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Hospital","Suwon","16499",{"type":63,"coordinates":278},[190,191],{"lat":191,"lon":190},{"type":281,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100624893","phase-2-phase-2-study-of-lesigercept-in-adult-patients-with-chronic-spontaneous-urticaria-who-are-inadequately-controlled-by-h1-antihistamines-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":294,"type":295},150,"ESTIMATED","INTERVENTIONAL",[298],"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.",[301,302],"Allergic Diseases","Chronic Spontaneous Urticaria (CSU)",[304,305,306,307,308,309,9,310],"CSU","YH35324","Allergic disease","Chronic Spontaneous Urticaria","Yuhan","GI-301","M9010","2026-04-12",{"date":313,"type":314},"2026-04-15","ACTUAL",{"date":316,"type":314},"2026-03-26",{"date":318,"type":295},"2027-07-24",{"name":5,"class":6},30]