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).
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.
Conditions/Diseases Affecting Efficacy Evaluation
Nasal septum deviation causing ≥1 nostril obstruction；
Perforation of the nasal septum
Acute sinusitis, nasal infection, or upper respiratory infection within 2 weeks pre-screening or during screening/run-in periods；
Parallel
TQC2731 injection
DrugTQC2731 injection is a humanized monoclonal antibody that targets TSLP, blocks the TSLP signaling pathway, inhibits the production of downstream cytokines, and exerts anti-inflammatory effects.
Placebo of TQC2731
DrugTQC2731 injection is a humanized monoclonal antibody that targets TSLP, blocks the TSLP signaling pathway, inhibits the production of downstream cytokines, and exerts anti-inflammatory effects.
Nasal Polyp Score (NPS)
Change in Nasal Polyp Score (NPS) from baseline to Week 24 in CRSwNP subjects.
Nasal Congestion Score (NCS)
Change in Nasal Congestion Score (NCS) from baseline to Week 24 in CRSwNP subjects
Change in nasal polyp score (NPS) from baseline
Change in nasal polyp score (NPS) from baseline at week 24 in ECRSwNP subjects.
Change from baseline in Nasal Congestion Score (NCS)
Change from baseline in Nasal Congestion Score (NCS) at Week 24 in ECRSwNP subjects
Lund-Mackay score
The change in Lund-Mackay score from baseline for the subject's CT scan at week 24. The higher the score, the more severe the CRS condition.
Olfactory loss score
The change in anosmia score assessed in the electronic logs of subjects at each visit point relative to baseline. A reduction in the olfactory loss score implies therapeutic efficacy or ongoing recovery.
22-item Sino-Nasal Outcome Test (SNOT-22) score
The change from baseline in the 22-item Sino-Nasal Outcome Test (SNOT-22) score at each visit.
Total Symptom Score (TSS)
The change in Total Symptom Score (TSS) from baseline at each visit point for the subjects. A reduction in the Total Nasal Symptom Score (TSS) post-treatment suggests effective therapeutic response.
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