Clinical Trial of MG-K10 in Stage III of Moderate to Severe Asthma
ConditionAsthma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-75
SponsorShanghai Mabgeek Biotech.Co.Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 12~75 years old (including the critical value), male and female, weight ≥ 30kg;
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
MG-K10/Placebo
DrugMG-K10 Humanized Monoclonal Antibody Injection
Treatment groups
504 Participants
are divided into 2 treatment groupsGroup A: MG-K10 placeboPlacebo comparator 1 intervention
Group B: MG-K10 Humanized Monoclonal Antibody InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary purpose
Compared with placebo, the annualized incidence of severe asthma exacerbation events within 52 weeks of MG - K10 treatment
Time frame
52 weeks of treatmentSecondary outcomes
1
effectiveness
The percentage change in the absolute value of FEV1 before the use of bronchodilators at week 12 compared to the baseline
Time frame
12week2
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.
Time frame
52week3
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.
Time frame
12week4
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.
Time frame
From the baseline to within 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov