Asthma
Conditions
Keywords
Asthma
Brief 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.
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.
Interventions
DRUGMG-K10/Placebo
MG-K10 Humanized Monoclonal Antibody Injection
Sponsors
Shanghai Mabgeek Biotech.Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 12\ 75 years old (including the critical value), male and female, weight ≥ 30kg; 2. 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.
Exclusion criteria
1. Subjects with known hypersensitivity to the investigational product or its excipients; 2. 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. 3. 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. 4. Subjects who have received systemic glucocorticoid therapy from 1 month before screening until drug administration (excluding those with topical, ophthalmic, or intranasal glucocorticoid use) 5. Subjects who have received intravenous immunoglobulin (IVIG) therapy or allergen-specific immunotherapy (SIT) within 1 month prior to drug administration. 6. 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. 7. Subjects with a history of substance abuse or illicit drug use. 8. Subjects with any other conditions that, in the investigator's judgment, may compromise subject safety or trial integrity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary purpose | 52 weeks of treatment | Compared with placebo, the annualized incidence of severe asthma exacerbation events within 52 weeks of MG - K10 treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity: The incidence rates of anti-drug antibodies (ADA) and neutralizing antibodies (NAb), and their impacts on pharmacokinetics (PK), safety, and efficacy. | 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. |
| effectiveness | 12week | The percentage change in the absolute value of FEV1 before the use of bronchodilators at week 12 compared to the baseline |
| The annualized incidence rate of severe asthma exacerbation events within 52 weeks | 52week | 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. |
| potentency | 12week | 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. |
| The annualized incidence rate of acute asthma attacks within 52 weeks after treatment | From the baseline to within 52 weeks | The annualized incidence rate of hospitalization or emergency treatment caused by severe acute asthma exacerbation events within 52 weeks of treatment. |
| 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. | 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. |
| PK (Pharmacokinetic) parameter: The drug concentration after administration | From the baseline to within 52 weeks | PK (Pharmacokinetic) parameter: The drug concentration after administration |
| The annualized incidence rate of hospitalizations or emergency department treatments caused by severe asthma exacerbation events within 52 weeks of treatment | 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 Loss of Asthma Control (LOAC) events within 52 weeks of treatment | From the baseline to within 52 weeks | The annualized incidence rate of Loss of Asthma Control (LOAC) events within 52 weeks of treatment |
| he time of the first Loss of Asthma Control (LOAC) event | From the baseline to within 52 weeks | he time of the first Loss of Asthma Control (LOAC) event |
| The time of the first severe asthma exacerbation event | From the baseline to within 52 weeks | The time of the first severe asthma exacerbation event |
| The changes compared to the baseline in the Standard Version of the Asthma Quality of Life Questionnaire (AQLQ(S)) at various evaluation time points. | 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 (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 | 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 evaluation time points. |
Countries
China
Contacts
Primary Contactlipeng.liu L lipeng.liu, bachelor 02151371305 lipeng.liu@mabgeek.com, bachelor
Outcome results
None listed