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
Qualifiers
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
Treatments tested in this trial
- MG-K10/Placebo
Treatment groups
504 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov