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A Study of GR1802 in Participants With Chronic Sinusitis With Nasal Polyps
Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Summary
The goal of this clinical trial is to learn if GR1802 works to treat severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. It will also learn about the safety of GR1802. The main questions it aims to answer are: 1. Does GR1802 reduce the need for surgery and systemic corticosteroid use? 2. What medical problems do participants have when taking GR1802? Researchers will compare GR1802 to a placebo (a look-alike substance that contains no drug) to see if GR1802 works to treat CRSwNP. Participants will: Take GR1802 or a placebo once every 2 weeks for 13months. Visit the clinic once every 2 weeks for checkups and tests. Keep a diary of their symptoms and the dosage and number of times they use mometasone furoate nasal spray.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy, Safety, and Immunogenicity of GR1802 in Participants With Chronic Rhinosinusitis With Nasal Polyps
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
228
Start Date
2024-09-19
Completion Date
2026-10
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
GR1802
GR1802 will be administered SC.
Placebo
The placebo will be administered SC.
Locations (1)
Beijing Tongren Hospital, Capital Medical University
Beijing, China