Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-28 @ 11:28 AM
Study NCT ID:
NCT07098403
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 408}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-07-25', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annual asthma exacerbation rate', 'timeFrame': 'During 48 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline in pre-dose/pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1)', 'timeFrame': 'At Week 48.'}, {'measure': 'Proportion of participants who had asthma exacerbations', 'timeFrame': 'From randomization to Week 48.'}, {'measure': 'Time to the first asthma exacerbation', 'timeFrame': 'From randomization to Week 48.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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 \\< 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.'}, 'identificationModule': {'nctId': 'NCT07098403', 'briefTitle': 'A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong Hengrui Pharmaceutical Co., Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SHR-1905-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1905 Group', 'interventionNames': ['Drug: SHR-1905 Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SHR-1905 Placebo Group', 'interventionNames': ['Drug: SHR-1905 Placebo Injection']}], 'interventions': [{'name': 'SHR-1905 Injection', 'type': 'DRUG', 'description': 'SHR-1905 injection.', 'armGroupLabels': ['SHR-1905 Group']}, {'name': 'SHR-1905 Placebo Injection', 'type': 'DRUG', 'description': 'SHR-1905 placebo Injection.', 'armGroupLabels': ['SHR-1905 Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510830', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Nanshan Zhong', 'role': 'CONTACT', 'email': 'nanshan@vip.163.com', 'phone': '+86-020-83062893'}, {'name': 'Xinyan Yang', 'role': 'CONTACT', 'email': 'iceyxy@126.com', 'phone': '+86-020-81567196'}, {'name': 'Nanshan Zhong', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xinyan Yang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zhou Li', 'role': 'CONTACT', 'email': 'zhou.li.zl69@hengrui.com', 'phone': '+86-020-62726806'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Hengrui Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}