Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps

Inclusion criteria

• Weight ≥40kg
• Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP).
• Bilateral nasal polyps at screening and baseline, total NPS ≥5, ≥2 points for each nostril.
• NCS ≥2 at screening and baseline.
• SNOT-22≥20 at screening period and baseline.
• Recorded persistent NP symptoms for over 4 weeks prior to screening.
• Subjects received standard therapy with intranasal corticosteroids (INCS) and remained stable during the 4 weeks prior to randomization.
• NP surgery in the past and/or ACERS treated with SCS occurred within 2 years before randomization (or with contraindications/ intolerances).

Exclusion criteria

• Any comorbidities that may affect the efficacy evaluation of nasal polyps.
• Any comorbidities except for asthma that may affect blood EOS levels.
• Concomitant with immunodeficiency.
• Concomitant with contraindications or not suitable for nasal endoscopy.
• Uncontrolled hypertension.
• Uncontrolled diabetes.
• Infection within 2 weeks prior to screening to randomization that is clinically significant and/or should be treated with systemic antibiotics.
• Uncontrolled epistaxis within 4 weeks prior to randomization.
• Major surgery performed within 3 months prior to randomization, or surgery planned during the study, or treatments that may affect evaluations according to investigators.
• Parasitic infection within 6 months before randomization.
• Sinus or intranasal surgery (except for diagnostic biopsy) within 6 months prior to randomization, or changes in the nasal walls caused by sinus or intranasal surgery that made NPS evaluation impossible.
• Malignancies diagnosed within 5 years before randomization (except those with a low risk of metastasis or death).
• Abnormalities of laboratory tests at screening or baseline.
• Concomitant with active hepatitis B, positive hepatitis C virus antibodies, positive human immunodeficiency virus antibodies, or positive treponema pallidum antibodies.
• Prolonged QTc interval (>450ms for male and >470ms for female) or other clinically significant abnormal results of ECG at screening or baseline that may cause significant safety risks to subjects.
• FEV1 before the use of bronchodilator (pre-BD) was less than 50% at screening.
• Transfusion of blood products or immunoglobulin within 4 weeks prior to randomization.
• SCS or additional INCS use within 4 weeks before randomization, or planned use during treatment period.
• Regular use of decongestants (local or systemic) within 4 weeks before randomization, except for during the endoscopic procedure.
• Adnimistration of live vaccine or viral vector vaccine within 4 weeks before randomization.
• Allergen immunotherapy within 8 weeks before randomization.
• Smoking history ≥10 pack-years, smoking at screening, or smoking cessation less than 6 months at screening.
• Substance abuse, drug abuse, and/or excessive alcohol consumption within 1 year prior to randomization.
• Pregnancy (including positive pregnancy test at screening or baseline), lactation, or pregnancy plan during study period.