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.
This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the preliminary efficacy and safety of GR1802 injection in patients with chronic rhinosinusitis with nasal polyps. The study consists of a Screening/run-in Period (up to 4 weeks), a Randomized, Double Blind Treatment Period (16 weeks) and a Safety Follow-up Period (8 weeks). 70 subjects will be randomized 1:1 into the 300 mg first dose doubling Q2W group and the placebo Q2W group. Throughout the dosing period, all subjects continued treatment with standard therapy at a stable dose. Patient-reported outcome including Nasal congestion score will be collected using patient diary. Central reading will be implemented to Nasal endoscopic nasal polyp score (NPS) and nasal polyp biopsy tissue analysis to eosinophil counts \& percentage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
0mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
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.
Time frame: 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.
Time frame: at Week 16
Time to the first response of NPS
Time to the first response of NPS (defined as bilateral endoscopic NPS improved ≥1).
Time frame: Baseline up to Week 24
Lund-Mackay score
Change from baseline in the Lund-Mackay score on CT scan. The range of LM score is 0-24. Higher score means worse rhinosinusitis.
Time frame: at Week 16
Bilateral endoscopic NPS
Change from baseline in the bilateral endoscopic NPS at Week 4, 8, 12, 24.
Time frame: at Week 4, 8, 12, 24
Nasal Congestion/Obstruction Symptom score(NCS)
Change from baseline in NCS at Week 4, 8, 12, 24.
Time frame: at Week 4, 8, 12, 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: at Week 16
Total Nasal Symptom Score(TNSS) score
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Change from baseline in TNSS score. TNSS score (0-9). Higher score means worse nasal symptom.
Time frame: at Week 16
Visual Analogue Scale (VAS) for Rhinosinusitis
Change from baseline in VAS score. VAS score (0-10). Higher score means worse nasal symptom.
Time frame: at Week 16
Proportion of subjects receiving rescue therapy for nasal polyps
Rescue therapy includes Systemic Corticosteroids and endoscopic surgery
Time frame: Baseline up to Week 24
Pharmacokinetics(PK)
Plasma concentration of GR1802 injection. PK parameter including trough concentration and exposure（CL/F, Vz/F etc.）
Time frame: Baseline up to Week 24
Pharmacodynamics(PD)
Change from baseline in serum biomarker level (Periostin, TARC, total IgE and eosinophil level) and biomarkers in nasal secretions and nasal exfoliated cells。
Time frame: at Week 16
Anti-drug antibodies(ADA)
Incidence of ADA
Time frame: Baseline up to Week 24
Safety parameters
Incidence of treatment-emergent adverse events (TEAEs), of treatment-emergent serious AEs (TESAEs), etc.
Time frame: Baseline up to Week 24