Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Description

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

Conditions

Plaque Psoriasis

Study Overview

Study Details

Study overview

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

A Phase 3 Study of Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Condition
Plaque Psoriasis
Intervention / Treatment

-

Contacts and Locations

Rogers

Dermavant Clinical Site, Rogers, Arkansas, United States, 72758

Fountain Valley

Dermavant Clinical Site, Fountain Valley, California, United States, 92708

Rancho Santa Margarita

Dermavant Clinical Site, Rancho Santa Margarita, California, United States, 92688

Clearwater

Dermavant Clinical Site, Clearwater, Florida, United States, 33759

Miami Lakes

Dermavant Clinical Site, Miami Lakes, Florida, United States, 45324

Chicago

Dermavant Clinical Site, Chicago, Illinois, United States, 60611

Indianapolis

Dermavant Clinical Site, Indianapolis, Indiana, United States, 46250

West Lafayette

Dermavant Clinical Site, West Lafayette, Indiana, United States, 47906

Fairborn

Dermavant Clinical Site, Fairborn, Ohio, United States, 45324

Portland

Dermavant Clinical Site, Portland, Oregon, United States, 97210

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 ≥ 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 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
  • * 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) ≥2.0x 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dermavant Sciences, Inc.,

Diana Villalobos, STUDY_DIRECTOR, Dermavant Sciences, Inc.

Study Record Dates

2026-06