Clinical Trial of MG-K10 in Stage III of Moderate to Severe Asthma

Phase 3

Recruiting

• Conditions: Asthma
• Interventions: Drug: MG-K10/Placebo

• Registration Number: NCT06837922
• Lead Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

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.

Study Timeline

• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-16
• Study First Posted: 2025-02-20
• Study Start: 2025-03-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-11-15
• Study Completion: 2028-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MG-K10 placebo	MG-K10/Placebo	Every four weeks, subcutaneous injection ，total of 52W
MG-K10 Humanized Monoclonal Antibody Injection	MG-K10/Placebo	Every four weeks, subcutaneous injection ，total of 52W

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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
PK (Pharmacokinetic) parameter: The drug concentration after administration	From the baseline to within 52 weeks	PK (Pharmacokinetic) parameter: The drug concentration after administration
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.
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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China