Asthma
Conditions
Brief summary
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.
Interventions
SHR-1905 injection.
SHR-1905 placebo Injection.
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18. 2. Documented physician-diagnosed asthma for at least 12 months. 3. Participants who have received asthma controller medication with medium or high dose ICS for at least 6 months. 4. 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. 5. 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. 6. Pre-BD FEV1 \< 80% predicted normal. 7. Objective evidence of asthma as documented. 8. 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. 9. ACQ-6 score ≥ 1.5 at screening and on day of baseline. 10. ePRO adherence ≥ 70% in the 7 days prior to randomization.
Exclusion criteria
1. Clinically significant pulmonary disease other than asthma. 2. History of cancer. 3. History of a clinically significant infection. 4. Current smokers or participants with smoking history ≥ 10 pack-yrs. 5. History of chronic alcohol or drug abuse within 12 months. 6. Hepatitis B, C or HIV. 7. Pregnant or breastfeeding. 8. History of anaphylaxis following any biologic therapy. 9. participant randomized in the current study or previous SHR-1905 studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual asthma exacerbation rate | During 48 weeks of treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in pre-dose/pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1) | At Week 48. |
| Proportion of participants who had asthma exacerbations | From randomization to Week 48. |
| Time to the first asthma exacerbation | From randomization to Week 48. |
Countries
China
Contacts
Primary ContactZhou Li
Outcome results
None listed