Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects

NCT ID: NCT07054034

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-11
• Study Completion Date: 2027-05-26

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).

Conditions

Bronchial Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MG-ZG122 Regimen 1

Group MG-ZG122 210 mg Q12W: Subcutaneous injection of MG-ZG122 210 mg + subcutaneous injection of 2.0 mL placebo (to maintain blinding), administered once every 12 weeks, with a total of 4 administrations.

Group Type: EXPERIMENTAL

MG-ZG122 Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

MG-ZG122 Humanized Monoclonal Antibody Injection

MG-ZG122 Regimen 2

MG-ZG122 210 mg administered via subcutaneous injection plus 2.0 mL placebo via subcutaneous injection (to maintain blinding), once every 24 weeks. To maintain blinding, 4.0 mL placebo injections will be administered at Weeks 12 and 36, for a total of 4 doses.

Group Type: EXPERIMENTAL

MG-ZG122 Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

MG-ZG122 Humanized Monoclonal Antibody Injection

MG-ZG122 Regimen 3

MG-ZG122 420 mg administered via subcutaneous injection, once every 24 weeks. To maintain blinding, 4.0 mL placebo injections will be administered at Weeks 12 and 36, for a total of 4 doses.

Group Type: EXPERIMENTAL

MG-ZG122 Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

MG-ZG122 Humanized Monoclonal Antibody Injection

Placebo

Subcutaneous injection of 0 mg (4.0 mL placebo) once every 12 weeks, for a total of 4 administrations.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

MG-ZG122 Humanized Monoclonal Antibody Injection Placebo

Interventions

MG-ZG122 Humanized Monoclonal Antibody Injection

MG-ZG122 Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

Placebo

MG-ZG122 Humanized Monoclonal Antibody Injection Placebo

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mabgeek Biotech.Co.Ltd

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China-Japan Friendship Hospital, Beijing, China

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

MG-ZG122-AS-001

Identifier Type: -

Identifier Source: org_study_id