Type 2 Chronic Rhinosinusitis with Nasal Polyps
Conditions
Interventions
Arm A: Surgery + Stapokibart:Endoscopic Sinus Surgery (ESS) + Stapokibart 300 mg subcutaneous injection (q2w × 12 weeks, then adjusted to q4w maintenance up to 12 months if responder)
all patients receive standard background therapy (INCS + nasal irrigation).
Arm B: Surgery + Standard of Care:Endoscopic Sinus Surgery (ESS) + standard perioperative care (INCS maintenance ± short-course oral corticosteroids, nasal irrigation), without biologics.
Arm C: Non-surgery + Stapokibart:Stapokibart 300 mg subcutaneous injection (q2w × 12 weeks, then adjusted to q4w maintenance up to 12 months if responder)
Arm D: Non-surgery + Standard of Care:Standard medical therapy (long-term INCS ± short-course oral corticosteroids, nasal irrigation), without biologics.
Arm E: Conservative Management:Patient education, adherence support, and environmental control + INCS maintenance
without surgery or biologics.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
17 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Basic Conditions (1) Adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP); (2) Non-special types, excluding cases related to cystic fibrosis, primary ciliary dyskinesia, etc. 2.EPOS 2020 Reference Criteria (at least 3 of the following 5 must be met): (1) Tissue eosinophils (EOS) >= 10/HPF, or blood EOS >= 150/µL, or total IgE >= 100 IU/mL; (2) >= 2 courses of systemic corticosteroids per year, or > 3 months of corticosteroid use; (3) SNOT-22 score >= 40; (4) Presence of anosmia; (5) Comorbid asthma requiring regular inhaled corticosteroid therapy.
Exclusion criteria
Exclusion criteria: 1.Receipt of monoclonal antibodies targeting the same pathway, or anti-IgE monoclonal antibody therapy, within 1 month prior to enrollment; 2.Vaccination with, or planned vaccination with, a live attenuated vaccine within 12 weeks prior to enrollment; 3.Presence of severe infections or significant hepatic/renal impairment (ALT >= 3 × ULN, and/or estimated glomerular filtration rate [eGFR] <= 30 mL/min by any validated formula); 4.History of human immunodeficiency virus (HIV) infection or HIV antibody–positive status; 5.History of uncontrolled major clinical diseases other than CRSwNP that, in the investigator’s opinion, may pose a risk to the safety of the subject when participating in the study (including but not limited to significant cardiovascular, endocrine, neurological, hematological, immunological, psychiatric, or metabolic disorders); 6.Pregnant or lactating women, or women planning to become pregnant during the study period; 7.Known hypersensitivity to Stapokibart or any of its excipients; 8.Participation in another clinical trial that may interfere with data collection for this study; 9.Any other condition that, in the opinion of the investigator, makes the subject unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Nasal Polyp Score (NPS);Postoperative Recurrence Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Surgical Intervention;Visual Analog Scale (VAS) for Nasal Symptoms;Sinonasal Outcome Test-22 (SNOT-22) Score;Biomarkers of Type 2 Inflammation; | — |
Countries
China
Contacts
Public ContactLiu Feng
West China Hospital, Sichuan University
Outcome results
None listed