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

NCT07453602 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ARQ-234-131
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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

Atopic Dermatitis (AD); Eczema

Keywords

ARQ-234

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (11)

• Serum concentrations of study drug to characterize the pharmacokinetic (PK) profile

  From Baseline to Week 16

• Percentage of participants achieving at least a 50% improvement from baseline in EASI total score (EASI-50)

  From Baseline to Week 16

• Percentage of participants achieving at least a 75% improvement from baseline in EASI total score (EASI-75)

  From Baseline to Week 16

• Absolute change and percent change from baseline in the percentage of body surface area affected by atopic dermatitis

  From Baseline to Week 16

• Absolute change and percent change from baseline in itch severity as measured by the Itch Numeric Rating Scale

  From Baseline to Week 16

Study Arms (2)

ARQ-234

EXPERIMENTAL

Biological: ARQ-234

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ARQ-234 BIOLOGICAL

ARQ-234 subcutaneous injectable solution

ARQ-234

Placebo DRUG

Placebo subcutaneous injectable solution

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (1)

Clinical Site 101

Fair Lawn, New Jersey, 07410, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• David Berk, MD

  Arcutis Biotherapeutics

  STUDY DIRECTOR

Central Study Contacts

Arcutis Medical Information

CONTACT

1-844-692-6729; medinfo@arcutis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)