This trial is active, not recruiting.

Condition asthma
Treatment mepolizumab
Phase phase 3
Sponsor GlaxoSmithKline
Start date September 2012
End date April 2018
Trial size 150 participants
Trial identifier NCT01691859, 115666


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Subjects will receive 100 mg of mepolizumab (in 1ml polypropylene syringe) injected subcutaneously (SC) approximately every 4 weeks.
100 mg of mepolizumab will be injected subcutaneously (SC) once every 4 weeks

Primary Outcomes

Frequency of all Adverse Events
time frame: 48 months

Secondary Outcomes

ECG parameters
time frame: 48 months
Clinical laboratory tests
time frame: 48 months
Vital Signs
time frame: 48 months
Annualized rate of exacerbation
time frame: 48 months
Quality of Life (QOL)
time frame: 48 months
Lung Function
time frame: 48 months
time frame: 48 months
Number of participant withdrawals
time frame: 48 months
Number of hospitalizations due to adverse events including asthma exacerbations
time frame: 48 months
Frequency of immune reactions
time frame: 48 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title MEA115666: A Multi-centre, Open-label, Long Term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in the MEA112997 Trial
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.