This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus placebo in patients with severe nasal polyposis.
Approximately 250 patients will be randomized to receive benralizumab 30 mg SC or matching placebo. After enrolment, eligible patients will enter a 6-week screening/run in period. Patients who meet eligibility criteria will be randomised 1:1 at Week 0 (Day 0) to receive either placebo or benralizumab 30 mg SC every 4 weeks for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks thereafter (Weeks 16, 24, 32, 40 and 48). An end of treatment visit will be conducted at Week 56.All patients who complete the 56-week DB treatment period on investigational product (IP) may be eligible to continue into around one year OLE (Open Label Extension), during which all patients will receive 8 doses of benralizumab 30 mg. Patients in Benra arm during DB period will receive one dummy dose for the second dose during OLE (Open Label Extension). The last study visit will occur at 8 weeks after the last dose of IP (Week 112/FU). Patients who do not enter OLE (Open Label Extension), will have their last study visit at Week 56 (EoDB) for follow-up and without administration of IP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
293
Benralizumab is 30 mg/ml solution for injection in accessorized pre-filled syringe, 1 ml fill volume. Benralizumab 30 mg subcutaneously will be injected every 4 weeks for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks thereafter (Weeks 16, 24, 32, 40 and 48). For OLE, Benralizumab 30 mg subcutaneously will be injected every 4 weeks for the first 3 doses and every 8 weeks for the rest 5 doses. For the patients on Benralizumab treatment during double blind period, placebo will be dosed at the second dose during OLE.
Matching placebo solution for injection in accessorized pre-filled syringe. 1 ml fill volume. Matching placebo subcutaneously will be injected every 4 weeks for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks thereafter (Weeks 16, 24, 32, 40 and 48).
Nasal Polyp Burden
Change from baseline in endoscopic total nasal polyp score (NPS).
Time frame: Baseline to Week 56
Patient-reported Nasal Blockage (NB)
Change from baseline in mean nasal blockage score (NBS).
Time frame: Baseline to week 56
Sense of Smell
Change from baseline in difficulty with sense of smell (DSS) score
Time frame: Baseline to Week 56
Sinus Opacification by CT Scan
Change from baseline in Lund Mackay score
Time frame: Baseline to Week 56
Disease specific health-related quality of life (HRQoL)
Change from baseline in SinoNasal Outcome Test (SNOT-22) score.
Time frame: Baseline to Week 56
Nasal Polyp Surgery
Time to first nasal polyp surgery
Time frame: Baseline to Week 56
Systemic corticosteroid (SCS) use
Time to first SCS course for CRSwNP
Time frame: Baseline to Week 56
Symptoms associated with CRSwNP
Change from baseline in nasal symptom score(s)
Time frame: Baseline to Week 56
Nasal polyp surgery and/or systemic corticosteroids (SCS)for relief of nasal symptoms
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Research Site
Huntington Beach, California, United States
Research Site
Grand Junction, Colorado, United States
Research Site
Gainesville, Florida, United States
Research Site
Louisville, Kentucky, United States
Research Site
White Marsh, Maryland, United States
Research Site
The Bronx, New York, United States
Research Site
White Plains, New York, United States
Research Site
Tulsa, Oklahoma, United States
Research Site
Bethlehem, Pennsylvania, United States
Research Site
Fort Worth, Texas, United States
...and 106 more locations
Time to first NP surgery and/or SCS use for CRSwNP
Time frame: Baseline to Week 56
Nasal polyp surgery and/or systemic corticosteroids (SCS)for relief of nasal symptoms
Proportion of patients with NP urgery and/orSCS use for CRSwNP
Time frame: Baseline to Week 56
Nasal polyp surgery
Proportion of patients with surgery for CRSwNP
Time frame: Baseline to Week 56
Systemic corticosteroids (SCS) use for relief of nasal symptoms
Proportion of patients with SCS use for CRSwNP
Time frame: Baseline to Week 56