[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556476":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":25,"studyPopulation":13,"armGroups":26,"interventions":39,"overallOfficials":49,"centralContacts":54,"locations":60,"responsibleParty":76,"collaborators":13,"id":78,"slug":13,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":13,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":13,"overallStatus":63,"whyStopped":13,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Keymed Biosciences Co.Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 4 weeks of treatment.","The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.","Up to week 4",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"QUADRUPLE",[21,22,23,24],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"Stapokibart Group","EXPERIMENTAL","Stapokibart, subcutaneous, once every two weeks",[32],"Biological: Stapokibart Injection",{"label":34,"type":35,"description":36,"interventionNames":37},"Placebo Group","PLACEBO_COMPARATOR","Placebo, subcutaneous, once every two weeks",[38],"Drug: Placebo",[40,45],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":13},"BIOLOGICAL","Stapokibart Injection","IL-4Rα monoclonal antibody",[28],{"type":46,"name":47,"description":47,"armGroupLabels":48,"otherNames":13},"DRUG","Placebo",[34],[50],{"name":51,"affiliation":52,"role":53},"Luo Zhang","Beijing Tong-Ren hospital","PRINCIPAL_INVESTIGATOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":13,"email":59},"Qian Jia","CONTACT","028-88610620","qianjia@keymedbio.com",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":13,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Beijing Tongren Hospital, CMU","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":69,"coordinates":70},"Point",[71,72],116.39723,39.9075,{"lat":72,"lon":71},[75],{"name":51,"role":57,"phone":13,"phoneExt":13,"email":13},{"type":77,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"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":89,"type":90},120,"ESTIMATED","INTERVENTIONAL",[93],"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.",[96],"Allergic Rhinitis","2024-11-07",{"date":99,"type":100},"2024-11-08","ACTUAL",{"date":102,"type":100},"2024-09-30",{"date":104,"type":90},"2025-10-30",{"name":5,"class":6},1]