[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556476":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":58,"collaborators":26,"id":60,"slug":26,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":26,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Keymed Biosciences Co.Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stapokibart Group","EXPERIMENTAL","Stapokibart, subcutaneous, once every two weeks",[13],"Biological: Stapokibart Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Placebo, subcutaneous, once every two weeks",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Stapokibart Injection","IL-4Rα monoclonal antibody",[9],null,{"type":28,"name":29,"description":29,"armGroupLabels":30,"otherNames":26},"DRUG","Placebo",[15],[32],{"name":33,"affiliation":34,"role":35},"Luo Zhang","Beijing Tong-Ren hospital","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Qian Jia","CONTACT","028-88610620","qianjia@keymedbio.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Beijing Tongren Hospital, CMU","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57],{"name":33,"role":39,"phone":26,"phoneExt":26,"email":26},{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100556476",false,"NCT06525597","Study of Stapokibart Injection in Patients With Allergic Rhinitis","A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Patients With Allergic Rhinitis","MIZAR","Inclusion Criteria:\n\n* Able to understand the study and voluntarily sign the Informed consent form.\n* Diagnosed Allergic Rhinitis according to the Criteria stated in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition).\n* Subjects with asthma must be evaluated by the researcher as having a stable condition.\n* Has a positive skin prick test (SPT) or positive antigen-specific serum immunoglobulin E (IgE).\n\nExclusion Criteria:\n\n* Use of anti-interleukin 4 receptor alpha subunit (IL-4Rα) monoclonal antibody, thymic stromal lymphopoietin (TSLP) monoclonal antibody, anti-IgE monoclonal antibody, other monoclonal antibodies, or other biologics within 10 weeks or 5 half-lives (whichever is longer) prior to the screening visit.\n* Use of any investigational product within 4 weeks prior to the screening visit or planning to participate in other clinical studies during this study.\n* Forced expiratory volume in 1 second (FEV1) ≤ 50% of the predicted value during the screening\u002Frun-in period.\n* Have acute sinusitis, nasal infection, or upper respiratory tract infection at screening or within 2 weeks prior to screening.\n* Have received a live-attenuated vaccine within 12 weeks prior to randomization or planning to receive one during the study.","ALL","12 Years","65 Years",{"count":71,"type":72},120,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","This study is a Randomized, Double-blind, Placebo-controlled phase II clinical study evaluating the efficacy and safety of Stapokibart injection in patients with allergic rhinitis.",[78],"Allergic Rhinitis","2024-11-07",{"date":81,"type":82},"2024-11-08","ACTUAL",{"date":84,"type":82},"2024-09-30",{"date":86,"type":72},"2025-10-30",{"name":5,"class":6},1]