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NCT03638258 · ClinicalTrials.gov registry record · Phase 2
The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis
A Phase 2 study of Plaque Psoriasis, sponsored by Arcutis Biotherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 331
- Enrollment target
- 20
- Study locations
NCT03638258: Completed Phase 2 study of Plaque Psoriasis, sponsored by Arcutis Biotherapeutics.
NCT03638258 is a Phase 2 study of Plaque Psoriasis that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 331 participants, below the 409-participant average among 45 other Plaque Psoriasis trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03638258, a Phase 2 study of Plaque Psoriasis, has completed, sponsored by Arcutis Biotherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 331 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 6 is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
Conditions Studied
Interventions
- DRUG Vehicle Cream
- DRUG Roflumilast Cream 0.3%
- DRUG Roflumilast Cream 0.15%
Study Locations (20)
Texas
- Arcutis Clinical Site 19 - College Station
- Arcutis Clinical Site 37 - Houston
- Arcutis Clinical Site 13 - Houston
- Arcutis Clinical Site 23 - San Antonio
- Arcutis Clinical Site 24 - Webster
California
- Arcutis Clinical Site 35 - Beverly Hills
- Arcutis Clinical Site 29 - Northridge
- Arcutis Clinical Site 28 - San Diego
- Arcutis Clinical Site 27 - Santa Monica
Florida
- Arcutis Clinical Site 12 - Miami
- Arcutis Clinical Site 16 - Sanford
Michigan
- Arcutis Clinical Site 34 - Clinton Township
- Arcutis Clinical Site 33 - Detroit
Kentucky
- Arcutis Clinical Site 21 - Louisville
Minnesota
- Arcutis Clinical Site 20 - Fridley
New York
- Arcutis Clinical Site 22 - New York
North Carolina
- Arcutis Clinical Site 14 - High Point
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2018-09-21 |
| Est. Completion | 2019-05-29 |
| Phase | Phase 2 |
What the finished NCT03638258 record still lists
NCT03638258 is an interventional study that assigns participants to a tested intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, below the 409-participant average among 45 other Plaque Psoriasis trials with a reported enrollment target (19% lower).
The record links to 1 condition, with Plaque Psoriasis appearing as the primary indexed condition, and to 3 interventions - of which Vehicle Cream is the first listed.
NCT03638258 names 20 study sites across 11 states, led by Texas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03638258 about?
NCT03638258 is a clinical study titled "The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis". 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.
What is the current status of trial NCT03638258?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 331 participants. The study started on 2018-09-21. Estimated completion is 2019-05-29.
What conditions does trial NCT03638258 study?
This clinical trial studies the following conditions: Plaque Psoriasis.
What interventions are being tested in trial NCT03638258?
The interventions under investigation include: Vehicle Cream (DRUG), Roflumilast Cream 0.3% (DRUG), Roflumilast Cream 0.15% (DRUG).
Who is sponsoring clinical trial NCT03638258?
This trial is sponsored by Arcutis Biotherapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03638258 being conducted?
This trial has 20 study locations across California, Florida, Kentucky, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Plaque Psoriasis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03638258's enrollment target sits among peer trials
331 14th of 45 higher than 32 of 45 other Plaque Psoriasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Plaque Psoriasis 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.
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