Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)

Last updated: July 3, 2024
Sponsor: Dermavant Sciences, Inc.
Overall Status: Completed

Phase

3

Condition

Atopic Dermatitis

Allergy

Allergies & Asthma

Treatment

vehicle cream

tapinarof cream, 1%

Clinical Study ID

NCT05032859
DMVT-505-3102
  • Ages > 2
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 3months for ages 2 to 5 years old

  • Female subjects of childbearing potential who are engaging in sexual activity thatcould 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 writteninformed consent/assent

Exclusion

Exclusion Criteria:

  • Immunocompromised at screening

  • Chronic or acute systemic or superficial infection requiring treatment with systemicantibacterials or antifungals within one week prior to baseline visit

  • Significant dermatological or inflammatory condition other than AD that, in theInvestigator's opinion, would make it difficult to interpret data or assessmentsduring the study

  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upperlimit 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 cutaneousbasal 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 thebaseline visit including other investigational product within 30 days or 5half-lives of the investigational product (whichever is longer)

  • History of or ongoing serious illness or medical, physical, or psychiatriccondition(s) that, in the Investigator's opinion, may interfere with the subject'sparticipation in the study, interpretation of results, or ability to understand andgive informed consent.

  • Pregnant or lactating females

  • History of sensitivity to the study medications, or components thereof or a historyof drug or other allergy that, in the opinion of the -Investigator or MedicalMonitor, contraindicates their participation

  • Previous known participation in a clinical study with tapinarof (previously known asGSK2894512 and WBI-1001)

Study Design

Total Participants: 406
Treatment Group(s): 2
Primary Treatment: vehicle cream
Phase: 3
Study Start date:
September 23, 2021
Estimated Completion Date:
February 08, 2023

Study 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.

Connect with a study center

  • Dermavant Investigative Site

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • Dermavant Investigative Site

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Dermavant Investigative Site

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • Dermavant Investigative Site

    Cerritos, California 90702
    United States

    Site Not Available

  • Dermavant Investigative Site

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Dermavant Investigative Site

    Lancaster, California 93534
    United States

    Site Not Available

  • Dermavant Investigative Site

    Long Beach, California 90806
    United States

    Site Not Available

  • Dermavant Investigative Site

    Los Angeles, California 90045
    United States

    Site Not Available

  • Dermavant Investigative Site

    San Diego, California 92123
    United States

    Site Not Available

  • Dermavant Investigative Site

    San Francisco, California 94115
    United States

    Site Not Available

  • Dermavant Investigative Site

    Santa Ana, California 92701
    United States

    Site Not Available

  • Dermavant Investigative Site

    Santa Monica, California 90404
    United States

    Site Not Available

  • Dermavant Investigative Site

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • Dermavant Investigative Site

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • Dermavant Investigative Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Dermavant Investigative Site

    Miami, Florida 33165
    United States

    Site Not Available

  • Dermavant Investigative Site

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Dermavant Investigative Site

    Tampa, Florida 33607
    United States

    Site Not Available

  • Dermavant Investigative Site

    Snellville, Georgia 30078
    United States

    Site Not Available

  • Dermavant Investigative Site

    Evansville, Indiana 47715
    United States

    Site Not Available

  • Dermavant Investigative Site

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Dermavant Investigative Site

    Lexington, Kentucky 40517
    United States

    Site Not Available

  • Dermavant Investigative Site

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Dermavant Investigative Site

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Dermavant Investigative Site

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Dermavant Investigative Site

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Dermavant Investigative Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Dermavant Investigative Site

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Dermavant Investigative Site

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Dermavant Investigative Site

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Dermavant Investigative Site

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Dermanvant Investigative Site

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Dermavant Investigative Site

    Watertown, New York 13601
    United States

    Site Not Available

  • Dermavant Investigative Site

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Dermavant Investigative Site

    Dayton, Ohio 45414
    United States

    Site Not Available

  • Dermavant Investigative Site

    Mason, Ohio 45040
    United States

    Site Not Available

  • Dermavant Investigative Site

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • Dermavant Investigative Site

    Tulsa, Oklahoma 74114
    United States

    Site Not Available

  • Dermavant Investigative Site

    Medford, Oregon 97504
    United States

    Site Not Available

  • Dermavant Investigative Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Dermavant Investigative Site

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Dermavant Clinical Site

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • Dermavant Investigative Site

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Dermavant Investigative Site

    North Charleston, South Carolina 29420
    United States

    Site Not Available

  • Dermavant Investigative Site

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Dermavant Investigative Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Dermavant Investigative Site

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Dermavant Investigative Site

    Dripping Springs, Texas 78620
    United States

    Site Not Available

  • Dermavant Investigative Site

    Grapevine, Texas 76051
    United States

    Site Not Available

  • Dermavant Investigative Site

    Houston, Texas 77004
    United States

    Site Not Available

  • Dermavant Investigative Site

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Dermavant Investigative Site

    Webster, Texas 77598
    United States

    Site Not Available

  • Dermavant Investigative Site

    Spokane, Washington 99202
    United States

    Site Not Available

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