Bronchial AsthmaPhase 2NCT07054034
Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects
A Phase 2 study testing MG-ZG122 Humanized Monoclonal Antibody Injection in people with Bronchial Asthma, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- MG-ZG122 Humanized Monoclonal Antibody Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2025to 26 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital, Beijing, China
Beijing, Beijing Municipality, 100029
About this study
Official title: 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
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
Read the 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
- Being tested
- MG-ZG122 Humanized Monoclonal Antibody Injection, Placebo
- Keywords
- Bronchial Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MG-ZG122 Humanized Monoclonal Antibody InjectionDrug
MG-ZG122 Humanized Monoclonal Antibody Injection
PlaceboOther
MG-ZG122 Humanized Monoclonal Antibody Injection Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual incidence rate of asthma exacerbations
Annualized rate of severe asthma exacerbations over 48 weeks of treatment with MG-ZG122 compared to placebo.
Measured: 48week
Secondary outcomes (4)
Absolute change in FEV1 from baseline
Absolute change in pre-bronchodilator FEV1 from baseline at Week 12
Measured: 12week
Absolute change in FEV1 from baseline
Absolute change in pre-bronchodilator FEV1 from baseline at Week 2424
Measured: 24week
Hospitalization due to asthma exacerbation events
Annualized rate of hospitalizations or emergency department treatments due to severe asthma exacerbations during 48 weeks of treatment
Measured: 48week
Proportion of subjects with asthma exacerbations
Proportion of subjects who experienced asthma exacerbations during 48 weeks of treatment
Measured: 48week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start11 May 2025
- Primary completion26 May 2026 (estimated)
- Study completion26 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Shanghai Mabgeek Biotech.Co.LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054034
- Sponsor's protocol ID
- MG-ZG122-AS-001
- Status last verified
- Jul 2025
- First submitted
- 27 May 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07054034
- Acronym / sponsor ID
- MG-ZG122-AS-001
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 11 May 2025 (actual)
- Primary completion
- 26 May 2026 (estimated)
- Study completion
- 26 May 2027 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| MG-ZG122 Regimen 1 | Experimental | Drug: MG-ZG122 Humanized Monoclonal Antibody InjectionGroup 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. |
| MG-ZG122 Regimen 2 | Experimental | Drug: MG-ZG122 Humanized Monoclonal Antibody InjectionMG-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. |
| MG-ZG122 Regimen 3 | Experimental | Drug: MG-ZG122 Humanized Monoclonal Antibody InjectionMG-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. |
| Placebo | Placebo comparator | Other: PlaceboSubcutaneous injection of 0 mg (4.0 mL placebo) once every 12 weeks, for a total of 4 administrations. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18 to 75 years old (inclusive), male or female.
- 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).
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MG-ZG122 Humanized Monoclonal Antibody InjectionMG-ZG122 Humanized Monoclonal Antibody Injection | Drug | MG-ZG122 Regimen 1, MG-ZG122 Regimen 2, MG-ZG122 Regimen 3 |
| PlaceboMG-ZG122 Humanized Monoclonal Antibody Injection Placebo | Other | Placebo |
Primary outcome
Annual incidence rate of asthma exacerbations
Time frame: 48week
Annualized rate of severe asthma exacerbations over 48 weeks of treatment with MG-ZG122 compared to placebo.
4 secondary outcomes
Absolute change in FEV1 from baseline
Time frame: 12week
Absolute change in FEV1 from baseline
Time frame: 24week
Hospitalization due to asthma exacerbation events
Time frame: 48week
Proportion of subjects with asthma exacerbations
Time frame: 48week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MG-ZG122 Humanized Monoclonal Antibody Injection in people with Bronchial Asthma, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual incidence rate of asthma exacerbations (time frame: 48week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.