[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624893":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":277,"collaborators":25,"id":279,"slug":25,"hasResults":280,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":280,"sex":286,"minAge":287,"maxAge":288,"enrollmentInfo":289,"targetDuration":25,"studyType":292,"phases":293,"briefSummary":295,"conditions":296,"keywords":299,"overallStatus":192,"whyStopped":25,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":316},{"fullName":5,"class":6},"Yuhan Corporation","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lesigercept","EXPERIMENTAL","* A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group.\n* Active Dose, Q4W",[13],"Drug: Lesigercept",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","* A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group.\n* Q4W",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Subcutaneous injection of Lesigercept",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Subcutaneous injection of None of active ingredient",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"JinHyun Choi","CONTACT","+82-2-828-0850","clinicaltrials@yuhan.co.kr",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":34},"JeungJin Yoon","+82-2-828-0396",[39,45,48,51,54,66,75,86,96,102,111,121,127,137,147,157,163,173,179,190,201,208,218,228,237,244,251,257,263,270],{"facility":40,"status":41,"city":42,"state":42,"zip":43,"country":44,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Diagnostic & Consultative Centre Ascendent EOOD","NOT_YET_RECRUITING","Sofia","1202","Bulgaria",{"facility":46,"status":41,"city":42,"state":42,"zip":47,"country":44,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"UMHAT \"Aleksandrovska\"","1431",{"facility":49,"status":41,"city":42,"state":42,"zip":50,"country":44,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Medical Center Hera EOOD","1510",{"facility":52,"status":41,"city":42,"state":42,"zip":53,"country":44,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"UMHATEM \"N. 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Pirogov\"","1606",{"facility":55,"status":41,"city":56,"state":57,"zip":58,"country":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":25},"Dermatology Hospital of Southern Medical University (Guangdong Province Dermatology Hospital)","Guangzhou","Guangdong","510000","China",{"type":61,"coordinates":62},"Point",[63,64],113.25,23.11667,{"lat":64,"lon":63},{"facility":67,"status":41,"city":68,"state":57,"zip":69,"country":59,"cosmosGeoPoint":70,"geoPoint":74,"contacts":25},"The University of Hong Kong-Shenzhen Hospital","Shenzhen","518053",{"type":61,"coordinates":71},[72,73],114.0683,22.54554,{"lat":73,"lon":72},{"facility":76,"status":41,"city":77,"state":78,"zip":79,"country":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":25},"Alergologia Plus Sp. z o. o.","Poznan","Greater Poland Voivodeship","60-693","Poland",{"type":61,"coordinates":82},[83,84],16.92993,52.40692,{"lat":84,"lon":83},{"facility":87,"status":41,"city":88,"state":89,"zip":90,"country":80,"cosmosGeoPoint":91,"geoPoint":95,"contacts":25},"Centrum Medyczne ALL-MED","Krakow","Lesser Poland Voivodeship","30-033",{"type":61,"coordinates":92},[93,94],19.93658,50.06143,{"lat":94,"lon":93},{"facility":97,"status":41,"city":88,"state":89,"zip":98,"country":80,"cosmosGeoPoint":99,"geoPoint":101,"contacts":25},"Centrum Nowoczesnych Terapii \"Dobry Lekarz\" Sp. z o.o.","31-011",{"type":61,"coordinates":100},[93,94],{"lat":94,"lon":93},{"facility":103,"status":41,"city":104,"state":89,"zip":105,"country":80,"cosmosGeoPoint":106,"geoPoint":110,"contacts":25},"Alergo-Med Ośrodek Badań Klinicznych Sp. z o.o.","Tarnów","33-100",{"type":61,"coordinates":107},[108,109],20.98698,50.01381,{"lat":109,"lon":108},{"facility":112,"status":41,"city":113,"state":114,"zip":115,"country":80,"cosmosGeoPoint":116,"geoPoint":120,"contacts":25},"ALL-MED Specjalistyczna Opieka Medyczna","Wroclaw","Lower Silesian Voivodeship","53-201",{"type":61,"coordinates":117},[118,119],17.03006,51.10286,{"lat":119,"lon":118},{"facility":122,"status":41,"city":113,"state":114,"zip":123,"country":80,"cosmosGeoPoint":124,"geoPoint":126,"contacts":25},"DERMACEUM sp. z o.o., DERMACEUM Centrum Medyczne","53-613",{"type":61,"coordinates":125},[118,119],{"lat":119,"lon":118},{"facility":128,"status":41,"city":129,"state":130,"zip":131,"country":80,"cosmosGeoPoint":132,"geoPoint":136,"contacts":25},"Prof. Dorota Krasowska LUXDERM Specjalistyczny Gabinet Dermatologiczny","Lublin","Lublin Voivodeship","20-573",{"type":61,"coordinates":133},[134,135],22.57009,51.25058,{"lat":135,"lon":134},{"facility":138,"status":41,"city":139,"state":140,"zip":141,"country":80,"cosmosGeoPoint":142,"geoPoint":146,"contacts":25},"Uniwersytecki Szpital Kliniczny w Opolu","Opole","Opolskie Voivodeship","45-401",{"type":61,"coordinates":143},[144,145],17.92604,50.67119,{"lat":145,"lon":144},{"facility":148,"status":41,"city":149,"state":150,"zip":151,"country":80,"cosmosGeoPoint":152,"geoPoint":156,"contacts":25},"Prywatny Gabinet Internistyczno-Alergologiczny Prof. dr hab. Zenon Siergiejko","Bialystok","Podlaskie Voivodeship","15-010",{"type":61,"coordinates":153},[154,155],23.16433,53.13333,{"lat":155,"lon":154},{"facility":158,"status":41,"city":149,"state":150,"zip":159,"country":80,"cosmosGeoPoint":160,"geoPoint":162,"contacts":25},"Bio Zdrowie sp. z o.o.","15-698",{"type":61,"coordinates":161},[154,155],{"lat":155,"lon":154},{"facility":164,"status":41,"city":165,"state":166,"zip":167,"country":80,"cosmosGeoPoint":168,"geoPoint":172,"contacts":25},"NZOZ GynCentrum Oddział Libero","Katowice","Silesian Voivodeship","40-600",{"type":61,"coordinates":169},[170,171],19.02173,50.2597,{"lat":171,"lon":170},{"facility":174,"status":41,"city":165,"state":166,"zip":175,"country":80,"cosmosGeoPoint":176,"geoPoint":178,"contacts":25},"Clinic Infertility Treatment Angelius Provita (Centrum Medyczne Angelius Provita)","40-611",{"type":61,"coordinates":177},[170,171],{"lat":171,"lon":170},{"facility":180,"status":41,"city":181,"state":182,"zip":183,"country":184,"cosmosGeoPoint":185,"geoPoint":189,"contacts":25},"Seoul National University Bundang Hospital","Gyeonggi-do","Bundang-gu","13620","South Korea",{"type":61,"coordinates":186},[187,188],126.76917,37.58944,{"lat":188,"lon":187},{"facility":191,"status":192,"city":193,"state":194,"zip":195,"country":184,"cosmosGeoPoint":196,"geoPoint":200,"contacts":25},"Keimyung University Dongsan Hospital","RECRUITING","Daegu","Dalseo-gu","42601",{"type":61,"coordinates":197},[198,199],128.59111,35.87028,{"lat":199,"lon":198},{"facility":202,"status":41,"city":181,"state":203,"zip":204,"country":184,"cosmosGeoPoint":205,"geoPoint":207,"contacts":25},"Korea University Ansan Hospital","Danwon-gu","15355",{"type":61,"coordinates":206},[187,188],{"lat":188,"lon":187},{"facility":209,"status":192,"city":210,"state":211,"zip":212,"country":184,"cosmosGeoPoint":213,"geoPoint":217,"contacts":25},"Chung-Ang University Hospital","Seoul","Dongjak-gu","06973",{"type":61,"coordinates":214},[215,216],126.9784,37.566,{"lat":216,"lon":215},{"facility":219,"status":41,"city":220,"state":221,"zip":222,"country":184,"cosmosGeoPoint":223,"geoPoint":227,"contacts":25},"Pusan National University Yangsan Hospital","Yangsan","Gyeongsangnam-do","50612",{"type":61,"coordinates":224},[225,226],129.03358,35.34199,{"lat":226,"lon":225},{"facility":229,"status":41,"city":230,"state":230,"zip":231,"country":184,"cosmosGeoPoint":232,"geoPoint":236,"contacts":25},"Inha University Hospital","Incheon","22332",{"type":61,"coordinates":233},[234,235],126.70515,37.45646,{"lat":235,"lon":234},{"facility":238,"status":192,"city":210,"state":239,"zip":240,"country":184,"cosmosGeoPoint":241,"geoPoint":243,"contacts":25},"Seoul St. Mary's Hospital, The Catholic University of Korea","Seocho-gu","06591",{"type":61,"coordinates":242},[215,216],{"lat":216,"lon":215},{"facility":245,"status":41,"city":210,"state":246,"zip":247,"country":184,"cosmosGeoPoint":248,"geoPoint":250,"contacts":25},"Severance Hospital, Yonsei University Health System","Seodaemun-gu","03722",{"type":61,"coordinates":249},[215,216],{"lat":216,"lon":215},{"facility":252,"status":41,"city":210,"state":210,"zip":253,"country":184,"cosmosGeoPoint":254,"geoPoint":256,"contacts":25},"Kyung Hee University Hospital at Gangdong","05278",{"type":61,"coordinates":255},[215,216],{"lat":216,"lon":215},{"facility":258,"status":41,"city":210,"state":210,"zip":259,"country":184,"cosmosGeoPoint":260,"geoPoint":262,"contacts":25},"Hallym University Kangnam Sacred Heart Hospital","07441",{"type":61,"coordinates":261},[215,216],{"lat":216,"lon":215},{"facility":264,"status":41,"city":210,"state":265,"zip":266,"country":184,"cosmosGeoPoint":267,"geoPoint":269,"contacts":25},"Asan Medical Center","Songpa-gu","05505",{"type":61,"coordinates":268},[215,216],{"lat":216,"lon":215},{"facility":271,"status":41,"city":181,"state":272,"zip":273,"country":184,"cosmosGeoPoint":274,"geoPoint":276,"contacts":25},"Ajou University Hospital","Suwon","16499",{"type":61,"coordinates":275},[187,188],{"lat":188,"lon":187},{"type":278,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100624893",false,"NCT07415551","Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines (CLEAR)","CLEAR","Inclusion Criteria:\n\n* Chronic spontaneous urticaria for ≥6 months, uncontrolled on 2nd-generation H1-antihistamines (UAS7≥16, ISS7≥8, HSS7≥8).\n* Stable dose of 2nd-generation H1-antihistamines for ≥7 days; symptom diary compliance ≥80%.\n* Adults 18-75 years; informed consent signed; contraception and pregnancy test requirements for both genders.\n* ≥80% adherence to antihistamines during screening.\n\nExclusion Criteria:\n\n* Any medical or lab findings suggesting risk of worsening co-existing conditions during the study.\n* Clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematologic, gastrointestinal, or immunodeficiency disorders that may compromise safety or study results.\n* History of malignancy within 5 years (except certain cured skin\u002Fcervical cancers) or chronic urticaria with known etiology other than CSU (e.g., inducible urticaria, autoimmune diseases).\n* Active or high-risk parasitic infections, chronic\u002Frecurrent infections (e.g., TB, HBV, HCV, HIV), or hypersensitivity\u002Fanaphylaxis to study drugs or related classes.\n* Skin diseases affecting assessments (e.g., atopic dermatitis, psoriasis) or history of drug\u002Falcohol abuse within 6 months.","ALL","18 Years","75 Years",{"count":290,"type":291},150,"ESTIMATED","INTERVENTIONAL",[294],"PHASE2","This study aims to evaluate the efficacy and safety of lesigercept in approximately 150 participants with CSU. By enrolling participants with an inadequate response to H1-antihistamines, including those previously treated with omalizumab, this study is expected to provide evidence for the clinical utility of lesigercept and to further characterize its benefit-risk profile in the target participant population.",[297,298],"Allergic Diseases","Chronic Spontaneous Urticaria (CSU)",[300,301,302,303,304,305,9,306],"CSU","YH35324","Allergic disease","Chronic Spontaneous Urticaria","Yuhan","GI-301","M9010","2026-04-12",{"date":309,"type":310},"2026-04-15","ACTUAL",{"date":312,"type":310},"2026-03-26",{"date":314,"type":291},"2027-07-24",{"name":5,"class":6},30]