Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Trial Parameters
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * Signed informed consent form prior to trial participation, demonstrating full understanding of trial objectives, procedures, and potential adverse reactions. * Age between 18 and 75 years (inclusive) at the time of informed consent signing, regardless of gender. * Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) meeting the diagnostic criteria of the "Chinese Guidelines for the Diagnosis and Treatment of Chronic Rhinosinusitis (2018)" * At least one prior course of systemic corticosteroids (prednisone 0.5-1 mg/kg/day or 15-30 mg/day or equivalent for minimum 5 days) within 2 years before screening, with persistent bilateral CRSwNP; AND/OR contraindication/intolerance to systemic corticosteroids; AND/OR prior nasal polyp surgery performed more than 6 months before screening. * Bilateral Nasal Polyp Score (NPS) ≥5 (maximum score 8) with ≥2 points per nostril, as assessed by nasal endoscopy during screening and randomization. * Nasal Congestio