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ACTIVE NOT RECRUITING
NCT06516302
PHASE3

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

Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

GR1802

GR1802 will be administered SC.

DRUG

Placebo

The placebo will be administered SC.

Locations (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, China