A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects

NCT ID: NCT01842607

Last Updated: 2018-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 651 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-27
• Study Completion Date: 2015-03-13

Brief Summary

This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to consent for this study.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mepolizumab Arm

Subjects will receive 100 mg of Mepolizumab (in polypropylene syringe) injected subcutaneously (SC) once every 4 weeks for 12 months

Group Type: EXPERIMENTAL

Mepolizumab

Intervention Type: BIOLOGICAL

Mepolizumab (a fully humanised IgG antibody) 100 mg injected SC once every 4 weeks for 12 months. Mepolizumab will be provided as a lyophilised cake in sterile vials

Interventions

Mepolizumab

Mepolizumab (a fully humanised IgG antibody) 100 mg injected SC once every 4 weeks for 12 months. Mepolizumab will be provided as a lyophilised cake in sterile vials

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
• Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent.
• MEA115588 or MEA115575 study completion: Completion of the double-blind investigational product treatment during MEA115588 or MEA115575.
• Current Anti-Asthma Therapy: Asthma is currently being treated with a controller medication (i.e., inhaled corticosteroids [ICS] or other asthma controlled medication) and the subject has been on a controller medication for the past 12 weeks. Subjects will be expected to continue controller therapy for the duration of the study.
• 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.
• A serum pregnancy test is required of all females at the initial Baseline Visit (Visit 1). In addition, a urine pregnancy test will be performed for all females prior to enrollment, during each scheduled study visit prior to the injection of investigational product, and during the Follow-up Visit.

Exclusion Criteria

• Hypersensitivity: Hypersensitivity reaction related to study medication during the MEA115588 or MEA115575 that led to patient withdrawal. Subjects who experienced a localized injection site reaction do not need to be excluded.
• Health Status: Clinically significant change in health status during MEA115588 or MEA115575 which in the opinion of the investigator would make the subject unsuitable for participation in this long-term study.
• Malignancy: A current malignancy or malignancy that developed during MEA115588 or MEA115575 (subjects that had localized carcinoma of the skin which was resected for cure will not be excluded). [Note for South Korea: Korean subjects with a diagnosis of malignancy within 5 years are excluded]
• Prior SAE: A study related SAE in MEA115588 or MEA115575 that was assessed as possibly related to study medication by the investigator.
• Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
• ECG: Baseline ECG which has a clinically significant abnormality or which shows corrected QT interval with Fridericia (QTcF) >=450 millisecond (msec) or QTcF >=480 msec for subjects with Bundle Branch Block.
• Smoking status: Current smokers
• Liver Function: Liver function tests that meet any of the following during one of the last treatment visits in MEA115588 or MEA115575 : alanine transaminase (ALT) >=2 x upper limit of normal (ULN); aspartate transaminase (AST) >=2 x ULN; alkaline phosphatase >=2 x ULN; Bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%
• Hepatitis Status: Positive Hepatitis B Surface Antigen (HBsAg) screen at Visit 1
• ECG Over-read: Clinically significant abnormality identified during the central over-read during one of the last treatment visits in MEA115588 or MEA115575

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Newport Beach, California, United States

GSK Investigational Site

Riverside, California, United States

GSK Investigational Site

Rolling Hills Estates, California, United States

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Denver, Colorado, United States

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New Haven, Connecticut, United States

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Albany, Georgia, United States

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Baltimore, Maryland, United States

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Rochester, Minnesota, United States

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New York, New York, United States

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Rochester, New York, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Hershey, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

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Salt Lake City, Utah, United States

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Mar del Plata, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

GSK Investigational Site

San Rafael, Mendoza Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Mendoza, , Argentina

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New Lambton, New South Wales, Australia

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Bedford Park, South Australia, Australia

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Clayton, Victoria, Australia

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Nedlands, Western Australia, Australia

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Brussels, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Hamilton, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Saint-Charles-Borromée, Quebec, Canada

GSK Investigational Site

Trois-Rivières, Quebec, Canada

GSK Investigational Site

Rancagua, Reg Del Libert Bern Ohiggins, Chile

GSK Investigational Site

Santiago, , Chile

GSK Investigational Site

Talcahuano, , Chile

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Brno, , Czechia

GSK Investigational Site

Olomouc, , Czechia

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Olomouc, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Gières, , France

GSK Investigational Site

Le Kremlin-Bicêtre, , France

GSK Investigational Site

Lille, , France

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Lyon, , France

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Marseille, , France

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Montpellier, , France

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Nantes, , France

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Paris, , France

GSK Investigational Site

Perpignan, , France

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Strasbourg, , France

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Aschaffenburg, Bavaria, Germany

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Rüdersdorf, Brandenburg, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Gelnhausen, Hesse, Germany

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Neu-Isenburg, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Mainz, Rhineland-Palatinate, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Lübeck, Schleswig-Holstein, Germany

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Berlin, , Germany

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Hamburg, , Germany

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Foggia, Apulia, Italy

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Napoli, Campania, Italy

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Parma, Emilia-Romagna, Italy

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Genoa, Liguria, Italy

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Pietra Ligure (SV), Liguria, Italy

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Pisa, Tuscany, Italy

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Perugia, Umbria, Italy

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Cittadella (PD), Veneto, Italy

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Chiba, , Japan

GSK Investigational Site

Fukuoka, , Japan

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Fukuoka, , Japan

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Gunma, , Japan

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Hiroshima, , Japan

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Hokkaido, , Japan

GSK Investigational Site

Hyōgo, , Japan

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Ibaraki, , Japan

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Kanagawa, , Japan

GSK Investigational Site

Mie, , Japan

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Okinawa, , Japan

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Okinawa, , Japan

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Osaka, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

GSK Investigational Site

Guadalajara, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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Amsterdam, , Netherlands

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Leeuwarden, , Netherlands

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Bialystok, , Poland

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Krakow, , Poland

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Chelyabinsk, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

GSK Investigational Site

Anyang-si, , South Korea

GSK Investigational Site

Bucheon-si, , South Korea

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Cheongju, Chungcheongbuk-do, , South Korea

GSK Investigational Site

Daegu, , South Korea

GSK Investigational Site

Donggu Gwangju, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Kangwon-do, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Suwon, Kyonggi-do, , South Korea

GSK Investigational Site

Alicante, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

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Barcelona, , Spain

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Pozuelo de Alarcón/Madrid, , Spain

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Mykolayiv, , Ukraine

GSK Investigational Site

Vinnytsia, , Ukraine

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Leicester, Leicestershire, United Kingdom

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Bradford, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Plymouth, , United Kingdom

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Southampton, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Canada; Chile; Czechia; France; Germany; Italy; Japan; Mexico; Netherlands; Poland; Russia; South Korea; Spain; Ukraine; United Kingdom

References

Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4.

Reference Type: DERIVED

PMID: 34098955 (View on PubMed)

Yancey SW, Ortega HG, Keene ON, Bradford ES. Efficacy of add-on mepolizumab in adolescents with severe eosinophilic asthma. Allergy Asthma Clin Immunol. 2019 Sep 3;15:53. doi: 10.1186/s13223-019-0366-x. eCollection 2019.

Reference Type: DERIVED

PMID: 31507641 (View on PubMed)

Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.

Reference Type: DERIVED

PMID: 31447130 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30954640 (View on PubMed)

Lugogo N, Domingo C, Chanez P, Leigh R, Gilson MJ, Price RG, Yancey SW, Ortega HG. Long-term Efficacy and Safety of Mepolizumab in Patients With Severe Eosinophilic Asthma: A Multi-center, Open-label, Phase IIIb Study. Clin Ther. 2016 Sep;38(9):2058-2070.e1. doi: 10.1016/j.clinthera.2016.07.010. Epub 2016 Aug 21.

Reference Type: DERIVED

PMID: 27553751 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

115661

Identifier Type: -

Identifier Source: org_study_id