A Study of GR1802 in Participants With Chronic Sinusitis With Nasal Polyps

NCT06516302 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: GR1802-007
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if GR1802 works to treat severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. It will also learn about the safety of GR1802. The main questions it aims to answer are:

1. 1.Does GR1802 reduce the need for surgery and systemic corticosteroid use？
2. 2.What medical problems do participants have when taking GR1802?

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (2)

• Change from baseline in nasal polyps score at week 24.

  Nasal polyps score score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.

  At week 24

• Change from baseline in nasal congestion score at week 24.

  Nasal congestion score (0-3), higher score means worse nasal symptom.

  At week 24

Secondary Outcomes (20)

• Change from baseline in reduction/loss of smell at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and 60.

  From baseline to week 60

• Change from baseline in nasal discharge (anterior/posterior) at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and 60.

  From baseline to week 60

• Change from baseline in Total Nasal Symptom Score (TNSS) at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and 60.

  From baseline to week 60

• Change from baseline in nasal endoscopy nasal polyps score in participants with a high power field of vision < 55 eosinophil granulocytes in nasal polyp tissue at week 24.

  At week 24

• Change from baseline in nasal congestion score in participants with a high power field of vision < 55 eosinophil granulocytes in nasal polyp tissue at week 24.

  At week 24

Study Arms (2)

GR1802 group

EXPERIMENTAL

GR1802 300mg is administrated every 2 weeks (first dose doubled) for a total of 26 doses, of which an additional 2 ml of placebo is given at week 24.

Drug: GR1802

placebo group

PLACEBO COMPARATOR

Placebo is administered every 2 weeks for the first 16 weeks. GR1802 is given every 2 weeks from week 24 to W50.

Drug: Placebo

Interventions

GR1802 DRUG

GR1802 will be administered SC.

GR1802 group

Placebo DRUG

The placebo will be administered SC.

placebo group

Eligibility Criteria

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

You may qualify if:

• Diagnosed as CRSwNP and treated with systemic glucocorticoid within 2 years before screening; and/or those who had undergone surgery for nasal polyps before screening.
• An endoscopic bilateral NPS at screening/lead-in period and the baseline period of at least 5 out of a maximum score of 8 (with a minimum socre of 2 in each nasal cavity).
• Nasal congestion/blockade/obstruction with moderate or severe symptom severity at at screening period (score 2 or 3 ) .
• Willing to sign an informed consent, able to comply with clinic visits and study-related procedures as per protocol.

You may not qualify if:

• Biologic therapy within 5 half-lives or within 10 weeks before baseline.
• Anti-IL-4Rα antibody before screening.
• An experimental drug within 5 half-lives or 1 months before baseline.
• Systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 2 months or 5 half-lives before baseline.
• Initiation of allergen immunotherapy within 3 months before screening.
• Participants receiving leukotriene antagonist/modifier before screening unless on continous treatment for at least 30 days.
• Participants with FEV1 50% or less of predicted normal were excluded.
• Participants who have undergone any intranasal and/or sinus surgery within 6 months before screening.
• Acute sinusitis or upper respiratory infection within a defined time period before screening.
• A nasal cavity tumor (malignant or benign).
• Evidence of fungal rhinosinusitis.
• Presence of another diagnosis associated with nasal polyps (i.e., eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, cystic fibrosis).
• Rhinitis medicamentosa.
• Nasal septal deviation occluding at least one nostril.
• Antrochoanal polyps.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Location

Study Officials

• Luo Zhang, Doctor

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 23, 2024
• Study Start: September 19, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2025-07

Locations

CN (1)