Bronchial Asthma
Conditions
Keywords
Bronchial Asthma
Brief summary
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
Detailed description
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).
Interventions
MG-ZG122 Humanized Monoclonal Antibody Injection
OTHERPlacebo
MG-ZG122 Humanized Monoclonal Antibody Injection Placebo
Sponsors
Shanghai Mabgeek Biotech.Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of MG-ZG122 Humanized Monoclonal Antibody Injection in Adult Subjects with Moderate-to-Severe Asthma to Evaluate Efficacy and Safety
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following criteria to be enrolled in this study: Age: 18 to 75 years old (inclusive), male or female. Asthma Diagnosis: Diagnosed with asthma for at least 1 year, and current disease status meets the diagnostic criteria of the 2024 GINA Guidelines (Global Initiative for Asthma). Additionally: Has received moderate-to-high dose inhaled corticosteroids (ICS) for at least 2 consecutive months prior to screening. Pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at screening and baseline visits is ≤80% of predicted normal value. Asthma Control Questionnaire-5 (ACQ-5) score ≥1.5 at screening and baseline visits. Has experienced ≥1 severe asthma exacerbation within the 12 months prior to screening.
Exclusion criteria
* 1， Known hypersensitivity to the investigational product or its excipients. 2，Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases potentially impairing lung function (e.g., idiopathic pulmonary fibrosis, pneumothorax, atelectasis, pulmonary fibrosis, bronchial dysplasia, etc.), as determined by the investigator., 3，Experienced a severe asthma exacerbation during the screening period or within 1 month prior to dosing., 4，Received systemic glucocorticoid therapy from 1 month prior to screening to prior to dosing (excluding topical, ophthalmic, or intranasal glucocorticoids). 5，Had pulmonary or other site infections requiring intravenous antibiotics, antifungal, or antiviral medications within 1 month prior to dosing. 6，Received intravenous immunoglobulin (IVIG) therapy or allergen-specific immunotherapy (SIT) within 3 months prior to dosing. 7，Used traditional Chinese herbal medicines with bronchodilatory or anti-asthmatic effects (excluding topical preparations) within 1 month prior to dosing. 8，Underwent major surgery within 8 weeks prior to screening or planned to undergo major surgery during the study period (including hospitalized surgery and day-case surgery).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annual incidence rate of asthma exacerbations | 48week | Annualized rate of severe asthma exacerbations over 48 weeks of treatment with MG-ZG122 compared to placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in FEV1 from baseline | 12week | Absolute change in pre-bronchodilator FEV1 from baseline at Week 12 |
| Hospitalization due to asthma exacerbation events | 48week | Annualized rate of hospitalizations or emergency department treatments due to severe asthma exacerbations during 48 weeks of treatment |
| Proportion of subjects with asthma exacerbations | 48week | Proportion of subjects who experienced asthma exacerbations during 48 weeks of treatment |
Countries
China
Outcome results
None listed