[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605722":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":37,"locations":43,"responsibleParty":56,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":11,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Keymed Biosciences Co.Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL",null,[13],"Biological: CM512 injection",{"label":15,"type":16,"description":11,"interventionNames":17},"Group 2","PLACEBO_COMPARATOR",[18],"Drug: placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"BIOLOGICAL","CM512 injection","subcutaneous injection",[9],{"type":26,"name":27,"description":23,"armGroupLabels":28,"otherNames":11},"DRUG","placebo",[15],[30,34],{"name":31,"affiliation":32,"role":33},"Litao Zhang","Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":32,"role":36},"Zuotao Zhao","STUDY_CHAIR",[38],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"Qian Jia","CONTACT","86+028-88610620","clinicaltrial@keymedbio.com",[44],{"facility":32,"status":45,"city":46,"state":47,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":11},"RECRUITING","Tianjin","Tianjin Municipality","China","CN",{"type":51,"coordinates":52},"Point",[53,54],117.17667,39.14222,{"lat":54,"lon":53},{"type":57,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100605722","phase-2-study-of-cm512-injection-in-subjects-with-chronic-spontaneous-urticariacsu-100605722",false,"NCT07166211","Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)","A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM512 Injection in Subjects With CSU","Inclusion Criteria:\n\n* Voluntarily sign the Informed Consent Form.\n* Age ≥ 18 years old and ≤ 75 years old.\n* Patients with a diagnosis of CSU before screening visit, and the duration was ≥6 months.\n* Pruritus and wheals existed for more than 6 weeks before screening, despite regular H1-Antihistamines(AH) treatment during this period.\n* A stable dose of the second-generation H1-Antihistamines(AH) has been continuously used for at least 7 days before randomization, and the individual is willing to continue to use it stably as stipulated in the protocol during the study period.\n* Within 7 days before randomization, UAS7≥16 and ISS7 ≥8.\n\nExclusion Criteria:\n\n* Not enough washing-out period for previous therapy.\n* Planned major surgical procedure during the patient's participation in this study.\n* Has ever experienced a systemic allergic reaction or immediate allergic reaction to any biological product (including any excipients).\n* CM512 has been used before.\n* Women who are pregnant or breastfeeding. During the study period, subjects who had plans to have children, or did not agree to contraception.\n* With any medical or non-medical conditions that are not suitable for participation in this study by investigators.","ALL","18 Years","75 Years",{"count":69,"type":70},48,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with CSU.",[76],"Chronic Spontaneous Urticaria (CSU)","2026-04-06",{"date":79,"type":80},"2026-04-09","ACTUAL",{"date":82,"type":80},"2025-11-27",{"date":84,"type":70},"2027-01-14",{"name":5,"class":6},1]