Preoperative Stapokibart for Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Nasal Polyps (NCT07616609) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Preoperative Stapokibart for Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Nasal Polyps
China48 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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);
* Persistent presence of the following symptoms for ≥12 weeks prior to the screening/introduction period:
* Nasal congestion;
* Any other symptom such as decreased/loss of smell or rhinorrhea;
* At the screening/introduction period and baseline, total NPS ≥ 4 points and NPS ≥ 2 points in each nasal cavity;
* At the screening/introduction period and baseline, the subject reports moderate to severe nasal congestion or decreased smell (NCS or LoS score of 2 or 3 points);
* During the screening/introduction period, the Lund-Mackay score on sinus CT is ≥12 points bilaterally and ≥6 points unilaterally;
* Must meet any of the following criteria for type 2 inflammation: Eosinophil count \>55/high-power field or eosinophil percentage \>27% in nasal polyp tissue during the induction period; eosinophil percentage ≥3.75% in peripheral blood in patients with asthma; eosinophil percentage ≥6.9% in patients without asthma;
* If the subject has asthma, the condition must be stable as assessed by the investigator or specialist. For subjects treated with a stable dose of inhaled corticosteroids for at least 4 weeks before screening, the treatment may be continue…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Nasal Polyp Score (NPS) at Week 48 Postoperatively