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Clinical trial

Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)

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Last updated:24th Mar 2020
Status: Recruiting
Identifier: NCT04157335
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

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