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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
Adverse events
to characterise the safety and tolerability of GR1802 injection, including abnormal vital signs, laboratory tests, electrocardiogram.
Time frame: Baseline up to Week 24
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.
Time frame: Baseline up to Week 24
Change From Baseline at each evaluation time 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to Week 24
Proportion of subjects receiving rescue therapy for nasal polyps
Rescue therapy includes Systemic Corticosteroids and endoscopic surgery
Time frame: Baseline up to Week 24
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Ctrough
PK parameter: trough concentration of GR1802 injection. and exposure(CL/F, Vz/F etc.)
Time frame: Baseline up to Week 24
Vz/F
PK parameter: The volume of distribution based on the terminal elimination phase adjusted by bioavailability.
Time frame: 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.
Time frame: Baseline up to Week 24
Anti-drug antibodies(ADA)
Incidence of ADA
Time frame: Baseline up to Week 24