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

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Mepolizumab	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	MEA115666: A Multi-centre, Open-label, Long Term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in the MEA112997 Trial

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Frequency of all Adverse Events [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ECG parameters [ Time Frame: 48 months ] [ Designated as safety issue: No ]
ECG parameters as measured by mean change and maximum change from baseline in QTcF and QT
Clinical laboratory tests [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Clinical laboratory tests as measured by abnormal parameters for hematology and clinical chemistry
Vital Signs [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Vital signs as measured by change in pulse and BP from baseline
Annualized rate of exacerbation [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Quality of Life (QOL) [ Time Frame: 48 months ] [ Designated as safety issue: No ]
QOL as measured by Asthma Control Questionnaire score (ACQ)-5
Lung Function [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Lung function as measured by changes from baseline in Forced vital capacity (FVC) and Forced expiratory volume in 1 second (FEV1) measured by clinic spirometry
Immunogenecity [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Immunogenecity as measured by positive neutralizing antibody
Number of participant withdrawals [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Number of participant withdrawals due to lack of efficacy or due to adverse events were summarized
Number of hospitalizations due to adverse events including asthma exacerbations [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Frequency of immune reactions [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	September 2012
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Mepolizumab Subjects will receive 100 mg of mepolizumab (in 1ml polypropylene syringe) injected subcutaneously (SC) approximately every 4 weeks.	Drug: Mepolizumab 100 mg of mepolizumab will be injected subcutaneously (SC) once every 4 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691859

Show 65 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01691859 History of Changes
Other Study ID Numbers:	115666
Study First Received:	September 13, 2012
Last Updated:	April 25, 2013
Health Authority:	Ukraine: Ministry of Health of Ukraine, State Expert Center (SEC) of the Ministry of Health of Ukraine Romania: Agentia Nationala a Medicamentului Chile:Ministerio de Salud de Chile France: Agence Nationale de Sécurité du Médicament et des produits de santé Poland: URZAD REJESTRACJI PRODUKTOW LECZNICZYCH, WYROBOW MEDYCZNYCH I PRODUKTOW BIOBOJCZYCH United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Russia: Russian Ministry of Health Canada: Health Canada Korea: Korea Food & Drug Administration Germany: Bundesinstitut für Arzneimittel und Medizinprodukte United Kingdom: Medicines and Healthcare Products Regulatory Agency Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

extension study
Severe refractory asthma
safety

SB-240563
mepolizumab
eosinophils

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013