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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 is a Phase 3 study that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 1,220 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04804605
The ClinicalTrials.gov registry entry for NCT04804605 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arcutis Biotherapeutics, which has 25 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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