Arcutis Enrolls First Participant in 125-Subject Phase 1a/1b ARQ-234 Trial
Arcutis has enrolled the first participant in a 125-subject Phase 1a/1b study evaluating safety and tolerability of ARQ-234, a CD200R fusion-protein agonist, in healthy volunteers and adults with moderate to severe atopic dermatitis. The randomized trial will assess single- and multiple-ascending doses for safety, clinical improvement and pharmacokinetics.
1. Phase 1a/1b Trial Launch
Arcutis has initiated its first-in-human ARQ-234-131 study by enrolling the inaugural participant. This double-blind, randomized, placebo-controlled trial will administer ARQ-234 subcutaneously in sequential single- and multiple-ascending dose cohorts.
2. ARQ-234 Mechanism and Preclinical Insights
ARQ-234 is a fusion-protein agonist targeting the CD200 receptor, an immune-regulatory checkpoint that moderates overactive immune cells. Preclinical comparisons indicate ARQ-234 offers superior potency, extended half-life and a larger steady-state distribution versus a clinically validated CD200R antibody.
3. Study Cohorts and Objectives
Approximately 125 participants aged 18–65 will enroll across three parts: Part A (single-ascending dose), Part B (multiple-ascending dose) and Part C (proof-of-concept expansion). Primary objectives focus on safety, tolerability and clinical improvement in adults with moderate to severe atopic dermatitis, with pharmacokinetics as a secondary endpoint.