Clinical trial NCT01691859: MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects
Official title: MEA115666: A Multi-centre, Open-label, Long Term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in the MEA112997 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: extension study
Severe refractory asthma
safety
SB-240563
mepolizumab
eosinophils
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-09-25
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE)
timeFrame: Baseline (Week 0) to Week 240
Secondary outcomes:
measure: Number of Participants Who Experienced On-treatment Systemic (i.e., Allergic/Immunoglobulin E [IgE]-Mediated and Non-allergic) and On-treatment Local Site Reactions
timeFrame: Baseline (Week 0) to Week 240
measure: Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B])
timeFrame: Baseline (Week 0) to Week 240
measure: Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F])
timeFrame: Baseline (Week 0) to Week 240
measure: Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B)
timeFrame: Baseline (Week 0) to Week 240
measure: Number of Participants With Clinical Chemistry Data of Potential Clinical Concern
timeFrame: Baseline (Week 0) to Week 240
measure: Number of Participants With Hematology Data of Potential Clinical Concern
timeFrame: Baseline (Week 0) to Week 240
measure: Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure
timeFrame: Baseline (Week 0) to Week 240
measure: Mean Change From Baseline in Vital Signs-Sitting Pulse Rate
timeFrame: Baseline (Week 0) to Week 240
measure: Annualized Rate of On-treatment Exacerbations
timeFrame: Baseline (Week 0) to Week 240
measure: Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score
timeFrame: Baseline (Week 0) to Week 240
measure: Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline (Week 0) to Week 240
measure: Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb)
timeFrame: Baseline (Week 0) to Week 240
measure: Number of Participants Who Withdrew Due to Lack of Efficacy
timeFrame: Baseline (Week 0) to Week 240
measure: Number of Participants Requiring Hospitalizations Due to Adverse Events Including Asthma Exacerbations
timeFrame: Baseline (Week 0) to Week 240
measure: Number of Participants Who Withdrew Due to AE
timeFrame: Baseline (Week 0) to Week 240
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Riverside
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: New Haven
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Albany
country: United States
facility: GSK Investigational Site
state: Georgia
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Hershey
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Mar del Plata
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: New Lambton
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Clayton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Quebec City
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Puente Alto - Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Valparaiso
country: Chile
facility: GSK Investigational Site
state: Valparaíso
city: Santiago
country: Chile
facility: GSK Investigational Site
city: Talcahuano
country: Chile
facility: GSK Investigational Site
city: Le Kremlin-Bicêtre Cedex
country: France
facility: GSK Investigational Site
city: Marseille cedex 20
country: France
facility: GSK Investigational Site
city: Montpellier cedex 5
country: France
facility: GSK Investigational Site
city: Saint Pierre cedex
country: France
facility: GSK Investigational Site
city: Ruedersdorf
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Frankfurt am Main
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Luebeck
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Magdeburg
country: Germany
facility: GSK Investigational Site
city: Cheongju, Chungcheongbuk-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon, Kyonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Iasi
country: Romania
facility: GSK Investigational Site
city: Targu Mures
country: Romania
facility: GSK Investigational Site
city: Barnaul
country: Russian Federation
facility: GSK Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: GSK Investigational Site
city: Kazan
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St'Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Donetsk
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kiev
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Leicester
country: United Kingdom
facility: GSK Investigational Site
state: Leicestershire
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Southampton
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Khatri S, Moore W, Gibson PG, Leigh R, Bourdin A, Maspero J, Barros M, Buhl R, Howarth P, Albers FC, Bradford ES, Gilson M, Price RG, Yancey SW, Ortega H. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019 May;143(5):1742-1751.e7. doi: 10.1016/j.jaci.2018.09.033. Epub 2018 Oct 23.
citation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5. No abstract available.