Actively Recruiting
Phase 1a/1b Double-Blind, Randomized, Placebo-Controlled Study of ARQ-234 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis
Led by Arcutis Biotherapeutics, Inc. · Updated on 2026-05-22
125
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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 drug's 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
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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 weeks depending on study part
Participants receive either ARQ-234 or placebo through single or multiple ascending doses to assess safety and efficacy in atopic dermatitis.
Multiple visits throughout dosing period
Duration - Up to 16 weeks or longer after last dose depending on study part
Participants are monitored for safety and response after completing treatment.
Regular follow-up visits for safety assessments
Trial Site Locations
Total: 1 location
1
Clinical Site 101
Fair Lawn, New Jersey, United States, 07410
Actively Recruiting
Research Team
A
Arcutis Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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