A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

NCT07107256 Phase 3 RECRUITING

TQC2731 injection is a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin (TSLP), blocks the TSLP pathway, and inhibits the production of downstream cytokines, thereby exerting anti-inflammatory effects. The purpose of this study is to evaluate the efficacy and safety of TQC2731 injection in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

Details

Lead sponsor	Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Phase	Phase 3
Status	RECRUITING
Enrolment	246
Start date	2025-09-25
Completion	2027-09

Conditions

• Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Interventions

• TQC2731 injection
• Placebo of TQC2731

Primary outcomes

• Nasal Polyp Score (NPS) — From baseline to Week 24
  Change in Nasal Polyp Score (NPS) from baseline to Week 24 in CRSwNP subjects.
• Nasal Congestion Score (NCS) — From baseline to Week 24
  Change in Nasal Congestion Score (NCS) from baseline to Week 24 in CRSwNP subjects
• Change in nasal polyp score (NPS) from baseline — From baseline to Week 24
  Change in nasal polyp score (NPS) from baseline at week 24 in ECRSwNP subjects.
• Change from baseline in Nasal Congestion Score (NCS) — From baseline to Week 24
  Change from baseline in Nasal Congestion Score (NCS) at Week 24 in ECRSwNP subjects

Countries

China