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

NCT ID: NCT06015243

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-18
• Study Completion Date: 2025-03-30

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: GR1802

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

Group Type: EXPERIMENTAL

GR1802 injection

Intervention Type: DRUG

150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous

Interventions

GR1802 injection

150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

GR1802-010

Identifier Type: -

Identifier Source: org_study_id