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A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis

NCT02020889 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2018-01-31

Study results available
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Summary

The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram \[mg\] administered subcutaneously \[SC\] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. During the treatment period, in accordance with standard of care, corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of \<=4 mg/day prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid requirement.

Conditions

  • Churg-Strauss Syndrome

Interventions

BIOLOGICAL

Mepolizumab

Mepolizumab will be provided as a lyophilized cake in sterile vials for individual use to be reconstituted with sterile water for Injection, just prior to use.

DRUG

Placebo

Placebo will be available as 0.9% sodium chloride

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-05
Primary Completion
2016-09-05
Completion
2016-09-05

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Japan
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT02020889 on ClinicalTrials.gov