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

Who is this study for? Patients with Plaque Psoriasis
What treatments are being studied? Tapinarof Cream, 1%
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
Northwest Arkansas Clinical Trials Center, PLLC
RECRUITING
Rogers
California
First OC Dermatology
RECRUITING
Fountain Valley
Mission Dermatology Center
RECRUITING
Rancho Santa Margarita
Florida
RM Medical Research
RECRUITING
Miami Lakes
San Marcus Research Clinic, Inc.
RECRUITING
Miami Lakes
Olympian Clinical Research
ACTIVE_NOT_RECRUITING
Tampa
Illinois
Northwestern University Feinberg School of Medicine
RECRUITING
Chicago
Indiana
Dawes Fretzin Clinical Research Group
RECRUITING
Indianapolis
Options Research Group
RECRUITING
West Lafayette
Ohio
Wright State Physicians Pharmacology Translational Unit
RECRUITING
Fairborn
Oregon
Oregon Dermatology & Research Center
ACTIVE_NOT_RECRUITING
Portland
Washington
Dermatology Specialists of Spokane
RECRUITING
Spokane
Other Locations
Canada
Dermatology Research Institute Inc.
RECRUITING
Calgary
Rejuvenation Laser Dermatology Clinics
RECRUITING
Edmonton
Lynderm Research Inc.
RECRUITING
Markham
Innovaderm Research, Inc.
RECRUITING
Montreal
Skincare Studio INC
RECRUITING
St. John's
Alliance Clinical Trials
RECRUITING
Waterloo
Whitby Health Centre Dermatology Trials
ACTIVE_NOT_RECRUITING
Whitby
Contact Information
Primary
Clinical Lead Late-Stage Clinical Development
studysites@organon.com
551-430-6000
Time Frame
Start Date: 2021-12-02
Estimated Completion Date: 2026-09
Participants
Target number of participants: 100
Treatments
Experimental: Open Label
Related Therapeutic Areas
Sponsors
Leads: Organon and Co

This content was sourced from clinicaltrials.gov

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