TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection
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.
Conditions studied
Asthma
About this study
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.
Interventions
- Drug: TQC2731 injection — TQC2731 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.
- Drug: Placebo — Placebo without drug substance.
Primary outcomes
- Annualized incidence of asthma exacerbations (From the first day of dosing to the completion of 52 weeks of treatment)
Eligibility information
Study locations
- The People's Hospital of Bozhou, Bozhou, Anhui 236000 China
- Anhui Chest Hoispital, Hefei, Anhui 230022 China
- The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230022 China
- Lu'an People's Hospital of Anhui Province, Lu'an, Anhui 237000 China
- Tongling People's Hospital, Tongling, Anhui 244000 China
- Peking University First Hospital, Beijing, Beijing Municipality 100000 China
- Beijing No.6 Hospital, Beijing, Beijing Municipality 100007 China
- The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361000 China
- Zhangzhou Municipal Hospital of Fujian, Zhangzhou, Fujian 363000 China
- The First Hospital of Lanzhou University, Lanzhou, Gansu 730000 China
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Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-05.