Clinical Trial

Preoperative Stapokibart for Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Nasal Polyps

Not Yet Recruiting
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Summary
This is a single-center, randomized, double-blinded, placebo-controlled clinical trial in adults with moderate-to-severe chronic rhinosinusitis with nasal polyps (CRSwNP) who have no previous nasal surgery. The purpose of this study is to evaluate the effectiveness and safety of using stapokibart for 4 weeks before endoscopic sinus surgery (ESS), compared with placebo before ESS. The main questions this study aims to answer are: * Does preoperative stapokibart combined with endoscopic sinus surgery achieve better efficacy and comparable safety compared with surgery alone? * What influences four-week preoperative stapokibart administration has on pharmacodynamic data and intraoperative surgical parameters? * Is there a correlation between the efficacy of four-week stapokibart therapy and postoperative recurrence tendency after endoscopic sinus surgery? Researchers will randomly assign participants to receive either stapokibart or a placebo (an inactive substance that looks like the study drug) for 4 weeks before surgery. All participants will have the same standard endoscopic sinus surgery and will be followed for 48 weeks to check polyp status, symptoms, quality of life, and adverse events. This study will provide evidence about whether short-term preoperative stapokibart improves surgical and long-term outcomes for adults with CRSwNP undergoing ESS.
Trial Details
NCT Number NCT07616609
Lead Sponsor Beijing Tongren Hospital
Conditions Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Enrollment 48 participants
Start Date 2026-06-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-01