Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis

An Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream, 1% in Subjects With Atopic Dermatitis

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Tapinarof cream, 1%

Detailed Description

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 (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.

• Study Type: Interventional
• Enrollment (Actual): 728
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Philip Brown, MD, JD; Phone Number: 480-666-0844; Email: dermavantclinicaltrials@dermavant.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3A 2N1
      • Dermavant Investigative Site
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dermavant Investigative Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Dermavant Investigative Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Dermavant Investigative Site
    • Cobourg, Ontario, Canada, K9A 0Z4
      • Dermavant Investigative Site
    • Oakville, Ontario, Canada, L6J 7W5
      • Dermavant Investigative Site
    • Ottawa, Ontario, Canada, K2C 3N2
      • Dermavant Investigative Site
    • Waterloo, Ontario, Canada, N2J 7G1
      • Dermavant Investigative Site
    • Windsor, Ontario, Canada, N8W 1E6
      • Dermavant Investigative Site
  • Quebec
    • Montréal, Quebec, Canada, H2X 2V1
      • Dermavant Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Dermavant Investigative Site
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Dermavant Investigative Site
    • Scottsdale, Arizona, United States, 85255
      • Dermavant Investigative Site
    • Scottsdale, Arizona, United States, 85260
      • Dermavant Investigative Site
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Dermavant Investigative Site
    • Fort Smith, Arkansas, United States, 72916
      • Dermavant Investigative Site
  • California
    • Cerritos, California, United States, 90702
      • Dermavant Investigative Site
    • Fountain Valley, California, United States, 92708
      • Dermavant Investigative Site
    • Fremont, California, United States, 94538
      • Dermavant Investigative Site
    • Huntington Beach, California, United States, 92647
      • Dermavant Investigative Site
    • Inglewood, California, United States, 90301
      • Dermavant Investigative Site
    • Lancaster, California, United States, 93534
      • Dermavant Investigative Site
    • Long Beach, California, United States, 90806
      • Dermavant Investigative Site
    • Los Angeles, California, United States, 90045
      • Dermavant Investigative Site
    • Los Angeles, California, United States, 90033
      • Dermavant Investigative Site
    • Los Angeles, California, United States, 90017
      • Dermavant Investigative Site
    • Mission Viejo, California, United States, 92691
      • Dermavant Investigative Site
    • Sacramento, California, United States, 95815
      • Dermavant Investigative Site
    • San Diego, California, United States, 92123
      • Dermavant Investigative Site
    • San Francisco, California, United States, 94115
      • Dermavant Investigative Site
    • Santa Ana, California, United States, 92701
      • Dermavant Investigative Site
    • Santa Monica, California, United States, 90404
      • Dermavant Investigative Site
    • Thousand Oaks, California, United States, 91320
      • Dermavant Investigative Site
  • Colorado
    • Thornton, Colorado, United States, 80112
      • Dermavant Investigative Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Dermavant Investigative Site
  • Florida
    • Boca Raton, Florida, United States, 33428
      • Dermavant Investigative Site
    • Boca Raton, Florida, United States, 33486
      • Dermavant Investigative Site
    • Brandon, Florida, United States, 33511
      • Dermavant Investigative Site
    • Coral Gables, Florida, United States, 33146
      • Dermavant Investigative Site
    • Delray Beach, Florida, United States, 33484
      • Dermavant Investigative Site
    • Hialeah, Florida, United States, 33016
      • Dermavant Investigative Site
    • Jacksonville, Florida, United States, 32256
      • Dermavant Investigative Site
    • Margate, Florida, United States, 33063
      • Dermavant Investigative Site
    • Miami, Florida, United States, 33165
      • Dermavant Investigative Site
    • Miami, Florida, United States, 33173
      • Dermavant Investigative Site
    • Miami Lakes, Florida, United States, 33014
      • Dermavant Investigative Site
    • Orlando, Florida, United States, 32801
      • Dermavant Investigative Site
    • Pinellas Park, Florida, United States, 33781
      • Dermavant Investigative Site
    • Sweetwater, Florida, United States, 33172
      • Dermavant Investigative Site
    • Tampa, Florida, United States, 33607
      • Dermavant Investigative Site
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Dermavant Investigative Site
    • Sandy Springs, Georgia, United States, 30328
      • Dermavant Investigative Site
    • Savannah, Georgia, United States, 31406
      • Dermavant Investigative Site
    • Snellville, Georgia, United States, 30078
      • Dermavant Investigative Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Dermavant Investigative Site
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Dermavant Investigative Site
    • Plainfield, Indiana, United States, 46168
      • Dermavant Investigative Site
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Dermavant Investigative Site
  • Kentucky
    • Lexington, Kentucky, United States, 40517
      • Dermavant Investigative Site
    • Louisville, Kentucky, United States, 40217
      • Dermavant Investigative Site
    • Louisville, Kentucky, United States, 40241
      • Dermavant Investigative Site
    • Owensboro, Kentucky, United States, 42301
      • Dermavant Investigative Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Dermavant Investigative Site
    • Baton Rouge, Louisiana, United States, 70808
      • Dermavant Investigative Site
    • Covington, Louisiana, United States, 70433
      • Dermavant Investigative Site
    • Monroe, Louisiana, United States, 71201
      • Dermavant Investigative Site
    • New Orleans, Louisiana, United States, 70115
      • Dermavant Investigative Site
  • Maryland
    • Largo, Maryland, United States, 20774
      • Dermavant Investigative Site
    • Rockville, Maryland, United States, 20850
      • Dermavant Investigative Site
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Dermavant Investigative Site
    • Clarkston, Michigan, United States, 48346
      • Dermavant Investigative Site
    • Warren, Michigan, United States, 48088
      • Dermavant Investigative Site
    • Ypsilanti, Michigan, United States, 48197
      • Dermavant Investigative Site
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Dermavant Investigative Site
  • Montana
    • Missoula, Montana, United States, 59808
      • Dermavant Investigative Site
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Dermavant Investigative Site
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Dermavant Investigative Site
  • New York
    • Garden City, New York, United States, 11530
      • Dermavant Investigative Site
    • New York, New York, United States, 10075
      • Dermavant Investigative Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Dermavant Investigative Site
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Dermavant Investigative Site
    • Cleveland, Ohio, United States, 44106
      • Dermavant Investigative Site
    • Dayton, Ohio, United States, 45414
      • Dermavant Investigative Site
    • Mason, Ohio, United States, 45040
      • Dermavant Investigative Site
    • Mayfield Heights, Ohio, United States, 44124
      • Dermavant Investigative Site
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Dermavant Investigative Site
    • Oklahoma City, Oklahoma, United States, 73120
      • Dermavant Investigative Site
    • Tulsa, Oklahoma, United States, 74114
      • Dermavant Investigative Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • Dermavant Investigative Site
    • Portland, Oregon, United States, 97223
      • Dermavant Investigative Site
    • Portland, Oregon, United States, 97210
      • Dermavant Investigative Site
    • Portland, Oregon, United States, 97239
      • Dermavant Investigative Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Dermavant Investigative Site
    • Greenville, South Carolina, United States, 29615
      • Dermavant lnvestigative Site
    • Mount Pleasant, South Carolina, United States, 29445
      • Dermavant Investigative Site
    • North Charleston, South Carolina, United States, 29420
      • Dermavant Investigative Site
    • Spartanburg, South Carolina, United States, 29303
      • Dermavant Investigative Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Dermavant Investigative Site
    • Memphis, Tennessee, United States, 38119
      • Dermavant Investigative Site
  • Texas
    • Bellaire, Texas, United States, 77401
      • Dermavant Investigative Site
    • Cypress, Texas, United States, 77433
      • Dermavant Investigative Site
    • Dallas, Texas, United States, 75230
      • Dermavant Investigative Site
    • Dripping Springs, Texas, United States, 78620
      • Dermavant Investigative Site
    • Grapevine, Texas, United States, 76051
      • Dermavant Investigative Site
    • Houston, Texas, United States, 77004
      • Dermavant Investigative Site
    • San Antonio, Texas, United States, 78213
      • Dermavant Investigative Site
    • San Antonio, Texas, United States, 78229
      • Dermavant Investigative Site
    • San Antonio, Texas, United States, 78218
      • Dermavant Investigative Site
    • Sugar Land, Texas, United States, 77479
      • Dermavant Investigative Site
    • Webster, Texas, United States, 77598
      • Dermavant Investigative Site
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Dermavant Investigative Site
  • Washington
    • Spokane, Washington, United States, 99202
      • Dermavant Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

For Roll-over Subjects Only:

• Met the criteria as a Study Completer in one of three studies (DMVT-505-3101 study, DMVT-505-3102 study, or DMVT-505-2104 study).
• Must not be pregnant at Baseline

For Direct-Enrolling Subjects Only:

• Male and female subjects ages 2 years to < 18 years at the time of consent with clinical diagnosis of AD
• 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. 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.
• AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
• Must not be pregnant at Screening or Baseline

For All Subjects:

• Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
• Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent

Exclusion Criteria:

For Rollover Subjects Only:

1. Subjects who were not receiving study drug at the time of the last visit in the pivotal study (DMVT-505-3101, DMVT-505-3102, or DMVT-505-2104)
2. Used a prohibited concomitant product or procedure to treat AD during the pivotal study.
3. Had an SAE that was related to treatment or experienced an AE that led to permanent discontinuation of treatment in the pivotal study.
4. Pregnant females

For Direct-Enrolling Subjects:

• Immunocompromised at screening
• Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit
• Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN).
• Screening total bilirubin > 1.5x ULN
• Current or chronic history of liver disease
• Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
• Subjects who would not be considered suitable for topical therapy
• Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)
• 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, or ability to understand and give informed consent.
• Pregnant or lactating females
• History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation
• Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: tapinarof cream; Tapinarof 1%, cream

Drug: Tapinarof cream, 1%; Tapinarof cream, 1%, applied daily Subjects entering with vIGA-AD ≥1 received treatment with tapinarof cream, 1% until they achieved vIGA-AD=0, at which time treatment was discontinued and subjects were monitored for durability of response (remittive response). If/when disease worsening occurred, as evidenced by vIGA-AD ≥2, treatment was re-initiated and continued until vIGA-AD =0 was achieved. Subjects entering with a vIGA-AD=0 had treatment discontinued and were monitored for duration of remittive response. If/when disease worsening occurred, as evidenced by vIGA-AD ≥2, treatment was re-initiated and continued until vIGA-AD =0 was achieved. This treatment and re-treatment pattern of use was continued until the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events	For rollover subjects, all AEs reported in this extension study were considered as TEAEs except for those AEs ongoing at the end of previous studies but resolved prior to the Visit 1 date for this extension study. For direct-enrolling subjects, all AEs that start after the first dose of study drug will be considered a TEAE.	Baseline to Week 49
Frequency of Adverse Events and Serious Adverse Events	All AEs reported in this extension study were considered as TEAEs except for those AEs ongoing at the end of previous studies but resolved prior to the Visit 1 date for this extension study. Subjects could have reported more than one TEAE.	Baseline up to Week 49
Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs	The mean chemistry and hematology parameters and vital signs were assessed for changes and trends over the course of the study. Shifts from Baseline in chemistry and hematology parameters and vital signs for individual subjects were assessed for clinical relevance. The number of subjects with clinically significant changes from baseline in laboratory values or vital signs were assessed for clinical relevance.	Baseline up to Week 48
Complete Disease Clearance During LTE: Number of Subjects Achieving Disease Clearance vIGA-AD =0 (Clear) While on Therapy for Subjects Entered LTE vIGA-AD ≥ 1 (Almost Clear )	The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point (0-4) morphological assessment of overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Higher vIGA-AD scores represents more severe disease.	Baseline to 49 weeks
Response During LTE: Number of Subjects Achieving vIGA-AD =0 or 1 (Clear or Almost Clear) While on Therapy for Subjects Who Entered LTE With vIGA-AD ≥ 2 (Mild)	The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point (0-4) morphological assessment of overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Higher vIGA-AD scores represents more severe disease.	Baseline to 49 weeks
Change From Baseline in %BSA Affected	Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses the change from baseline in %BSA affected in all subjects, including those on and those off therapy. Assessment of BSA with Atopic Dermatitis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. Lesions on the scalp will not be included in the calculation of %BSA affected. Estimates of the % involvement in each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall.	Baseline to 48 weeks
Percent Change From Baseline in %BSA Affected	Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses the % change from baseline in %BSA affected in all subjects, including those on and those off therapy. Assessment of BSA with Atopic Dermatitis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. Lesions on the scalp will not be included in the calculation of %BSA affected. Estimates of the % involvement in each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall.	Baseline to 48 weeks
Change From Baseline in Eczema Area and Severity Index (EASI) Score	Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses the change from baseline in EASI score in all subjects, including those on and those off therapy. The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. Higher EASI scores indicate more severe disease.	Time Frame: Baseline to 48 weeks
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score	Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses the % change from baseline in EASI score in all subjects, including those on and those off therapy. The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. Higher EASI scores indicate more severe disease.	Baseline to 48 weeks
Percent of Subjects With ≥ 50% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48.	The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.	Baseline to Week 48
Percent of Subjects With ≥ 75% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48.	The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. Higher EASI scores indicate more severe disease.	Baseline to Week 48
Percent of Subjects With ≥ 90% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48.	The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. Higher EASI scores indicate more severe disease.	Baseline to Week 48
Mean change in Peak Pruritis-Numeric Rating Scale (PP-NRS) from Baseline	The Peak Pruritus Numeric Rating Scale (PP-NRS) is used to quickly assess itch/pruritus severity over a 24-hour period. The PP-NRS is scored on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". The subject or caregiver will utilize the scale to assess peak pruritis once per day and record the results in their diaries. The daily ratings are averaged to generate a score for the week.	Baseline to Week 48
Number of subjects with a Baseline Peak Pruritis-Numeric Rating Scale (PP-NRS) score ≥ 4 who achieve ≥ 4-point reduction in the PP-NRS from Baseline	The Peak Pruritus Numeric Rating Scale (PP-NRS) is used to quickly assess itch/pruritus severity over a 24-hour period. The PP-NRS is scored on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". The subject or caregiver will utilize the scale to assess peak pruritis once per day and record the results in their diaries. The daily ratings are averaged to generate a score for the week.	Baseline to Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects who experience vIGA-AD of clear (0) after treatment	The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting.	Baseline up to Week 48
Proportion of subjects who experience vIGA-AD score of clear or almost clear (0 or 1) after treatment	The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point (0-4) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Higher vIGA-AD scores represents more severe disease.	Baseline up to Week 48
Proportion of subjects who do not experience disease worsening (vIGA-AD ≥ 2)	The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point (0-4) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Higher vIGA-AD scores represents more severe disease.	Baseline up to Week 48
Absolute value, change and percent change from Baseline in %BSA affected by visit	The assessment of %BSA affected is an estimate of the percentage of total involved skin with AD. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by AD will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.	Baseline to each visit
Absolute value, change and percent change from Baseline in Eczema Area and Severity Index (EASI) score by visit	The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.	Baseline to each visit
Proportion of subjects with ≥ 50%, 75%, and 90% improvement in EASI score from Baseline by visit	The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.	Baseline to each visit
Mean change in PP- NRS score	The PP-NRS is a scale from 0-10 used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus. Higher PP-NRS ratings represent more itch reported.	Baseline to each 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	The PP-NRS is a scale used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus.Higher PP-NRS ratings represent more itch reported.	Baseline to each visit

Collaborators and Investigators

• Sponsor: Dermavant Sciences, Inc.
• Investigators: Study Director: Diana Villalobos, Dermavant Sciences, Inc.

Publications and helpful links

General Publications

• Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available.
• Carroll CL, Balkrishnan R, Feldman SR, Fleischer AB Jr, Manuel JC. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol. 2005 May-Jun;22(3):192-9. doi: 10.1111/j.1525-1470.2005.22303.x.
• Furue M, Hashimoto-Hachiya A, Tsuji G. Aryl Hydrocarbon Receptor in Atopic Dermatitis and Psoriasis. Int J Mol Sci. 2019 Oct 31;20(21):5424. doi: 10.3390/ijms20215424.
• Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Dermato-Venereologica Supplementum. 1980;92:44-7.
• Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8. doi: 10.1034/j.1600-0625.2001.100102.x.
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Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2021
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): March 7, 2024

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: eczema; pediatric; topical; phase 3; tapinarof
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: DMVT-505-3103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No