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

May 20, 2026 updated by: Arcutis Biotherapeutics, Inc.

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study consists of 3 parts with staggered initiation:

  • Part A - Phase 1a SAD: ARQ-234 will be assessed in single ascending dose cohorts in healthy volunteer participants and participants with atopic dermatitis.
  • Part B - Phase 1b MAD: ARQ-234 will be assessed in multiple ascending cohorts in participants with atopic dermatitis.
  • Part C - Phase 1b POC Expansion: ARQ-234 will be assessed in participants with atopic dermatitis.

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Fair Lawn, New Jersey, United States, 07410
        • Recruiting
        • Clinical Site 101
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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%, 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 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 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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo subcutaneous injectable solution
Experimental: ARQ-234
Biological: ARQ-234
ARQ-234 subcutaneous injectable solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and percentage of participants who experience an adverse event (AE) or serious adverse event (SAE)
Time Frame: From screening to the last follow up visit for each study part (Part A: 16 weeks, Part B: 30 weeks, Part C: 30 weeks)
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.
Time Frame: From Baseline to Week 16
From Baseline to Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum concentrations of study drug to characterize the pharmacokinetic (PK) profile
Time Frame: From Baseline to Week 16
From Baseline to Week 16
Percentage of participants achieving at least a 50% improvement from baseline in EASI total score (EASI-50)
Time Frame: From Baseline to Week 16
From Baseline to Week 16
Percentage of participants achieving at least a 75% improvement from baseline in EASI total score (EASI-75)
Time Frame: From Baseline to Week 16
From Baseline to Week 16
Absolute change and percent change from baseline in the percentage of body surface area affected by atopic dermatitis
Time Frame: From Baseline to Week 16
From Baseline to Week 16
Absolute change and percent change from baseline in itch severity as measured by the Itch Numeric Rating Scale
Time Frame: From Baseline to Week 16
From Baseline to Week 16
Absolute change and percent change from baseline in SCORing Atopic Dermatitis (SCORAD) score
Time Frame: From Baseline to Week 16
From Baseline to Week 16
Percentage of participants achieving at least a 50% improvement from baseline in SCORAD total score
Time Frame: From Baseline to Week 16
From Baseline to Week 16
Percentage of participants achieving at least a 75% improvement from baseline in SCORAD score
Time Frame: From Baseline to Week 16
From Baseline to Week 16
Absolute change and percent change from baseline in Patient-Oriented Eczema Measure (POEM) score
Time Frame: From Baseline to Week 16
From Baseline to Week 16
Percentage of participants achieving a Validated Investigator's Global Assessment (vIGA-AD) score of 0 (Clear) or 1 (Almost Clear) with at least a 2-grade improvement from baseline
Time Frame: From Baseline to Week 16
From Baseline to Week 16
Percentage of participants with a vIGA-AD score of 0 (Clear)
Time Frame: From Baseline to Week 16
From Baseline to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arcutis Biotherapeutics, Inc.

Investigators

  • Study Director: David Berk, MD, Arcutis Biotherapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARQ-234-131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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