Atopic Dermatitis (AD)Phase 1NCT07453602
Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234
A Phase 1 study testing ARQ-234 in people with Atopic Dermatitis (AD) and Eczema, run by Arcutis Biotherapeutics, Inc. at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (AD), Eczema
- What is being tested?
- ARQ-234
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 7 sitesUnited States
- Study dates
- 2 Mar 2026to Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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):
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- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Clinical Site 102
College Station, Texas, 77845
Clinical Site 102, 1-844-692-6729, medinfo@arcutis.com
- Recruiting
Clinical Site 101
Fair Lawn, New Jersey, 07410
Clinical Site 101, 1-844-692-6729, medinfo@arcutis.com
- Recruiting
Clinical Site 112
Miami, Florida, 33126
Clinical Site 112, 1-844-692-6729, medinfo@arcutis.com
- Recruiting
Clinical Site 110
Miami, Florida, 33174
Clinical Site 110, 1-844-692-6729, medinfo@arcutis.com
- Recruiting
Clinical Site 106
Plainfield, Indiana, 46168
Clinical Site 106, 1-844-692-6729, medinfo@arcutis.com
- Recruiting
Clinical Site 104
San Antonio, Texas, 78213
Clinical Site 104, 1-844-692-672, medinfo@arcutis.com
- Recruiting
Clinical Site 109
South Jordan, Utah, 84095
Clinical Site 109, medinfo@arcutis.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Atopic Dermatitis (AD), Eczema
- Being tested
- ARQ-234, Placebo
- Keywords
- ARQ-234
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ-234Biological
ARQ-234 subcutaneous injectable solution
PlaceboDrug
Placebo subcutaneous injectable solution
| Study group | Role | What they receive |
|---|---|---|
| ARQ-234 | Experimental | Not described Receives: Biological: ARQ-234 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants who experience an adverse event (AE) or serious adverse event (SAE)
Measured: 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.
Measured: From Baseline to Week 16
Secondary outcomes (11)
Serum concentrations of study drug to characterize the pharmacokinetic (PK) profile
Measured: From Baseline to Week 16
Percentage of participants achieving at least a 50% improvement from baseline in EASI total score (EASI-50)
Measured: From Baseline to Week 16
Percentage of participants achieving at least a 75% improvement from baseline in EASI total score (EASI-75)
Measured: From Baseline to Week 16
Absolute change and percent change from baseline in the percentage of body surface area affected by atopic dermatitis
Measured: From Baseline to Week 16
Absolute change and percent change from baseline in itch severity as measured by the Itch Numeric Rating Scale
Measured: From Baseline to Week 16
Absolute change and percent change from baseline in SCORing Atopic Dermatitis (SCORAD) score
Measured: From Baseline to Week 16
Percentage of participants achieving at least a 50% improvement from baseline in SCORAD total score
Measured: From Baseline to Week 16
Percentage of participants achieving at least a 75% improvement from baseline in SCORAD score
Measured: From Baseline to Week 16
Absolute change and percent change from baseline in Patient-Oriented Eczema Measure (POEM) score
Measured: 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
Measured: From Baseline to Week 16
Percentage of participants with a vIGA-AD score of 0 (Clear)
Measured: From Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start2 Mar 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Berk, MD, Study director, Arcutis Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453602
- Sponsor's protocol ID
- ARQ-234-131
- Status last verified
- Oct 2026
- First submitted
- 2 Mar 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07453602
- Acronym / sponsor ID
- ARQ-234-131
- Conditions
- Atopic Dermatitis (AD), Eczema
- Keywords
- ARQ-234
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARQ-234 | Experimental | Biological: ARQ-234 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (27 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARQ-234ARQ-234 subcutaneous injectable solution | Biological | ARQ-234 |
| PlaceboPlacebo subcutaneous injectable solution | Drug | Placebo |
Primary outcome
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)
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
11 secondary outcomes
Serum concentrations of study drug to characterize the pharmacokinetic (PK) profile
Time frame: 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
Percentage of participants achieving at least a 75% improvement from baseline in EASI total score (EASI-75)
Time frame: 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
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
Absolute change and percent change from baseline in SCORing Atopic Dermatitis (SCORAD) score
Time frame: 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
Percentage of participants achieving at least a 75% improvement from baseline in SCORAD score
Time frame: 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
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
Percentage of participants with a vIGA-AD score of 0 (Clear)
Time frame: From Baseline to Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Berk, MD study director
Arcutis Biotherapeutics
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARQ-234 in people with Atopic Dermatitis (AD) and Eczema, run by Arcutis Biotherapeutics, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arcutis Medical Information (1-844-692-6729, medinfo@arcutis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.