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NCT04053387 · ClinicalTrials.gov registry record · Phase 3
Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)
A Phase 3 study, sponsored by Organon and.
- Completed
- Registry status
- Phase 3
- Development phase
- 763
- Enrollment target
NCT04053387: Completed Phase 3 study, sponsored by Organon and.
NCT04053387 is a Phase 3 study that has completed, run by Organon and. The registered enrollment target is 763 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04053387, a Phase 3 study, has completed, sponsored by Organon and.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 763 participants
- Enrollment target
Study 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.
Primary Outcome
All AEs reported in this extension study were considered as TEAEs except for those AEs ongoing at the end of the pivotal Phase 3 studies but resolved prior to the Visit 1 date for this extension study. All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.
Interventions
- DRUG tapinarof cream, 1%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 763 participants |
| Start Date | 2019-08-13 |
| Est. Completion | 2021-04-06 |
| Phase | Phase 3 |
What the finished NCT04053387 record still lists
NCT04053387 is an interventional study that assigns participants to a tested intervention. The registered 763 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which tapinarof cream, 1% is the first listed.
NCT04053387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04053387 about?
NCT04053387 is a clinical study titled "Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)". 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 ...
What is the current status of trial NCT04053387?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 763 participants. The study started on 2019-08-13. Estimated completion is 2021-04-06.
What interventions are being tested in trial NCT04053387?
The interventions under investigation include: tapinarof cream, 1% (DRUG).
Who is sponsoring clinical trial NCT04053387?
This trial is sponsored by Organon and, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04053387's enrollment target sits among peer trials
763 449th of 2000 higher than 1,552 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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