Efficacy and Safety of SHR-1905 Injection in Subjects With Chronic Rhinosinusitis With Nasal Polyps
Trial Parameters
Brief Summary
The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP)
Eligibility Criteria
Inclusion Criteria: 1. Weight ≥40kg 2. Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP). 3. Bilateral nasal polyps at screening and baseline, total NPS ≥5, ≥2 points for each nostril. 4. NCS ≥2 at screening and baseline. 5. SNOT-22≥30 at screening period and baseline. 6. Recorded persistent NP symptoms for over 4 weeks prior to screening. 7. Subjects received standard therapy with intranasal corticosteroids (INCS) prior to randomization. 8. NP surgery in the past and/or SCS use within 1 years before screening(or with contraindications/ intolerances). Exclusion Criteria: 1. Any comorbidities that may affect the efficacy evaluation of nasal polyps. 2. Any comorbidities except for asthma that may affect blood EOS levels. 3. Concomitant with immunodeficiency. 4. Concomitant with contraindications or not suitable for nasal endoscopy. 5. Uncontrolled hypertension and/or uncontrolled diabetes. 6. Concomitant with infection within 4 weeks prior to randomization. 7. Uncontrolled