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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

NCT06516302•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.

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosed as CRSwNP and treated with systemic glucocorticoid within 2 years before screening; and/or those who had undergone surgery for nasal polyps before screening.
•An endoscopic bilateral NPS at screening/lead-in period and the baseline period of at least 5 out of a maximum score of 8 (with a minimum socre of 2 in each nasal cavity).
•Nasal congestion/blockade/obstruction with moderate or severe symptom severity at at screening period (score 2 or 3 ) .
•Willing to sign an informed consent, able to comply with clinic visits and study-related procedures as per protocol.

Exclusion Criteria

•Biologic therapy within 5 half-lives or within 10 weeks before baseline.
•Anti-IL-4Rα antibody before screening.
•An experimental drug within 5 half-lives or 1 months before baseline.
•Systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 2 months or 5 half-lives before baseline.
•Initiation of allergen immunotherapy within 3 months before screening.
•Participants receiving leukotriene antagonist/modifier before screening unless on continous treatment for at least 30 days.
•Participants with FEV1 50% or less of predicted normal were excluded.
•Participants who have undergone any intranasal and/or sinus surgery within 6 months before screening.
•Acute sinusitis or upper respiratory infection within a defined time period before screening.
•A nasal cavity tumor (malignant or benign).
+6 more criteria

Locations (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Key Dates

Start Date

September 19, 2024

Primary Completion Date

March 1, 2026

Completion Date

October 1, 2026

Last Updated

March 3, 2026

Enrollment

228

ESTIMATED participants

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Interventions

GR1802

DRUG

Placebo

DRUG

Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study

NCT06914908

Chronic Rhinosinusitis With Nasal Polyps

View study

RECRUITING

Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis

NCT05246267

Chronic Rhinosinusitis With Nasal Polyps

View study

RECRUITINGNA

Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study

Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis

Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy

3D Printing to Improve Nasal Irrigation Outcome

Biomarkers of Response to Mepolizumab Treatment in Patients With Nasal Polyps With or Without Bronchial Asthma

Effect of Celecoxib on Postoperative Analgesia and Disease Severity in AERD Patients with CRS