Clinical Trial

Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234

Recruiting Phase 1
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Summary
This is a first-in-human, Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study evaluating ARQ-234. The study is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARQ-234 in two populations: healthy volunteers and participants with moderate to severe atopic dermatitis (AD). Healthy volunteers will participate in Single Ascending Dose (SAD) Cohorts 1-5. Participants with moderate to severe AD will be enrolled in SAD Cohorts 6-7, Multiple Ascending Dose (MAD) Cohorts, and a Proof-of-Concept (POC) expansion cohort.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-03-02; most recent amendment 2026-05-20.
Status change: Not Yet Recruiting → Recruiting 2026-03-06
Trial Details
NCT Number NCT07453602
Lead Sponsor Arcutis Biotherapeutics, Inc.
Conditions Atopic Dermatitis (AD), Eczema
Enrollment 125 participants
Start Date 2026-03-02
Primary Completion 2028-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-22