A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma

• Status: Not yet recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Criteria

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