EVERY question. Thank you.  
 
©M.S. Lewis-Jones, A.Y. Finlay, May 1993, This must not be copied without the permission of the authors.