Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.
Conditions:
🦠 Plaque Psoriasis
πŸ—“οΈ Study Start (Actual) 2 December 2021
πŸ—“οΈ Primary Completion (Estimated) May 2026
βœ… Study Completion (Estimated) June 2026
πŸ‘₯ Enrollment (Estimated) 100
πŸ”¬ Study Type INTERVENTIONAL
πŸ“Š Phase PHASE3
Locations:
πŸ“ Rogers, Arkansas, United States
πŸ“ Fountain Valley, California, United States
πŸ“ Rancho Santa Margarita, California, United States
πŸ“ Clearwater, Florida, United States
πŸ“ Miami Lakes, Florida, United States
πŸ“ Chicago, Illinois, United States
πŸ“ Indianapolis, Indiana, United States
πŸ“ West Lafayette, Indiana, United States
πŸ“ Fairborn, Ohio, United States
πŸ“ Portland, Oregon, United States
πŸ“ Spokane, Washington, United States
πŸ“ Spokane, Washington, United States
πŸ“ Calgary, Alberta, Canada
πŸ“ Edmonton, Alberta, Canada
πŸ“ Saint John's, Newfoundland and Labrador, Canada
πŸ“ Markham, Ontario, Canada
πŸ“ Oshawa, Ontario, Canada
πŸ“ Waterloo, Ontario, Canada
πŸ“ MontrΓ©al, Quebec, Canada

πŸ“‹ Eligibility Criteria

Description

    Inclusion Criteria:

    • * Male and female subjects ages 2 to 17 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 3 months prior to the baseline visit
    • * Subject with plaque psoriasis covering β‰₯ 3% of the BSA at screening and baseline
    • * A PGA score of β‰₯ 2 at screening and baseline
    • * 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:

    • * 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) β‰₯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
    • * Major surgery within 8 weeks prior to baseline or has a major surgery planned during the study
    • * Known history of clinically significant drug or alcohol abuse in the last year prior to baseline
    • * Use of any prohibited medication or procedure within the indicated period before the baseline visit until the completion of the study completion or study discontinuation
    • * 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
    • * 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)
Ages Eligible for Study: 2 Years to 17 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

πŸ—“οΈ 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 Registration Dates

  • First Submitted 28 October 2021
  • First Submitted that Met QC Criteria 10 December 2021
  • First Posted 29 December 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 September 2023
  • Last Update Posted 11 September 2023
  • Last Verified September 2023