NCT07054034Active, not recruitingPhase 2
Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects
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
Source: ClinicalTrials.gov · Last updated 8 Jul 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 27 May 2025
- Start date
- 11 May 2025
- Primary completion date
- 26 May 2026
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Diseases
- Asthma
- NCT number
- NCT07054034
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 160
- From 11 May 2025 to the primary completion date, 26 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Who the study is looking for
- 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.
Age in the registry: 15 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China-Japan Friendship Hospital, Beijing, China Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.