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Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma (DREAM)

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Mepolizumab 750

Mepolizumab 250

Mepolizumab 75

Placebo saline

About this trial

This is an interventional treatment trial for Asthma focused on measuring Dose-ranging, Safety, Pharmacodynamics, eosinophils, SB-240563, Efficacy, Severe refractory asthma, mepolizumab, Placebo

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female
Aged 12 to 65 years inclusive
Minimum weight 45kg
Clinical features of severe refractory asthma
Well documented requirement for high dose inhaled corticosteroids (ICS) [i.e. >= 880mcg/day fluticasone propionate or equivalent daily] for at least 12 months
Using additional controller medication in addition to high dose ICS for at least 12 months
Persistent airflow obstruction indicated by a pre-bronchodilator FEV1<80% predicted at visit 1 or 2 or peak flow diurnal variability of >20% on 3 or more days during the run-in
Airway inflammation which is likely to be eosinophilic in nature demonstrated by either raised peripheral blood eosinophils (>=300/microL), sputum eosinophils (>=3%), exhaled nitric oxide (>=50ppb) or prompt deterioration of asthma control following a <=25% reduction in regular maintenance dose of inhaled or oral corticosteroids (OCS)
History of 2 or more exacerbations requiring systemic corticosteroids in the previous 12 months
Evidence of asthma documented by airway reversibility, airway hyperresponsiveness or airflow variability
ECG assessment demonstrating QTc<450msec or QTc<480msec for patients with bundle branch block
Liver function tests demonstrating ALT<2xUpper Limit of Normal (ULN), AST<2xULN, Alk Phos <=1.5xULN, bilirubin <=1.5xULN
Female of non-child-bearing potential or child-bearing potential with a negative pregnancy test at screening and prepared to agree to an acceptable method of contraception
Able to give written informed consent
Able to read, comprehend and write at a sufficient level to complete study materials

Exclusion Criteria:

Current smokers or smoking history of >=10 pack years
Clinically important lung condition other than asthma
Diagnosis of malignancy or in the process of investigation
Unstable liver disease
Churg-Strauss syndrome
Using methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine or any experimental anti-inflammatory therapy within 3 months of screening
Omalizumab (Xolair) or any other biological for the treatment of inflammatory disease within 6 months of Visit 1
Regular use of oral or systemic corticosteroids for diseases other than asthma within 12 months or any intra-articular, short-acting intramuscular corticosteroid within 1 month or intramuscular, long-acting depot corticosteroid within 3 months
Allergy/intolerance to the excipients in the mepolizumab formulation
Any investigational drug within 30 days or 5 terminal half-lives, whichever is longer
Pregnant or breastfeeding or planning to become pregnant
Clinically significant disease which is uncontrolled with standard treatment
History of alcohol misuse or substance abuse
Parasitic infestation within previous 6 months
Known immunodeficiency
Unable to follow instructions, use the electronic diary or peak flow meter
Known evidence of lack of adherence to controller medications and/or follow physician's recommendations
Previous participation in a study of mepolizumab and received study medication within 90 days

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mepolizumab 750mg

Mepolizumab 250mg

Mepolizumab 75mg

Placebo

Arm Description

Mepolizumab 750mcg i.v. every 4 weeks

Mepolizumab 250mcg i.v. every 4 weeks

Mepolizumab 75mcg i.v. every 4 weeks

Placebo saline every 4 weeks i.v.

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 oral/systemic corticosteroids (for participants on maintenance oral corticosteroids [OCS], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable

Secondary Outcome Measures

Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit

Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance OCS, an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).

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

The frequency of exacerbations of asthma requiring hospitalization (including intubation and admittance to an intensive care unit [ICU]) or ED visit over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.

Time to First Exacerbation Requiring Hospitalization or ED Visit

Exacerbations of asthma requiring hospitalization or ED visit were assessed. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).

Number of All Recorded Exacerbations Per Year

Clinically significant exacerbations (ex) of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for par. on maintenance OCS, an ex requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. In the case, an event described as an ex was not associated with a deterioration in >=1 of the objectives of eDiary parameters, the investigator (inv) provided an explanation to support the decision for defining the event as an ex. All recorded ex were defined as those recorded by inv, regardless of the outcome of the ex review process. Analysis was performed using Negative Binomial regression model with covariates of treatment group, BL maintenance OCS therapy (OCS vs. no OCS), region, ex in the year prior to the study (as an ordinal variable) and BL % predicted FEV1, and with logarithm of time on treatment as an offset variable.

Time to First All Recorded Exacerbation

All recorded exacerbations are defined as those recorded by investigators, regardless of the outcome of the exacerbation review process. In the case, an event described as an exacerbation was not associated with a deterioration in at least one of the objectives of eDiary parameters, the investigator provided an explanation to support the decision for defining the event as an exacerbation. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by week 16, week 32 and week 52).

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 each clinic visit. 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 was 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 Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period

FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Post-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 32 and Week 52. Post bronchodilator values were recorded following reversibility testing, using the maximum post bronchodilator method. Participants unable to achieve >=12% reversibility and 200 mL change at Visit 1, reversibility test was repeated at Visit 2. These procedures to achieve the maximum post-bronchodilator are generated by the Asthma Clinical Research Network. 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 was 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

Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period

The ACQ-6 is a six-item questionnaire. The six questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze) and use of short-acting bronchodilator over the previous week. 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 6 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Change from BL is defined as the difference between the value of the endpoint at the time point of interest and BL value. Analysis was performed using mixed model repeated measures with covariates of BL, region, BL maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1, treatment and visit, plus interaction terms for visit by BL and visit by treatment group.

Full Information

NCT ID

NCT01000506

First Posted

October 22, 2009

Last Updated

January 18, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01000506

Brief Title

Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma

Acronym

DREAM

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Determine the Effect of Mepolizumab on Exacerbation Rates in Subjects With Severe Uncontrolled Refractory Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

November 1, 2009 (undefined)

Primary Completion Date

March 23, 2012 (Actual)

Study Completion Date

March 23, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comparison to a placebo.

Detailed Description

A double-blind, placebo-controlled study to evaluate the efficacy, safety and pharmacodynamics of three doses (75 mg, 250 mg and 750 mg) of mepolizumab intravenous (i.v.) administered every 4 weeks compared with placebo over a 52-week treatment period in subjects with severe uncontrolled refractory asthma. Efficacy will be measured by the frequency of asthma exacerbations. In addition lung function, rescue medication usage, daily symptoms, asthma control score, asthma quality of life score and withdrawals due to asthma exacerbations will be assessed. Safety will be assessed by adverse events, clinical laboratory evaluations, ECGs, immunogenicity and vital signs. Pharmacodynamics will be assessed by eosinophil levels in blood, serum IL-5 and eosinophil levels in induced sputum.

6. Conditions and Keywords

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

Asthma

Keywords

Dose-ranging, Safety, Pharmacodynamics, eosinophils, SB-240563, Efficacy, Severe refractory asthma, mepolizumab, Placebo

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

621 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mepolizumab 750mg

Arm Type

Active Comparator

Arm Description

Mepolizumab 750mcg i.v. every 4 weeks

Arm Title

Mepolizumab 250mg

Arm Type

Active Comparator

Arm Description

Mepolizumab 250mcg i.v. every 4 weeks

Arm Title

Mepolizumab 75mg

Arm Type

Active Comparator

Arm Description

Mepolizumab 75mcg i.v. every 4 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo saline every 4 weeks i.v.

Intervention Type

Biological

Intervention Name(s)

Mepolizumab 750

Intervention Description

Mepolizumab 750mg every four weeks by i.v.

Intervention Type

Biological

Intervention Name(s)

Mepolizumab 250

Intervention Description

Mepolizumab 250mg every four weeks by i.v.

Intervention Type

Biological

Intervention Name(s)

Mepolizumab 75

Intervention Description

Mepolizumab 75mg every four weeks by i.v.

Intervention Type

Drug

Intervention Name(s)

Placebo saline

Intervention Description

Placebo saline every four weeks by i.v.

Primary Outcome Measure Information:

Title

Number of Clinically Significant Exacerbations of Asthma Per Year

Description

Time Frame

From randomization (Week 0) to Week 52 or early withdrawal (EW)

Secondary Outcome Measure Information:

Title

Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit

Description

Time Frame

From randomization (Week 0) to Week 52 or EW

Title

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

Description

Time Frame

From randomization (Week 0) to Week 52 or EW

Title

Time to First Exacerbation Requiring Hospitalization or ED Visit

Description

Time Frame

From randomization (Week 0) to Week 52 or EW

Title

Number of All Recorded Exacerbations Per Year

Description

Time Frame

From randomization (Week 0) to Week 52 or EW

Title

Time to First All Recorded Exacerbation

Description

Time Frame

From randomization (Week 0) to Week 52 or EW

Title

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

Description

Time Frame

From Baseline up to Week 52 or EW

Title

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

Description

Time Frame

From Baseline up to Week 52 or EW

Title

Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period

Description

Time Frame

From Baseline up to Week 52 or EW

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female Aged 12 to 65 years inclusive Minimum weight 45kg Clinical features of severe refractory asthma Well documented requirement for high dose inhaled corticosteroids (ICS) [i.e. >= 880mcg/day fluticasone propionate or equivalent daily] for at least 12 months Using additional controller medication in addition to high dose ICS for at least 12 months Persistent airflow obstruction indicated by a pre-bronchodilator FEV1<80% predicted at visit 1 or 2 or peak flow diurnal variability of >20% on 3 or more days during the run-in Airway inflammation which is likely to be eosinophilic in nature demonstrated by either raised peripheral blood eosinophils (>=300/microL), sputum eosinophils (>=3%), exhaled nitric oxide (>=50ppb) or prompt deterioration of asthma control following a <=25% reduction in regular maintenance dose of inhaled or oral corticosteroids (OCS) History of 2 or more exacerbations requiring systemic corticosteroids in the previous 12 months Evidence of asthma documented by airway reversibility, airway hyperresponsiveness or airflow variability ECG assessment demonstrating QTc<450msec or QTc<480msec for patients with bundle branch block Liver function tests demonstrating ALT<2xUpper Limit of Normal (ULN), AST<2xULN, Alk Phos <=1.5xULN, bilirubin <=1.5xULN Female of non-child-bearing potential or child-bearing potential with a negative pregnancy test at screening and prepared to agree to an acceptable method of contraception Able to give written informed consent Able to read, comprehend and write at a sufficient level to complete study materials Exclusion Criteria: Current smokers or smoking history of >=10 pack years Clinically important lung condition other than asthma Diagnosis of malignancy or in the process of investigation Unstable liver disease Churg-Strauss syndrome Using methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine or any experimental anti-inflammatory therapy within 3 months of screening Omalizumab (Xolair) or any other biological for the treatment of inflammatory disease within 6 months of Visit 1 Regular use of oral or systemic corticosteroids for diseases other than asthma within 12 months or any intra-articular, short-acting intramuscular corticosteroid within 1 month or intramuscular, long-acting depot corticosteroid within 3 months Allergy/intolerance to the excipients in the mepolizumab formulation Any investigational drug within 30 days or 5 terminal half-lives, whichever is longer Pregnant or breastfeeding or planning to become pregnant Clinically significant disease which is uncontrolled with standard treatment History of alcohol misuse or substance abuse Parasitic infestation within previous 6 months Known immunodeficiency Unable to follow instructions, use the electronic diary or peak flow meter Known evidence of lack of adherence to controller medications and/or follow physician's recommendations Previous participation in a study of mepolizumab and received study medication within 90 days

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

Los Angeles

State/Province

California

ZIP/Postal Code

90095

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

San Diego

State/Province

California

ZIP/Postal Code

92103-8415

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

06510

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

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

GSK Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40508

Country

United States

Facility Name

GSK Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

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

Canton

State/Province

Ohio

ZIP/Postal Code

44718

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

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

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

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

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

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

Facility Name

GSK Investigational Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

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

Buenos Aires

ZIP/Postal Code

1425

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

M5500CCG

Country

Argentina

Facility Name

GSK Investigational Site

City

Tucuman

ZIP/Postal Code

4000

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

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

GSK Investigational Site

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

GSK Investigational Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

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

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

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

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5A 3V4

Country

Canada

Facility Name

GSK Investigational Site

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5M 2V8

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

Puente Alto - Santiago

State/Province

Región Metro De Santiago

ZIP/Postal Code

8207257

Country

Chile

Facility Name

GSK Investigational Site

City

Valparaiso

State/Province

Valparaíso

ZIP/Postal Code

2341131

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

Clamart

ZIP/Postal Code

92140

Country

France

Facility Name

GSK Investigational Site

City

Marseille cedex 20

ZIP/Postal Code

13915

Country

France

Facility Name

GSK Investigational Site

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

GSK Investigational Site

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

GSK Investigational Site

City

Saint Pierre cedex

ZIP/Postal Code

97448

Country

France

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

60596

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

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

14050

Country

Germany

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

Seoul

ZIP/Postal Code

133--792

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

152-703

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

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

GSK Investigational Site

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

01-138

Country

Poland

Facility Name

GSK Investigational Site

City

Wroclaw

ZIP/Postal Code

54-239

Country

Poland

Facility Name

GSK Investigational Site

City

Zawadzkie

ZIP/Postal Code

47-120

Country

Poland

Facility Name

GSK Investigational Site

City

Zgierz

ZIP/Postal Code

95-100

Country

Poland

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

050159

Country

Romania

Facility Name

GSK Investigational Site

City

Bucuresti

ZIP/Postal Code

70000

Country

Romania

Facility Name

GSK Investigational Site

City

Iasi

ZIP/Postal Code

700115

Country

Romania

Facility Name

GSK Investigational Site

City

Targu Mures

ZIP/Postal Code

540143

Country

Romania

Facility Name

GSK Investigational Site

City

Barnaul

ZIP/Postal Code

656 045

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Chelyabinsk

ZIP/Postal Code

454106

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Kazan

ZIP/Postal Code

420015

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

105 077

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

115478

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

198216

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Tomsk

ZIP/Postal Code

634001

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Cherkassy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

GSK Investigational Site

City

Dnipropetrovsk

ZIP/Postal Code

49006

Country

Ukraine

Facility Name

GSK Investigational Site

City

Dnipropetrovsk

ZIP/Postal Code

49027

Country

Ukraine

Facility Name

GSK Investigational Site

City

Dnipropetrovsk

ZIP/Postal Code

49051

Country

Ukraine

Facility Name

GSK Investigational Site

City

Donetsk

ZIP/Postal Code

83003

Country

Ukraine

Facility Name

GSK Investigational Site

City

Donetsk

ZIP/Postal Code

83099

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kharkiv

ZIP/Postal Code

61035

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kiev

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

03038

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

03115

Country

Ukraine

Facility Name

GSK Investigational Site

City

Mykolayiv

ZIP/Postal Code

54003

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

London

ZIP/Postal Code

E1 2AT

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

SW3 6HP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M23 9LT

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

22901886

Citation

Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X.

Results Reference

background

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

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

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

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

24983709

Citation

Ortega H, Li H, Suruki R, Albers F, Gordon D, Yancey S. Cluster analysis and characterization of response to mepolizumab. A step closer to personalized medicine for patients with severe asthma. Ann Am Thorac Soc. 2014 Sep;11(7):1011-7. doi: 10.1513/AnnalsATS.201312-454OC.

Results Reference

derived

PubMed Identifier

24834924

Citation

Prazma CM, Wenzel S, Barnes N, Douglass JA, Hartley BF, Ortega H. Characterisation of an OCS-dependent severe asthma population treated with mepolizumab. Thorax. 2014 Dec;69(12):1141-2. doi: 10.1136/thoraxjnl-2014-205581. Epub 2014 May 16.

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

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

112997

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

112997

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

112997

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

112997

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

112997

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

112997

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

112997

Available IPD/Information Comments

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

Learn more about this trial

Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma

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Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma (DREAM)

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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