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ARQ-234

Phase 1

Atopic Dermatitis (AD) | Monoclonal antibody | Dermatology |Arcutis Biotherapeutics, Inc.|Last Updated: Sep 10, 2026

Target and mechanism

Molecular targetCD200R
Target classReceptor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment125

FDA Designations

No designations recorded

Clinical trial landscape

ARQ-234 · 1 trial · 2 indications

Phase 1 1
NCT07453602Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234Atopic Dermatitis (AD)
RECRUITING125 Analytics
PHASE1RECRUITING
Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234
Atopic Dermatitis (AD)Unlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARQ-234EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ARQ-234BIOLOGICALARQ-234 subcutaneous injectable solution
PlaceboDRUGPlacebo subcutaneous injectable solution
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites5

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). * Contr...

Countries:United States
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Recent Changes (Last 90 Days)

LOWSep 10, 2026NCT07453602lastUpdatePostDate: changed
LOWSep 10, 2026NCT07453602lastUpdatePostDate: changed
LOWAug 17, 2026NCT07453602lastUpdatePostDate: changed
LOWAug 17, 2026NCT07453602lastUpdatePostDate: changed

Frequently asked questions about ARQ-234

What is ARQ-234 used for in Atopic Dermatitis?

ARQ-234 is an investigational monoclonal antibody being developed for the treatment of Atopic Dermatitis (AD), also known as eczema. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with this condition to evaluate its safety and efficacy.

What does ARQ-234 target?

ARQ-234 targets CD200R, a receptor involved in immune regulation. By binding to this receptor, the monoclonal antibody aims to modulate immune responses that contribute to Atopic Dermatitis. This mechanism is being investigated in early-stage clinical trials to understand its potential therapeutic effect.

Who makes ARQ-234?

ARQ-234 is being developed by Arcutis Biotherapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ARQT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Atopic Dermatitis.

What phase is ARQ-234 in?

ARQ-234 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1a/1b study is recruiting participants to assess the drug's safety, tolerability, and pharmacokinetics in healthy volunteers and patients with Atopic Dermatitis.

What clinical trials is ARQ-234 in?

ARQ-234 is being studied in a Phase 1a/1b clinical trial registered as NCT07453602. This randomized, double-blind, placebo-controlled study is evaluating single ascending doses and multiple ascending doses of ARQ-234. The trial is recruiting 125 participants in the United States, including healthy volunteers and individuals with Atopic Dermatitis.

Is ARQ-234 the same as any other drug?

ARQ-234 is a unique investigational monoclonal antibody and is not known to be the same as any other approved or marketed drug. It is being developed specifically for Atopic Dermatitis and is currently in early-stage clinical trials to determine its safety and potential efficacy.