A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Adolescents and Adults With Scalp and Body Psoriasis
Phase: PHASE2
Conditions: Plaque Psoriasis
Sponsor: Arcutis Biotherapeutics, Inc.



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

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

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

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LIST OF TABLES 
Table 1: 
Excluded Medications and Treatments ................................................................... 36 
Table 2: 
Laboratory Tests ...................................................................................................... 41 
 
 
LIST OF FIGURES 
Figure 1: 
ARQ-151-201: Achievement of IGA Success (IGA=0/1 plus 2-grade 
improvement) (ITT) ................................................................................................ 26 
Figure 2: 
ARQ-151-201: Achievement of Intertriginous-IGA (I-IGA) Success 
(I-IGA=0 or 1 plus 2-grade improvement) (ITT) .................................................... 27 
Figure 3: 
Primary and Secondary Endpoint Testing ............................................................... 60 
 
 
LIST OF APPENDICES 
Appendix 1: Patient Health Questionnaire Depression Scale (PHQ-8) ....................................... 70 
Appendix 2: Patient Health Questionnaire Depression Scale (Modified PHQ-A) ...................... 71 
Appendix 3: Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline/Screening 
Version .................................................................................................................... 72 
Appendix 4: Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version ....... 75 
Appendix 5: Psoriasis Symptom Diary (PSD) ............................................................................. 78 
Appendix 6: Dermatology Life Quality Index (DLQI) ................................................................ 81 
Appendix 7: Children’s Dermatology Life Quality Index (CDLQI) ........................................... 83 
Appendix 8: National Institute of Allergy and Infectious Diseases, Division of 
Microbiology and Infectious Diseases (DMID) Toxicity Table for Use in 
Trials Enrolling Healthy Adults (2014) Modified ................................................... 85 
 
 
 

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

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

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with spermicide), then 2 forms of conception 
are required. The use of abstinence as a 
contraceptive measure is acceptable as long as 
this is the preferred and usual lifestyle choice 
of the subject and a backup method has been 
identified if the subject becomes sexually 
active. 
11. Females of non-childbearing potential should 
either be pre-menarchal, or post-menopausal 
with spontaneous amenorrhea for at least 
12 months or have undergone surgical 
sterilization (permanent sterilization methods 
include hysterectomy, bilateral 
oophorectomy, hysteroscopic sterilization, 
bilateral tubal ligation or bilateral 
salpingectomy). 
12. In good health as judged by the Investigator, 
based on medical history, physical 
examination, vital signs, serum chemistry 
labs, hematology values, and urinalysis. 
13. Subjects are considered reliable and capable 
of adhering to the Protocol and visit schedule, 
according to the Investigator judgment. 
Exclusion Criteria: 
1. Subjects who cannot discontinue medications 
and treatments prior to the Baseline visit and 
during the study according to Excluded 
Medications and Treatments (Table 1). 
2. Planned excessive exposure of treated area(s) 
to either natural or artificial sunlight, 
tanning bed or other LED. 
3. Subjects currently taking lithium or 
antimalarial drugs. 
4. Planned initiation or changes to concomitant 
medication that could, in the opinion of the 
Investigator, affect psoriasis vulgaris 
(e.g. beta blockers, ACE inhibitors). 
5. Current diagnosis of non-plaque forms of 
psoriasis (e.g., guttate, erythrodermic/ 
exfoliative, palmoplantar only involvement, 
or pustular psoriasis). Current diagnosis of 
drug-induced psoriasis.   
6. Subjects with any condition on the treatment 
area which, in the opinion of the Investigator, 
could confound efficacy measurements. 

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significant risk, as determined by the 
Investigator. 
16. Subjects with a history of chronic alcohol or 
drug abuse within 6 months of initiation of 
the investigational product. 
17. Subjects with a history of a major surgery 
within 4 weeks prior to Baseline (Visit 2) or 
has a major surgery planned during the 
study. 
18. Subjects who are unable to communicate, 
read or understand the local language, or 
who display another condition, which in the 
Investigator’s opinion, makes them 
unsuitable for clinical study participation.  
Subjects unable to apply product to the scalp 
(and/or psoriasis elsewhere) due to physical 
limitations. 
19. Current or a history of cancer within 5 years 
with the exception of fully treated skin basal 
cell carcinoma, cutaneous squamous cell 
carcinoma or carcinoma in situ of the cervix. 
20. Subjects with active infection that required 
oral or intravenous administration of 
antibiotics, antifungals, or antiviral agents 
within 7 days of Baseline/Day 0. 
21. Subjects who are family members of the 
clinical study site, clinical study staff, or 
sponsor, or family members residing in the 
same household of enrolled subjects. 
Number of Subjects: 
Approximately 300 subjects; randomized 2:1 to 
ARQ-154 foam 0.3% : vehicle foam  
Duration of Participation for Subjects: Screening (up to 4 weeks) + Treatment phase 
(8 weeks) and follow-up (1 week post-treatment 
completion) for a total of 13 weeks 
Key Assessments: 
Safety will be monitored through application site 
assessments, safety labs, and AEs. Safety will 
also be monitored by C-SSRS, and either PHQ-8 
(in adults) or a modified version of the PHQ-A 
(in adolescents) assessments. 
Efficacy assessments will include IGA, S-IGA, 
B IGA, PSSI, BSA, PASI/mPASI, WI-NRS, 
Scalp Pruritis NRS, PSD, and DLQI/CDLQI  

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

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

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

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

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

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

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

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2 
ABBREVIATIONS 
Abbreviation 
Definition 
AE 
Adverse Event 
AMP 
Adenosine Monophosphate 
AUC 
Area Under the Curve 
BSA 
Body Surface Area 
B-IGA 
Body Investigator Global Assessment 
Cmax 
Maximum Concentration 
CDLQI 
Children’s Dermatology Life Quality Index 
COPD 
Chronic Obstructive Pulmonary Disease 
CRF 
Case Report Form 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
CTCAE 
Common Terminology Criteria for Adverse Events 
DLQI 
Dermatology Life Quality Index 
DNA 
Deoxyribonucleic Acid 
ERB 
Ethics Review Board 
FDA 
U.S. Food and Drug Administration 
FOCBP 
Female of Child Bearing Potential 
GCP 
Good Clinical Practices 
HC 
Health Canada 
IB 
Investigational Brochure 
IC50 
Half Maximal Inhibitory Concentration 
ICF 
Informed Consent Form 
ICH  
International Conference on Harmonisation 
IGA 
Investigator Global Assessment 
I-IGA 
Intertriginous Investigator Global Assessment  
IND 
Investigational New Drug 
IP 
Investigational Product 
IRB 
Institutional Review Board 
ITT 
Intent to Treat 
IWRS 
Interactive Web Response System  
LED 
Light Emitting Device 
g 
Microgram 
MedDRA 
Medical Dictionary for Regulatory Activities 

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Abbreviation 
Definition 
mITT 
Modified Intent to Treat 
mL 
Milliliter 
mPASI 
Modified Psoriasis Area and Severity Index 
mPASI-75 
Modified Psoriasis Area and Severity Index-75; subjects who achieve 
a 75% reduction in mPASI from Baseline 
mPASI-90 
Modified Psoriasis Area and Severity Index-90; subjects who achieve 
a 90% reduction in mPASI from Baseline  
NCI 
National Cancer Institute 
NIH 
National Institutes of Health 
NOAEL 
No Observed Adverse Effect Level 
Ng 
Nanogram 
NRS 
Numerical Rating Score  
PASI 
Psoriasis Area and Severity Index 
PASI-75 
Psoriasis Area and Severity Index-75; subjects who achieve a 75% 
reduction in PASI from Baseline 
PASI-90 
Psoriasis Area and Severity Index-90; subjects who achieve a 90% 
reduction in PASI from Baseline  
PDE-4 
Phosphodiesterase 4 
PHQ-A 
Modified PHQ-9 for Adolescents 
PHQ-8 
Patient Health Questionnaire depression scale 
PI 
Principal Investigator  
PK 
Pharmacokinetics 
PP 
Per Protocol  
PSSI 
Psoriasis Scalp Severity Index 
PSD 
Psoriasis Symptoms Diary 
QD 
Once Daily ("quaque die") 
SAE 
Serious Adverse Event 
S-IGA 
Scalp Investigator Global Assessment 
SI-NRS 
Scalp Itch – Numeric Rating Score 
TEAE 
Treatment Emergent Adverse Event 
Th1 
Type 1 T Helper Cell 
Th17 
Type 17 T Helper Cell 
Tmax 
Time to reach maximum concentration 
WI-NRS 
Worst Itch – Numeric Rating Score 
 
 

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3 
BACKGROUND AND RATIONALE 
3.1 
Introduction 
Roflumilast is a phosphodiesterase 4 (PDE-4) inhibitor approved globally to reduce the risk of 
exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) associated 
with chronic bronchitis.  Roflumilast and its active metabolite, roflumilast N-oxide, are high 
affinity selective inhibitors of PDE-4 (a major cyclic-3′,5′-adenosine monophosphate 
(cyclic AMP)-metabolizing enzyme), whose activity leads to accumulation of intracellular 
cyclic AMP.  There are four different subtypes of PDE-4: PDE-4a, PDE-4b, PDE-4c, and 
PDE-4d, each with several isoforms (splicing variants).  IC50 values of both roflumilast and 
roflumilast N-oxide for the different PDE-4 isoforms and subtypes are mostly sub-nanomolar 
and single digit nanomolar (Hatzelmann 2010).  The PDE-4 family of enzymes are the most 
prevalent phosphodiesterases in immune cells and inhibition of PDE-4 subtypes has been 
associated with anti-inflammatory effects in many biological systems. 
 
Psoriasis is a chronic inflammatory skin disease characterized by raised, well-demarcated, 
erythematous oval plaques with adherent silvery scales.  Numerous past reports have suggested a 
deficiency of cyclic AMP-dependent protein kinases in human psoriatic skin (Brion 1986).  
More recently, various cytokines produced by Th1 and Th17 cells have been shown to play a 
crucial role in the pathogenesis of psoriasis.  It has been postulated that the anti-inflammatory 
effects of PDE-4 inhibitors may provide a beneficial therapeutic intervention in the treatment of 
chronic plaque psoriasis, and recently Otezla® (apremilast) a PDE-4 inhibitor has been approved 
for the oral treatment of chronic plaque psoriasis. 
 
The scalp is a common area of psoriasis involvement, and often the first area on the body to be 
affected.  The scalp is considered an underdiagnosed, undertreated, and difficult to manage area 
for psoriasis.  Scalp psoriasis may be associated with pruritus, pain, flaking, and hair loss, and 
may disproportionately impact quality of life relative to psoriasis elsewhere.  Treatment of scalp 
psoriasis is often limited to topical therapy, unless there are sufficient additional non-scalp 
psoriasis to merit systemic treatment.  Intralesional therapy represents another approach.  Current 
treatment options for scalp psoriasis include topical steroids, vitamin D derivatives, 
tar preparations, and salicylic acid products, but considerable unmet need remains for safe and 
effective products (Blakely 2016, Schlager 2016, Wang 2017, Merola 2018, Kivelevitch 2018).  
Given the scalp is a hair-bearing site, choice of formulation is critical, and foams are a favored 
option. 
 
The past 15 years have witnessed a transformation in the systemic treatment of moderate to 
severe psoriasis with the advent of biological therapies.  However, for patients with milder forms 
of disease, best treated with topical options, the therapeutic landscape has not significantly 
changed in several decades.  Similarly, topical treatment options for the scalp have also not 
significantly changed in several decades.  Topical steroids come in all shapes and forms, but the 
lower potency steroids are not effective and the higher potency steroids are beset with issues of 
local skin atrophy and the potential for hypothalamic-pituitary axis suppression when applied 
over larger body surface areas and for prolonged periods of time.  Vitamin D has been the other 
staple of topical psoriasis treatment, but it is irritating, not suitable for use on the face or 

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4 
INVESTIGATIONAL PLAN 
4.1 
Overall Study Design and Plan 
This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam 0.3% or 
vehicle foam is applied QD x 8 weeks to adolescent and adults with scalp and body psoriasis of 
at least mild severity, involving up to 25% BSA (scalp and body, not including palms/soles). 
4.2 
Number of Subjects 
A total of up to approximately 300 subjects will be enrolled at approximately 40-45 study sites in 
the North America, Australia, and Europe. Additional study sites may be added or removed as 
necessary.  Subjects will be adolescent and adult males or females with scalp and body psoriasis.  
Subjects must have a Scalp – Investigator’s Global Assessment of disease severity (S-IGA) of at 
least Moderate (‘3’) at Baseline.  Subjects must have a Body (i.e., non-scalp) – Investigator’s 
Global Assessment of disease severity (B-IGA) of at least Mild (‘2’) at Baseline.  Subjects must 
have no more than 25% BSA of psoriasis (excluding palms/soles).  All psoriasis lesions on a 
subject will be treated including the scalp, face, trunk, and intertriginous areas.  The palms and 
soles will be treated but will not be counted towards any measurements of efficacy (IGA, BSA, 
PASI/mPASI). 
4.3 
Subject Participation 
There will be a minimum of 6 clinic visits, including Screening, Baseline, Week 2, Week 4, and 
Week 8, of treatment, as well as a Week 9 follow-up visit (1 week after last dose).  Since the 
interval between the Screening and Baseline visits may be up to 4 weeks, the anticipated 
maximum duration of subject participation is approximately 13 weeks. 
4.3.1 
Randomization 
Assignment of active drug or vehicle will be made at a 2:1 ratio according to a computer-
generated randomization list, stratified by country, Baseline S-IGA (S-IGA=2 vs. S-IGA≥3), 
and Baseline B-IGA (B-IGA=2 vs. B-IGA≥3).   
Randomization will take place at Baseline after the subject has been found to be fully eligible for 
participation.  Kits containing IP will be assigned to each subject using an internet-based 
randomization system (IWRS). A subject may receive more than one kit for the treatment period. 
Subjects will be trained by the study site staff to apply ARQ-154 foam 0.3% QD or vehicle foam 
QD to lesions of scalp and body psoriasis up to a maximum application area of 25% BSA. 
 
The kits and foam cans are blinded and each kit is numbered with a unique kit number. 
4.3.2 
Numbering of Subjects 
All screened subjects will be identified by a unique five-digit subject ID number.  The first two 
digits correspond to the site number (assigned by the Sponsor), the next three digits correspond 
to the sequential order in which the subject is screened for the study (e.g., Subject ID 10001: 
Site 10, first subject screened 001 for that site). Site number 10 will be the first site in the study. 

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The clinical site is responsible for maintaining a current log of subject ID number assignments 
and the kit number assigned to that subject.  The subject ID number is required to be entered on 
all clinical study documentation (e.g., case report forms, labeling of clinical materials and sample 
containers, investigational product accountability logs, etc.).  
4.4 
Selection of Study Population 
4.4.1 
Inclusion Criteria 
Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the 
study: 
1. Participants legally competent to read, write, and sign and give informed consent, or, in the 
case of adolescents, assent with consent of a parent(s) or legal guardian, as required by local 
laws. 
2. Males and females ages 12 years and older (inclusive) at the time of consent or assent 
(for adolescents)  
3. Scalp psoriasis with an Investigator Global Assessment of Scalp disease severity (S-IGA) of 
at least Moderate (‘3’) at Baseline  
4. Extent of scalp psoriasis involving ≥10% of the total scalp at Baseline  
5. A Psoriasis Scalp Severity Index (PSSI) score of at least 6 at Baseline. 
6. An IGA of body (i.e., non-scalp) psoriasis (B-IGA) of at least Mild (‘2’) at Baseline 
7. A PASI score of at least 2 (excluding the palms, and soles) at Baseline 
8. Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the 
Investigator.  Stable disease for the past 4 weeks. 
9. Psoriasis involvement on scalp and non-scalp areas totaling <25% BSA (not including 
palms/soles) 
10. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at 
Screening (Visit 1) and a negative urine Baseline (Visit 2). In addition, sexually active 
FOCBP must agree to use at least one form of an acceptable effective contraception 
throughout the trial.  Acceptable effective forms of contraception may include: combine 
estrogen and progesterone containing hormonal contraception associated with inhibition of 
ovulation (oral, intravaginal, transdermal); progesterone only contraception associated with 
inhibition of ovulation (oral, injectable, implantable); intrauterine device, intrauterine 
hormone releasing system, bilateral tubal occlusion, and partner’s vasectomy.  If barrier 
methods are used (e.g., condom with spermicide, diaphragm with spermicide), then 2 forms 
of conception are required. The use of abstinence as a contraceptive measure is acceptable as 
long as this is the preferred and usual lifestyle choice of the subject and a backup method has 
been identified if the subject becomes sexually active. 
11. Females of non-childbearing potential should either be pre-menarchal, or post-menopausal 
with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization 
(permanent sterilization methods include hysterectomy, bilateral oophorectomy, 
hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy). 

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13. Previous treatment with ARQ-151 or ARQ-154. 
14. Subjects who have received oral roflumilast (Daxas®, Daliresp®) or other PDE-4 inhibitors 
(apremilast) within the past 4 weeks. 
15. Subjects with any serious medical condition or laboratory abnormality that would prevent 
study participation or place the subject at significant risk, as determined by the Investigator. 
16. Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of the 
investigational product. 
17. Subjects with a history of a major surgery within 4 weeks prior to Baseline (Visit 2) or has a 
major surgery planned during the study. 
18. Subjects who are unable to communicate, read or understand the local language, or who 
display another condition, which in the Investigator’s opinion, makes them unsuitable for 
clinical study participation. Subjects unable to apply product to the scalp (and/or psoriasis 
elsewhere) due to physical limitations. 
19. Current or a history of cancer within 5 years with the exception of fully treated skin basal cell 
carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix. 
20. Subjects with active infection that required oral or intravenous administration of antibiotics, 
antifungal, or antiviral agents within 7 days of Baseline/Day 0.  
21. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, 
or family members residing in the same household of enrolled subjects. 
4.4.3 
Removal of Subjects from Investigational Product 
A subject may discontinue from receiving the IP for any of the following reasons: 
1. Occurrence of any medical condition or circumstance that, in the opinion of the Investigator, 
exposes the subject to substantial risk and/or does not allow the subject to adhere to the 
requirements of the Protocol. 
2. Occurrence of a treatment-emergent adverse event (TEAE) or considerable worsening of an 
AE that, in the opinion of the investigator in consultation with the Medical Monitor and 
Sponsor, represents an unacceptable risk to the subject if he/she continues in the study.  
The investigator must follow the subject until the AE resolves or satisfactorily stabilizes. 
3. Pregnancy. 
4. Subject's decision to withdraw from administration of the IP. 
5. Weight loss of >5% if not dieting and after consultation with the Sponsor, at the 
Investigator’s discretion. 
6. C-SSRS indicative of suicidal ideation or a PHQ-8 or modified PHQ-A score ≥15, after 
consultation with a mental health professional, the Sponsor, and at the Investigator’s 
discretion. 
7. Requirement for use of prohibited concomitant medication (see Table 1) after consultation 
with the Sponsor and Medical Monitor. 
8. Subject’s repeated failure to comply with protocol requirements or study related procedures. 

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9. The subject interrupts trial IP application for more than 50% of scheduled doses. 
4.4.4 
Removal of Subjects from the Study 
A subject may be removed from study participation for any of the following reasons: 
1. Subject’s decision to withdraw from the study. 
2. Subject is lost to follow up. 
3. Termination of the study by the Sponsor, FDA, or other regulatory authorities. 
4.5 
Study Restrictions 
4.5.1 
Prohibitions and Concomitant Therapy 
Prohibited medications and products are detailed in Table 1. 
 
Table 1: 
Excluded Medications and Treatments 
Excluded Medications and Treatments 
Washout Period Prior to Day 0 
Etanercept 
4 weeks 
Adalimumab, infliximab 
8 weeks 
All other biologics 
12 weeks 
Oral corticosteroids, retinoids, apremilast, roflumilast, methotrexate, 
cyclosporine, fumarates, and other systemic immunosuppressants 
4 weeks 
Medicated shampoos (eg, coal tar, keratolytics, antifungals, zinc 
pyrithione, selenium sulfide, corticosteroids, medical devices) 
2 weeks 
Topical medications used on the scalp for conditions besides psoriasis, 
eg, use of topical minoxidil for androgenetic alopecia 
4 weeks 
Topical anti-psoriasis medications (e.g., topical corticosteroids, 
vitamin D analogs, prescription shampoos) (except for emollients) 
2 weeks 
PUVA or UVB phototherapy 
4 weeks 
Investigational drugs 
12 weeks (biologics); 
5 half-lives (orals);  
2 weeks (topical) 
Antihistamines – if prescribed for pruritus associated with psoriasis 
2 weeks 
Notes:   
(1) Eye drop, ear, and nasal corticosteroid preparations are allowed.  Inhaled corticosteroid preparations are 
allowed if used for a stable condition and at a stable dose for > 28 days before screening, and are continued 
at the same dose throughout the study. 
(2) Non-medicated emollients, moisturizers and sunscreens will be allowed as used normally by the subjects. 
These can be applied to non-treated areas as needed and should not be used within 12 hours of a study visit. 
(3) No emollients or moisturizers should be applied on treated areas.   
 

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Generally, the addition of new medications, including nonprescription medications, during the 
course of the study is discouraged.  However, the short-term use of a medication may be 
authorized by the Investigator.  The Investigator must make the decision to authorize the use of 
any such a medication only after consideration of the clinical situation, the potential for masking 
symptoms of a more significant underlying event, and whether the use of the medication will 
compromise the outcome or validity of the clinical investigation.  If medication is required, 
the name, strength, frequency, duration of use, and reason for use will be recorded in source 
documents and transcribed to Case Report Forms.  Medications which have been used 
chronically by subjects, in particular statins and anti-hypertensives, are allowed for use during 
the study, except as prohibited in ‘Exclusions’ (Table 1). 
 
Only non-medicated shampoos are permitted.  Medicated shampoos (eg, coal tar, keratolytics 
including salicylic acid, antifungals, zinc pyrithione, selenium sulfide, corticosteroids, medical 
devices) are prohibited.  Subjects should not use other hair products for at least an hour before or 
after application of investigational product. 
4.6 
Treatment 
4.6.1 
Investigational Product Supplies, Packaging and Labeling 
ARQ-154 foam 0.3% or vehicle foam will be provided in a dispense can containing 
approximately 60 grams of foam.  The cans will be packaged in kits, each containing two cans. 
The number of kits dispensed to a subject will be based on the BSA involvement.  It is 
anticipated that the maximum number of kits dispensed to a subject will be four. The kits and 
pumps will be labeled in a blinded manner.  The kit(s) dispensed to a subject will be labeled with 
a unique number. 
 
The Sponsor will supply sufficient quantities of the IP (ARQ-154 foam 0.3%, and matching 
vehicle foam) to each site to allow for completion of this study. 
 
Records will be made of the receipt and dispensing of the IP supplied. At the conclusion of the 
study, any unused IP will be returned to the Sponsor or designee, or destroyed, as per Sponsor 
instructions. 
 
Refer to the most current version of the IP Handling Manual for details on the accountability, 
storage, and management of ARQ-154 and matching vehicle. 
4.6.2 
Blinding 
This is a double-blind study, therefore neither the subjects nor the Investigator, Sponsor and 
clinical personnel will be aware of which treatment an individual has received. 

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

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4.6.4 
Treatment Compliance 
Weight of the IP applied will be measured for reporting purposes. IP cans will be weighed at 
each follow-up clinic visit. The weight of the IP can will be collected prior to the IP application 
and after the IP application at Baseline, Weeks 2, and 4. Weight of the IP applied, and the IP 
cans will be recorded in the source notes and in the eCRF.  
Subjects will complete a daily diary recording the date and time of each dose applied, any missed 
doses, and a comment section should the subjects have a comment, e.g., record potential AEs. 
Site personnel will review the diaries at each clinic visit and use the information to question the 
subject regarding compliance and AEs and then record appropriate information in source 
documents and complete Case Report Forms (CRFs).  If a subject misses a dose, they should be 
instructed to return to the protocol IP administration schedule (i.e. if subject forgets a dose they 
should wait until that evening and apply as usual).   
A subject will be considered compliant with the dosing regimen if the subject applies at least 
80% of the expected applications during the IP application period and does not miss more than 
3 consecutive doses.  
Compliance will be assessed by review of the dosing diary. If the diary shows less than 80% of 
expected use, the subject is using too little IP and retraining must be conducted and documented.  
Compliance will be documented in source and in eCRF. 
5 
STUDY PROCEDURES 
5.1 
Safety Assessments 
The Schedule of Visits and Assessments (Section 1.3) summarizes the clinical procedures to be 
performed at each visit. Individual clinical procedures are described in detail below. Additional 
evaluations/testing may be deemed necessary by the PI and/or the Sponsor for reasons related to 
subject safety. 
This study assesses the safety and efficacy of ARQ-154 foam 0.3%. Safety will be determined by 
evaluating physical examinations, local tolerability assessments, vital signs/weight, clinical 
laboratory parameters, PHQ-8 (adults)/modified PHQ-A (adolescents), C-SSRS and AEs as 
outlined in the Schedule of Visits and Assessments (Section 1.3). If deemed necessary, additional 
safety assessments will be performed at the discretion of the Investigator. 
5.1.1 
Screening 
Within 4 weeks prior to the first dosing (Baseline visit), subjects will be provided details of study 
requirements and sign an informed consent.  Medical history and demographic data including 
sex, age, race, ethnicity, body weight (kg), and height (cm) will be recorded. Each subject will 
undergo psoriatic plaque assessments, a physical examination, vital sign measurements 
(blood pressure, heart rate, and temperature), PHQ-8 (adults)/modified PHQ-A (adolescents), 
C-SSRS, and laboratory tests: hematology, chemistry, urinalysis and serum (Screening) and 
urine (Baseline) pregnancy tests for female subjects of child bearing potential. 

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All screened subjects will receive a screening number and be entered into the electronic subject 
tracking system. Subjects may be re-screened one time, the original assigned Subject ID will be 
used for re-screening. 
5.1.2 
Baseline 
Randomization will take place at the Baseline visit (Day 0) after the subject has been found to be 
fully eligible for participation. The subject is considered enrolled into the study once 
randomization occurs and the subject has been assigned to one of the treatment groups. 
 
If the Baseline visit occurs within 14 days of Screening, the Screening lab results may be 
utilized. 
5.1.3 
Physical Examination 
Physical examinations will be performed according to the Schedule of Visits and Assessments 
(Section 1.3): 
 
Screening, Baseline and Week 8. 
The physical exam will be limited to skin, lungs and heart only. System driven physical 
examination will be conducted in case of symptoms and adverse events. 
5.1.4 
Vital Signs, Height and Weight 
Vital signs will be collected according to the Schedule of Visits and Assessments (Section 1.3): 
 
Blood pressure, heart rate, and temperature will be measured at Screening, Baseline, Weeks 2, 4, 
8, and 9.  
 
Height will be collected at Baseline and Week 8. 
 
Weight will be collected at Screening, Baseline, Weeks 2, 4, 8, and 9. Subject to void prior to 
weight being taken and remove any jackets, outerwear and shoes. Remove any objects of 
significant weight (i.e. cell phones, wallet, key chains). A 5% weight loss should be reported to 
the medical monitor. Blood pressure will be collected while the subject is sitting/resting for at 
least 5 minutes. 
5.1.5 
Laboratory Tests 
All tests listed below will be performed as follows: 
Screening, Baseline, Weeks 4 and 8. 
All tests listed in Table 2 below will be performed according to the Schedule of Visits and 
Assessments (Section 1.3) unless otherwise noted. The collection of specimens will be in a 
non-fasting state. In addition, laboratory safety tests may be performed at various unscheduled 
time points, if deemed necessary by the Investigator. 

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Table 2: 
Laboratory Tests 
Hematology 
 
Serum Chemistry 
• 
Hemoglobin 
• 
Hematocrit  
• 
Total and differential leukocyte count 
• 
Red blood cell count with indices and 
morphology 
• 
Platelet count 
 
• 
Blood Urea Nitrogen 
• 
Bilirubin (total and direct) 
• 
Alkaline phosphatase 
• 
Aspartate aminotransferase 
• 
Alanine aminotransferase 
• 
Albumin 
• 
Sodium 
• 
Potassium 
• 
Chloride 
• 
Glucose 
• 
Creatinine  
Urinalysis 
 
Additional Tests 
• 
pH 
• 
Specific gravity 
• 
Protein* 
• 
Glucose 
• 
Ketones 
• 
Bilirubin 
• 
Blood* 
• 
Nitrite* 
• 
Urobilinogen 
• 
Leukocyte esterase* 
 
• 
Urine pregnancy test** 
(for females of child bearing potential only) 
• 
Serum pregnancy test (hCG)*** 
* If urinalysis is positive for protein, blood, nitrite and/or leukocyte esterase, a microscopic examination 
(for red blood cells, white blood cells, bacteria, casts, and epithelial cells) will be performed. 
** At Baseline, Weeks 4, and 8, for FOCBP only  
*** At Screening, for FOCBP only 
5.1.6 
Patient Health Questionnaire Depression Scale (PHQ-8) 
The 8 item PHQ-8 Assessment (see Appendix 1) will be performed in adult subjects as follows: 
 
Screening, Baseline, Weeks 4, and 8. 
 
Only adult subjects will complete PHQ-8 questionnaire. 
 
A subject with a PHQ-8 score of ‘15’ or above should be referred promptly to a mental health 
care professional and, if currently applying IP, consideration be given to discontinuation from 
the IP. 
 
PHQ-8 score is the sum of the responses for the 8 questions. 
 

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Five severity categories of depression are defined as follows:  
• None – Minimal depression (0 to 4)  
• Mild depression (5 to 9)  
• Moderate depression (10 to 14)  
• Moderately severe depression (15 to 19)  
• Severe depression (20 to 24) 
5.1.7 
Patient Health Questionnaire Depression Scale (Modified PHQ-A) 
The 8 item Modified PHQ-A Assessment (see Appendix 2) will be performed in adolescent 
subjects as follows: 
 
Screening, Baseline, Weeks 4, and 8 
 
Only adolescent subjects will complete PHQ-A questionnaire. 
 
A subject with a Modified PHQ-A score of ‘15’ or above should be referred promptly to a 
mental health care professional and, if currently applying IP, consideration be given to 
discontinuation from the IP. 
 
Modified PHQ-A score is the sum of the responses for the 8 questions. 
 
Five severity categories of depression are defined as follows:  
• None – Minimal depression (0 to 4)  
• Mild depression (5 to 9)  
• Moderate depression (10 to 14)  
• Moderately severe depression (15 to 19)  
• Severe depression (20 to 24) 
5.1.8 
Columbia-Suicide Severity Rating Scale (C-SSRS) 
C-SSRS Assessments will be performed as follows: 
 
Screening, Baseline, Weeks 4, and 8. 
 

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The administration schedule of the C-SSRS will be: 
• The Baseline-Screening version (Appendix 3) will be used at Screening to provide a pre-
treatment assessment baseline.  
• On all subsequent visits, the Since Last Visit version (Appendix 4) will be used. 
• If a subject has a score greater than 0 in suicidal ideation at Screening or Baseline, this is 
important and may indicate the need for mental health intervention. The investigator 
should not enroll the subject in the study.  
• Any score greater than 0 in the suicidal ideation score is important and may indicate the 
need for mental health intervention and consideration be given to discontinuation from 
the IP. This should result in prompt referral to a mental health professional and/or 
possibly the emergency room. The Medical Monitor should be contacted. 
 
The trained administrator will conduct the C-SSRS.  The C-SSRS administrator will be trained 
via the C-SSRS training video. A training certificate for the administer(s) will be on file in the 
trial master file at the site 
 
The Investigator must review the completed C-SSRS.  A qualified mental health care provider 
must be available, immediately if needed, to refer the subject for further evaluation. 
5.1.9 
Local Tolerability Assessments 
The Investigator Local Tolerability Assessment will be an overall assessment of local tolerability 
and performed as follows: 
Baseline, Weeks 4, and 8  
Application site reactions will be graded at the timepoints outlined in the Schedule of Visits and 
Assessments (Section 1.3).  Irritation reactions are graded using the scale detailed in the 
following section (Berger 1982).  Reactions at the site of product application, which may 
occur post-Baseline, should be differentiated from the preexisting inflammation associated 
with the subject’s psoriasis.   
 
The investigator assessments will be conducted by the investigator prior to IP application in the 
clinic for applicable visits.  
 
Dermal Response 
 
0 = no evidence of irritation 
 
1 = minimal erythema, barely perceptible 
 
2 = definite erythema, readily visible; minimal edema or minimal papular response 
 
3 = erythema and papules 
 
4 = definite edema 
 
5 = erythema, edema, and papules 

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6 = vesicular eruption 
 
7 = strong reaction spreading beyond application site 
 
Other Effects 
 
A = slight glazed appearance 
 
B = marked glazing 
 
C = glazing with peeling and cracking 
 
D = glazing with fissures 
 
E = film of dried serous exudates 
 
F = small petechial erosions and/or scabs 
 
G = no other effects 
 
The Subject Local Tolerability Assessment will be an overall assessment of local tolerability and 
performed as follows: 
 
Baseline, Weeks 4, and 8 
 
The assessment will be administered by the site 10 to 15 minutes after IP application in the clinic 
at Baseline and Week 4, and a recall assessment at Week 8. 
 
Grade 
Sensation Following Drug Application 
0 (none) 
No sensation 
1 (mild)  
Slight warm, tingling sensation; not really bothersome 
2 (moderate) 
Definite warm, tingling sensation that is somewhat bothersome 
3 (severe) 
Hot, tingling/stinging sensation that has caused definite discomfort  
5.1.10 
Adverse Events 
Adverse events (AEs) will be collected beginning at informed consent and assessed at the 
following visits and throughout the study: 
Screening, Baseline, Weeks 2, 4, 8, and 9 
Any treatment emergent AEs will be followed in the clinic for up to one month at the 
Investigator’s discretion until resolved or otherwise judged as clinically stable. 
For further details on Adverse Events please see Section 5.7. 

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5.2 
Efficacy Evaluations 
5.2.1 
Scalp (S-IGA) and Body/Non-scalp (B-IGA) Investigator’s Global Assessment 
Investigator’s Global Assessments (‘scalp’ and ‘body’) will be performed at the following study 
visits according to the Schedule of Visits and Assessments (Section 1.3). The IGAs should be 
completed prior to other physician assessments.  The ‘scalp’ and ‘body’ IGAs are the same 
instrument applied to different areas of the body. 
 
Screening, Baseline, Weeks 2, 4, 8, and 9 
 
The IGA is a static evaluation of qualitative overall psoriasis severity. This global assessment 
scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). Each grade 
is defined by a distinct and clinically relevant morphologic description that minimizes 
inter-observer variability.  
 
Note: Palms and soles will be treated in this study with the IP, but will not be counted towards 
B-IGA, PASI/mPASI, or BSA assessments. 
 
Every effort must be made for the same Evaluator to complete the S-IGA and B-IGA for 
the subject at every study visit. 
 
Scalp - Investigator Global Assessment of Disease (S-IGA) 
Scale 
Grade 
Description 
0 
Clear  
Plaque thickening = no elevation or thickening over normal skin 
Scaling = no evidence of scaling 
Erythema = none (no residual red coloration but post-inflammatory 
hyperpigmentation may be present) 
1 
Almost Clear 
Plaque thickening = none or possible thickening but difficult to ascertain if there is a 
slight elevation above normal skin level 
Scaling = none or residual surface drying and scaling 
Erythema = light pink coloration 
2 
Mild  
Plaque thickening = slight but definite elevation 
Scaling = fine scales partially or mostly covering the lesions 
Erythema = light red coloration 
3 
Moderate 
Plaque thickening = moderate elevation with rounded or sloped edges 
Scaling = most lesions at least partially covered 
Erythema = definite red coloration 
4 
Severe 
Plaque thickening = marked or very marked elevation typically with hard or sharp 
edges 
Scaling = non-tenacious or thick tenacious scale, covering most or all of lesions 
Erythema = very bright red coloration; extreme red coloration; deep red coloration  

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The S-IGA (scalp IGA) will be the first efficacy assessment performed at clinic visits.  
As with other efficacy assessments, the S-IGA should be performed prior to the application 
of any Investigational Product. 
Body - Investigator Global Assessment of Disease (B-IGA, i.e. non-scalp) 
Scale 
Grade 
Description 
0 
Clear  
Plaque thickening = no elevation or thickening over normal skin 
Scaling = no evidence of scaling 
Erythema = none (no residual red coloration but post-inflammatory 
hyperpigmentation may be present) 
1 
Almost 
Clear 
Plaque thickening = none or possible thickening but difficult to ascertain if there is a 
slight elevation above normal skin level 
Scaling = none or residual surface drying and scaling 
Erythema = light pink coloration 
2 
Mild  
Plaque thickening = slight but definite elevation 
Scaling = fine scales partially or mostly covering the lesions 
Erythema = light red coloration 
3 
Moderate 
Plaque thickening = moderate elevation with rounded or sloped edges 
Scaling = most lesions at least partially covered 
Erythema = definite red coloration 
4 
Severe 
Plaque thickening = marked or very marked elevation typically with hard or sharp 
edges 
Scaling = non-tenacious or thick tenacious scale, covering most or all of lesions 
Erythema = very bright red coloration; extreme red coloration; deep red coloration  
The B-IGA (Body-IGA) will be the second efficacy assessment performed at clinic visits 
(after the S-IGA).  As with other efficacy assessments, the B-IGA should be performed 
prior to the application of any Investigational Product.  In assessing B-IGA, the scalp, 
palms, and soles should not be considered. 
5.2.2 
Psoriasis Scalp Severity Index (PSSI) 
PSSI assessments will be performed at the following study visits according to the Schedule of 
Visits and Assessments (Section 1.3): 
Screening, Baseline, Weeks 2, 4, 8, and 9 
Every effort must be made for the same Evaluator to complete the PSSI for the subject at 
every study visit. 
 
The PSSI is used for the measurement of severity of psoriasis.  
 
PSSI combines the assessment of the severity of scalp lesions and the area of scalp affected into 
a single score in the range 0 (no disease) to 72 (maximal disease). 
 

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The extent of scalp affected is scored based on the following: 
 
0. 0% of involved area 
1. < 10% of involved area 
2. 10–29% of involved area 
3. 30–49% of involved area 
4. 50–69% of involved area 
5. 70–89% of involved area 
6. 90–100% of involved area 
 
The severity is estimated by three clinical signs: erythema (‘E’; redness), induration 
(‘T’; thickness) and desquamation (‘S’; scaling). Severity parameters are measured on a scale of 
0 to 4, from none to maximum severity possible: 
 
0. absent 
1. slight 
2. moderate 
3. severe 
4. severest possible 
 
To calculate the PSSI, the sum of the severity rating for the three main signs are multiplied with 
the numerical value of the area affected: 
 
PSSI = Sum of scores for erythema, induration and desquamation x involved area (range 0–72) 
5.2.3 
Psoriasis Area and Severity Index (PASI) and Modified Psoriasis Area and 
Severity Index (mPASI) 
Assessments will be performed as single assessments at each timepoint, from which both PASI’s 
and mPASI’s will be calculated. 
PASI/mPASI assessments will be performed at the following study visits according to the 
Schedule of Visits and Assessments (Section 1.3): 
Screening, Baseline, Weeks 2, 4, 8, and 9 
Every effort must be made for the same Evaluator to complete the PASI/mPASI for the 
subject at every study visit. 
 
Psoriasis Area and Severity Index (PASI)/Modified Psoriasis Area and Severity Index (mPASI) 
is used for the measurement of severity of psoriasis.  
 

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PASI/mPASI combines the assessment of the severity of lesions and the area affected into a 
single score in the range 0 (no disease) to 72 (maximal disease). 
 
The body is divided into four sections (head (h) (10% of a person's skin); arms (a) (20%); trunk 
(t) (30%); legs (l) (40%)). Each of these areas is scored by itself, and then the four scores are 
combined into the final PASI/mPASI. For each section, the percent of area (A) of skin involved 
is estimated and then transformed into a grade from 0 to 6 (A): 
 
0. 0% of involved area 
1. < 10% of involved area 
2. 10–29% of involved area 
3. 30–49% of involved area 
4. 50–69% of involved area 
5. 70–89% of involved area 
6. 90–100% of involved area 
 
mPASI: for subjects with < 10% of an involved anatomic area, the mPASI will be calculated 
using the actual percentage of the anatomical area involved (e.g. 0.1 for 1%, 0.2 for 2%, 0.3 for 
3%, … 0.9 for 9%), corresponding to the actual percentage of that particular anatomical area of 
involvement. 
 
Note: Palms and soles may be treated with the IP in this study, but will not be counted towards 
IGA, PASI/mPASI, or BSA assessments. 
 
Within each area, the severity is estimated by three clinical signs: erythema (‘E’; redness), 
induration (‘T’; thickness) and desquamation (‘S’; scaling). Severity parameters are measured on 
a scale of 0 to 4, from none to maximum severity possible. 
 
To calculate the PASI/mPASI, the sum of the severity rating for the three main signs are 
multiplied with the numerical value of the area affected and with the various percentages of the 
four body areas. These values are then added to complete the formula as follows: 
 
PASI = 0.1 (Eh + Th + Sh) Ah + 0.2 (Ea + Ta + Sa) Aa + 0.3 (Et + Tt + St)  
At + 0.4 (El + Tl + Sl) Al 
5.2.4 
Body Surface Area (BSA) 
BSA Assessments will be performed at the following study visits according to the Schedule of 
Visits and Assessments (Section 1.3): 

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Screening, Baseline, Weeks 2, 4, 8, and 9 
The BSA affected by psoriasis will be determined by the subject’s hand method, where the 
subject’s hand (including fingers) surface area is assumed to equal 1% of body surface area 
(BSA).   
 
Note: Palms and soles will be treated with the IP but will not be counted towards B-IGA, 
PASI/mPASI, or BSA assessments. 
5.2.5 
Worst Itch Numerical Rating Scale (WI-NRS) 
WI-NRS Assessments will be performed at the following study visits according to the Schedule 
of Visits and Assessments (Section 1.3):  
Screening, Baseline, Weeks 2, 4, and 8. 
The WI-NRS has been developed as a simple, single item to assess the patient-reported severity 
of this symptom at its highest intensity during the previous 24-hour period. (Naegeli 2015). 
The WI-NRS will be determined by asking the subject’s assessment of worst itch over the past 
24 hours. The scale is from ‘0 to 10’ (“no itch” to “worst imaginable itch”). Subjects will 
complete the WI-NRS pruritus assessment. 
 
 
5.2.6 
Scalp Itch Numerical Rating Scale 
Scalp Itch-NRS Assessment will be performed at the following study visits according to the 
Schedule of Visits and Assessments (Section 1.3): 
Screening, Baseline, Weeks 2, 4, and 8  
 
The Scalp Itch-NRS is a single-item scale to assess the patient-reported severity of their 
symptom at the highest intensity of scalp itching over the past 24 hours. Scalp Itch-NRS will be 
determined by asking the subject’s assessment of worst itching of the scalp over the past 
24 hours. The scale is from ‘0’ to ‘10’ (‘no scalp itch’ to ‘worst scalp itch imaginable’). Subjects 
will complete the Scalp Itch-NRS assessment (Wang 2019). 
 
 

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

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5.4 
Final Study Visit 
The approximate final study visit will occur at Week 9. The procedures performed during these 
visits are described in the Schedule of Visits and Assessments (Section 1.3). A 5-day scheduling 
window is allowed for this visit. Adverse events will be recorded as reported by the participant 
or followed to resolution as outlined in Section 5.1.10. 
5.5 
Early Termination Visit 
If a subject is withdrawn or wishes to exit the study, a termination visit will be scheduled. This 
visit should include the procedures and assessments that would be performed at the Week 9 visit 
(Day 63). 
5.6 
Unscheduled Visit 
Unscheduled visits may be necessary to repeat testing following abnormal laboratory results, for 
follow-up of AEs, or for any other reason, as warranted in the judgment of the Investigator. 
5.7 
Adverse Events 
5.7.1 
Adverse Event Definition 
An AE means any untoward medical occurrence associated with the use of a drug in humans, 
whether or not considered IP related. An AE can therefore be any unfavorable and unintended 
sign (including an abnormal laboratory finding), symptom, or disease temporally associated with 
the use of a medicinal (investigational) product, whether or not related to the medicinal 
(investigational) product.  
AEs will be collected following informed consent of the subject through subject study 
completion.  
A treatment emergent adverse event (TEAE) is defined as an AE that started post application of 
IP at the Baseline visit through study completion.  
Application site reactions will be considered adverse events if they require intervention, 
suspension or discontinuation of the IP.  
5.7.2 
Serious Adverse Event 
The definitions and reporting requirements of Health Canada/the Food and Drug Administration 
(FDA)/ICH Guidelines for Clinical Safety Data Management, Definitions and Standards for 
Expedited Reporting, Topic E2A will be adhered to. If any AEs are serious, as defined by ICH 
Guidelines for Clinical Safety, required procedures will be followed.  
All SAEs will be reported to the Sponsor via fax or e-mail within 24 hours of becoming aware of 
the event, whether or not the SAEs are deemed IP-related. Refer to the Safety Reporting 
Instructions for details on how to submit the SAE Report. All serious event reporting will adhere 
to ICH E6: Guideline for Good Clinical Practice and ICH E2A: Clinical Safety Data 

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Management: Definitions and Standards for Expedited Reporting.:  The ERB/IRB will be 
notified of the Alert Reports as per HC, FDA, ICH and the IRB/ERB’s policies and procedures. 
An SAE is any AE that in the view of either the PI or Sponsor, results in any of the following 
outcomes:  Death, a life-threatening AE, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions, or a congenital anomaly/birth defect.  Important medical events 
that may not result in death, be life-threatening, or require hospitalization may be considered 
serious when, based upon appropriate medical judgment, they may jeopardize the subject and 
may require medical or surgical intervention to prevent one of the outcomes listed in the above 
definition. Examples of such medical events include allergic bronchospasm requiring intensive 
treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalization, or the development of drug dependency or drug abuse.  
 
Life-threatening is defined as an AE that in the view of the PI or Sponsor, places the subject at 
immediate risk of death. It does not include an AE that, had it occurred in a more severe form, 
might have caused death. 
 
Hospitalization does not include the following: 
• Rehabilitation facilities, hospice facilities or respite care (e.g. caregiver relief) 
• Nursing homes or skilled nursing facilities 
• Emergency room visits 
• Same day surgeries (as outpatient/same day/ambulatory procedures) 
• <24 hour admissions for observation or evaluation 
 
Hospitalization or prolongation of hospitalization in the absence of a precipitating, clinical AE is 
not in itself an SAE.  Examples include: 
• Admission for treatment of a preexisting condition that did not worsen 
• Hospitalizations for cosmetic elective surgery, social, and/or convenience admissions 
• Pre-planned treatments or surgical procedures should be noted in the baseline 
documentation for the individual subject. 
• Diagnostic and therapeutic procedures, such as surgery, should not be reported as AEs; 
however, the medical condition for which the procedure was performed should be 
reported if it occurs during the reporting period and meets the definition of an AE.  
For example, an acute appendicitis that begins during the AE reporting period should be 
reported as an AE, and the resulting appendectomy should be recorded as treatment of the 
AE. 
 
Unexpected is defined as an AE that is not listed in the IB or is not listed at the specificity or 
severity that has been observed; or is not consistent with the risk information described in the 
general investigational plan or elsewhere in the current IND/CTA. 

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If a SAE occurs to a subject on this study, contact the Medical Monitor within one business day 
of knowledge of event.  
5.7.3 
Suspected Unexpected Serious Adverse Reaction (SUSAR) 
This is defined as a serious adverse reaction, the nature or severity of which is not consistent 
with the known study treatment information. A serious event or reaction is not defined as a 
SUSAR when: ‘it is serious but expected’ or it does not fit the definition of an SAE, whether 
expected or not.  
5.7.4 
Safety Review 
At each follow-up visit, subjects will be queried with an open-ended question such as: 
‘How have you been feeling since your last visit?’  Additionally, the study staff will review 
subject diaries and, if it appears that a potential AE was recorded, study staff will query the 
subject and determine if an AE occurred. 
 
AEs (whether serious or non-serious) and clinically significant abnormal laboratory test value(s) 
will be evaluated by the Investigator and treated and/or followed up for up to one month after 
end of treatment until the symptoms or value(s) return to normal, or acceptable levels, as judged 
by the Investigator. 
 
Where appropriate, medical test(s) and/or examination(s) will be performed to document 
resolution of event(s). Outcome may be classified as resolved, improved, unchanged, worse, fatal 
or unknown (lost to follow-up). 
5.7.5 
Adverse Event Reporting 
The Investigator will review each event and assess its relationship to IP treatment (unrelated, 
unlikely, possibly, probably, likely). Each sign or symptom reported will be graded on the 
NIH NCI CTCAE toxicity grading scale 5-point severity scale (Grade 1, 2, 3, 4 and 5). The date 
and time of onset, time relationship to IP dosing, duration, and outcome (resolved, improved, 
unchanged, worse, fatal, or unknown/lost to follow-up) of each event will be noted. 
 

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The relationship of each AE to the IP will be assessed using the following definitions: 
Unrelated 
• 
The AE must clearly be caused by the subject’s clinical state, or the study 
procedure/conditions. 
• 
Definitely not related to drug. 
• 
Temporal sequence of an AE onset relative to administration of drug not reasonable. 
• 
Another obvious cause of an AE. 
Unlikely 
• 
Time sequence is unreasonable. 
• 
There is another more likely cause for an AE. 
Possibly 
• 
Corresponds to what is known about the drug. 
• 
Time sequence is reasonable. 
• 
Could have been due to another equally, likely cause. 
Probably 
• 
Is a known effect of the drug. 
• 
Time sequence from taking drug is reasonable. 
• 
Ceases on stopping the drug. 
• 
Cannot be reasonably explained by the known characteristics of the subject’s clinical state. 
Likely 
• 
Is a known effect of the drug (e.g., listed in Physicians' Desk Reference, Compendium of 
Pharmaceuticals and Specialties, IB). 
• 
Time sequence from taking drug is reasonable. 
• 
Event stops upon stopping drug, event returns upon restarting drug. 
 
The following CTCAE toxicity grading scale 5-point severity scale definitions for rating 
maximum severity will be used: 
 
Grade 1 
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention 
not indicated. 
Grade 2 
Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental activities of daily living.* 
Grade 3 
Severe or medically significant but not immediately life-threatening; Hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily 
living.** 
Note: An experience may be severe but may not be serious, e.g., severe headache). 
Grade 4 
Life-threatening consequences; urgent intervention indicated. 
Grade 5 
Death related to AE. 
Note:  A semi-colon indicates ‘or’ within the description of the grade. 
*Instrumental activities of daily living refer to preparing meals, shopping for groceries or clothes, using the 
telephone, managing money, etc. 
**Self-care activities of daily living refer to bathing, dressing and undressing, feeding self, using the toilet, taking 
medications, and not bedridden. 
AEs will be coded using the most current MedDRA® version available at the start of the study 
(e.g., 21.0 or higher). 

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5.8 
Reporting Pregnancy 
During study participation, all female subjects should be instructed to contact the Investigator 
immediately if they suspect they might be pregnant (e.g., missed or late menstrual period).  
If pregnancy is confirmed, Investigational Product must be discontinued immediately, the subject 
should be referred to an obstetrician experienced in reproductive toxicity for evaluation and 
counseling, and the subject should be followed until the conclusion of the pregnancy.  Subject 
may be required to sign a separate informed consent form to obtain pregnancy follow-up 
information, per local requirements or consent to their pregnancy medical data being collected 
within the main study consent form. 
The Investigator is responsible for reporting all available pregnancy information on the 
pregnancy report and submitting to the Medical Monitor within 24 hours of becoming aware of 
the event, although pregnancy itself is not considered an AE.  Monitoring of the subject should 
continue until the conclusion of the pregnancy if the female subject has agreed on providing 
these medical data.  Follow-up information detailing the outcome of the pregnancy and the 
health of the newborn should be reported as it becomes available. Any pregnancy complication 
must be reported as a SAE. In addition, any pregnancy resulting in a congenital abnormality or 
birth defect of the newborn, or neonatal death occurring within 30 days of the birth must be 
reported as a SAE, regardless of causality. Any infant death that occurs after the 30 day reporting 
period that the Investigator suspects is related to the Investigational Product must also be 
reported as a SAE. 
Partner pregnancies of a male subject do not need to be reported. 
5.9 
Treatment Stopping Rules 
If a subject has non-cutaneous adverse events of concern, clinically significant laboratory values 
or any condition that the investigator determines could possibly be related to the IP, 
the Investigator should immediately contact the Medical Monitor to discuss if the subject should 
be discontinued from the IP.   
 
Treatment for any individual subject will be discontinued if the subject: 
• Experiences a serious adverse event (SAE) or a clinically significant non-serious AE 
which in the opinion of the Principal Investigator or Medical Monitor warrants 
discontinuation from the IP for that subject’s well-being. 
• A severe (Grade 3) laboratory abnormality (confirmed by repeat sample and considered 
related to IP).  
o See Appendix 8 for details. 
Dosing of IP for an individual subject may be suspended for safety concerns other than those 
described above, at the discretion of the investigator if he/she feels the subject’s safety may be 
threatened. 
A subject with a PHQ-8 or modified PHQ-A score of ‘15’ or above should be referred promptly 
to a mental health care professional and consideration be given to discontinuation from IP.   

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A subject that is experiencing suicidal ideation and behavior should be referred immediately to a 
qualified mental health care provider and consideration given to discontinuation from IP. 
As noted above, study treatment must be discontinued immediately in the event of a female 
subject’s pregnancy. 
Treatment should be interrupted: 
• If a subject develops an application site reaction with the clinical appearance of an 
‘irritation reaction’, and with a severity of a Dermal Response Score of 5 (erythema, 
edema and papules) or greater on the scale of Berger and Bowman, treatment should be 
interrupted for up to one week and may then be resumed if the reaction has, in the 
opinion of the Investigator, adequately resolved. 
 
Treatment should be discontinued: 
• 
If the reaction reoccurs, treatment should be discontinued permanently, and the subject 
followed until the reaction resolves.  Given the excellent local toleration in the Phase 1/2a 
and 2b studies, such reactions are possible, but unlikely. 
5.9.1 
Emergency Unblinding 
Treatment assignment should remain blinded unless the knowledge is necessary to determine 
emergency medical care, as determined by the Investigator. Emergency unblinding will be done 
using the study IWRS system in consultation with the Medical Monitor and the Sponsor. 
Blinding of study treatment is critical to the integrity of this clinical trial and therefore, if a 
subject’s treatment assignment is disclosed to the Investigator, the subject will have the IP 
discontinued.  
6 
DATA ANALYSIS 
Data will be handled and processed according to the Contract Research Organization’s Standard 
Operating Procedures, which are written based on the principles of GCP. 
6.1 
Statistical Methods 
The methodology presented below is a summary of the more detailed analysis plan that will be 
presented in the Statistical Analysis Plan (SAP).  The SAP will be finalized before the database 
is locked and unblinded.  Any changes to the methods described in the final SAP will be 
described and justified in the clinical study report.  
All statistical processing will be performed using SAS® (Version 9.4) unless otherwise stated. 
No interim efficacy analyses are planned. 
Descriptive statistics will be used to provide an overview of the efficacy, safety and 
pharmacokinetic results.  For categorical parameters, the number and percentage of subjects in 
each category will be presented. The denominator for percentage will be based on the number of 
subjects appropriate for the purpose of analysis.  For continuous parameters, descriptive statistics 

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will include n (number of subjects), mean, standard deviation (SD), median, minimum, 
and maximum. 
6.1.1 
Determination of Sample Size 
There are approximately 300 subjects planned for this study.  Approximately 200 subjects will 
receive ARQ-154 foam 0.3% QD; approximately 100 subjects will receive vehicle foam QD.  
The sample size was selected to provide an adequate number of subjects to compare the efficacy 
of ARQ-154 treatment to vehicle and to provide an adequate number of subjects needed for a 
safety database.  
This sample size provides 96% power at the α=0.05 level to detect a 22.4% difference between 
treatment groups for S-IGA Success at Week 8 using a 2-sided Chi-squared test.  The results 
from a recent phase 2b study (ARQ-151-201) of ARQ-151 compared to vehicle treatment were 
used to estimate the treatment difference and it is assumed that the S-IGA response in the present 
study are similar to IGA responses seen with ARQ-151.  Specifically, in the phase 2b trial, 
32.2% of subjects reported IGA success in the ARQ-151 0.3% group and 9.8% of subjects 
reported IGA success in the vehicle group. 
The number of subjects to be enrolled will also provide sufficient power for most secondary 
endpoints. 
6.1.2 
Subjects to Analyze 
Safety population will include all subjects who are enrolled and received at least one confirmed 
dose of IP. This population will be used for all safety analyses. 
The Intention-to-Treat (ITT) population will include all randomized subjects. This population 
will be the primary analysis population for the analysis of efficacy endpoints. 
Per-Protocol (PP) Population will include all subjects who are in the safety population, were at 
least 80% compliant with IP application, and showed no other serious deviations from the study 
protocol. This population will be used as a sensitivity analysis of primary and secondary efficacy 
endpoints. 
The Pruritis population is a subset of the ITT population and includes subjects with Scalp Itch 
NRS score ≥ 4 at Baseline.  This population will be used for the analysis of achievement of a 
4-point reduction in Scalp Itch NRS pruritus score as compared to Baseline. 
The PK population will include all subjects receiving the active drug with sufficient plasma 
concentrations of roflumilast to define a profile, as determined by the pharmacokineticist. 
This population will be used for analyses of PK parameters. 
6.1.3 
Interim Analysis 
No interim efficacy analyses are planned. 

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

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

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

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6.3.3 
Exploratory Endpoints 
 
The Exploratory Endpoints will include: 
• PASI-75 (subjects who achieve a 75% reduction in PASI from Baseline) at Week 8 
• Time to success in PASI-50 
• Changes from Baseline in the mPASI 
• For subjects with Baseline WI-NRS score ≥4, achievement of ≥4-point improvement 
from Baseline in WI-NRS at Weeks 8, 4, and 2 
• Change from Baseline in DLQI/CDLQI at Weeks 8, 4, and 2 
• Change from Baseline in % BSA affected by disease at Weeks 8, 4, and 2 
 
The analysis of all exploratory endpoints will be descriptive statistics. 
6.4 
Safety Evaluation 
Descriptive statistics will be calculated for safety data and presented by visit and treatment group 
for quantitative safety data and frequency counts will be compiled for classification of qualitative 
safety data.  Summaries of local tolerability will be presented by visit and treatment group. 
6.4.1 
Adverse Events 
All treatment-emergent AEs occurring during the study will be recorded and classified on the 
basis of MedDRA terminology for the safety population. Treatment-emergent AEs are those AEs 
with an onset on or after the date of study treatment. All treatment-emergent AEs will be 
summarized by treatment group, the number of subjects reporting treatment-emergent AEs, 
system organ class, preferred term, severity, relationship, and seriousness. 
 
Serious adverse events (SAEs) will be listed by subject.  SAEs will be summarized by treatment 
group, severity, and relationship to study treatment. 
 
For AEs, each subject will be counted only once within a system organ class or a preferred term 
using the event with the greatest relationship and greatest severity. 
All information pertaining to AEs noted during the study will be listed by subject, detailing the 
verbatim description given by the Investigator, preferred term, system organ class, start date, 
stop date, severity, action taken regarding IP, corrective treatment, outcome, and IP relatedness.  
The event onset will also be shown relative (in number of days) to date of first application.  
In addition, a listing of subjects who prematurely discontinue from the IP due to adverse events 
will also be provided. 

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6.4.2 
Local Tolerance Assessments 
For the Investigator’s and Subject’s assessment, the numeric application site reaction scores will 
be summarized individually by using number and percentage of subjects by visit, as well as 
mean/median scores.   
6.4.3 
Medical History and Physical Examinations 
Clinically significant changes observed during physical examination will be captured as adverse 
events and included in AE tabulations. 
6.4.4 
PHQ-8 and Modified PHQ-A 
Data for PHQ-8 and Modified PHQ-A will be analyzed by a shift in state of severity using the 
following scoring system: 
• None – Minimal depression (0 to 4) 
• Mild depression (5 to 9) 
• Moderate depression (10 to 14) 
• Moderately severe depression (15 to 19) 
• Severe depression (20 to 24) 
6.4.5 
C-SSRS 
The C-SSRS will be analyzed per the Columbia–Suicide Severity Rating Scale Scoring and 
Data Analysis Guide. 
6.4.6 
Clinical Laboratory Results and Vital Signs/Weight Measurements 
All clinical laboratory results and vital signs measurements and their change from baseline 
(pre-dose), will be summarized along with time point of collection. 
 
A shift table describing out-of-normal range shifts from Baseline will be provided for clinical 
laboratory results.  
 
Shift tables will identify subjects who gain or lose >5% body weight over the course of the 
study, as well as subjects who gain or lose >10% body weight over the course of the study. 
6.4.7 
Prior and Concomitant Medications 
Prior and concomitant medication information for all randomized subjects will be presented in a 
by-subject listing.  Summary tables will be presented by World Health Organization-Anatomical 
Therapeutic Chemical Classification System (WHO-ATC) therapeutic category and product. 

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6.5 
Patient Reported Outcomes Analyses 
6.5.1 
Scalp Itch-NRS 
Change from baseline in scalp itch severity will be analyzed by treatment group and over time 
using the Scalp Itch-NRS scale. For subjects with Scalp Itch-NRS pruritus score ≥ 6 at baseline, 
the proportion of subjects with a 4-point reduction in Scalp Itch-NRS pruritus score at Week 8 as 
compared to Baseline will be calculated by treatment group and analyzed using a Cochran-
Mantel-Haenszel test stratified by country baseline S-IGA, and baseline B-IGA (see secondary 
endpoints). 
6.5.2 
Dermatology Life Quality Index (DLQI) and Children’s Dermatology Life Quality 
Index (CDLQI) 
Both the DLQI and CDLQI will be analyzed by evaluation of the reduction in total score at 
Weeks 2, 4, and 8 as compared to Baseline. 
6.5.3 
Psoriasis Symptom Diary (PSD) 
The PSD will be analyzed as the improvement in responses to the questions of PSD Weeks 2, 4, 
and 8 as compared to Baseline.  
6.6 
Pharmacokinetic Analysis 
Plasma drug concentrations at pre-dose will be summarized using descriptive statistics. 
 
For all subjects, blood samples for the determination of roflumilast and its N-oxide metabolite 
will be collected at scheduled time points as delineated in the Schedule of Visits and 
Assessments (Section 1.3).   
A manual for blood sampling, collection, processing, and sample shipment will be provided in a 
separate document.  
7 
STUDY ADMINISTRATION 
7.1 
Ethics 
7.1.1 
Ethics Review Board 
Before enrollment of patients into the study, the current protocol, ICF, and any accompanying 
material to be provided to the subjects will be reviewed and approved by an appropriate IRB or 
IEC, as required by ICH GCP and other local/regional regulatory requirements.  A letter 
documenting the IRB or IEC approval must be received by the Sponsor before the initiation of 
the study at a clinical site. Amendments to the protocol will be subject to the same requirements 
as the original protocol.  
The Investigator, Sponsor, or designee will submit a progress report at least once yearly to the 
IRB or IEC. However, the frequency of these reports will depend on IRB or IEC requirements. 

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

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7.2.2 
Study Termination 
The Sponsor reserves the right to close the investigational site or terminate the study at any time 
for any reason at the sole discretion of the Sponsor. Investigational sites will be closed upon 
study completion. An investigational site is considered closed when all required documents and 
study supplies have been collected and a site closure visit has been performed. The investigator 
may initiate site closure at any time, provided there is reasonable cause and sufficient notice is 
given in advance of the intended termination. 
 
Reasons for the early closure of an investigational site by the Sponsor or investigator may 
include but are not limited to: 
• 
Failure of the investigator to comply with the protocol, the Sponsor’s procedures, 
or GCP guidelines. 
• 
Inadequate recruitment of subjects by the investigator. 
• 
Discontinuation of further IP development. 
7.3 
Study Monitoring 
Prior to the initiation of the clinical investigation, Sponsor representatives or designees will visit 
the clinical site where the investigation is to be conducted.  Sponsor representatives or designees 
shall ensure that the Investigator understands the investigational status of the investigational 
product, all requirements of the investigation to be undertaken, and all of his/her responsibilities 
as an Investigator.  Sponsor representatives or designees will also visit the clinical site at 
appropriate intervals as required to ensure compliance with the protocol and to verify the 
accuracy and completeness of data reported on the CRFs.  The Study Director or designees shall 
be available for consultation with the Investigator and serve as liaisons between the clinical site 
and the Sponsor. 
The Sponsor or authorized designees may inspect all documents and records required to be 
maintained by the Investigator, including but not limited to medical records (office, clinic, 
or hospital) and investigational product dispensation logs for the subjects in this clinical 
investigation.  The Investigator must permit access to such records.  The Investigator must 
obtain, as part of informed consent, permission for an authorized representative of the Sponsor, 
or regulatory authorities, to review, in confidence, any records identifying subjects. 
7.4 
Data Quality Assurance 
In order to ensure the collection of accurate, consistent, complete, and reliable data during this 
clinical investigation, Sponsor representatives or designees may conduct audits of participating 
sites at appropriate intervals throughout the study.  The results of these periodic site audits may 
be subject to review by independent auditors at completion of the clinical investigation.  
The Clinical Study Report will be audited by the Premier Research’s Quality Assurance (QA) 
department and the QA audit certificate will be included in the study report. 

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All clinical data will undergo a 100% quality control check prior to clinical database lock. 
Edit checks are then performed for appropriate databases as a validation routine to check for 
missing data, data inconsistencies, data ranges etc. Corrections are made prior to database lock. 
7.4.1 
Verification of Blinding 
The treatment assignments for all enrolled subjects will be unblinded only after the conclusion of 
the study. Specifically, the blind will be broken only after all data are verified, entered into the 
database, and validated; subject evaluability assessments are performed and entered into the 
database; and the database is locked. 
7.5 
Data Handling and Record Keeping 
During the clinical study, the Investigator will maintain adequate records, including medical 
records, records detailing the progress of the study for each subject, laboratory reports, signed 
informed consent forms, investigational product disposition records, correspondence with the 
ERB/IRB and Study Monitor/Sponsor, AE reports, and information regarding subject 
discontinuation and completion of the clinical investigation. 
 
All required study data will be recorded on eCRFs.  Any change of data will be recorded on the 
audit trail and a reason for the change will be entered.  
 
The principal investigator must retain all documentation relating to the study for a period of at 
least 2 years after the last marketing application approval or, if not approved, 2 years following 
the discontinuance of the test article for investigation.  If this requirement differs from any local 
regulations, the local regulations will take precedence unless the local retention policy is less 
than 2 years. 
7.6 
Protocol Amendments and Deviations 
No change or amendment to this protocol may be made by the investigator or Sponsor after the 
protocol has been agreed to and signed by all parties unless such change(s) or amendment(s) has 
(have) been agreed upon by the investigator and Sponsor.  Any change agreed upon will be 
recorded in writing, and the written amendment will be signed by the investigator and Sponsor.  
Institutional review board approval is required prior to the implementation of an amendment, 
unless overriding safety reasons warrant immediate action, in which case the IRB(s) will be 
promptly notified. 
 
No deviation from the protocol will be made except to protect the life or physical well-being of a 
subject in an emergency.  Except in such emergencies, prior approval of the Sponsor, and the 
IRB, is required before deviations from the planned protocol.  All protocol deviations that occur 
during the study will be documented and reported to Sponsor and to the IRB(s), if applicable, 
according to regulations.  Further details about the documentation, evaluation, and follow-up of 
protocol deviations are detailed in this study’s clinical monitoring plan.  
 

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No waivers to inclusion/exclusion criteria will be granted; subjects need to meet all criteria, 
exactly as specified, to be enrolled.  Additionally, prospective deviations from the protocol or 
investigational plan are not permitted except to protect the life or physical well-being of a subject 
in an emergency.  Deviations that occur unintentionally or are the result of action by the subject 
must be documented and reported to the IRB(s), if applicable, according to regulations.  Further 
details about the documentation, evaluation, and follow-up of protocol deviations are detailed in 
this study’s clinical monitoring plan. 
7.7 
Confidentiality and Privacy 
The investigator must assure that subjects’ confidentiality will be strictly maintained and that 
their identities are protected from unauthorized parties. Only an identification code and any other 
unique identifier(s) as allowed by local law (such as date of birth) will be recorded on any form 
or biological sample submitted to the Sponsor. 
 
The investigator agrees that all information received from Arcutis Inc., including but not limited 
to the investigator brochure, this protocol, CRF/eCRF, the IP, and any other study information, 
remain the sole and exclusive property of Arcutis Inc. during the conduct of the study and 
thereafter. This information is not to be disclosed to any third party (except employees or agents 
directly involved in the conduct of the study or as required by law) without prior written consent 
from Arcutis Inc. The investigator further agrees to take all reasonable precautions to prevent the 
disclosure by any employee or agent of the study site to any third party or otherwise into the 
public domain. 
7.8 
Conflict of Interest 
All study investigators will provide documentation of their financial interest or arrangements 
with Arcutis Inc., or proprietary interests in the IP under study. This documentation must be 
provided prior to the investigator’s participation in the study. All investigators with reported 
conflict of interest will be required to have such conflicts managed in a way that is appropriate to 
their participation in the design and conduct of this study. 
7.9 
Report Format 
According to the ICH Harmonized Tripartite Guideline (Organization of the Common Technical 
Document for the Registration of Pharmaceuticals for Human Use M4 and the ICH M2 Expert 
Working Group), the final report will be written according to the ICH E3 Guideline 
(Structure and Content of Clinical Study Reports).  
7.10 Publication Policy 
The Sponsor is supportive of publishing clinical trial findings.  Any form of publication that is 
derived from this study must be submitted to Arcutis, Inc. for review and approval. The process 
of coordinating publication efforts is detailed in the Clinical Trial Agreement. 

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8 
REFERENCES 
Berger, RS, Bowman JP. A reappraisal of the 21-day Cumulative Irritation Test in man.  
J. Toxicol Ot & Ocular Toxicol 1982:1(2);109-115. 
Bethke, TD, Lahu, G.  High absolute bioavailability of the new oral phosphodiesterase-4 
inhibitor roflumilast.  Int. J Clin Pharmacol Ther.  2011;49:51-57. 
Blakely K, Gooderham M. Management of scalp psoriasis: current perspectives. Psoriasis 
(Auckl). 2016; 6:33-40. Published 2016 Mar 29. Doi: 10.2147/PTT.S85330  
Brion DE, Raynaud F, Plet A, Laurent P, et al.  Deficiency of cyclic AMP-dependent protein 
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DALIRESP (roflumilast) tablets [package insert]. AstraZeneca Pharmaceuticals LP, Wilmington, 
DE USA; 2017. 
DAXAS (roflumilast) film-coated tablets [product monograph]. AstraZeneca Canada, Inc., 
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Hatzelmann A, Morcillo EJ, Lungarella G, et al. The preclinical pharmacology of roflumilast – a 
selective, oral phosphodiesterase 4 inhibitor in development for chronic obstructive pulmonary 
disease. Pulm Pharmacol Ther. 2010;23:235–256. 
Investigator’s Brochure, Edition 1.0, September 2019 
Kivelevitch D, Frieder J, Watson I, et al. Pharmacotherapeutic approaches for treating psoriasis 
in difficult-to-treat areas. Expert Opin Pharmacother. 2018;19(6):561-575. 
Merola JF, Qureshi A, Husni ME. Underdiagnosed and undertreated psoriasis: Nuances of 
treating psoriasis affecting the scalp, face, intertriginous areas, genitals, hands, feet, and nails. 
Dermatol Ther. 2018;31(3):e12589. 
Michalski JM., Golden G., Ikari J., et al. PDE4: A Novel Target in the Treatment of Chronic 
Obstructive Pulmonary Disease. Clinical Pharmacology & Therapeutics. 2012;91:134-142. 
Naegeli AN, Flood E, Tucker J, et al. The Worst Itch Numeric Rating Scale for patients with 
moderate to severe plaque psoriasis or psoriatic arthritis. Int J Dermatol. 2015;54(6):715–22. 
Snape SD, Wigger-Alberti W, Goehring UM.  A phase I randomized trial to assess the effect on 
skin inﬁltrate thickness and tolerability of topical phosphodiesterase inhibitors in the treatment of 
psoriasis vulgaris using a modiﬁed psoriasis plaque test.  Br J Dermatol.  2016;175:479-486. 
Schlager JG, Rosumeck S, Werner RN, et al. Topical treatments for scalp psoriasis: summary of 
a Cochrane Systematic Review. Br. J. Dermatol. 2016;176(3):604-614. 
Wang TS, Tsai TF. Managing Scalp Psoriasis: An Evidence-Based Review. Am J Clin Dermatol. 
2017;18(1):17-43. 

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Wang Y, Coyne K, Sofen H, et al. Qualitative analysis and reproducibility assessment of the 
Scalp Itch Numeric Rating Scale among patients with moderate to severe plaque psoriasis of the 
scalp. Journal of Dermatological Treatment. 2019. DOI: 10.1080/09546634.2019.1577546 
Wedzicha JA, Calverley PMA, Klaus FR.  Roflumilast: a review of its use in the treatment of 
COPD.  International Journal of Chronic Obstructive Pulmonary Disease. 2016;11:81-90. 

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9 
APPENDICES 
Appendix 1: Patient Health Questionnaire Depression Scale (PHQ-8) 
 
 
  
  
 

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Amendment 2 
10 April 2020 
 
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Appendix 2: Patient Health Questionnaire Depression Scale (Modified PHQ-A) 
 
 
 
 

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Amendment 2 
10 April 2020 
 
Confidential 
 Page 72 of 91 
Appendix 3: Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline/Screening 
Version 
 
 
COLUMBIA-SUICIDE SEVERITY 
RATING SCALE 
(C-SSRS)  
Baseline/Screening Version 
Version 1/14/09 
 
  
Posner, K.; Brent, D.; Lucas, C.; Gould, M.; Stanley, B.; Brown, G.; Fisher, P.; Zelazny, J.; 
Burke, A.; Oquendo, M.; Mann, J.  
 
Disclaimer: 
This scale is intended to be used by individuals who have received training in its administration. The questions contained in 
the Columbia-Suicide Severity Rating Scale are suggested probes. Ultimately, the determination of the presence of suicidal 
ideation or behavior depends on the judgment of the individual administering the scale. 
 
 
Definitions of behavioral suicidal events in this scale are based on those used in The Columbia Suicide History Form, 
developed by John Mann, MD and Maria Oquendo, MD, Conte Center for the Neuroscience of Mental Disorders 
(CCNMD), New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032. (Oquendo M. A., 
Halberstam B. & Mann J. J., Risk factors for suicidal behavior: utility and limitations of research instruments. In M.B. First 
[Ed.] Standardized Evaluation in Clinical Practice, pp. 103 -130, 2003.) 
For reprints of the C-SSRS contact Kelly Posner, Ph.D., New York State Psychiatric Institute, 1051 Riverside Drive, New 
York, New York, 10032; inquiries and training requirements contact posnerk@nyspi.columbia.edu 
© 2008 The Research Foundation for Mental Hygiene, Inc. 

Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 73 of 91 
 
 
 
SUICIDAL IDEATION 
Ask questions 1 and 2.  If both are negative, proceed to “Suicidal Behavior” section. If the answer to 
question 2 is “yes”, ask questions 3, 4 and 5.  If the answer to question 1 and/or 2 is “yes”, complete 
“Intensity of Ideation” section below. 
Lifetime: Time 
He/She Felt 
Most Suicidal 
Past 
 
Months 
1.  Wish to be Dead  
Subject endorses thoughts about a wish to be dead or not alive anymore, or wish to fall asleep and not wake up   
Have you wished you were dead or wished you could go to sleep and not wake up?  
 
If yes, describe: 
 
Yes       No 
□    □ 
 
Yes     No 
□   □ 
2.  Non-Specific Active Suicidal Thoughts 
General non-specific thoughts of wanting to end one’s life/commit suicide (e g , “I’ve thought about killing myself”) without thoughts 
of ways to kill oneself/associated methods, intent, or plan during the assessment period   
Have you actually had any thoughts of killing yourself? 
 
If yes, describe: 
 
    Yes       No 
   □    □ 
 
Yes     No 
□   □ 
3.  Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act 
Subject endorses thoughts of suicide and has thought of at least one method during the assessment period  This is different than a 
specific plan with time, place or method details worked out (e g   thought of method to kill self but not a specific plan)   Includes person 
who would say, “I thought about taking an overdose but I never made a specific plan as to when, where or how I would actually do 
it…and I would never go through with it.” 
Have you been thinking about how you might do this? 
 
If yes, describe: 
 
 
    Yes      No 
 □    □ 
 
Yes     No 
□   □ 
4.  Active Suicidal Ideation with Some Intent to Act, without Specific Plan 
Active suicidal thoughts of killing oneself and subject reports having some intent to act on such thoughts, as opposed to “I have the 
thoughts but I definitely will not do anything about them.” 
Have you had these thoughts and had some intention of acting on them?  
 
If yes, describe: 
 
 
   Yes      No 
□    □ 
 
Yes     No 
□   □ 
5.  Active Suicidal Ideation with Specific Plan and Intent 
Thoughts of killing oneself with details of plan fully or partially worked out and subject has some intent to carry it out  
Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan? 
   
If yes, describe: 
 
 
   Yes       No 
 □    □ 
 
Yes     No 
□   □ 
INTENSITY OF IDEATION 
The following features should be rated with respect to the most severe type of ideation (i.e., 1-5 from above, with 1 being 
the least severe and 5 being the most severe).  Ask about time he/she was feeling the most suicidal.  
                                   
Lifetime -           Most Severe Ideation:  _______                  ________________________________________ 
                                                                       Type # (1-5)                                                 Description of  Ideation 
 
Past X Months - Most Severe Ideation:  _______                   ________________________________________ 
                                                                      Type # (1-5)                                                 Description of  Ideation 
Most  
Severe 
Most 
Severe 
Frequency 
How many times have you had these thoughts?  
(1) Less than once a week    (2) Once a week   (3)  2-5 times in week    (4) Daily or almost daily    (5) Many times each day 
 
 
____ 
 
 
____ 
Duration 
When you have the thoughts how long do they last? 
(1) Fleeting - few seconds or minutes                                                 (4) 4-8 hours/most of day 
(2) Less than 1 hour/some of the time                                                 (5) More than 8 hours/persistent or continuous 
(3) 1-4 hours/a lot of time 
____ 
____ 
Controllability 
Could/can you stop thinking about killing yourself or wanting to die if you want to? 
(1) Easily able to control thoughts                                                      (4) Can control thoughts  with a lot of difficulty 
(2) Can control thoughts with little difficulty                                     (5) Unable to control thoughts 
(3) Can control thoughts with some difficulty                                    (0) Does not attempt to control thoughts 
____ 
____ 
Deterrents 
Are there things - anyone or anything (e.g., family, religion, pain of death) - that stopped you from wanting to 
die or acting on thoughts of committing suicide? 
(1) Deterrents definitely stopped you from attempting suicide            (4) Deterrents most likely did not stop you  
(2) Deterrents probably stopped you                                                    (5) Deterrents definitely did not stop you  
(3) Uncertain that deterrents stopped you                                             (0) Does not apply 
____ 
____ 
Reasons for Ideation 
What sort of reasons did you have for thinking about wanting to die or killing yourself?  Was it to end the pain 
or stop the way you were feeling (in other words you couldn’t go on living with this pain or how you were 
feeling) or was it to get attention, revenge or a reaction from others? Or both? 
(1) Completely to get attention, revenge or a reaction from others       (4) Mostly to end or stop the pain (you couldn’t go on 
(2) Mostly to get attention, revenge or a reaction from others                     living with the pain or how you were feeling) 
(3) Equally to get attention, revenge or a reaction from others               (5) Completely to end or stop the pain (you couldn’t go on  
       and to end/stop the pain                                                                         living with the pain or  how you were feeling) 
                                                                                                                 (0)  Does not apply 
 
 
____ 
 
 
 
 
© 2008 Research Foundation for Mental Hygiene, Inc. 
 
        C-SSRS—Baseline/Screening (Version 1/14/09)    
 
 
                             Page 1 of 2      

Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 74 of 91 
 
 
 
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      

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Amendment 2 
10 April 2020 
 
Confidential 
 Page 75 of 91 
Appendix 4: Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version 
 
 
 
 
 
 
 
 
 
 
COLUMBIA-SUICIDE SEVERITY 
RATING SCALE 
(C-SSRS) 
Since Last Visit 
Version 1/14/09 
 
Posner, K.; Brent, D.; Lucas, C.; Gould, M.; Stanley, B.; Brown, G.; Fisher, P.; Zelazny, J.; 
Burke, A.; Oquendo, M.; Mann, J.  
 
 
Disclaimer: 
This scale is intended to be used by individuals who have received training in its administration. The questions contained 
in the Columbia-Suicide Severity Rating Scale are suggested probes. Ultimately, the determination of the presence of 
suicidal ideation or behavior depends on the judgment of the individual administering the scale. 
 
 
Definitions of behavioral suicidal events in this scale are based on those used in The Columbia Suicide History 
Form, developed by John Mann, MD and Maria Oquendo, MD, Conte Center for the Neuroscience of Mental Disorders 
(CCNMD), New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032. (Oquendo M. A., 
Halberstam B. & Mann J. J., Risk factors for suicidal behavior: utility and limitations of research instruments. In M.B. First 
[Ed.] Standardized Evaluation in Clinical Practice, pp. 103 -130, 2003.) 
 
For reprints of the C-SSRS contact Kelly Posner, Ph.D., New York State Psychiatric Institute, 1051 Riverside Drive, New 
York, New York, 10032; inquiries and training requirements contact posnerk@nyspi.columbia.edu 
 
© 2008 The Research Foundation for Mental Hygiene, Inc. 

Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 76 of 91 
 
 
SUICIDAL IDEATION 
Ask questions 1 and 2.  If both are negative, proceed to “Suicidal Behavior” section. If the answer to question 2 is “yes”, 
ask questions 3, 4 and 5.  If the answer to question 1 and/or 2 is “yes”, complete “Intensity of Ideation” section below. 
 
Since Last 
Visit 
1.  Wish to be Dead  
Subject endorses thoughts about a wish to be dead or not alive anymore, or wish to fall asleep and not wake up   
Have you wished you were dead or wished you could go to sleep and not wake up?  
 
If yes, describe: 
 
 
Yes       No 
 □    □ 
2.  Non-Specific Active Suicidal Thoughts 
General, non-specific thoughts of wanting to end one’s life/commit suicide (e g , “I’ve thought about killing myself”) without thoughts of ways to kill 
oneself/associated methods, intent, or plan during the assessment period   
Have you actually had any thoughts of killing yourself? 
 
If yes, describe: 
 
 Yes      No 
 □    □ 
3.  Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act 
Subject endorses thoughts of suicide and has thought of at least one method during the assessment period  This is different than a specific plan with time, 
place or method details worked out (e g , thought of method to kill self but not a specific plan)   Includes person who would say, “I thought about taking an 
overdose but I never made a specific plan as to when, where or how I would actually do it…and I would never go through with it.” 
Have you been thinking about how you might do this? 
 
If yes, describe: 
 
 Yes      No 
 □    □ 
4.  Active Suicidal Ideation with Some Intent to Act, without Specific Plan 
Active suicidal thoughts of killing oneself and subject reports having some intent to act on such thoughts, as opposed to “I have the thoughts but I 
definitely will not do anything about them.” 
Have you had these thoughts and had some intention of acting on them?  
 
If yes, describe: 
 
 
Yes       No 
 □    □ 
5.  Active Suicidal Ideation with Specific Plan and Intent 
Thoughts of killing oneself with details of plan fully or partially worked out and subject has some intent to carry it out  
Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan? 
   
If yes, describe: 
 
 
 Yes      No 
 □    □ 
INTENSITY OF IDEATION 
The following features should be rated with respect to the most severe type of ideation (i.e., 1-5 from above, with 1 being the least severe 
and 5 being the most severe).  
                                             
Most Severe Ideation:             _____                      _________________________________________________ 
                                               
                                                                                                           Type # (1-5)                                         Description of  Ideation 
Most 
Severe 
Frequency 
How many times have you had these thoughts?  
(1) Less than once a week    (2) Once a week   (3)  2-5 times in week    (4) Daily or almost daily    (5) Many times each day 
 
____ 
Duration 
When you have the thoughts, how long do they last? 
(1) Fleeting - few seconds or minutes                                                 (4) 4-8 hours/most of day 
(2) Less than 1 hour/some of the time                                                 (5) More than 8 hours/persistent or continuous 
(3) 1-4 hours/a lot of time                                                                    
____ 
Controllability 
Could/can you stop thinking about killing yourself or wanting to die if you want to? 
(1) Easily able to control thoughts                                                      (4) Can control thoughts with a lot of difficulty 
(2) Can control thoughts with little difficulty                                     (5) Unable to control thoughts 
(3) Can control thoughts with some difficulty                                    (0) Does not attempt to control thoughts 
____ 
Deterrents 
Are there things - anyone or anything (e.g., family, religion, pain of death) - that stopped you from wanting to die or acting on 
thoughts of committing suicide? 
(1) Deterrents definitely stopped you from attempting suicide            (4) Deterrents most likely did not stop you  
(2) Deterrents probably stopped you                                                    (5) Deterrents definitely did not stop you  
(3) Uncertain that deterrents stopped you                                             (0) Does not apply 
____ 
Reasons for Ideation 
What sort of reasons did you have for thinking about wanting to die or killing yourself?  Was it to end the pain or stop the way 
you were feeling (in other words you couldn’t go on living with this pain or how you were feeling) or was it to get attention, 
revenge or a reaction from others? Or both? 
(1) Completely to get attention, revenge or a reaction from others       (4) Mostly to end or stop the pain (you couldn’t go on 
(2) Mostly to get attention, revenge or a reaction from others                     living with the pain or how you were feeling) 
(3) Equally to get attention, revenge or a reaction from others               (5) Completely to end or stop the pain (you couldn’t go on  
       and to end/stop the pain                                                                         living with the pain or  how you were feeling) 
                                                                                                                 (0)  Does not apply 
 
 
 
 
____ 
© 2008 Research Foundation for Mental Hygiene, Inc. 
 
        C-SSRS—Since Last Visit (Version 1/14/09)    
 
 
                          Page 1 of 2        

Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 77 of 91 
 
 
 
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                 

Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 78 of 91 
Appendix 5: Psoriasis Symptom Diary (PSD) 
 
  
 
 Psoriasis Symptom Diary (PSD) 
 
 
 
 
 
 1 Overall, how severe was 
your psoriasis-related 
itching over the past 
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
 No itching 
Itching as bad as you  
can imagine 
 
  
 
 2 Overall, how bothered  
were you by your psoriasis-
related itching over the 
past 24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Not bothered  
at all 
As bothered as you  
can imagine 
 
  
 
 3 Overall, how severe was 
your psoriasis-related 
stinging over the past 
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
No stinging 
Stinging as bad as you  
can imagine 
 
  
 
 4 Overall, how bothered  
were you by your psoriasis-
related stinging over the 
past 24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Not bothered  
at all 
As bothered as you  
can imagine 
 
  
 
 
5 Overall, how severe was 
your psoriasis-related 
burning over the past 
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
No burning 
Burning as bad as you  
can imagine 
 
 
 
 
 
 
 
 
 
 
 

Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 79 of 91 
  
 
 
6 Overall, how bothered  
were you by your psoriasis-
related burning over the 
past 24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Not bothered  
at all 
As bothered as you  
can imagine 
 
  
 
 7 Overall, how severe was 
your psoriasis-affected skin 
cracking over the past 
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
 No pain 
Pain as bad as you  
can imagine 
 
  
 
 8 Overall, how bothered  
were you by your psoriasis-
affected skin cracking over 
the past 24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Not bothered  
at all 
As bothered as you  
can imagine 
 
  
 
 9 Overall, how severe was 
your psoriasis-related pain 
over the past 24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
No pain 
Pain as bad as you  
can imagine 
 
  
 
 10 Overall, how bothered  
were you by your psoriasis-
related pain over the past 
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Not bothered  
at all 
As bothered as you  
can imagine 
 
  
 
 
11 Overall, how severe was 
your psoriasis scaling over 
the past 24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
No scaling  
Scaling as bad as you  
can imagine 
 
 
 
 
 
 
 
 
 

Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 80 of 91 
  
 
 
12 Overall, how bothered were 
you by your psoriasis 
scaling over the past 
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Not bothered  
at all 
As bothered as you  
can imagine 
 
  
 
 13 Overall, how noticeable did 
you think the color of your 
psoriasis-affected skin was 
over the past 24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Not at all  
noticeable 
As noticeable as you  
can imagine 
 
  
 
 14 Overall, how much did you 
try to hide your psoriasis-
affected skin over the past 
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
Did not try to  
hide at all 
Totally avoided being seen 
by others 
 
  
 
 15 Overall, how much did  
your psoriasis cause you  
to avoid activities with other 
people over the past  
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
You did not avoid  
other people  
Avoided other people as 
much as you ever have 
 
  
 
 16 Overall, how embarrassed 
were you because of your 
psoriasis over the past  
24 hours? 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10   
 
No embarrassment 
As embarrassed as you  
can imagine 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
© Novartis 2018 
 
 

Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 81 of 91 
Appendix 6: Dermatology Life Quality Index (DLQI) 
 
 
 
DERMATOLOGY LIFE QUALITY INDEX 
 
 
 
 
 
 
 
 
 
 
 
 
 DLQI 
Site No:  
 
 
 
 
Date: 
 
 
 
 
Score: 
Name:  
 
 
 
 
 
 
 
 
 
 
 
Address: 
 
 
 
 
Diagnosis: 
 
 
 
 
 
 
The aim of this questionnaire is to measure how much your skin problem has affected your life OVER 
THE LAST WEEK.  Please tick  one box for each question. 
 
 
1. 
Over the last week, how itchy, sore,  
 
 
 
Very much 
 
 
painful or stinging has your skin    
 
 
 
A lot 
 
 
 
been?   
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
2. 
Over the last week, how embarrassed 
 
 
 
Very much 
 
 
or self conscious have you been because   
 
 
A lot 
 
 
 
of your skin? 
 
  
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
3. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin interfered with you going 
 
  
 
 
A lot 
 
 
 
shopping or looking after your home or   
 
 
A little  
 
 
garden?        
 
 
 
 
 
 
Not at all 
 
Not relevant 
 
 
4. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin influenced the clothes  
 
 
 
 
A lot 
 
 
 
you wear? 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
Not relevant  
 
 
5. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin affected any social or  
 
 
 
 
A lot 
 
 
 
leisure activities? 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant  
 
 
6. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin made it difficult for   
 
 
 
 
A lot 
 
 
 
you to do any sport? 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant 
 
 
7. 
Over the last week, has your skin prevented 
 
 
Yes 
 
 
 
you from working or studying?  
 
 
 
No 
 
 
 
 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 
If "No", over the last week how much has   
 
 
A lot 
 
 
 
your skin been a problem at  
 
 
 
 
A little  
 

Protocol ARQ-154-204 
Arcutis, Inc. 
Amendment 2 
10 April 2020 
 
Confidential 
 Page 82 of 91 
 
work or studying? 
 
 
 
 
 
Not at all 
 
 
8. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin created problems with your   
 
 
 
A lot 
 
 
 
partner or any of your close friends 
 
 
 
A little  
 
 
or relatives?  
 
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant 
 
 
9. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin caused any sexual   
 
 
 
 
A lot 
 
 
 
difficulties? 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant 
 
 
10. 
Over the last week, how much of a  
 
 
 
Very much 
 
 
problem has the treatment for your 
 
 
 
A lot 
 
 
 
skin been, for example by making  
 
 
 
A little  
 
 
your home messy, or by taking up time?   
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant 
 
 
 
Please check you have answered EVERY question. Thank you.  
 
 
 
©AY Finlay, GK Khan, April 1992 www.dermatology.org.uk, this must not be copied without the permission of the authors. 
 
 
 

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

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