This study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of TQC2731 injection (420 mg Q4W) in adult subjects with inadequately controlled severe asthma. A total of 660 trial participants are expected to be enrolled, with trial participants randomized in a 1:1 ratio to receive either TQC2731 (420 mg Q4W) or placebo (Q4W) via subcutaneous (SC) administration.
Sign the informed consent form before the trial to fully understand the purpose, process and possible adverse reactions of the trial;
Age 18 ~ 75 years old, gender is not limited;
Documented physician diagnosis of asthma at least 12 months prior to Visit 1;
Subjects who received high-dose Inhaled Corticosteroids (ICS) in asthma control medications prescribed by their physicians at least 6 months prior to Visit 1;
Have a clinically significant lung disease other than asthma；
Pre-existing autoimmune disease;
A history of known or suspected immunosuppression, including a history of invasive opportunistic infections;
Any disease that has not been determined to be stable by the investigator；
Parallel
TQC2731 injection
DrugTQC2731 injection can specifically bind to the Thymic Stromal Lymphopoietin (TSLP) protein, blocking TSLP-dependent downstream signaling expression in engineered cells and inhibiting the production of inflammatory cytokines.
Placebo
DrugPlacebo without drug substance.
Annualized incidence of asthma exacerbations
Annualized incidence of asthma exacerbations (AAER) during the 52-week treatment period.
The change in forced expiratory volume in 1 second (FEV1)
At Week 52, the change from baseline in forced expiratory volume in 1 second (FEV1) prior to dosing and before the use of a bronchodilator (pre-BD administration).
Change in total score of standardized asthma quality of life questionnaire
Change from baseline in standardized asthma quality of life questionnaire (AQLQ(S)+12) total score at week 52. Scores above 5 points indicate a relatively good quality of life, while scores below 3 points suggest a relatively poor quality of life.
Change in Asthma Control Questionnaire-6 (ACQ-6) score
Mean change from baseline in weekly mean asthma symptom diary score at week 52, , The higher the score, the more severe the asthma symptoms.
Mean change in weekly mean asthma symptom diary score
Mean change from baseline in weekly mean asthma symptom diary score at week 52
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