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Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

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

NCT05172726•Organon and Co

Summary

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

Detailed 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.

Eligibility

Age

2 - 17 years

Sex

ALL

Healthy Volunteers

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 ≥ 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

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) ≥2.0x 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
+4 more criteria

Locations (19)

Northwest Arkansas Clinical Trials Center, PLLC

Rogers, Arkansas, United States

First OC Dermatology

Fountain Valley, California, United States

Mission Dermatology Center

Rancho Santa Margarita, California, United States

RM Medical Research

Miami Lakes, Florida, United States

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, United States

Olympian Clinical Research

Tampa, Florida, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States

Options Research Group

West Lafayette, Indiana, United States

Wright State Physicians Pharmacology Translational Unit

Fairborn, Ohio, United States

Key Dates

Start Date

December 2, 2021

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2026

Last Updated

December 17, 2025

Enrollment

ACTUAL participants

Conditions

Plaque Psoriasis

Interventions

tapinarof cream, 1%

DRUG

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

View study

RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Plaque Psoriasis

View study

RECRUITINGPHASE2

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

NCT07449702

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis