Effect of Benralizumab in Patients With Severe Nasal Polyps

Nasal Polyps Clinical Trial

— OSTRO  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03627286
• Other study ID #: IRB00162153
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Nasal Polyps
• Polyps

Intervention

Drug:
• Benralizumab
benralizumab 30mg SC
• Placebo
saline injection SC

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Nasal Polyp Score (NPS)	Bilateral endoscopic polyp score. Maximum score 8 (0-4 per side) with higher score indicating worse outcome. Scores will be compared at visit 3 and visit 11 following 56 weeks of treatment.	56 weeks
Primary	Mean Nasal Blockage Score (NBS)	Change from baseline in the mean nasal blockage score (NBS). Score range is 0-3 with higher score indicating worse outcome. Scores will be compared at visit 3 and visit 11 following 56 weeks of treatment.	56 weeks
Secondary	Sino-Nasal Outcome Test (SNOT)-22 Score	Change from baseline in the SNOT-22 symptom score. Score range is 0-110 with higher score indicating worse symptoms. Scores will be compared at visit 3 and visit 11 following 56 weeks of treatment.	56
Secondary	Time to Nasal Polyp Surgery	Time to nasal polyp surgery from baseline will be compared during 56 weeks of treatment.	56 weeks
Secondary	CT score	Polyp size will be determined by CT scan using the Lund-Mackay score (range 0-10) with higher score indicating bigger polyp size. Scores will be compared at visit 3 and visit 11 following 56 weeks of treatment.	56 weeks
Secondary	Smell Test	Change from baseline in the University of Pennsylvania Smell Identification Test (UPSIT). Score range is 0-40. Scores will be compared at visit 3 and visit 11 following 56 weeks of treatment.	56 weeks