RecruitingPhase 1NCT07453602

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

A Phase 1a/1b, Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234 in Healthy Volunteers and Subjects With Moderate to Severe Atopic Dermatitis.

Sponsor

Arcutis Biotherapeutics, Inc.

Enrollment

125 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

Eczema Atopic Dermatitis (AD)

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

Able and willing to provide written informed consent.
Adults 18-65 years (inclusive) at consent.
Generally healthy at screening/baseline (no clinically significant findings on medical history, exam, vitals, ECG, or safety labs, per investigator).
Contraception requirements: Females of childbearing potential: negative pregnancy tests at screening and baseline and agree to use highly effective contraception (plus barrier method) during the study and for 4 months after last dose. Males if sexually active with a pregnant partner or a female of childbearing potential, agree to condom use during the study and for 4 months after last dose.
Body weight by study part: Part A (SAD) \& Part B (MAD): 50-100 kg (inclusive), Part C (POC): 50-125 kg (inclusive)
Diagnosis of moderate-to-severe atopic dermatitis for ≥ 6 months prior to screening.
Meets minimum disease severity at baseline: Part A Cohorts 6-7: BSA ≥7%, IGA-AD 3-4, EASI ≥10 at Baseline, Parts B and C: BSA ≥10%, IGA-AD 3-4, EASI ≥16 at Baseline.
Inadequate response, intolerance, or medical inappropriateness of topical AD therapies (and/or prior systemic AD therapy failure within the last year may qualify as inadequate response).

Exclusion Criteria26

Any clinically significant medical or psychiatric condition that could increase risk, interfere with participation, or confound results (per investigator).
Significant renal impairment or clinically significant hepatic impairment (per protocol/part-specific definitions).
Clinically significant cytopenias or clinically significant abnormal liver tests at screening (per protocol).
History of anaphylaxis/serious hypersensitivity (including significant hypersensitivity to local anesthetics).
History of attempted suicide or significant current risk, per investigator).
Chronic or significant infection history or positive screening tests for hepatitis B, hepatitis C, HIV, or tuberculosis (including positive QuantiFERON or history of active/latent TB).
Known/suspected immunosuppression or history of invasive opportunistic infections or unusually frequent/recurrent/prolonged infections (per investigator).
Recent herpes zoster that poses risk or may affect interpretation (per investigator).
Malignancy within 5 years prior to screening
Positive urine drug screen at screening (Part A/Part B only) or drug/alcohol abuse within 12 months, or other condition likely to impair compliance (per investigator).
Unable to discontinue prohibited medications/treatments per protocol.
Major surgery within 4 weeks prior to baseline or planned during participation.
Participation in another trial or receipt of investigational product within 12 weeks (or 5 half-lives, whichever longer) before baseline.
Prior cell-depleting therapy (e.g., rituximab) within 6 months prior to baseline (or until lymphocytes normalize, whichever longer).
Blood products within 4 weeks prior to screening or planned during participation.
Live (attenuated) vaccines within 28 days prior to baseline or planned during the study.
Pregnant or breastfeeding, or planning pregnancy during the study or within 4 months after last dose.
Known/suspected allergy to ARQ-234 or its excipients.
Unable to communicate/understand the local language or otherwise unsuitable per investigator.
Family member of study staff or sponsor.
Skin disease(s) other than AD that would interfere with assessments.
Active systemic/local infection, including actively infected AD, or infection requiring oral/IV antimicrobials within 14 days before baseline.
Phototherapy/tanning bed use within 4 weeks prior to baseline.
Biologic therapy for AD within 3 months or 5 half-lives (whichever longer) prior to baseline.
Expected need for rescue therapy for AD within the first 2 weeks after baseline.
History of eczema herpeticum within 12 months or ≥2 prior episodes.