MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects

• Status: Completed
• Trial end date: 2017-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion Criteria:

• 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.

• Currently being treated with a controller medication and the subject has been on a controller medication for the past 12 weeks.

• Male or Eligible Female Subjects. To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control for the duration of the trial and for 4 months after the last study drug administration.

Exclusion Criteria:

• Hypersensitivity related to mepolizumab.

• Clinically significant change in health status since completing participation in the MEA112997 trial.

• A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.

• For those subjects who had a SAE in MEA112997 that was assessed as possibly related to mepolizumab by the investigator.

• Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.

• Screening ECG which has a clinically significant abnormality.

• Received Xolair (omalizumab) within the past 130 days.

• Participated in a clinical trial within the past 30 days or have received investigational medication within five terminal half-lives of Screen Visit, whichever is longer.

• Current smokers.