A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to Evaluate the Efficacy and Safety of SHR-1905 in Subjects With Severe Uncontrolled Asthma.

SHR-1905-201

This study is a phase 2 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.

2023-01-17

2024-10-31

2025-04-30

Early phase I

248

Inclusion Criteria: 1. Male or female aged between 18 and 75 years (inclusive) 2. Weight ≥ 40 kg 3. Meet the diagnostic criteria for asthma and have a medical history of at least 1 year 4. Treatment with a total daily dose of either medium or high dose inhaled glucocorticoids (ICS) for at least 6 months before screening, with a stable use for 3 months before randomization 5. At least one additional maintenance asthma controller with stable use for at least 3 months before randomization 6. No birth plan and must agree to take effective contraceptive methods 7. Sign informed consent form voluntarily for the trial Exclusion Criteria: 1. Any clinically important pulmonary disease 2. Any disease other than asthma that may affect lung function 3. Any disease other than asthma related to elevation of eosinophils 4. Any immunodeficiency disease 5. Any clinically important serious cardiovascular diseases unstable or uncontrolled 6. Uncontrolled Hypertension 7. Uncontrolled Diabetes Mellitus 8. Any clinically important infections within 4 weeks before randomization 9. Any major surgery within 3 months before randomized, or any surgical plan during the study, or any treatment that the investigator think affect the evaluation of the subjects 10. Any parasitic infections within 6 months before randomization 11. Malignancy diagnosed within 5 years before randomization 12. Abnormal laboratory tests during screening and baseline 13. Positive infectious disease test 14. Prolonged QTc interval or other clinical significant abnormal findings in ECG at screening that may causesafety risk to the subject 15. Current smoker or smoking cessation for less than 6 months at screening, and/or positive nicotine test during screening，or smoking history ≥10 pack- years 16. Positive alcohol breath test and positive urine drug test at screening 17. Allergy history to any biological or other agent that investigator think the subject should not participate in the study 18. Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study 19. Participated in other clinical trials and used investigational drugs containing active ingredients within 4 weeks or 5 half-lives before screening 20. Any other circumstance judged by the investigatorinappropriate for participating in the clinical trial

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'SHR-1905 compared with placebo', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 248, 'type': 'ESTIMATED'}}

2023-02-03