NCT03956355

Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)

A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Plaque Psoriasis in Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, vehicle-controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks.

Detailed description

This study is a 12-week double-blind, vehicle-controlled treatment study in which subjects will be randomized to receive tapinarof cream, 1% or vehicle cream once daily for 12 weeks. At the end of the 12-week study treatment, qualified subjects completing the study will have the option to enter a separate open-label, long-term safety and efficacy study for an additional 40 weeks of treatment with tapinarof cream, 1%. Subjects who do not enroll in the open-label long-term study will complete a follow-up visit approximately 4 weeks after end of treatment in this study (at Week 16).

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Tapinarof	Tapinarof cream, 1%, applied once daily
DRUG	Vehicle Cream	Vehicle cream applied once daily

Timeline

• Start date: 2019-05-21
• Primary completion: 2020-05-26
• Completion: 2020-05-26
• First posted: 2019-05-20
• Last updated: 2025-06-12
• Results posted: 2022-10-13

Locations

53 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study