NCT06516302

A Study of GR1802 in Participants With Chronic Sinusitis With Nasal Polyps

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A randomized, double-blind, placebo-controlled, multi-center clinical trial was designed. The clinical trial was divided into 4 stages: screening/introduction period, double-blind treatment period , maintenance treatment period and safety follow-up period. The clinical trial aimed to evaluate the efficacy, safety and immunogenicity of GR1802 injection in CRSwNP participants.

Conditions

• Chronic Rhinosinusitis With Nasal Polyps

Interventions

Type	Name	Description
DRUG	GR1802	GR1802 will be administered SC.
DRUG	Placebo	The placebo will be administered SC.

Timeline

• Start date: 2024-09-19
• Primary completion: 2026-03-01
• Completion: 2026-10-01
• First posted: 2024-07-23
• Last updated: 2026-03-03

Locations

1 site across 1 country: China