Actively Recruiting
Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234
Led by Arcutis Biotherapeutics, Inc. · Updated on 2026-03-09
125
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 18-65 years (inclusive) at consent
- Generally healthy at screening and baseline with no significant medical findings
- 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 4 months after last dose
- Males sexually active with pregnant partners or females of childbearing potential must agree to condom use during the study and 4 months after last dose
- Body weight between 50-100 kg for Parts A and B, and 50-125 kg for Part C
- For atopic dermatitis participants: diagnosis of moderate-to-severe AD for at least 6 months prior to screening
- Minimum disease severity at baseline: Part A Cohorts 6-7: BSA ≥7%, IGA-AD 3-4, EASI ≥10; Parts B and C: BSA ≥10%, IGA-AD 3-4, EASI ≥16
- Inadequate response, intolerance, or inappropriateness of topical AD therapies or prior systemic AD therapy failure within last year
You will not qualify if you...
- Any significant medical or psychiatric condition increasing risk or interfering with participation
- Significant renal or 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 screening for hepatitis B, hepatitis C, HIV, tuberculosis
- Known or suspected immunosuppression or history of invasive opportunistic infections
- Recent herpes zoster posing risk or affecting interpretation
- Malignancy within 5 years prior to screening
- Positive urine drug screen or drug/alcohol abuse within 12 months
- Unable to discontinue prohibited medications/treatments
- Major surgery within 4 weeks prior to baseline or planned during study
- Participation in another trial or investigational product within 12 weeks prior to baseline
- Prior cell-depleting therapy within 6 months prior to baseline
- Blood products within 4 weeks prior to screening or planned during participation
- Live vaccines within 28 days prior to baseline or planned during study
- Pregnant, breastfeeding, or planning pregnancy during study or within 4 months after last dose
- Known or suspected allergy to ARQ-234 or its excipients
- Unable to communicate or understand local language or unsuitable per investigator
- Family member of study staff or sponsor
- For AD participants: skin diseases interfering with assessments
- Active systemic or local infection including infected AD or infection requiring 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 two or more prior episodes
AI-Screening
AI-Powered Screening
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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
CONTACT
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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