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

NCT06015243 | Unknown Phase 2

• 1 other identifier: GR1802-010
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Adverse events

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

  Baseline up to Week 24

Secondary Outcomes (10)

• 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

Study Arms (1)

Experimental: GR1802

EXPERIMENTAL

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

Drug: GR1802 injection

Interventions

GR1802 injection DRUG

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

Experimental: GR1802

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Other.

Sponsors & Collaborators

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 29, 2023
• Study Start: August 18, 2023
• Primary Completion: December 30, 2024
• Study Completion: March 30, 2025
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share