Chronic rhinosinusitis with nasal polyps (CRSwNP)
Conditions
Interventions
Stapokibart group:None
Sponsors
Eye & ENT hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. aged =18 years at baseline, male or female; 2. voluntarily participated in the study and provided written informed consent; 3. diagnosed with bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) in accordance with the Chinese Guidelines for Diagnosis and Treatment of Chronic Rhinosinusitis (2024 Edition); 4. high nasal polyp burden, with a bilateral Nasal Polyp Score (NPS) =4 (=2 on each side); 5. met the prescribing criteria for Kangyueda (stapokibart).
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to the active ingredient of Kangyueda (stapokibart) or any excipients. 2. Currently enrolled in or planning to participate in other interventional clinical trials during the study period. 3. Presence of lymphohematopoietic malignancies. 4. Pregnant women of childbearing age. 5. Any condition that, in the investigator's judgment, renders the participant unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Nasal Polyp Score (NPS) at Week 24 of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| EuroQol Five-Dimensional Health Questionnaire Visual Analogue Scale (EQ-5D VAS);Chronic Rhinosinusitis Patient-Reported Outcome (CRS-PRO);Asthma Control Test (ACT);Nasal Congestion Score (NCS);Patient-reported disease control status;Routine blood, serum biochemistry, and urinalysis;Nasal Polyp Score (NPS);Sino-Nasal Outcome Test-22 (SNOT-22);Olfactory Score;Visual Analogue Scale (VAS); | — |
Countries
China
Contacts
Public ContactXicai Sun
Eye & ENT hospital of Fudan University
Outcome results
None listed