Asthma
Conditions
Brief 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.
Interventions
DRUGSHR-1905
subcutaneous
DRUGplacebo
subcutaneous ,placebo
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
SHR-1905 compared with placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. At least 2 exacerbations within 12 months before screening 7. No birth plan and must agree to take effective contraceptive methods 8. 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 may affect the evaluation of the subjects considered by the investigator 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 cause safety risk to the subject 15. Current smoker or smoking cessation for less than 6 months at screening, or smoking history ≥10 pack- years 16. Drug or alcohol abuse 17. Allergy history to any biologicsl 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 inappropriate for participating in the clinical trial considered by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy：Annual asthma exacerbation rate (AAER) | From randomisation to 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes of fractional exhaled nitric oxide (FeNO) compared with baseline | Baseline to72 weeks |
| Changes from baseline in Asthma Control questionnaire (ACQ-6) scores | Baseline to 72 weeks |
| Changes from baseline in Asthmatic Quality of Life Questionnaire (AQLQ) scores | Baseline to 72 weeks |
| AAER associated with hospitalization at 48 weeks | From randomisation to 48 weeks |
| Changes from baseline in Asthma Symptom Diary scores | Baseline to 72 weeks |
| The proportion of subjects with acute exacerbations of asthma | Baseline to 72 weeks |
| Changes from baseline in weekly reliever use | Baseline to 72 weeks |
| Changes from baseline in weekly mean morning and evening peak expiratory flow (PEF) | Baseline to 72 weeks |
| Changes from baseline in weekly mean number of night time awakenings | Baseline to 72 weeks |
| Time to the first acute asthma exacerbation | Baseline to 72 weeks |
| The proportion of subjects with composite endpoint for asthma (CompEx) | Baseline to72 weeks |
| Pharmacokinetics (PK): Serum concentration of SHR-1905 | 72 weeks |
Countries
China
Outcome results
None listed