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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Mepolizumab

About this trial

This is an interventional treatment trial for Asthma focused on measuring eosinophils, mepolizumab, SB-240563, safety, extension study, Severe refractory asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mepolizumab Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions

AEs were collected from the Baseline visit until the follow-up visit (approx. 12 weeks post-last dose). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.

Secondary Outcome Measures

Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies (NAb) at the Indicated Time Points

Blood samples were collected for the determination of anti-mepolizumab antibodies (ADA) just prior to administration of mepolizumab at indicated time points. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. Participants who switched from the 250 mg vial to the 100 mg vial required one immunogenicity sample prior to the first dose from the 100 mg vial and one sample prior to the second dose from the 100 mg vial at the next visit. The highest value post-baseline visit are based on each participant's highest post-baseline titer. NAb assay result was only presented for participants with positive ADA assay. Highest value post-baseline would be positive for a participant who had both negative and positive post-baseline results.

Annualized Rate of Exacerbations Per Year

Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of region, exacerbations in the year prior to the start of MEA115588 or MEA115575 (as an ordinal variable) and baseline percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.

Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score

The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze). The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 5 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.

Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period

FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 28 and Week 52. Spirometry was performed within ± 1 hour of the Baseline assessment. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value.

Number of Participants Withdrawn Due to Lack of Efficacy and Adverse Events From the Study

AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.

Number of Participants Hospitalized Due to Exacerbations and Adverse Events

AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit.

Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions

Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Hypersensitivity reactions (i.e., allergic or IgE-mediated reactions) were monitored using the diagnostic criteria for anaphylaxis as outlined by the 2006 Joint NIAID/FAAN Second Symposium on Anaphylaxis. Information was also collected to assess localized site reactions as determined by the investigator. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.

Number of Participants With Electrocardiogram (ECG) Findings at Any Time Post Baseline

12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). ECG findings were summarised at any time post Baseline for participants as normal, abnormal-not clinically significant(A-NCS) and abnormal-clinically significant (A-CS).

Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose)

12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value.

Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline

12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarised at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial.

Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline

12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarized at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Week 52

Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point.

Change From Baseline in Pulse Rate Assessed at Week 52

Vital sign measurements including sitting pulse was performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point.

Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline

Clinical chemistry laboratory parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase, high density lipoprotein (HDL) cholesterol, indirect bilirubin, low density lipoprotein (LDL) cholesterol, lactate dehydrogenase, phosphate, plasma/serum protein, potassium, serum glucose, sodium, triglycerides, urea, and very low density lipoprotein (VLDL) cholesterol assessed at the indicated time points. Laboratory abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.

Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline

Haematology laboratory parameters included basophils, basophils/leukocytes, blood erythrocytes, blood leukocytes, eosinophils, eosinophils/leukocytes, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes distribution width (EDW), hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils segmented (NS), neutrophils/leukocytes, platelets, reticulocytes assessed at Baseline, Week 4, Week 16, Week 28, Week 52 and follow-up visit (approx. 12 weeks post-last dose). Hematology abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline is equal to all visits (including scheduled and unscheduled) post Baseline were considered for this visit derivation. If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.

Full Information

NCT ID

NCT01842607

First Posted

April 25, 2013

Last Updated

August 2, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01842607

Brief Title

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

Official Title

A Multi-centre, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in theMEA115588 or MEA115575 Trials

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

May 27, 2013 (Actual)

Primary Completion Date

March 13, 2015 (Actual)

Study Completion Date

March 13, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

651 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mepolizumab Arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Mepolizumab

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions

Description

Time Frame

From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose])

Secondary Outcome Measure Information:

Title

Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies (NAb) at the Indicated Time Points

Description

Time Frame

From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Title

Annualized Rate of Exacerbations Per Year

Description

Time Frame

Baseline up to Exit Visit (approx. 52 weeks) or if Early Withdrawal 4 weeks post last dose

Title

Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score

Description

Time Frame

From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Title

Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period

Description

Time Frame

From Baseline and up to Week 52

Title

Number of Participants Withdrawn Due to Lack of Efficacy and Adverse Events From the Study

Description

Time Frame

From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Title

Number of Participants Hospitalized Due to Exacerbations and Adverse Events

Description

AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit.

Time Frame

From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Title

Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions

Description

Time Frame

From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Title

Number of Participants With Electrocardiogram (ECG) Findings at Any Time Post Baseline

Description

Time Frame

From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Title

Description

12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value.

Time Frame

From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Title

Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline

Description

Time Frame

From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Title

Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline

Description

12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarized at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Time Frame

From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Title

Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Week 52

Description

Time Frame

Baseline and Week 52

Title

Change From Baseline in Pulse Rate Assessed at Week 52

Description

Time Frame

Baseline and Week 52

Title

Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline

Description

Time Frame

From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

Title

Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline

Description

Time Frame

From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90808

Country

United States

Facility Name

GSK Investigational Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

GSK Investigational Site

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

GSK Investigational Site

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

GSK Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

GSK Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

GSK Investigational Site

City

Albany

State/Province

Georgia

ZIP/Postal Code

31707

Country

United States

Facility Name

GSK Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

GSK Investigational Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

GSK Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

GSK Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

Facility Name

GSK Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

GSK Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

GSK Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Facility Name

GSK Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

GSK Investigational Site

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

PA 15213

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

GSK Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

GSK Investigational Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

7600

Country

Argentina

Facility Name

GSK Investigational Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

B7600FZN

Country

Argentina

Facility Name

GSK Investigational Site

City

San Rafael

State/Province

Mendoza

ZIP/Postal Code

5600

Country

Argentina

Facility Name

GSK Investigational Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DBS

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1424BSF

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autónoma de Buenos Aires

ZIP/Postal Code

C1426ABP

Country

Argentina

Facility Name

GSK Investigational Site

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

GSK Investigational Site

City

New Lambton

State/Province

New South Wales

ZIP/Postal Code

2310

Country

Australia

Facility Name

GSK Investigational Site

City

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5042

Country

Australia

Facility Name

GSK Investigational Site

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

GSK Investigational Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

GSK Investigational Site

City

Bruxelles

ZIP/Postal Code

1020

Country

Belgium

Facility Name

GSK Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

GSK Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

GSK Investigational Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

GSK Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

GSK Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2G3

Country

Canada

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

GSK Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2H 2A6

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1T8

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 2P4

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

GSK Investigational Site

City

St-Charles-Borromée

State/Province

Quebec

ZIP/Postal Code

J6E 2B4

Country

Canada

Facility Name

GSK Investigational Site

City

Trois Rivieres

State/Province

Quebec

ZIP/Postal Code

G8T 7A1

Country

Canada

Facility Name

GSK Investigational Site

City

Rancagua

State/Province

Reg Del Libert Bern Ohiggins

ZIP/Postal Code

2841959

Country

Chile

Facility Name

GSK Investigational Site

City

Santiago

ZIP/Postal Code

8380453

Country

Chile

Facility Name

GSK Investigational Site

City

Talcahuano

ZIP/Postal Code

4270918

Country

Chile

Facility Name

GSK Investigational Site

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

GSK Investigational Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

GSK Investigational Site

City

Olomouc

ZIP/Postal Code

775 25

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 4

ZIP/Postal Code

140 00

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 8

ZIP/Postal Code

180 01

Country

Czechia

Facility Name

GSK Investigational Site

City

Gières

ZIP/Postal Code

38610

Country

France

Facility Name

GSK Investigational Site

City

Le Kremlin-Bicêtre Cedex

ZIP/Postal Code

94275

Country

France

Facility Name

GSK Investigational Site

City

Lille cedex

ZIP/Postal Code

59037

Country

France

Facility Name

GSK Investigational Site

City

Lyon cedex 04

ZIP/Postal Code

69317

Country

France

Facility Name

GSK Investigational Site

City

Marseille cedex 20

ZIP/Postal Code

13915

Country

France

Facility Name

GSK Investigational Site

City

Montpellier cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

GSK Investigational Site

City

Nantes cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

GSK Investigational Site

City

Paris Cedex 18

ZIP/Postal Code

75877

Country

France

Facility Name

GSK Investigational Site

City

Perpignan

ZIP/Postal Code

66000

Country

France

Facility Name

GSK Investigational Site

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

GSK Investigational Site

City

Aschaffenburg

State/Province

Bayern

ZIP/Postal Code

63739

Country

Germany

Facility Name

GSK Investigational Site

City

Ruedersdorf

State/Province

Brandenburg

ZIP/Postal Code

15562

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60389

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60596

Country

Germany

Facility Name

GSK Investigational Site

City

Gelnhausen

State/Province

Hessen

ZIP/Postal Code

63571

Country

Germany

Facility Name

GSK Investigational Site

City

Neu-Isenburg

State/Province

Hessen

ZIP/Postal Code

63263

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30173

Country

Germany

Facility Name

GSK Investigational Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

GSK Investigational Site

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39112

Country

Germany

Facility Name

GSK Investigational Site

City

Luebeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23552

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10367

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22299

Country

Germany

Facility Name

GSK Investigational Site

City

Napoli

State/Province

Campania

ZIP/Postal Code

80131

Country

Italy

Facility Name

GSK Investigational Site

City

Parma

State/Province

Emilia-Romagna

ZIP/Postal Code

43100

Country

Italy

Facility Name

GSK Investigational Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

GSK Investigational Site

City

Pietra Ligure (SV)

State/Province

Liguria

ZIP/Postal Code

17027

Country

Italy

Facility Name

GSK Investigational Site

City

Foggia

State/Province

Puglia

ZIP/Postal Code

71100

Country

Italy

Facility Name

GSK Investigational Site

City

Pisa

State/Province

Toscana

ZIP/Postal Code

56124

Country

Italy

Facility Name

GSK Investigational Site

City

Perugia

State/Province

Umbria

ZIP/Postal Code

06156

Country

Italy

Facility Name

GSK Investigational Site

City

Cittadella (PD)

State/Province

Veneto

ZIP/Postal Code

35013

Country

Italy

Facility Name

GSK Investigational Site

City

Chiba

ZIP/Postal Code

296-8602

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

802-0052

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

811-1394

Country

Japan

Facility Name

GSK Investigational Site

City

Gunma

ZIP/Postal Code

370-0615

Country

Japan

Facility Name

GSK Investigational Site

City

Hiroshima

ZIP/Postal Code

732-0052

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

070-8644

Country

Japan

Facility Name

GSK Investigational Site

City

Hyogo

ZIP/Postal Code

672-8064

Country

Japan

Facility Name

GSK Investigational Site

City

Ibaraki

ZIP/Postal Code

319-1113

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

252-0392

Country

Japan

Facility Name

GSK Investigational Site

City

Mie

ZIP/Postal Code

515-8544

Country

Japan

Facility Name

GSK Investigational Site

City

Okinawa

ZIP/Postal Code

901-2132

Country

Japan

Facility Name

GSK Investigational Site

City

Okinawa

ZIP/Postal Code

904-2293

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

596-8501

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

102-0083

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

171-0014

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

187-0024

Country

Japan

Facility Name

GSK Investigational Site

City

Anyang-Si

ZIP/Postal Code

431-070

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Bucheon-si,

ZIP/Postal Code

420-767

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Cheongju, Chungcheongbuk-do

ZIP/Postal Code

361-711

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Daegu

ZIP/Postal Code

705-717

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Donggu Gwangju

ZIP/Postal Code

501757

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Kangwon-do

ZIP/Postal Code

220-701

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Suwon, Kyonggi-do

ZIP/Postal Code

443-721

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44100

Country

Mexico

Facility Name

GSK Investigational Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64020

Country

Mexico

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

GSK Investigational Site

City

Bialystok

ZIP/Postal Code

15-044

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

31-024

Country

Poland

Facility Name

GSK Investigational Site

City

Chelyabinsk

ZIP/Postal Code

454021

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

123 182

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

194356

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Alicante

ZIP/Postal Code

03004

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

GSK Investigational Site

City

Pozuelo De Alarcón/Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

GSK Investigational Site

City

Kharkiv

ZIP/Postal Code

61124

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

GSK Investigational Site

City

Mykolayiv

ZIP/Postal Code

54003

Country

Ukraine

Facility Name

GSK Investigational Site

City

Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

GSK Investigational Site

City

Leicester

State/Province

Leicestershire

ZIP/Postal Code

LE3 9QP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bradford

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

EC1M 6BQ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

34098955

Citation

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.

Results Reference

derived

PubMed Identifier

31507641

Citation

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.

Results Reference

derived

PubMed Identifier

31447130

Citation

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.

Results Reference

derived

PubMed Identifier

30954640

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.

Results Reference

derived

PubMed Identifier

27553751

Citation

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.

Results Reference

derived

Links:

URL

https://www.clinicalstudydatarequest.com

Description

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

Available IPD and Supporting Information:

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115661

Available IPD/Information Comments

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

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115661

Available IPD/Information Comments

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

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115661

Available IPD/Information Comments

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

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115661

Available IPD/Information Comments

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

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115661

Available IPD/Information Comments

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

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115661

Available IPD/Information Comments

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

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115661

Available IPD/Information Comments

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

Learn more about this trial

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

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

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial