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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Stapokibart
Biological/VaccineSubcutaneous 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.
Matched placebo
DrugMatched 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Stapokibart Treatment GroupExperimental treatment 1 intervention
Group B: Placebo Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Nasal Polyp Score (NPS) at Week 48 Postoperatively
Nasal Polyp Score (NPS) is assessed bilaterally with 0-4 points per side (0 = no polyps, 4 = nearly complete nasal obstruction). Total score ranges 0-8; higher scores represent more severe polyposis. This outcome measures the change from baseline to 48 weeks after endoscopic sinus surgery.
Time frame
Baseline and Week 48 postoperativelySecondary outcomes
1
Change from Baseline in Total Nasal Symptom Score (TSS)
The total symptom score (TSS) was used to evaluate nasal congestion, loss of smell and comprehensive nasal symptoms. All symptoms were rated on a 3-point scale: 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms. The total TSS ranges from 0 to 9, with higher scores indicating more severe nasal symptoms. Symptom changes were assessed at scheduled follow-up time points.
Time frame
Baseline, postoperative Week 2 , Week 4 , Week 12 , Week 24 , Week 36 , Week 482
Change from Baseline in Nasal Symptom Visual Analog Scale (VAS) Score
Patients rated the severity of nasal congestion, hyposmia, rhinorrhea and craniofacial pain using a 0-10 visual analog scale (VAS). Score 0 indicates no relevant symptoms, and score 10 indicates the most severe symptoms. Changes in VAS scores from baseline were evaluated at each specified visit.
Time frame
Baseline, postoperative Week 2 , Week 4 , Week 12 , Week 24 , Week 36 , Week 483
Change from Baseline in 22-item Sino-Nasal Outcome Test (SNOT-22) Score
SNOT-22 is a validated scale for assessing health-related quality of life in patients with chronic rhinosinusitis. Each item is scored on a 6-point scale from 0 (no problem) to 5 (severe problem). The total score ranges from 0 to 110, and higher scores represent poorer quality of life. The minimal clinically important difference is 8.90 points.
Time frame
Baseline, postoperative Week 2 , Week 4 , Week 12, Week 24 , Week 36 , Week 484
Change from Baseline in Lund-Kennedy Endoscopic Score
Lund-Kennedy endoscopic scale contains 5 items: polyp, mucosal edema, nasal discharge, synechia and crusting, with 0-2 points for each item on both sides of the nasal cavity. The total score ranges from 0 to 20. Higher scores reflect more severe mucosal inflammation and worse postoperative recovery.
Time frame
Baseline, postoperative Week 2 , Week 4 , Week 12 , Week 24 , Week 36, Week 48Sponsors and contacts
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Source ClinicalTrials.gov
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