Conditions: Atopic Dermatitis
Keywords: eczema pediatric tapinarof phase 3 topical
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 728
Healthy volunteers: no

Brief summary:
This is an open-label, long-term multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in subjects with atopic dermatitis. Subjects in this study have completed treatment in one of two Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) or completed treatment in the DMVT-505-2104 study, or directly enrolled into this study. This study will consist of up to 48 weeks of treatment and a 1 week safety follow-up period.

Detailed description:
At the completion of the Week 8 visit of study DMVT-505-3101 (NCT05014568) or study DMVT-505-3102 (NCT05032859) or the Day 28 visit of study DMVT-505-2104 (NCT05186805) (Day 1 \[Baseline\] in this study), all eligible subjects will be offered enrollment in this open-label long-term extension (OL-LTE) study. Approximately 125 additional pediatric subjects ages 2 to \< 18 years who are not eligible for participation in the Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) will be enrolled directly into this OL-LTE study. Study visits during the treatment period for all subjects will occur every 4 weeks (± 3 days). The total duration of study participation will be approximately 48 weeks for rollover subjects (Baseline to Final Visit) with a 1-week Safety Follow-up Period and approximately 52 weeks for direct-enrolling subjects (Screening to Final Visit) with a 1-week Safety Follow-up Period.

Arms:
arm 1: Subjects entering with vIGA-AD (Validated Investigator Global Assessment of Atopic Dermatitis) ≥1 receive treatment with study drug until they achieve vIGA-AD=0, at which time treatment is discontinued and subjects are monitored for durability of response (remittive response). If/when disease worsening occurs (vIGA-AD ≥2), treatment is re-initiated and continued until vIGA-AD =0 is achieved.

Subjects entering with a vIGA-AD=0 discontinue treatment and are monitored for duration of remittive response. If/when disease worsening occurs (vIGA-AD ≥2), treatment is re-initiated and continued until vIGA-AD =0 is achieved.

This treatment and re-treatment pattern of use continue until the end of the study.

Interventions: intervention 1: Tapinarof cream, 1%
Intervention descriptions: intervention 1: Tapinarof cream, 1%, applied daily to affected areas by subjects or their caregivers based on vIGA-AD. Subjects are advised to choose the application time they prefer and apply the study drug at that approximate time each day of study participation.

Protocol document:
Prot_000.pdf: 
Tapinarof 
Protocol No.: DMVT-505-3103 
Dermavant Sciences, Inc. 
Clinical Study Protocol 
Confidentiality Statement 
The information contained in this document, particularly unpublished data, is the property or under control of Dermavant Sciences, 
Inc., and is provided to you in confidence as an investigator, potential investigator, or consultant, for review by you, your staff, and 
an applicable Institutional Review Board or Independent Ethics Committee.  The information is only to be used by you in 
connection with authorized clinical studies of the investigational drug described in the protocol.  You will not disclose any of the 
information to others without written authorization from Dermavant Sciences, Inc., except to the extent necessary to obtain 
informed consent from those persons to whom the drug may be administered. 
Confidential 
Page | 1 
 
 
 
 
  
 
Clinical Study Protocol  
Study Title: 
An Open-Label, Long-Term Extension Study to Evaluate the Safety and 
Efficacy of Tapinarof Cream 1% in Subjects with Atopic Dermatitis 
Sponsor: 
Dermavant Sciences, Inc. 
3300 Paramount Parkway, Suite 150 
Morrisville, NC, USA  27560 
Compound Name: 
Tapinarof (DMVT-505) 
Protocol Number: 
DMVT-505-3103 
Indication: 
Atopic Dermatitis 
Development Phase: 
3 
IND Number: 
104601 
Current Version: 
2.0 
Original Protocol 
Approved/Effective Date 
4/18/2021 
Amendment 1 
Approved/Effective Date: 
6/16/2021 
 
 
 
 
 
 


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Protocol No.: DMVT-505-3103 
Dermavant Sciences, Inc.  
Clinical Study Protocol  
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Sponsor Signature Page 
 
 
 
 
Study Title: 
An Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of 
Tapinarof Cream 1% in Subjects with Atopic Dermatitis 
Protocol Number: 
DMVT-505-3103 
 
 
 
 
 
 
This protocol has been approved by a representative of Dermavant Sciences, Inc.  The following signature 
documents this approval. 
 
 
 
6/16/2021 
Date 
 
This electronic signature is legally binding equivalent of traditional handwritten signatures and is captured in the audit trail of 
the document. 
 
 
 
 




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Protocol No.: DMVT-505-3103 
Dermavant Sciences, Inc.  
Clinical Study Protocol  
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Investigator Statement 
 
Study Title: 
An Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of 
Tapinarof Cream 1% in Subjects with Atopic Dermatitis 
 
 
 
• I confirm agreement to conduct the study in compliance with the protocol. 
• I acknowledge that I am responsible for overall study conduct.  I agree to personally conduct or 
supervise the described study. 
• I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study 
are informed about their obligations and comply with the study protocol.  Mechanisms are in place 
to ensure that site staff receives the appropriate information throughout the study. 
 
 
 
 
 
Principal Investigator Name 
 
Signature 
 
 
 
 
 
 
 
 
 
Date 
 
Site 
 
 
 
 
 
 
 
 
 


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Protocol No.: DMVT-505-3103 
Dermavant Sciences, Inc.  
Clinical Study Protocol  
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Table of Contents  
Synopsis     . ..................................................................................................................................................... 12 
1 
Introduction ................................................................................................................................... 23 
1.1 
Background Information and Study Rationale ............................................................................. 23 
1.1.1 
Background Information ............................................................................................................... 23 
1.1.2 
Study Rationale ............................................................................................................................. 24 
1.2 
Rationale for Study Design, Dose, and Control Groups ............................................................... 25 
1.3 
Potential Risks and Benefits ......................................................................................................... 25 
 
 
 
 
 
 
 
 
1.3.2 
Benefit Assessment ....................................................................................................................... 26 
1.3.3 
Overall Benefit Risk ..................................................................................................................... 26 
2 
Objectives and Endpoints ............................................................................................................. 27 
3 
Study Design ................................................................................................................................. 29 
3.1 
Overall Design .............................................................................................................................. 29 
3.2 
Treatment Groups and Duration ................................................................................................... 30 
4 
Study Population ........................................................................................................................... 31 
4.1 
Type and Number of Subjects ...................................................................................................... 31 
4.2 
Inclusion Criteria .......................................................................................................................... 31 
4.3 
Exclusion Criteria ......................................................................................................................... 32 
4.4 
Lifestyle Restrictions .................................................................................................................... 35 
4.5 
Withdrawal Criteria ...................................................................................................................... 35 
4.5.1 
Reasons for Withdrawal from the Study ...................................................................................... 35 
4.5.2 
Withdrawal Procedures ................................................................................................................. 36 
4.6 
Lost to Follow-Up......................................................................................................................... 36 
5 
Study Treatment ............................................................................................................................ 37 
5.1 
Study Drug .................................................................................................................................... 37 
5.1.1 
Description, Packaging, and Labeling .......................................................................................... 37 
5.1.2 
Storage .......................................................................................................................................... 37 
5.1.3 
Handling and Disposal .................................................................................................................. 37 
5.1.4 
Preparation .................................................................................................................................... 37 
5.1.5 
Administration of Study Drug ...................................................................................................... 37 
5.1.5.1 
Treatment Based on Validated Investigator Global Assessment of Atopic Dermatitis ................ 37 




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Clinical Study Protocol  
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6.3.3 
Optional Clinical Photography ..................................................................................................... 49 
6.4 
Treatment of Study Drug Overdose .............................................................................................. 49 
6.5 
Virtual Assessments ...................................................................................................................... 49 
7 
Timing of Procedures and Assessments ....................................................................................... 51 
7.1 
Visit 0; Screening Period for Direct-Enrolling Subjects (Day -30 to Day -1) .............................. 51 
7.2 
Visit 1; Baseline (Day 1) .............................................................................................................. 51 
7.2.1 
Baseline Visit for Subjects Rolling Over from DMVT-505-3101 and DMVT-505-3102 ........... 51 
7.2.2 
Baseline Visit for Subjects Rolling Over from DMVT-505-2104 ............................................... 52 
7.2.3 
Baseline Visit for Subjects Enrolling Directly into DMVT-505-3103 ......................................... 53 
7.3 
Visits 2 to 13; Treatment Period ................................................................................................... 54 
7.4 
Phone Contact at Week 2 (Day 15 ± 3 Days) ............................................................................... 55 
7.5 
Follow-Up Visit 14; Week 49 (Day 344 ±3 Days) ....................................................................... 55 
7.6 
Unscheduled Visits ....................................................................................................................... 56 
7.7 
Early Termination Visit ................................................................................................................ 56 
7.8 
End of Study ................................................................................................................................. 57 
8 
Safety Monitoring and Reporting ................................................................................................. 58 
8.1 
Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest ..................... 58 
8.1.1 
Definition of Adverse Events ....................................................................................................... 58 
8.1.2 
Definition of Serious Adverse Event ............................................................................................ 59 
8.1.3 
Adverse Events of Special Interest ............................................................................................... 60 
8.2 
Classification of Adverse Events .................................................................................................. 61 
8.2.1 
Assigning Severity Rating for Adverse Events ............................................................................ 61 
8.2.1.1 
Criteria for Determining Adverse Event Severity ........................................................................ 61 
8.2.1.2 
Toxicity Management Criteria ...................................................................................................... 61 
8.2.1.2.1 
Grade 1 or Grade 2 Adverse Event ............................................................................................... 61 
8.2.1.2.2 
Grade 3 Adverse Event ................................................................................................................. 61 
8.2.1.2.3 
Grade 4 Adverse Event ................................................................................................................. 61 
8.2.1.2.4 
Folliculitis ..................................................................................................................................... 62 
8.2.1.2.5 
Other Management Criteria: ......................................................................................................... 62 
8.2.2 
Assigning Causal Relationship to Study Drug ............................................................................. 62 
8.3 
Time Period and Frequency for Event Assessment and Follow-Up ............................................. 62 
8.3.1 
Adverse Event Reporting .............................................................................................................. 62 
8.3.2 
Follow-Up of Adverse Events ...................................................................................................... 63 
8.4 
Reporting Procedures .................................................................................................................... 63 
8.4.1 
Serious Adverse Event Reporting ................................................................................................. 63 


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8.4.2 
Regulatory Reporting Requirements for Serious Adverse Events ............................................... 63 
8.5 
Pregnancy Management and Reporting ........................................................................................ 64 
9 
Data Management ......................................................................................................................... 65 
10 
Statistical Considerations and Data Analyses ............................................................................... 66 
10.1 
General Considerations ................................................................................................................. 66 
10.2 
Determination of Sample Size ...................................................................................................... 66 
10.3 
Analysis Populations .................................................................................................................... 66 
10.4 
Planned Analyses .......................................................................................................................... 66 
10.4.1 
Disposition and Demographics ..................................................................................................... 66 
10.4.2 
Efficacy Analyses ......................................................................................................................... 66 
10.4.3 
Safety Analyses ............................................................................................................................ 68 
10.4.4 
 ................................................ 68 
10.4.5 
 ............................................................................. 69 
10.5 
Interim Analyses ........................................................................................................................... 69 
10.6 
Handling of Missing Data ............................................................................................................. 69 
11 
Responsibilities ............................................................................................................................. 70 
11.1 
Investigator Responsibilities ......................................................................................................... 70 
11.1.1 
Good Clinical Practice .................................................................................................................. 70 
11.1.2 
Institutional Review Board/Independent Ethics Committee Approval ........................................ 70 
11.1.3 
Informed Consent/Assent ............................................................................................................. 70 
11.1.4 
Confidentiality .............................................................................................................................. 70 
11.1.5 
Study Files and Retention of Records .......................................................................................... 71 
11.1.6 
Electronic Case Report Forms ...................................................................................................... 72 
11.1.7 
Drug Accountability ..................................................................................................................... 72 
11.1.8 
Inspections .................................................................................................................................... 72 
11.1.9 
Protocol Compliance .................................................................................................................... 72 
11.2 
Sponsor Responsibilities ............................................................................................................... 73 
11.2.1 
Protocol Modifications ................................................................................................................. 73 
11.2.2 
Study Report and Publications...................................................................................................... 73 
11.2.3 
Posting of Information on Publicly Available Clinical Trial Registers ........................................ 73 
11.3 
Joint Investigator/Sponsor Responsibilities .................................................................................. 73 
11.3.1 
Access to Information for Monitoring .......................................................................................... 73 
11.3.2 
Access to Information for Auditing or Inspections ...................................................................... 74 
11.3.3 
Study Discontinuation .................................................................................................................. 74 
12 
References ..................................................................................................................................... 75 




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Clinical Study Protocol  
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Table of Abbreviations 
Term 
Full Description 
AD 
atopic dermatitis 
AE 
adverse event 
AESI 
adverse event of special interest 
AhR 
Aryl hydrocarbon receptor 
ALT 
alanine aminotransferase 
Anti-HBc 
anti-hepatitis B core antigen 
Anti-HBs 
anti-hepatitis B surface antigen 
ARNT 
AhR nuclear translocator 
AST 
aspartate aminotransferase 
BID 
twice daily 
BMI 
body mass index 
BSA 
body surface area 
%BSA 
percent of total body surface area 
BUN 
blood urea nitrogen 
BWTP 
Beijing Wenfeng Tianji Pharmaceutical Technology Co. 
C 
collect 
 
 
CFR 
Code of Federal Regulations 
CRF 
case report form 
CTCAE 
Common Terminology Criteria for Adverse Events 
CV 
cardiovascular  
D 
dispense 
Dermavant 
Dermavant Sciences, Inc. 
 
 
EASI 
Eczema Area and Severity Index 
 
  
ET 
early termination 
FU 
follow-up 
GSK 
GlaxoSmithKline 
HBsAg 
hepatitis B surface antigen 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
 
 
IEC 
Independent Ethics Committee 
IL 
interleukin 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
JAK 
Janus kinase 
LOCF 
last observation carried forward 
 
 
MCH 
mean corpuscular hemoglobin 
MCHC 
mean corpuscular hemoglobin concentration 
MCV  
mean corpuscular volume 
NA 
not applicable 
Nrf2 
nuclear factor erythroid 2-related factor 2 
OC 
observed case 
OL-LTE 
open-label, long-term extension 


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Clinical Study Protocol  
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Term 
Full Description 
P/C 
phone contact 
PGA 
Physician’s Global Assessment 
PK 
pharmacokinetic(s) 
 
 
PP-NRS 
Peak Pruritus-Numeric Rating Scale 
QD 
once daily 
RBC 
red blood cell(s) 
SAE 
serious adverse event 
SD 
standard deviation 
TAMA 
therapeutic AhR-modulating agent 
TEAE 
treatment-emergent adverse event 
ULN 
upper limit of normal 
US 
United States 
V 
visit 
vIGA-AD™ 
validated Investigator Global Assessment for Atopic Dermatitis 
WBC 
white blood cell(s) 
WOCBP 
women of child-bearing potential 
 
 
 
 


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Clinical Study Protocol  
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Synopsis       
Name of Sponsor/Company: 
Dermavant Sciences, Inc. 
Name of Investigational Product: 
DMVT-505 (tapinarof cream, 1%) 
Name of Active Ingredient:   
Tapinarof 
Protocol Number: 
DMVT-505-3103 
Phase: 
3 
Country: 
United States (US) and Canada 
Title of Study: 
An Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream 1% in Subjects with Atopic 
Dermatitis 
Study Site(s): 
Up to approximately 135 sites in the US and Canada 
Objectives: 
• 
To evaluate the safety and tolerability of tapinarof cream, 1% in subjects with atopic dermatitis (AD) 
• 
To evaluate the efficacy of tapinarof cream, 1% over an extended period of time in subjects with AD 
• 
To describe the effect of tapinarof cream, 1% on AD symptom severity and the associated impact on daily 
activities and attitudes in subjects with AD 
Methodology: 
This is an open-label, long-term multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in subjects 
with AD.  Subjects in this study will have either: a) completed treatment with tapinarof or vehicle in one of two Phase 3 pivotal 
safety and efficacy studies, DMVT-505-3101 or DMVT-505-3102, and rolled over into this study; b) completed treatment with 
tapinarof in the Phase 2 maximal use pharmacokinetics [PK] study, DMVT-505-2104, and rolled over into this study; or c) 
enrolled directly into this study.  This study will consist of up to 48 weeks of treatment and a 1-week safety follow-up period. 
At the completion of the Week 8 visit of study DMVT-505-3101 or study DMVT-505-3102 or the Day 28 visit of study DMVT-
505-2104 (Baseline [Day 1] in this study), all eligible subjects will be offered enrollment in this open-label long-term extension 
(OL-LTE) study.  Approximately 125 additional pediatric subjects ages 2 to < 18 years who are not eligible for participation in the 
Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) will be enrolled directly into this OL-LTE study.  Study visits 
during the treatment period for all subjects will occur every 4 weeks (± 3 days).  Unscheduled visits may occur, as needed.  
Subjects who withdraw from the study before Week 48 will return to the study site for an Early Termination visit.  The total 
duration of subject participation in this study will be approximately 49 weeks for rollover subjects (Baseline to Follow-Up) and 
approximately 53 weeks for direct-enrolling subjects (Screening to Follow-Up). 
Rollover subjects in this study will begin treatment based on their validated Investigator Global Assessment in Atopic Dermatitis 
(vIGA-ADTM) score from the final visit in one of the three aforementioned studies (DMVT-505-3101, DMVT-505-3102, or 
DMVT-505-2104).  Subjects entering with a vIGA-ADTM ≥ 1 will receive treatment once daily (QD) with tapinarof cream, 1% 
until they achieve a vIGA-ADTM score of 0, at which time treatment will be discontinued and subjects monitored for maintenance 
of disease control (i.e., the extent of the remittive effect).  If/when disease worsening occurs, as evidenced by a flare to 
vIGA-ADTM ≥ 2, treatment will be re-initiated and continued until a vIGA-ADTM of 0 is achieved. Subjects entering with a 
vIGA-ADTM of 0 will have treatment discontinued beginning at the Baseline visit and will be monitored for maintenance of the 
remittive effect.  If/when disease worsening occurs, as evidenced by a flare to vIGA-ADTM ≥ 2, treatment will be re-initiated and 
continued until a vIGA-ADTM of 0 is achieved.   This regimen of treatment and re-treatment will continue until the end of the 
study (i.e., subjects may receive study drug up until the Week 48 visit). 
Subjects enrolling directly into this study will receive treatment QD with tapinarof cream, 1% beginning at Baseline and continue 
treatment until they achieve a vIGA-ADTM score of 0, at which time treatment will be discontinued and subjects monitored for 
maintenance of the remittive effect.  If/when disease worsening occurs, as evidenced by a flare to vIGA-ADTM ≥ 2, treatment will 
be re-initiated and continued until a vIGA-ADTM of 0 is achieved.  This regimen of treatment and re-treatment will continue until 
the end of the study (i.e., subjects may receive study drug up until the Week 48 visit). 
Study drug will be dispensed to subjects or their caregivers, applied during the clinic visits, and applied at home between clinic 
visits as instructed by site personnel.  Subjects or their caregivers will be instructed to apply study drug QD to all affected areas, 
including newly appearing lesions and lesions/areas that improve during the study until a vIGA-ADTM of 0 is achieved.  Once a 
vIGA-ADTM of 0 is achieved, the treatment period ends. If/when disease worsening occurs, and treatment is re-initiated at a 
vIGA-ADTM of ≥ 2, all lesions currently present and any new lesions that occur during the new treatment period should be treated.  
Subjects or caregivers will apply sufficient study drug to cover each lesion completely with a thin layer of study drug and will 
record the time of study drug application and daily itch score (Peak Pruritus-Numeric Rating Scale [PP-NRS]) in a daily diary 


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Protocol No.: DMVT-505-3103 
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Clinical Study Protocol  
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provided by the study site.  Subjects are allowed, but not required, to treat scalp lesions with study drug; however, efficacy 
analyses will not include assessment of improvement for AD on the scalp.  At the first clinic visit, if applicable, subjects and/or 
caregivers will be instructed to maintain the approximate dosing time for the daily application of study drug.  If applicable to the 
subject, study drug application instructions will be reviewed at subsequent clinic visits.  During subsequent clinic visits, after 
efficacy and safety assessments (except for Local Tolerability Scale [LTS] if applicable) are completed, subjects or caregivers will 
apply the study drug to the affected areas while under the supervision of site personnel.  The time of the study drug application and 
assessments will depend on the time of the clinic visit (either morning or afternoon visit).  For subjects receiving study drug, 
subjects should resume their regular chosen application time the following day and thereafter. 
Number of Subjects: 
Up to 961 subjects ages 2 years and above will be enrolled in the study, including up to 836 rollover subjects from studies DMVT-
505-3101, DMVT-505-3102, and DMVT-505-2104 and approximately 125 subjects enrolling directly into this study. 
Diagnosis and Main Criteria for Inclusion: 
Inclusion Criteria: 
Each subject must meet all the following criteria to be eligible to participate in the study: 
 
For Rollover Subjects Only: 
1. Met the criteria as a Study Completer in one of three parent studies (Phase 3 pivotal safety and efficacy study DMVT-
505-3101, Phase 3 pivotal safety and efficacy study DMVT-505-3102, or Phase 2 maximal use PK study DMVT-505-
2104) and was still receiving study drug at the last visit of one of these studies.  
NOTE: To meet the criteria as a Study Completer in one of the three parent studies, a subject must have completed ≥ 
80% of the intended doses in that study. 
2. Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline (Day 1). 
 
For Direct-Enrolling Subjects Only: 
3. Male and female subjects ages 2 years to < 18 years at the time of consent with clinical diagnosis of AD by Hanifin and 
Rajka criteria. 
4. Subjects with a vIGA-AD™ score of ≥ 3 and AD covering ≥ 40% of the body surface area (BSA) at Screening and 
Baseline (pre-randomization), or subjects with a vIGA-AD™ score of 2 at Screening and Baseline (pre-randomization) 
regardless of BSA.  Scalp should be excluded from the BSA calculation to determine eligibility during Screening and at 
Baseline, and for all efficacy assessments.  Subjects must have screened for the DMVT-505-3101 or DMVT-505-3102 
study and failed to meet BSA and/or vIGA-AD™ eligibility criteria. 
NOTE: Subjects with disease only on palms and soles are not eligible. 
5. AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old, confirmed by prior 
medical documentation and/or according to the subject/caregiver report. 
6. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine 
pregnancy test at Baseline (Day 1). 
 
For All Subjects (Rollover Subjects and Direct-Enrolling Subjects): 
7. Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use one 
of the following acceptable birth control methods while on study and for 4 weeks after the last exposure to study drug.   
• 
Acceptable contraception methods include intrauterine device, hormonal contraceptives, barrier method (e.g., 
condom or diaphragm), or surgical sterilization of male partner (vasectomy)  
• 
Subjects who claim abstinence as their method of contraception are allowed provided they agree to use a barrier 
method (e.g., condom or diaphragm) should they become sexually active from Baseline to 4 weeks after the last dose 
of study drug 
Non-child-bearing potential is defined as:  
• 
premenarchal  
• 
pre-menopausal females with a documented bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or 
hysteroscopic sterilization 


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• 
postmenopausal female with a cessation of menses for at least 12 months without an alternative medical cause; a 
blood sample with follicle stimulating hormone > 40 mIU/mL is confirmatory in questionable cases 
8. Subject, subject’s parent(s), or legal representative must be capable of giving written informed consent/assent, which 
includes compliance with the requirements and restrictions listed in the consent/assent form; written informed consent 
must be obtained prior to any study related procedures. 
Exclusion Criteria: 
A subject who meets any of the following criteria will be excluded and considered ineligible for participation in the study:  
 
For Rollover Subjects Only: 
1. Subjects who were not receiving study drug at the time of the last visit in the parent study (DMVT-505-3101, DMVT-
505-3102, or DMVT-505-2104). 
2. Used a prohibited concomitant product or procedure to treat AD during the parent study.  
3. Had a serious adverse event (SAE) that was related to treatment or experienced an adverse event (AE) that led to 
permanent discontinuation of treatment in the parent study.  
4. Pregnant females as determined by positive urine human chorionic gonadotropin test at Baseline. 
 
For Direct-Enrolling Subjects Only: 
5. Concurrent conditions:  
a. 
Immunocompromised (e.g., lymphoma, acquired immunodeficiency syndrome) or medical history of positive 
human immunodeficiency virus antibody at Screening.  
b. Chronic or acute systemic infection requiring treatment with antiparasitics or antiprotozoals, within 4 weeks 
prior to the Baseline visit.  
c. 
Chronic or acute systemic bacterial infection requiring treatment with systemic antibiotics within one week prior 
to the Baseline visit. 
d. Chronic or acute superficial fungal infection requiring treatment with systemic antifungals within one week prior 
to the Baseline visit. 
e. 
Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection within 1 week 
prior to the Baseline visit; the condition should be completely resolved one week prior to Baseline Visit. 
f. 
Significant dermatologic or inflammatory condition other than AD that, in the Investigator’s opinion, would 
make it difficult to interpret data or assessments during the study.  For example, subjects with an active skin 
condition such as Kaposi's varicelliform eruption, scabies, molluscum contagiosum, impetigo, psoriasis, severe 
acne, connective tissue disorder, or Netherton's syndrome, or any other concurrent active disease.  
g. Concurrent skin lesions in the treatment area or pruritus due to conditions other than AD that, in the opinion of 
the Investigator, would either interfere with study evaluations or affect the safety of the subject. 
6. Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.0 x the upper limit of normal (ULN). 
7. Screening total bilirubin > 1.5x ULN; total bilirubin > 1.5x ULN is acceptable if bilirubin is fractionated and direct 
bilirubin < 35%. 
8. Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert’s 
syndrome or asymptomatic gallstones), presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody 
test result, or presence of anti-hepatitis B core antigen (anti-HBc).  Subjects having a negative HBsAg and a positive 
anti-HBc may enroll if they have a positive anti-hepatitis B surface antigen demonstrating natural immunity.  Subjects 
with a history of hepatitis C virus infection who were medically cured and have an undetectable viral load are eligible to 
enroll.  Subjects with a history of stable non-alcoholic fatty liver disease without evidence of active inflammation 
(elevated ALT/AST ≥ 2.0x ULN) or cirrhosis are eligible to enroll. 
9. Current or a history of cancer within 5 years except for adequately treated skin basal cell carcinoma, cutaneous squamous 
cell carcinoma or carcinoma in situ of the cervix (surgical excision or electrodessication and curettage). 
10. Pregnant females as determined by positive serum (Screening) or urine (Baseline) human chorionic gonadotropin test. 


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11. Lactating females. 
12. Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001). 
13. Use of any prohibited medication or procedure within the indicated period before the Baseline visit.  
NOTE:  Prohibited concomitant medications, therapy, etc. during the defined period are as listed in the bullets below.  If 
a subject requires any of these medications throughout the study period, he/she may be excluded from or discontinued 
from the study, at the discretion of the Investigator and Medical Monitor.  
a. 
From 4 months prior to Baseline:  
o 
DUPIXENT® (dupilumab) injection.  
o 
Any monoclonal antibody product that becomes approved for AD during the course of the trial. 
b. From 28 days prior to Baseline:  
o 
Oral, injectable, and suppository preparations of corticosteroids.  Eye drops and nasal preparations are 
allowed.  Inhaled preparations are allowed when used for a stable condition and stable dose for > 28 
days before Screening and are continued at the same dose throughout the study.  
o 
Oral preparations and injections of immunosuppressants (cyclosporine, methotrexate, azathioprine, 
tacrolimus, Janus kinase [JAK] inhibitors, etc.). 
o 
Excessive sun exposure, tanning booth, other ultraviolet light source and phototherapy including 
psoralen and ultraviolet A therapy or is unwilling to minimize natural and artificial sunlight exposure.  
o 
Treatment with antivirals with the exception of short-term treatment for acute upper respiratory viral 
infections (i.e., influenza) or viral suppressive therapy for a history of recurrent herpes labialis or 
genital herpes. 
c. 
From 14 days prior to Baseline:  
o 
EUCRISA® (crisaborole) and any other PDE4 inhibitor. 
o 
Tacrolimus ointment and pimecrolimus cream. 
o 
Topical JAK inhibitors. 
o 
Topical corticosteroids that are classified as medium or high potency (e.g., fluocinonide, triamcinolone 
acetonide) or super-high potency (e.g., clobetasol propionate).  Eye drops and nasal preparations are 
allowed.  
o 
Over the counter or herbal medicines for AD (topical and oral preparations).  If subjects are using 
emollients, they may continue to use the same emollient on nonlesional skin during the study.  
Emollients containing salicylic acid are prohibited during the study. 
d. From 7 days prior to Baseline:  
o 
Topical corticosteroids that are classified as low potency (e.g., desonide, hydrocortisone).    
o 
Oral, injectable, or intravenous antibiotics or antifungal medications. 
o 
Topical doxepin, topical gentamicin, or topical neomycin sulfate. 
NOTE: Oral doxepin is allowed for treatment of depression if subject has been on a stable dose (4 
weeks) at Screening. 
o 
Topical products containing urea, except for the treatment of follicular events. 
o 
Antihistamines/antiallergics (oral, topical and injections):  diphenhydramine, chlorpheniramine 
maleate, hydroxyzine.  
NOTE:  For direct-enrolling subjects, the following antihistamines are allowed from Screening 
throughout the treatment period: loratadine, fexofenadine hydrochloride, cetirizine hydrochloride.  
Subjects are allowed to switch from non-allowed antihistamines to allowed antihistamines during 
Screening but must be on a stable dose for 7 days prior to Baseline. 
e. 
The subject has received an investigational product within the following time period prior to the first dosing day 
in the current study:  Minimum of 30 days or 5 half-lives of the investigational product (whichever is longer). 
 
For All Subjects (Rollover Subjects and Direct-Enrolling Subjects): 








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Dermavant Sciences, Inc.  
Clinical Study Protocol  
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Procedures and Assessment 
 
Subjects Rolling Over 
From DMVT-505-3101 or 
DMVT-505-3102 
 
Subjects Rolling Over 
From DMVT-505-2104 
 
Subjects Enrolling Directly Into 
DMVT-505-3103 
Visit 1 
Visit 1 
Visit 0 
Visit 1 
Baselinea 
Day 1 
Baselineb 
Day 1 
Screening 
Day -30 to    Day -
1 
Baseline 
Day 1 
Concomitant medication 
X 
 
X 
 
X 
X 
Dispense (D) /collect (C) diaryp 
D 
D 
 
D 
Dispense (D) /collect (C) study drugs 
D 
D 
 
D 
Review instructions for study drug applicationt 
X 
X 
 
X 
Study drug application under supervisions 
X 
X 
 
X 
 
 




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Protocol No.: DMVT-505-3103 
Dermavant Sciences, Inc.  
Clinical Study Protocol  
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Long-term Extension Period for All Subjects 
FU 
ETv 
Procedures and 
Assessment 
P/Cw 
V 2 
V 3 
V 4 
V 5 
V 6 
V 7 
V 8 
V 9 
V 10 
V 11 
V12 
V 13 
V 14 
NA 
Week  
2 
Day 15 
(±3 
days) 
Week  
4 
Day 29 
(± 3 
days) 
Week 
8 
Day 57 
(±3 
days) 
Week  
12 
Day 85 
(±3 
days) 
Week  
16 
Day113 
(±3 
days) 
Week  
20 
Day 141 
(±3   
days) 
Week  
24 
Day 169 
(±3   
days) 
Week  
28 
Day 197 
(±3   
days) 
Week  
32 
Day 225 
(±3   
days) 
Week  
36  
Day 253 
(±3   
days) 
Week  
40 
Day 281 
(±3   
days) 
Week 
44 
Day 309 
(±3   
days) 
Week 
48 
Day 337 
(±3  
days) 
Week 
49 
Day 344 
(±3   
days) 
NA 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medication 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Dispense (D) /collect (C) 
diaryp 
 
C/D 
C/D 
C/D 
C/D 
C/D 
C/D 
C/D 
C/D 
C/D 
C/D 
C/D 
C 
 
C 
Review diaries for 
treatment compliance 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
Dispense (D) /collect (C) 
study drugs 
 
C/D 
C/D 
C/D 
C/D 
C/D 
C/D 
C/D 
C/D 
C/D 
C/D 
C/D 
C 
 
C 
Review instructions for 
study drug applicationt 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Study drug application 
under supervisionu 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
a. Baseline Visit to occur at the time of completion of Visit 6 (Week 8) from the DMVT-505-3101 or DMVT-505-3102 studies. Assessments with an unbracketed X should be 
completed at the Baseline visit.  For assessments with a bracketed X, the assessment completed at the final visit of the parent study will be used as the Baseline value for this study.   
b. Baseline Visit to occur at the time of completion of Visit 4 (Day 28) from the DMVT-505-2104 study. Assessments with an unbracketed X should be completed at the Baseline visit.  
For assessments with a bracketed X, the assessment completed at the final visit of the parent study will be used as the Baseline value for this study. 
c. Demographics/Fitzpatrick skin type as collected at Screening in one of three parent studies (Phase 3 pivotal safety and efficacy study DMVT-505-3101, Phase 3 pivotal safety and 
efficacy study DMVT-505-3102, or Phase 2 maximal use PK study DMVT-505-2104).   
d. Review medical history as collected in one of three parent studies. 
e. Medical history will include year of AD diagnosis, CV family history, allergic conditions, and risk factors (including height, weight, medical conditions) and family history of liver 
disease.  As part of the subject’s medical history, all systemic (oral and injectable) medications used by the subject for treatment of AD prior to 30 days before the Screening visit will 
be collected. 
f. Review medical history at Baseline and record any changes. 
g. Physical examination will include height and weight (BMI will be calculated in the CRF) at the Screening visit; a brief physical examination will be performed at other visits. 
h. Vital signs will include blood pressure, pulse rate, and body temperature and should be measured after the subject is seated for at least 5 minutes. Vital signs will be measured before 
blood collection for clinical laboratory assessments (where applicable). 
i. Serum pregnancy test to be performed at the Screening visit only and urine pregnancy test to be performed at subsequent clinic visits when pregnancy testing is performed. 
j. Urine pregnancy test to be performed before randomization. 
k. Includes serum chemistry and liver chemistry tests, and hematology. 
l. Blood sample collection for clinical laboratory tests is not required at the Baseline Visit if it has been ≤14 days since samples were collected at Screening and the results of those 
clinical laboratory tests were within the normal range. 
m. Urine sample collection for urinalysis is not required at the Baseline Visit if it has been ≤14 days since samples were collected at Screening and the results of those clinical 
laboratory tests were within the normal range. 




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1 Introduction  
1.1 Background Information and Study Rationale  
1.1.1 Background Information  
Atopic dermatitis (AD) (also called atopic eczema) is an intensely pruritic, chronic, relapsing, inflammatory 
skin disease [Bieber, 2008].  The characteristic signs and symptoms of AD include sensations of pruritis and 
burning, xerosis, erythematous papules and plaques, exudation, crusting, and lichenification.  Quality of life is 
affected through sleep deprivation due to the intense and constant itching, as well as the stigma associated 
with having a visible skin disease [Carroll, 2005; Lewis-Jones, 2006].  Up to 30% of children may be affected 
by AD at some point, and 2% to 10% of adults have AD [Bieber, 2008].  Currently there is no curative 
therapy.  Stabilizing the disease and reducing the number and severity of flares are the primary goals of 
treatment.  Topical treatments directed at skin inflammation are a key factor in disease management, as is 
symptomatic relief of itching.  Although multiple topical treatment options are available, there still remains a 
need for a topical treatment that combines a high level of efficacy with an acceptable safety profile that 
permits application to a large body surface area (BSA) without restrictions on duration of treatment. 
Tapinarof (DMVT-505), formerly known as GSK2894512 and WBI-1001, is a fully synthetic naturally 
identified stilbene that is being developed by Dermavant Sciences, Inc. (Dermavant) as a novel 
anti-inflammatory agent for the topical treatment of AD and plaque psoriasis.  The compound (number 
WBI-1001) was initially developed by Welichem Biotech Inc.  (Welichem; Burnaby, British Columbia, 
Canada) and then was acquired by GlaxoSmithKline (GSK) on 31 July 2012 for further development in the 
rest of the world except China.  Dermavant acquired the drug from GSK on 20 August 2018 for continued 
development in all other territories.  Development of tapinarof cream in Japan is being jointly pursued with 
Japan Tobacco Inc. (JT), with a Phase 3 program in PSO and AD scheduled to commence in late 2021.  In 
China, the compound was independently developed by Beijing Wenfeng Tianji Pharmaceutical Technology 
Co. (BWTP) (Shenzhen Celestial) under the name benvitimod (active ingredient corresponds to tapinarof).  
BWTP was granted authorization to market benvitimod cream (a different formulation and excipient profile 
compared to tapinarof cream) as Symbiox® in China in July 2019. 
Tapinarof cream, 1% is a white to off-white, oil-in-water emulsion intended for topical application to AD and 
psoriatic skin lesions, which has a novel mechanism of action.  Tapinarof is a nonsteroidal, small molecule 
therapeutic aryl hydrocarbon receptor (AhR) modulating agent (TAMA), which exerts its therapeutic effects 
via agonism of AhR, a cytosolic ligand-dependent transcription factor.  Upon ligand binding, AhR 
translocates to the nucleus and dimerizes with AhR nuclear translocator (ARNT) forming an AhR-ARNT 
heterodimer [Smith, 2017]. The AhR-ARNT heterodimer modulates gene transcription through direct and 
indirect interaction with DNA. By activation of this AhR signaling pathway, tapinarof has the potential to 
downregulate the expression of pro-inflammatory cytokines, including interleukin (IL)-4, IL-5, IL-6, IL-13, 
IL-17A and F, and eotaxin, and upregulate the expression of several skin barrier proteins, including filaggrin, 
hornerin, and involucrin.   In addition, AhR also activates the antioxidative transcription factor nuclear factor-
erythroid 2-related factor-2 (Nrf2), upregulating the expression of antioxidative enzymes [Smith, 2017; Furue, 
2019].  By targeting AhR, tapinarof has a biological profile that differs from that of currently available 
products, offering patients a truly novel therapeutic treatment option for plaque psoriasis and AD.   
Two Phase 2b, 12-week, randomized, double-blind, vehicle-controlled, 6-arm, parallel group, dose-finding 
studies with topically applied tapinarof cream were conducted by GSK; 1 study each in subjects with AD or 
psoriasis.  These 2 studies evaluated the safety and efficacy of tapinarof cream (Formulation F) at 


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Protocol No.: DMVT-505-3103 
Dermavant Sciences, Inc.  
Clinical Study Protocol  
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Page | 24 
2 concentrations (0.5% or 1% weight/weight [w/w]) and 2 application frequencies (once daily [QD] or twice 
daily [BID]) in 247 adult and adolescent subjects with AD and in 227 adult subjects with plaque psoriasis.  In 
both studies, tapinarof showed a clear therapeutic effect compared with vehicle, with the 1% w/w 
concentration treatment groups demonstrating a higher proportion of subjects with treatment success 
compared with the 0.5% w/w concentration groups (applied QD and BID in the AD study).  In both 
indications, the tapinarof 1% dosing groups showed a faster onset of action than the 0.5% dosing groups, and 
QD application had similar efficacy to BID application.  In both Phase 2b studies, tapinarof showed an 
acceptable safety profile.  Treatment-emergent adverse events (TEAEs) were reported with a higher frequency 
in the tapinarof groups than in the vehicle groups.  The most frequent TEAEs (≥ 5% in any arm or in total) 
were nasopharyngitis, folliculitis, dermatitis contact, atopic dermatitis, upper respiratory tract infection, 
headache, vomiting, acne, application site dermatitis, miliaria, dermatitis allergic, and impetigo.  The majority 
of TEAEs were mild or moderate in severity.  In each study, the tapinarof 1% QD treatment group had a 
lower frequency of TEAEs than the tapinarof 1% BID treatment group. 
Tapinarof has been evaluated in two identical Phase 3, 12-week, randomized, double-blind, vehicle-controlled 
trials in adult subjects with plaque psoriasis.  These studies evaluated the safety and efficacy of tapinarof 
cream, 1% QD versus vehicle cream QD in a combined 1025 subjects randomized 2:1 tapinarof to vehicle.  In 
both trials, tapinarof demonstrated superiority against vehicle on the primary endpoint, a Physician Global 
Assessment (PGA) score of 0 (clear) or 1 (almost clear) with a 2-point improvement at Week 12.  In addition, 
tapinarof was highly statistically significant compared to vehicle on all secondary endpoints which included 
proportion of subjects achieving a 75% improvement in the Psoriasis Area and Severity Index, a PGA score of 
0 or 1, change in percent body surface area (%BSA), and proportion of subjects achieving a 90% 
improvement in the Psoriasis Area and Severity Index at Week 12.  TEAEs were reported with a higher 
frequency in the tapinarof group than in the vehicle group.  The most frequent TEAEs (≥ 5% in any arm or in 
total) were folliculitis, nasopharyngitis, and contact dermatitis.  The majority of TEAEs were mild or 
moderate in intensity. 
Tapinarof has also been evaluated in an open-label, long-term extension (OL-LTE) study in adult subjects 
with plaque psoriasis.  The OL-LTE study in adults with plaque psoriasis evaluated the safety and efficacy of 
tapinarof cream, 1% QD for 40 weeks in 763 subjects enrolled from the two identical 12-week studies.  While 
the study remains ongoing at this time, in a pre-specified interim analysis of the study tapinarof demonstrated 
continued and substantial improvement in efficacy endpoints beyond the 12 weeks of treatment observed in 
the identical Phase 3 studies. A high rate of complete disease clearance was achieved, with a remittive effect 
of approximately 4 months of disease control off therapy.  Tapinarof was well tolerated with long-term use 
and had a safety profile consistent with previous studies. 
1.1.2 Study Rationale  
This 48-week, Phase 3, OL-LTE study is being conducted as part of a clinical development program to 
evaluate the long-term safety and continued efficacy of tapinarof cream, 1% for the treatment of AD in 
children and adults.  Subjects who complete one of three parent studies (Phase 3 pivotal safety and efficacy 
study DMVT-505-3101, Phase 3 pivotal safety and efficacy study DMVT-505-3102, or Phase 2 maximal use 
pharmacokinetics [PK] study DMVT-505-2104) and meet the predefined criteria will have the option to 
participate in this study.  Additionally, approximately 125 pediatric subjects ages 2 to < 18 years who are not 
eligible for participation in the Phase 3 pivotal studies will also be enrolled directly into this OL-LTE study. 


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Dermavant Sciences, Inc.  
Clinical Study Protocol  
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1.2 Rationale for Study Design, Dose, and Control Groups  
As in the three parent studies, this Phase 3 study will be conducted at multiple study sites in more than one 
country to enhance the possibility of inclusion of a wider range of population groups and to subsequently 
increase generalizability of the results.  Tapinarof cream is intended for long-term, intermittent use in non-
life-threatening inflammatory dermatologic conditions.  Therefore, the 48-week duration of long-term, 
intermittent use of tapinarof cream, 1% in this study is expected to be an adequate duration to assess safety 
and efficacy of repeated treatment courses of tapinarof as recommended in the International Conference on 
Harmonisation E1A (ICH E1A) guideline on the extent of population exposure to assess clinical safety for 
drugs intended for long-term treatment of non-life-threatening conditions, which recommends a minimum of 
100 subjects treated with the intended clinical dose to be followed for at least one year. 
1.3 Potential Risks and Benefits  
To assess any potential impact on subject eligibility with regard to safety, the Investigator must refer to the 
current version of the tapinarof Investigator’s Brochure for detailed information regarding warnings, 
precautions, contraindications, adverse events (AEs), and other significant data pertaining to the study drug 
being used in this study 
  
 
  
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
   
   
 
  
 
 
 


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Clinical Study Protocol  
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1.3.2 Benefit Assessment  
Subjects may experience improvements in their AD during the course of the study and may benefit from the 
additional safety assessments conducted as part of the study (e.g., physical examination, laboratory tests).  
Subjects in the study will also contribute to the process of developing a novel anti-inflammatory agent for the 
topical treatment of AD. 
1.3.3 Overall Benefit Risk  
Taking into account the measures taken to minimize risk to subjects in this study, the potential risks identified 
in association with tapinarof are justified by the anticipated benefits that may be afforded to subjects with AD. 


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Dermavant Sciences, Inc.  
Clinical Study Protocol  
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Page | 27 
2 Objectives and Endpoints  
The objectives and associated endpoints of the study are as follows: 
Objectives 
Associated Endpoint 
• 
To evaluate the safety and 
tolerability of tapinarof cream, 1% 
in subjects with AD 
• 
Incidence, frequency, and duration of TEAEs and serious adverse events (SAEs) 
• 
Change from Baseline in laboratory values 
• 
Change from Baseline in vital signs 
• 
 
 
 
 
• 
To evaluate the efficacy of tapinarof 
cream, 1% over an extended period 
of time in subjects with AD 
• 
 
 
o 
 
o 
 
 
o 
 
 
 
 
 
• 
For subjects entering the study with a vIGA-ADTM score ≥ 1: 
o 
Proportion of subjects who achieve vIGA-ADTM = 0 at least 1 time 
during the study 
o 
 
 
 
 
 
 
 
• 
For subjects entering the study with a vIGA-ADTM score ≥ 2: 
o 
Proportion of subjects who achieved vIGA-ADTM = 0 or 1 at least 1 
time during the study 
o 
 
 
• 
The following endpoints will be summarized over subjects in the intent-to-treat 
(ITT) population: 
o 
 
 
 
 
 
 
 
 
 


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Dermavant Sciences, Inc.  
Clinical Study Protocol  
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o 
 change and percent change from Baseline in %BSA 
affected by visit (OC and LOCF) 
o 
 
 
  
o 
 change and percent change from Baseline in 
Eczema Area and Severity Index (EASI) score by visit (OC and 
LOCF) 
o 
Proportion of subjects with ≥ 50% improvement in EASI score 
from Baseline by visit (OC and LOCF) 
o 
Proportion of subjects with ≥ 75% improvement in EASI score 
from Baseline by visit (OC and LOCF) 
o 
Proportion of subjects with ≥ 90% improvement in EASI score 
from Baseline by visit (OC and LOCF) 
• 
To describe the effect of 
tapinarof cream, 1% on AD 
symptom severity and the associated 
impact on daily activities and 
attitudes in subjects with AD 
• 
Mean change in Peak Pruritus-Numeric Rating Scale (PP-NRS) score from 
Baseline at each study visit  
• 
Proportion of subjects with a Baseline PP-NRS score > 4 who achieve ≥ 4-point 
reduction in the PP-NRS from Baseline at each study visit 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Clinical Study Protocol  
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3 Study Design  
3.1 Overall Design  
This is an open-label, long-term multicenter, study to evaluate the safety and efficacy of topical tapinarof 
cream, 1% in subjects with AD.  Subjects in this study will have either: a) completed treatment with tapinarof 
or vehicle in one of two Phase 3 pivotal safety and efficacy studies, DMVT-505-3101 or DMVT-505-3102, 
and rolled over into this study; b) completed treatment with tapinarof in the Phase 2 maximal use PK study, 
DMVT-505-2104, and rolled over into this study; or c) enrolled directly into this study.  This study will 
consist of up to 48 weeks of treatment and a 1-week safety follow-up period. 
At the completion of the Week 8 visit of study DMVT-505-3101 or study DMVT-505-3102 or the Day 28 
visit of study DMVT-505-2104 (Baseline [Day 1] in this study), all eligible subjects will be offered 
enrollment in this OL-LTE study.  Approximately 125 additional pediatric subjects ages 2 to < 18 years who 
are not eligible for participation in the Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) will be 
enrolled directly into this OL-LTE study.  Study visits during the treatment period for all subjects will occur 
every 4 weeks (± 3 days).  Unscheduled visits may occur, as needed.  Subjects who withdraw from the study 
before Week 48 will return to the study site for an Early Termination visit.  The total duration of subject 
participation in this study will be approximately 49 weeks for rollover subjects (Baseline to Follow-Up) and 
approximately 53 weeks for direct-enrolling subjects (Screening to Follow-Up). 
Rollover subjects in this study will begin treatment based on their vIGA-ADTM score from the final visit in 
one of the three aforementioned studies (DMVT-505-3101, DMVT-505-3102, or DMVT-505-2104).  
Subjects entering with a vIGA-ADTM ≥ 1 will receive treatment with tapinarof cream, 1% QD until they 
achieve a vIGA-ADTM score of 0, at which time treatment will be discontinued and subjects monitored for 
maintenance of disease control (i.e., the extent of the remittive effect).  If/when disease worsening occurs, as 
evidenced by a flare to vIGA-ADTM ≥ 2, treatment will then be re-initiated and continued until a vIGA-ADTM 
of 0 is achieved.  Subjects entering with a vIGA-ADTM of 0 will have treatment discontinued beginning at the 
Baseline visit and will be monitored for maintenance of the remittive effect. If/when disease worsening 
occurs, as evidenced by a vIGA-ADTM ≥ 2, treatment will then be re-initiated and continued until a vIGA-
ADTM of 0 is achieved.  This treatment and re-treatment pattern of use will be continued until the end of the 
study (i.e., subjects may receive study treatment up until the Week 48 visit) (see Section 5.1.5.2 for additional 
details). 
Subjects enrolling directly into this study will receive treatment QD with tapinarof cream, 1% beginning at 
Baseline and continue treatment until they achieve a vIGA-ADTM score of 0, at which time treatment will be 
discontinued and subjects monitored for maintenance of the remittive effect.  If/when disease worsening 
occurs, as evidenced by a flare to vIGA-ADTM ≥ 2, treatment will be re-initiated and continued until a 
vIGA-ADTM of 0 is achieved.  This regimen of treatment and re-treatment will continue until the end of the 
study (i.e., subjects may receive study drug up until the Week 48 visit) (see Section 5.1.5.2 for additional 
details). 
Study drug will be dispensed to subjects or their caregivers, applied during the clinic visits, and applied at 
home between clinic visits as instructed by site personnel.  Subjects or their caregivers will be instructed to 
apply study drug QD to all affected areas, including newly appearing lesions and lesions/areas that improve 
during the study until a vIGA-ADTM of 0 is achieved.  Once a vIGA-ADTM of 0 is achieved, the treatment 
period ends.  If/when disease worsening occurs, and treatment is re-initiated at a vIGA-ADTM of ≥ 2, all 
lesions currently present and any new lesions that occur during the new treatment period should be treated.  


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Protocol No.: DMVT-505-3103 
Dermavant Sciences, Inc.  
Clinical Study Protocol  
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Subjects or their caregivers will apply sufficient study drug to cover each lesion completely with a thin layer 
of study drug and will record the time of study drug application and daily itch score (PP-NRS) in a daily diary 
provided by the study site.  Subjects are allowed, but not required, to treat scalp lesions with study drug; 
however, efficacy analyses will not include assessment of AD on the scalp.  At the first clinic visit, if 
applicable, subjects and/or caregivers will be instructed to maintain the approximate dosing time for the daily 
application of study drug.  At the phone contact at Week 2, subjects or caregivers should be reminded to 
complete their daily diary and bring it with them to the next clinic visit. 
Study drug application instructions will be reviewed at all post-randomization clinic visits and during any 
planned study phone calls.  On clinic visit days, subjects and/or caregivers will be instructed/reminded on how 
to apply study drug (except during the final treatment/end-of-study visits).  During the clinic visits, subjects or 
their caregivers will apply the daily dose of study drug while on-site under the supervision of site personnel, 
after efficacy and safety assessments have been completed 
).  The 
time of the dose application and assessments will depend on the time of the clinic visit.  Therefore, the timing 
of the clinic visit may lead to a change in the subject’s chosen dosing time for that day. 
Safety assessments will include AEs, clinical laboratory tests, physical examination, vital signs, and LTS.  
Efficacy assessments will include vIGA-AD™ score, %BSA affected, EASI, PP-NRS,
 
   
Refer to Section 6 for descriptions of study procedures and assessments and Section 7 and Table 1 for timing 
of procedures and assessments.   
3.2 Treatment Groups and Duration  
Subjects entering with a vIGA-AD™ ≥ 1 will receive treatment with tapinarof cream, 1% until they achieve a 
vIGA-AD™ score of 0, at which time treatment will be discontinued and subjects monitored for remittive 
effect.  If/when disease worsening occurs, as evidenced by a vIGA-AD™ ≥ 2, treatment will then be 
re-initiated and continued until a vIGA-AD™ of 0 is achieved.  Subjects entering with a vIGA-AD™ of 0 will 
have treatment discontinued beginning at the Baseline visit and will be monitored for remittive effect. If/when 
disease worsening occurs, as evidenced by a vIGA-AD™ ≥ 2, treatment will then be re-initiated and 
continued until a vIGA-AD™ of 0 is achieved.  (Section 5.1.5.2 for additional details). 
A subject will be considered to have completed the study when he/she completes all required 
procedures/visits for the 48-week treatment period and the Week 49 (Follow-Up) visit. The end of the study is 
defined as when the last active subject has completed the Follow-up Visit. 


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Protocol No.: DMVT-505-3103 
Dermavant Sciences, Inc.  
Clinical Study Protocol  
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Page | 31 
4 Study Population  
4.1 Type and Number of Subjects  
Up to 961 pediatric and adult subjects with AD will be enrolled in the study at up to approximately 135 study 
sites in the US and Canada.   
Protocol violations from inclusion and exclusion criteria are prohibited because ineligible study subjects can 
potentially jeopardize the scientific integrity of the study, regulatory acceptability, or subject safety.  
Therefore, adherence to the criteria as specified in the protocol is essential. 
4.2 Inclusion Criteria  
Each subject must meet all of the following criteria to be eligible to participate in the study: 
For Rollover Subjects Only: 
1. Met the criteria as a Study Completer in one of three parent studies (Phase 3 pivotal safety and 
efficacy study DMVT-505-3101, Phase 3 pivotal safety and efficacy study DMVT-505-3102, or Phase 
2 maximal use PK study DMVT-505-2104) and was still receiving study drug at the last visit of one of 
these studies. 
NOTE: To meet the criteria as a Study Completer in one of the three parent studies, a subject must 
have completed ≥ 80% of the intended doses in that study. 
2. Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline 
(Day 1). 
For Direct-Enrolling Subjects Only: 
3. Male and female subjects ages 2 years to < 18 years at the time of consent with clinical diagnosis of 
AD by Hanifin and Rajka criteria [Hanifin, 1980] (see Appendix 1). 
4. Subjects with a vIGA-AD™ score of ≥ 3 and AD covering ≥ 40% of the BSA at Screening and 
Baseline (pre-randomization), or subjects with a vIGA-AD™ score of 2 at Screening and Baseline 
(pre-randomization) regardless of BSA.  Scalp should be excluded from the BSA calculation to 
determine eligibility during Screening and at Baseline, and for all efficacy assessments.  Subjects must 
have screened for the DMVT-505-3101 or DMVT-505-3102 study and failed to meet BSA and/or 
vIGA-AD™ eligibility criteria. 
NOTE: Subjects with disease only on palms and soles are not eligible. 
5. AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old, 
confirmed by prior medical documentation and/or according to the subject/caregiver report. 
6. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and 
a negative urine pregnancy test at Baseline (Day 1). 
For All Subjects (Rollover Subjects and Direct-Enrolling Subjects): 
7. Female subjects of childbearing potential who are engaging in sexual activity that could lead to 
pregnancy should use one of the following acceptable birth control methods while on study and for 4 
weeks after the last exposure to study drug. 


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• Acceptable contraception methods include intrauterine device, hormonal contraceptives, barrier 
method (e.g., condom or diaphragm), or surgical sterilization of male partner (vasectomy) 
• Subjects who claim abstinence as their method of contraception are allowed provided they agree to 
use a barrier method (e.g., condom or diaphragm) should they become sexually active from 
Baseline to 4 weeks after the last dose of study drug 
Non-child-bearing potential is defined as: 
• premenarchal 
• pre-menopausal females with a documented bilateral tubal ligation, bilateral oophorectomy, 
hysterectomy, or hysteroscopic sterilization 
• postmenopausal female with a cessation of menses for at least 12 months without an alternative 
medical cause; a blood sample with follicle stimulating hormone > 40 mIU/mL is confirmatory in 
questionable cases 
8. Subject, subject’s parent(s), or legal representative must be capable of giving written informed 
consent/assent, which includes compliance with the requirements and restrictions listed in the 
consent/assent form; written informed consent must be obtained prior to any study related procedures. 
4.3 Exclusion Criteria  
A subject who meets any of the following criteria will be excluded and considered ineligible for participation 
in the study: 
For Rollover Subjects Only: 
1. Subjects who were not receiving study drug at the time of the last visit in the parent study (DMVT-
505-3101, DMVT-505-3102, or DMVT-505-2104) 
2. Used a prohibited concomitant product or procedure to treat AD during the parent study. 
3. Had an SAE that was related to treatment or experienced an AE that led to permanent discontinuation 
of treatment in the parent study. 
4. Pregnant females as determined by positive urine human chorionic gonadotropin test at Baseline. 
For Direct-Enrolling Subjects Only: 
5. Concurrent conditions: 
a. Immunocompromised (e.g., lymphoma, acquired immunodeficiency syndrome) or medical history 
of positive human immunodeficiency virus antibody at Screening.  
b. Chronic or acute systemic infection requiring treatment with antiparasitics or antiprotozoals, 
within 4 weeks prior to the Baseline visit.  
c. Chronic or acute systemic bacterial infection requiring treatment with systemic antibiotics within 
one week prior to the Baseline visit. 
d. Chronic or acute superficial fungal infection requiring treatment with systemic antifungals within 
one week prior to the Baseline visit. 
e. Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection 
within 1 week prior to the Baseline visit; the condition should be completely resolved one week 
prior to Baseline Visit. 


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f. Significant dermatologic or inflammatory condition other than AD that, in the Investigator’s 
opinion, would make it difficult to interpret data or assessments during the study.  For example, 
subjects with an active skin condition such as Kaposi's varicelliform eruption, scabies, molluscum 
contagiosum, impetigo, psoriasis, severe acne, connective tissue disorder, or Netherton's 
syndrome, or any other concurrent active disease.  
g. Concurrent skin lesions in the treatment area or pruritus due to conditions other than AD that, in 
the opinion of the Investigator, would either interfere with study evaluations or affect the safety of 
the subject. 
6. Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.0 x the upper limit 
of normal (ULN). 
7. Screening total bilirubin > 1.5x ULN; total bilirubin > 1.5x ULN is acceptable if bilirubin is 
fractionated and direct bilirubin < 35%. 
8. Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception 
of Gilbert’s syndrome or asymptomatic gallstones), presence of hepatitis B surface antigen (HBsAg), 
or positive hepatitis C antibody test result, or presence of anti-hepatitis B core antigen (anti-HBc).  
Subjects having a negative HBsAg and a positive anti-HBc may enroll if they have a positive anti-
hepatitis B surface antigen demonstrating natural immunity.  Subjects with a history of hepatitis C 
virus infection who were medically cured and have an undetectable viral load are eligible to enroll.  
Subjects with a history of stable non-alcoholic fatty liver disease without evidence of active 
inflammation (elevated ALT/AST ≥ 2.0x ULN) or cirrhosis are eligible to enroll. 
9. Current or a history of cancer within 5 years except for adequately treated skin basal cell carcinoma, 
cutaneous squamous cell carcinoma or carcinoma in situ of the cervix (surgical excision or 
electrodessication and curettage). 
10. Pregnant females as determined by positive serum (Screening) or urine (Baseline) human chorionic 
gonadotropin test. 
11. Lactating females. 
12. Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 
and WBI-1001). 
13. Use of any prohibited medication or procedure within the indicated period before the Baseline visit.  
NOTE:  Prohibited concomitant medications, therapy, etc. during the defined period are as listed in the 
bullets below.  If a subject requires any of these medications throughout the study period, he/she may 
be excluded from or discontinued from the study, at the discretion of the Investigator and Medical 
Monitor. 
a. From 4 months prior to Baseline: 
o DUPIXENT® (dupilumab) injection.  
o Any monoclonal antibody product that becomes approved for AD during the course of 
the trial. 
b. From 28 days prior to Baseline: 


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o Oral, injectable, and suppository preparations of corticosteroids.  Eye drops and nasal 
preparations are allowed.  Inhaled preparations are allowed when used for a stable 
condition and stable dose for > 28 days before Screening and are continued at the same 
dose throughout the study.  
o Oral preparations and injections of immunosuppressants (cyclosporine, methotrexate, 
azathioprine, tacrolimus, Janus kinase [JAK] inhibitors, etc.). 
o Excessive sun exposure, tanning booth, other ultraviolet light source and phototherapy 
including psoralen and ultraviolet A therapy or is unwilling to minimize natural and 
artificial sunlight exposure.  
o Treatment with antivirals with the exception of short-term treatment for acute upper 
respiratory viral infections (i.e., influenza) or viral suppressive therapy for a history of 
recurrent herpes labialis or genital herpes. 
c. From 14 days prior to Baseline: 
o EUCRISA® (crisaborole) and any other PDE4 inhibitor. 
o Tacrolimus ointment and pimecrolimus cream. 
o Topical JAK inhibitors. 
o Topical corticosteroids that are classified as medium or high potency 
(e.g., fluocinonide, triamcinolone acetonide) or super-high potency (e.g., clobetasol 
propionate).  Eye drops and nasal preparations are allowed.  
o Over the counter or herbal medicines for AD (topical and oral preparations).  If subjects 
are using emollients, they may continue to use the same emollient on nonlesional skin 
during the study.  Emollients containing salicylic acid are prohibited during the study. 
d. From 7 days prior to Baseline: 
o Topical corticosteroids that are classified as low potency (e.g., desonide, 
hydrocortisone).    
o Oral, injectable, or intravenous antibiotics or antifungal medications. 
o Topical doxepin, topical gentamicin, or topical neomycin sulfate. 
NOTE: Oral doxepin is allowed for treatment of depression if subject has been on a 
stable dose (4 weeks) at Screening 
o Topical products containing urea, except for the treatment of follicular events. 
o Antihistamines/antiallergics (oral, topical and injections):  diphenhydramine, 
chlorpheniramine maleate, hydroxyzine.  
NOTE:  For direct-enrolling subjects, the following antihistamines are allowed from 
Screening throughout the treatment period: loratadine, fexofenadine hydrochloride, 
cetirizine hydrochloride.  Subjects are allowed to switch from non-allowed 
antihistamines to allowed antihistamines during Screening but must be on a stable dose 
for 7 days prior to Baseline. 


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e. The subject has received an investigational product within the following time period prior to 
the first dosing day in the current study:  Minimum of 30 days or 5 half-lives of the 
investigational product (whichever is longer). 
For All Subjects (Rollover Subjects and Direct-Enrolling Subjects): 
14. A history of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the 
Investigator’s opinion, may interfere with the subject’s participation in the study, interpretation of 
results, safety of the subject or ability to understand and give informed consent. 
15. Known hypersensitivity to tapinarof or excipients. 
4.4 Lifestyle Restrictions  
Subjects must avoid ultraviolet light, phototherapy, and excessive sun exposure throughout the study.  When 
prolonged exposure cannot be avoided, use of sunscreen products (except on AD lesions) and protective 
apparel are recommended. 
4.5 Withdrawal Criteria  
A subject may voluntarily discontinue treatment and/or withdraw from participation in this study at any time 
at his/her own request or may be discontinued from study treatment at any time at the discretion of the 
Investigator for safety, behavioral, compliance, or administrative reasons.  Subjects withdrawn from the study 
will not be replaced. 
4.5.1 Reasons for Withdrawal from the Study  
Study drug will be discontinued and the subject withdrawn from the study for any of the following reasons: 
• Subject has an AE that is considered to be related to study drug or procedures AND is severe 
enough to warrant treatment discontinuation, as determined by the Investigator (Section 8.1). 
• Pregnancy 
• Any Grade 3 or 4 AE, based on Cancer Institute Common Terminology Criteria for Adverse 
Events (CTCAE) criteria, considered causally related to study drug (Section 8.2.2) 
Study drug may be discontinued and the subject withdrawn from the study for any of the following reasons: 
• 
Subject requires concurrent prohibited medication during the study (Section 5.6.2).  Nonmedicated 
emollients that do not contain salicylic acid may be used on nonlesional skin but the subject (or 
caregiver) should wait at least 30 minutes after applying study drug before applying nonmedicated 
emollients; emollients should not be applied to lesional skin during treatment.  The same emollient 
should be used throughout the subject’s participation in the study.   
NOTE:  If, in the opinion of the Investigator and the study Medical Monitor, such medication will 
not interfere with the conduct or interpretation of the study or compromise the safety of the 
subject, then the subject may continue to receive study drug. 
• 
Subject noncompliance 
• Investigator noncompliance 
• Discontinuation of the study at the request of the Sponsor, regulatory agency, or an Institutional 
Review Board (IRB)/Independent Ethics Committee (IEC). 


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If a subject meets a withdrawal criterion during treatment, an Early Termination visit will be required (Section 
7.7). 
4.5.2 Withdrawal Procedures  
The primary reason for the discontinuation of study drug and/or withdrawal from study must be recorded in 
the source document and on the case report form (CRF).  If a subject is prematurely discontinued from study 
drug, the Investigator must make every effort to perform an Early Termination Visit (Section 7.7) and 
document the primary reason for withdrawal. 
4.6 Lost to Follow-Up  
A subject is considered lost to follow-up if he/she repeatedly fails to return to the study site for scheduled 
visits and is unable to be contacted by the study site.  The following actions must be taken if a subject fails to 
return to the clinic for a required study visit: 
• The site must attempt to contact the subject or caregiver and reschedule the missed visit as soon as 
possible, counsel the subject and/or caregiver on the importance of maintaining the assigned visit 
schedule, and ascertain whether or not the subject wishes to and/or should continue in the study. 
• Before a subject is deemed lost to follow-up, the Investigator or designee must make every effort 
to regain contact with the subject or caregiver (where possible, 3 telephone calls and, if necessary, 
a certified letter to the subject’s last known mailing address or local equivalent methods).  These 
contact attempts should be documented in the subject’s medical record. 
• Should the subject or caregiver continue to be unreachable, he/she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up.  In this case, the 
discontinuation date will be listed as the date the certified letter was mailed to the subject. 




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have treatment discontinued beginning at the Baseline visit and will be monitored for maintenance of the 
remittive effect. If/when disease worsening occurs, as evidenced by a flare to vIGA-ADTM ≥ 2, treatment will 
be re-initiated and continued until a vIGA-ADTM of 0 is achieve.  Once a vIGA-ADTM of 0 is achieved, the 
treatment period ends. If/when disease worsening occurs, and treatment is re-initiated at a vIGA-ADTM of ≥ 2, 
all lesions currently present and any new lesions that occur during the new treatment period should be treated.  
This treatment and re-treatment pattern of use will be continued until the end of the study (i.e., subjects may 
receive study treatment up until the Week 48 visit).   
Subjects who experience suspected disease worsening between scheduled study visits may contact the study 
site to arrange an unscheduled visit (Section 7.6).  See Section 5.1.5.2 for further instructions.  Upon 
confirmation of disease worsening, subjects will restart treatment with study drug. 
5.1.5.2 
Disease Worsening (Validated Investigator Global Assessment of Atopic Dermatitis ≥ 2 During 
the Study)  
If disease worsening is suspected between scheduled study visits, an unscheduled visit may be performed.  If 
disease worsening (i.e., vIGA-ADTM ≥ 2) is not confirmed, the subject will continue to be assessed at routine, 
scheduled visits (see Table 1). 
For each confirmed episode of disease worsening (i.e., vIGA-ADTM ≥ 2) during the study (at either a 
scheduled or unscheduled visit), a treatment course of tapinarof cream, 1% QD will be initiated and will 
continue until the subject achieves a vIGA-ADTM of 0, as assessed at scheduled visits, approximately every 4 
weeks beginning at Baseline. 
5.1.5.3 
Application of Study Drug  
Study drug will be dispensed to subjects or their caregivers at the clinical site in appropriately labeled tubes. 
Subjects or caregivers will take the tubes home and self-administer study drug (or have caregiver apply if 
necessary) to affected areas QD, except on clinic visit days when study drug is applied under supervision at 
the site. 
Subjects will be instructed to apply study drug as follows: 
• QD application to affected areas; subjects or their caregivers are advised to choose the application 
time they prefer and to apply the study drug at that approximate time each day of study 
participation.  Subjects should avoid dosing around midnight to avoid potentially dosing twice in 
one calendar day. 
• If a subject misses a daily dose, it will be recorded as a protocol deviation.  The subject should 
continue dosing the next day and should not apply more than once daily to make up for the missed 
dose on the previous day.  If a dose is missed, the missed dose and the reason for the missed dose 
should be recorded in the daily diary as such.  Itch rating can still be recorded in the diary even if a 
daily dose was missed. 
• Study drug should be applied to dry, clean skin. 
• Study drug may be applied to skin around the eye but avoid direct contact with the eye – study 
drug is not for ophthalmic use. 
• Wash hands after application, unless treating lesions on the hands. 


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• Study drug should be applied to all lesions, including newly appearing lesions and lesions/areas 
that  improve during the study until a vIGA-ADTM of 0 is achieved.  Once a vIGA-ADTM of 0 is 
achieved, the treatment period ends. If/when disease worsening occurs, and treatment is re-
initiated at a vIGA-ADTM of ≥ 2, all lesions currently present and any new lesions that occur 
during the new treatment period should be treated.  A body diagram identifying locations of 
lesions may be provided to the subject and/or caregiver.  
• Subjects are allowed, but not required, to treat scalp lesions with study drug; however, efficacy 
analyses will not include assessment of AD in this area.   
• If there is residual cream visible on the disease-affected lesional skin, then the subject or caregiver 
should be instructed to continue to lightly rub the cream into the skin until it is no longer visible. 
• If study drug is applied to the subject by another person, that person should thoroughly wash 
his/her hands after application. 
• When dosing at home subjects or caregiver should record the time of study drug application in the 
daily diary.  Itch rating should also be recorded in the diary. 
• On clinic visit days, study drug should be applied in the clinic under the supervision of site 
personnel and after safety and efficacy assessments have been completed 
 
 
NOTE:  The time of the dose and assessments on clinic visit days will depend on the time of the 
clinic visit.  Therefore, the timing of the clinic visit may differ from the subject’s chosen dosing 
time.  The intention is to allow flexibility to accommodate subjects’ schedules. 
• 
Nonmedicated emollients that do not contain salicylic acid may be used on nonlesional skin but 
the subject (or caregiver) should wait at least 30 minutes after applying study drug before applying 
nonmedicated emollients; emollients should not be applied to lesional skin during treatment.  The 
same emollient should be used throughout the subject’s participation in the study. 
 
  
 
 
 
  
 
 
 
   
 
 
5.2 Randomization/Treatment Assignment  
All subjects will receive treatment with tapinarof cream, 1% as needed per protocol. 


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5.3 Blinding  
This study is an open-label study; blinding is not applicable. 
5.4 Compliance with Study Drug Administration  
At Baseline, study staff will provide the subject or caregiver with detailed instructions concerning protocol 
requirements and use of study drug.  Additionally, subjects or caregivers will be asked to complete a daily 
diary with the time of each application of study drug, except on study visit days.  At each post-Baseline study 
visit, study staff will review use of study drug, as applicable, with the subject or caregiver.  Subject 
compliance will be assessed via study diary completion. 
When subjects are dosed at the site, they and/or their caregiver will apply the study drug under supervision of 
the study staff.  The date and time of each dose administered in the clinic will be recorded in the source 
documents.  The study drug and study subject identification should be confirmed at the time of dosing by a 
member of the study site staff other than the person dispensing the study drug. 
At the time of dispensing study drug to each subject, site personnel will weigh the tubes to be dispensed with 
the cap on and will record the weight of all tubes dispensed at each visit in the drug accountability logs.  
Subjects and/or caregivers will be instructed to bring all used and unused tubes with them to each study visit.  
Site personnel will weigh the returned tubes (used and unused) with the cap on and record the weight in the 
drug accountability logs.  If a tube has been lost, discarded, or forgotten by the subject, then the site personnel 
will make a notation of this on the drug accountability logs.  Forgotten tubes should be returned by the subject 
at the next study visit.  Tubes of study medication dispensed at the most recent prior visit which remain 
unopened (the foil cap on the tube remains fully intact/undisturbed) may be re-dispensed to study subjects at 
the current visit.  Unopened tubes may only be re-dispensed once.  Opened, partially used tubes or tubes with 
foil overlay removed are not to be re-dispensed to study subjects.  If there is any question as to 
re-dispensation, sites should issue new tubes of study medication to the subject(s). 
5.5 Treatment after the End of the Study  
Subjects will not receive any additional treatment with the study drug from the Sponsor after completion of 
the study because the indication being studied is not life threatening or seriously debilitating and other 
treatment options are available. 
The Investigator is responsible for ensuring that consideration has been given to the post study care of the 
subject’s medical condition, whether or not the Sponsor is providing specific post-study drug. 
5.6 Prior and Concomitant Therapy  
For rollover subjects, any medication (including over the counter or prescription medication, vitamins and/or 
herbal supplements) administered to the subject at the time of enrollment and during the study must be 
recorded on the CRF along with the reason for use.  For direct-enrolling subjects, any medication (including 
over the counter or prescription medication, vitamins and/or herbal supplements) administered to the subject 
up to 30 days before the Screening visit, at the time of enrollment, and during the study must be recorded in 
the CRF along with the reason for use.  The information to be recorded must also include name of the 
medication (generic name, as a general rule), dose, frequency, administration routes, and dates of the first and 
last dose, as applicable. 
The Medical Monitor should be contacted if there are any questions regarding concomitant or prior therapy. 


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5.6.1 Permitted Medications and Nondrug Therapies  
Concomitant medications for medical treatment of other conditions are allowed under the condition that the 
dosage and administration of these treatments is not planned to change from the Baseline visit to the 
completion of the treatment phase (Week 48) and that the medication is not a prohibited medication as 
described in the Exclusion Criteria (Section 5.6.2). 
In the event of skin infection, topical antibacterial agents with the exception of gentamicin and neomycin 
sulfate can be applied to the infected area; however, study drug must not be applied to the area until the skin 
infection is healed. 
Nonmedicated emollients that do not contain salicylic acid may be used on nonlesional skin but the subject 
(or caregiver) should wait at least 30 minutes after applying study drug before applying nonmedicated 
emollients; emollients should not be applied to lesional skin during treatment.  The same emollient should be 
used throughout the subject’s participation in the study.  
Any emollient used during the study must be recorded as a concomitant medication. 
5.6.2 Prohibited Medications and Nondrug Therapies  
Medications and nondrug therapies that are prohibited throughout the study duration are as follows: 
• DUPIXENT® (dupilumab) injection, or any monoclonal antibody product that becomes approved 
for AD during the course of the trial 
• Oral, injectable, and suppository preparations of corticosteroids.  Eye drops and nasal preparations 
are allowed.  Inhaled preparations are allowed when used for a stable condition and stable dose for 
> 28 days before Baseline and are continued at the same dose throughout the study. 
• Oral preparations and injections of immunosuppressants (cyclosporine, methotrexate, azathioprine, 
tacrolimus, JAK inhibitors, etc.). 
• Excessive sun exposure, tanning booth, other ultraviolet light source and phototherapy including 
psoralen and ultraviolet A therapy or is unwilling to minimize natural and artificial sunlight 
exposure. 
• Treatment with antivirals with the exception of short-term treatment for acute upper respiratory 
viral infections (i.e., influenza) or viral suppressive therapy for a history of recurrent herpes 
labialis or genital herpes. 
• EUCRISA® (crisaborole) and any other phosphodiesterase 4 inhibitor. 
• Tacrolimus ointment and pimecrolimus cream. 
• Topical JAK inhibitors. 
• Topical corticosteroids that are classified as low potency (e.g., desonide, hydrocortisone), medium 
or high potency (e.g., fluocinonide, triamcinolone acetonide) or super-high potency (e.g., 
clobetasol propionate).  Eye drops and nasal preparations are allowed.  
• Over the counter or herbal medicines for AD (topical and oral preparations).  If subjects are using 
emollients, they may continue to use the same emollient on nonlesional skin during the study.  
Emollients containing salicylic acid are prohibited during the study. 
• Oral, injectable, or intravenous antibiotics or antifungal medications.  
• Topical doxepin or topical antibiotics. 


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NOTE: Oral doxepin is allowed for treatment of depression if subject has been on a stable dose (4 
weeks) at Screening 
• Antihistamines/antiallergics (oral, topical and injections):  diphenhydramine, chlorpheniramine 
maleate, hydroxyzine. 
NOTE:  The following antihistamines are allowed from Screening throughout the treatment period: 
loratadine, fexofenadine hydrochloride, cetirizine hydrochloride.  Subjects are allowed to switch 
from non-allowed antihistamines to allowed antihistamines during Screening but must be on a 
stable dose for 7 days prior to Baseline. 
• Any investigational products or procedures. 
A list of prohibited medications, emollients and nondrug therapies may be provided as a separate document.  
If a subject chooses to treat scalp with study drug, then medicated shampoos are prohibited for use.  
Emollients containing salicylic acid are prohibited. 


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6 Study Assessments and Procedures  
Study procedures and assessments are summarized in the Schedule of Assessments (Table 1) and in Section 7.  
Adherence to the study design requirements, including those specified in the Schedule of Assessments are 
essential and required for study conduct.  Protocol waivers or exemptions are not allowed, except for 
immediate safety concerns. 
For rollover subjects, age is determined as age at the time of consent in the parent study.  For direct-enrolling 
subjects, age is determined as age at the time of consent in this study.  In both cases, the determined age will 
remain the same throughout the duration of this study for the purposes of completing all study assessments. 
6.1 Medical History, Demography, and Baseline Characteristics  
6.1.1 Demographics  
For rollover subjects, demographic information collected during the parent study will be used for this study, 
including age, sex, race, and ethnicity. 
For direct-enrolling subjects, demographic information collected will include age, sex, race, ethnicity, and 
Fitzpatrick skin type.  Information on Fitzpatrick skin type can be found in Appendix 2. 
6.1.2 Medical History  
For rollover subjects, medical, medication, and family history collected during the parent study will be used 
for this study. 
For direct-enrolling subjects, Medical history will be collected to ensure subjects are eligible for participation 
in the study per inclusion (Section 4.2) and exclusion (Section 4.3) criteria.  Data collected for direct-enrolling 
subjects will include year of AD diagnosis, allergic conditions, cardiovascular (CV) medical history and risk 
factors (including height, weight, blood pressure, medical conditions, and family history of premature CV 
disease), and family history of liver disease.  As part of the direct-enrolling subject’s medical history, all 
systemic (oral and injectable) medications used by the subject for treatment of AD prior to 30 days before the 
Screening visit will be collected.  
For all subjects (rollover subjects and direct-enrolling subjects), if a subject has previously tested positive for 
COVID-19 or has previously received a COVID-19 vaccine, it should be documented in the subject’s medical 
history. 
6.2 Safety Assessments  
6.2.1 Adverse Events  
All AEs and SAEs will be collected from the time the subject signs the informed consent form (ICF) until the 
final visit/contact with the subject.  AEs that began during the parent study and were ongoing at the end of 
that study will be reported as ongoing AEs.  Additional safety information, including the definition of an AE 
and the methods for recording, evaluating, and assessing causality of AEs and the procedures for completing 
and transmitting SAE reports are provided in Section 8. 
6.2.2 Brief Physical Examination  
A brief physical examination will include, at a minimum, assessments of the skin, lungs, cardiovascular 
system, and abdomen (liver and spleen). Assess for changes in onset of menses (female participants) or sexual 
activity (male or female participants). Determine if there is a need for contraception or barrier use. 
Investigators should pay special attention to clinical signs related to previous serious illness. 


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For direct-enrolling subjects, height and weight will be measured at Screening only. 
6.2.3 Vital Signs  
Vital signs will be measured before blood collection for clinical laboratory assessments and will include 
measurements of systolic and diastolic blood pressure, pulse rate, and body temperature. Subjects should be in 
a seated position for at least 5 minutes before vital signs measurement. 
6.2.4 Clinical Safety Laboratory Assessments  
All protocol-required laboratory assessments must be conducted in accordance with the Study Reference 
Manual or Laboratory Manual and the protocol Schedule of Assessments (Table 1).  Laboratory requisition 
forms must be completed, and samples must be clearly labeled with the subject number, protocol number, site 
number, and visit date.  Details for the preparation and shipment of samples will be provided by the laboratory 
and are detailed in the Study Reference Manual or the Laboratory Manual.  Reference ranges for all safety 
parameters will be provided to the site by the laboratory responsible for the assessments. 
A list of clinical laboratory tests and parameters is provided in Table 3. 
All laboratory tests with values that are considered clinically significantly abnormal during participation in the 
study should be repeated until the values return to normal or Baseline.  If such values do not return to normal 
within a period judged reasonable by the Investigator, the etiology should be identified, if possible, and the 
Sponsor and Medical Monitor notified. 
Table 3: 
Laboratory Tests  
Diagnostic Tests 
• 
All subjects 
• 
Urine pregnancy tests (WOCBP only)a 
• 
Direct-Enrolling Subjects Only 
• 
Serum pregnancy test at Screening (WOCBP only) 
• 
HBsAg 
• 
Hepatitis C antibody 
• 
Anti-HBc 
• 
Anti-HBsb 
• 
At the Investigator’s discretion, subjects may be screened for alcohol and illicit drug use. 
Serum Chemistry 
• 
BUN 
• 
Creatinine 
• 
Glucose (fasting not required) 
• 
Sodium 
• 
Potassium 
• 
Chloride 
• 
Total carbon dioxide 
• 
Calcium 
• 
AST 
• 
ALT 
• 
Alkaline phosphatase 
• 
Uric acid 
• 
Total bilirubin (+fractionated if 
required) 
• 
Total protein 
• 
Albumin 
Hematology 
• 
Platelet count 
• 
RBC count 
• 
WBC count (absolute) 
• 
Reticulocyte count 
• 
Hemoglobin 
• 
Hematocrit 
• 
RBC Indices: 
• 
MCV 
• 
MCH 
• 
MCHC 
• 
Reticulocyte percentage 
• 
WBC Differential: 
• 
Neutrophils 
• 
Lymphocytes 
• 
Monocytes 
• 
Eosinophils 
• 
Basophils 


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Urinalysis 
Specific gravity 
Microscopic examination (if blood or protein is abnormal) 
Dipstick:  pH, Glucose, Protein, Blood 
Ketones 
a. Pregnancy tests should be administered based on CBP, which may change after the start of the study (e.g. a premenarchal female 
subject experiences menarche or a female subject ceases to meet the criteria of CBP)  
b. Reflex test: a negative HBsAg and a positive anti-HBc may enroll if there is a positive anti-HBs demonstrating natural immunity  
ALT = alanine aminotransferase; Anti-HBc = anti-hepatitis B core antigen; Anti-HBs = anti-hepatitis B surface antigen; 
AST = aspartate aminotransferase; BUN = blood urea nitrogen; HBsAg = hepatitis B surface antigen; MCH = mean corpuscular 
hemoglobin; MCHC = mean corpuscular hemoglobin concentration; MCV = mean corpuscular volume; RBC = red blood cell(s); 
WBC = white blood cell(s); WOCBP = women of child-bearing potential 
 
  
 
  
 
 
 
 
 
 
   
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
, 






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rating can be done before or after study drug administration since it should reflect the past 24 hours.  On clinic 
visit days, the PP-NRS will be assessed in the clinic. PP-NRS should be completed every day, even if subjects 
are not actively applying study drug.  For subjects ages 2 to < 12 years, the PP-NRS will be completed by the 
caregiver.  For subjects ages > 12 years, the PP-NRS will be completed by the subject. 
An example of the PP-NRS is provided in Appendix 13. 
 
  
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 


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6.3.3 Optional Clinical Photography  
Clinical photography may be performed in a subgroup of subjects at selected study sites.  Informed 
consent/assent and photographic release will be required.  The photographs may not be referred to by the 
Investigator at any subsequent study visit for the purposes of grading. 
Photographs will be taken of a representative area of the subject’s disease area at the time points specified in 
the Schedule of Assessments (Table 1).  Photographs of the selected skin area will be taken in a standardized 
fashion (i.e., same camera, angle, background, distance). 
6.4 Treatment of Study Drug Overdose  
For this study, accidental or intentional oral ingestion of drug product will be considered an overdose.  
Ingestion of a 30-gram tube of tapinarof cream, 1% would result in an oral dose of 300 mg. 
The Sponsor does not recommend specific treatment for an overdose; however, in the event of an overdose, 
the Investigator (or treating physician) should do the following: 
• Contact Medical Monitor to discuss the event 
• Closely monitor the subject for AEs/SAEs and laboratory abnormalities 
• Provide general symptomatic treatment as necessary 
• Document the quantity of the excess dose as well as the duration of the overdosing. 
Decisions regarding dose interruptions or modifications following an overdose will be made by the 
Investigator in consultation with the Medical Monitor based on the clinical evaluation of the subject. 
6.5 Virtual Assessments  
In the event that a subject cannot attend their regularly scheduled study visits in person due to a COVID-19-
like situation necessitating a limit on in-person contact, the Investigator may perform safety and efficacy 
assessments by phone or video.  Source documentation should note if the visit was performed by phone or by 
video.  The Investigator may use the technology platform that is currently available to them.  Suggested 
platforms include Apple FaceTime, Zoom for Healthcare, Facebook Messenger video chat, Microsoft Teams, 
Google Hangouts video, and Skype.  Additional details of the visit should be included in source 
documentation, as detailed in the Study Reference Manual. 
If the subject can only be contacted by phone, the following should be assessed or performed: 


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• AEs 
• Concomitant Medications 
• Reminder to complete diary 
• Instruction not to discard empty tubes of study drug 
If the subject has video capabilities, the following items should be assessed or performed: 
• AEs 
• Concomitant Medications  
• vIGA-AD™ assessment (excluding subject’s scalp) 
• %BSA assessment (excluding subject’s scalp) 
• EASI (excluding subject’s scalp) 
• 
 
 
 
• Application of study drug by the subject or caregiver, if applicable 
• Completion of the PP-NRS (the subject or caregiver [as applicable] can verbally indicate the 
answer which the study coordinator will document in the source document).  
• Reminder to complete diary 
• Instruction not to discard empty tubes of study drug 
The reason that assessments cannot be completed during a virtual assessment (i.e., labs, vital signs, physical 
exams, etc.) must be noted (e.g., COVID-19) and the missed assessments will be recorded as protocol 
deviations. 


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7 Timing of Procedures and Assessments  
This section lists the procedures and assessment to be performed at scheduled time points during the study as 
outlined in the Schedule of Assessments (Table 1).  Information on study procedures and assessments is 
provided in Section 6. 
• Any change in timing or any addition of a time point(s) for any planned study assessment must be 
documented in a “Note to File,” which is approved by the relevant Sponsor study team member 
and then archived in the study Sponsor and site study files; this will NOT constitute a protocol 
amendment. 
• The IRB/IEC will be informed of any safety issues that require alteration of the safety monitoring  
or amendment of the ICF. 
7.1 Visit 0; Screening Period for Direct-Enrolling Subjects (Day -30 to Day -1)  
After the subject has signed the consent/assent form, potential study subjects will undergo Screening 
procedures and assessments to confirm eligibility to participate in the study.  Screening assessments will 
include the following: 
• Demography recording 
• Fitzpatrick skin type 
• Medical history recording 
• Brief physical examination (including height and weight, body mass index will be calculated in the 
CRF) 
• Vital signs measurements 
• Serum pregnancy test (women of child-bearing potential [WOCBP]) 
• Blood sample collection for clinical laboratory tests (serum chemistry, hematology, diagnostic 
tests) 
• Urinalysis 
• vIGA-AD™ score (excluding subject’s scalp)  
• %BSA affected calculation (excluding subject’s scalp) 
• EASI (excluding subject’s scalp) 
• AE recording (from the time the ICF is signed) 
• Concomitant medication recording (including all medications administered up to 30 days prior to 
screening, and all systemic [oral and injectable] medications used by the subject for the treatment 
of AD prior to 30 days before Screening) 
7.2 Visit 1; Baseline (Day 1)  
7.2.1 Baseline Visit for Subjects Rolling Over from DMVT-505-3101 and DMVT-505-3102  
On Day 1, subjects from the parent studies DMVT-505-3101 or DMVT-505-3102 who were considered 
eligible for this study will sign the ICF and be reassessed to confirm eligibility to participate in this study. All 
subjects who continue to meet study eligibility criteria will be enrolled. Subjects entering with a vIGA-ADTM 
≥ 1 will receive treatment with tapinarof cream, 1% until they achieve a vIGA-ADTM score of 0, at which time 
treatment will be discontinued and subjects monitored for maintenance of the remittive effect.  If/when 


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disease worsening occurs, as evidenced by a vIGA-ADTM ≥ 2, treatment will then be re-initiated and 
continued until a vIGA-ADTM of 0 is observed.  Subjects entering with a vIGA-ADTM of 0 will have treatment 
discontinued beginning at the Baseline visit and will be monitored for maintenance of the remittive effect.   
The following procedures and assessments will be performed at the Baseline visit: 
• Demographics and Fitzpatrick skin type (carried over from parent study) 
• Medical history (carried over from parent study) 
• Brief physical exam (last assessment from parent study) 
• Vital signs measurements (last assessment from parent study) 
• Urine pregnancy test (WOCBP; last assessment from parent study) 
• Blood sample collection for clinical laboratory tests (serum chemistry and hematology; last 
assessment from parent study) 
• Urinalysis (last assessment from parent study) 
• vIGA-AD™ score (excluding subject’s scalp; last assessment from parent study)  
• %BSA affected calculation (excluding subject’s scalp; last assessment from parent study) 
• EASI (excluding subject’s scalp; last assessment from parent study) 
• 
 
 
 
 
 
• PP-NRS (last assessment from parent study) 
• 
 
 
 
 
 
• Photography of a representative area of the subject’s disease area (at a subset of study sites only; 
last photograph from parent study) 
• AE recording (ongoing from parent study at the time the ICF is signed in this study) 
• Concomitant medication recording (ongoing from parent study at the time the ICF is signed in this 
study) 
• Dispense diary (subjects or their caregivers will be instructed in how and when to complete diary) 
• Dispense study drug, if applicable 
• Instruction on how to apply study drug, if applicable 
• Study drug application under supervision, if applicable 
7.2.2 Baseline Visit for Subjects Rolling Over from DMVT-505-2104  
On Day 1, subjects from the parent studies DMVT-505-2104 who were considered eligible for this study will 
sign the ICF and be reassessed to confirm eligibility to participate in this study. All subjects who continue to 
meet study eligibility criteria will be enrolled. Subjects entering with a vIGA-ADTM ≥ 1 will receive treatment 
with tapinarof cream, 1% until they achieve a vIGA-ADTM score of 0, at which time treatment will be 
discontinued and subjects monitored for maintenance of the remittive effect.  If/when disease worsening 


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occurs, as evidenced by a vIGA-ADTM ≥ 2, treatment will then be re-initiated and continued until a vIGA-
ADTM of 0 is observed.  Subjects entering with a vIGA-ADTM of 0 will have treatment discontinued beginning 
at the Baseline visit and will be monitored for maintenance of the remittive effect.   
The following procedures and assessments will be performed at the Baseline visit: 
• 
Demographics and Fitzpatrick skin type (carried over from parent study) 
• 
Medical history (carried over from parent study) 
• 
Brief physical exam (last assessment from parent study) 
• 
Vital signs measurements (last assessment from parent study) 
• 
Urine pregnancy test (WOCBP; last assessment from parent study) 
• 
Blood sample collection for clinical laboratory tests (serum chemistry and hematology; last 
assessment from parent study) 
• 
Urinalysis (last assessment from parent study) 
• 
vIGA-AD™ score (excluding subject’s scalp; last assessment from parent study)  
• 
%BSA affected calculation (excluding subject’s scalp; last assessment from parent study) 
• 
EASI (excluding subject’s scalp; last assessment from parent study) 
• 
 
 
 
 
 
• 
PP-NRS (last assessment from parent study) 
• 
 
 
 
 
 
• 
AE recording (ongoing from parent study at the time the ICF is signed in this study) 
• 
Concomitant medication recording (ongoing from parent study at the time the ICF is signed in this 
study) 
• 
Dispense diary (subjects or their caregivers will be instructed in how and when to complete diary) 
• 
Dispense study drug, if applicable 
• 
Instruction on how to apply study drug, if applicable 
• 
Study drug application under supervision, if applicable 
7.2.3 Baseline Visit for Subjects Enrolling Directly into DMVT-505-3103  
On Day 1, subjects will be reassessed to confirm continued eligibility to participate in the study.  All subjects 
who continue to meet study eligibility criteria will be randomized to treatment. 
The following additional procedures and assessments will be performed at the Baseline Visit: 
• Changes to medical history will be recorded 
• Brief physical examination 
• Vital signs measurement 
• Urine pregnancy test (WOCBP) 


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• Blood sample collection for clinical laboratory tests (serum chemistry and hematology) 
NOTE: Blood sample collection for clinical laboratory tests is not required at the Baseline Visit if 
it has been ≤14 days since samples were collected at Screening and the results of those clinical 
laboratory tests were within the normal range.  
• Urinalysis 
NOTE: Urine sample collection for urinalysis is not required at the Baseline Visit if it has been 
≤14 days since samples were collected at Screening and the results of those analyses were within 
the normal range.  
• vIGA-AD™ score (excluding subject’s scalp) 
• %BSA affected calculation (excluding subject’s scalp) 
• EASI (excluding subject’s scalp) 
• 
 
 
 
 
 
• PP-NRS (by subject or caregiver) 
• 
 
 
 
 
 
• Photography of a representative area of the subject’s disease area (at a subset of study sites only) 
• AE recording 
• Concomitant medication recording 
• Dispense diary (subjects or their caregivers will be instructed on how and when to complete diary) 
• Dispense study drug 
• Instruction on how to apply study drug 
• Study drug application under supervision 
7.3 Visits 2 to 13; Treatment Period  
Subjects will return to the study site at least every 4 weeks (±3 days) during the 48-week monitoring period. 
The following assessments will be performed: 
• Brief physical exam; Weeks 12, 24, 36 and 48 only 
• Vital signs measurements 
• Urine pregnancy test (WOCBP) 
• Blood sample collection for clinical laboratory tests (serum chemistry and hematology); Weeks 12, 
24, 36 and 48 only 
• Urinalysis; Week 48 only 
• vIGA-AD™ score (excluding subject’s scalp)  
• %BSA affected calculation (excluding subject’s scalp) 
• EASI (excluding subject’s scalp) 


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• 
 
 
 
 
 
• PP-NRS (by subject or caregiver) 
• 
 
 
 
 
 
• 
 
• Photography of a representative area of the subject’s disease area (at a subset of study sites only); 
Weeks 12, 24, 36 and 48 only 
• AE recording 
• Concomitant medication recording 
• Collect and review subject diaries for treatment compliance 
• Dispense diary 
• Collect and dispense study drug, if applicable 
• Review instructions on how to apply study drug, if applicable 
• Study drug application under supervision, if applicable 
7.4 Phone Contact at Week 2 (Day 15 ± 3 Days)  
Subjects or their caregivers will be contacted by phone at Week 2 to review study drug application 
instructions, if applicable, and to record AEs and concomitant medication use.  Subjects or their caregivers 
should be reminded to complete their daily diary and bring it with them to the next clinic visit. 
7.5 Follow-Up Visit 14; Week 49 (Day 344 ±3 Days)  
Subjects will return to the study site 1 week (±3 days) after last treatment to complete follow-up assessments 
as follows: 
• Brief physical examination 
• Vital signs measurement 
• Blood sample collection for clinical laboratory tests (serum chemistry and hematology) 
• Urinalysis 
• vIGA-AD™ score (excluding subject’s scalp) 
• %BSA affected calculation (excluding subject’s scalp)  
• EASI (excluding subject’s scalp) 
• 
 
 
 
• PP-NRS (by subject or caregiver) 
• 
 
 
 


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• AE recording 
• Concomitant medication recording 
7.6 Unscheduled Visits  
Unscheduled visits may occur, as needed. For subjects who experience suspected disease worsening 
(vIGA-AD™ ≥ 2) between scheduled study visits may contact the study site to arrange an unscheduled visit 
(see Section 5.1.5.2).  The following assessments may be performed: 
• Brief physical exam 
• Vital signs measurements 
• Urine pregnancy test (WOCBP) 
• Blood sample collection for clinical laboratory tests (serum chemistry and hematology) 
• Urinalysis 
• vIGA-AD™ score (excluding subject’s scalp) 
• %BSA affected calculation (excluding subject’s scalp) 
• EASI (excluding subject’s scalp) 
• 
 
• PP-NRS (by subject or caregiver) 
• 
 
• AE recording 
• Concomitant medication recording 
• Collect and review subject diaries for treatment compliance, if applicable 
• Dispense subject diaries, if applicable 
• Collect and dispense study drug, if applicable 
• Review instructions on how to apply study drug, if applicable 
• Study drug application under supervision, if applicable 
If disease worsening is confirmed, a new treatment course will be initiated. 
7.7 Early Termination Visit  
Subjects who withdraw early from the study will be asked to return to the study site to complete early 
termination assessments as follows: 
• Brief physical examination 
• Vital signs measurement 
• Urine pregnancy test (WOCBP) 
• Blood sample collection for clinical laboratory tests (serum chemistry and hematology) 
• Urinalysis 
• vIGA-AD™ score (excluding subject’s scalp) 
• %BSA affected calculation (excluding subject’s scalp)  
• EASI (excluding subject’s scalp) 




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8 Safety Monitoring and Reporting  
8.1 Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest  
The Investigator or site staff is responsible for detecting, documenting, and reporting events that meet the 
definition of an AE, SAE, or adverse event of special interest (AESI).  At each visit/contact, subjects should 
be questioned in a general way so as not to introduce bias in detecting AEs and/or SAEs.  Open-ended and 
non-leading verbal questioning of the subject is the preferred method to inquire about AE occurrence. 
Investigators are not obligated to actively seek AEs or SAEs in former study subjects.  However, if the 
Investigator learns of any SAE, including a death, at any time after a subject has been discharged from the 
study, and he/she considers the event reasonably related to the study drug or study participation, the 
Investigator should promptly notify the Sponsor. 
A narrative will be written and included in the Clinical Study Report for all SAEs and AESIs, and for all AEs 
that lead to study discontinuation 
8.1.1 Definition of Adverse Events  
An AE is any untoward medical occurrence in a subject temporally associated with the use of a medicinal 
product, whether considered causally related or not related to the medicinal product. 
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. 
Events meeting the definition of an AE include: 
• Any abnormal laboratory test results (hematology, clinical chemistry) or other safety assessments 
(e.g., vital signs measurements), including those that worsen from Baseline, and felt to be 
clinically significant in the medical and scientific judgment of the Investigator 
• Exacerbation of a chronic or intermittent pre-existing condition (e.g., plaque psoriasis) including 
either an increase in frequency and/or intensity of the condition 
• For skin-related AEs, it should be noted whether or not the event is in the area of active application 
of study drug, and/or if spreading beyond the application site. 
• New conditions detected or diagnosed after study drug administration even though it may have 
been present prior to the start of the study 
• Signs, symptoms, or the clinical sequelae of a suspected interaction 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study drug or a 
concomitant medication (overdose per se will not be reported as an AE/SAE) 
• "Lack of efficacy" or "failure of expected pharmacological action" per se will not be reported as an 
AE or SAE.  Such instances will be captured in the efficacy assessments.  However, the signs, 
symptoms, and/or clinical sequelae resulting from lack of efficacy will be reported as AE or SAE 
if they fulfill the definition of an AE or SAE. 
Events that do not meet the definition of an AE include: 
• Any clinically significant abnormal laboratory findings or other abnormal safety assessments that 
are associated with the underlying disease, unless judged by the Investigator to be more severe 
than expected for the subject’s condition 


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• The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the subject’s condition 
• Medical or surgical procedure (e.g., endoscopy, appendectomy); the condition that leads to the 
procedure is an AE 
• Situations where an untoward medical occurrence did not occur (social and/or convenience 
admission to a hospital) 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at 
the start of the study that do not worsen 
8.1.2 Definition of Serious Adverse Event  
If an event is not an AE per Section 8.1.1, then it cannot be an SAE even if serious conditions are met (e.g., 
hospitalization for signs/symptoms of the disease under study, death due to progression of disease, etc.). 
An SAE is any untoward medical occurrence that, at any dose: 
• Results in death 
• Is life-threatening 
− The term “life threatening” refers to an event in which the subject was at risk of death at the time 
of the event.  It does not refer to an event, which hypothetically might have caused death, if it were 
more severe. 
• Requires hospitalization or prolongation of existing hospitalization 
− In general, signifies that the subject has been detained (usually involving at least an overnight stay) 
at the hospital or emergency ward for observation and/or treatment that would not have been 
appropriate in the physician’s office or outpatient setting.  Complications that occur during 
hospitalization are AEs.  If a complication prolongs hospitalization or fulfills any other serious 
criteria, the event is serious.  When in doubt as to whether “hospitalization” occurred or was 
necessary, the AE should be considered serious. 
− Hospitalization for elective treatment of a pre-existing condition that did not worsen from Baseline 
is not considered an AE. 
• Results in disability/incapacity:  a substantial disruption of a person’s ability to conduct normal life 
functions. 
− This definition is not intended to include experiences of relatively minor medical significance such 
as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma (e.g., 
sprained ankle) which may interfere or prevent everyday life functions but do not constitute a 
substantial disruption. 
• Results in a congenital anomaly/birth defect 
Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other 
situations, such as important medical events that may not be immediately life-threatening or result in death or 
hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one 
of the other outcomes listed in the above definition.  These should also be considered serious.  Examples of 
such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for 


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allergic bronchospasm, blood dyscrasias, or convulsions that do not result in hospitalization, or development 
of drug dependency or drug abuse. 
8.1.3 Adverse Events of Special Interest  
In prior clinical studies, contact dermatitis, folliculitis, and headache have been identified as AEs of particular 
clinical importance and will be reported as AESIs in this study whether or not the AE is considered related to 
study drug.   
In each case study drug may be continued or discontinued, based on Investigator judgment, and may be 
restarted when the event resolves.  In addition, the following information must be collected for each of these 
AESIs: 
Contact Dermatitis 
Contact dermatitis:  the study site should collect location, duration, size, associated symptoms (itching, 
burning, pain), severity (mild, moderate, severe), time to onset, and photograph the affected site (if possible).  
If the subject or caregiver contacts the study site to report significant skin irritation at or near the site of study 
drug application between study visits, the subject should be brought in for an unscheduled visit, if possible. 
Headache   
The study site should collect duration, severity (mild, moderate, severe), time to onset, and location (e.g., 
frontal, temporal, occipital, diffuse). 
Follicular Event 
The study site should collect the location, duration, size, associated signs and symptoms (itching, burning, 
pain, erythema), severity (mild, moderate, severe), describe morphology [scale (keratotic/cornified) or no 
scale (non-keratotic/non-cornified)], time to onset, and photograph the affected site (if possible).   Additional 
information regarding management of folliculitis is provided in Section 8.2.1.2.4. 
In particular, the term ‘folliculitis’ may not correctly describe the morphology of the observed local follicular 
events as these appear to be more consistent with a keratoses pilaris-like follicular based papule. Tapinarof 
upregulates components of the stratum corneum, including involucrin, hornerin, and filaggrin and increased 
cornification at, and subsequent mechanical occlusion of, the follicular ostia has been suggested to be a 
potentially on target mechanism by which these lesions may develop in some individuals treated with 
tapinarof cream. Additional morphologic description will help to more fully and appropriately characterize 
these follicular events.      
Possible descriptors include, but are not limited to:  
• Folliculitis 
− Non-inflammatory 
− Inflammatory  
• Milia 
− Non-inflammatory 
− Inflammatory  
• Keratosis pilaris  
− Non-inflammatory 


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− Inflammatory  
Additional AESIs may be identified during the evaluation of safety data for the Clinical Study Report.   
8.2 Classification of Adverse Events  
8.2.1 Assigning Severity Rating for Adverse Events  
8.2.1.1 
Criteria for Determining Adverse Event Severity  
The Investigator will make an assessment of the severity of each AE and SAE according to the National 
Cancer Institute CTCAE, v. 5.0, 2017.  For terms not specified with the CTCAE, the criteria in Table 5 should 
be used to determine the grade severity. 
Table 5: 
Criteria for Determining the Grade/Severity of Adverse Event Terms Not Specified by 
the National Cancer Institute CTCAE  
Grade 
Criteria 
1 
Mild; asymptomatic or mild symptoms, clinical or diagnostic observations only; intervention not indicated 
2 
Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of 
daily livinga 
3 
Severe or medically significant but not immediately life threatening; hospitalization or prolongation of 
hospitalization indicated; disabling; limiting self-care activities of daily livingb 
4 
Life threatening consequences; urgent intervention indicated 
5 
Death related to adverse event 
a. Instrumental activities of daily living refer to preparing meals, shopping for groceries or clothes, using the telephone, managing 
money, etc. 
b. Self-care activities of daily living refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and 
not bedridden. 
CTCAE = Common Terminology Criteria for Adverse Events. 
 
AE severity should be recorded in the appropriate section of the AE CRF and in the subject’s source 
documents. 
8.2.1.2 
Toxicity Management Criteria  
8.2.1.2.1 Grade 1 or Grade 2 Adverse Event  
Subjects who develop a Grade 1 or Grade 2 AE may continue investigational product at the discretion of the 
Investigator.  Subjects who choose to withdraw from study due to a Grade 1 or 2 AE should have study 
withdrawal/early termination evaluations completed. 
8.2.1.2.2 Grade 3 Adverse Event  
Subjects who develop a Grade 3 AE should be managed as follows: 
• If the Investigator has compelling evidence that the Grade 3 AE has not been caused by 
investigational product, then dosing may continue after discussion with the Medical Monitor. 
• Subjects who develop a Grade 3 AE that the Investigator considers related to investigational 
product should have the investigational product discontinued.  Subjects experiencing Grade 3 AEs 
requiring permanent discontinuation of investigational product should be followed weekly until 
resolution or stability of the AE and encouraged to have withdrawal study evaluations completed. 
8.2.1.2.3 Grade 4 Adverse Event  
Subjects who develop a Grade 4 AE should have investigational product permanently discontinued. 


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Subjects experiencing Grade 4 AEs requiring permanent discontinuation of investigational product should be 
followed weekly until resolution or stability of the AE and encouraged to have withdrawal study evaluations 
completed. 
8.2.1.2.4 Folliculitis  
Subjects using tapinarof topically may experience folliculitis. The majority of these events are mild or 
moderate and do not require intervention or interruption in study drug use. On close inspection, the 
morphology is similar to that of keratosis pilaris suggesting that the potential mechanism may be increased 
follicular cornification with subsequent follicular plugging.  Importantly, AhR regulates the epidermal 
differentiation complex and tapinarof has been shown to repair the skin barrier through activation of stratum 
corneum components including fillagrin, hornerin and involucrin. This latter point suggests that the keratosis 
pilaris-like reaction may be an on-target effect predictive of a therapeutic response to tapinarof cream.  
Several approaches can be employed to manage those patients with folliculitis who may be symptomatic 
including temporary interruption of study drug use at sites of folliculitis and/or the local application to 
affected areas of topical keratolytics such as 12% lactic acid lotion or 5-10% urea creams or lotions. 
8.2.1.2.5 Other Management Criteria:  
The Medical Monitor should be notified if any of the following occur: 
• Severe signs or symptoms, or significant changes in any of the safety assessments, that put the 
safety of the subject at risk (e.g., laboratory tests or vital signs, etc.) as judged by the Investigator. 
8.2.2 Assigning Causal Relationship to Study Drug  
The Principal Investigator or sub-Investigator is to make the causality assessment.  The reasonable possibility 
of the relationship of an AE to study drug is to be assessed with careful medical consideration at the time of 
evaluation of an AE.  The following definitions are to be used for the relationship of the AE to study drug: 
• Related:  A clinical event, including laboratory test abnormality, with a temporal relationship to 
study drug administration that makes a causal relationship plausible, unlikely attributed to 
concurrent disease or other drugs or chemicals, and that follows a clinically reasonable response 
on re administration (rechallenge) or withdrawal (dechallenge), although information on drug 
withdrawal may be lacking or unclear. 
• Not related:  A clinical event, including laboratory test abnormality, with a temporal relationship 
to study drug administration that makes a causal relationship improbable and/or in which other 
drugs, chemicals, or underlying disease provide a plausible explanation. 
Any AEs /SAEs assessed as related to study participation (e.g., protocol mandated procedures, invasive tests, 
or change in existing therapy) or related to study drug will be recorded from the time a subject consented to 
participate in the study up to and including any follow-up contact. 
All AEs, whether related to study drug or not, must be fully and completely documented on the AE page of 
the CRF and in the subject’s clinical record.  In the event a subject is withdrawn from the study because of an 
AE, the primary reason for withdrawal (i.e., due to an AE) must be recorded on the CRF as such. 
8.3 Time Period and Frequency for Event Assessment and Follow-Up  
8.3.1 Adverse Event Reporting  
All AEs will be collected from the time of signed informed consent until the final visit. 


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Any AEs assessed as related to study participation (e.g., protocol mandated procedures, invasive tests, or 
change in existing therapy) will be collected from the time a subject consented to participate in the study up to 
and including any follow-up contact. 
All SAEs will be recorded on the CRF and reported to the Sponsor within 24 hours via email or phone (refer 
to Medical Monitor / Sponsor Information Page for contact information) (see Section 8.4). 
8.3.2 Follow-Up of Adverse Events  
After the initial AE/SAE report, the Investigator is required to proactively follow each subject at subsequent 
visits/contacts.  All SAEs and nonserious AEs will be followed until resolution, until the condition stabilizes, 
until the event is otherwise explained, or until the subject is lost to follow-up. 
The Investigator will assess the outcome of each AE using the following criteria: 
• Recovered/Resolved:  The event has improved or subject recuperated. 
• Recovered/Resolved with sequelae:  The subject has recuperated but retained pathological 
conditions resulting from the prior disease or injury. 
• Recovering/Resolving:  The event is improving. 
• Not recovered/Not resolved:  The event has not improved or subject recuperated. 
• Unknown:  The outcome of the event is not known, not observed, not recorded, or refused. 
• Fatal:  Termination of life as an outcome of the AE. 
8.4 Reporting Procedures  
8.4.1 Serious Adverse Event Reporting  
When an Investigator determines that an AE meets the protocol definition of an SAE during the study, he/she 
must notify the Sponsor using an SAE Report Form within 24 hours of the study site personnel’s 
knowledge of the event, regardless of the Investigator assessment of the relationship of the event to study 
drug.  Relevant information will be entered on the AE page and on all other applicable pages of the CRF; 
source documentation should not be sent with the SAE Report Form unless requested. 
Follow-up information received on SAEs should be emailed or faxed to the Sponsor within 1 business day of 
receipt (refer to Medical Monitor / Sponsor Information Page for contact information).  This information 
should be included on a follow-up SAE form and filed with the original SAE information. 
All SAEs will be followed until resolution, until the condition stabilizes, until the event is otherwise 
explained, or until the subject is lost to follow-up. 
The completed SAE Report Form should be submitted via email or fax to the SAE Reporting Contact which 
can be found on the Medical Monitor / Sponsor Information Page of this protocol. 
Do not delay reporting a suspected SAE in order to obtain additional information.  Any additional 
information, if collected, can be reported as a follow-up to the initial report. 
8.4.2 Regulatory Reporting Requirements for Serious Adverse Events  
Prompt notification by the Investigator to the Sponsor of SAEs (even for non-interventional post-marketing 
studies) is essential so that legal obligations and ethical responsibilities towards the safety of subjects and the 
safety of a product under clinical investigation are met. 


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The Sponsor has a legal responsibility to notify both the local regulatory authority and other regulatory 
agencies about the safety of a product under clinical investigation.  The Sponsor will comply with 
country-specific regulatory requirements relating to safety reporting to the regulatory authority, IRB/IEC, and 
investigators. 
Investigator safety reports are prepared for suspected unexpected serious adverse reactions according to local 
regulatory requirements and are forwarded to Investigators as necessary. 
An Investigator who receives an investigator safety report describing a SAE(s) or other specific safety 
information (e.g., summary or listing of SAEs) from the Sponsor will file it with the Investigator’s Brochure 
and will notify the IRB/IEC, if appropriate, according to local requirements. 
8.5 Pregnancy Management and Reporting  
Any female subject who becomes pregnant during the study will be withdrawn.  Details will be collected for 
all pregnancies in female subjects and female partners of male subjects that begin after the start of dosing and 
through the Follow-up visit.  Pregnancy is not automatically considered an AE. 
If a pregnancy is reported, then the Investigator should complete a Pregnancy Report Form and submit via 
email or fax to the Pregnancy Reporting Contact for which contact information can be found on the Medical 
Monitor / Sponsor Information Page of this protocol, within 2 weeks of learning of the pregnancy.  The 
subject will also be followed to determine the outcome of the pregnancy.  Information on the status of the 
mother and child will be forwarded to the Sponsor.  Generally, follow-up will be no longer than 6 to 8 weeks 
following the estimated delivery date.  Any premature termination of the pregnancy will be reported. 
Any SAE occurring in association with a pregnancy brought to the Investigator’s attention after the subject 
has completed the study and considered by the Investigator as possibly related to the study drug must be 
promptly reported to the Sponsor or the Sponsor’s representative. 
The Investigator must attempt to collect pregnancy information on any female partners of male study subjects 
who become pregnant while the subject is enrolled in the study.  Pregnancy information must be reported to 
the Sponsor or the Sponsor’s representative as described above.  The partner will also be followed to 
determine the outcome of the pregnancy.  Information on the status of the mother and child will be forwarded 
to Sponsor or the Sponsor’s representative.  Generally, follow-up will be no longer than 6 to 8 weeks 
following the estimated delivery date.  Any premature termination of the pregnancy will be reported on the 
Pregnancy Report Form. 


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9 Data Management  
For this study, subject data will be entered into the Sponsor-defined CRFs, transmitted electronically to the 
Sponsor or designee, and combined with data provided from other sources in a validated data system. 
Management of clinical data will be performed in accordance with applicable Sponsor standards and data 
cleaning procedures will be used to ensure the integrity of the data, e.g. errors will be corrected, and 
inconsistencies queried in the data. 
Adverse events and relevant medical history will be coded using the most current version of the Medical 
Dictionary for Regulatory Activities.  Concomitant medications will be coded with the most current version of 
World Health Organization Drug Global Dictionary. 
The Investigator will retain original source documents and the Sponsor will receive CRF-required data as 
electronic datasets.  Subject initials will not be collected or transmitted to the Sponsor. 


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10 Statistical Considerations and Data Analyses  
This study is intended to show that tapinarof cream has a favorable safety and efficacy profile during 
repeated, intermittent treatment courses over an extended period of time. 
10.1 General Considerations  
All study data will be summarized using descriptive statistics for the ITT population overall and by the 
following categories: received tapinarof treatment in either DMVT-505-3101 or DMVT-505-3102; received 
vehicle treatment in either DMVT-505-3101 or DMVT-505-3102; received tapinarof treatment in DMVT-
505-2104; and enrolled directly into DMVT-505-3103.  Categorical variables will be reported using 
frequency and percentage (e.g., sex, race).  Continuous variables will be reported using number of subjects, 
mean, standard deviation (SD), median, minimum, and maximum.  All efficacy and safety data will be listed 
by subject. 
10.2 Determination of Sample Size  
The sample size of this study is based on the ICH E1A guideline on extent of population exposure to assess 
clinical safety for drugs intended for long-term treatment of non-life-threatening conditions. Up to 
961 subjects will be enrolled in this study across all regions, including up to 836 rollover subjects from 
studies DMVT-505-3101, DMVT-505-3102, and DMVT-505-2104 and approximately 125 subjects directly 
enrolling into this study. 
10.3 Analysis Populations  
All subjects enrolled into the study will be included in the ITT population. 
10.4 Planned Analyses  
All efficacy and safety measures over the course of the study will be presented.  All analyses will be based on 
the ITT population. Details of planned analyses will be described in the Statistical Analysis Plan, which will 
be finalized prior to database lock. 
10.4.1 Disposition and Demographics  
Demographic and baseline characteristics as well as medical history will be summarized using the ITT 
population, including frequency and percentages for categorical variables and mean, SD, median, minimum, 
and maximum for continuous variables. 
The numbers of subjects will be summarized by the following categories: received tapinarof treatment in 
either DMVT-505-3101 or DMVT-505-3102; received vehicle treatment in either DMVT-505-3101 or 
DMVT-505-3102; received tapinarof treatment in DMVT-505-2104; and enrolled directly into DMVT-505-
3103. 
10.4.2 Efficacy Analyses  
All efficacy analyses will be performed based on the ITT population as described above. Summaries will be 
presented overall and by the following categories: received tapinarof treatment in either DMVT-505-3101 or 
DMVT-505-3102; received vehicle treatment in either DMVT-505-3101 or DMVT-505-3102; received 
tapinarof treatment in DMVT-505-2104; and enrolled directly into DMVT-505-3103. Summaries of efficacy 
endpoints by visit will be performed using OC and LOCF methods. 
Efficacy endpoints are as follows: 




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• 
 
 
 
 
For analyses of time to event, such as the time to first worsening (vIGA-ADTM ≥ 2) or the time to first 
reaching a vIGA-ADTM score of 0, the Kaplan-Meier product limit method will be used to estimate the 
median time (if estimable). If the median is not estimable (e.g., < 50% of subjects reach the event), other 
methods for estimating the median and/or other percentiles will be applied. 
The remaining efficacy endpoints will be summarized descriptively as follows: continuous data will include 
the mean, SD, minimum, maximum, median, and number of observations; descriptive summary statistics for 
categorical data will include frequency counts and percentages. 
10.4.3 Safety Analyses  
The ITT Population will be used in the analysis of safety data.  Summaries will be presented overall and by 
the following categories: received tapinarof treatment in either DMVT-505-3101 or DMVT-505-3102; 
received vehicle treatment in either DMVT-505-3101 or DMVT-505-3102; received tapinarof treatment in 
DMVT-505-2104; and enrolled directly into DMVT-505-3103.  
The number and percent of subjects with TEAEs will be summarized by system organ class, and preferred 
term for all TEAEs, all TEAEs considered by the Investigator to be related to study drug, all SAEs, all TEAEs 
leading to study drug discontinuation, and all TEAEs leading to study discontinuation.   TEAEs will be 
defined as follows:  
• For rollover subjects, all AEs reported in DMVT-505-3103 will be considered to be a TEAE 
except for those AEs ongoing at the end of the parent study (DMVT-505-3101, DMVT-505-3102, 
or DMVT-505-2104) but resolved prior to the Visit 1 date in DMVT-505-3103.  
• For subjects enrolled directly into DMVT-505-3103, all AEs that start after the first dose of study 
medication will be considered to be a TEAE.   
Data listings will be provided for subjects who discontinued the study due to an AE and for subjects with an 
SAE.   
Laboratory values will be classified as normal, low or high based on normal ranges supplied by the 
laboratory.  Changes from Baseline in abnormality status will be summarized using shift tables.  For 
quantitative laboratory measures, observed values and changes from Baseline will be summarized 
descriptively by visit.  
Observed vital sign values (systolic and diastolic blood pressure, pulse rate, and body temperature) and 
change from Baseline in vital signs will be summarized similarly to the laboratory values. 
LTS scores will be summarized by visit for subject (or caregiver) overall assessment and Investigator overall 
assessment separately. 
  
 


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• 
 
 
 
 
 
 
 
 
  
 
 
10.4.5 
  
. 
10.5 Interim Analyses  
A data-cut will be made at the time of preparation of the marketing application to present interim results; the 
final analysis will be conducted after study completion (e.g., the last subject’s last visit). 
10.6 Handling of Missing Data  
Summaries of efficacy endpoints by visit will be performed using OC and LOCF methods. 


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11 Responsibilities  
11.1 Investigator Responsibilities  
11.1.1 Good Clinical Practice  
The Investigator will ensure that this study is conducted in accordance with the principles of the “Declaration 
of Helsinki” (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and South Africa), ICH guidelines, or 
with the laws and regulations of the country in which the research is conducted, whichever affords the greater 
protection to the study subject.  For studies conducted under a United States Investigational New Drug 
Application, the Investigator will ensure that the basic principles of “Good Clinical Practice,” as outlined in 
21 Code of Federal Regulations (CFR) 312, subpart D, “Responsibilities of Sponsors and Investigators,” 
21 CFR, part 50, 1998, and 21 CFR, part 56, 1998, are adhered to.  These standards are consistent with the 
requirements of the European Community Directive 2001/20/EC. 
Since this is a “covered” clinical trial, the Investigator will ensure that 21 CFR, Part 54, 1998, is adhered to; a 
“covered” clinical trial is any “study of a drug or device in humans submitted in a marketing application or 
reclassification petition subject to this part that the applicant or Food and Drug Administration relies on to 
establish that the product is effective (including studies that show equivalence to an effective product) or that 
make a significant contribution to the demonstration of safety.”  This requires that Investigators and all sub-
Investigators must provide documentation of their financial interest or arrangements with the Sponsor, or 
proprietary interests in the drug being studied.  This documentation must be provided before participation of 
the Investigator and any sub-Investigator.  The Investigator and sub-Investigator agree to notify the Sponsor 
of any change reportable interests during the study and for 1 year following completion of the study.  Study 
completion is defined as the date that the last subject has completed the protocol-defined activities. 
11.1.2 Institutional Review Board/Independent Ethics Committee Approval  
This protocol and any accompanying material to be provided to the subject (such as advertisements, subject 
information sheets, or descriptions of the study used to obtain informed consent) will be submitted by the 
Investigator or on behalf of the Investigator to an IRB or IEC.  Approval from the IRB or IEC must be 
obtained before starting the study and should be documented in a letter to the Investigator specifying the 
protocol number, protocol version, protocol date, documents reviewed, and date on which the committee met 
and granted the approval. 
Any modifications made to the protocol after receipt of IRB or IEC approval must also be submitted to the 
IRB or IEC for approval before implementation. 
11.1.3 Informed Consent/Assent  
The Investigator is responsible for obtaining written informed consent/assent from each individual 
participating in this study after adequate explanation of the aims, methods, objectives, and potential hazards of 
the study and before undertaking any study-related procedures.  The Investigator must utilize an IRB- or IEC-
approved consent form for documenting written informed consent.  Each informed consent/assent will be 
appropriately signed and dated by the subject or the subject’s legally authorized representative and the person 
obtaining consent. 
11.1.4 Confidentiality  
The Investigator must assure that subjects’ anonymity will be strictly maintained and that their identities are 
protected from unauthorized parties.  Only subject number, date of birth, and an identification code (i.e., not 


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names) should be recorded on any form or biological sample submitted to the Sponsor, IRB or IEC, or 
laboratory.  The Investigator must keep a log showing codes, names, and addresses for all subjects enrolled in 
the trial. 
The Investigator agrees that all information received from the Sponsor, including but not limited to the 
Investigator Brochure, this protocol, CRFs, the investigational new drug, and any other study information, 
remain the sole and exclusive property of the Sponsor 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 the Sponsor.  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. 
11.1.5 Study Files and Retention of Records  
The Investigator must maintain adequate and accurate records to enable the conduct of the study to be fully 
documented and the study data to be subsequently verified.  These documents should be classified into at least 
the following 2 categories: (1) Investigator’s study file, and (2) subject clinical source documents. 
The Investigator’s study file will contain the protocol/amendments, CRF and query forms, IRB or IEC and 
governmental approval with correspondence, informed consent, drug records, staff curriculum vitae and 
authorization forms, and other appropriate documents and correspondence. 
The required source data should include at least the following information for each subject: 
• Subject identification (name, date of birth, gender) 
• Documentation that subject meets eligibility criteria, i.e., history, physical examination, and 
confirmation of diagnosis (to support inclusion and exclusion criteria) 
• Participation in trial (including trial number) 
• Trial discussed and date of informed consent 
• Dates of all visits 
• Documentation that protocol-specific procedures were performed 
• Results of efficacy parameters, as required by the protocol 
• Start and end dates (including dose regimen) of trial medication (preferably drug dispensing and 
return should be documented as well) 
• Record of all adverse events and other safety parameters (start and end date, and preferably 
including causality and intensity) 
• Concomitant medication (including start and end dates, dose if relevant; dose changes should be 
recorded) 
• Date of trial completion and reason for early discontinuation, if applicable 
All clinical study documents must be retained by the Investigator until at least 2 years after the last approval 
of a marketing application in an ICH region (i.e., United States, Europe, or Japan) and until there are no 
pending or contemplated marketing applications in an ICH region; or, if no application is filed or if the 
application is not approved for such indication, until 2 years after the investigation is discontinued and 
regulatory authorities have been notified.  Investigators may be required to retain documents longer if 


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required by applicable regulatory requirements, by local regulations, or by an agreement with the Sponsor.  
The Investigator must notify the Sponsor before destroying any clinical study records. 
Should the Investigator wish to assign the study records to another party or move them to another location, the 
Sponsor must be notified in advance. 
If the Investigator cannot guarantee this archiving requirement at the study site for any or all of the 
documents, special arrangements must be made between the Investigator and the Sponsor to store these in 
sealed containers outside of the site so that they can be returned sealed to the Investigator in case of a 
regulatory audit.  When source documents are required for the continued care of the subject, appropriate 
copies should be made for storage outside of the site. 
11.1.6 Electronic Case Report Forms  
For each subject enrolled, a CRF must be completed and signed by the Investigator.  This also applies to 
records for those subjects who fail to complete the study.  If a subject withdraws from the study, the reason 
must be noted on the CRF.  If a subject is withdrawn from the study because of a treatment-limiting AE, 
thorough efforts should be made to clearly document the outcome. 
11.1.7 Drug Accountability  
The Investigator or designee (i.e., pharmacist) is responsible for ensuring adequate accountability of all used 
and unused investigational medicinal product.  This includes acknowledgment of receipt of each shipment of 
study product (quantity and condition), subject dispensing records, and returned or destroyed study product.  
Dispensing records will document quantities received from the Sponsor and quantities dispensed to subjects, 
including kit or lot number, date dispensed, subject identifier number, and the initials of the person dispensing 
the medication. 
At study initiation, the monitor will evaluate the site’s procedure for investigational medicinal product 
disposal/destruction in order to ensure that it complies with the Sponsor requirements.  At the end of the 
study, following final drug inventory reconciliation by the monitor, the study site will dispose of and/or 
destroy all unused investigational medicinal product supplies, including empty containers, according to these 
procedures.  If the site cannot meet the Sponsor’s requirements for disposal, arrangements will be made 
between the site and the Sponsor or its representative for destruction or return of unused investigational 
medicinal product supplies. 
All drug supplies and associated documentation will be periodically reviewed and verified by the study 
monitor over the course of the study. 
11.1.8 Inspections  
The Investigator should understand that source documents for this trial should be made available to 
appropriately qualified personnel from the Sponsor or its representatives, to IRBs or IECs, or to regulatory 
authority or health authority inspectors. 
11.1.9 Protocol Compliance  
The Investigator is responsible for ensuring the study is conducted in accordance with the procedures and 
evaluations described in this protocol. 


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11.2 Sponsor Responsibilities  
11.2.1 Protocol Modifications  
Protocol modifications, except those intended to reduce immediate risk to study subjects, may be made only 
by the Sponsor.  All protocol modifications must be submitted to the IRB or IEC and regulatory authorities in 
accordance with local requirements.  Approval must be obtained before changes can be implemented. 
11.2.2 Study Report and Publications  
A clinical study report will be prepared and provided to the regulatory agency(ies).  The Sponsor will ensure 
that the report meets the standards set out in the ICH Guideline for Structure and Content of Clinical Study 
Reports (ICH E3).  Note that an abbreviated report may be prepared in certain cases. 
After conclusion of the study and without prior written approval from Dermavant Sciences, Inc., Investigators 
in this study may communicate, orally present, or publish in scientific journals or other scholarly media only 
after the following conditions have been met: 
• The results of the study in their entirety have been publicly disclosed by or with the consent of 
Dermavant Sciences, Inc., in an abstract, manuscript, or presentation form; OR 
• The study has been completed at all study sites for at least 5 years. 
No such communication, presentation, or publication will include Dermavant Sciences, Inc. confidential 
information (see Section 11.1.4). 
The Investigator will submit any proposed publication or presentation along with the respective scientific 
journal or presentation forum at least 30 days before submission of the publication or presentation.  The 
Investigator will comply with Dermavant Sciences, Inc. request to delete references to its confidential 
information (other than the study results) in any paper or presentation and agrees to withhold publication or 
presentation for an additional 60 days in order to obtain patent protection if deemed necessary. 
11.2.3 Posting of Information on Publicly Available Clinical Trial Registers  
Study information from this protocol will be posted on publicly available clinical trial registers as required by 
applicable regulations.  Results will be posted as required. 
11.3 Joint Investigator/Sponsor Responsibilities  
11.3.1 Access to Information for Monitoring  
In accordance with ICH Good Clinical Practice guidelines, the study monitor must have direct access to the 
Investigator’s source documentation in order to verify the data recorded in the CRFs for consistency. 
The monitor is responsible for routine review of the CRFs at regular intervals throughout the study to verify 
adherence to the protocol and the completeness, consistency, and accuracy of the data being entered on them.  
The monitor should have access to any subject records needed to verify the entries on the CRFs.  The 
Investigator agrees to cooperate with the monitor to ensure that any problems detected in the course of these 
monitoring visits are resolved. 
In the event of COVID-19-like situation necessitating a limit on in-person contact, remote monitoring may be 
performed. 


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11.3.2 Access to Information for Auditing or Inspections  
To ensure compliance with Good Clinical Practices and all applicable regulatory requirements, Dermavant 
Sciences, Inc. may conduct a quality assurance audit. 
Authorized representatives of Dermavant Sciences, Inc., a regulatory authority, an Independent Ethics 
Committee or an Institutional Review Board may visit the site to perform audits or inspections, including 
source data verification.  The purpose of a Dermavant Sciences, Inc. audit or inspection is to systematically 
and independently examine all study-related activities and documents to determine whether these activities 
were conducted, and data were recorded, analyzed, and accurately reported according to the protocol, Good 
Clinical Practice guidelines of the ICH, and any applicable regulatory requirements.  The Investigator should 
contact Dermavant Sciences, Inc. immediately if contacted by a regulatory agency about an inspection. 
Representatives of regulatory authorities or of the Sponsor may conduct inspections or audits of the clinical 
study.  If the Investigator is notified of an inspection by a regulatory authority the Investigator agrees to notify 
the Sponsor Medical Monitor immediately.  The Investigator agrees to provide to representatives of a 
regulatory agency or the Sponsor access to records, facilities, and personnel for the effective conduct of any 
inspection or audit. 
11.3.3 Study Discontinuation  
The Sponsor reserves the right to terminate the study at any time.  Should this be necessary, the Sponsor will 
arrange discontinuation procedures and notify the appropriate regulatory authority(ies), IRBs, and IECs.  In 
terminating the study, the Sponsor and the Investigator will assure that adequate consideration is given to the 
protection of the subjects’ interests. 
 
 




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13 Appendices  
Appendix 1. Hanifin and Rajka Criteria for Atopic Dermatitis Diagnosis  
Major Criteria (must have at least three) 
• Pruritus 
• Typical morphology and distribution: 
− Adults: flexural lichenification or linearity 
− Children and infants: involvement of facial and extensor surfaces 
• Chronic or chronically relapsing dermatitis 
• Personal or family history of atopy (asthma, allergic rhinitis, atopic dermatitis) 
Minor Criteria (must have at least three) 
• Xerosis 
• Ichthyosis/keratosis pilaris/palmar hyperlinearity 
• Immediate (Type 1) skin test reactivity 
• Elevated serum IgE 
• Early age at onset 
• Tendency to skin infections (Staphylococcus aureus, herpes simplex)/impaired cellular immunity  
• Tendency to nonspecific hand/foot dermatitis 
• Nipple eczema 
• Cheilitis 
• Recurrent conjunctivitis 
• Dennie-Morgan infraorbital fold 
• Keratoconus 
• Anterior subcapsular cataracts 
• Orbital darkening 
• Facial pallor/erythema 
• Pityriasis alba 
• Anterior neck folds 
• Itch when sweating 
• Intolerance to wool and lipid solvents 
• Perifollicular accentuation 
• Food intolerance 
• Course influenced by environmental/emotional factors 
• White dermographism/delayed blanch 
 
Source: Hanifin, 1980. 
 


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Appendix 2. Fitzpatrick Skin Type Scale  
 
Skin Type 
Sunburn Tendency 
Suntan Tendency  
Type I 
Always burns easily 
Never tan 
Type II 
Always burns easily 
Tans slightly 
Type III 
Burns moderately 
Tans gradually 
Type IV 
Burns minimally 
Tans moderately 
Type V 
Rarely burns 
Tans profusely 
Type VI 
Never burns 
Tans profusely 
 
 




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Appendix 5. Validated Investigator Global Assessment Scale for Atopic Dermatitis  
Instructions: 
The vIGA-ADTM score is selected using the descriptors below that best describe the overall appearance of the 
lesions (excluding lesions on the scalp) at a given time point. It is not necessary that all characteristics under 
Morphological Description be present. 
 
 
Score 
Morphological Description 
0 – Clear 
No inflammatory signs of atopic dermatitis (no erythema, no 
induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory 
hyperpigmentation and/or hypopigmentation may be present. 
1 – Almost clear 
Barely perceptible erythema, barely perceptible induration/papulation, and/or 
minimal lichenification. No oozing or crusting. 
2 – Mild 
Slight but definite erythema (pink), slight but definite induration/papulation, and/or 
slight but definite lichenification. No oozing or crusting. 
3 – Moderate 
Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, 
and/or clearly perceptible lichenification. Oozing and crusting may be present. 
4 – Severe 
Marked erythema (deep or bright red), marked induration/papulation, and/or 
marked lichenification. Disease is widespread in extent. Oozing or crusting may be 
present. 
Notes: 
1. In indeterminate cases, please use extent to differentiate between scores. 
For example: 
Patient with marked erythema (deep or bright red), marked papulation and/or marked lichenification that is 
limited in extent, will be considered “3 – Moderate”. 
2. Excoriations should not be considered when assessing disease severity. 
 
Copyright ©2017 Eli Lilly and Company – Used with the permission of Eli Lilly and Company under a Creative Commons 
Attribution-No Derivatives 4.0 International License – https://creativecommons.org/licenses/by-nd/4.0/. 
 
 




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Calculation of EASI score (scalp excluded) 
Four anatomic sites – head, upper extremities, trunk, and lower extremities – are assessed for erythema, 
edema/papulation, excoriation and lichenification as seen on the day of the examination.  The severity of each 
sign is assessed using a 4-point scale, half points may be used (e.g. 0.5, 1.5, 2.5): 
0 = Absent 
1 = Mild 
2 = Moderate 
3 = Severe 
The area affected by AD within a given anatomic site is estimated as a percentage of the total area of that 
anatomic site, based on the %BSA calculation, and assigned a numerical value according to the degree of AD 
involvement.  For the purpose of assigning a numerical value for each anatomic site, %BSA ranges will be 
used as follows: 
0 = no (0%) involvement 
1 = > 0% to < 9.50% involvement 
2 = ≥ 9.50% to < 29.50% involvement 
3 = ≥ 29.50% to < 49.50% involvement 
4 = ≥ 49.50% to < 69.50% involvement 
5 = ≥ 69.50% to < 89.50% involvement  
6 = ≥ 89.50% to 100% involvement 
The EASI score will be calculated in the CRF based on the subject’s age, the rating scores for each region, 
and the number of handprints involved for each region. 
 
 








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Appendix 13. Peak Pruritus-Numeric Rating Scale  
The PP-NRS is a scale used to quickly assess itch/pruritus severity over a 24-hour period which will be used 
daily to assess peak pruritus.   
For subjects ages 2 to < 12 years, the PP-NRS will be completed by the caregiver.  For subjects ages > 12 
years, the PP-NRS will be completed by the subject.   
 
PP-NRS 
On a scale of 0 to 10, with 0 being ’no itch‘ and 10 being ’worst itch imaginable‘, how would you rate your 
itch at the worst moment during the previous 24 hours? 
 
 
 
 
PP-NRS © 2019 Regeneron Pharmaceuticals, Inc. and SAR&D. All rights reserved. Used with permission of 
Regeneron Pharmaceuticals, Inc. and SAR&D 
 
 
 
 
 


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SAP_001.pdf: 
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Statistical Analysis Plan
Dermavant Sciences, Inc.
DMVT-505-3103
An Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of 
Tapinarof Cream 1% in Subjects with Atopic Dermatitis
Protocol Version: 2.0 16JUN2021
Sponsor:
Dermavant Sciences, Inc.
3300 Paramount Parkway, Suite 150
Morrisville, NC 27560
Prepared by:
Version
Date
1.0
21APR2023


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Approval
Upon review of this document, including the table, listing, and figure shells, the undersigned 
approves the statistical analysis plan. The analysis methods and data presentation are acceptable.
Signature / Date
 
 
 
 
 
 
 
 




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APPENDIX B: SAS PROGRAMMING QC REQUIREMENTS .........................................................................36
37
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LIST OF ABBREVIATIONS
Abbreviation
Full Notation
AD
atopic dermatitis
ADaM
Analysis Dataset
AE
adverse event
AESI
adverse event of special interest
ATC
Anatomical/Therapeutic/Chemical
BMI
body mass index
BSA
body surface area
%BSA
percent of total body surface area
CSR
clinical study report
CRF
case report form
CTCAE
Common Terminology Criteria for Adverse Events
DBP
diastolic blood pressure
Dermavant
Dermavant Sciences, Inc.
 
EASI
Eczema Area and Severity Index
EOS
End of Study
EOT
End of Treatment
ICH
International Council for Harmonisation
ITT
Intent-to-Treat
LOCF
last observation carried forward
MedDRA
Medical Dictionary for Regulatory Activities
OC
observed cases
OL-LTE
Open-Label, Long-Term Extension study
PK
Pharmacokinetic(s)
PP-NRS
peak pruritus-numeric rating scale (daily itch score)
PT
preferred term
QC
quality control
QD
once daily


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Abbreviation
Full Notation
RTF
rich text format
SAE
serious adverse event
SAP
Statistical Analysis Plan
SAS®
Statistical Analysis Software
SBP
systolic blood pressure
SD
standard deviation
SOC
System organ class
TEAE
Treatment-emergent adverse event
TLFs
Tables, listings, and figures
VAS
visual analog scale
vIGA-AD™
validated Investigator Global Assessment for Atopic Dermatitis
WHO-Drug Global
World Health Organization Global Drug Dictionary


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1. INTRODUCTION
This document outlines the statistical methods to be implemented during the analyses of data 
collected within the scope of DMVT-505-3103 [An Open-Label, Long-Term Extension Study to 
Evaluate the Safety and Efficacy of Tapinarof Cream 1% in Subjects with Atopic Dermatitis]. 
The purpose of this plan is to provide specific guidelines for the statistical analyses. Any 
deviations from this plan will be documented in the clinical study report (CSR).
2. STUDY DOCUMENTS
The following study documents are used for the preparation of the Statistical Analysis Plan 
(SAP):
Protocol, Version 2.0, 16JUN2021
Annotated case report form (CRF), Version 1.0, 09SEP2021.
Data management plan, Version 1, 08OCT2021.
3. STUDY OBJECTIVES
To evaluate the safety and tolerability of tapinarof cream, 1% in subjects with atopic 
dermatitis (AD)
To evaluate the efficacy of tapinarof cream, 1% over an extended period of time in subjects 
with AD
To describe the effect of tapinarof cream, 1% on AD symptom severity and the associated 
impact on daily activities and attitudes in subjects with AD
4. STUDY DESIGN AND PLAN
This is an open-label, long-term multicenter, study to evaluate the safety and efficacy of topical 
tapinarof cream, 1% in subjects with AD. Subjects in this study will have either: a) completed 
treatment with tapinarof or vehicle in one of two Phase 3 pivotal safety and efficacy studies, 
DMVT-505-3101 or DMVT-505-3102, and rolled over into this study; b) completed treatment 
with tapinarof in the Phase 2 maximal use PK study, DMVT-505-2104, and rolled over into this 
study; or c) enrolled directly into this study. This study will consist of up to 48 weeks of 
treatment and a 1-week safety follow-up period.
At the completion of the Week 8 visit of study DMVT-505-3101 or study DMVT-505-3102 or 
the Day 28 visit of study DMVT-505-2104 (Baseline [Day 1] in this study), all eligible subjects 
will be offered enrollment in this open-label, long-term extension (OL-LTE) study.
Approximately 125 additional pediatric subjects ages 2 to <18 years who are not eligible for 
participation in the Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) will be 
enrolled directly into this OL-LTE study. Study visits during the treatment period for all subjects 
will occur every 4 weeks (±3 days). Unscheduled visits may occur, as needed. Subjects who 
withdraw from the study before Week 48 will return to the study site for an Early Termination 
 
 
 
 
 
 


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visit. The total duration of subject participation in this study will be approximately 49 weeks for 
rollover subjects (Baseline to Follow-Up) and approximately 53 weeks for direct-enrolling 
subjects (Screening to Follow-Up).
Rollover subjects in this study will begin treatment based on their validated Investigator Global 
Assessment for Atopic Dermatitis (vIGA-ADTM) score from the final visit in one of the three 
aforementioned studies (DMVT-505-3101, DMVT-505-3102, or DMVT-505-2104). Subjects 
entering with a vIGA-ADTM
1 will receive treatment with tapinarof cream, 1% once daily (QD)
until they achieve a vIGA-ADTM score of 0, at which time treatment will be discontinued and 
subjects monitored for maintenance of disease control (i.e., the extent of the remittive effect). 
If/when disease worsening occurs, as evidenced by a flare to vIGA-ADTM
2, treatment will then 
be re-initiated and continued until a vIGA-ADTM of 0 is achieved. Subjects entering with a 
vIGA-ADTM of 0 will have treatment discontinued beginning at the Baseline visit and will be 
monitored for maintenance of the remittive effect. If/when disease worsening occurs, as 
evidenced by a vIGA-ADTM
2, treatment will then be re-initiated and continued until a 
vIGA-ADTM of 0 is achieved. This treatment and re-treatment pattern of use will be continued 
until the end of the study (i.e., subjects may receive study treatment up until the Week 48 visit).
Subjects enrolling directly into this study will receive treatment QD with tapinarof cream, 1% 
beginning at Baseline and continue treatment until they achieve a vIGA-ADTM score of 0, at 
which time treatment will be discontinued and subjects monitored for maintenance of the 
remittive effect. If/when disease worsening occurs, as evidenced by a flare to vIGA-ADTM
2, 
treatment will be re-initiated and continued until a vIGA-ADTM of 0 is achieved. This regimen of 
treatment and re-treatment will continue until the end of the study (i.e., subjects may receive 
study drug up until the Week 48 visit).
Study drug will be dispensed to subjects or their caregivers, applied during the clinic visits, and 
applied at home between clinic visits as instructed by site personnel. Subjects or their caregivers 
will be instructed to apply study drug QD to all affected areas, including newly appearing lesions 
and lesions/areas that improve during the study until a vIGA-ADTM of 0 is achieved. Once a 
vIGA-ADTM of 0 is achieved, the treatment period ends. If/when disease worsening occurs, and 
treatment is re-initiated at a vIGA-ADTM
2, all lesions currently present and any new lesions 
that occur during the new treatment period should be treated.
Subjects or their caregivers will apply sufficient study drug to cover each lesion completely with 
a thin layer of study drug and will record the time of study drug application and daily itch score 
(PP-NRS) in a daily diary provided by the study site. Subjects are allowed, but not required, to 
treat scalp lesions with study drug; however, efficacy analyses will not include assessment of AD 
on the scalp. At the first clinic visit, if applicable, subjects and/or caregivers will be instructed to 
maintain the approximate dosing time for the daily application of study drug. At the phone 
contact at Week 2, subjects or caregivers should be reminded to complete their daily diary and 
bring it with them to the next clinic visit.
 
 
 
 


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Study drug application instructions will be reviewed at all post-randomization clinic visits and 
during any planned study phone calls. On clinic visit days, subjects and/or caregivers will be 
instructed/reminded on how to apply study drug (except during the final treatment/end-of-study 
visit). During the clinic visits, subjects or their caregivers will apply the daily dose of study drug 
while on-site under the supervision of site personnel, after efficacy and safety assessments have 
been completed (except for Local Tolerability Scale [LTS] at Week 4 through Week 44). The 
time of the dose application and assessments will depend on the time of the clinic visit. 
Therefore, the timing of the clinic visit may lead to a change in the subject’s chosen dosing time 
for that day.
Safety assessments will include Adverse Events (AEs), clinical laboratory tests, physical 
examination, vital signs, and 
. Efficacy assessments will include vIGA-AD™score, percent 
of body surface area (%BSA) affected, Eczema Area and Severity Index (EASI), Peak Pruritus-
Numeric Rating Scale (PP-NRS), 
 
 
 
 
Refer to Protocol Section 6 for descriptions of study procedures and assessments and Protocol 
Section 7 for timing of procedures and assessments.
5. DETERMINATION OF SAMPLE SIZE
The sample size of this study is based on the International Council for Harmonisation (ICH) E1A 
guideline on extent of population exposure to assess clinical safety for drugs intended for long 
term treatment of non-life-threatening conditions. Up to 961 subjects will be enrolled in this 
study across all regions, including up to 836 rollover subjects from studies DMVT-505-3101, 
DMVT-505-3102, and DMVT-505-2104 and approximately 125 subjects directly enrolling into 
this study.
6. GENERAL ANALYSIS CONSIDERATIONS
The statistical analyses will be reported using summary tables, listings, and figures (TLFs). The 
ICH numbering convention will be used for all TLFs. The efficacy and safety results from this 
study will be summarized descriptively. There will be no statistical testing.
Continuous variables will be summarized by presenting the number of observations, means, 
standard deviations, medians, minimums, and maximums. 
Categorical variables will be summarized by presenting counts and percentages of subjects in 
corresponding categories. All possible categories as defined in the CRF should be populated,
even if they have zero counts. Percentages for missing values are omitted and do not account for 
the percent calculation of other categories. Percentages are based on the total category count 


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excluding the missing category if not otherwise mentioned. In certain tables (e.g., treatment-
emergent adverse events [TEAE]), the total number of subjects is used as denominator. 
Footnotes will specify the percent basis in those cases. 
Data will be summarized by the following categories: received tapinarof treatment in pivotal 
study; received vehicle treatment in pivotal study; total pivotal; received tapinarof treatment in 
maximal use study; enrolled directly; and overall total.
Individual subject data obtained from the CRFs, external vendors, central clinical laboratory, and
any derived data will be presented by subject in data listings.
The analyses described in this plan are considered a priori, in that they have been defined before
database lock.
All analyses and tabulations will be performed using SAS
software Version 9.4 or higher. 
Tables, listings, and figures will be presented in RTF format.  
The process for SAS program validation and quality control (QC) for programs and outputs is 
documented in the Synteract working instruction “SAS programming quality control.” 
Study-specific QC requirements can be found in Appendix B: SAS programming QC 
requirements. 
7. NOTATION OF TREATMENT GROUPS AND VISITS  
Notation of treatment groups
The following notation of treatment groups will be used throughout the report: 
Full Notation (as used in the study protocol) 
Notation Used Throughout All Tables, 
Listings, and Figures
Tapinarof Cream 1%, rolling over from 
DMVT-505-3101 or DMVT-505-3102 
Tapinarof Cream 1% (Pivotal)
Vehicle Cream, rolling over from DMVT-
505-3101 or DMVT-505-3102 
Vehicle Cream (Pivotal)
Tapinarof Cream 1%  and Vehicle Cream 
(Pivotal)
Total (Pivotal)
Tapinarof Cream 1%, rolling over from
DMVT-505-2104 
Tapinarof Cream 1% (2104)
Tapinarof Cream 1%, enrolling directly into 
DMVT-505-3103 
Tapinarof Cream 1% (Direct-Enroll)
Tapinarof Cream 1%
Total (Overall)
 


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Visit terminology
Visit
Notation Used Throughout All 
Tables, Listings, and Figures
Screening, Days -30 to Day -1, Visit V0
Screening
Baseline, Day 1, Visit V1
Baseline
Week 4, Day 29 (±3 days), Visit V2
Week 4
Week 8, Day 57 (±3 days), Visit V3
Week 8
Week 12, Day 85 (±3 days), Visit V4
Week 12
Week 16, Day 113 (±3 days), Visit V5
Week 16
Week 20, Day 141 (±3 days), Visit V6
Week 20
Week 24, Day 169 (±3 days), Visit V7
Week 24
Week 28, Day 197 (±3 days), Visit V8
Week 28
Week 32, Day 225 (±3 days), Visit V9
Week 32
Week 36, Day 253 (±3 days), Visit V10
Week 36
Week 40, Day 281 (±3 days), Visit V11
Week 40
Week 44, Day 309 (±3 days), Visit V12
Week 44
Week 48, Day 337 (±3 days), Visit V13 (End of Treatment)
Week 48
Week 49, Day 344 (±3 days), Visit V14 (End of 
Study/Follow-up)
Week 49
Note: A phone call to review study drug application instructions, if applicable, and to record AEs 
and concomitant medication use will occur on Week 2, Day 15 (±3 days). 
Analysis visits
Study days are measured from baseline (Visit 1) in the extension study. Study days 
corresponding to measurements are calculated as:
Assessment date – date of baseline (Visit 1) + 1 if assessment date is on or after the date of 
baseline (Visit 1)
Assessment date – date of baseline (Visit 1) if assessment date is before the date of baseline 
(Visit 1)
Efficacy and safety endpoints will be summarized according to the nominal visit as assigned by 
the investigator except for assessments collected on early termination visits.  Early termination 
visit will be assigned based on the last nominal visit across all procedures and assessments and 
re-numbered to the last nominal visit number + 1. For example, if a subject attended Visit 1
(Baseline), Visit 2 (Week 4), Visit 3 (Week 8) and then early terminated, the early termination 
visit will be re-numbered and analyzed as Visit 4 (Week 12). 
Unscheduled visits will not be re-numbered and will not be included in OC summaries but will 
be included in listings. Unscheduled visits will be included in the LOCF imputation by using 
 
 


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target day listed in the Visit Terminology table; for missing visits LOCF values will be based on 
scheduled and unscheduled visits occurring on or before target day.
8. ANALYSIS SETS
The following subject population will be used for safety and efficacy analyses: 
The intent-to-treat (ITT) population will include all subjects enrolled into the study. 
9. STUDY POPULATION
9.1
Subject Disposition
Subject disposition information will be summarized and will include: the number of enrolled 
subjects, the number of subjects who apply any study medication, the number of subjects who
complete the study and who withdraw from the study (together with reasons for withdrawal). 
The number of subjects whose drug was permanently withdrawn or interrupted due to AE, 
vIGA-AD™score or other reasons will also be summarized over the entire study and by visit.
The number of days in the study, defined as the duration between date of study completion / 
discontinuation (or date of last visit if the study completion/discontinuation date is missing) and 
the date of Visit 1, will be summarized using descriptive statistics. A figure with Kaplan-Meier 
curves will also be generated to illustrate this information.
In order to describe the impact of COVID-19 on current study, the following disposition events 
will be summarized in the tables separately:
Subjects discontinued from the treatment/study as a result of a positive COVID-19 
diagnosis. 
Subjects discontinued from the treatment/study due to other reasons related to 
COVID-19. This is excluding COVID-19 diagnosis but may include reasons such as site 
closure, travel restrictions, fear of infection, etc.
Subjects with study visits altered (including modified in-clinic visit, virtual and phone 
visits) and missed due to COVID-19.
Previous COVID-19 diagnosis and previous/on-study COVID-19 vaccination, and COVID-19 
related protocol deviations will be summarized separately. The impact of COVID-19 (including 
protocol deviation, visit alteration, treatment/study discontinuation and diagnosis of COVID-19) 
will also be flagged at subject-level in a data listing. Subject profile will be used to compile all 
COVID-19 related information for affected subjects. 
 
 
 
 


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Also, all COVID-19 related symptoms and confirmed cases that occur during the study will be 
reported as AEs and included in the summaries. 
9.2
Protocol Deviations  
Protocol deviations will be summarized by deviation category (major, minor) and will be listed 
by subject. In addition, COVID-19 related protocol deviations will be summarized separately.
9.3
Eligibility  
Subjects not fulfilling any eligibility criteria (i.e., screen failures) will be presented in a data 
listing. Screen failure reasons for direct-enrolling subjects will be summarized by frequency in a 
table.
9.4
Demographic and Baseline Characteristics  
Demographic variables include age, sex, ethnicity, race, and Fitzpatrick skin type. For subjects 
rolling over into the OL-LTE study, age will be based on age at time informed consent was 
signed in the pivotal or maximal use studies. Age for direct-enrolling subjects will be based on 
age at time informed consent was signed in the OL-LTE study. 
Other baseline characteristics include height, weight, body mass index (BMI), vIGA-ADTM, 
%BSA, EASI score, and PP-NRS.
Medical history
The verbatim term of the medical history condition/event will be coded using the Medical 
Dictionary for Regulatory Activities (MedDRA), Version 24.0.  
Medical history will be summarized descriptively. The summary will show the system organ 
class (SOC) and preferred terms (PT) sorted alphabetically by SOC followed by descending 
frequency preferred terms in the Total (Overall) column.  
9.5
Prior and Concomitant Medications  
Prior and concomitant medication verbatim terms in the eCRFs will be mapped to 
Anatomical/Therapeutic/Chemical (ATC) class and preferred names using the WHO-Drug 
Global dictionary (Version B3 01MAR2021).
Prior Medications
For rollover subjects, prior medications are those that were still being used within 30 days before 
Visit 1 (Baseline), and with a stop date prior to Visit 1.  These medications will have been 
documented in the parent studies, and therefore, will not be presented in this study.  For direct-
enrolling subjects, prior medications are those that were still being used within 30 days before 
Screening (Visit 0), and with a stop date prior to first dose of study drug. 


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For direct-enrolling subjects, it is necessary to exclude previous medications that were stopped 
more than 30 days prior to Screening.  Since the medication stop dates are sometimes partial dates, 
the following rules for medication stop dates will be used to distinguish between previous 
medications that will not be summarized (those stopping more than 30 days prior to Screening) 
and medications that will be summarized as Prior or Concomitant medications.
If only year was recorded, and it is before the year of Screening Date – 30 days, it is a 
previous medication that will not be summarized; if year is same or after the year of 
Screening Date – 30 days, it will be summarized as a Prior or Concomitant Medication.  
If day is missing, but month and year are before those of the Screening Date – 30 days, it 
is a previous medication that will not be summarized; if month and year are the same as, 
or after, those of the Screening Date – 30 days, it will be summarized as a Prior or 
Concomitant Medication. 
If start date is after Screening Date – 30 days, it will be summarized as a Prior or 
Concomitant Medication. 
Prior medications for direct-enrolling subjects will be summarized by WHO ATC class (level 2) 
and preferred name. The summary will present the number and percentage of subjects using each 
medication. Subjects may have more than 1 medication per ATC class and preferred name. At 
each level of summarization, a subject is counted once if he/she reported one or more 
medications at that level. The summary will be sorted alphabetically by ATC class followed by 
descending frequency preferred name. Prior medications for direct-enrolling subjects will be 
listed by subject. 
Prior Systemic AD Medications
All systemic (oral and injectable) medications used by the subject for treatment of AD prior to 30 
days before the Screening visit will be reported for direct-enrolling subjects. Prior systemic AD 
medications for direct-enrolling subjects will be summarized by frequency count and percent. 
Concomitant Medications
Concomitant medications are those medications that started on or after Visit 1 or medications 
that started before Visit 1 and continued until on or after baseline (Visit 1) for rollover subjects 
and continued on or after date of first dose for direct-enrolling subjects. If the medication is 
ongoing or the stop year is missing, the medication will be considered as received for the entire 
duration of the study.  
To distinguish prior vs concomitant medications for rollover subjects, the following rules for 
medication stop dates will apply: 
 
 
 


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If only year was recorded, and it is before Baseline, it is a prior medication; if year is 
same or after Baseline, it is assumed to be a concomitant medication. 
If day is missing, but month and year are before Baseline, it is a prior medication; if 
month and year are the same as Baseline, it is assumed to be a concomitant medication; if 
month and year are after Baseline, it is a concomitant medication.  
If start date is after Baseline, it is a concomitant medication regardless. 
To distinguish prior vs concomitant medications for direct-enrolling subjects, the following rules 
for medication stop dates will apply: 
If the date of first dose of study drug is missing, it is a prior medication.
If only year was recorded, and it is before the year of first dose of study drug, it is a prior 
medication; if year is same or after the year of first dose of study drug, it is assumed to be 
a concomitant medication.
If day is missing, but month and year are before the first dose of study drug, it is a prior 
medication; if month and year are the same as the first dose of study drug, it is assumed 
to be a concomitant medication; if month and year are after the first dose of study drug, it 
is a concomitant medication.  
If start date is after the date of first dose of study drug, it is a concomitant medication 
regardless. 
Concomitant medications will be listed by subject. Concomitant medications that are ongoing as 
of the end of the previous studies will be identified in the same listing. 
Concomitant medications will be summarized by WHO ATC class and preferred name. Subjects 
may have more than one concomitant medication per ATC class and preferred name. At each 
level of summarization, a subject is counted once if he/she reported one or more medications at 
that level. The summary will be sorted alphabetically by ATC class followed by descending 
frequency preferred name in the Total (Overall) column. 
10. EFFICACY ANALYSES  
The efficacy analysis will be based on the ITT population. 
10.1 Efficacy Variables  
Efficacy endpoints 
 
 
 
 
 
 
 


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For subjects entering the study with a vIGA-ADTM
1:
Proportion of subjects who achieve vIGA-ADTM=0 at least 1 time on or before Week 48
 
For subjects entering the study with a vIGA-ADTM
2:
Proportion of subjects who achieve vIGA-ADTM=0 or 1 at least 1 time on or before Week 
48
 
 
 
 
 
 
 
 
 
 
 
 
. 
 
 
 
 
 
 
 
 
 
 




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10.2 Baseline Values
For subjects rolling over from DMVT-505-3101 or DMVT-505-3102 studies, baseline is defined 
as the assessment collected at Visit 6 (Week 8) in the pivotal study. If Visit 6 (Week 8) 
assessment is missing, then Visit 5 (Week 4) will be used as the baseline. If Visit 5 (Week 4) 
assessment is still missing, the baseline value will be considered as missing. For PP-NRS, 
baseline is defined as the assessment collected at Visit 6 (Week 8) in the pivotal study. If Visit 6 
(Week 8) assessment is missing, then the last PP-NRS at home assessment will be used as the 
baseline.
For subjects rolling over from DMVT-505-2104 study, baseline is defined as the assessment 
collected at Visit 4 (Day 28) in the PK study. If Visit 4 (Day 28) assessment is missing, then 
Visit 3 (Day 8) will be used as the baseline. If Visit 3 (Day 8) assessment is still missing, the 
baseline value will be considered as missing.
 
 
 
 For PP-NRS, baseline is defined as the assessment collected at Visit 4 
(Day 28) in the PK study. If Visit 4 (Day 28) assessment is missing, then the last PP-NRS at 
home assessment will be used as the baseline.
 
 
 
 
 
 


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For subjects rolling over from DMVT-505-3101, DMVT-505-3102 or DMVT-505-2104 studies, 
if there are multiple records on the same visit, use the one with later date as the baseline.
For subjects enrolling directly into DMVT-505-3103 study, baseline is defined as the last 
non-missing value recorded before the first dose of study drug. 
Unscheduled visits will not be used in the determination of baseline values.
10.3 Adjustments for Covariates
No adjustments for covariates are planned for this study.
10.4 Handling of Dropouts or Missing Data
Efficacy endpoints will be summarized by visit using OC. Additionally, efficacy endpoints will 
be summarized by visit using LOCF to impute missing data. LOCF will include scheduled and 
unscheduled visits. Baseline values will not be carried forward.
Average weekly PP-NRS scores will be calculated for all nominal visits as the average of 7 daily 
post-baseline PP-NRS scores prior to and including the values assessed on the visit date. If daily 
PP-NRS scores are missing for more than 3 days in a 7-day period, the average weekly PP-NRS 
score will be set to missing. If two or more scores are reported on the same day, the maximum 
score on that day will be used.
10.5 Interim Analysis and Data Monitoring
An interim analysis will be performed to review safety data after at least 100 pediatric subjects 
(<18 years of age) have reached 48 weeks of potential active study drug treatment, inclusive of 
active study drug treatment in one of three parent (i.e., pivotal and maximal use) studies. All 
summaries will be produced for interim analysis. 
The final analysis will be conducted after study completion (i.e., the last subject’s last visit) and 
database lock.
10.6 Examination of Subgroups
For the following efficacy outcomes:
1. Proportions of subjects who achieve vIGA-ADTM=0 at least 1 time during the study (for 
subjects entering the study with a vIGA-ADTM
1): 
2.
 
 
3. vIGA-ADTM scores at Week 48 (LOCF)
  


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4.
 change and percent change from Baseline in %BSA affected at Week 48 
(LOCF)
5.
 change and percent change from Baseline in EASI score at Week 48 
(LOCF)
Subgroup analyses will be generated for the following groupings:
Baseline vIGA-ADTM
Age (2-6 yrs, 7-11 yrs, 12-
rs)
Sex 
Race (White, Asian, Black or African American, and Other)
Baseline %BSA affected (<10%, 10%-<20%, 20%-
)
Duration of disease (<2 yrs, 2-5 yrs, >5 yrs)
Prior Systemic AD Medication
Country (USA and Canada)
Race subgroup “Other” includes “American Indian or Alaska Native”, “Native Hawaiian or other 
Pacific Islander” and “Multiple Races Checked”,
10.7 Multiple Comparison/Multiplicity
No adjustments for multiplicity will be made in this study.
10.8 Multicenter Studies
This is multicenter study, with up to approximately 135 sites in the US and Canada participating 
in the study. Up to 961 subjects will be enrolled in this study across all regions, including up to 
836 rollover subjects from studies DMVT-505-3101, DMVT-505-3102, and DMVT-505-2104 
and approximately 125 subjects directly enrolling into this study.
Efficacy endpoints will be summarized by country.
11. METHODS OF EFFICACY ANALYSIS
11.1 Efficacy Analyses
All efficacy parameters will be summarized based on the ITT population. Summaries of efficacy 
endpoints by visit will be performed using OC and/or LOCF methods.
 
 
 
 
  
 
 
 
 
 
 
 
 












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13.1 Extent of Exposure
Subjects will be characterized by a series of treatment periods as defined in Section 10.1. These 
treatment period definitions are based on attainment of specified vIGA-ADTM values.    
The following exposure and compliance parameters will be summarized descriptively:
Total expected number of days exposed, calculated as the sum of number of days over all 
treatment periods. 
Total number of doses administered within treatment periods, calculated from the subject 
dose diary including in-clinic dosing and summed over all treatment periods. If a subject 
returns no diary records, then the number of home doses is assumed to be 0.  If a subject 
has no clinic visits where study drug was administered, then the number of clinical doses 
is assumed to be 0.   
Percent compliance will be calculated as the (total number of doses administered within 
treatment periods) / (total expected number of days exposed) * 100.
Subject compliance, def
while enrolled in the study. If the 
percentage of study medication compliance cannot be computed, the subject is assumed 
to be less than 80% compliant. 
In addition, the following exposure parameters will be summarized descriptively for the entire 
study (regardless of vIGA-ADTM status):
Total number of doses administered, calculated from the subject dose diary and in-clinic 
dosing. If a subject returns no diary records, then the number of home doses is assumed 
to be 0.  If a subject has no clinic visits where study drug was administered, then the 
number of clinical doses is assumed to be 0.
Grams (g) of study drug administered. Drug administered is calculated as the summation 
of the difference between dispensed weight and returned weight for all returned tubes. 
Unreturned/unopened tubes will be assumed unused and will be included as 0 grams in 
the amount drug used calculation. Average grams of study drug administered per dose 
will be calculated as the total grams / total number of doses administered. Subjects that 
had no diaries returned will not have average grams per dose reported.
13.2 Adverse Events
All AE summaries will be restricted to TEAEs. For rollover subjects, all AEs reported in this 
study will be considered as TEAEs except for those AEs resolved prior to the Visit 1 date in this
study. For direct-enrolling subjects, all AEs that start after the first dose of study drug will be 
 
 
 
 
 
 
 
 
 
 


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considered a TEAE. Verbatim terms in the eCRFs will be mapped to PTs and SOCs using 
MedDRA, Version 24.0.  
Imputation of start and end dates of AEs 
To calculate duration of AEs, the following rules will be used where applicable to impute partial 
or completely missing start dates or end dates: 
If only the day is missing for a start date, the 1st of the month will be imputed. If the new 
estimated date falls before the Visit 1 date, while the known month and year match the 
month and year of the Visit 1 date, the date of Visit 1 will be used as the new estimated 
date. 
If only the day is missing for an end date, the last day of the month will be imputed. If the 
new estimated date falls after the date of last study visit, the date of last study visit will be 
used as the new estimated date.
If both the day and the month are missing for a start date or end date, no imputation will 
be used, and the duration will not be calculated.  
If the start date or end date is completely missing, duration will not be calculated. 
For AEs ongoing at the end of the previous studies, duration will be computed using the DMVT-
505-3103 Visit 1 date as the AE start date. 
Imputation of missing relationship and/or missing severity 
If relationship to treatment is missing, the event will be conservatively treated as related to study 
drug.  
If severity is missing and the AE is reported as serious and fatal, severity will be imputed as 
CTCAE=5. If severity is missing and the AE is reported as serious and not fatal, severity will be 
imputed as CTCAE=4. If severity is missing and the AE is not reported as serious, severity will 
be imputed as CTCAE=3.
All TEAEs will be listed by subject, detailing the verbatim term given by the investigator, PT, 
SOC, onset date, end date, ongoing at the end of parent studies (Y/N), duration (days), CTCAE 
grade, outcome, relationship to study drug, action taken with study drug, other action taken to 
treat the event, AE of special interest (AESI) (Y/N), seriousness and criteria for seriousness.  
AEs resolved prior to the Visit 1 date, Serious TEAEs, TEAEs leading to study drug 
discontinuation, TEAEs leading to study discontinuation and TEAEs related to study drug will 
also be listed separately. The following AESIs will be identified and listed separately: contact 
dermatitis, follicular event, and headache.  
 
 
 
 


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The frequency and percent of subjects with AEs will be summarized as incidence rates of:
Any AE
The frequency and percent of subjects with TEAEs will be summarized as incidence rates of:
Any TEAE 
Any TEAE excluding those ongoing at the end of the previous studies  
Any TEAE ongoing at the end of the previous studies
Any treatment-emergent AESIs 
Any treatment-emergent AESIs excluding those ongoing at the end of the previous 
studies 
Any treatment-emergent AESIs ongoing at the end of the previous studies
Any treatment-related TEAE 
Any TEAE leading to study drug discontinuation
Any TEAE leading to study discontinuation
Any serious TEAE 
Death
Treatment-related serious TEAE
Serious TEAE leading to study drug discontinuation 
Serious TEAE leading to study discontinuation
TEAE (COVID-19)
TEAEs will be sorted alphabetically by SOC and decreasing PT frequency in the Total (Overall) 
group for the following:
All TEAEs
All TEAEs by maximum CTCAE grade
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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All TEAEs by maximum causality (not related, related) to the study drug 
All TEAEs excluding those ongoing at the end of the previous studies  
All TEAEs ongoing at the end of the previous studies 
All treatment-related TEAEs  
All TEAEs leading to study discontinuation 
All TEAEs leading to study drug discontinuation 
All serious TEAEs
All serious TEAEs leading to study discontinuation 
All serious TEAEs leading to study drug discontinuation 
All TEAEs and all serious TEAEs will also be summarized by SOC (alphabetical order) and PT 
(descending order) for the following subgroups:
Age (2-6 yrs, 7-11 yrs, 12-
rs)
Sex 
Race (White, Asian, Black or African American and Other)
TEAEs by maximum CTCAE grade, TEAEs by maximum causality, TEAEs leading to study 
drug discontinuation and TEAEs leading to study discontinuation, will be summarized by SOC 
(alphabetical order) and PT (descending order) for the Age subgroup.
Furthermore, TEAEs will be categorized by day of onset among the following 4 categories:
>
weeks 
>48 weeks.
For each of these categories, TEAEs will be summarized by SOC in alphabetical order and PT in 
descending order of frequency. TEAEs ongoing at the end of the previous studies will be 
considered in the first category (i.e.,
12 weeks).
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  


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At each level of summarization, a subject will be counted once if he/she reported one or more 
events. The severity of TEAEs and relationship to study drug will be summarized in a similar 
manner. For summaries of relationship to study drug, a subject will be classified according to 
related or not related. For summaries of TEAE CTCAE grade, a subject will be classified 
according to the worst grade.
For treatment-emergent AESIs, summarization will be more extensive, reflecting the more 
detailed information collected.  Information summarized will include number of events per 
subject, earliest onset day, duration (in days), causality, grade and seriousness of AESIs, 
outcome, actions taken, assorted physical characteristics of the AESIs, and demographic/baseline 
characteristics and vIGA-ADTM status of the subjects experiencing them.  Each type of AESI 
will be summarized separately. If a subject has more than one treatment-emergent occurrence of 
an AESI, the subject’s maximum duration, highest levels of causality and seriousness, maximum 
grade and generally the most extreme level of each characteristic will be summarized.  If an 
AESI was ongoing at end of study (EOS), it will not be included in the duration summary. AESIs 
ongoing at the end of previous studies will also be included in the summary.
A Kaplan-Meier figure will be generated for each AESI of time to first event for events starting 
during the study.  Time to first onset will be computed as Onset Date of First Occurrence – Date 
of Visit 1 + 1 if onset date is on or after visit 1 date. Otherwise, time to first onset will be 
computed as Onset Date of First Occurrence – Date of Visit 1. Subjects not experiencing the 
AESI will be censored at the date of study completion or discontinuation. AESIs ongoing at the 
end of the previous studies will not be included. 
 
 
 
 
 
 
 
 
13.4 Clinical Laboratory Evaluation
All clinical laboratory (hematology, clinical chemistry, and urinalysis) values will be listed by
treatment group and subject.  The reference normal ranges and reference range indicators (e.g.,
high, low, normal) will be supplied by the central laboratory and displayed in the data listings. 
Values outside the normal range for chemistry and hematology laboratory parameters will be 




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15. REFERENCES
1 
 
 
2
 
 
 
 
 
 
 
 
7
 
 
 
 


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16. APPENDICES
APPENDIX A: PRESENTATION OF DATA AND PROGRAMMING SPECIFICATIONS
General
Specialized text styles, such as bold, italics, borders, shading, and superscripted and 
subscripted text will not be used in tables, figures, and data listings unless they add 
significant value to the table, figure, or data listing.
Only standard keyboard characters are to be used in tables and data listings.
Special characters, such as nonprintable control characters, printer-specific, or font-
specific characters, will not be used on a table, figure, or data listing.
Hexadecimal character representations are allowed (e.g., µ, , ß).
All footnotes will be left justified and at the bottom of a page. Footnotes must be used 
sparingly and must add value to the table, figure, or data listing.
Tables
Means and medians will be presented to 1 more decimal place than the raw data. 
Standard deviations will be presented to 2 more decimal places than the raw data. 
Minimums and maximums will be reported with the same number of decimal places as 
the raw data. If raw data has more than 2 decimal places, the same rule will be applied as 
the raw data with 2 decimal places.
Percentages will be presented to the tenths place.
For frequency counts of categorical variables, categories whose counts are zero will be 
displayed for the sake of completeness. For example, if none of the subjects discontinue 
due to “lost to follow-up,” this reason will be included in the table with a count of 0. 
Categories with zero counts will have zero percentages (i.e., 0.0%) displayed if the 
denominator of the percentage is greater than 0. Categories with zero counts will be 
displayed as ‘0’ without percentage if the denominator of the percentage is 0. Results of 
one hundred percent and zero percent will have the same decimal accuracy in tables as 
other percentages.
Percentiles (e.g., 25%, 75%) must be presented to 1 decimal place more than the 
raw/derived data.
The last footnotes will be
-
“Source: xxx”, where xxx indicates the source table number(s) if applicable (in case aggregated 
results like mean or median are plotted), or the source listing(s) (in case individual responses are 
plotted), and/or source datatset(s) (e.g., ADaM). 
-
“PROGRAM SOURCE: ...\\xx.sas, DATA CUT-OFF DATE: DDMMMYYYY, RUN DATE: 
DDMMYY hh:mm”.
Figures
 
 
 
 
 
 
 
 
 
 
 


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Legends will be used for all figures with more than 1 variable or item displayed.
Figures will be in black and white but can be in color to add value to the clarity and 
readability of a figure. Lines must be wide enough to see the line after being copied.
The last footnotes will be
-
“Source: xxx”, where xxx indicates the source listing number(s) and/or source datatset(s) (e.g., 
ADaM). 
-
“PROGRAM SOURCE: ...\\xx.sas, DATA CUT-OFF DATE: DDMMMYYYY, RUN DATE: 
DDMMYY hh:mm”.
Listings
If not otherwise specified, all data listings will be sorted by sequence/treatment
(pivotal/PK/direct enrolling), center, subject number, visit, and date/time, as appropriate.
All date values will be presented in a SAS date (e.g., 29AUG2001) format. 
All observed time values will be presented using a 24-hour clock HH:MM:SS format 
(e.g., 01:35:45 or 11:26). Seconds will only be reported if they were measured as part of 
the study.
The last footnote will be
-
“PROGRAM SOURCE: ...\\xx.sas, DATA CUT-OFF DATE: DDMMMYYYY, RUN DATE: 
DDMMYY hh:mm”.
Standard Calculations
Variables requiring calculation will be derived using the following formulas:
Days – A duration expressed in days between 1 date (date1) and another later date (date2) is 
calculated using the formulas noted below:
duration in days = date2 – date1 + 1
Months – A duration expressed in months is calculated using the INTCK function of SAS as 
follows: months=intck('month','date1'd,date2'd, 'continuous').
Years – A duration expressed in years between one date (date1) and another later date 
(date2) is calculated as follows: 
duration in years = intck('year', 'date1'd, 'date2'd, 'continuous').
Age – Age at time of informed consent will be reported on the CRF. 
Height – Height entries made in inches (in) are converted to centimeters (cm) using the 
following formula:
height (cm) = height (in) × 2.54.
Weight – Weight entries made in pounds (lb) are converted to kilograms (kg) using the 
following formula:
weight (kg) = weight (lb)/2.2046.
 
 
 
 
 
 
 
 
 
 
 
 
 


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Temperature – Temperature entries in degrees Fahrenheit are converted to degrees 
centigrade using the following formula:
temp (degrees centigrade) = 5/9 × [temp (degrees Fahrenheit) – 32].
Body Mass Index (BMI) – BMI is calculated using height (cm) and weight (kg) using the 
following formula:
BMI (kg/m2) = weight (kg)/[[height (cm)/100]2].
Change from baseline – Change from baseline will be calculated as:
Change = post-baseline value – baseline value.
Percent change from baseline – Percent change from baseline will be calculated as:
Percent change from baseline = (post-baseline value – baseline value)/baseline value 
× 100.
 
 
 
 


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APPENDIX B: SAS PROGRAMMING QC REQUIREMENTS
Derived datasets are independently reprogrammed by a second programmer. The separate 
datasets produced by the 2 programmers must match 100%. Detailed specifications for the 
derived datasets are documented in the study Analysis Dataset (ADaM) Specifications provided 
to Dermavant at study conclusion.
Tables are independently reprogrammed by a second programmer for numeric results.
Listings are checked for consistency against corresponding tables, figures, and derived datasets.
Figures are checked for consistency against corresponding tables and listings, or independently 
reprogrammed if there are no corresponding tables or listings.
The entire set of TLFs is checked for completeness and consistency prior to its delivery to 
Dermavant by the lead biostatistician and a senior level, or above, reviewer.