Effect of Benralizumab in Patients With Severe Nasal Polyps
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/16/2018 |
| Start Date: | July 1, 2018 |
| End Date: | July 1, 2020 |
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis (OSTRO)
This is a randomized placebo controlled trial to evaluate the effect of benralizumab on
people with severe nasal polyps.
people with severe nasal polyps.
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.
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.
Inclusion Criteria:
- Age 18-75
- Severe bilateral nasal polyps (score 5 out of 8)
- SNOT-22 score > 30
- At least 70% compliance with inhaled nasal steroid based on daily diary
- Minimum weight of 40kg
- Negative pregnancy test for documented post menopausal for women
Exclusion Criteria:
- Any sinus surgery within the past 6 months
We found this trial at
1
site
733 North Broadway
Baltimore, Maryland 21205
Baltimore, Maryland 21205
(410) 955-3182
Phone: 410-550-8017
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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