Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Last updated: May 30, 2025
Sponsor: Organon and Co
Overall Status: Active - Recruiting

Phase

3

Condition

Psoriasis And Psoriatic Disorders

Rosacea

Warts

Treatment

tapinarof cream, 1%

Clinical Study ID

NCT05172726
DMVT-505-3004
  • Ages 2-17
  • All Genders

Study Summary

This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female subjects ages 2 to 17 years with clinical diagnosis of chronicplaque psoriasis and stable disease for at least 3 months prior to the baselinevisit

  • Subject with plaque psoriasis covering ≥ 3% of the BSA at screening and baseline

  • A PGA score of ≥ 2 at screening and baseline

  • 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:

  • Psoriasis other than plaque variant

  • Any sign of infection of any of the psoriatic lesions

  • Immunocompromised at screening

  • Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0xthe 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 cutaneousbasal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix

  • Major surgery within 8 weeks prior to baseline or has a major surgery planned duringthe study

  • Known history of clinically significant drug or alcohol abuse in the last year priorto baseline

  • Use of any prohibited medication or procedure within the indicated period before thebaseline visit until the completion of the study completion or study discontinuation

  • 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, safety of the subject orability to understand and give 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: 100
Treatment Group(s): 1
Primary Treatment: tapinarof cream, 1%
Phase: 3
Study Start date:
December 02, 2021
Estimated Completion Date:
September 30, 2026

Study Description

This study is an open-label study, consisting of a 12-week primary treatment phase and an optional 40-week long-term extension phase in which all eligible subjects will receive tapinarof cream, 1% once daily. At the end of the 12-week primary treatment phase subjects will have the option to continue for 40 additional weeks of treatment. Subjects who choose not to participate in the optional 40-week long-term extension phase will complete a follow-up visit approximately one week after the end of the primary treatment phase.

Connect with a study center

  • Clinical Site

    Calgary, Alberta T2J7E1
    Canada

    Active - Recruiting

  • Dermavant Clinical Site

    Calgary, Alberta T2J7E1
    Canada

    Active - Recruiting

  • Clinical Site

    Edmonton, Alberta T5J3S9
    Canada

    Active - Recruiting

  • Dermavant Clinical Site

    Edmonton, Alberta T5J3S9
    Canada

    Active - Recruiting

  • Clinical Site

    Saint John's, Newfoundland and Labrador A1E1V4
    Canada

    Active - Recruiting

  • Dermavant Clinical Site

    Saint John's, Newfoundland and Labrador A1E1V4
    Canada

    Active - Recruiting

  • Clinical Site

    Markham, Ontario L3P1X3
    Canada

    Active - Recruiting

  • Dermavant Clinical Site

    Markham, Ontario L3P1X3
    Canada

    Active - Recruiting

  • Clinical Trials

    Oshawa, Ontario L1H1B9
    Canada

    Active - Recruiting

  • Dermavant Clinical Trials

    Oshawa, Ontario L1H1B9
    Canada

    Active - Recruiting

  • Clinical Site

    Waterloo, Ontario N2J1C4
    Canada

    Active - Recruiting

  • Dermavant Clinical Site

    Waterloo, Ontario N2J1C4
    Canada

    Active - Recruiting

  • Clinical Site

    Montréal, Quebec H2X2V1
    Canada

    Active - Recruiting

  • Dermavant Clinical Site

    Montréal, Quebec H2X2V1
    Canada

    Active - Recruiting

  • Clinical Site

    Rogers, Arkansas 72758
    United States

    Active - Recruiting

  • Dermavant Clinical Site

    Rogers, Arkansas 72758
    United States

    Active - Recruiting

  • Clinical Site

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Dermavant Clinical Site

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Clinical Site

    Rancho Santa Margarita, California 92688
    United States

    Active - Recruiting

  • Dermavant Clinical Site

    Rancho Santa Margarita, California 92688
    United States

    Active - Recruiting

  • Clinical Site

    Clearwater, Florida 33759
    United States

    Active - Recruiting

  • Dermavant Clinical Site

    Clearwater, Florida 33759
    United States

    Active - Recruiting

  • Clinical Site

    Miami Lakes, Florida 45324
    United States

    Active - Recruiting

  • Dermavant Clinical Site

    Miami Lakes, Florida 45324
    United States

    Active - Recruiting

  • Clinical Site

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Dermavant Clinical Site

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Clinical Site

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Dermavant Clinical Site

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Clinical Site

    West Lafayette, Indiana 47906
    United States

    Active - Recruiting

  • Dermavant Clinical Site

    West Lafayette, Indiana 47906
    United States

    Active - Recruiting

  • Clinical Site

    Fairborn, Ohio 45324
    United States

    Active - Recruiting

  • Dermavant Clinical Site

    Fairborn, Ohio 45324
    United States

    Active - Recruiting

  • Clinical Site

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Dermavant Clinical Site

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Clinical Site

    Spokane, Washington 99202
    United States

    Active - Recruiting

  • Dermavant Clinical Site

    Spokane, Washington 92688
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.