A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of MG-ZG122 Humanized Monoclonal Antibody Injection in Asthma Subjects, with Dosing Every 12 or 24 Weeks for 48 Weeks
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II study. Approximately 160 adult asthma subjects are scheduled to receive multiple subcutaneous injections (every 12 or 24 weeks for 48 weeks). The study is divided into a screening period (1 week), a run-in period (4 weeks), a treatment period (48 weeks), and a follow-up period (12 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
MG-ZG122 Humanized Monoclonal Antibody Injection
MG-ZG122 Humanized Monoclonal Antibody Injection Placebo
China-Japan Friendship Hospital, Beijing, China
Beijing, Beijing Municipality, China
Annual incidence rate of asthma exacerbations
Annualized rate of severe asthma exacerbations over 48 weeks of treatment with MG-ZG122 compared to placebo.
Time frame: 48week
Absolute change in FEV1 from baseline
Absolute change in pre-bronchodilator FEV1 from baseline at Week 12
Time frame: 12week
Absolute change in FEV1 from baseline
Absolute change in pre-bronchodilator FEV1 from baseline at Week 2424
Time frame: 24week
Hospitalization due to asthma exacerbation events
Annualized rate of hospitalizations or emergency department treatments due to severe asthma exacerbations during 48 weeks of treatment
Time frame: 48week
Proportion of subjects with asthma exacerbations
Proportion of subjects who experienced asthma exacerbations during 48 weeks of treatment
Time frame: 48week
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