Trials / Completed
CompletedNCT03764475
Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis
A Phase 2, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Adult Subjects With Chronic Plaque Psoriasis Who Have Completed Preceding Study ARQ-151-201 Phase 2 Randomized Controlled Trial (Cohort 1) and Non-ARQ-151-201 Subjects (Cohort 2)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 332 (actual)
- Sponsor
- Arcutis Biotherapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Cohort 1 of this study consisted of participants who previously completed study ARQ-151-201 (NCT03638258), and Cohort 2 consisted of participants who were not previously enrolled in ARQ-151-201.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Roflumilast | Roflumilast cream 0.3% for topical application |
Timeline
- Start date
- 2018-12-18
- Primary completion
- 2020-10-08
- Completion
- 2020-10-08
- First posted
- 2018-12-05
- Last updated
- 2022-09-02
- Results posted
- 2022-08-18
Locations
30 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03764475. Inclusion in this directory is not an endorsement.