ACTIVE_NOT_RECRUITING

Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Conditions

Plaque Psoriasis pediatric phase 3 topical tapinarof

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-12-02

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05172726

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.

Ages Eligible for Study:2 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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)

Inclusion Criteria

Exclusion 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)

Contacts and Locations

Principal Investigator

Clinical Lead Late-Stage Clinical Development

STUDY_DIRECTOR

Organon and Co

Study Locations (Sites)

Northwest Arkansas Clinical Trials Center, PLLC

Rogers, Arkansas, 72758

United States

First OC Dermatology

Fountain Valley, California, 92708

United States

Mission Dermatology Center

Rancho Santa Margarita, California, 92688

United States

RM Medical Research

Miami Lakes, Florida, 33014

United States

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, 33014

United States

Olympian Clinical Research

Tampa, Florida, 33615

United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611

United States

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46250

United States

Options Research Group

West Lafayette, Indiana, 47906

United States

Wright State Physicians Pharmacology Translational Unit

Fairborn, Ohio, 45324

United States

Oregon Dermatology & Research Center

Portland, Oregon, 97210

United States

Dermatology Specialists of Spokane

Spokane, Washington, 99202

United States

Collaborators and Investigators

Sponsor: Organon and Co

Clinical Lead Late-Stage Clinical Development, STUDY_DIRECTOR, Organon and Co

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

Study Start Date2021-12-02

Study Completion Date2026-10

Study Record Updates

Study Start Date2021-12-02

Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

plaque psoriasis
pediatric
phase 3
topical
tapinarof

Additional Relevant MeSH Terms

Plaque Psoriasis