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

September 8, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • Recruiting
        • Clinical Site 106
        • Contact:
    • New Jersey
      • Fair Lawn, New Jersey, United States, 07410
        • Recruiting
        • Clinical Site 101
        • Contact:
    • Texas
      • College Station, Texas, United States, 77845
        • Recruiting
        • Clinical Site 102
        • Contact:
      • San Antonio, Texas, United States, 78213
        • Recruiting
        • Clinical Site 104
        • Contact:
    • Utah
      • South Jordan, Utah, United States, 84095

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arcutis Biotherapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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