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NCT03392168 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis
A Phase 1 study, sponsored by Arcutis Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 91
- Enrollment target
NCT03392168: Completed Phase 1 study, sponsored by Arcutis Biotherapeutics.
NCT03392168 is a Phase 1 study that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 91 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03392168, a Phase 1 study, has completed, sponsored by Arcutis Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 91 participants
- Enrollment target
Study Summary
This study assessed the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm\^2 of psoriatic plaque(s) (Cohort 1). The study also assessed the safety, PK and efficacy of ARQ-151 cream 0.5% vs vehicle and ARQ-151 cream 0.15% vs vehicle applied once a day for 28 days to individuals with 0.5% to 5.0% body surface area (BSA) of chronic plaque psoriasis (Cohort 2).
Primary Outcome
Difference in least squares mean percent change from baseline at Week 4 in the product of target plaque severity score (TPSS) x target plaque area (TPA) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPSS x TPA score as a covariate. For TPSS, all target lesions were scored individually for signs of indur
Interventions
- DRUG ARQ-151 cream 0.15%
- DRUG ARQ-151 cream 0.5%
- DRUG ARQ-151 vehicle cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2017-12-11 |
| Est. Completion | 2018-05-02 |
| Phase | Phase 1 |
What the finished NCT03392168 record still lists
NCT03392168 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% higher).
The record links to 0 conditions, and to 3 interventions - of which ARQ-151 cream 0.15% is the first listed.
NCT03392168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03392168 about?
NCT03392168 is a clinical study titled "Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis". This study assessed the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm\^2 of psoriatic plaque(s) (Cohort 1). The study also assessed the safety, PK and efficacy of ARQ-151 cream 0.5% vs vehicle and ARQ-151 cream 0.15% vs vehicle applied once a day for 28...
What is the current status of trial NCT03392168?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 91 participants. The study started on 2017-12-11. Estimated completion is 2018-05-02.
What interventions are being tested in trial NCT03392168?
The interventions under investigation include: ARQ-151 cream 0.15% (DRUG), ARQ-151 cream 0.5% (DRUG), ARQ-151 vehicle cream (DRUG).
Who is sponsoring clinical trial NCT03392168?
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 NCT03392168's enrollment target sits among peer trials
91 626th of 2000 higher than 1,373 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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