Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:18 PM
Study NCT ID:
NCT07453602
Status:
RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and percentage of participants who experience an adverse event (AE) or serious adverse event (SAE)', 'timeFrame': 'From screening to the last follow up visit for each study part (Part A: 16 weeks, Part B: 30 weeks, Part C: 30 weeks)'}, {'measure': 'Percent change from Baseline in the Eczema Area and Severity Index (EASI) score, a validated measure of disease severity in atopic dermatitis.', 'timeFrame': 'From Baseline to Week 16'}], 'secondaryOutcomes': [{'measure': 'Serum concentrations of study drug to characterize the pharmacokinetic (PK) profile', 'timeFrame': 'From Baseline to Week 16'}, {'measure': 'Percentage of participants achieving at least a 50% improvement from baseline in EASI total score (EASI-50)', 'timeFrame': 'From Baseline to Week 16'}, {'measure': 'Percentage of participants achieving at least a 75% improvement from baseline in EASI total score (EASI-75)', 'timeFrame': 'From Baseline to Week 16'}, {'measure': 'Absolute change and percent change from baseline in the percentage of body surface area affected by atopic dermatitis', 'timeFrame': 'From Baseline to Week 16'}, {'measure': 'Absolute change and percent change from baseline in itch severity as measured by the Itch Numeric Rating Scale', 'timeFrame': 'From Baseline to Week 16'}, {'measure': 'Absolute change and percent change from baseline in SCORing Atopic Dermatitis (SCORAD) score', 'timeFrame': 'From Baseline to Week 16'}, {'measure': 'Percentage of participants achieving at least a 50% improvement from baseline in SCORAD total score', 'timeFrame': 'From Baseline to Week 16'}, {'measure': 'Percentage of participants achieving at least a 75% improvement from baseline in SCORAD score', 'timeFrame': 'From Baseline to Week 16'}, {'measure': 'Absolute change and percent change from baseline in Patient-Oriented Eczema Measure (POEM) score', 'timeFrame': 'From Baseline to Week 16'}, {'measure': "Percentage of participants achieving an Investigator's Global Assessment (IGA) score of 0 (Clear) or 1 (Almost Clear) with at least a 2-grade improvement from baseline", 'timeFrame': 'From Baseline to Week 16'}, {'measure': 'Percentage of participants with an IGA score of 0 (Clear) or 1 (Almost Clear)', 'timeFrame': 'From Baseline to Week 16'}, {'measure': 'Percentage of participants with an IGA score of 0 (Clear)', 'timeFrame': 'From Baseline to Week 16'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARQ-234'], 'conditions': ['Atopic Dermatitis (AD)', 'Eczema']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The study consists of 3 parts with staggered initiation:\n\n* Part A - Phase 1a SAD: ARQ-234 will be assessed in single ascending dose cohorts in healthy volunteer participants and participants with atopic dermatitis.\n* Part B - Phase 1b MAD: ARQ-234 will be assessed in multiple ascending cohorts in participants with atopic dermatitis.\n* Part C - Phase 1b POC Expansion: ARQ-234 will be assessed in participants with atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (All Participants):\n\n* Able and willing to provide written informed consent.\n* Adults 18-65 years (inclusive) at consent.\n* Generally healthy at screening/baseline (no clinically significant findings on medical history, exam, vitals, ECG, or safety labs, per investigator).\n* 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.\n* Body weight by study part: Part A (SAD) \\& Part B (MAD): 50-100 kg (inclusive), Part C (POC): 50-125 kg (inclusive)\n\nInclusion Criteria for atopic dermatitis (AD) Participants (Parts A Cohorts 6-7, Part B, Part C):\n\n* Diagnosis of moderate-to-severe atopic dermatitis for ≥ 6 months prior to screening.\n* Meets minimum disease severity at baseline: Part A Cohorts 6-7: BSA ≥7%, IGA-AD 3-4, EASI ≥10 at Baseline, Parts B and C: BSA ≥10%, IGA-AD 3-4, EASI ≥16 at Baseline.\n* 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).\n\nExclusion Criteria (All Participants):\n\n* Any clinically significant medical or psychiatric condition that could increase risk, interfere with participation, or confound results (per investigator).\n* Significant renal impairment or clinically significant hepatic impairment (per protocol/part-specific definitions).\n* Clinically significant cytopenias or clinically significant abnormal liver tests at screening (per protocol).\n* History of anaphylaxis/serious hypersensitivity (including significant hypersensitivity to local anesthetics).\n* History of attempted suicide or significant current risk, per investigator).\n* 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).\n* Known/suspected immunosuppression or history of invasive opportunistic infections or unusually frequent/recurrent/prolonged infections (per investigator).\n* Recent herpes zoster that poses risk or may affect interpretation (per investigator).\n* Malignancy within 5 years prior to screening\n* 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).\n* Unable to discontinue prohibited medications/treatments per protocol.\n* Major surgery within 4 weeks prior to baseline or planned during participation.\n* Participation in another trial or receipt of investigational product within 12 weeks (or 5 half-lives, whichever longer) before baseline.\n* Prior cell-depleting therapy (e.g., rituximab) within 6 months prior to baseline (or until lymphocytes normalize, whichever longer).\n* Blood products within 4 weeks prior to screening or planned during participation.\n* Live (attenuated) vaccines within 28 days prior to baseline or planned during the study.\n* Pregnant or breastfeeding, or planning pregnancy during the study or within 4 months after last dose.\n* Known/suspected allergy to ARQ-234 or its excipients.\n* Unable to communicate/understand the local language or otherwise unsuitable per investigator.\n* Family member of study staff or sponsor.\n\nExclusion Criteria for atopic dermatitis (AD) Participants (Parts A Cohorts 6-7, Part B, Part C):\n\n* Skin disease(s) other than AD that would interfere with assessments.\n* Active systemic/local infection, including actively infected AD, or infection requiring oral/IV antimicrobials within 14 days before baseline.\n* Phototherapy/tanning bed use within 4 weeks prior to baseline.\n* Biologic therapy for AD within 3 months or 5 half-lives (whichever longer) prior to baseline.\n* Expected need for rescue therapy for AD within the first 2 weeks after baseline.\n* History of eczema herpeticum within 12 months or ≥2 prior episodes.'}, 'identificationModule': {'nctId': 'NCT07453602', 'briefTitle': 'Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arcutis Biotherapeutics, Inc.'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'ARQ-234-131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARQ-234', 'interventionNames': ['Biological: ARQ-234']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ARQ-234', 'type': 'BIOLOGICAL', 'description': 'ARQ-234 subcutaneous injectable solution', 'armGroupLabels': ['ARQ-234']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo subcutaneous injectable solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07410', 'city': 'Fair Lawn', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Site 101', 'role': 'CONTACT', 'email': 'medinfo@arcutis.com', 'phone': '1-844-692-6729'}], 'facility': 'Clinical Site 101', 'geoPoint': {'lat': 40.94038, 'lon': -74.13181}}], 'centralContacts': [{'name': 'Arcutis Medical Information', 'role': 'CONTACT', 'email': 'medinfo@arcutis.com', 'phone': '1-844-692-6729'}], 'overallOfficials': [{'name': 'David Berk, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Arcutis Biotherapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arcutis Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}