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

NCT05873803 | Active Not Recruiting Phase 2

• 1 other identifier: GR1802-005
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis with Nasal Polyps

Outcome Measures

Primary Outcomes (2)

• Change From Baseline at Week 16 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.

  at Week 16

• Change From Baseline at Week 16 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.

  at Week 16

Secondary Outcomes (12)

• Time to the first response of NPS

  Baseline up to Week 24

• Lund-Mackay score

  at Week 16

• Bilateral endoscopic NPS

  at Week 4, 8, 12, 24

• Nasal Congestion/Obstruction Symptom score(NCS)

  at Week 4, 8, 12, 24

• University of Pennsylvania Smell Identification Test (UPSIT)

  at Week 16

Study Arms (2)

Experimental: GR1802

EXPERIMENTAL

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

Biological: GR1802 injection

Placebo Comparator: Placebo

PLACEBO COMPARATOR

Placebo every two weeks for 16-week treatment

Biological: placebo

Interventions

GR1802 injection BIOLOGICAL

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

Experimental: GR1802

placebo BIOLOGICAL

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

Placebo Comparator: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity at screening and at baseline.
• Ongoing symptoms of nasal congestion/obstruction(NCS score of 2 or 3 at screening and at baseline).
• Recorded use of intranasal corticosteroids for at least 4 weeks before screening

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 24, 2023
• Study Start: February 8, 2023
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)