[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618504":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":147,"collaborators":149,"id":152,"slug":153,"hasResults":154,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":154,"sex":160,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":11,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},{"fullName":5,"class":6},"EMD Serono","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Enpatoran","EXPERIMENTAL",null,[13,14],"Drug: Enpatoran","Drug: Standard of care (SoC)",{"label":16,"type":17,"description":11,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR",[19,14],"Drug: Placebo",[21,27,30],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.",[9],[26],"M5049",{"type":22,"name":16,"description":28,"armGroupLabels":29,"otherNames":11},"Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168.",[16],{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":11},"Standard of care (SoC)","Participants will receive Investigator-recommended SoC.",[9,16],[35],{"name":36,"affiliation":37,"role":38},"Medical Responsible","Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","STUDY_DIRECTOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":11,"email":44},"Communication Center","CONTACT","+49 6151 72 5200","service@emdgroup.com",[46,60,69,79,88,94,103,113,123,133,138],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":11},"Dermatology Research Associates - 300204025","RECRUITING","Los Angeles","California","90045","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-118.24368,34.05223,{"lat":58,"lon":57},{"facility":61,"status":48,"city":62,"state":50,"zip":63,"country":52,"countryCode":53,"cosmosGeoPoint":64,"geoPoint":68,"contacts":11},"Cohen Medical Centers","Thousand Oaks","91360",{"type":55,"coordinates":65},[66,67],-118.83759,34.17056,{"lat":67,"lon":66},{"facility":70,"status":48,"city":71,"state":72,"zip":73,"country":52,"countryCode":53,"cosmosGeoPoint":74,"geoPoint":78,"contacts":11},"GNP Research at Mark Jaffe, MD","Cooper City","Florida","33024",{"type":55,"coordinates":75},[76,77],-80.27172,26.05731,{"lat":77,"lon":76},{"facility":80,"status":48,"city":81,"state":72,"zip":82,"country":52,"countryCode":53,"cosmosGeoPoint":83,"geoPoint":87,"contacts":11},"Advance Medical Research Center","Miami","33135",{"type":55,"coordinates":84},[85,86],-80.19366,25.77427,{"lat":86,"lon":85},{"facility":89,"status":48,"city":81,"state":72,"zip":90,"country":52,"countryCode":53,"cosmosGeoPoint":91,"geoPoint":93,"contacts":11},"Diverse Clinical Research LLC","33175",{"type":55,"coordinates":92},[85,86],{"lat":86,"lon":85},{"facility":95,"status":48,"city":96,"state":72,"zip":97,"country":52,"countryCode":53,"cosmosGeoPoint":98,"geoPoint":102,"contacts":11},"Clinical Research of West Florida, Inc.","Tampa","33606",{"type":55,"coordinates":99},[100,101],-82.45843,27.94752,{"lat":101,"lon":100},{"facility":104,"status":48,"city":105,"state":106,"zip":107,"country":52,"countryCode":53,"cosmosGeoPoint":108,"geoPoint":112,"contacts":11},"Emory University School of Medicine","Atlanta","Georgia","30303",{"type":55,"coordinates":109},[110,111],-84.38798,33.749,{"lat":111,"lon":110},{"facility":114,"status":48,"city":115,"state":116,"zip":117,"country":52,"countryCode":53,"cosmosGeoPoint":118,"geoPoint":122,"contacts":11},"Revival Research Institute, LLC","Troy","Michigan","48084",{"type":55,"coordinates":119},[120,121],-83.14993,42.60559,{"lat":121,"lon":120},{"facility":124,"status":48,"city":125,"state":126,"zip":127,"country":52,"countryCode":53,"cosmosGeoPoint":128,"geoPoint":132,"contacts":11},"Allen Arthritis","Allen","Texas","75013",{"type":55,"coordinates":129},[130,131],-96.67055,33.10317,{"lat":131,"lon":130},{"facility":134,"status":48,"city":125,"state":126,"zip":127,"country":52,"countryCode":53,"cosmosGeoPoint":135,"geoPoint":137,"contacts":11},"Arthritis and Rheumatology Research Institute PLLC",{"type":55,"coordinates":136},[130,131],{"lat":131,"lon":130},{"facility":139,"status":48,"city":140,"state":126,"zip":141,"country":52,"countryCode":53,"cosmosGeoPoint":142,"geoPoint":146,"contacts":11},"Arthritis Care of Texas","Corpus Christi","78415",{"type":55,"coordinates":143},[144,145],-97.39638,27.80058,{"lat":145,"lon":144},{"type":148,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[150],{"name":151,"class":6},"Merck KGaA, Darmstadt, Germany","100618504","phase-3-a-study-of-enpatoran-in-participants-with-cutaneous-manifestations-of-lupus-with-or-without-systemic-disease-100618504",false,"NCT07332481","A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease","A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-1)","ELOWEN-1","Inclusion Criteria\n\n* Vaccinations are up to date according to local guidelines\u002Frecommendations. Recombinant zoster vaccination is encouraged but not mandatory.\n* Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and\u002For Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE).\n* Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit.\n* Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and\u002For SCLE and\u002For ACLE.\n\nFor participants with SLE:\n\n* Participants with diagnosis of SLE and fulfill EULAR\u002FACR 2019 classification criteria.\n* Participants with disease duration (cutaneous disease and, where applicable, SLE) of \\>= 6 months from time of diagnosis to Screening.\n* Participants with CLASI-A score \\>= 8 at Screening and Day 1 visits.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria\n\n* Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE.\n* Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled disease (e.g. asthma, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension), or life-threatening manifestations of lupus (e.g. active systemic vasculitis) that in Investigator's or Sponsor\u002Fdesignee's opinion constitutes inappropriate risk or contraindication for participation.\n* Participants with drug-induced lupus (SLE or CLE).\n* Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral calcineurin inhibitor is allowed).\n* Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (\\>) 339 milligrams per millimole (mg\u002Fmmol), and\u002For estimated Glomerular Filtration Rate (eGFR) less than 40 milliliters per minute per 1.73 square meters of body surface area (mL\u002Fmin\u002F1.73 m\\^2), as calculated by the Modification of Diet in Renal Disease (MDRD) equation.\n* Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures.\n* Other protocol-defined exclusion criteria may apply.","ALL","18 Years","75 Years",{"count":164,"type":165},202,"ESTIMATED","INTERVENTIONAL",[168],"PHASE3","The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include:\n\nStudy Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo.\n\nIntervention Form: Film-coated tablet.",[171,172],"Systemic Lupus Erythematosus (SLE)","Cutaneous Lupus Erythematosus (CLE)",[174,175,176,177,178,179,180,181,26,9,182,183,184,185],"Toll-like Receptor 7","Toll-like Receptor 8","Adults","SLE","CLE","Lupus","Discoid lupus erythematosus (DLE)","Subacute Cutaneous Lupus Erythematosus (SCLE)","Cutaneous manifestations","Lupus erythematosus","Acute cutaneous lupus erythematosus (ACLE)","Interferon gene signature","2026-07-01",{"date":188,"type":189},"2026-07-02","ACTUAL",{"date":191,"type":189},"2026-03-10",{"date":193,"type":165},"2029-05-24",{"name":195,"class":6},"EMD Serono Research & Development Institute, Inc.",11]