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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Mepolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01691859

115666

2012-001643-51 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 347 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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347 participants in 1 patient group

Mepolizumab

Experimental group

Description:

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

Treatment:

Drug: Mepolizumab