A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Efficacy and Safety Study of SHR-1905 in Patiens With Chronic Rhinosinusitis With Nasal Polyps
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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≥30 at screening period and baseline.
• Recorded persistent NP symptoms for over 4 weeks prior to screening.
• Subjects received standard therapy with intranasal corticosteroids (INCS) prior to randomization.
• NP surgery in the past and/or SCS use within 1 years before screening(or with contraindications/ intolerances).
Locations
Other Locations
China
Eye & Ent Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
HuanHuan Huang
huanhuan.huang.hh30@hengrui.com
+0518-81220121
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2028-04
Participants
Target number of participants: 280
Treatments
Experimental: SHR-1905 Injection
Placebo_comparator: SHR-1905 Placebo Injection
Related Therapeutic Areas
Sponsors
Leads: Guangdong Hengrui Pharmaceutical Co., Ltd