The Study of Long-term Outcomes of GR1802 in Patients With Chronic Rhinosinusitis With Nasal Polyps

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Rhinosinusitis With Nasal Polyps
• Intervention / Treatment: Drug: GR1802 injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. the investigator judges that the subject may benefit from continued use of the test drug.
3. 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:

1. Poor compliance in the GR1802-005 trial and in the judgment of the investigator is unable to complete this continuation trial;
2. 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.
3. The time to first dosing in the extension trial program was greater than 4 weeks from the GR1802-005 study W16 visit;
4. 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;
5. 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;
6. 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;
7. Other.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: GR1802; GR1802 injection 300mg every two weeks for 16-week treatment	Drug: GR1802 injection; 150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	to characterise the safety and tolerability of GR1802 injection, including abnormal vital signs, laboratory tests, electrocardiogram.	Baseline up to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects receiving rescue therapy for nasal polyps	Rescue therapy includes Systemic Corticosteroids and endoscopic surgery	Baseline up to Week 24
Anti-drug antibodies(ADA)	Incidence of ADA	Baseline up to Week 24
Change From Baseline at each evaluation time point in Nasal Polyp Score	NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.	Baseline up to Week 24
Change From Baseline at each evaluation time in Nasal Congestion/Obstruction Symptom(NCS) Severity Score	Change from baseline in the NCS score. NCS score (0-3), higher score means worse nasal symptom.	Baseline up to Week 24
Total Nasal Symptom Score(TNSS) score	Change from baseline in TNSS score. TNSS score (0-9). Higher score means worse nasal symptom.	Baseline up to Week 24
University of Pennsylvania Smell Identification Test (UPSIT)	Change from baseline in UPSIT. UPSIT score (0-40). Higher score means better sense of smell.	Baseline up to Week 24
Visual Analogue Scale (VAS) for Rhinosinusitis	Change from baseline in VAS score. VAS score (0-10). Higher score means worse nasal symptom.	Baseline up to Week 24
Ctrough	PK parameter: trough concentration of GR1802 injection. and exposure（CL/F, Vz/F etc.）	Baseline up to Week 24
Vz/F	PK parameter: The volume of distribution based on the terminal elimination phase adjusted by bioavailability.	Baseline up to Week 24
CL/F	PK parameter: The apparent volume of the central compartment cleared of drug per unit time adjusted by bioavailability.	Baseline up to Week 24

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 18, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Nasal Polyps; Polyps
• Other Study ID Numbers: GR1802-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No