Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects

NCT07054034 | Active Not Recruiting Phase 2

• 1 other identifier: MG-ZG122-AS-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Bronchial Asthma

Keywords

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

• Annual incidence rate of asthma exacerbations

  Annualized rate of severe asthma exacerbations over 48 weeks of treatment with MG-ZG122 compared to placebo.

  48week

Secondary Outcomes (4)

• Absolute change in FEV1 from baseline

  12week

• Absolute change in FEV1 from baseline

  24week

• Hospitalization due to asthma exacerbation events

  48week

• Proportion of subjects with asthma exacerbations

  48week

Study Arms (4)

MG-ZG122 Regimen 1

EXPERIMENTAL

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.

Drug: MG-ZG122 Humanized Monoclonal Antibody Injection

MG-ZG122 Regimen 2

EXPERIMENTAL

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.

Drug: MG-ZG122 Humanized Monoclonal Antibody Injection

MG-ZG122 Regimen 3

EXPERIMENTAL

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.

Drug: MG-ZG122 Humanized Monoclonal Antibody Injection

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

MG-ZG122 Humanized Monoclonal Antibody Injection DRUG

MG-ZG122 Humanized Monoclonal Antibody Injection

MG-ZG122 Regimen 1; MG-ZG122 Regimen 2; MG-ZG122 Regimen 3

Placebo OTHER

MG-ZG122 Humanized Monoclonal Antibody Injection Placebo

Placebo

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• ， 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).
• ，Had pulmonary or other site infections requiring intravenous antibiotics, antifungal, or antiviral medications within 1 month prior to dosing.
• ，Received intravenous immunoglobulin (IVIG) therapy or allergen-specific immunotherapy (SIT) within 3 months prior to dosing.
• ，Used traditional Chinese herbal medicines with bronchodilatory or anti-asthmatic effects (excluding topical preparations) within 1 month prior to dosing.
• ，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).

Sponsors & Collaborators

• Shanghai Mabgeek Biotech.Co.Ltd: lead

Study Sites (1)

China-Japan Friendship Hospital, Beijing, China

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: July 8, 2025
• Study Start: May 11, 2025
• Primary Completion (Estimated): May 26, 2026
• Study Completion (Estimated): May 26, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)