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NCT03956355 · ClinicalTrials.gov registry record · Phase 3
Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)
A Phase 3 study, sponsored by Organon and.
- Completed
- Registry status
- Phase 3
- Development phase
- 510
- Enrollment target
NCT03956355: Completed Phase 3 study, sponsored by Organon and.
NCT03956355 is a Phase 3 study that has completed, run by Organon and. The registered enrollment target is 510 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03956355, a Phase 3 study, has completed, sponsored by Organon and.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 510 participants
- Enrollment target
Study 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.
Primary Outcome
The PGA is a clinical tool for assessing the current state/severity of a subject's psoriasis at a given timepoint. A static 5-point scale is used to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, and is calculated as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher PGA scores represent more severe disease. Analyses were done using multiple imputation.
Interventions
- DRUG Tapinarof
- DRUG Vehicle Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2019-05-21 |
| Est. Completion | 2020-05-26 |
| Phase | Phase 3 |
What the finished NCT03956355 record still lists
NCT03956355 is an interventional study that assigns participants to a tested intervention. The registered 510 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 2 interventions - of which Tapinarof is the first listed.
NCT03956355 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03956355 about?
NCT03956355 is a clinical study titled "Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)". 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 tapinaro...
What is the current status of trial NCT03956355?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 510 participants. The study started on 2019-05-21. Estimated completion is 2020-05-26.
What interventions are being tested in trial NCT03956355?
The interventions under investigation include: Tapinarof (DRUG), Vehicle Cream (DRUG).
Who is sponsoring clinical trial NCT03956355?
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 NCT03956355's enrollment target sits among peer trials
510 729th of 2000 higher than 1,264 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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