The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP), as well as to explore the reasonable dosage of SHR-1905 injection for CRSwNP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
114
SHR-1905 Injection
SHR-1905 Placebo Injection
Eye & Ent Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Nasal polyp scores (NPS)
Change from baseline in NPS at Week 24.
Time frame: Baseline to Week 24
NPS
Changes from baseline in NPS from baseline at each evaluation time point.
Time frame: Baseline to Week 48
Nasal Congestion Scores (NCS)
Changes from baseline in NCS at each evaluation time point.
Time frame: Baseline to Week 48
Loss of smell
Changes from baseline in scores of loss of smell at each evaluation time point.
Time frame: Baseline to Week 48
Runny nose/postnasal drip
Change from baseline in scores of runny nose/postnasal drip at each evaluation time point.
Time frame: Baseline to Week 48
Facial pain and/or pressure
Change from baseline in facial pain and/or pressure scores at each evaluation time point.
Time frame: Baseline to Week 48
Total symptoms score (TSS)
Changes from baseline in TSS each evaluation time point.
Time frame: Baseline to Week 48
Sino-nasal outcome test-22 (SNOT-22) scores
Changes from baseline in SNOT-22 scores at each evaluation time point.
Time frame: Baseline to Week 48
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Proportion of subjects exposed to SCS for acute exacerbation of chronic rhinosinusitis (AECRS) over 24 weeks.
Time frame: Baseline to Week 24
Dose of SCS used for AECRS over 24 weeks (converted to equivalent dose of prednisone).
Time frame: Baseline to Week 24