NCT06829784

TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Asthma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-21
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-02-17
• Last updated: 2025-04-01

Locations

74 sites across 1 country: China