[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623867":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":41,"locations":46,"responsibleParty":48,"collaborators":46,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":46,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":46,"enrollmentInfo":59,"targetDuration":46,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":70,"whyStopped":46,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":46},{"fullName":5,"class":6},"Jemincare","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"JYB1904 Injection Group","EXPERIMENTAL","300 mg JYB1904 injection administered SC",[13],"Drug: JYB1904",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Placebo and 300 mg JYB1904 injection administered SC",[19],"Drug: Placebo+JYB1904",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","JYB1904","300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from Day 1 to Week 48.",[9],[27],"JYB1904 Injection",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo+JYB1904","Placebo administered SC on D1 and W12; 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from W24 to W48.",[15],[33],"Placebo+JYB1904 Injection",[35,39],{"name":36,"affiliation":37,"role":38},"Jianzhong Zhang","Peking University People's Hospital","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":37,"role":38},"Cheng Zhou",[42],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Mingming Tan","CONTACT","021-58306003",null,"tanmingming@jeyoupharma.com",{"type":49,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100623867","phase-3-trial-of-jyb1904-injection-in-adult-patients-with-chronic-spontaneous-urticaria-100623867",false,"NCT07402213","Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines","Inclusion Criteria:\n\n* Male or female participant must be ≥18 years old at the time of signing the informed consent.\n* Participants are diagnosed with CSU for ≥6 months before screening.\n* Participants suffer from itching and hives for at least 6 consecutive weeks at any time before screening.\n* UAS7 (range 0\\~42) ≥16, ISS7 (range 0\\~21) ≥8 during 7 days before randomization.\n* Participants treated with stable dose of second-generation H1 antihistamines (up to 4x approved dose) for at least 6 consecutive weeks before randomization, switching medications, or changing drug dosage or frequency is not allowed within 3 weeks before randomization.\n* Participants have ≥6 days record of UAS7 before randomization.\n\nExclusion Criteria:\n\n* Participants who suffer from inducible urticaria with definite inducements, including urticaria factitia (dermatographism), cold contact, heat contact, solar, pressure, delayed pressure, aquagenic, cholinergic or contact urticaria, etc.\n* Participants who suffer from any other skin diseases with chronic itching, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis, etc.\n* Participants who suffer from other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria or acquired\u002Fdrug-induced urticaria.\n* Participants who are contraindicated or hypersensitive to antihistamines or any of its component (such as fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine).\n* History of anaphylactic shock.","ALL","18 Years",{"count":60,"type":61},180,"ESTIMATED","INTERVENTIONAL",[64],"PHASE3","This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.",[67],"Chronic Spontaneous Urticaria",[69],"CSU","NOT_YET_RECRUITING","2026-02-03",{"date":73,"type":74},"2026-02-11","ACTUAL",{"date":76,"type":61},"2026-03-31",{"date":78,"type":61},"2028-04-28",{"name":5,"class":6}]