Completed

MEA115666: A Multi-centre, Open-label, Long Term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in the MEA112997 Trial

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What is being tested

Mepolizumab

Drug
Who is being recruted

Bronchial Diseases+6

+ Hypersensitivity

+ Hypersensitivity, Immediate

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorGlaxoSmithKline
Last updated: June 28, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: September 28, 2012

Actual date on which the first participant was enrolled.

This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab administered subcutaneously (SC) in addition to standard of care in subjects who participated in the MEA112997 study. At each clinic visit, adverse events will be assessed and exacerbations will also be reviewed.

NCT01691859
Principal SponsorGlaxoSmithKline
Last updated: June 28, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

347 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract DiseasesAsthma

Criteria

5 inclusion criteria required to participate
Currently being treated with a controller medication and the subject has been on a controller medication for the past 12 weeks
Informed Consent
MEA112997 Study Participation: Received at least 2 doses of double-blind investigational product during the MEA112997 trial
MEA112997 Treatment Assignment: If the subject received mepolizumab, they must have had a positive risk: benefit ratio
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9 exclusion criteria prevent from participating
A current malignancy or previous history of cancer in remission for less than 12 months prior to screening
Clinically significant change in health status since completing participation in the MEA112997 trial
Current smokers
For those subjects who had a SAE in MEA112997 that was assessed as possibly related to mepolizumab by the investigator
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects will receive 100 mg of mepolizumab (in 1ml polypropylene syringe) injected subcutaneously (SC) approximately every 4 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 64 locations

GSK Investigational Site

Long Beach, United StatesOpen GSK Investigational Site in Google Maps

GSK Investigational Site

Riverside, United States

GSK Investigational Site

Denver, United States

GSK Investigational Site

New Haven, United States
Completed64 Study Centers