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Mepolizumab in Nasal Polyposis

NCT01362244 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2021-04-12

Study results available
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Summary

A two-part, randomised, double-blind, placebo controlled, multi-centre study to investigate the use of mepolizumab (SB-240563) in reducing the need for surgery in subjects with severe bilateral nasal polyposis.

Conditions

  • Nasal Polyps

Interventions

DRUG

Mepolizumab

750 mg of mepolizumab by IV infusion

DRUG

Placebo

Placebo by IV infusion

DRUG

Run In Medication

subjects will undergo a run-in period of 10 - 14 days on a low dose of Intranasal Steroids (INS).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-12
Primary Completion
2014-12-05
Completion
2014-12-05

Countries

  • Belgium
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01362244 on ClinicalTrials.gov