A Study of GR1802 in Participants With Chronic Sinusitis With Nasal Polyps
NCT Number: NCT06516302
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Interventions: DRUG: GR1802|DRUG: Placebo
Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 228
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-10

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

Researchers will compare GR1802 to a placebo (a look-alike substance that contains no drug) to see if GR1802 works to treat CRSwNP.

Participants will:

Take GR1802 or a placebo once every 2 weeks for 13months. Visit the clinic once every 2 weeks for checkups and tests. Keep a diary of their symptoms and the dosage and number of times they use mometasone furoate nasal spray.

Primary Outcome Measures: 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 Outcome Measures: 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., The reduction/loss of smell severity was reported by the participant on a daily basis using a 0 to 3 categorical scale. Higher score means a worse sense of smell., 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., The nasal discharge severity was reported by the participant on a daily basis using a 0 to 3 categorical scale. Higher score means a worse nasal symptom., 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., TNSS score (0-9). Higher score means worse nasal symptom., 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., 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 in participants with a high power field of vision < 55 eosinophil granulocytes in nasal polyp tissue at week 24., Nasal congestion score (0-3), higher score means worse nasal symptom., At week 24|Change from baseline in nasal polyps score at weeks 2、4、8、16、32、40、52 and 60., Nasal polyps score score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome., From baseline to week 60|Proportion of participants with improvement by at least 1 point in nasal polyps score at weeks 2、4、8、16、24、32、40、52 and 60., Nasal polyps score score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome., From baseline to week 60|Proportion of participants with improvement by at least 2 point in nasal polyps score at weeks 2、4、8、16、24、32、40、52 and 60., Nasal polyps score score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome., From baseline to week 60|Time to first response (≥1 point improvement) in nasal polyps score., Nasal polyps score score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome., From baseline to week 60|Change from baseline in nasal congestion score at weeks 4、8、12、16、20、28、32、36、40、44、48、52、56 and 60., Nasal congestion score (0-3), higher score means worse nasal symptom., From baseline to week 60|Proportion of participants with improvement by at least 1 point in nasal congestion score at weeks 4、8、12、16、20、24、28、32、36、40、44、48、52、56 and 60., Nasal congestion score (0-3), higher score means worse nasal symptom., From baseline to week 60|Proportion of participants with improvement by at least 2 point in nasal congestion score at weeks 4、8、12、16、20、24、28、32、36、40、44、48、52、56 and 60., Nasal congestion score (0-3), higher score means worse nasal symptom., From baseline to week 60|Change from baseline in Lund-Mackay score at week 24 and 52., The range of LM score is 0-24. Higher score means worse rhinosinusitis., From baseline to week 60|Change from baseline in 22-item Sinonasal Outcome Test (SNOT-22) at weeks 2, 4, 8, 16, 24, 32, 40, 52 and 60., The range of SNOT-22 score is 0 to 110. Higher scores indicating more severe disease., From baseline to week 60|Change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) at weeks 2, 4, 16, 24, 32, 40, 52 and 60., UPSIT score (0-40). Higher score means better sense of smell., From baseline to week 60|Change from baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) at weeks 4、16、24、40、52 and 60., The EQ-5D-5L descriptive system comprises five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), and each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each of the five dimensions., From baseline to week 60|Safety parameters., Incidence of treatment-emergent adverse events (TEAEs), incidence of treatment-emergent serious AEs (TESAEs), etc., From baseline to week 60|Pharmacokinetics, include Ctrough, etc., GR1802 concentrations were measured in CRSwNP population using sparse sampling (samples collected at predose, during treatment, and the follow up period)., From baseline to week 60|Pharmacodynamics., Levels of the type 2 inflammation biomarkers were assessed as markers for disease activity/severity., From baseline to week 60|Immunogenicity, include ADA and Nab., Anti GR1802 antibody status was determined at baseline and at prespecified time points., From baseline to week 60