NCT04053387

Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)

A Long-Term, Open-Label, Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream, 1% for the Treatment of Plaque Psoriasis in Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 763 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety follow-up period.

Detailed description

At the completion of the Week-12 visit of the pivotal study (Baseline \[Day 1\] in this study), all eligible subjects will be offered enrollment in the long-term extension study. Study visits during the treatment period for all subjects will occur every 4 weeks (± 3 days). The total duration of study participation will be approximately 44 weeks.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	tapinarof cream, 1%	Intermittent use of Tapinarof cream, 1%, applied once daily according to PGA score

Timeline

• Start date: 2019-08-13
• Primary completion: 2021-04-06
• Completion: 2021-04-06
• First posted: 2019-08-12
• Last updated: 2025-08-06
• Results posted: 2022-08-08

Locations

104 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study