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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Tongren Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Possess the ability to understand the nature of the study and voluntarily sign an informed consent form (ICF);

Age between 18 and 75 years old, with no limitation on gender;

Bilateral CRSwNP meeting the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Chronic Sinusitis (2024);

Nasal congestion;

Disqualifiers

Previous ESS surgery including but not limited to septoplasty, turbinate reduction, nasal polyp removal, and sinus surgery;

Contraindications to general anesthesia;

Contraindications to stapokibart therapy;

Previous use of any anti-IL-4Rα biologic;

Trial design

Treatments tested in this trial

  • Stapokibart
  • Matched placebo

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators