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This is an open-label, single-arm, multicenter, extension study to evaluate the long-term safety and efficacy of GR1802 injection in patients with Chronic Rhinosinusitis With Nasal Polyps
This trial was designed as an open, extension trial with the primary objective of evaluating the safety of long-term administration of GR1802 injection in patients with chronic rhinosinusitis with nasal polyps, and to a lesser extent, also evaluating the efficacy, immunogenicity, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: GR1802 | Experimental | GR1802 injection 300mg every two weeks for 16-week treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR1802 injection | Drug | 150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | to characterise the safety and tolerability of GR1802 injection, including abnormal vital signs, laboratory tests, electrocardiogram. | Baseline up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at each evaluation time point 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. | Baseline up to Week 24 |
| Change From Baseline at each evaluation time in Nasal Congestion/Obstruction Symptom(NCS) Severity Score |
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Inclusion Criteria:
Exclusion Criteria:
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Change from baseline in the NCS score. NCS score (0-3), higher score means worse nasal symptom. |
| Baseline up to Week 24 |
| Total Nasal Symptom Score(TNSS) score | Change from baseline in TNSS score. TNSS score (0-9). Higher score means worse nasal symptom. | Baseline up to Week 24 |
| University of Pennsylvania Smell Identification Test (UPSIT) | Change from baseline in UPSIT. UPSIT score (0-40). Higher score means better sense of smell. | Baseline up to Week 24 |
| Visual Analogue Scale (VAS) for Rhinosinusitis | Change from baseline in VAS score. VAS score (0-10). Higher score means worse nasal symptom. | Baseline up to Week 24 |
| Proportion of subjects receiving rescue therapy for nasal polyps | Rescue therapy includes Systemic Corticosteroids and endoscopic surgery | Baseline up to Week 24 |
| Ctrough | PK parameter: trough concentration of GR1802 injection. and exposure(CL/F, Vz/F etc.) | Baseline up to Week 24 |
| Vz/F | PK parameter: The volume of distribution based on the terminal elimination phase adjusted by bioavailability. | Baseline up to Week 24 |
| CL/F | PK parameter: The apparent volume of the central compartment cleared of drug per unit time adjusted by bioavailability. | Baseline up to Week 24 |
| Anti-drug antibodies(ADA) | Incidence of ADA | Baseline up to Week 24 |