TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection
NCT06829784 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 660
Last updated 2025-04-01
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
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 without drug substance.
Sponsors & Collaborators
-
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-21
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
Countries
- China
Study Locations
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