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Effect of Benralizumab in Patients With Severe Nasal Polyps — OSTRO  

Nasal Polyps Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis (OSTRO)

Clinical Trial Summary

This is a randomized placebo controlled trial to evaluate the effect of benralizumab on people with severe nasal polyps.

Clinical Trial Description

The aim of this present study is to investigate the use of benralizumab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), with or without concomitant asthma/ aspirin exacerbated respiratory disease (AERD), whose severity is consistent with a need for surgery (total nasal polyps score (NPS) ≥5 and moderate to severe nasal blockage) despite treatment with intranasal corticosteroids (INCS) and a history of treatment with systemic corticosteroids (SCS) or prior surgery for NP. The effect of benralizumab 30 mg on nasal polyps will be assessed over a 56 week treatment period. All patients will have received standard adjunctive therapy (INCS) for at least 4 weeks prior to randomization, and the INCS will be continued throughout the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03627286
Study type Interventional
Source Johns Hopkins University
Contact
Status Recruiting
Phase Phase 3
Start date July 1, 2018
Completion date July 1, 2020
View Details
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