[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600508":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":11,"studyPopulation":11,"armGroups":33,"interventions":44,"overallOfficials":11,"centralContacts":54,"locations":60,"responsibleParty":87,"collaborators":11,"id":89,"slug":11,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":11,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":11,"enrollmentInfo":97,"targetDuration":11,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":11,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Guangdong Hengrui Pharmaceutical Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Annual asthma exacerbation rate",null,"During 48 weeks of treatment.",[14,17,20],{"measure":15,"description":11,"timeFrame":16},"Mean change from baseline in pre-dose\u002Fpre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1)","At Week 48.",{"measure":18,"description":11,"timeFrame":19},"Proportion of participants who had asthma exacerbations","From randomization to Week 48.",{"measure":21,"description":11,"timeFrame":19},"Time to the first asthma exacerbation",{"allocation":23,"interventionModel":24,"interventionModelDescription":11,"primaryPurpose":25,"observationalModel":11,"timePerspective":11,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":11,"whoMasked":28},"QUADRUPLE",[29,30,31,32],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[34,39],{"label":35,"type":36,"description":11,"interventionNames":37},"SHR-1905 Group","EXPERIMENTAL",[38],"Drug: SHR-1905 Injection",{"label":40,"type":41,"description":11,"interventionNames":42},"SHR-1905 Placebo Group","PLACEBO_COMPARATOR",[43],"Drug: SHR-1905 Placebo Injection",[45,50],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":11},"DRUG","SHR-1905 Injection","SHR-1905 injection.",[35],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":11},"SHR-1905 Placebo Injection","SHR-1905 placebo Injection.",[40],[55],{"name":56,"role":57,"phone":58,"phoneExt":11,"email":59},"Zhou Li","CONTACT","+86-020-62726806","zhou.li.zl69@hengrui.com",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"The First Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","510830","China","CN",{"type":70,"coordinates":71},"Point",[72,73],113.25,23.11667,{"lat":73,"lon":72},[76,80,84,86],{"name":77,"role":57,"phone":78,"phoneExt":11,"email":79},"Nanshan Zhong","+86-020-83062893","nanshan@vip.163.com",{"name":81,"role":57,"phone":82,"phoneExt":11,"email":83},"Xinyan Yang","+86-020-81567196","iceyxy@126.com",{"name":77,"role":85,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"name":81,"role":85,"phone":11,"phoneExt":11,"email":11},{"type":88,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100600508",false,"NCT07098403","A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma","A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase Ⅲ Study to Evaluate the Efficacy and Safety of SHR-1905 in Subjects With Severe Uncontrolled Asthma","Inclusion Criteria:\n\n1. Age ≥ 18.\n2. Documented physician-diagnosed asthma for at least 12 months.\n3. Participants who have received asthma controller medication with medium or high dose ICS for at least 6 months.\n4. Documented treatment with a total daily dose of either medium or high dose ICS (Refer to Guidelines for the prevention and management of bronchial asthma (2024 edition)) for at least 3 months.\n5. At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.\n6. Pre-BD FEV1 \\\u003C 80% predicted normal.\n7. Objective evidence of asthma as documented.\n8. Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.\n9. ACQ-6 score ≥ 1.5 at screening and on day of baseline.\n10. ePRO adherence ≥ 70% in the 7 days prior to randomization.\n\nExclusion Criteria:\n\n1. Clinically significant pulmonary disease other than asthma.\n2. History of cancer.\n3. History of a clinically significant infection.\n4. Current smokers or participants with smoking history ≥ 10 pack-yrs.\n5. History of chronic alcohol or drug abuse within 12 months.\n6. Hepatitis B, C or HIV.\n7. Pregnant or breastfeeding.\n8. History of anaphylaxis following any biologic therapy.\n9. participant randomized in the current study or previous SHR-1905 studies.","ALL","18 Years",{"count":98,"type":99},408,"ESTIMATED","INTERVENTIONAL",[102],"PHASE3","This study is a phase III study of SHR-1905 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of SHR-1905 in subjects with severe uncontrolled asthma.",[105],"Asthma","2025-09-08",{"date":108,"type":109},"2025-09-09","ACTUAL",{"date":111,"type":109},"2025-09-03",{"date":113,"type":99},"2028-06",{"name":5,"class":6},1]