A Phase 2, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Adult Subjects With Chronic Plaque Psoriasis Who Have Completed Preceding Study ARQ-151-201 Phase 2 Randomized Controlled Trial (Cohort 1) and Non-ARQ-151-201 Subjects (Cohort 2)
Phase: PHASE2
Conditions: Plaque Psoriasis
Sponsor: Arcutis Biotherapeutics, Inc.

 
 
Study 
Number: 
ARQ-151-202 
NCT #: 
NCT03764475 
Official 
Title: 
A Phase 2, Multicenter, Open-Label Extension 
Study of the Long-Term Safety of ARQ-151 
Cream 0.3% in Adult Subjects With Chronic 
Plaque Psoriasis Who Have Completed 
Preceding Study ARQ-151-201 Phase 2 
Randomized Controlled Trial (Cohort 1) and 
Non-ARQ-151-201 Subjects (Cohort 2) 
Protocol 
Date: 
12-Apr-2019 
 

April 12, 2019 
Confidential 
 Page 1 of 69 
 
 
 
 
Protocol ARQ-151-202 
A Phase 2, Multicenter, Open-Label Extension Study of the 
Long-Term Safety of ARQ-151 Cream 0.3% in Adult Subjects 
with Chronic Plaque Psoriasis who have Completed Preceding 
Study ARQ-151-201 Phase 2 Randomized Controlled Trial 
(Cohort 1) and non-ARQ-151-201 Subjects (Cohort 2) 
 
 
ORIGINAL ISSUE DATE: 
November 21, 2018 
AMENDMENT 1: 
April 12, 2019 
 
 
 
 
GCP Statement 
This study is to be performed in full compliance with the protocol, Good Clinical Practices 
(GCP), and applicable regulatory requirements. All required study documentation will be 
archived as required by regulatory authorities. 
 
Confidentiality Statement 
This document is confidential. It contains proprietary information of Arcutis, Inc. Any 
viewing or disclosure of such information that is not authorized in writing by Arcutis, Inc. is 
strictly prohibited. Such information may be used solely for the purpose of reviewing or 
performing this study. 

 
 
Study 
Number: 
ARQ-151-202 
NCT #: 
NCT03764475 
Official 
Title: 
A Phase 2, Multicenter, Open-Label Extension 
Study of the Long-Term Safety of ARQ-151 
Cream 0.3% in Adult Subjects With Chronic 
Plaque Psoriasis Who Have Completed 
Preceding Study ARQ-151-201 Phase 2 
Randomized Controlled Trial (Cohort 1) and 
Non-ARQ-151-201 Subjects (Cohort 2) 
Protocol 
Date: 
12-Apr-2019 
 

Protocol ARQ-151-202 Amendment 1 
Arcutis, Inc. 
 
 
 
April 12, 2019 
Confidential 
 Page 4 of 69 
 
 
PROTOCOL REVISION HISTORY 
Version/Date 
Description 
ARQ-151-202 Version 1 
November 21, 2018 
Original protocol 
ARQ-151-202 Amendment 1 
April 12, 2019 
 Added protocol revision history section 
 Updated Sponsor address 
 Added I-IGA and mPASI to secondary endpoints 
throughout 
 Added Cohort 2 (non ARQ-151-201) subjects 
throughout 
 Added phone visits at Weeks 18, 30 and 44 and added 
instructions for the subject to call the site prior to 
restarting study medication  
 Added additional inclusion and exclusion criteria for 
Cohorts 1 and 2  
 Updated exclusion criteria to exclude moderate to 
severe liver impairment (Child-Pugh B or C) 
 Added Screening visit for non-ARQ-151-201 subjects 
including the Screening C-SSRS 
 Added Table 2, Wash out period for Medications and 
Treatments for Cohort 2 
 Added Appendix 1 Columbia-Suicide Severity Rating 
Scale (C-SSRS) Baseline/Screening Version 
 Updated Columbia-Suicide Severity Rating Scale (C-
SSRS) Since Last Visit Version to Appendix 2 and 
updated 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 to 
Appendix 3 
 Editorial and administrative changes throughout the 
protocol to clarify language and formatting to improve 
readability. 
 
 
 

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3 
TABLE OF CONTENTS 
 
1 
PRINCIPAL INVESTIGATOR AND SPONSOR – SIGNATORIES ............................. 2 
2 
KEY CONTACTS FOR THE STUDY ............................................................................... 5 
3 
TABLE OF CONTENTS ..................................................................................................... 6 
4 
SYNOPSIS ........................................................................................................................... 10 
5 
SCHEDULE OF VISITS AND ASSESSMENTS ............................................................ 15 
6 
ABBREVIATIONS ............................................................................................................. 17 
7 
BACKGROUND AND RATIONALE .............................................................................. 19 
7.1 
Introduction ................................................................................................................. 19 
7.2 
Preclinical Studies ....................................................................................................... 19 
7.2.1 Repeat-Dose Toxicity ............................................................................................... 20 
7.2.2 Oral (Systemic) Studies of Roflumilast and N-Oxide Metabolite ............................ 21 
7.2.3 Reproductive Toxicity .............................................................................................. 22 
7.2.4 Genotoxicity .............................................................................................................. 22 
7.2.5 Carcinogenicity ......................................................................................................... 22 
7.2.6 Special Toxicity:  Local Tolerance of Topical Formulation ..................................... 23 
7.2.7 Conclusions on Toxicity Findings ............................................................................ 23 
7.3 
Clinical Studies ............................................................................................................ 24 
7.3.1 Topical Roflumilast Cream ....................................................................................... 24 
7.3.2 Phase 1/2a Study of Topical ARQ-151 Cream ......................................................... 24 
7.3.3 Phase 2b Study of Topical ARQ-151 Cream ............................................................ 26 
7.3.4 Oral Roflumilast Tablet ............................................................................................ 27 
7.4 
Rationale for Development......................................................................................... 27 
7.4.1 Dose Selection .......................................................................................................... 28 
7.4.2 Risks and/or Benefits to Subjects ............................................................................. 28 
8 
STUDY OBJECTIVE AND ENDPOINTS ....................................................................... 28 
8.1 
Study Objective ........................................................................................................... 28 
8.2 
Study Endpoints .......................................................................................................... 29 
8.2.1 Primary Endpoint ...................................................................................................... 29 
8.2.2 Secondary Endpoints ................................................................................................ 29 
9 
INVESTIGATIONAL PLAN ............................................................................................ 29 
9.1 
Overall Study Design and Plan .................................................................................. 29 
9.2 
Subject Participation .................................................................................................. 30 
9.3 
Randomization ............................................................................................................ 30 
9.4 
Numbering of Subjects ............................................................................................... 30 
9.5 
Blinding ........................................................................................................................ 30 

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9.6 
Selection of Patient Population .................................................................................. 30 
9.6.1 Inclusion Criteria ...................................................................................................... 30 
9.6.2 Exclusion Criteria ..................................................................................................... 31 
9.6.3 Removal of Subjects from the Study ........................................................................ 32 
9.7 
Study Restrictions ....................................................................................................... 33 
9.7.1 Prohibitions and Concomitant Therapy .................................................................... 33 
9.8 
Investigational Product and Treatment .................................................................... 35 
9.8.1 Drug Supplies, Packaging and Labeling ................................................................... 35 
9.8.2 Treatment Administration ......................................................................................... 35 
9.8.3 Treatment Compliance .............................................................................................. 35 
10 STUDY PROCEDURES .................................................................................................... 36 
10.1 
Safety Assessments ...................................................................................................... 36 
10.1.1 
Physical Examination............................................................................................ 37 
10.1.2 
Vital Signs, Height and Weight ............................................................................ 37 
10.1.3 
12-lead ECGs ........................................................................................................ 37 
10.1.4 
Laboratory Tests ................................................................................................... 37 
10.1.5 
Patient Health Questionnaire depression scale (PHQ-8) ...................................... 38 
10.1.6 
Columbia-Suicide Severity Rating Scale (C-SSRS) ............................................. 39 
10.1.7 
Local Tolerability Assessments ............................................................................ 40 
10.1.8 
Adverse Events ..................................................................................................... 41 
10.1.9 
Phone Visits .......................................................................................................... 41 
10.2 
Efficacy Evaluations ................................................................................................... 41 
10.2.1 
Investigator’s Global Assessment (IGA) .............................................................. 41 
10.2.2 
Modified Psoriasis Area and Severity Index (mPASI) ......................................... 43 
10.2.3 
Body Surface Area (BSA) .................................................................................... 44 
10.3 
Final Study Visit – End of Study ............................................................................... 44 
10.4 
Early Termination Visit ............................................................................................. 44 
10.5 
Unscheduled Visit........................................................................................................ 44 
10.6 
Adverse Events ............................................................................................................ 45 
10.6.1 
Adverse Event Definition ..................................................................................... 45 
10.6.2 
Serious Adverse Event .......................................................................................... 45 
10.6.3 
Suspected Unexpected Serious Adverse Reaction (SUSAR) ............................... 47 
10.6.4 
Safety Review ....................................................................................................... 47 
10.6.5 
Adverse Event Reporting ...................................................................................... 47 
10.7 
Reporting Pregnancy .................................................................................................. 48 
10.8 
Treatment Stopping Rules ......................................................................................... 49 
11 DATA ANALYSIS .............................................................................................................. 50 
11.1 
Statistical Methods ...................................................................................................... 50 
11.1.1 
Baseline Definition ............................................................................................... 50 
11.1.2 
Determination of Sample Size .............................................................................. 51 
11.1.3 
Subjects to Analyze............................................................................................... 51 

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11.1.4 
Interim Analysis .................................................................................................... 51 
11.1.5 
Background and Demographic Characteristics ..................................................... 51 
11.1.6 
Study Medication Compliance .............................................................................. 51 
11.2 
Safety Evaluation ........................................................................................................ 51 
11.2.1 
Adverse Events ..................................................................................................... 51 
11.2.2 
Medical History and Physical Examinations ........................................................ 52 
11.2.3 
Clinical Laboratory Results and Vital Signs/Weight Measurements ................... 52 
11.2.4 
ECG: ..................................................................................................................... 52 
11.2.5 
Local Tolerance Assessments: .............................................................................. 53 
11.2.6 
PHQ-8 ................................................................................................................... 53 
11.2.7 
C-SSRS ................................................................................................................. 53 
11.2.8 
Prior and Concomitant Medications ..................................................................... 53 
11.3 
Efficacy Evaluation ..................................................................................................... 53 
12 STUDY ADMINISTRATION ........................................................................................... 54 
12.1 
Ethics ............................................................................................................................ 54 
12.1.1 
Ethics Review Board............................................................................................. 54 
12.1.2 
Ethical Conduct of the Study ................................................................................ 54 
12.1.3 
Subject Information and Consent.......................................................................... 55 
12.2 
Study Monitoring ........................................................................................................ 55 
12.3 
Data Quality Assurance .............................................................................................. 55 
12.4 
Data Handling and Record Keeping ......................................................................... 55 
12.5 
Protocol Amendments and Deviations ...................................................................... 56 
12.6 
Report Format ............................................................................................................. 56 
12.7 
Publication Policy........................................................................................................ 56 
13 REFERENCES .................................................................................................................... 57 
14 APPENDICES ..................................................................................................................... 58 
 
 
LIST OF TABLES 
Table 1.  Excluded Medications and Treatments .................................................................... 34 
Table 2.  Wash Out Period for Medications and Treatments (Cohort 2) ................................ 34 
 
 
LIST OF FIGURES 
Figure 1.  TPSS x TPA Fitted Summary Statistics from MMRM (mITT Population) ........... 25 
 
 
 
 

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LIST OF APPENDICES 
Appendix 1. Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline/Screening 
Version .............................................................................................................. 58 
Appendix 2. Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit 
Version .............................................................................................................. 60 
Appendix 3. 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......................................... 63 
 
 

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4 
SYNOPSIS 
Compound 
ARQ-151 cream 0.3%  
IND 
135,681 
Clinical 
Indication 
Chronic Plaque Psoriasis 
Study Phase and 
Type 
 Phase 2 (2b)  
 52 week, long-term safety study of ARQ-151 cream 0.3% 
Study Objectives 
To assess long-term safety in a multicenter, open-label, 52-week study 
in subjects treated with ARQ-151 cream 0.3% after completing a 12-
week Phase 2b study (ARQ-151-201) Cohort 1 and non-ARQ-151-201 
subjects (Cohort 2). 
Study Endpoints 
Primary Endpoints 
 Occurrence of treatment emergent AEs (TEAEs) 
 Occurrence of Serious Adverse Events (SAEs)  
 
Secondary Endpoints 
 Proportion (%) of subjects achieving an Investigator Global 
Assessment (IGA) of clear or almost clear, as observed at 
Week 12 and subsequent scheduled visits.  
 Proportion (%) of subjects who achieve 'clear' IGA, I-IGA (if 
applicable) and mPASI (Modified Psoriasis Area Severity 
Index) score and stop treatment to all lesions, time to re-starting 
study drug (duration of response). 
 Proportion (%) of applicable subjects with intertriginous area 
involvement, ‘I-IGA’ score of ‘clear’ or ‘almost clear’ at week 
12 and subsequent visits. 
 Proportion of subjects who achieve a 75% reduction in mPASI 
at Week 12 and subsequent scheduled visits as compared to 
baseline.  
Summary of 
Study Design 
Open-label, long-term safety study of ARQ-151 cream 0.3% in 
subjects with chronic plaque psoriasis involving up to 25% total BSA. 
Cohort 1 eligible subjects will enroll into the long-term safety study on 
the same day as the Week 12 visit for the previous study 
(ARQ-151-201). Cohort 2 eligible subjects will enroll on Day 1 of this 
study. Study medication will be applied by the qualifying subjects 
topically QD for 52 weeks at home. Periodic clinic visits will include 
assessments for clinical safety, application site reactions evaluated in 
the clinic using the method of Berger and Bowman, and disease 
improvement or progression.  
 

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Blinding 
 This study is open label 
 All participants will receive ARQ-151 cream 0.3% 
Countries: 
United States and Canada 
Number of sites 
Approximately 30 sites  
Study Population 
Subjects who have completed the 12 week treatment period in study 
ARQ-151-201 and are willing to enroll in this 52-week extension study 
(Cohort 1) and qualified non-ARQ-151-201 subjects (Cohort 2).  
Inclusion Criteria 
All Subjects 
1. Participants legally competent to sign and give informed consent 
2. Males and females ages 18 years and older  
3. Females of childbearing potential (FOCBP) must have a negative 
urine pregnancy test at  all study visits. In addition, sexually active 
FOCBP must agree to use at least one form of highly effective 
contraception throughout the trial.  Highly effective forms of 
contraception include: oral/implant/injectable/transdermal 
contraceptives, intrauterine device, or partner’s vasectomy.  If 
barrier methods are used (e.g., condom with spermicide, diaphragm 
with spermicide), then 2 forms of conception are required. The use 
of abstinence as a contraceptive measure is acceptable as long as 
this is a consistent part of a lifestyle choice and a backup method 
has been identified if the subject becomes sexually active. 
4. Post-menopausal women 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). 
Inclusion Criteria  
Cohort 1 Only 
5. Subjects with chronic plaque psoriasis who met eligibility criteria 
for ARQ-151-201, successfully completed ARQ-151-201 through 
Week 12, and are able to enroll into this long-term safety study on 
the Week 12 visit of the previous study (ARQ-151-201). 
Inclusion Criteria 
Cohort 2 Only 
6. Clinical diagnosis of psoriasis vulgaris of at least 6 months 
duration as determined by the Investigator. 
7. Psoriasis vulgaris on the face, extremities, trunk, and/or 
intertriginous areas involving 2% to 25% of BSA (excluding the 
scalp, palms and soles). 
8. An Investigator's Global Assessment of disease severity (IGA) of at least 
Mild ('2') at Day 1. 
Exclusion Criteria 
All Subjects 
1. Subjects that use any Excluded Medications and Treatments (see 
Table 1). 
2. Subjects currently taking lithium or antimalarial drugs. 
3. Planned initiation or changes to concomitant medication that could, 

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16. 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. 
Exclusion Criteria 
Cohort 1 Only 
17. Subjects who experienced an ARQ-151 treatment-related AE or a 
serious AE (SAE) that precluded further treatment with ARQ-151 
cream in Study ARQ-151-201. 
Exclusion Criteria 
Cohort 2 Only 
18. Subjects who cannot discontinue medication and treatments  prior 
to the Day 1 visit according to Excluded Medications and 
Treatments (Table 2). 
Number of 
Subjects 
Up to approximately 300 subjects (Cohort 1) 
Up to approximately 100 subjects (Cohort 2) 
Duration of 
Participation for 
Subjects 
Approximately 52 weeks  
Study Products 
ARQ-151 drug product will be supplied as a 0.3% cream in a 
squeezable tube. 
Planned Dose 
Level 
 Subjects with up to 25% total BSA of psoriatic lesions will receive 
ARQ-151 cream 0.3% to be applied QD topically to all lesions. 
 Application will be to all areas affected including the face and 
intertriginous/genital regions (except for the scalp). 
 Subjects may stop treatment to lesions/areas that have cleared and 
completely resolved. Treatment may resume in these or new areas 
should psoriatic lesions emerge during the study. 
 If treatment is judged by the Investigator as being ineffective, then 
the subject may be withdrawn from the study at any time.  
Safety 
Assessments 
Safety will be monitored through application site assessments in  the 
clinic using the method of Berger and Bowman, clinical laboratory 
testing, 12-lead ECGs, PHQ-8, C-SSRS and AEs. 
Safety Analysis 
Adverse Events 
A subject-by-subject treatment-emergent AE (TEAE) data listing, 
including verbatim term, preferred term, treatment, severity, and 
relationship to study drug, will be provided. 
The number of subjects experiencing AEs and number of AEs will be 
summarized by treatment using frequency counts. 
Physical Examinations 
Vital signs will be collected at all study visits. Physical examinations 
and 12-lead ECGs will be collected periodically throughout the study.  
Clinical Laboratory Results 
Routine blood chemistries will be obtained at all study visits. Urine 

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pregnancy tests will be collected periodically throughout the study. 
Patient Health Questionnaires 
PHQ-8 and C-SSRS questionnaires will be completed by the subjects 
at all study visits. Descriptive statistics will be calculated for the PHQ-
8. The C-SSRS will be analyzed per the Scoring and Data Analysis 
Guide from the Columbia Lighthouse Project. 
Efficacy Analysis 
The efficacy endpoints will be defined as:  
 Proportion (%) of subjects achieving an Investigator Global 
Assessment (IGA) of clear or almost clear, as observed at 
Week 12 and subsequent scheduled visits.   
 In subjects who achieve 'clear' IGA, I-IGA and MPASI scores 
and stop treatment to all lesions, time to re-starting study drug 
(duration of response) 
 Proportion (%) of applicable subjects with intertriginous area 
involvement, ‘I-IGA’ score of ‘clear’ or ‘almost clear’ at week 
12 and subsequent visits 
 Proportion (%) of subjects achieving a 75% reduction from 
Baseline of Modified Psoriasis Area Severity Index-75 
(mPASI-75) at weeks 12, 24, 36 and 52 as compared to 
Baseline. 
Power and 
Sample Size 
Up to approximately 300 subjects are planned for Cohort 1 and up to 
approximately100 subjects are planned for Cohort 2.   
The sample size will provide a sufficient population size to evaluate 
the long-term safety of ARQ-151 cream 0.3% at 52 weeks. 
Statistical 
Analysis: 
This study is not intended to assess efficacy, but rather the IGA, I-IGA 
and mPASI are included to determine the need for treatment and 
subsequent re-treatment after treatment course in Study ARQ-151-201 
or Study ARQ-151-202.  Certain efficacy data and endpoints will, 
however, be summarized. 
Descriptive statistics will be presented for the endpoint data collected 
in the clinical trial. For analysis of the proportion (%) of subjects 
achieving an IGA of clear or almost clear at week 52, as observed, no 
imputation for missing data will be performed. The proportion of 
successes for the secondary variables of I-IGA and 75% reduction in 
mPASI will be tabulated. 
The duration of response will be analyzed using the Kaplan-Meier 
method. 
No formal inferential statistics will be performed on safety 
assessments. Descriptive statistics will be calculated for quantitative 
safety data and frequency counts will be compiled for classification of 
qualitative safety data.   
 

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5 
SCHEDULE OF VISITS AND ASSESSMENTS 
STUDY EVENTS FLOW CHART: 
 
Study Procedure 
Washout 
Cohort 2 
Day 1 
(Cohort 
2) 
Wk 4 Wk 
12 
 
Wk  
18 
Wk 24 
 
Wk 
30 
Wk 
36 
 
Wk 
44 
Wk 
52 
Visit 
Screening 
Visit 7 
(Week 12) 
of ARQ-
151-201 
Study 
(Cohort 
1) 
1 
2 
Phone 
Visit 
3 
Phone 
Visit 
4 
Phone 
Visit 
5 
Visit Window 
-35 days 
+/- 3 
days 
+/- 5 
days 
 
 
+/- 7 
days 
+/- 7 
days 
 
 
+/- 7 
days 
+/- 7 
days 
 
 
+/- 7 
days 
+/- 7 
days 
Informed consent 
Xi 
Xi 
 
 
 
 
 
 
 
 
Physical examinationa 
 
Xh 
 
 
 
X 
 
 
 
X 
I/E criteria 
X 
X 
 
 
 
 
 
 
 
 
Hematology, Serum 
Chemistries, and Urine 
Analysis  
X 
Xh 
X 
X 
 
X 
 
X 
 
X 
12 lead ECG 
X 
Xh 
 
 
 
X 
 
 
 
X 
Vital signs, height, weightb 
 
Xh 
X 
X 
 
X 
 
X 
 
X 
IGAc, I-IGA, mPASI and 
BSAc 
X 
Xh 
X 
X 
 
X 
 
X 
 
X 
C-SSRS, PHQ-8  
X 
 Xh 
X 
X 
 
X 
 
X 
 
X 
Urine pregnancy testd 
X 
Xh 
X 
X 
 
X 
 
X 
 
X 
Local Tolerability 
Assessmente 
 
Xh 
X 
X 
 
X 
 
X 
 
X 
Dispense study medication 
kitf 
 
X 
X 
X 
 
X 
 
X 
 
 
Dispense/review diary 
 
X 
X 
X 
 
X 
 
X 
 
X 
Weigh study medication 
 
X 
X 
X 
 
X 
 
X 
 
X 
Adverse event assessmentg 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
a Limited physical examination: skin, lungs, and heart only 
b  Height will be collected at Day 1 only. 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% weight loss should be reported to the medical monitor. 
c   IGA will be a 5-point scale ranging from clear (0) to severe (4). IGA should be completed prior to other 
physician assessments. Total BSA affected by psoriasis will be determined at each visit. A body diagram should 
be used to record areas of psoriasis involvement. 
d A urine pregnancy test will be administered to all females of child-bearing potential. A negative result is required 
for continued participation in the study, and results must be available prior to dispensing of study drug at each 
visit. 
e Local tolerability will be assessed by the clinic using the method of Berger and Bowman.   
f Kits will be dispensed based on %BSA affected. See IP Handling Manual for details.   

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g 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. 
h  For Cohort 1, this data will be obtained from Week 12 of ARQ-151-201 Study and used as the Day 1 data for this 
long-term safety study (ARQ-151-202). If after ARQ-151-201 completion, subjects should complete the 
screening visit procedures. The Baseline values for Safety tabulations will be taken from the day that the subject 
received their first active study drug (across studies ARQ-151-201 and ARQ-151-202). Baseline  values for 
efficacy will be those recorded on Day 1 of Study ARQ-151-201. For Cohort 2, Baseline evaluations will be 
obtained for all procedures and the Baseline/Screening version of the C-SSRS will be utilized at Screening.  For 
Cohort 2, labs that are collected within 14 days of Baseline do not need to be repeated.  
i  For Cohort 1, the consent will be signed after completion of Week 12 in ARQ-151-201. Cohort 2 will sign 
consent prior to any study-related procedures at the Screening Visit.  
 
 

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7 
BACKGROUND AND RATIONALE 
7.1 
Introduction 
Roflumilast is a phosphodiesterase 4 (PDE-4) inhibitor approved globally to reduce the risk of 
exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) associated 
with chronic bronchitis.  Roflumilast and its active metabolite, roflumilast N-oxide, are high 
affinity selective inhibitors of PDE-4 (a major cyclic-3′,5′-adenosine monophosphate (cyclic 
AMP)-metabolizing enzyme), whose activity leads to accumulation of intracellular cyclic AMP.  
There are four different subtypes of PDE-4: PDE-4a, PDE-4b, PDE-4c, and PDE-4d, each with 
several isoforms (splicing variants).  IC50 values of both roflumilast and roflumilast N-oxide for 
the different PDE-4 isoforms and subtypes are mostly sub-nanomolar and single digit nanomolar 
(Hatzelmann 2010).  The PDE-4 family of enzymes are the most prevalent phosphodiesterases in 
immune cells and inhibition of PDE-4 subtypes has been associated with anti-inflammatory 
effects in many biological systems. 
 
Psoriasis is a chronic inflammatory skin disease characterized by raised, well-demarcated, 
erythematous oval plaques with adherent silvery scales.  Numerous past reports have suggested a 
deficiency of cyclic AMP-dependent protein kinases in human psoriatic skin (Brion 1986).  More 
recently, various cytokines produced by Th1 and Th17 cells have been shown to play a crucial 
role in the pathogenesis of psoriasis.  It has been postulated that the anti-inflammatory effects of 
PDE-4 inhibitors may provide a beneficial therapeutic intervention in the treatment of chronic 
plaque psoriasis and recently Otezla® (apremilast), a PDE-4 inhibitor, has been approved for the 
oral treatment of chronic plaque psoriasis. 
 
The past 15 years have witnessed a transformation in the systemic treatment of moderate to 
severe psoriasis with the advent of biological therapies.  However, for patients with milder forms 
of disease, best treated with topical options, the therapeutic landscape really has not changed in 
several decades.  Topical steroids come in all shapes and forms, but the lower potency steroids 
are not effective and the higher potency steroids are beset with issues of local skin atrophy and 
the potential for hypothalamic-pituitary axis suppression when applied over larger body surface 
areas and for prolonged periods of time.  Vitamin D has been the other staple of topical psoriasis 
treatment but it is irritating, not suitable for use on the face or intertriginous areas, and its 
efficacy is rather modest.  Hence, there is substantial medical need for additional topical 
approaches in the treatment of psoriasis. The study sponsor is developing a topical formulation 
of roflumilast for the treatment of chronic plaque psoriasis.  Our Phase 2a results suggest that 
ARQ-151 may be a highly efficacious and well-tolerated topical treatment for psoriasis. 
7.2 
Preclinical Studies  
Roflumilast was initially developed as a 500 g tablet for oral therapy in patients with COPD, 
and as such has been thoroughly evaluated in nonclinical studies.  The safety profile is well-
established and the results of those studies are relevant to the dermal roflumilast (ARQ-151 
cream) development program.  Oral roflumilast (500 g tablet) was approved by Health Canada 
as DAXAS® in December 2010 and by the US FDA as DALIRESP® in February 2011 for the 
treatment of COPD.  The study sponsor is conducting nonclinical studies in which roflumilast is 
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8.2 
Study Endpoints 
8.2.1 Primary Endpoint 
 
The primary endpoint will be analysis of safety monitored through application site assessments 
in  the clinic using the method of Berger and Bowman, clinical laboratory testing, 12-lead ECGs, 
PHQ-8, C-SSRS and adverse events.  Two primary endpoint analyses are planned: 
 
 Occurrence of Treatment Emergent Adverse Events  
 Occurrence of Serious Adverse Events  
8.2.2 Secondary Endpoints 
 
The secondary endpoints are related to efficacy and will include: 
 
 Proportion (%) of subjects achieving an Investigator Global Assessment (IGA) of clear or 
almost clear, as observed at Week 12 and subsequent scheduled visits.  
 In subjects who achieve 'clear' scores for IGA, I-IGA (if applicable and mPASI 
(Modified Psoriasis Area Severity Index) and stop treatment to all lesions, time to re-
starting study drug (duration of response). 
 Proportion (%) of applicable subjects with intertriginous area involvement, ‘I-IGA’ score 
of ‘clear’ or ‘almost clear’ at week 12 and subsequent visits 
 Proportion (%) of subjects achieving a 75% reduction from Baseline of Modified 
Psoriasis Area Severity Index-75 (mPASI-75) at weeks 12, 24, 36 and 52 as compared to 
Baseline. 
9 
INVESTIGATIONAL PLAN 
9.1 
Overall Study Design and Plan 
This is an open-label, long-term safety study of ARQ-151 cream 0.3% in subjects with chronic 
plaque psoriasis involving between 0 and 25% BSA. Eligible subjects will enroll into the long-
term safety study on the same day as the Week 12 visit for the previous study (ARQ-151-201) 
for Cohort 1 and on Day 1 for non ARQ-151-201 subjects in Cohort 2. Study medication will be 
applied by the subjects topically QD for 52 weeks at home.  
 
A total of up to approximately 300 subjects (Cohort 1) and up to approximately 100 non ARQ-
151-201 subjects (Cohort 2) will be enrolled at approximately 30 study sites in the United States 
and Canada.  Subjects will be adult (≥18 y/o) males or females with chronic plaque psoriasis. 
Periodic clinic visits will include assessments for clinical safety, application site reactions 
evaluated in the clinic using the method of Berger and Bowman, disease improvement or 
progression, and IGA.   
 
 

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9.2 
Subject Participation 
Subject participation involves a minimum of five clinic visits at Week 4, Week 12, Week 24, 
Week 36 and Week 52 of treatment. There will be three phone visits conducted at Weeks 18, 30 
and 44. The Day 1 visit of this study will be Week 12 of the ARQ-151-201 study (Cohort 1) and 
Day 1 for Cohort 2. The Baseline values for Safety tabulations will be taken from the day that 
the subject received their first active study drug. Baseline values for efficacy will be those 
recorded on Day 1 of Study ARQ-151-201. The anticipated maximum duration of subject 
participation is about 52 weeks. Subjects in the ARQ-151-201 study that choose to participate in 
the long-term extension study will transition directly into the ARQ-151-202 study at the Day 1 
visit (Week 12 of Study ARQ-151-201). 
9.3 
Randomization 
This is an open-label study and all subjects will be treated with ARQ-151 cream 0.3% QD to 
psoriatic plaques up to a maximum application area of 25% BSA.    
9.4 
Numbering of Subjects 
All screened subjects enrolled will retain their unique five-digit subject ID number previously 
assigned during the ARQ-151-201 study (Cohort 1). For Cohort 2 subjects will be numbered 
with the 2 digit site number and a three digit subject number starting with 500.    
 
The clinical site is responsible for maintaining a current log of subject ID number assignments 
and study drug kits assigned to that subject.  The subject ID number is required to be entered on 
all clinical study documentation (e.g., case report forms, labeling of clinical materials and sample 
containers, investigational product accountability logs, etc.).  
9.5 
Blinding 
This is an open-label study and no blinding is planned. 
9.6 
Selection of Patient Population 
9.6.1 Inclusion Criteria 
All Subjects  
Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the 
study: 
1. Participants legally competent to sign and give informed consent 
2. Males and females ages 18 years and older  
3. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all 
study visits. In addition, sexually active FOCBP must agree to use at least one form of highly 
effective contraception throughout the trial.  Highly effective forms of contraception include: 
oral/implant/injectable/transdermal contraceptives, intrauterine device, and partner’s 
vasectomy.  If barrier methods are used (e.g., condom with spermicide, diaphragm with 

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9. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, 
nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, and rifampin 
during the study period.  
10. Subjects who have received oral roflumilast (Daxas®, Daliresp®) within the past 4 weeks.  
11. Known or suspected:  
 severe renal insufficiency or moderate to severe liver impairment (Child-Pugh B 
or C) 
 hypersensitivity to component(s) of the investigational products  
 history of severe depression, suicidal ideation 
12. Females who are pregnant, wishing to become pregnant during the study, or are breast-
feeding. 
13. 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. 
14. Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of 
study medication. 
15. History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or 
anaphylactoid reaction) to PDE-4 inhibitors. 
16. 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. 
17. 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. 
Cohort 1 Only 
18. Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that 
precluded further treatment with ARQ-151 cream in Study ARQ-151-201. 
Cohort 2 Only 
19. Subjects who cannot discontinue medication and treatments  prior to the Day 1 visit 
Excluded Medications and Treatments (Table 2). 
9.6.3 Removal of Subjects from the Study 
Subject participation in this trial may be discontinued for any of the following reasons: 
1. Occurrence of any medical condition or circumstance that, in the opinion of the Investigator, 
exposes the subject to substantial risk and/or does not allow the subject to adhere to the 
requirements of the Protocol. 
2. Occurrence of a treatment-emergent adverse event (TEAE) or considerable worsening of an 
AE that, in the opinion of the investigator in consultation with the Medical Monitor and 

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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. 
5. Weight loss of >5% if not dieting or intentionally trying to lose weight and after consultation 
with the Sponsor, at the Investigator’s discretion. 
6. C-SSRS indicative of suicidal ideation or a PHQ-8 score ≥15, after consultation with a 
mental health professional, the Sponsor, and at the Investigator’s discretion. 
7. Requirement for use of prohibited concomitant medication. 
8. Subject’s repeated failure to comply with protocol requirements or study related procedures. 
9. Termination of the study by the Sponsor, FDA, or other regulatory authorities. 
9.7 
Study Restrictions 
9.7.1 Prohibitions and Concomitant Therapy 
Prohibited medications and products are detailed in Table 1 (Excluded Medications and 
Treatments).   
Generally, the addition of new medications, including nonprescription medications, during the 
course of the study is discouraged.  However, it is recognized that this is a 52-week study and 
subjects may be required to start chronic medications for health benefits.  The use of such 
chronic medications may be authorized by the Investigator.  The Investigator must make the 
decision to authorize the use of any such 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.  Short-term medications, such as antibiotics to treat acute infections, are allowed.  
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 already been used chronically by subjects, in particular statins and anti-hypertensives, are 
allowed for use during the study.   
 
 

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Table 1.  Excluded Medications and Treatments 
Excluded Medications and Treatments 
Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris  
Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (eg, oral 
corticosteroids, retinoids, apremilast, methotrexate, cyclosporine and other systemic 
immunosuppressants 
Topical anti-psoriasis medications (e.g., corticosteroids, vitamin D analogs, prescription shampoos) 
(except for emollients) 
PUVA phototherapy 
UVB  
Investigational drugs (except ARQ-151 cream) 
Note:   
Eye drop and nasal corticosteroid preparations are allowed.   
 
Inhaled corticosteroid preparations are allowed if used for a stable condition and at a stable 
dose for > 28 days before Day 1, and are continued at the same dose throughout the study. 
 
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. Study medication 
should be applied at least 20 minutes before going to bed and no other emollients or 
moisturizers should be applied to the treated area.   
 
A tar-containing or a dandruff shampoo (zinc pyrithione or selenium sulfide) shampoo is 
allowed for treatment of the scalp. 
 
Table 2.  Wash Out Period for Medications and Treatments (Cohort 2) 
 
Excluded Medications and Treatments 
Wash Out Period Prior to Day 1 
 Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris within the 
following time periods prior to enrollment: 
Etanercept 
4 weeks 
Adalimumab, infliximab 
8 weeks 
All other biologics 
12 weeks 
 All other therapies with a possible effect on psoriasis vulgaris: 
Oral corticosteroids, retinoids, apremilast, methotrexate, 
cyclosporine and other systemic immunosuppressants 
4 weeks 
Topical anti-psoriasis medications (e.g., topical 
corticosteroids, vitamin D analogs, prescription shampoos) 
(except for emollients) 
2 weeks 
PUVA phototherapy 
4 weeks 
UVB  
2 weeks  
Systemic retinoids 
12 weeks 
Investigational drugs 
12 weeks (biologics); 
5 half-lives (orals);  
2 weeks (topical) 

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9.8 
Investigational Product and Treatment 
9.8.1 Drug Supplies, Packaging and Labeling 
ARQ-151 cream 0.3% will be provided in 45 gram squeeze tubes.  The tubes will be packaged in 
kits, each containing 8 tubes of investigational product. The number of kits dispensed to a 
subject will be based on the BSA involvement of psoriasis.  It is anticipated that the maximum 
number of kits dispensed to a subject will be ten. The kits and tubes will be labeled including a 
location to record the subject ID on the label. 
 
The Sponsor will supply sufficient quantities of the study drug (ARQ-151 cream 0.3%,) to each 
site to allow for completion of this study. 
 
Records will be made of the receipt and dispensing of the study drugs supplied. At the 
conclusion of the study, any unused study drugs will be returned to the Sponsor or designee, or 
destroyed, as per Sponsor instructions. 
9.8.2 Treatment Administration 
At the Day 1 visit, subjects will be instructed to apply study medication once daily.  All subjects 
should apply medication each evening at least 15 minutes after showering or bathing (if they take 
an evening shower/bath) and then not wash areas where ARQ-151 cream has been applied until 
the following morning. Study medication should be applied at least 20 minutes before going to 
bed.  
 
Subjects should continue to apply study medication to all active psoriasis lesions including any 
new plaques that develop during the study.  A Body Diagram should be used to record existing 
and new areas of psoriasis involvement that are subject to treatment. 
 
Psoriasis plaques that have completely resolved, in the opinion of the investigator, do not require 
continued treatment. If psoriasis plaques appear to resolve at some time between study visits, 
study medication should continue to be applied until the next scheduled visit.  At that visit, the 
Investigator will perform an assessment and determine whether or not to discontinue treatment. 
Study medication will be weighed prior to dispensing at all visits where study medication is 
dispensed.. Study medication, both empty and full tubes, must be returned by subjects at each 
study visit and will be weighed.  
9.8.3 Treatment Compliance  
Study medication tubes will be weighed at each follow-up clinic visit.   
Subjects will complete a daily diary recording the date and time of each dose applied, any missed 
doses, and a comment section should the subjects have a comment, e.g., record potential AEs. 
Site personnel will review the diaries and use the information to question the subject regarding 
compliance and AEs and then record appropriate information in source documents and complete 
Case Report Forms (CRFs).  If a subject misses a dose, they should be instructed to return to the 

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protocol study medication administration schedule (i.e. if subject forgets a dose they should wait 
until that evening and apply as usual).   
Compliance will be assessed by review of the dosing diary. Weight of study medication applied 
will be measured for reporting purposes. Compliance will be documented in source and in eCRF. 
10 STUDY PROCEDURES  
10.1 Safety Assessments 
The Schedule of Visits and Assessments (see Section 5) summarizes the clinical procedures to be 
performed at each visit. Individual clinical procedures are described in detail below. Additional 
evaluations/testing may be deemed necessary by the PI and/or the Sponsor for reasons related to 
subject safety. 
This study assesses the long-term safety of ARQ-151 cream 0.3%. Safety will be monitored 
through application site assessments in  the clinic using the method of Berger and Bowman, 
physical examination, clinical laboratory testing, 12-lead ECGs, PHQ-8, C-SSRS and AEs as 
outlined in the Schedule of Visits and Assessments (Section 5). If deemed necessary, additional 
safety assessments will be performed at the discretion of the Investigator. 
Screening Visit (Cohort 2) 
Within 35 days prior to the first dosing, non ARQ-151-201 subjects will be provided details of 
study requirements and sign an informed consent.  Each subject will undergo psoriatic plaque 
assessments, a physical examination, vital sign measurements (blood pressure, heart rate, and 
temperature), PHQ-8, C-SSRS, and laboratory tests: hematology, chemistry, urinalysis and a 
pregnancy test for female subjects of child bearing potential. 
Screening should occur for Cohort 1 subjects if they have completed ARQ-151-201 previously. 
All screened subjects will receive a screening number and be entered into the electronic subject 
tracking system. 
Day 1 Visit 
At Day 1 (Week 12 of the ARQ-151-201 study or Day 1 for non ARQ-151-201) ARQ-151-201 
subjects will be provided details of study requirements and sign an informed consent.  Medical 
history and demographic data, psoriatic plaque assessments (IGA, I-IGA, mPASI and BSA), 
physical examination, vital sign measurements (blood pressure, heart rate, and temperature), 
PHQ-8, C-SSRS, laboratory tests: hematology, chemistry, urinalysis and a pregnancy test for 
female subjects of child bearing potential will be obtained at Week 12 visit of study ARQ-151-
201 and will serve as the Day 1 for ARQ-151-201 subjects (Cohort 1). Cohort 2 Day 1 
assessments for this long-term safety study (ARQ-151-202) will be completed within 35 days of 
Screening. The Baseline values for Safety tabulations will be taken from the day that the subject 
received their first active study drug (across studies ARQ-151-201 and ARQ-151-202). Baseline 
values for efficacy will be those recorded on Day 1 of Study ARQ-151-201 (Cohort 1) and Day 1 
of ARQ-151-202 for non ARQ-151-201 subjects (Cohort 2). 

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Cohort 2 subjects must meet the required wash out period for any excluded medications and 
treatments according to Table 2.  
All Cohort 1 subjects will retain their Subject ID from the previous study which will be entered 
into the electronic subject tracking system for this long-term safety study. Cohort 2 subject study 
numbers will include the 2 digit site number and the three digit subject number will begin with 
500. 
Scheduled Visits (Day 1 and Visits 1 – 5) 
10.1.1 Physical Examination 
 
Physical examinations will be performed as follows: 
 
Day 1, Week 24, and Week 52.   
The physical exam will be limited to skin, lungs and heart only. 
10.1.2 Vital Signs, Height and Weight 
 
Vital signs will be collected at timepoints noted below: 
 
Blood pressure, heart rate, and temperature will be measured at all study visits.  
 
Height will be collected at Day 1 only.  
 
Weight will be collected at all study visits. Subject to void prior to weight being taken and 
remove any jackets, outerwear and shoes. Remove any objects of significant weight (i.e. cell 
phones, wallet, key chains). A 5% weight loss should be reported to the medical monitor. 
10.1.3 12-lead ECGs 
 
12-lead ECGs will be performed as follows: 
 
Day 1, Week 24 and Week 52. 
 
ECGs will be performed on subjects after 5 minutes in the supine position. All ECG tracings and 
readouts will be reviewed by the central reader at the ECG laboratory. 
10.1.4 Laboratory Tests 
All tests listed below will be performed as follows: 
Day 1, Weeks 4, 12, 24, 36, 52.    
 
 

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All tests listed below will be performed according to the Study Events Flow Chart unless 
otherwise noted. The collection of specimens will be in a non-fasting state. In addition, 
laboratory safety tests may be performed at various unscheduled timepoints, if deemed necessary 
by the Investigator. 
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) 
* 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 Day 1, Weeks 4, 12, 24, 36 and 52 for FOCBP only  
10.1.5 Patient Health Questionnaire depression scale (PHQ-8)  
 
The 8 item PHQ-8 Assessment will be performed as follows: 
 
Day 1, Weeks 4, 12, 24, 36, and 52 
 
Subjects will complete PHQ-8 questionnaire. 
 
A subject with a PHQ-8 score of ‘15’ or above should be referred promptly to a mental health 
care professional and, if currently applying study drug, consideration be given to discontinuation 
from study drug.   
 

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The PHQ-8 
 
 
PHQ-8 score is the sum of the responses for the 8 questions. 
 
Five severity categories of depression are defined as follows:  
 None – Minimal depression (0 to 4)  
 Mild depression (5 to 9)  
 Moderate depression (10 to 14)  
 Moderately severe depression (15 to 19)  
 Severe depression (20 to 24) 
10.1.6 Columbia-Suicide Severity Rating Scale (C-SSRS)  
 
C-SSRS Assessments will be performed as follows: 
 
Day 1, Weeks 4, 12, 24, 36, and 52 
 
On all visits, the Since Last Visit version (Appendix 1) will be used for Cohort 1. 

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Cohort 2 will use the Baseline/Screening version (Appendix 2) for Day 1 and Since Last Visit 
version for all remaining visits.  
 
 
Any score greater than 0 in the suicidal ideation score is important and may indicate the 
need for mental health intervention and consideration be given to discontinuation from 
study drug. This should result in prompt referral to a mental health professional and/or 
possibly the emergency room. The Medical Monitor should be contacted.  
 
Clinical study staff that administer the C-SSRS will be trained via the C-SSRS training video. A 
training certificate for the administer(s) will be on file in the trial master file at the site. 
 
The Investigator must review the completed C-SSRS.  A qualified mental health care provider 
must be available, immediately if needed, to refer the subject for further evaluation. 
10.1.7 Local Tolerability Assessments  
The Investigator Local Tolerability Assessment will be performed as follows: 
Day 1, Weeks 4, 12, 24, 36, and 52 
Application site reactions will be graded at the timepoints outlined in the Schedule of Visits and 
Assessments (Section 5).  Irritation reactions are graded using the scale detailed in the following 
section (Berger-1982).  Reactions at the site of product application, which may occur post-Day 1 
visit, should be differentiated from the preexisting inflammation associated with the subject’s 
psoriasis.   
 
Dermal Response 
0 = no evidence of irritation 
1 = minimal erythema, barely perceptible 
2 = definite erythema, readily visible; minimal edema or minimal papular response 
3 = erythema and papules 
4 = definite edema 
5 = erythema, edema and papules 
6 = vesicular eruption 
7 = strong reaction spreading beyond application site 
 
 

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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 
 
10.1.8 Adverse Events  
 
Adverse events (AEs) will be collected beginning at informed consent and assessed as follows: 
Day 1, Weeks 4, 12, 24, 36, and 52 
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.  
A psoriasis flare will be considered an AE in this study. For further details on Adverse Events 
please see Section 10.6. 
 
10.1.9 Phone Visits 
 
Phone visits -- Weeks 18, 30 and 44 -- will be conducted for all subjects to review any adverse 
event or concomitant medication changes. 
 
Subjects will call the site when psoriasis returns prior to restarting application of study drug.  
10.2 Efficacy Evaluations  
10.2.1 Investigator’s Global Assessment (IGA) 
 
Investigator’s Global Assessments (‘whole body’) will be performed at the following study 
visits. The IGA should be completed prior to other physician assessments. 
 
Day 1, Weeks 4, 12, 24, 36, and 52 
 
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.  
 
Unlike the Phase 2b study, an Intertriginous-IGA will not be done in this open-label extension 
study.  However, study medication should be applied to intertriginous areas if affected. 
 

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For subjects with intertriginous area involvement of at least ‘mild’ severity by IGA (I-IGA≥2) at 
Day 1 (using the IGA scale shown above but evaluating intertriginous areas ONLY and NOT 
whole body involvement), an IGA for the intertriginous region alone (I-IGA) will be recorded at 
weeks 4, 12, 24, 36 and 52.   
This ‘intertriginous area IGA’ (I-IGA) should be done AFTER the ‘standard whole body 
IGA’ (primary endpoint) in subjects who qualify.  
10.2.2 
Modified Psoriasis Area and Severity Index (mPASI) 
mPASI Assessments will be performed as follows: 
Screening, Baseline, Weeks 4, 12, 24, 36 and 52 
Every effort should be made for the same Evaluator to complete the mPASI for the subject 
at every study visit. 
 
Modified Psoriasis Area and Severity Index (mPASI) is used for the measurement of severity of 
psoriasis.  
 
mPASI combines the assessment of the severity of lesions and the area affected into a single 
score in the range 0 (no disease) to 72 (maximal disease). 
The body is divided into four sections (head (h) (10% of a person's skin); arms (a) (20%); trunk 
(t) (30%); legs (l) (40%)). Each of these areas is scored by itself, and then the four scores are 
combined into the final mPASI. For each section, the percent of area (A) of skin involved is 
estimated and then transformed into a grade from 0 to 6 (A): 
 
0. 0% of involved area 
1. < 10% of involved area - see below for Modified PASI (mPASI) for this grade 
2. 10–29% of involved area 
3. 30–49% of involved area 
4. 50–69% of involved area 
5. 70–89% of involved area 
6. 90–100% of involved area 
 
mPASI: for subjects with < 10% of an involved anatomic area, the mPASI will be calculated 
using the actual percentage of the anatomical area involved (e.g. 0.1 for 1%, 0.2 for 2%, 0.3 for 
3%, … 0.9 for 9%), corresponding to the actual percentage of that particular anatomical area of 
involvement.  
 
Note: Palms and soles may be treated with study medication in this study, but will not be 
counted towards IGA, mPASI, or BSA assessments. 
 
Within each area, the severity is estimated by three clinical signs: erythema (‘E’; redness), 
induration (‘T’; thickness) and desquamation (‘S’; scaling). Severity parameters are measured on 
a scale of 0 to 4, from none to maximum severity possible. 

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To calculate the mPASI, the sum of the severity rating for the three main signs are multiplied 
with the numerical value of the area affected and with the various percentages of the four body 
areas. These values are then added to complete the formula as follows: 
 
PASI = 0.1 (Eh + Th + Sh) Ah + 0.2 (Ea + Ta + Sa) Aa + 0.3 (Et + Tt + St) At + 
0.4 (El + Tl + Sl) Al 
10.2.3 Body Surface Area (BSA) 
BSA Assessments will be performed as follows: 
Day 1, Weeks 4, 12, 24, 36, and 52 
The BSA affected by psoriasis will be determined by the subject’s hand method, where the 
subject’s hand (including fingers) surface area is assumed to equal 1% of body surface area 
(BSA).   
 
Note: Palms and soles will be treated with study medication, but will not be counted towards 
IGA or BSA assessments. The scalp is not treated and will not be counted towards any 
assessments. 
10.3 Final Study Visit – End of Study 
The final study visit will occur approximately at the end of week 52 of overall involvement in 
the study. The procedures performed during this visit are as described in Section 10.1 and 
Section 10.2 and the Schedule of Events for the Week 52 visit (Section 5). A 7 day scheduling 
leeway period is allowed for this visit. In addition to the listed procedures to be performed, 
adverse events will be recorded as reported by the participant or as observed and followed to 
resolution as necessary (see Section 10.1.8). 
10.4 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 final study 
visit (End of Study visit; see Section 10.3). 
10.5 Unscheduled Visit 
Subjects that clear between scheduled visits should return for an unscheduled visit for the 
investigator to confirm IGA, I-IGA (if applicable) and mPASI are clear and subject may stop 
application of study drug. Unscheduled visits may be necessary for the purpose of measuring 
time to restarting study drug for those subjects that stopped application of study medication due 
to resolution of psoriasis plaques. Subjects will call the site when psoriasis returns prior to 
restarting application of study drug. Unscheduled visits also may be necessary to repeat testing 
following abnormal laboratory results, for follow-up of AEs, or for any other reason, as 
warranted in the judgement of the Investigator. 
 
 
 

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The following information will be collected for all subjects: 
 Concomitant medications/procedures 
 AEs 
 
The following information will be collected for those subjects that had stopped study medication 
but are experiencing a reoccurrence of psoriasis plaques: 
 Time between stopping study medication and restarting application 
 Investigator’s Global Assessment (IGA) of psoriasis severity 
 Body Surface Area (BSA) of psoriasis involvement (not palms, soles, or scalp) 
 
An updated Body Diagram of psoriasis involvement should be provided to the subject. 
 
The rules for how to tally IGA or other proportions of categorical responses will be described in 
the Statistical Analysis Plan. 
10.6 Adverse Events 
10.6.1 Adverse Event Definition 
An AE means any untoward medical occurrence associated with the use of a drug in humans, 
whether or not considered drug related. An AE can therefore be any unfavorable and unintended 
sign (including an abnormal laboratory finding), symptom, or disease temporally associated with 
the use of a medicinal (investigational) product, whether or not related to the medicinal 
(investigational) product.  
AEs will be collected following informed consent of the subject through subject study 
completion.  
A treatment emergent adverse event (TEAE) is defined as an AE that started post application of 
study medication through study completion.  
Application site reactions will be considered adverse events if they require intervention, 
suspension or discontinuation of study drug.  
10.6.2 Serious Adverse Event 
The definitions and reporting requirements of Health Canada/the Food and Drug Administration 
(FDA)/ICH Guidelines for Clinical Safety Data Management, Definitions and Standards for 
Expedited Reporting, Topic E2A will be adhered to. If any AEs are serious, as defined by ICH 
Guidelines for Clinical Safety, required procedures will be followed. All SAEs will be reported 
to the Sponsor via fax or e-mail within 24 hours of becoming aware of the event, whether or not 
the serious events are deemed drug-related. All serious event reporting will adhere to ICH E6: 
Guideline for Good Clinical Practice and ICH E2A: Clinical Safety Data Management: 
Definitions and Standards for Expedited Reporting.:  The ERB/IRB will be notified of the Alert 
Reports as per HC, FDA, ICH and the IRB/ERB’s policies and procedures. 

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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 history 
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. 
If a SAE occurs to a subject on this study, contact the Sponsor personnel listed in Section 2 
within one business day of knowledge of event.  

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10.6.3 Suspected Unexpected Serious Adverse Reaction (SUSAR)  
This is defined as a serious adverse reaction, the nature or severity of which is not consistent 
with the known study treatment information. A serious event or reaction is not defined as a 
SUSAR when: ‘it is serious but expected’ or it does not fit the definition of an SAE, whether 
expected or not.  
10.6.4 Safety Review 
At each follow-up visit, subjects will be queried with an open-ended question such as: ‘How 
have you been feeling since your last visit?’  Additionally, the study staff will review subject 
diaries and, if it appears that a potential AE was recorded, study staff will query the subject and 
determine if an AE occurred.   
AEs (whether serious or non-serious) and clinically significant abnormal laboratory test value(s) 
will be evaluated by the PI and treated and/or followed up for up to one month after end of 
treatment until the symptoms or value(s) return to normal, or acceptable levels, as judged by the 
PI. 
Where appropriate, medical test(s) and/or examination(s) will be performed to document 
resolution of event(s). Outcome may be classified as resolved, improved, unchanged, worse, fatal 
or unknown (lost to follow-up). 
10.6.5 Adverse Event Reporting 
The PI will review each event and assess its relationship to drug treatment (unrelated, unlikely, 
possibly, probably, likely). Each sign or symptom reported will be graded on the NIH NCI 
CTCAE toxicity grading scale 5-point severity scale (Grade 1, 2, 3, 4 and 5). The date and time 
of onset, time relationship to drug dosing, duration, and outcome (resolved, improved, 
unchanged, worse, fatal, or unknown/lost to follow-up) of each event will be noted. 
The relationship of each AE to the study drug will be assessed using the following definitions: 
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 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. 

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 
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). 
10.7 Reporting Pregnancy  
During the study, all subjects should be instructed to contact the investigator immediately if they 
suspect they might be pregnant (e.g., missed or late menstrual period).  If pregnancy is 
confirmed, the subject will be withdrawn from the study and followed until the pregnancy comes 
to term.   
The investigator is responsible for reporting all available pregnancy information on the 
pregnancy report within 24 hours of becoming aware of the event, although pregnancy itself is 
not considered an AE.  Study treatment must be discontinued immediately in the event of a 
pregnancy.  The subject should be referred to an obstetrician/gynecologist experienced in 
reproductive toxicity for further evaluation and counseling. Monitoring of the subject should 
continue until the conclusion of the pregnancy.  Follow-up information detailing the outcome of 
the pregnancy and the health of the newborn should be reported as it becomes available.   
Partner pregnancies of a male subject do not need to be reported. 

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Any pregnancy complication or premature terminations including miscarriage, spontaneous 
abortion or elective termination of a pregnancy for medical reasons will be reported as an SAE, 
as described in Section 10.6.2. Should the pregnancy result in a congenital abnormality or birth 
defect, a separate SAE report must be submitted.  Furthermore, all neonatal deaths that occur 
within 30 days of the birth should be reported as SAEs, without regard to causality.  In addition, 
any infant death that occurs after the 30-day reporting period that the investigator suspects is 
related to the in-utero exposure to the study treatment should also be reported.  
10.8 Treatment Stopping Rules 
For subjects that clear (i.e. have an IGA score of 0 (Clear), an I-IGA (if applicable) of 0 (Clear) 
and an mPASI of 0) treatment may be stopped.  The subject will be instructed to document in 
their diary when they resume treatment with study drug if psoriasis returns. If the subject clears 
between study visits they should be scheduled for an unscheduled visit for the Investigator to 
confirm the subject has cleared.  
 
Subjects will call the site when psoriasis returns prior to restarting application of study drug.  
 
If a subject has non-cutaneous adverse events of concern, clinically significant laboratory values 
or any condition that the investigator determines could possibly be related to the study drug, 
the Investigator should immediately contact the Medical Monitor to discuss if the subject should 
be discontinued from the study.   
 
Treatment for any individual subject will be discontinued if the subject experiences:  
 
A serious adverse event (SAE) or a clinically significant non-serious AE which in the 
opinion of the Principal Investigator or Medical Monitor warrants discontinuation from 
the study for that subject’s well-being. 
 
A severe (Grade 3) laboratory abnormality (confirmed by repeat sample and considered 
related to study drug).  
o See Appendix 2 for details. 
Dosing of study drug for an individual subject may be suspended for safety concerns other than 
those described above, at the discretion of the investigator if he/she feels the subject’s safety may 
be threatened. 
A subject with a PHQ-8 score of ‘15’ or above should be referred promptly to a mental health 
care professional and consideration be given to discontinuation from study drug.   
A subject that is experiencing suicidal ideation and behavior should be referred immediately to a 
qualified mental health care provider and consideration given to discontinuation from study drug. 
As noted above, study treatment must be discontinued immediately in the event of a female 
subject’s pregnancy.   
Treatment should be interrupted: 

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 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 can be 
interrupted for up to one week and may then be resumed if the reaction has, in the 
opinion of the Investigator, adequately resolved.   
 
Treatment should be discontinued: 
 
If the reaction reoccurs, treatment should be discontinued permanently, and the subject 
followed until the reaction resolves.  Given the excellent local toleration in the Phase 1/2a 
study, such reactions are possible, but unlikely. 
11 DATA ANALYSIS 
Data will be handled and processed according to the Contract Research Organization’s Standard 
Operating Procedures, which are written based on the principles of GCP. 
11.1 Statistical Methods 
The methodology presented below is a summary of the more detailed analysis plan that will be 
presented in the Statistical Analysis Plan (SAP).  The SAP will be finalized before the database 
is locked and unblinded.  Any changes to the methods described in the final SAP will be 
described and justified in the clinical study report.  
All statistical processing will be performed using SAS® (Version 9.4) unless otherwise stated. 
No interim efficacy analyses are planned. 
Descriptive statistics will be used to provide an overview of the safety and efficacy results.  For 
categorical parameters, the number and percentage of subjects in each category will be 
presented. The denominator for percentage will be based on the number of subjects appropriate 
for the purpose of analysis.  For continuous parameters, descriptive statistics will include n 
(number of subjects), mean, standard deviation (SD), median, minimum, and maximum. 
Missing efficacy and/or safety data will remain missing and will not be estimated. 
11.1.1 Baseline Definition 
 
Cohort 1 baseline value for each parameter will be defined as the last observation prior to first 
dose of ARQ-151 cream 0.3% or ARQ-151 cream 0.15%.  For subjects receiving either active 
study drug in ARQ-151-201, the baseline values from ARQ-151-201 will be considered the 
baseline values for calculations in ARQ-151-202. For subjects receiving Vehicle in ARQ-151-
201, baseline values will most commonly be from the Week 12/study exit visit of ARQ-151-201. 
If subjects choose to enroll in this study, study procedures will not be repeated; study sites will 
carry over the information from the ARQ-151-201 study (Week 12 visit) to the Day 1 visit for 
this study.  Baseline values for IGA, however, will be taken from Day 1 of Study ARQ-151-201 
for all subjects. 
 
Cohort 2 baseline value for each parameter will be collected on Day 1.  

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11.1.2 Determination of Sample Size 
A sample size of approximately 300 subjects is planned for Cohort 1 and up to approximately100 
subjects in Cohort 2 is planned for the study. This sample size will provide a sufficient 
population size to evaluate the long-term safety of ARQ-151 cream 0.3% at 52 weeks. 
11.1.3 Subjects to Analyze 
All analyses will be performed using the Safety Population which includes all subjects who are 
enrolled and received at least one confirmed dose of ARQ-151 cream 0.15% or ARQ-151 cream 
0.3% study medication either in the Phase 2b Study (ARQ-151-201) or this extension study 
(ARQ-151-202). The number of patients included in the Safety Population will be summarized. 
11.1.4 Interim Analysis 
No interim efficacy analyses are planned. 
11.1.5 Background and Demographic Characteristics 
Descriptive statistics will be used to summarize demographic characteristics (age, sex, and race) 
and background characteristics for the enrolled subjects.  Past/coexistent medical history 
information and physical examination observations and vital signs information for all subjects 
will be presented in a by-subject listing.   
11.1.6 Study Medication Compliance 
The number of study drug applications by each subject based on diary data will be summarized 
using summary statistics (mean, standard deviation [SD], median, minimum, and maximum), and 
categorically.  
The amount of study medication used by each subject based on tube weight will be summarized 
using summary statistics (mean, SD, median, minimum, and maximum), and categorically.   
11.2 Safety Evaluation 
The following analyses will be performed; however, no formal inferential statistics will be done 
on safety assessments. 
Descriptive statistics will be presented by scheduled study visit for quantitative safety data and 
frequency counts will be compiled for classification of qualitative safety data. Summaries of 
local tolerability will be presented by scheduled study visit. 
11.2.1 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 

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summarized by scheduled study visit, 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 severity 
and relationship to study treatment. Each subject will be counted only once within a system 
organ class or a preferred term using the event with the greatest relationship and greatest 
severity. 
All information pertaining to AEs noted during the study will be listed by subject, detailing the 
verbatim description given by the Investigator, preferred term, system organ class, start date, 
stop date, severity, action taken regarding study drug, corrective treatment, outcome, and drug 
relatedness. The event onset will also be shown relative (in number of days) to date of first 
application. In addition, a list of subjects who prematurely discontinue from the study due to 
adverse events will also be provided. 
A subject-by-subject treatment-emergent AE (TEAE) data listing, including verbatim term, 
preferred term, treatment, severity, and relationship to study drug, will be provided.  
Medical history will be listed by subject. Physical examinations and 12-lead ECGs will be listed 
by subject. 
11.2.2 Medical History and Physical Examinations 
Medical history for all subjects will be presented in a by-subject listing.  
Physical examination findings for all subjects will be presented in a by-subject listing.  Changes 
in physical examinations will be described in the text of the final report. 
11.2.3 Clinical Laboratory Results and Vital Signs/Weight Measurements 
Vital signs will be tabulated by scheduled study visit. 
Routine blood chemistries and urinalysis will be obtained throughout the study and the results 
summarized by parameter and at scheduled study visits. 
All clinical laboratory results and vital signs measurements and their change from baseline will 
be summarized along with timepoint of collection. 
A shift table describing out-of-normal range shifts will be provided for clinical laboratory results.  
A shift table will identify subjects who gain or lose >5% body weight over the course of the 
study. 
11.2.4 ECG: 
ECGs will be tabulated by scheduled study visit. 

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11.2.5 Local Tolerance Assessments: 
For the Investigator’s assessment the numeric application site reaction scores will be summarized 
individually by using number and percentage of subjects by visit. 
11.2.6 PHQ-8 
Data will be analyzed by a shift in state of severity using the following scoring system: 
 None – Minimal depression (0 to 4) 
 Mild depression (5 to 9) 
 Moderate depression (10 to 14) 
 Moderately severe depression (15 to 19) 
 Severe depression (20 to 24) 
 
11.2.7 C-SSRS 
The C-SSRS will be analyzed per the Columbia–Suicide Severity Rating Scale Scoring and Data 
Analysis Guide. 
11.2.8 Prior and Concomitant Medications 
Prior and concomitant medication information for all subjects will be presented in a by-subject 
listing.  Summary tables will be presented by World Health Organization-Anatomical 
Therapeutic Chemical Classification System (WHO-ATC) therapeutic category and product. 
11.3 Efficacy Evaluation 
This study is not intended to assess efficacy, but rather the IGA, I-IGA and mPASI are included 
to determine the need for treatment and subsequent re-treatment after treatment course in Study 
ARQ-151-201 or Study ARQ-151-202.  Certain efficacy data and endpoints will, however, be 
summarized. 
 
Descriptive statistics will be used to summarize the assessment of efficacy.  IGA scores will be 
summarized at Baseline Visit of Study ARQ-151-201 and every scheduled visit through end of 
the study (Day 1 and Weeks 4, 12, 24, 36, and 52).  The efficacy variable in this study is success 
in Investigator Global Assessment (IGA) of disease severity, defined as an IGA of ‘Clear’ or 
‘Almost Clear’.  The number and percentage of patients who achieve treatment success at the 
scheduled study visits will be tabulated. The proportion of successes for the secondary variables 
of I-IGA and 75% reduction in mPASI will be tabulated in a similar manner. 
 
The number of treatment free days until the first retreatment (relapse) will be calculated and 
analyzed. For rollover subjects previously treated with Vehicle Cream, the number of treatment 
free days will be the number of days between the end of the initial treatment in study ARQ-151-
202 and the start of the next treatment in study ARQ-151-202 if one should be needed or the end 
of the subject’s participation in study ARQ-151-202. For rollover subjects previously treated 

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with ARQ-151 cream 0.3% or ARQ-151 cream 0.15%, the number of treatment free days will be 
the number of days between the last treatment that began in Study ARQ-151-201 and the start of 
the next treatment in study ARQ-151-202 if one should be needed or the end of the subject’s 
participation in the study ARQ-151-202. There may be additional analyses comparing subjects 
that were previously treated with ARQ-151 cream 0.3% and ARQ-151 cream 0.15% in the ARQ-
151-201 study.  
 
Descriptive statistics for retreatment rates will be presented. The time (number of days) to 
relapse will be analyzed using the Kaplan–Meier method. The median time to relapse will be 
calculated in addition to other appropriate descriptive statistics. Patients who discontinue study  
ARQ-151-202 without relapse will be considered censored in the Kaplan–Meier analysis. 
12 STUDY ADMINISTRATION 
12.1 Ethics 
12.1.1 Ethics Review Board  
Before enrollment of patients into the study, the current protocol and ICF will be reviewed and 
approved by an appropriate IRB or IEC, as required by FDA (21 CFR § 56), Health Canada, and 
ICH GCP regulations.  A letter documenting the IRB or IEC approval must be received by the 
Sponsor before the initiation of the study at a clinical site. Amendments to the protocol will be 
subject to the same requirements as the original protocol.  
The Investigator, Sponsor, or designee will submit a progress report at least once yearly to the 
IRB or IEC. However, the frequency of these reports will depend on IRB or IEC requirements. 
As soon as possible after completion or termination of the study, the Investigator will submit a 
final report to the IRB or IEC per the IRB or IEC requirements, and in compliance with FDA and 
Health Canada regulations and ICH GCP guidelines. 
The Investigator, the Sponsor, or designee shall promptly notify the IRB or IEC of any SAEs, 
SUSARs, or any other information that may affect the safe use of the study drug(s) during the 
study, per the IRB or IEC local requirements, and in compliance with FDA and Health Canada 
regulations and ICH GCP guidelines. 
12.1.2 Ethical Conduct of the Study 
 
This research will be carried out in accordance with the protocol, the principles of the 
Tri-Council Policy Statement (TCPS), the ethical principles set forth in the Declaration of 
Helsinki, and the ICH harmonized tripartite guideline regarding GCP (E6 Consolidated 
Guidance, April 1996). 
 
 

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

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All required study data will be recorded on eCRFs.  Any change of data will be recorded on the 
audit trail and a reason for the change will be entered.  
The principal investigator must retain all documentation relating to the study for a period of at 
least 2 years after the last marketing application approval or, if not approved, 2 years following 
the discontinuance of the test article for investigation.  If this requirement differs from any local 
regulations, the local regulations will take precedence unless the local retention policy is less 
than 2 years.   
12.5 Protocol Amendments and Deviations  
No change or amendment to this protocol may be made by the investigator or Sponsor after the 
protocol has been agreed to and signed by all parties unless such change(s) or amendment(s) has 
(have) been agreed upon by the investigator and Sponsor.  Any change agreed upon will be 
recorded in writing, and the written amendment will be signed by the investigator and Sponsor.  
Institutional review board approval is required prior to the implementation of an amendment, 
unless overriding safety reasons warrant immediate action, in which case the IRB(s) will be 
promptly notified. 
No deviation from the protocol will be made except to protect the life or physical well-being of a 
subject in an emergency.  Except in such emergencies, prior approval of the Sponsor, and the 
IRB, is required before deviations from the planned protocol.  All protocol deviations that occur 
during the study will be documented and reported to Sponsor and to the IRB(s), if applicable, 
according to regulations.  Further details about the documentation, evaluation, and follow-up of 
protocol deviations are detailed in this study’s clinical monitoring plan.  
No waivers to inclusion/exclusion criteria will be granted; subjects need to meet all criteria, 
exactly as specified, to be enrolled.  Additionally, prospective deviations from the protocol or 
investigational plan are not permitted except to protect the life or physical well-being of a subject 
in an emergency.  Deviations that occur unintentionally or are the result of action by the subject 
must be documented and reported to the IRB(s), if applicable, according to regulations.  Further 
details about the documentation, evaluation, and follow-up of protocol deviations are detailed in 
this study’s clinical monitoring plan. 
12.6 Report Format 
According to the ICH Harmonized Tripartite Guideline (Organization of the Common Technical 
Document for the Registration of Pharmaceuticals for Human Use M4 and the ICH M2 Expert 
Working Group), the final report will be written according to the ICH E3 Guideline (Structure 
and Content of Clinical Study Reports).  
12.7 Publication Policy 
The Sponsor is supportive of publishing clinical trial findings.  The process of coordinating 
publication efforts is detailed in the Clinical Trial Agreement. 
 

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13 REFERENCES 
Berger, RS, Bowman JP. A reappraisal of the 21-day Cumulative Irritation Test in man.  
J. Toxicol Ot & Ocular Toxicol 1982:1(2);109-115. 
Bethke, TD, Lahu, G.  High absolute bioavailability of the new oral phosphodiesterase-4 
inhibitor roflumilast.  Int. J Clin Pharmacol Ther.  2011; 49:51-57. 
Brion DE, Raynaud F, Plet A, Laurent P, Leduc B, and Anderson W.  Deficiency of cyclic 
AMP-dependent protein kinases in human psoriasis.  Proc. Natl. Acad. Sci.  1986; 83:5272-5276. 
DALIRESP (roflumilast) tablets [package insert]. AstraZeneca Pharmaceuticals LP, Wilmington, 
DE USA; 2017. 
DAXAS (roflumilast) film-coated tablets [product monograph]. AstraZeneca Canada, Inc., 
Mississauga, Ontario Canada; 2017. 
Hatzelmann A, Morcillo EJ, Lungarella G, Adnot S, Sanjar S, Beume R, et al. The preclinical 
pharmacology of roflumilast – a selective, oral phosphodiesterase 4 inhibitor in development for 
chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2010; 23:235–256. 
Investigator’s Brochure, Edition 2.1, October 2018. 
Michalski, J. M., Golden, G., Ikari, J. and Rennard, S. I. (2012), PDE4: A Novel Target in the 
Treatment of Chronic Obstructive Pulmonary Disease. Clinical Pharmacology & Therapeutics, 
91: 134–142. 
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. 
Wedzicha, JA, Calverley, PMA, Klaus, FR.  Roflumilast: a review of its use in the treatment of 
COPD.  International Journal of Chronic Obstructive Pulmonary Disease (2016) 11:81-90. 

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14 APPENDICES 
Appendix 1. 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. 

Protocol ARQ-151-202 Amendment 1 
Arcutis, Inc. 
 
April 12, 2019 
Confidential 
 Page 59 of 69 
 
 
 
 
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)    
 
 
                             Page 2 of 2     

Protocol ARQ-151-202 Amendment 1 
Arcutis, Inc. 
 
April 12, 2019 
Confidential 
 Page 60 of 69 
 
Appendix 2. 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. 

Protocol ARQ-151-202 Amendment 1 
Arcutis, Inc. 
 
April 12, 2019 
Confidential 
 Page 61 of 69 
 
 
 
 
 
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)    
 
 
                          Page 1 of 2        

Protocol ARQ-151-202 Amendment 1 
Arcutis, Inc. 
 
April 12, 2019 
Confidential 
 Page 62 of 69 
 
 
 
 
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)    
 
 
                          Page 2 of 2