Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

NCT ID: NCT05172726

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-02
• Study Completion Date: 2026-10-31

Brief 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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Label

Group Type: EXPERIMENTAL

tapinarof cream, 1%

Intervention Type: DRUG

applied topically once daily

Interventions

tapinarof cream, 1%

applied topically once daily

Intervention Type: DRUG

Eligibility Criteria

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
• 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)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Lead Late-Stage Clinical Development

Role: STUDY_DIRECTOR

Organon and Co

Locations

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

Oregon Dermatology & Research Center

Portland, Oregon, United States

Dermatology Specialists of Spokane

Spokane, Washington, United States

Dermatology Research Institute Inc.

Calgary, Alberta, Canada

Rejuvenation Laser Dermatology Clinics

Edmonton, Alberta, Canada

Skincare Studio INC

St. John's, Newfoundland and Labrador, Canada

Lynderm Research Inc.

Markham, Ontario, Canada

Alliance Clinical Trials

Waterloo, Ontario, Canada

Whitby Health Centre Dermatology Trials

Whitby, Ontario, Canada

Innovaderm Research, Inc.

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

DMVT-505-3004

Identifier Type: -

Identifier Source: org_study_id