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

A Randomized, Placebo-Controlled, Double-Blinded Trial of Preoperative Stapokibart With Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyps

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
• Intervention / Treatment: Biological: Stapokibart; Drug: Matched placebo

Detailed Description

This is a single-center, randomized, double-blind, placebo-controlled, parallel-group interventional study designed to investigate the clinical value of short-term preoperative use of stapokibart in adult participants with moderate-to-severe chronic rhinosinusitis with nasal polyps (CRSwNP) who are scheduled for primary endoscopic sinus surgery (ESS).

Chronic rhinosinusitis with nasal polyps is a chronic inflammatory disorder of the nasal and sinus mucosa characterized by type 2 inflammation, tissue eosinophilia, and frequent disease recurrence despite standard surgical and medical management. Stapokibart is a humanized monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), which blocks the shared signaling pathway of interleukin-4 and interleukin-13, key drivers of type 2 inflammation in CRSwNP.

Eligible participants who provide written informed consent will enter a 2-week screening period to confirm compliance with all enrollment criteria. Eligible participants will be randomized 1:1 using a stratified block randomization approach (stratified by asthma comorbidity) to receive either stapokibart 300 mg or placebo via subcutaneous injection every two weeks for a total of two doses. All participants, investigators, outcome assessors, and study personnel remain blinded to treatment assignment throughout the study to minimize assessment bias.

Endoscopic sinus surgery will be performed two weeks after the second study drug injection (four weeks after the first injection) using a standardized bilateral full-house sinus opening technique under general anesthesia.Intraoperative data including operative duration, estimated blood loss, and surgical field visualization quality are prospectively recorded. All participants will receive uniform postoperative care consisting of intranasal corticosteroids and nasal irrigation according to standard clinical practice.

Participants will be followed for up to 48 weeks after surgery, with scheduled assessments at 2, 4, 12, 24, 36, and 48 weeks postoperatively. Throughout the entire study period, all participants receive routine maintenance treatment with nasal corticosteroid spray. During the study, serial clinical evaluations will be conducted, and biomaterial samples will be collected at baseline and during surgery to explore changes in local inflammatory markers, inflammatory cell infiltration, vascular endothelial activation, and epithelial tight junction protein expression. These exploratory analyses aim to clarify the mechanisms by which stapokibart modulates mucosal inflammation in the perioperative setting.

Safety monitoring will be conducted throughout the study, including documentation of all adverse events, serious adverse events, and clinically significant changes in vital signs or laboratory parameters. The study design incorporates strict rules for rescue therapy, including systemic corticosteroids, additional biologic therapy, or repeat surgery, which will be recorded as study endpoints.

Statistical analyses will be performed using predefined analysis populations, including the Full Analysis Set (FAS) population and safety analysis set. The primary analysis will evaluate differences between treatment groups in the primary efficacy endpoint, with appropriate handling of missing data and adjustment for baseline covariates and stratification factors.

This study is designed to generate high-quality clinical evidence regarding the efficacy and safety of preoperative short-course stapokibart as a perioperative intervention, with the goal of supporting optimized, personalized, and cost-effective integrated management strategies for adults with moderate-to-severe CRSwNP undergoing primary endoscopic sinus surgery.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mu Xian, MD; Phone Number: +86 13671138761; Email: mu_xian@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Tongren Hospital, Capital Medical University
      • Contact: Mu Xian, MD; Phone Number: +86 13671138761; Email: mu_xian@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 continued during the study period, and the daily dose of inhaled corticosteroids must be ≤1000 μg fluticasone propionate or an equivalent dose of other inhaled corticosteroids.

Exclusion Criteria:

• 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;
• The patient has conditions or comorbidities that may prevent them from being evaluated for the primary efficacy endpoint, such as acute rhinitis, nasal infection or upper respiratory tract infection within 2 weeks prior to the screening period, acute asthma exacerbation within 4 weeks, current drug-induced rhinitis, allergic fungal sinusitis (AFRS), benign or malignant nasal tumors;
• Important clinical comorbidities that may interfere with clinical efficacy results, including but not limited to active upper or lower respiratory tract infection, cystic fibrosis, eosinophilic granuloma with polyangiitis (Churg-Strauss syndrome), granuloma with polyangiitis (Wegener's granulomatosis), Young's syndrome, etc.;
• Accompanied by other poorly controlled serious diseases or recurrent chronic diseases such as (but not limited to) active infection, cardiovascular disease, tuberculosis or other pathogen infection, diabetes, autoimmune diseases, HIV, hepatitis B, hepatitis C or parasitic diseases, malignant tumors, etc.;
• Subjects with severe liver or kidney dysfunction, such as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels > 2 times the upper limit of normal, and serum creatinine > the upper limit of normal;
• Subjects with known or suspected immunosuppression, including those with a history of invasive opportunistic infections (such as tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pulmonary cystitis, aspergillosis), even if the infection has subsided;
• Women who are pregnant or planning to become pregnant during the study period, or who are breastfeeding;
• Subjects of childbearing age who do not wish to use medically approved effective contraception;
• Subjects with a history of alcohol or drug abuse;
• Subjects deemed by the investigator to have other medical or non-medical conditions that make them unsuitable for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stapokibart Treatment Group; Eligible CRSwNP participants receive 300 mg stapokibart by subcutaneous injection every other week. Two weeks after the second injection, they undergo bilateral full-group sinus opening under general anesthesia via endoscopic sinus surgery. Postoperative follow-up lasted until 48 weeks. Throughout the entire study period, all participants receive routine maintenance treatment with nasal corticosteroid spray.	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.; Other Names: CM310; kangyueda
Placebo Comparator: Placebo Control Group; Eligible CRSwNP participants receive matched placebo by subcutaneous injection every other week. Two weeks after the second injection, they undergo bilateral full-group sinus opening under general anesthesia via endoscopic sinus surgery. Postoperative follow-up lasts until 48 weeks. Throughout the entire study period, all participants receive routine maintenance treatment with nasal corticosteroid spray.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 48 postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, postoperative Week 2 , Week 4 , Week 12 , Week 24 , Week 36 , Week 48
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.	Baseline, postoperative Week 2 , Week 4 , Week 12 , Week 24 , Week 36 , Week 48
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.	Baseline, postoperative Week 2 , Week 4 , Week 12, Week 24 , Week 36 , Week 48
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.	Baseline, postoperative Week 2 , Week 4 , Week 12 , Week 24 , Week 36, Week 48
Change from Baseline in Lund-Mackay (LMK) Sinus CT Score at 48 Weeks Postoperatively	Lund-Mackay (LMK) CT score is an objective indicator for evaluating the severity of chronic rhinosinusitis. Six anatomical regions of bilateral sinuses were assessed, with a total score ranging from 0 to 24. Higher scores indicate more serious sinus lesions and severe disease.	Baseline and 48 weeks after endoscopic sinus surgery
Overall Incidence of Treatment and Perioperative Related Adverse Events	All adverse events occurring during stapokibart treatment, perioperative period and long-term 48-week follow-up were collected and recorded to evaluate the overall safety profile of the study intervention.An adverse event (AE) refers to any untoward medical occurrence following the administration of the investigational product in a participant, which may manifest as signs, symptoms, diseases, or abnormal laboratory findings.	From first study intervention administration through 48 weeks postoperatively
Incidence of Rescue Treatment and Re-intervention During the 48-week Follow-up Period	Rescue interventions included oral glucocorticoids, additional biologic therapy, and revision endoscopic sinus surgery due to uncontrolled inflammation or nasal polyp recurrence.	Baseline through postoperative Week 48
Change from Baseline in 6-item Asthma Control Questionnaire (ACQ-6) Score in Participants with Asthma	ACQ-6 was used to evaluate asthma control level over the past week. The scale consists of 6 equally weighted items, with an average total score ranging from 0 to 6. A score below 1.0 indicates well-controlled asthma, while a score above 1.0 indicates poor asthma control. The minimal clinically important difference is 0.5 points.	Baseline and 48 weeks after endoscopic sinus surgery
Change from baseline in Nasal Polyp Score (NPS) at postoperative Week 2 , Week 4 , Week 12 , Week 24 , Week 36	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.	Baseline, postoperative Week 2 , Week 4 , Week 12 , Week 24 , Week 36

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Investigators: Principal Investigator: Mu Xian, MD, Beijing Tongren Hospital

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; nasal polyps; endoscopic sinus surgery; treatment efficacy; type 2 inflammation; surgical outcome; chronic rhinosinusitis with nasal polyps; disease recurrence; clinical safety; stapokibart; preoperative biologic therapy; double-blinded method
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Signs and Symptoms; Nasal Polyps
• Other Study ID Numbers: TREC2026-KY074

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No