Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults

May 23, 2023 updated by: Dermavant Sciences GmbH

A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to Severe Atopic Dermatitis in Children and Adults

This is a double-blind, randomized, vehicle controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared to vehicle control cream in pediatric and adult subjects with atopic dermatitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a 8-week double-blind, vehicle-controlled treatment study in which subjects will be randomized to receive tapinarof cream, 1% or vehicle cream once daily for 8 weeks. At the end of the 8-week study treatment, qualified subjects will have the option to enroll in an open-label, long-term extension study for an additional 48 weeks of treatment. Subjects who do not participate in the open-label, long-term extension study will complete a follow-up visit approximately one week after the end of treatment in this study.

Study Type

Interventional

Enrollment (Actual)

407

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Dermavant Clinical Site
    • Ontario
      • Burlington, Ontario, Canada, L7L 6W6
        • Dermavant Clinical Site
      • Cobourg, Ontario, Canada, K9A 0Z4
        • Dermavant Clinical Site
      • Hamilton, Ontario, Canada, L8S 1G5
        • Dermavant Clinical Site
      • Oakville, Ontario, Canada, L6J 7W5
        • Dermavant Clinical Site
      • Ottawa, Ontario, Canada, K2C 3N2
        • Dermavant Clinical Site
    • Quebec
      • Montréal, Quebec, Canada, H2X 2V1
        • Dermavant Clinical Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Dermavant Clinical Site
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Dermavant Clinical Site
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Dermavant Clinical Site
    • California
      • Beverly Hills, California, United States, 90212
        • Dermavant Clinical Site
      • Fountain Valley, California, United States, 92708
        • Dermavant Clinical Site
      • Fremont, California, United States, 94538
        • Dermavant Clinical Site
      • Inglewood, California, United States, 90301
        • Dermavant Clinical Site
      • Los Angeles, California, United States, 90017
        • Dermavant Clinical Site
      • Los Angeles, California, United States, 90033
        • Dermavant Clinical Site
      • Mission Viejo, California, United States, 92691
        • Dermavant Clinical Site
      • Sacramento, California, United States, 95815
        • Dermavant Investigative Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Dermavant Clinical Site
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Dermavant Clinical Site
      • Boca Raton, Florida, United States, 33486
        • Dermavant Clinical Site
      • Brandon, Florida, United States, 33511
        • Dermavant Investigative Site
      • Coral Gables, Florida, United States, 33146
        • Dermavant Investigative Site
      • Jacksonville, Florida, United States, 32256
        • Dermavant Clinical Site
      • Margate, Florida, United States, 33063
        • Dermavant Clinical Site
      • Miami, Florida, United States, 33126
        • Dermavant Clinical Site
      • Miami Lakes, Florida, United States, 33014
        • Dermavant Clinical Site
      • Orlando, Florida, United States, 32801
        • Dermavant Clinical Site
      • Pinellas Park, Florida, United States, 33781
        • Dermavant Clinical Site
      • Sweetwater, Florida, United States, 33172
        • Dermavant Investigative Site
      • Tampa, Florida, United States, 33615
        • Dermavant Clinical Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Dermavant Investigative Site
      • Sandy Springs, Georgia, United States, 30328
        • Dermavant Clinical Site
      • Savannah, Georgia, United States, 31406
        • Dermavant Clinical Site
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • Dermavant Clinical Site
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Dermavant Clinical Site
      • Owensboro, Kentucky, United States, 42303
        • Dermavant Investigative Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Dermavant Clinical Site
      • Monroe, Louisiana, United States, 71201
        • Dermavant Clinical Site
    • Maryland
      • Largo, Maryland, United States, 20774
        • Dermavant Clinical Site
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Dermavant Clinical Site
      • Clarkston, Michigan, United States, 48346
        • Dermavant Clinical Site
      • Warren, Michigan, United States, 48088
        • Dermavant Clinical Site
      • Ypsilanti, Michigan, United States, 48197
        • Dermavant Clinical Site
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Dermavant Clinical Site
    • Montana
      • Missoula, Montana, United States, 59808
        • Dermavant Clinical Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Dermavant Clinical Site
    • New York
      • Garden City, New York, United States, 11530
        • Dermavant Clinical Site
      • New York, New York, United States, 10075
        • Dermavant Investigative Site
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Dermavant Clinical Site
      • Cleveland, Ohio, United States, 44106
        • Dermavant Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73071
        • Dermavant Clinical Site
      • Oklahoma City, Oklahoma, United States, 73120
        • Dermavant Clinical Site
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Dermavant Clinical Site
      • Portland, Oregon, United States, 97223
        • Dermavant Clinical Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Dermavant Clinical Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Dermavant Clinical Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Dermavant Clinical Site
    • Texas
      • Austin, Texas, United States, 78745
        • Dermavant Clinical Site
      • Bellaire, Texas, United States, 77401
        • Dermavant Investigative Site
      • Cypress, Texas, United States, 77433
        • Dermavant Clinical Site
      • Dallas, Texas, United States, 75230
        • Dermavant Clinical Site
      • Houston, Texas, United States, 77098
        • Dermavant Clinical Site
      • San Antonio, Texas, United States, 78218
        • Dermavant Clinical Site
      • San Antonio, Texas, United States, 78229
        • Dermavant Clinical Site
      • Sugar Land, Texas, United States, 77479
        • Dermavant Clinical Site
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Dermavant Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female subjects ages 2 and above with clinical diagnosis of AD
  • Subject with atopic dermatitis covering ≥5% and ≤ 35% of the BSA
  • A vIGA-AD score of ≥3 at screening and baseline
  • An EASI score of ≥6 at screening and baseline
  • Atopic dermatitis present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
  • Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
  • Must not be pregnant
  • Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent

Exclusion Criteria:

  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tapinarof cream
tapinarof cream, 1%, applied topically once daily
Drug: tapinarof cream, 1%
applied topically once daily
Placebo Comparator: vehicle cream
vehicle cream, applied topically once daily
Drug: Vehicle cream
applied topically once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of subjects who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) with a Minimum 2-grade Improvement from Baseline to Week 8. Analyses were done using Multiple Imputation.
Time Frame: Baseline to Week 8
The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is calculated as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.
Baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of subjects with ≥ 75% improvement in Eczema Area and Severity Index (EASI) from Baseline to Week 8. Analyses were done using Multiple Imputation.
Time Frame: Baseline to Week 8
The Eczema Area and Severity Index (EASI) is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -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 percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease.
Baseline to Week 8
Mean change in in Percent of Total Body Surface Area (%BSA) affected from Baseline to Week 8.
Time Frame: Baseline to Week 8
Assessment of percent body surface area (%BSA) is an estimate of the percentage of total involved skin with atopic dermatitis. Estimates were made using the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumbs together) represented approximately 1% of the total BSA. Body regions are assigned a specific number of handprints with associated percentages (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]). Estimates of the percent involvement of 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 Week 8
Percent of subjects with ≥ 90% improvement in Eczema Area and Severity Index (EASI) from Baseline to Week 8. Analyses were done using Multiple Imputation.
Time Frame: Baseline to Week 8
The Eczema Area and Severity Index (EASI) is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -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 percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease.
Baseline to Week 8
Percent of subjects ≥ 12 years old with a Baseline Peak Pruritis-Numeric Rating Scale (PP-NRS) score ≥ 4 who achieve ≥ 4-point reduction in the average weekly PP-NRS from Baseline to Week 8.
Time Frame: Baseline to Week 8
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 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 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dermavant Sciences GmbH

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

April 7, 2023

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMVT-505-3101

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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