[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600508":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":62,"collaborators":11,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":11,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":11,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Guangdong Hengrui Pharmaceutical Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-1905 Group","EXPERIMENTAL",null,[13],"Drug: SHR-1905 Injection",{"label":15,"type":16,"description":11,"interventionNames":17},"SHR-1905 Placebo Group","PLACEBO_COMPARATOR",[18],"Drug: SHR-1905 Placebo Injection",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","SHR-1905 Injection","SHR-1905 injection.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"SHR-1905 Placebo Injection","SHR-1905 placebo Injection.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Zhou Li","CONTACT","+86-020-62726806","zhou.li.zl69@hengrui.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The First Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","510830","China","CN",{"type":45,"coordinates":46},"Point",[47,48],113.25,23.11667,{"lat":48,"lon":47},[51,55,59,61],{"name":52,"role":32,"phone":53,"phoneExt":11,"email":54},"Nanshan Zhong","+86-020-83062893","nanshan@vip.163.com",{"name":56,"role":32,"phone":57,"phoneExt":11,"email":58},"Xinyan Yang","+86-020-81567196","iceyxy@126.com",{"name":52,"role":60,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"name":56,"role":60,"phone":11,"phoneExt":11,"email":11},{"type":63,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100600508","phase-3-a-trial-of-shr-1905-in-subjects-with-severe-uncontrolled-asthma-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":74,"type":75},408,"ESTIMATED","INTERVENTIONAL",[78],"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.",[81],"Asthma","2025-09-08",{"date":84,"type":85},"2025-09-09","ACTUAL",{"date":87,"type":85},"2025-09-03",{"date":89,"type":75},"2028-06",{"name":5,"class":6},1]