Phase 3 Study of SHR-1905 Injection for Adults with Chronic Rhinosinusitis and Nasal Polyps

What this Trial Is About

Researchers are evaluating the effectiveness and safety of SHR-1905 injection in adults with chronic rhinosinusitis with nasal polyps CRSwNP, a condition where nasal polyps cause persistent symptoms. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess how well SHR-1905 works and its safety profile compared to placebo in this patient group. Participants are randomly assigned to receive either SHR-1905 injection or a placebo injection. The treatment period lasts 24 weeks, during which nasal polyp scores and nasal congestion scores are closely monitored. The study also measures other outcomes like sinus CT scan scores, sense of smell, symptom questionnaires, and overall symptom scores to comprehensively evaluate the treatment effects. Throughout the 24-week study, participants undergo regular assessments including nasal polyp scoring, nasal congestion evaluation, sinus imaging, and symptom questionnaires such as the Sino-nasal Outcome Test-22. Researchers carefully monitor safety and collect data to understand how SHR-1905 impacts symptoms and quality of life. The total duration of participation aligns with the 24-week treatment and evaluation period.

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