The Study of GR1802 in Patients with Chronic Rhinosinusitis with Nasal Polyps

NCT ID: NCT05873803

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-08
• Study Completion Date: 2024-12-30

Brief Summary

This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). Patients will receive GR1802 injection or Placebo every 2 Weeks.

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the preliminary efficacy and safety of GR1802 injection in patients with chronic rhinosinusitis with nasal polyps.

The study consists of a Screening/run-in Period (up to 4 weeks), a Randomized, Double Blind Treatment Period (16 weeks) and a Safety Follow-up Period (8 weeks).

70 subjects will be randomized 1:1 into the 300 mg first dose doubling Q2W group and the placebo Q2W group. Throughout the dosing period, all subjects continued treatment with standard therapy at a stable dose.

Patient-reported outcome including Nasal congestion score will be collected using patient diary. Central reading will be implemented to Nasal endoscopic nasal polyp score (NPS) and nasal polyp biopsy tissue analysis to eosinophil counts & percentage.

Conditions

Chronic Rhinosinusitis with Nasal Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental: GR1802

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

Group Type: EXPERIMENTAL

GR1802 injection

Intervention Type: BIOLOGICAL

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

Placebo Comparator: Placebo

Placebo every two weeks for 16-week treatment

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

0mg/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: BIOLOGICAL

placebo

0mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Bilateral CRSwNP with prior treatment with systemic corticosteroids (SCS), and/or contraindicate to or intolerance to SCS, and/or with prior surgery to nasal polyps

2. Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity at screening and at baseline.

3. Ongoing symptoms of nasal congestion/obstruction(NCS score of 2 or 3 at screening and at baseline).

4. Recorded use of intranasal corticosteroids for at least 4 weeks before screening

Exclusion Criteria

1. Insufficient washout time for drugs that have an impact on the evaluation of efficacy and safety。

2. Concurrent disease that may interfere with the evaluation of safety and efficacy in subjects, or affect the risk- benefit evaluation of subjects. eg. specific ongoing nasal diseases, severe asthma, active infection, Severe cardiovascular disease, Severe laboratory test abnormalities.

3. Other.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

GR1802-005

Identifier Type: -

Identifier Source: org_study_id