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NCT04211363 · ClinicalTrials.gov registry record · Phase 3
Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
A Phase 3 study, sponsored by Arcutis Biotherapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 439
- Enrollment target
NCT04211363: Completed Phase 3 study, sponsored by Arcutis Biotherapeutics.
NCT04211363 is a Phase 3 study that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 439 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04211363, a Phase 3 study, has completed, sponsored by Arcutis Biotherapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 439 participants
- Enrollment target
Study Summary
This is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP.
Primary Outcome
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented (observed data only) for each arm. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Interventions
- DRUG Vehicle Cream
- DRUG Roflumilast 0.3% cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 439 participants |
| Start Date | 2019-12-20 |
| Est. Completion | 2020-11-16 |
| Phase | Phase 3 |
What the finished NCT04211363 record still lists
NCT04211363 is an interventional study that assigns participants to a tested intervention. The registered 439 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 (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle Cream is the first listed.
NCT04211363 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04211363 about?
NCT04211363 is a clinical study titled "Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis". This is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP.
What is the current status of trial NCT04211363?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 439 participants. The study started on 2019-12-20. Estimated completion is 2020-11-16.
What interventions are being tested in trial NCT04211363?
The interventions under investigation include: Vehicle Cream (DRUG), Roflumilast 0.3% cream (DRUG).
Who is sponsoring clinical trial NCT04211363?
This trial is sponsored by Arcutis Biotherapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04211363's enrollment target sits among peer trials
439 872nd of 2000 higher than 1,127 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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