An Open-label, Single-arm, Multicenter, Extension Study to Evaluate the Long-term Safety and Efficacy of GR1802 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps

Genrix (Shanghai) Biopharmaceutical Co., Ltd.0 sites70 target enrollmentAugust 18, 2023

ConditionsChronic Rhinosinusitis With Nasal Polyps

InterventionsGR1802 injection

DrugsGR1802 injection

Overview

Phase: Phase 2
Intervention: GR1802 injection
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Enrollment: 70
Primary Endpoint: Adverse events
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is an open-label, single-arm, multicenter, extension study to evaluate the long-term safety and efficacy of GR1802 injection in patients with Chronic Rhinosinusitis With Nasal Polyps

Detailed Description

This trial was designed as an open, extension trial with the primary objective of evaluating the safety of long-term administration of GR1802 injection in patients with chronic rhinosinusitis with nasal polyps, and to a lesser extent, also evaluating the efficacy, immunogenicity, etc.

Registry

clinicaltrials.gov

Start Date

August 18, 2023

End Date

March 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participation in a clinical study of GR1802 injection for the treatment of chronic rhinosinusitis with nasal polyps (Protocol No. GR1802-005) and fulfillment of the following: completion of prescribed treatment as required by the protocol and completion of the W16 visit.
•the investigator judges that the subject may benefit from continued use of the test drug.
•Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign the informed consent form

Exclusion Criteria

•Poor compliance in the GR1802-005 trial and in the judgment of the investigator is unable to complete this continuation trial;
•Use of any protocol-specified prohibited medication/treatment during the GR1802-005 trial and prior to the first dose of this study that, in the judgment of the investigator, makes continued participation in the continuation trial unsuitable.
•The time to first dosing in the extension trial program was greater than 4 weeks from the GR1802-005 study W16 visit;
•Nasal polyp scoring is not available for nasal polyp scores for nasal or sinus surgery (e.g., nasal polypectomy, balloon dilatation, or intranasal stent placement) that was performed prior to the first administration of the drug in the extension trial that alters the structure of the nasal sidewall;
•Individuals who have received live/attenuated vaccination within 8 weeks prior to the first dose of the extension trial or who plan to receive live/attenuated vaccination during the trial;
•Any serious progressive or poorly controlled concomitant disease (e.g., asthma exacerbation requiring adjustment of background medication) identified during the GR1802-005 study period for which, in the judgment of the Principal Investigator, the subject is considered unsuitable for participation in the trial;

Arms & Interventions

Experimental: GR1802

GR1802 injection 300mg every two weeks for 16-week treatment

Intervention: GR1802 injection

Outcomes

Primary Outcomes

Adverse events

Time Frame: Baseline up to Week 24

to characterise the safety and tolerability of GR1802 injection, including abnormal vital signs, laboratory tests, electrocardiogram.

Secondary Outcomes

Change From Baseline at each evaluation time point in Nasal Polyp Score(Baseline up to Week 24)
Change From Baseline at each evaluation time in Nasal Congestion/Obstruction Symptom(NCS) Severity Score(Baseline up to Week 24)
Total Nasal Symptom Score(TNSS) score(Baseline up to Week 24)
University of Pennsylvania Smell Identification Test (UPSIT)(Baseline up to Week 24)
Visual Analogue Scale (VAS) for Rhinosinusitis(Baseline up to Week 24)
Proportion of subjects receiving rescue therapy for nasal polyps(Baseline up to Week 24)
Ctrough(Baseline up to Week 24)
Vz/F(Baseline up to Week 24)
CL/F(Baseline up to Week 24)
Anti-drug antibodies(ADA)(Baseline up to Week 24)