NCT05172726

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	tapinarof cream, 1%	applied topically once daily

Timeline

• Start date: 2021-12-02
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2021-12-29
• Last updated: 2026-04-17

Locations

19 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study