[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Arcutis Biotherapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100627820","phase-1-ph-1a1b-single-ascending-dose-and-multiple-ascending-dose-study-of-arq-234-100627820",false,"NCT07453602","Ph 1a\u002F1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234","A Phase 1a\u002F1b, 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.","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\u002Fbaseline (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%, vIGA-AD 3-4, EASI ≥10 at Baseline, Parts B and C: BSA ≥10%, vIGA-AD 3-4, EASI ≥16 at Baseline.\n* Inadequate response, intolerance, or medical inappropriateness of topical AD therapies (and\u002For 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\u002Fpart-specific definitions).\n* Clinically significant cytopenias or clinically significant abnormal liver tests at screening (per protocol).\n* History of anaphylaxis\u002Fserious 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\u002Flatent TB).\n* Known\u002Fsuspected immunosuppression or history of invasive opportunistic infections or unusually frequent\u002Frecurrent\u002Fprolonged 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\u002FPart B only) or drug\u002Falcohol abuse within 12 months, or other condition likely to impair compliance (per investigator).\n* Unable to discontinue prohibited medications\u002Ftreatments 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 baseline 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\u002Fsuspected allergy to ARQ-234 or its excipients.\n* Unable to communicate\u002Funderstand 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\u002Flocal infection, including actively infected AD, or infection requiring oral\u002FIV antimicrobials within 14 days before baseline.\n* Phototherapy\u002Ftanning 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.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},125,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","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.",[28,29],"Atopic Dermatitis (AD)","Eczema",[31],"ARQ-234","RECRUITING","2026-05-20",{"date":35,"type":36},"2026-05-22","ACTUAL",{"date":38,"type":36},"2026-03-02",{"date":40,"type":22},"2028-04",{"name":42,"class":43},"Arcutis Biotherapeutics, Inc.","INDUSTRY",""]