Asthma
Conditions
Brief summary
The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.
Detailed description
The total duration of study per patient is approximately 66 weeks, including 6 weeks of screening period, 52 weeks of treatment period and 8 weeks of follow-up period.
Interventions
DRUG610
610 subcutaneously injection.
DRUGPlacebo
Placebo subcutaneously injection.
Sponsors
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Able to give written informed consent prior to participation in the study. 2. Male or female adults ages 18 to 75 years old when signing the informed consent. 3. Documented diagnosis of asthma for at least one year prior to screening. 4. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
Exclusion criteria
1. Presence of a known pre-existing, clinically important lung condition other than asthma. 2. Severe asthma exacerbation within 4 weeks prior to randomization. 3. Subjects with any eosinophilic diseases other than asthma. 4. Known, pre-existing severe or clinically significant cardiovascular disease. 5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment. 6. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. 7. Subjects with allergy/intolerance to a monoclonal antibody.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized rate of severe exacerbation events | Up to 52 weeks | Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit | Up to 52 weeks | Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 52-week placebo-controlled treatment period |
| Change from baseline in ACQ score | Up to 52 weeks | Change from baseline to week 52 in ACQ score |
| Time to first severe exacerbation event | Up to 52 weeks | Time to first severe exacerbation event during the 52-week placebo-controlled treatment period |
| Change in pre-bronchodilator forced expiratory volume (FEV1) | Up to 52 weeks | Absolute change from baseline to week 52 in pre-bronchodilator FEV1 |
| Assessment of adverse events (AEs) | Up to 60 weeks | Number of participants with adverse events (AEs) |
| Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ) | Up to 52 weeks | Change from baseline to week 52 in SGRQ score |
Countries
China
Contacts
Primary ContactQinghong Zhou, MD
Outcome results
None listed