Clinical trial

A Randomized, Double Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy, Safety of GR1802 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Name

GR1802-005

Description

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.

Trial arms

Trial start

2023-02-08

Estimated PCD

2024-10-30

Trial end

2024-12-30

Status

Recruiting

Phase

Early phase I

Treatment

GR1802 injection

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

Arms:

Experimental: GR1802

placebo

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

Arms:

Placebo Comparator: Placebo

Size

Primary endpoint

Change From Baseline at Week 16 in Nasal Congestion/Obstruction Symptom(NCS) Severity Score

at Week 16

Change From Baseline at Week 16 in Nasal Polyp Score

at Week 16

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double blind', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}

Updated at

2023-05-24

1 organization

2 products

1 indication

Organization

Genrix (Shanghai) Biopharmaceutical

Product

GR1802

Indication

Chronic Rhinosinusitis

Product

placebo