A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQC2731 Injections in Patients With Poorly Controlled Severe Asthma

NCT06829784 Phase 3 RECRUITING

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 subjects are expected to be enrolled, with subjects randomized in a 1:1 ratio to receive either TQC2731 (420 mg Q4W) or placebo (Q4W) via subcutaneous (SC) administration.

Details

Lead sponsor	Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Phase	Phase 3
Status	RECRUITING
Enrolment	660
Start date	2025-03-21
Completion	2027-06

Conditions

• Asthma

Interventions

• TQC2731 injection
• Placebo

Primary outcomes

• Annualized incidence of asthma exacerbations — From the first day of dosing to the completion of 52 weeks of treatment
  Annualized incidence of asthma exacerbations (AAER) during the 52-week treatment period.

Countries

China