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NCT03764475 · ClinicalTrials.gov registry record · Phase 2
Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis
A Phase 2 study, sponsored by Arcutis Biotherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 332
- Enrollment target
NCT03764475: Completed Phase 2 study, sponsored by Arcutis Biotherapeutics.
NCT03764475 is a Phase 2 study that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 332 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (150% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03764475, a Phase 2 study, has completed, sponsored by Arcutis Biotherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 332 participants
- Enrollment target
Study Summary
This is an open-label, long-term safety study of roflumilast (ARQ-151) 0.3% cream in subjects with chronic plaque psoriasis involving up to 25% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression.
Primary Outcome
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that began after initiating study treatment (treatment-emergent AEs \[TEAEs\]) in ARQ-151-202
Interventions
- DRUG Roflumilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 332 participants |
| Start Date | 2018-12-18 |
| Est. Completion | 2020-10-08 |
| Phase | Phase 2 |
What the finished NCT03764475 record still lists
NCT03764475 is an interventional study that assigns participants to a tested intervention. The registered 332 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (150% higher).
The record links to 0 conditions, and to 1 intervention - of which Roflumilast is the first listed.
NCT03764475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03764475 about?
NCT03764475 is a clinical study titled "Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis". This is an open-label, long-term safety study of roflumilast (ARQ-151) 0.3% cream in subjects with chronic plaque psoriasis involving up to 25% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 52 weeks at home. Periodic clinic visits...
What is the current status of trial NCT03764475?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 332 participants. The study started on 2018-12-18. Estimated completion is 2020-10-08.
What interventions are being tested in trial NCT03764475?
The interventions under investigation include: Roflumilast (DRUG).
Who is sponsoring clinical trial NCT03764475?
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 NCT03764475's enrollment target sits among peer trials
332 144th of 2000 higher than 1,856 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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