Phase 1 Study of ARQ-234 for Atopic Dermatitis
This study is testing a new injectable medicine called ARQ-234 for people with moderate to severe atopic dermatitis (eczema). It's a first-in-human study, meaning it's one of the first times ARQ-234 is being given to people. Researchers want to see how safe ARQ-234 is, how well your body handles it, and if it helps improve eczema symptoms. You might receive ARQ-234 or a placebo (an inactive substance like a sugar pill). The study will look at side effects and changes in your Eczema Area and Severity Index (EASI) score, which measures how severe your eczema is. Adults aged 18 to 65 who are generally healthy can join.
- Study design
- This is a Phase 1, double-blind, randomized, placebo-controlled study involving about 125 participants. It's designed to test different doses of ARQ-234.
- What's involved
- Participants will be followed from screening until their last follow-up visit, which could be up to 30 weeks depending on the study part.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety from screening until the last follow-up visit, which is 16 weeks for Part A and 30 weeks for Parts B and C.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07453602
Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234
Recruiting
PHASE1Ages 18–65InterventionalTreatmentArcutis Biotherapeutics, Inc.
~125 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:ARQ-234Placebo
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and percentage of participants who experience an adverse event (AE) or serious adverse event (SAE)
Measured over From screening to the last follow up visit for each study part (Part A: 16 weeks, Part B: 30 weeks, Part C: 30 weeks)
+1 more outcome measured
Conditions
Where it's being run
2 sites across 2 statesNew Jersey1
Texas1
Study leadership
- David Berk, MD · STUDY_DIRECTOR · Arcutis Biotherapeutics
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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%, vIGA-AD 3-4, EASI ≥10 at Baseline, Parts B and C: BSA ≥10%, vIGA-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
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 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/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.
What this trial measures
- Number and percentage of participants who experience an adverse event (AE) or serious adverse event (SAE)From screening to the last follow up visit for each study part (Part A: 16 weeks, Part B: 30 weeks, Part C: 30 weeks)
- Percent change from Baseline in the Eczema Area and Severity Index (EASI) score, a validated measure of disease severity in atopic dermatitis.From Baseline to Week 16