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NCT04804605 · ClinicalTrials.gov registry record · Phase 3
Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
A Phase 3 study, sponsored by Arcutis Biotherapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,220
- Enrollment target
NCT04804605: Completed Phase 3 study, sponsored by Arcutis Biotherapeutics.
NCT04804605 is a Phase 3 study that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 1,220 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04804605, a Phase 3 study, has completed, sponsored by Arcutis Biotherapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,220 participants
- Enrollment target
Study Summary
This study was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 to 5 years). Participants with mild to moderate atopic dermatitis (AD) applied roflumilast cream once daily (qd) for up to 52 weeks.
Primary Outcome
The number of participants with ≥1 TEAE(s) is reported.
Interventions
- DRUG ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,220 participants |
| Start Date | 2021-02-25 |
| Est. Completion | 2024-05-28 |
| Phase | Phase 3 |
What the finished NCT04804605 record still lists
NCT04804605 is an interventional study that assigns participants to a tested intervention. Its 1,220 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 1 intervention - of which ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% is the first listed.
NCT04804605 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04804605 about?
NCT04804605 is a clinical study titled "Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis". This study was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 ...
What is the current status of trial NCT04804605?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,220 participants. The study started on 2021-02-25. Estimated completion is 2024-05-28.
What interventions are being tested in trial NCT04804605?
The interventions under investigation include: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% (DRUG).
Who is sponsoring clinical trial NCT04804605?
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 NCT04804605's enrollment target sits among peer trials
1,220 214th of 2000 higher than 1,786 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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