Clinical Trial of MG-K10 in Stage III of Moderate to Severe Asthma
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
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 for