What is ARQ-234 studying for atopic dermatitis?

ARQ-234 is being studied to evaluate its safety, tolerability, and how it behaves in the body for people with moderate to severe atopic dermatitis. The research looks at its effects compared to a placebo in both healthy volunteers and those with the condition. Arcutis Biotherapeutics, Inc. is leading this investigation to better understand potential new treatment options.

Who may be eligible for this atopic dermatitis clinical trial?

Adults aged 18 to 65 years with moderate to severe atopic dermatitis may be eligible. Participants must be generally healthy and able to provide consent. Both men and women can join, with specific contraception requirements for females of childbearing potential. Please review eligibility criteria for more details.

Is there any cost to participate in this atopic dermatitis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses to and from study visits may vary and are not guaranteed to be covered. Participants should plan for any travel costs they might incur.

Actively Recruiting

Phase 1

Age: 18Years - 65Years

All Genders

Healthy Volunteers

ID07453602

Phase 1a1b Study of ARQ-234 in Healthy Adults and Adults With Moderate to Severe Atopic Dermatitis Evaluating Single and Multiple Doses

Led by Arcutis Biotherapeutics, Inc. · Updated on 2026-05-22

125

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating ARQ-234, a subcutaneous injectable biological drug, in a first-in-human, Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study. The study aims to assess the safety, tolerability, how the body processes the drug pharmacokinetics, and its biological effects pharmacodynamics in healthy volunteers and participants with moderate to severe atopic dermatitis. The study includes healthy volunteers and participants diagnosed with moderate to severe atopic dermatitis, a condition also known as eczema. The trial has three parts Part A involves single ascending doses SAD of ARQ-234 in both healthy volunteers and participants with atopic dermatitis Part B studies multiple ascending doses MAD in participants with atopic dermatitis and Part C is a proof-of-concept expansion evaluating ARQ-234 in participants with atopic dermatitis. Participants may receive ARQ-234 or a placebo, with doses increasing over time to assess safety and effects. Participants will be involved from screening through follow-up visits lasting up to 16 weeks for Part A and up to 30 weeks for Parts B and C. Assessments include monitoring adverse events, changes in the Eczema Area and Severity Index EASI, body surface area affected, itch severity, and other eczema severity scores. Blood tests will measure drug levels, and safety evaluations will include medical exams, vitals, ECGs, and lab tests. This comprehensive monitoring helps researchers understand the drugs impact and safety in both healthy individuals and those with atopic dermatitis.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Able and willing to provide written informed consent
Adults aged 18 to 65 years at consent
Generally healthy with no clinically significant findings on medical history, exam, vitals, ECG, or safety labs
Females of childbearing potential must have 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 sexually active with a pregnant partner or female of childbearing potential must agree to condom use during the study and for 4 months after last dose
Body weight: 50 to 100 kg for Parts A and B, 50 to 125 kg for Part C
Diagnosis of moderate-to-severe atopic dermatitis for at least 6 months prior to screening (for Parts A Cohorts 6-7, Part B, Part C)
Minimum disease severity at baseline: BSA ≥7%, vIGA-AD score 3-4, EASI score ≥10 for Part A Cohorts 6-7; BSA ≥10%, vIGA-AD score 3-4, EASI score ≥16 for Parts B and C
Inadequate response, intolerance, or medical inappropriateness of topical AD therapies or prior systemic AD therapy failure within the last year (for atopic dermatitis participants)

You will not qualify if you...

Any clinically significant medical or psychiatric condition that increases risk, interferes with participation, or confounds results
Significant renal or clinically significant hepatic impairment
Clinically significant cytopenias or abnormal liver tests at screening
History of anaphylaxis or serious hypersensitivity including to local anesthetics
History of attempted suicide or significant current risk
Chronic or significant infection history or positive tests for hepatitis B, hepatitis C, HIV, or tuberculosis
Known or suspected immunosuppression or history of invasive opportunistic infections or frequent infections
Recent herpes zoster posing risk or affecting interpretation
Malignancy within 5 years prior to screening
Positive urine drug screen at screening or drug/alcohol abuse within 12 months
Unable to discontinue prohibited medications or 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 prior to baseline
Prior cell-depleting therapy within 6 months prior to baseline or until lymphocytes normalize
Blood products within 4 weeks prior to baseline 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 or suspected allergy to ARQ-234 or its excipients
Unable to communicate or understand the local language or otherwise unsuitable
Family member of study staff or sponsor
Skin diseases other than AD interfering with assessments (for atopic dermatitis participants)
Active systemic or local infection including infected AD or infection requiring oral/IV antimicrobials within 14 days before baseline
Phototherapy or tanning bed use within 4 weeks prior to baseline
Biologic therapy for AD within 3 months or 5 half-lives prior to baseline
Expected need for rescue therapy for AD within first 2 weeks after baseline
History of eczema herpeticum within 12 months or 2 or more prior episodes (for atopic dermatitis participants)

Research Team

Arcutis Medical Information

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Phase 1a1b Study of ARQ-234 in Healthy Adults and Adults With Moderate to Severe Atopic Dermatitis Evaluating Single and Multiple Doses

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria