Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects

Shanghai Mabgeek Biotech

Status and phase: Active, not recruiting; Phase 2

Conditions: Bronchial Asthma

Treatments: Drug: MG-ZG122 Humanized Monoclonal Antibody Injection; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07054034

MG-ZG122-AS-001

Details and patient eligibility

About

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

Full 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).

Enrollment: 160 estimated patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups, including a placebo group

MG-ZG122 Regimen 1

Experimental group

Description:

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.

Treatment:

Drug: MG-ZG122 Humanized Monoclonal Antibody Injection

MG-ZG122 Regimen 2

Experimental group

Description:

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.

Treatment:

Drug: MG-ZG122 Humanized Monoclonal Antibody Injection

MG-ZG122 Regimen 3

Experimental group

Description:

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.

Treatment:

Drug: MG-ZG122 Humanized Monoclonal Antibody Injection

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo