Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
Brief Summary:
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.
Detailed Description:
Approximately 148 patients will be randomized to receive benralizumab 30 mg SC or matching placebo. After enrolment, eligible patients will enter a 5-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.The first up to 74 patients that complete the 56-week treatment will have a 24-week follow-up (FU) period without dosing to assess durability of benefit. These patients will have the FU for the final safety assessment at week 80. The remaining patients will have a last FU visit 12 weeks after last dose for final safety assessments at week 60.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Benralizumab in Patients With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
Actual Study Start Date: November 25, 2019
Estimated Primary Completion Date: July 12, 2022
Estimated Study Completion Date: July 12, 2022
Arm:
- Experimental: Benralizumab
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 148 |
| Actual Study start date | 25 November 2019 |
| Estimated Study Completion Date | 12 July 2022 |