ARQ-234 single and multiple rising dose testing

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.

This will test different single and repeated doses of ARQ-234 to see if they are safe and how the drug behaves in healthy adults and adults with moderate-to-severe atopic dermatitis.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 125 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Arcutis Biotherapeutics, Inc. (industry)
• Drugs / interventions: rituximab
• Locations: 1 site (Fair Lawn, New Jersey)
• Trial ID: NCT07453602 on ClinicalTrials.gov

What this trial studies

This first-in-human, randomized, double-blind, placebo-controlled Phase 1 trial uses dose-escalation to characterize safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARQ-234. Part A enrolls healthy volunteers and some AD participants in single ascending dose (SAD) cohorts, Part B enrolls AD participants in multiple ascending dose (MAD) cohorts, and Part C is a proof-of-concept expansion in AD. Participants are randomized to receive ARQ-234 or placebo with staggered dose increases and intensive safety and PK/PD monitoring. The design aims to identify tolerable dose ranges and early signals of biological activity in atopic dermatitis.

Who should consider this trial

Good fit: Adults 18–65 with a diagnosis of moderate-to-severe atopic dermatitis for at least six months who meet the study weight and contraception requirements and are otherwise generally healthy are the intended participants.

Not a fit: People with mild eczema, significant uncontrolled medical conditions, pregnant or unwilling to use required contraception, or those outside the specified age or weight ranges are unlikely to qualify or benefit from this Phase 1 study.

Why it matters

Potential benefit: If successful, ARQ-234 could become a new systemic option that improves symptoms of moderate-to-severe atopic dermatitis with an acceptable safety profile.

How similar studies have performed: ARQ-234 is being tested first-in-human in this protocol, though dose-escalation Phase 1 designs are standard and other systemic agents for AD have shown efficacy in later-stage trials.

Eligibility criteria

Inclusion Criteria (All Participants):

* 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)

Inclusion Criteria for atopic dermatitis (AD) Participants (Parts A Cohorts 6-7, Part B, Part C):

* 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 Criteria (All Participants):

* 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.

Exclusion Criteria for atopic dermatitis (AD) Participants (Parts A Cohorts 6-7, Part B, Part C):

* 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.

Where this trial is running

Fair Lawn, New Jersey

• Clinical Site 101 — Fair Lawn, New Jersey, United States (RECRUITING)

Study contacts

• Study coordinator: Arcutis Medical Information

Conditions: Atopic Dermatitis, Eczema, ARQ-234