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

NCT01691859 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 1156662012-001643-51
• Study Type: interventional
• Target: 347
• Locations: 13 countries
• Sites: 64

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.

Conditions

Asthma

Keywords

extension study; Severe refractory asthma; safety; SB-240563; mepolizumab; eosinophils

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE)

  AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product (MP), whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. As Treated (AT) Population consisted of participants who received at least one dose of open label mepolizumab. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.

  Baseline (Week 0) to Week 240

Secondary Outcomes (15)

• Number of Participants Who Experienced On-treatment Systemic (i.e., Allergic/Immunoglobulin E [IgE]-Mediated and Non-allergic) and On-treatment Local Site Reactions

  Baseline (Week 0) to Week 240

• Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B])

  Baseline (Week 0) to Week 240

• Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F])

  Baseline (Week 0) to Week 240

• Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B)

  Baseline (Week 0) to Week 240

• Number of Participants With Clinical Chemistry Data of Potential Clinical Concern

  Baseline (Week 0) to Week 240

Study Arms (1)

Mepolizumab

EXPERIMENTAL

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

Drug: Mepolizumab

Interventions

Mepolizumab DRUG

100 mg of mepolizumab will be injected subcutaneously (SC) once every 4 weeks

Mepolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (64)

GSK Investigational Site

Long Beach, California, 90808, United States

Location

GSK Investigational Site

Riverside, California, 92506, United States

Location

GSK Investigational Site

Denver, Colorado, 80206, United States

Location

GSK Investigational Site

New Haven, Connecticut, 06520, United States

Location

GSK Investigational Site

Albany, Georgia, 31707, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40508, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44195, United States

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GSK Investigational Site

Hershey, Pennsylvania, 17033, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37212, United States

Location

GSK Investigational Site

Mar del Plata, Buenos Aires, B7600FZN, Argentina

Location

GSK Investigational Site

Buenos Aires, C1121ABE, Argentina

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GSK Investigational Site

Buenos Aires, C1426ABP, Argentina

Location

GSK Investigational Site

Mendoza, M5500CCG, Argentina

Location

GSK Investigational Site

New Lambton, New South Wales, 2305, Australia

Location

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

Location

GSK Investigational Site

Clayton, Victoria, 3168, Australia

Location

GSK Investigational Site

Melbourne, Victoria, 3004, Australia

Location

GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

GSK Investigational Site

Calgary, Alberta, T2N 4Z6, Canada

Location

GSK Investigational Site

Vancouver, British Columbia, V5Z 1M9, Canada

Location

GSK Investigational Site

Mississauga, Ontario, L5A 3V4, Canada

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GSK Investigational Site

Québec, Quebec, G1V 4G5, Canada

Location

GSK Investigational Site

Valparaíso, Región de Valparaíso, 2341131, Chile

Location

GSK Investigational Site

Puente Alto - Santiago, Región Metro de Santiago, 8207257, Chile

Location

GSK Investigational Site

Santiago, 8380453, Chile

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GSK Investigational Site

Talcahuano, 4270918, Chile

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GSK Investigational Site

Le Kremlin-Bicêtre, 94275, France

Location

GSK Investigational Site

Marseille, 13915, France

Location

GSK Investigational Site

Montpellier, 34295, France

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GSK Investigational Site

Saint-Pierre, 97448, France

Location

GSK Investigational Site

Rüdersdorf, Brandenburg, 15562, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Lübeck, Schleswig-Holstein, 23552, Germany

Location

GSK Investigational Site

Berlin, 10367, Germany

Location

GSK Investigational Site

Berlin, 10717, Germany

Location

GSK Investigational Site

Magdeburg, 39120, Germany

Location

GSK Investigational Site

Lodz, 90-153, Poland

Location

GSK Investigational Site

Wroclaw, 54-239, Poland

Location

GSK Investigational Site

Bucharest, 011461, Romania

Location

GSK Investigational Site

Bucharest, 050159, Romania

Location

GSK Investigational Site

Iași, 700115, Romania

Location

GSK Investigational Site

Târgu Mureş, 540143, Romania

Location

GSK Investigational Site

Barnaul, 656 045, Russia

Location

GSK Investigational Site

Chelyabinsk, 454106, Russia

Location

GSK Investigational Site

Kazan', 420008, Russia

Location

GSK Investigational Site

Moscow, 105 077, Russia

Location

GSK Investigational Site

Moscow, 123182, Russia

Location

GSK Investigational Site

Saint Petersburg, 194354, Russia

Location

GSK Investigational Site

St'Petersburg, 191015, Russia

Location

GSK Investigational Site

Cheongju, Chungcheongbuk-do, 361-711, South Korea

Location

GSK Investigational Site

Suwon, Kyonggi-do, 443-721, South Korea

Location

GSK Investigational Site

Dnipropetrovsk, 49051, Ukraine

Location

GSK Investigational Site

Donetsk, 83099, Ukraine

Location

GSK Investigational Site

Kharkiv, 61035, Ukraine

Location

GSK Investigational Site

Kiev, 03680, Ukraine

Location

GSK Investigational Site

Kyiv, 03038, Ukraine

Location

GSK Investigational Site

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

GSK Investigational Site

London, EC1M 6BQ, United Kingdom

Location

GSK Investigational Site

London, SW3 6HP, United Kingdom

Location

GSK Investigational Site

Manchester, M23 9LT, United Kingdom

Location

GSK Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 30359681 BACKGROUND

• 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.

  PMID: 30954640 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 25, 2012
• Study Start: September 28, 2012
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: June 28, 2023
• Results First Posted: May 22, 2018

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

Locations

RO (4); KR (2); DE (7); RU (7); GB (5); UA (5); CL (4); FR (4); PL (2); AR (4); AU (5); US (11); CA (4)