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

NCT07616609 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Interventions

BIOLOGICAL

Stapokibart

Subcutaneous injection at a single dose of 300 mg, administered every other week for preoperative intervention. Bilateral endoscopic sinus surgery is performed after two injections. All participants receive standardized perioperative management and long-term follow-up up to 48 weeks.

DRUG

Matched placebo

Matched inactive placebo for subcutaneous injection, with identical appearance, administration route and dosing interval. The preoperative intervention schedule, surgical procedure and 48-week follow-up arrangement are fully consistent with the stapokibart group.

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Principal Investigators

  • Mu Xian, MD · Beijing Tongren Hospital

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
2026-06-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07616609 on ClinicalTrials.gov