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ARQ-234

Phase 1

Atopic Dermatitis (AD) | Monoclonal antibody | Immunology |Arcutis Biotherapeutics, Inc.|Last Updated: May 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment125
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07453602Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234PHASE1 RECRUITING 125 — — Mar 2, 2026Apr 1, 2028May 22, 20261 United States
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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 — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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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Competitive Landscape -Atopic Dermatitis 82 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY6PHASE3Baricitinib, corticosteroid, Lebrikizumab, Corticosteroid
AbbVie, Inc.ABBV10PHASE3Upadacitinib, corticosteroids, Dupilumab, Upadacitinib Dose, Dupilumab Dose
Pfizer Inc.PFE12PHASE3Abrocitinib, PF-08049820, PF-07275315, PF-07264660, Midazolam
Sanofi SA Sponsored ADRSNY13PHASE3Amlitelimab, corticosteroids, tacrolimus or pimecrolimus, calcineurin inhibitors, Dupilumab SAR231893
Regeneron Pharmaceuticals, Inc.REGN4PHASE3Dupilumab, REGN20423, dupilumab
Incyte CorporationINCY3PHASE3Ruxolitinib, Vehicle, TCS
Amgen Inc.AMGN1PHASE3Rocatinlimab
Organon & Co.OGN1PHASE3Tapinarof , 1%, Vehicle
Novartis AG Sponsored ADRNVS2PHASE2GIA632, GHZ339
Apogee Therapeutics, Inc.APGE3PHASE2APG777, APG990, Dupilumab
Johnson & JohnsonJNJ1PHASE2JNJ-95597528
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Nektar TherapeuticsNKTR1PHASE2Rezpegaldesleukin
Corvus Pharmaceuticals, Inc.CRVS1PHASE2Soquelitinib
Celldex Therapeutics, Inc.CLDX1PHASE2Barzolvolimab
Evommune, Inc.EVMN1PHASE2EVO756
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
Q32 Bio IncQTTB1PHASE2ADX-914
Turn Therapeutics Inc.TTRX1PHASE2GX-03
Arcutis Biotherapeutics IncARQT1PHASE1ARQ-234
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07453602primaryCompletionDate: changed
LOWMay 24, 2026NCT07453602studyFirstPostDate: changed