The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis
Part of paid clinical trials in Beverly Hills, California.
- Sponsor
- Arcutis Biotherapeutics, Inc.
- Study ID
- NCT03638258
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Roflumilast Cream 0.3% — DRUGApplied once daily for 12 weeks
- Roflumilast Cream 0.15% — DRUGApplied once daily for 12 weeks
- Vehicle Cream — DRUGApplied once daily for 12 weeks
Study Details
This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.
Key Dates
- Start date
- Sep 21, 2018
- Status verified
- Aug 2022
- Primary completion
- May 29, 2019
- Completion
- May 29, 2019
Study Design
- Enrollment
- 331 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Roflumilast Cream 0.3%Roflumilast cream 0.3% topically applied QD for 12 weeks.
- Experimental: Roflumilast Cream 0.15%Roflumilast cream 0.15% topically applied QD for 12 weeks.
- Placebo Comparator: Vehicle CreamVehicle cream matched to roflumilast cream (containing only excipients of active cream) applied QD for 12 weeks.
Primary Outcome Measure
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6 [ Time Frame: Week 6 ]
Locations (20)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arcutis Clinical Site 35 | Beverly Hills | California | 90212 | - |
| Arcutis Clinical Site 29 | Northridge | California | 91324 | - |
| Arcutis Clinical Site 28 | San Diego | California | 92123 | - |
| Arcutis Clinical Site 27 | Santa Monica | California | 90403 | - |
| Arcutis Clinical Site 12 | Miami | Florida | 33144 | - |
| Arcutis Clinical Site 16 | Sanford | Florida | 32771 | - |
| Arcutis Clinical Site 21 | Louisville | Kentucky | 40217 | - |
| Arcutis Clinical Site 34 | Clinton Township | Michigan | 48038 | - |
| Arcutis Clinical Site 33 | Detroit | Michigan | 48202 | - |
| Arcutis Clinical Site 20 | Fridley | Minnesota | 55432 | - |
| Arcutis Clinical Site 22 | New York | New York | 10029 | - |
| Arcutis Clinical Site 14 | High Point | North Carolina | 27262 | - |
| Arcutis Clinical Site 39 | Bexley | Ohio | 43209 | - |
| Arcutis Clinical Site 15 | Pittsburgh | Pennsylvania | 15213 | - |
| Arcutis Clinical Site 19 | College Station | Texas | 77845 | - |
| Arcutis Clinical Site 13 | Houston | Texas | 77056 | - |
| Arcutis Clinical Site 37 | Houston | Texas | 77004 | - |
| Arcutis Clinical Site 23 | San Antonio | Texas | 78213 | - |
| Arcutis Clinical Site 24 | Webster | Texas | 77598 | - |
| Arcutis Clinical Site 31 | Norfolk | Virginia | 23502 | - |
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