Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Running, not enrolling · Phase 3

Conditions studied: Plaque Psoriasis

In brief

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

Key facts

Study ID

NCT05172726

Run by

Organon and Co

People needed

58

Starts

2021-12-02

Expected to finish

2026-10-01

Last updated by the study team

2026-04-17

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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