AsthmaPhase 3NCT06837922
Clinical Trial of MG-K10 in Stage III of Moderate to Severe Asthma
A Phase 3 study of Asthma, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.
Trial summary
A randomized, double-blind, placebo-controlled Phase III clinical trial on the efficacy and safety of MG-K10 humanized monoclonal antibody injection in adolescent and adult patients with moderate to severe asthma. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Asthma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 504 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2025to 15 Jan 2028
- Phase
- Phase 3
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 12~75 years old (including the critical value), male and female, weight ≥ 30kg;
- Diagnosed with asthma for at least 1 year and current disease status that meets the diagnostic criteria of the 2024 GINA guidelines, and:
- 1) Subjects have received moderate-high dose ICS therapy for at least 2 consecutive months before screening (see Appendix 5 for details, fluticasone propionate ≥250 μg twice a day, or an equivalent dose of ICS, no more than 2000 μg/day or equivalent dose of fluticasone propionate) combined with 1 control drug (such as LABA, LTRA, LAMA or extended-release theophylline), and maintained a stable treatment regimen and dose therapy for ≥ 1 month before baseline. Subjects using the third control drug can also participate in the study, but the subjects must also use the third control drug for at least 2 consecutive months before screening, and maintain a stable treatment regimen and dose treatment ≥ 1 month before baseline; 2) 1-second forced expiratory volume (FEV1) before bronchodilator use at the screening and baseline visits, measured ≤ 80% of the normal predicted value for adults and 90% of the normal predicted value ≤ for adolescents; 3) Asthma Control Questionnaire-5 (ACQ-5) score ≥ 1.5 points at the screening and baseline visits; 4) Must have experienced ≥ 1 acute exacerbation event within 12 months prior to screening: need to receive 1 ≥ systemic glucocorticoids (oral or intravenous) treatment due to asthma exacerbation or need hospitalization/emergency treatment; 5）A positive bronchodilator test (a ≥12% increase in FEV1 after inhalation of bronchodilators and an absolute increase in FEV1 ≥200 mL) will be acceptable for bronchodilator test results within 24 months prior to screening； Positive bronchodilator test (after inhaling a bronchodilator, the forced expiratory volume in one second (FEV1) increases by ≥12%, and the absolute value of FEV1 increases by ≥200 mL). The results of the bronchodilator test conducted within 24 months before screening are acceptable.
- 3.The subjects (including adolescents aged 12 years old ≤ age < 18 years old) agree that they themselves and their partners will adopt effective contraceptive measures from the signing of the Informed Consent Form (ICF) until 6 months after the last administration of the drug.
- 4.The subject and his/her guardian (applicable to adolescents aged 12 years old ≤ age < 18 years old) are able to understand the procedures and methods of this study, willing to sign the Informed Consent Form, strictly abide by the clinical research protocol to complete the study, and capable of independently completing the study-related questionnaires.
Who cannot join
- Subjects with known hypersensitivity to the investigational product or its excipients;
- Subjects who, within 1 month prior to screening and drug administration, have required systemic glucocorticoid therapy (oral or intravenous) for asthma exacerbation at least once, or have required hospitalization/emergency treatment due to asthma exacerbation.
- Subjects who, within 1 month prior to screening and drug administration, have required at least one course of systemic glucocorticoid therapy (oral or intravenous administration) for asthma exacerbation, or have required hospitalization or emergency treatment due to asthma exacerbation.
- Subjects who have received systemic glucocorticoid therapy from 1 month before screening until drug administration (excluding those with topical, ophthalmic, or intranasal glucocorticoid use)
- Subjects who have received intravenous immunoglobulin (IVIG) therapy or allergen-specific immunotherapy (SIT) within 1 month prior to drug administration.
- Subjects who have undergone major surgery within 8 weeks prior to screening have scheduled major surgery during the study period, including inpatient and day-case outpatient procedures.
- Subjects with a history of substance abuse or illicit drug use.
- Subjects with any other conditions that, in the investigator's judgment, may compromise subject safety or trial integrity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
lipeng.liu L lipeng.liu, bachelor 02151371305 lipeng.liu@mabgeek.com, bachelor contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Jing Li, Medical Ph.D
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Adolescent and Adult Patients With Moderate-to-Severe Asthma
A randomized, double-blind, placebo-controlled Phase III clinical trial on the efficacy and safety of MG-K10 humanized monoclonal antibody injection in adolescent and adult patients with moderate to severe asthma.
Read the detailed description
A randomized, double-blind, placebo-controlled Phase III clinical trial on the efficacy and safety of MG-K10 humanized monoclonal antibody injection in adolescent and adult patients with moderate to severe asthma is planned to enroll 504 subjects. These patients will receive multiple subcutaneous injection treatments. This study is divided into: a screening period of 1 week, a lead-in period of 4 weeks, a treatment period of 52 weeks, and a follow-up period of 8 weeks.
- Conditions
- Asthma
- Being tested
- MG-K10/Placebo
- Keywords
- 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-K10/PlaceboDrug
MG-K10 Humanized Monoclonal Antibody Injection
| Study group | Role | What they receive |
|---|---|---|
| MG-K10 placebo | Placebo comparator | Every four weeks, subcutaneous injection ，total of 52W Receives: Drug: MG-K10/Placebo |
| MG-K10 Humanized Monoclonal Antibody Injection | Experimental | Every four weeks, subcutaneous injection ，total of 52W Receives: Drug: MG-K10/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary purpose
Compared with placebo, the annualized incidence of severe asthma exacerbation events within 52 weeks of MG - K10 treatment
Measured: 52 weeks of treatment
Secondary outcomes (13)
effectiveness
The percentage change in the absolute value of FEV1 before the use of bronchodilators at week 12 compared to the baseline
Measured: 12week
The annualized incidence rate of severe asthma exacerbation events within 52 weeks
The annualized incidence rate of severe asthma exacerbation events within 52 weeks of treatment in subjects with an absolute baseline blood eosinophil count of ≥ 0.3×10⁹/L.
Measured: 52week
potentency
The changes from the baseline in the absolute value of forced expiratory volume in one second (FEV1) before bronchodilator use at week 12 and the percentage of FEV1 to the normal predicted value in subjects with an absolute baseline blood eosinophil count of ≥ 0.15×10⁹/L.
Measured: 12week
The annualized incidence rate of acute asthma attacks within 52 weeks after treatment
The annualized incidence rate of hospitalization or emergency treatment caused by severe acute asthma exacerbation events within 52 weeks of treatment.
Measured: From the baseline to within 52 weeks
The changes compared to the baseline in the absolute values of FEV1 and the percentages of the normal predicted values of FEV1 before and after the use of bronchodilators at various evaluation time points.
The changes compared to the baseline in the absolute values of FEV1 and the percentages of the normal predicted values of FEV1 before and after the use of bronchodilators at various evaluation time points.
Measured: From the baseline to within 52 weeks
The changes (absolute values and percentages) compared to the baseline in the peak expiratory flow (PEF) in the morning and evening, forced vital capacity (FVC), and forced expiratory flow between 25% and 75% of vital capacity (FEF25-75%) at various eval
The changes (absolute values and percentages) compared to the baseline in the peak expiratory flow (PEF) in the morning and evening, forced vital capacity (FVC), and forced expiratory flow between 25% and 75% of vital capacity (FEF25-75%) at various evaluation time points.
Measured: From the baseline to within 52 weeks
The annualized incidence rate of hospitalizations or emergency department treatments caused by severe asthma exacerbation events within 52 weeks of treatment
The annualized incidence rate of hospitalizations or emergency department treatments caused by severe asthma exacerbation events within 52 weeks of treatment
Measured: From the baseline to within 52 weeks
The annualized incidence rate of Loss of Asthma Control (LOAC) events within 52 weeks of treatment
The annualized incidence rate of Loss of Asthma Control (LOAC) events within 52 weeks of treatment
Measured: From the baseline to within 52 weeks
he time of the first Loss of Asthma Control (LOAC) event
he time of the first Loss of Asthma Control (LOAC) event
Measured: From the baseline to within 52 weeks
The time of the first severe asthma exacerbation event
The time of the first severe asthma exacerbation event
Measured: From the baseline to within 52 weeks
PK (Pharmacokinetic) parameter: The drug concentration after administration
PK (Pharmacokinetic) parameter: The drug concentration after administration
Measured: From the baseline to within 52 weeks
Immunogenicity: The incidence rates of anti-drug antibodies (ADA) and neutralizing antibodies (NAb), and their impacts on pharmacokinetics (PK), safety, and efficacy.
Immunogenicity: The incidence rates of anti-drug antibodies (ADA) and neutralizing antibodies (NAb), and their impacts on pharmacokinetics (PK), safety, and efficacy.
Measured: From the baseline to within 52 weeks
The changes compared to the baseline in the Standard Version of the Asthma Quality of Life Questionnaire (AQLQ(S)) at various evaluation time points.
The changes compared to the baseline in the Standard Version of the Asthma Quality of Life Questionnaire (AQLQ(S)) at various evaluation time points.
Measured: From the baseline to within 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start25 Mar 2025
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JingLi L Li, Medical Ph.D, Study director, The First Affiliated Hospital of Guangzhou University of Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837922
- Sponsor's protocol ID
- MG-K10-AS-003
- Status last verified
- Apr 2025
- First submitted
- 4 Feb 2025
- Last updated
- 17 Apr 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 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Adolescent and Adult Patients With Moderate-to-Severe Asthma
- ClinicalTrials.gov ID
- NCT06837922
- Acronym / sponsor ID
- MG-K10-AS-003
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 20 Feb 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 III clinical trial on the efficacy and safety of MG-K10 humanized monoclonal antibody injection in adolescent and adult patients with moderate to severe asthma.
Detailed description
A randomized, double-blind, placebo-controlled Phase III clinical trial on the efficacy and safety of MG-K10 humanized monoclonal antibody injection in adolescent and adult patients with moderate to severe asthma is planned to enroll 504 subjects. These patients will receive multiple subcutaneous injection treatments. This study is divided into: a screening period of 1 week, a lead-in period of 4 weeks, a treatment period of 52 weeks, and a follow-up period of 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MG-K10 placebo | Placebo comparator | Drug: MG-K10/PlaceboEvery four weeks, subcutaneous injection ，total of 52W |
| MG-K10 Humanized Monoclonal Antibody Injection | Experimental | Drug: MG-K10/PlaceboEvery four weeks, subcutaneous injection ，total of 52W |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 12~75 years old (including the critical value), male and female, weight ≥ 30kg;
- Diagnosed with asthma for at least 1 year and current disease status that meets the diagnostic criteria of the 2024 GINA guidelines, and:
- 1) Subjects have received moderate-high dose ICS therapy for at least 2 consecutive months before screening (see Appendix 5 for details, fluticasone propionate ≥250 μg twice a day, or an equivalent dose of ICS, no more than 2000 μg/day or equivalent dose of fluticasone propionate) combined with 1 control drug (such as LABA, LTRA, LAMA or extended-release theophylline), and maintained a stable treatment regimen and dose therapy for ≥ 1 month before baseline. Subjects using the third control drug can also participate in the study, but the subjects must also use the third control drug for at least 2 consecutive months before screening, and maintain a stable treatment regimen and dose treatment ≥ 1 month before baseline; 2) 1-second forced expiratory volume (FEV1) before bronchodilator use at the screening and baseline visits, measured ≤ 80% of the normal predicted value for adults and 90% of the normal predicted value ≤ for adolescents; 3) Asthma Control Questionnaire-5 (ACQ-5) score ≥ 1.5 points at the screening and baseline visits; 4) Must have experienced ≥ 1 acute exacerbation event within 12 months prior to screening: need to receive 1 ≥ systemic glucocorticoids (oral or intravenous) treatment due to asthma exacerbation or need hospitalization/emergency treatment; 5）A positive bronchodilator test (a ≥12% increase in FEV1 after inhalation of bronchodilators and an absolute increase in FEV1 ≥200 mL) will be acceptable for bronchodilator test results within 24 months prior to screening； Positive bronchodilator test (after inhaling a bronchodilator, the forced expiratory volume in one second (FEV1) increases by ≥12%, and the absolute value of FEV1 increases by ≥200 mL). The results of the bronchodilator test conducted within 24 months before screening are acceptable.
- 3.The subjects (including adolescents aged 12 years old ≤ age < 18 years old) agree that they themselves and their partners will adopt effective contraceptive measures from the signing of the Informed Consent Form (ICF) until 6 months after the last administration of the drug.
- 4.The subject and his/her guardian (applicable to adolescents aged 12 years old ≤ age < 18 years old) are able to understand the procedures and methods of this study, willing to sign the Informed Consent Form, strictly abide by the clinical research protocol to complete the study, and capable of independently completing the study-related questionnaires.
Key exclusion criteria (8 listed)
- Subjects with known hypersensitivity to the investigational product or its excipients;
- Subjects who, within 1 month prior to screening and drug administration, have required systemic glucocorticoid therapy (oral or intravenous) for asthma exacerbation at least once, or have required hospitalization/emergency treatment due to asthma exacerbation.
- Subjects who, within 1 month prior to screening and drug administration, have required at least one course of systemic glucocorticoid therapy (oral or intravenous administration) for asthma exacerbation, or have required hospitalization or emergency treatment due to asthma exacerbation.
- Subjects who have received systemic glucocorticoid therapy from 1 month before screening until drug administration (excluding those with topical, ophthalmic, or intranasal glucocorticoid use)
- Subjects who have received intravenous immunoglobulin (IVIG) therapy or allergen-specific immunotherapy (SIT) within 1 month prior to drug administration.
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-K10/PlaceboMG-K10 Humanized Monoclonal Antibody Injection | Drug | MG-K10 Humanized Monoclonal Antibody Injection, MG-K10 placebo |
Primary outcome
Primary purpose
Time frame: 52 weeks of treatment
Compared with placebo, the annualized incidence of severe asthma exacerbation events within 52 weeks of MG - K10 treatment
13 secondary outcomes
effectiveness
Time frame: 12week
The annualized incidence rate of severe asthma exacerbation events within 52 weeks
Time frame: 52week
potentency
Time frame: 12week
The annualized incidence rate of acute asthma attacks within 52 weeks after treatment
Time frame: From the baseline to within 52 weeks
The changes compared to the baseline in the absolute values of FEV1 and the percentages of the normal predicted values of FEV1 before and after the use of bronchodilators at various evaluation time points.
Time frame: From the baseline to within 52 weeks
The changes (absolute values and percentages) compared to the baseline in the peak expiratory flow (PEF) in the morning and evening, forced vital capacity (FVC), and forced expiratory flow between 25% and 75% of vital capacity (FEF25-75%) at various eval
Time frame: From the baseline to within 52 weeks
The annualized incidence rate of hospitalizations or emergency department treatments caused by severe asthma exacerbation events within 52 weeks of treatment
Time frame: From the baseline to within 52 weeks
The annualized incidence rate of Loss of Asthma Control (LOAC) events within 52 weeks of treatment
Time frame: From the baseline to within 52 weeks
he time of the first Loss of Asthma Control (LOAC) event
Time frame: From the baseline to within 52 weeks
The time of the first severe asthma exacerbation event
Time frame: From the baseline to within 52 weeks
PK (Pharmacokinetic) parameter: The drug concentration after administration
Time frame: From the baseline to within 52 weeks
Immunogenicity: The incidence rates of anti-drug antibodies (ADA) and neutralizing antibodies (NAb), and their impacts on pharmacokinetics (PK), safety, and efficacy.
Time frame: From the baseline to within 52 weeks
The changes compared to the baseline in the Standard Version of the Asthma Quality of Life Questionnaire (AQLQ(S)) at various evaluation time points.
Time frame: From the baseline to within 52 weeks
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 17 Apr 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.
lipeng.liu L lipeng.liu, bachelor 02151371305 lipeng.liu@mabgeek.com, bachelor contact
JingLi L Li, Medical Ph.D study director
The First Affiliated Hospital of Guangzhou University of Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact lipeng.liu L lipeng.liu, bachelor 02151371305 lipeng.liu@mabgeek.com, bachelor (02151371305, lipeng.liu@mabgeek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary purpose (time frame: 52 weeks of treatment). 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 17 Apr 2025.