[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609130":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":40,"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":77,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Chengdu Kangnuoxing Biopharma,Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL",null,[13],"Biological: Stapokibart 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","Stapokibart injection","subcutaneous injection",[9],{"type":26,"name":27,"description":23,"armGroupLabels":28,"otherNames":11},"DRUG","Placebo",[15],[30],{"name":31,"affiliation":32,"role":33},"Hang Li, Chief physician","Peking University First Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Qian Jia","CONTACT","86+028-88610620","qianjia@keymedbio.com",[41],{"facility":32,"status":11,"city":42,"state":43,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Beijing","Beijing Municipality","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53],{"name":31,"role":37,"phone":54,"phoneExt":11,"email":55},"86+010-83572211","drlihang@126.com",{"type":57,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100609130","phase-3-study-of-stapokibart-injection-in-subjects-with-moderate-to-severe-bullous-pemphigoid-100609130",false,"NCT07210554","Study of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid","A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid","Inclusion Criteria:\n\n* Ability to understand the study content and voluntarily sign the Informed Consent Form (ICF).\n* Aged between 18 and 90 years, inclusive, regardless of gender.\n* Confirmed diagnosis of bullous pemphigoid prior to randomization.\n* Bullous Pemphigoid Disease Area Index (BPDAI) activity score ≥ 24 points at the screening visit and at randomization.\n* Weekly average of the Pruritus Numerical Rating Scale (NRS) score ≥ 4 points at randomization.\n* Karnofsky Performance Status score ≥50% at the screening visit.\n\nExclusion Criteria:\n\n* Diagnosis of other forms of pemphigoid or other autoimmune blistering diseases.\n* Presence of other active skin comorbidities that may interfere with the study evaluations, apart from bullous pemphigoid.\n* Insufficient washout period for prior treatments.\n* Any condition that, in the opinion of the investigator, would preclude the subject's participation in the study.","ALL","18 Years","90 Years",{"count":69,"type":70},200,"ESTIMATED","INTERVENTIONAL",[73],"PHASE3","This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Stapokibart in subjects with Moderate to Severe Bullous Pemphigoid.",[76],"Bullous Pemphigoid (BP)","NOT_YET_RECRUITING","2025-09-30",{"date":80,"type":81},"2025-10-07","ACTUAL",{"date":83,"type":70},"2025-11-11",{"date":85,"type":70},"2028-05-08",{"name":5,"class":6},1]