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Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Mepolizumab IV

Mepolizumab SC

IV Placebo

SC Placebo

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Able to give written informed consent prior to participation in the study
At least 12 years of age at visit 1 and a minimum weight of 45 kilogram (kg)
A well-documented requirement for regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS)
Current treatment with an additional controller medication, besides ICS, for at least 3 months or a documented failure in the past 12 months of an additional controller medication for at least 3 successive months
Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma
At Visit 1, a pre-bronchodilator FEV1 <80% (for subjects >= 18 years of age), a pre-bronchodilator FEV1 <90% or FEV1:FVC ratio <0.8 (for subjects 12-17 years of age).
Previously confirmed history of two or more exacerbations requiring treatment with systemic CS
Male or Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control)
French subjects will be included only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

Current smokers or former smokers with a smoking history of >=10 pack years
Presence of a known pre-existing, clinically important lung condition other than asthma
A current malignancy or previous history of malignancy in less than 12 months
Known, pre-existing, unstable liver disease cirrhosis and known biliary abnormalities
Known, pre-existing severe or clinically significant cardiovascular disease
known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment
Subjects with any eosinophilic diseases
QTc(F) ≥450msec or QTc(F) ≥480 msec
A history of alcohol/substance abuse
Subject with known immunodeficiency
Subjects who have received omalizumab within 130 days of Visit 1 or any monoclonal antibody (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1
Subjects who have received treatment with an investigational drug within the past 30 days or five terminal phase half-lives of the drug whichever is longer
Subjects with allergy/intolerance to a monoclonal antibody or biologic.
Subjects who are pregnant or breastfeeding
Subjects who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations
Previously participated in any study with mepolizumab and received investigational product (including placebo)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Mepolizumab IV

Mepolizumab SC

Placebo

Arm Description

Mepolizumab 75 mg will be administered intravenously approximately every 4 weeks with the last dose at week 32. Subjects in the Mepolizumab IV arm will receive mepolizumab 75 mg intravenously and placebo SC once every 4 weeks with the last dose at Week 28 (total of 8 doses)

Subjects in the Mepolizumab SC arm will receive mepolizumab 100 mg SC and placebo IV once every 4 weeks with the last dose at Week 28 (total of 8 doses)

Subjects in the Placebo arm will receive matching placebo SC and placebo IV once every 4 weeks with the last dose at Week 28 (total of 8 doses)

Outcomes

Primary Outcome Measures

Number of Clinically Significant Exacerbations of Asthma Per Year

Clinically significant exacerbations of asthma are defined as worsening of asthma which required 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 of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.

Secondary Outcome Measures

Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visits Per Year

Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an ICU) Per Year

Clinically significant exacerbations of asthma is defined as worsening of asthma which required 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 of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.

Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 32

FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the baseline value. Analysis performed using mixed model repeated measures with covariates of baseline, region, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by baseline and visit by treatment group.

Mean Change From Baseline in the St. George's Respiratory Questionnaire Total Score at Week 32

The St. George's Respiratory Questionnaire is an established instrument, comprising 50 questions, evaluating symptoms, activity, and impacts; to measure Quality of Life in participants with diseases of airway obstruction and to elicit the participant's opinion of his/her health. The lowest possible value is zero and the highest possible value is 100. The higher values correspond to greater impairment in quality of life. The questionnaire was administered at Baseline (Visit 2) and at the Exit Visit (approximately 4 weeks after the last dose of study treatment). The change from baseline is defined as the difference between the value of the endpoint at the time point of interest and the baseline value. Analysis performed using analysis of covariance with covariates of baseline, region, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), baseline % predicted FEV1, and treatment.

Full Information

NCT ID

NCT01691521

First Posted

September 20, 2012

Last Updated

August 2, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01691521

Brief Title

Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

Official Title

MEA115588 A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

October 8, 2012 (undefined)

Primary Completion Date

January 1, 2014 (Actual)

Study Completion Date

January 18, 2014 (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 study will evaluate two dose regimens of mepolizumab [75mg intravenous (i.v.) or 100mg subcutaneous (SC) every 4 weeks] compared with placebo over a 32 week treatment period in subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be measured by a reduction in the frequency of asthma exacerbations. Additional efficacy assessments will include measurements of lung function, symptom scores, and quality of life. Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse events. This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in MEA115588, who meet all eligibility criteria at screening visit, will enter the run-in period. Those subjects that are not able/eligible to be randomised at the end of the 6 week run-in period will be deemed run-in failures. Subjects will remain on their current maintenance therapy throughout the run-in, double-blind treatment administration and follow-up periods. Subjects who meet the randomisation eligibility criteria will be randomised in a 1:1:1 ratio to receive one of the following treatments every 4 weeks for a total of 8 doses: Mepolizumab 75 miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC and placebo i.v. or Placebo i.v. and placebo SC. Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to participate in the OLE trial.

6. Conditions and Keywords

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

Asthma

Keywords

safety, SB-240563, efficacy, placebo, eosinophils, mepolizumab, Severe refractory asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

580 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mepolizumab IV

Arm Type

Experimental

Arm Description

Arm Title

Mepolizumab SC

Arm Type

Experimental

Arm Description

Subjects in the Mepolizumab SC arm will receive mepolizumab 100 mg SC and placebo IV once every 4 weeks with the last dose at Week 28 (total of 8 doses)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects in the Placebo arm will receive matching placebo SC and placebo IV once every 4 weeks with the last dose at Week 28 (total of 8 doses)

Intervention Type

Drug

Intervention Name(s)

Mepolizumab IV

Intervention Description

Mepolizumab 75 mg IV will be administered every 4 weeks with the last dose at Week 28

Intervention Type

Drug

Intervention Name(s)

Mepolizumab SC

Intervention Description

Mepolizumab 100 mg SC will be administered every 4 weeks with the last dose at Week 28

Intervention Type

Drug

Intervention Name(s)

IV Placebo

Intervention Description

Normal saline (placebo) will be administered IV every 4 weeks with the last dose at Week 28

Intervention Type

Drug

Intervention Name(s)

SC Placebo

Intervention Description

Normal saline (placebo) will be administered SC every 4 weeks with the last dose at Week 28

Primary Outcome Measure Information:

Title

Number of Clinically Significant Exacerbations of Asthma Per Year

Description

Time Frame

From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose

Secondary Outcome Measure Information:

Title

Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visits Per Year

Description

Time Frame

From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose

Title

Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an ICU) Per Year

Description

Time Frame

From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose

Title

Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 32

Description

Time Frame

Baseline, Week 32

Title

Mean Change From Baseline in the St. George's Respiratory Questionnaire Total Score at Week 32

Description

Time Frame

Baseline, Week 32

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Able to give written informed consent prior to participation in the study At least 12 years of age at visit 1 and a minimum weight of 45 kilogram (kg) A well-documented requirement for regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS) Current treatment with an additional controller medication, besides ICS, for at least 3 months or a documented failure in the past 12 months of an additional controller medication for at least 3 successive months Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma At Visit 1, a pre-bronchodilator FEV1 <80% (for subjects >= 18 years of age), a pre-bronchodilator FEV1 <90% or FEV1:FVC ratio <0.8 (for subjects 12-17 years of age). Previously confirmed history of two or more exacerbations requiring treatment with systemic CS Male or Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control) French subjects will be included only if either affiliated to or a beneficiary of a social security category. Exclusion Criteria: Current smokers or former smokers with a smoking history of >=10 pack years Presence of a known pre-existing, clinically important lung condition other than asthma A current malignancy or previous history of malignancy in less than 12 months Known, pre-existing, unstable liver disease cirrhosis and known biliary abnormalities Known, pre-existing severe or clinically significant cardiovascular disease known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment Subjects with any eosinophilic diseases QTc(F) ≥450msec or QTc(F) ≥480 msec A history of alcohol/substance abuse Subject with known immunodeficiency Subjects who have received omalizumab within 130 days of Visit 1 or any monoclonal antibody (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1 Subjects who have received treatment with an investigational drug within the past 30 days or five terminal phase half-lives of the drug whichever is longer Subjects with allergy/intolerance to a monoclonal antibody or biologic. Subjects who are pregnant or breastfeeding Subjects who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations Previously participated in any study with mepolizumab and received investigational product (including placebo)

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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

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

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

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

27705

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

Columbus

State/Province

Ohio

ZIP/Postal Code

43221

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

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

84132-2409

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

2305

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

Parkville

ZIP/Postal Code

3052

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

T6G2E1

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

Burlington

State/Province

Ontario

ZIP/Postal Code

L7N 3V2

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

GSK Investigational Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 5A6

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

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

Perpignan

ZIP/Postal Code

66000

Country

France

Facility Name

GSK Investigational Site

City

Saint Pierre cedex

ZIP/Postal Code

97448

Country

France

Facility Name

GSK Investigational Site

City

Aschaffenburg

State/Province

Bayern

ZIP/Postal Code

63739

Country

Germany

Facility Name

GSK Investigational Site

City

Potsdam

State/Province

Brandenburg

ZIP/Postal Code

14478

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 am Main

State/Province

Hessen

ZIP/Postal Code

60596

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

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

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

43125

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

Fukuoka

ZIP/Postal Code

832-0059

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

062-8618

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

651-0072

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

Kumamoto

ZIP/Postal Code

861-1196

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

560-8552

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

Jeonju-si, Jeollabuk-Do

ZIP/Postal Code

561-712

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

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45040

Country

Mexico

Facility Name

GSK Investigational Site

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45200

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

México DF

ZIP/Postal Code

14050

Country

Mexico

Facility Name

GSK Investigational Site

City

Chelyabinsk

ZIP/Postal Code

454106

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

123182

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

08036

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08041

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

Kiev

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

Bradford

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Glasgow

ZIP/Postal Code

G11 6NT

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

EC1M 6BQ

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

34158028

Citation

Lemiere C, Taille C, Lee JK, Smith SG, Mallett S, Albers FC, Bradford ES, Yancey SW, Liu MC. Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials. Respir Res. 2021 Jun 22;22(1):184. doi: 10.1186/s12931-021-01767-z.

Results Reference

derived

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

33475231

Citation

Best N, Price RG, Pouliquen IJ, Keene ON. Assessing efficacy in important subgroups in confirmatory trials: An example using Bayesian dynamic borrowing. Pharm Stat. 2021 May;20(3):551-562. doi: 10.1002/pst.2093. Epub 2021 Jan 21.

Results Reference

derived

PubMed Identifier

32515118

Citation

Wardlaw A, Howarth PH, Israel E, Taille C, Quirce S, Mallett S, Bates S, Albers FC, Kwon N. Fungal sensitization and its relationship to mepolizumab response in patients with severe eosinophilic asthma. Clin Exp Allergy. 2020 Jul;50(7):869-872. doi: 10.1111/cea.13680. Epub 2020 Jun 25. No abstract available.

Results Reference

derived

PubMed Identifier

32450626

Citation

Kim MK, Park HS, Park CS, Min SJ, Albers FC, Yancey SW, Mayer B, Kwon N. Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. Korean J Intern Med. 2021 Mar;36(2):362-370. doi: 10.3904/kjim.2019.198. Epub 2020 May 26.

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

31262378

Citation

Khurana S, Lyness JM, Mallett S, Nelsen LM, Prazma CM, Albers FC, Forshag M, Llanos JP, Yancey SW, Ortega HG. Association of depressive symptoms with health status and markers of uncontrolled severe asthma. Allergy Asthma Proc. 2019 Jul 1;40(4):230-239. doi: 10.2500/aap.2019.40.4229.

Results Reference

derived

PubMed Identifier

31251094

Citation

Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28.

Results Reference

derived

PubMed Identifier

31047111

Citation

Yancey SW, Bradford ES, Keene ON. Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of >/=150-300 cells/muL. Respir Med. 2019 May;151:139-141. doi: 10.1016/j.rmed.2019.04.008. Epub 2019 Apr 8.

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

29949045

Citation

Ortega H, Menzies-Gow A, Llanos JP, Forshag M, Albers F, Gunsoy N, Bradford ES, Yancey SW, Kraft M. Rapid and Consistent Improvements in Morning PEF in Patients with Severe Eosinophilic Asthma Treated with Mepolizumab. Adv Ther. 2018 Jul;35(7):1059-1068. doi: 10.1007/s12325-018-0727-8. Epub 2018 Jun 15.

Results Reference

derived

PubMed Identifier

29398640

Citation

Ortega H, Yancey SW, Keene ON, Gunsoy NB, Albers FC, Howarth PH. Asthma Exacerbations Associated with Lung Function Decline in Patients with Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):980-986.e1. doi: 10.1016/j.jaip.2017.12.019. Epub 2018 Feb 15.

Results Reference

derived

PubMed Identifier

29258789

Citation

Gunsoy NB, Cockle SM, Yancey SW, Keene ON, Bradford ES, Albers FC, Pavord ID. Evaluation of Potential Continuation Rules for Mepolizumab Treatment of Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):874-882.e4. doi: 10.1016/j.jaip.2017.11.026. Epub 2017 Dec 16.

Results Reference

derived

PubMed Identifier

28687231

Citation

Albers FC, Price RG, Smith SG, Yancey SW. Mepolizumab efficacy in patients with severe eosinophilic asthma receiving different controller therapies. J Allergy Clin Immunol. 2017 Nov;140(5):1464-1466.e4. doi: 10.1016/j.jaci.2017.06.010. Epub 2017 Jul 4. No abstract available.

Results Reference

derived

PubMed Identifier

27087007

Citation

Magnan A, Bourdin A, Prazma CM, Albers FC, Price RG, Yancey SW, Ortega H. Treatment response with mepolizumab in severe eosinophilic asthma patients with previous omalizumab treatment. Allergy. 2016 Sep;71(9):1335-44. doi: 10.1111/all.12914. Epub 2016 May 24.

Results Reference

derived

PubMed Identifier

25199059

Citation

Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, Chanez P; MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1198-207. doi: 10.1056/NEJMoa1403290. Epub 2014 Sep 8. Erratum In: N Engl J Med. 2015 Apr 30;372(18):1777.

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

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115588

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

115588

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

115588

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

115588

Available IPD/Information Comments

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

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

115588

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

115588

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

115588

Available IPD/Information Comments

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

Learn more about this trial

Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

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Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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