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CM326 in Moderate to Severe Asthma
NCT05774340Phase 2
Key facts
- Status
- Unknown
- Start
- May 2023
- Primary completion
- Jan 2025
- Countries
- 1
- Modality
- Monoclonal Antibodies
- Drugs
- CM326
- Conditions
- asthma
01
Overview
Phase 2, randomised, double-blind trial of CM326 in asthma (3 arms), sponsored by CSPC ZhongQi Pharmaceutical Technology. Primary endpoint: Annualized rate of subjects experiencing severe asthma exacerbations at 24 weeks. Status: unknown.
02
Design
3 arms- Study design
- RandomizedDouble-blind
CM326 Low Dose
CM326 220 mg/2 mL, subcutaneous (Low Dose)
CM326 High Dose
CM326 220 mg/2 mL, subcutaneous (High Dose)
Placebo
Placebo subcutaneous
03
Who it enrols
Adults (18-75) with moderate to severe asthma diagnosed for at least 1 year, FEV1 <= 80%, positive bronchodilation, and history of at least one severe exacerbation in the past year. Must be on stable medium-to-high dose ICS plus a second controller. Smokers, patients with COPD, or recent biologic use are excluded.
04
Endpoints
Primary
Annualized rate of subjects experiencing severe asthma exacerbations
Secondary
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC)
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Rate of change from baseline in pre-bronchodilator FEV1
Time to the first onset of the severe asthma exacerbation event
Time to the onset of the first event of LOAC
Change from baseline in FEV1 percentage of predicted value (FEV1% Pred)
Change from baseline in Peak diurnal and nocturnal expiratory flow (PEF)
Change from baseline in Forced vital capacity (FVC)
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