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Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Reslizumab

Placebo

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

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

Inclusion Criteria:

Written informed consent is obtained.
The participant is male or female, 12 years of age and older, with a diagnosis of asthma.
The participant has Forced Expiratory Volume in 1 Second (FEV1) reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol.
The participant has required an inhaled corticosteroid.
The participant has required an additional asthma controller medication besides inhaled corticosteroids.
The participant has a history of asthma exacerbation.
The participant must be willing and able to comply with study restrictions, perform requisite procedures and remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.
- Additional criteria may apply, please contact the investigator for more information

Exclusion Criteria:

The participant has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient's safety.
The participant has another confounding underlying lung disorder
The participant has a known hypereosinophilic syndrome.
The participant has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
The participant is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study.
The participant is a current smoker or has a smoking history.
The participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
The participant was previously exposed to reslizumab.
The participant has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).
The participant has current or suspected drug and alcohol abuse.
The participant has an active helminthic parasitic infection or was treated for one within 6 months of screening.
The participant has a history of allergic reaction or hypersensitivity to any component of the study drug.
- Additional criteria may apply, please contact the investigator for more information

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Reslizumab

Placebo

Arm Description

Reslizumab

Matching Placebo

Outcomes

Primary Outcome Measures

Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment

A CAE was defined as a clinically-judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors. Results are presented as adjusted means. For this analysis, the offset variable is calculated as the logarithm of treatment duration minus the summed duration of exacerbations during the treatment period.

Secondary Outcome Measures

Change From Baseline to Week 52 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

Change in pre-bronchodilator FEV1 from baseline to week 52 is presented. FEV1 is a standard measurement of air movement in the lungs of participants with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score

AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses. Analysis of the change from baseline to each visit was performed using a MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

Change From Baseline to Week 52 in 6-item Asthma Control Questionnaire (ACQ-6) Score

The ACQ-6 is a 6-item validated asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ-6 has a possible score ranges from 0 to 6, and the total score is the mean of all responses. The total score ranging from 0-6 (0=totally controlled and 6=severely uncontrolled). A higher score indicated poorer asthma control. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

Change From Baseline to Week 52 in Total Asthma Symptom Scores (Day and Night)

Asthma symptoms were recorded by participant each day and night in an asthma control diary. Night score was assessed on a 5-point scale where 0=no symptoms, slept through night, to 4=bad night, no sleep. Day score was assessed on a 6-point scale where 0=very well, no symptoms, to 5= asthma very severe, unable to carry out daily activities. Total asthma symptom score was calculated by taking the sum of the night and day asthma symptom scores recorded, ranging from 0 (no symptom) to 9 (severe symptom). A lower symptom score indicated a better outcome. Analysis of the change from baseline to each visit was performed using a MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

Percentage of Asthma Control Days

The percentage of asthma control days over 52 weeks of treatment is presented. An asthma control day was defined as a day on which the participant used less than or equal to 2 puffs of inhaled short-acting beta-agonist, had no nighttime awakenings, and experienced no asthma exacerbations. Analysis of the change from baseline to each visit was performed using a mixed effect MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

Change From Baseline to Week 32 in St. George's Respiratory Questionnaire (SGRQ) Total Score

The SGRQ is a 17-item questionnaire with 50 weighted responses. It provides a total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.

Kaplan-Meier (K-M) Estimate of Probability (Percent [%]) of Not Experiencing a CAE by Week 52

CAE was defined as a clinically judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. The KM method was used to estimate and compare the distributions of time to first CAE between treatment groups. Participants without an event during the treatment period were censored at either the date of the end of treatment (Week 52) visit for participants who completed treatment or at the date of last dose (+4 weeks) for participants who discontinued early.

Number of CAEs Requiring Hospitalization and/or Emergency Department Visits During 52 Weeks of Treatment

A CAE was defined as a clinically judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. The frequency of CAEs over 52-week treatment period is expressed as adjusted CAEs rate in 52 weeks. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors (age group, blood eosinophil group) and number of prior exacerbations, and an offset variable.

Number of Moderate Exacerbations During 52 Weeks of Treatment

A moderate exacerbation was defined as a clinically judged deterioration in asthma control as determined by investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention requiring additional asthma controller medication that was not a systemic corticosteroid and did not result in an asthma-specific hospitalization or emergency department visit (that is, a medical intervention that did not otherwise meet the criteria for primary endpoint). Frequency of moderate exacerbations over 52-week treatment period is expressed as adjusted exacerbation rate in 52 weeks. Adjusted exacerbation rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors (age group, blood eosinophil group) and number of prior exacerbations, and an offset variable.

Full Information

NCT ID

NCT02452190

First Posted

May 13, 2015

Last Updated

November 5, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Collaborators

PPD

1. Study Identification

Unique Protocol Identification Number

NCT02452190

Brief Title

Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils

Official Title

A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

September 28, 2015 (Actual)

Primary Completion Date

December 4, 2017 (Actual)

Study Completion Date

January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Collaborators

PPD

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.

6. Conditions and Keywords

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

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

468 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reslizumab

Arm Type

Experimental

Arm Description

Reslizumab

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching Placebo

Intervention Type

Drug

Intervention Name(s)

Reslizumab

Intervention Description

Reslizumab will be administered subcutaneously in a dose of 110 mg every 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching Placebo

Primary Outcome Measure Information:

Title

Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment

Description

Time Frame

Day 1 to Week 52

Secondary Outcome Measure Information:

Title

Change From Baseline to Week 52 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline to Week 52 in 6-item Asthma Control Questionnaire (ACQ-6) Score

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline to Week 52 in Total Asthma Symptom Scores (Day and Night)

Description

Time Frame

Baseline, Week 52

Title

Percentage of Asthma Control Days

Description

Time Frame

Day 1 to Week 52

Title

Change From Baseline to Week 32 in St. George's Respiratory Questionnaire (SGRQ) Total Score

Description

Time Frame

Baseline, Week 32

Title

Kaplan-Meier (K-M) Estimate of Probability (Percent [%]) of Not Experiencing a CAE by Week 52

Description

Time Frame

Day 1 to Week 52

Title

Number of CAEs Requiring Hospitalization and/or Emergency Department Visits During 52 Weeks of Treatment

Description

Time Frame

Day 1 to Week 52

Title

Number of Moderate Exacerbations During 52 Weeks of Treatment

Description

Time Frame

Day 1 to Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent is obtained. The participant is male or female, 12 years of age and older, with a diagnosis of asthma. The participant has Forced Expiratory Volume in 1 Second (FEV1) reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol. The participant has required an inhaled corticosteroid. The participant has required an additional asthma controller medication besides inhaled corticosteroids. The participant has a history of asthma exacerbation. The participant must be willing and able to comply with study restrictions, perform requisite procedures and remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol. Additional criteria may apply, please contact the investigator for more information Exclusion Criteria: The participant has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient's safety. The participant has another confounding underlying lung disorder The participant has a known hypereosinophilic syndrome. The participant has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers. The participant is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study. The participant is a current smoker or has a smoking history. The participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer. The participant was previously exposed to reslizumab. The participant has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV). The participant has current or suspected drug and alcohol abuse. The participant has an active helminthic parasitic infection or was treated for one within 6 months of screening. The participant has a history of allergic reaction or hypersensitivity to any component of the study drug. Additional criteria may apply, please contact the investigator for more information

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teva Medical Expert, MD

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 13212

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Teva Investigational Site 13241

City

Flagstaff

State/Province

Arizona

ZIP/Postal Code

86001

Country

United States

Facility Name

Teva Investigational Site 13194

City

Glendale

State/Province

Arkansas

ZIP/Postal Code

85306

Country

United States

Facility Name

Teva Investigational Site 13215

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Teva Investigational Site 13181

City

Canoga Park

State/Province

California

ZIP/Postal Code

91303

Country

United States

Facility Name

Teva Investigational Site 13254

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Teva Investigational Site 13216

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647

Country

United States

Facility Name

Teva Investigational Site 13247

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

Teva Investigational Site 13205

City

Napa

State/Province

California

ZIP/Postal Code

94558

Country

United States

Facility Name

Teva Investigational Site 13764

City

San Jose

State/Province

California

ZIP/Postal Code

95117

Country

United States

Facility Name

Teva Investigational Site 13252

City

Stockton

State/Province

California

ZIP/Postal Code

95207

Country

United States

Facility Name

Teva Investigational Site 13251

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Teva Investigational Site 13229

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

Teva Investigational Site 13766

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

Teva Investigational Site 13196

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Teva Investigational Site 13256

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

Teva Investigational Site 13203

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34741

Country

United States

Facility Name

Teva Investigational Site 13197

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

Teva Investigational Site 13220

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Teva Investigational Site 13243

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Teva Investigational Site 13233

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34653

Country

United States

Facility Name

Teva Investigational Site 13201

City

Orlando

State/Province

Florida

ZIP/Postal Code

32811

Country

United States

Facility Name

Teva Investigational Site 13250

City

Orlando

State/Province

Florida

ZIP/Postal Code

32819

Country

United States

Facility Name

Teva Investigational Site 13246

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33029

Country

United States

Facility Name

Teva Investigational Site 13208

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

Teva Investigational Site 13255

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

Teva Investigational Site 13765

City

Albany

State/Province

Georgia

ZIP/Postal Code

31707

Country

United States

Facility Name

Teva Investigational Site 13249

City

Buford

State/Province

Georgia

ZIP/Postal Code

30518

Country

United States

Facility Name

Teva Investigational Site 13763

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30045

Country

United States

Facility Name

Teva Investigational Site 13230

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Teva Investigational Site 13211

City

Normal

State/Province

Illinois

ZIP/Postal Code

61761

Country

United States

Facility Name

Teva Investigational Site 13235

City

Shiloh

State/Province

Illinois

ZIP/Postal Code

62269

Country

United States

Facility Name

Teva Investigational Site 13202

City

Michigan City

State/Province

Indiana

ZIP/Postal Code

46360

Country

United States

Facility Name

Teva Investigational Site 13225

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

Teva Investigational Site 13222

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42301

Country

United States

Facility Name

Teva Investigational Site 13191

City

Lafayette

State/Province

Louisiana

ZIP/Postal Code

70503

Country

United States

Facility Name

Teva Investigational Site 13200

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

Teva Investigational Site 13226

City

Biloxi

State/Province

Mississippi

ZIP/Postal Code

39531

Country

United States

Facility Name

Teva Investigational Site 13204

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63143

Country

United States

Facility Name

Teva Investigational Site 13258

City

Boys Town

State/Province

Nebraska

ZIP/Postal Code

68010

Country

United States

Facility Name

Teva Investigational Site 13769

City

Belleville

State/Province

New Jersey

ZIP/Postal Code

07109

Country

United States

Facility Name

Teva Investigational Site 13210

City

Ocean City

State/Province

New Jersey

ZIP/Postal Code

07712

Country

United States

Facility Name

Teva Investigational Site 13188

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11040

Country

United States

Facility Name

Teva Investigational Site 13232

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Teva Investigational Site 13767

City

New York

State/Province

New York

ZIP/Postal Code

11570

Country

United States

Facility Name

Teva Investigational Site 13186

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

Teva Investigational Site 13253

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Teva Investigational Site 13240

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43606

Country

United States

Facility Name

Teva Investigational Site 13259

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73034

Country

United States

Facility Name

Teva Investigational Site 13238

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Teva Investigational Site 13195

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Teva Investigational Site 13242

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18020

Country

United States

Facility Name

Teva Investigational Site 13218

City

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Facility Name

Teva Investigational Site 13189

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Teva Investigational Site 13190

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

Teva Investigational Site 13209

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

?02914

Country

United States

Facility Name

Teva Investigational Site 13217

City

Lincoln

State/Province

Rhode Island

ZIP/Postal Code

02865

Country

United States

Facility Name

Teva Investigational Site 13223

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37919

Country

United States

Facility Name

Teva Investigational Site 13185

City

Arlington

State/Province

Texas

ZIP/Postal Code

76018

Country

United States

Facility Name

Teva Investigational Site 13199

City

Corsicana

State/Province

Texas

ZIP/Postal Code

75110

Country

United States

Facility Name

Teva Investigational Site 13260

City

Dallas

State/Province

Texas

ZIP/Postal Code

75225

Country

United States

Facility Name

Teva Investigational Site 13224

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Teva Investigational Site 13184

City

Waco

State/Province

Texas

ZIP/Postal Code

76712

Country

United States

Facility Name

Teva Investigational Site 13187

City

Provo

State/Province

Utah

ZIP/Postal Code

84604

Country

United States

Facility Name

Teva Investigational Site 13207

City

Abingdon

State/Province

Virginia

ZIP/Postal Code

24210

Country

United States

Facility Name

Teva Investigational Site 13183

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22030

Country

United States

Facility Name

Teva Investigational Site 13257

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22044

Country

United States

Facility Name

Teva Investigational Site 13239

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23233

Country

United States

Facility Name

Teva Investigational Site 13227

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Teva Investigational Site 20040

City

Buenos Aires

ZIP/Postal Code

C1122AAK

Country

Argentina

Facility Name

Teva Investigational Site 20033

City

Buenos Aires

ZIP/Postal Code

C1426ABP

Country

Argentina

Facility Name

Teva Investigational Site 20035

City

Buenos Aires

Country

Argentina

Facility Name

Teva Investigational Site 20041

City

Cordoba

ZIP/Postal Code

X5003DCE

Country

Argentina

Facility Name

Teva Investigational Site 20053

City

Lanus

ZIP/Postal Code

B1824 KAJ

Country

Argentina

Facility Name

Teva Investigational Site 20037

City

Mar Del Plata

ZIP/Postal Code

CP 7600

Country

Argentina

Facility Name

Teva Investigational Site 20036

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Teva Investigational Site 20054

City

Rosario

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Teva Investigational Site 20032

City

Rosario

ZIP/Postal Code

S2000DBS

Country

Argentina

Facility Name

Teva Investigational Site 20046

City

San Miguel de Tucuman

ZIP/Postal Code

T4000CHE

Country

Argentina

Facility Name

Teva Investigational Site 20045

City

San Rafael

ZIP/Postal Code

5600

Country

Argentina

Facility Name

Teva Investigational Site 78085

City

Bedford Park

ZIP/Postal Code

5042

Country

Australia

Facility Name

Teva Investigational Site 78083

City

Nedlands

ZIP/Postal Code

6009

Country

Australia

Facility Name

Teva Investigational Site 78088

City

Parkville

ZIP/Postal Code

3052

Country

Australia

Facility Name

Teva Investigational Site 78087

City

Sherwood

ZIP/Postal Code

4075

Country

Australia

Facility Name

Teva Investigational Site 78084

City

Woolloongabba

Country

Australia

Facility Name

Teva Investigational Site 37054

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Teva Investigational Site 37053

City

Erpent

ZIP/Postal Code

5101

Country

Belgium

Facility Name

Teva Investigational Site 37055

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Teva Investigational Site 11106

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E1

Country

Canada

Facility Name

Teva Investigational Site 11105

City

Etobicoke

State/Province

Ontario

ZIP/Postal Code

M9V 4B4

Country

Canada

Facility Name

Teva Investigational Site 11109

City

Windsor

ZIP/Postal Code

N8X 5A6

Country

Canada

Facility Name

Teva Investigational Site 54130

City

Jablonec nad Nisou

ZIP/Postal Code

46601

Country

Czechia

Facility Name

Teva Investigational Site 54128

City

Jindrichuv Hradec

ZIP/Postal Code

377 01

Country

Czechia

Facility Name

Teva Investigational Site 54129

City

Tabor

ZIP/Postal Code

39001

Country

Czechia

Facility Name

Teva Investigational Site 35182

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Teva Investigational Site 35183

City

Toulouse

ZIP/Postal Code

31000

Country

France

Facility Name

Teva Investigational Site 32559

City

Bad Worishofen

ZIP/Postal Code

86825

Country

Germany

Facility Name

Teva Investigational Site 32556

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

Teva Investigational Site 32561

City

Berlin

ZIP/Postal Code

10969

Country

Germany

Facility Name

Teva Investigational Site 32570

City

Berlin

ZIP/Postal Code

12159

Country

Germany

Facility Name

Teva Investigational Site 32567

City

Berlin

ZIP/Postal Code

13507

Country

Germany

Facility Name

Teva Investigational Site 32564

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Teva Investigational Site 32560

City

Frankfurt am Main

ZIP/Postal Code

60596

Country

Germany

Facility Name

Teva Investigational Site 32568

City

Frankfurt

ZIP/Postal Code

60389

Country

Germany

Facility Name

Teva Investigational Site 32562

City

Hamburg

ZIP/Postal Code

22299

Country

Germany

Facility Name

Teva Investigational Site 32566

City

Hannover

ZIP/Postal Code

30173

Country

Germany

Facility Name

Teva Investigational Site 32555

City

Koblenz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Teva Investigational Site 32563

City

Leipzig

ZIP/Postal Code

04357

Country

Germany

Facility Name

Teva Investigational Site 32557

City

Leipzig

ZIP/Postal Code

4275

Country

Germany

Facility Name

Teva Investigational Site 32565

City

Lubeck

ZIP/Postal Code

23552

Country

Germany

Facility Name

Teva Investigational Site 32551

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Teva Investigational Site 32569

City

Witten

ZIP/Postal Code

58452

Country

Germany

Facility Name

Teva Investigational Site 51216

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Teva Investigational Site 51228

City

Budapest

ZIP/Postal Code

H-1036

Country

Hungary

Facility Name

Teva Investigational Site 51221

City

Csorna

ZIP/Postal Code

9300

Country

Hungary

Facility Name

Teva Investigational Site 51220

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Teva Investigational Site 51223

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Teva Investigational Site 51255

City

Dombovar

ZIP/Postal Code

7200

Country

Hungary

Facility Name

Teva Investigational Site 51218

City

Godollo

ZIP/Postal Code

2100

Country

Hungary

Facility Name

Teva Investigational Site 51222

City

Gyor

ZIP/Postal Code

9023

Country

Hungary

Facility Name

Teva Investigational Site 51227

City

Hajdunanas

ZIP/Postal Code

4080

Country

Hungary

Facility Name

Teva Investigational Site 51226

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Teva Investigational Site 51231

City

Kapuvar

ZIP/Postal Code

9330

Country

Hungary

Facility Name

Teva Investigational Site 51224

City

Szazhalombatta

ZIP/Postal Code

2440

Country

Hungary

Facility Name

Teva Investigational Site 51219

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Teva Investigational Site 51225

City

Szigetvar

ZIP/Postal Code

7900

Country

Hungary

Facility Name

Teva Investigational Site 51217

City

Szombathely

Country

Hungary

Facility Name

Teva Investigational Site 51229

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Teva Investigational Site 80077

City

Ashkelon

ZIP/Postal Code

7830604

Country

Israel

Facility Name

Teva Investigational Site 80076

City

Haifa

ZIP/Postal Code

3436212

Country

Israel

Facility Name

Teva Investigational Site 80094

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Teva Investigational Site 80078

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Teva Investigational Site 80080

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Teva Investigational Site 80073

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Teva Investigational Site 80081

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Teva Investigational Site 80079

City

Ramat Gan

ZIP/Postal Code

5262160

Country

Israel

Facility Name

Teva Investigational Site 80075

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Teva Investigational Site 84039

City

Amagasaki

ZIP/Postal Code

660-8550

Country

Japan

Facility Name

Teva Investigational Site 84053

City

Ginowan

ZIP/Postal Code

901-2214

Country

Japan

Facility Name

Teva Investigational Site 84049

City

Hakodate

ZIP/Postal Code

?040-8611

Country

Japan

Facility Name

Teva Investigational Site 84034

City

Hiroshima

ZIP/Postal Code

734-8530

Country

Japan

Facility Name

Teva Investigational Site 84036

City

Kanazawa-shi

ZIP/Postal Code

920-8530

Country

Japan

Facility Name

Teva Investigational Site 84037

City

Kishiwada-shi

ZIP/Postal Code

596-8501

Country

Japan

Facility Name

Teva Investigational Site 84048

City

Kobe

ZIP/Postal Code

651-0073

Country

Japan

Facility Name

Teva Investigational Site 84044

City

Kobe

ZIP/Postal Code

651-2273

Country

Japan

Facility Name

Teva Investigational Site 84047

City

Kodaira

ZIP/Postal Code

187-8510

Country

Japan

Facility Name

Teva Investigational Site 84045

City

Kumamoto

ZIP/Postal Code

862-0965

Country

Japan

Facility Name

Teva Investigational Site 84043

City

Mizunami-shi

ZIP/Postal Code

509-6134

Country

Japan

Facility Name

Teva Investigational Site 84041

City

Sagamihara

ZIP/Postal Code

252-5188

Country

Japan

Facility Name

Teva Investigational Site 84031

City

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

Teva Investigational Site 84032

City

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

Teva Investigational Site 84038

City

Toyama-shi

ZIP/Postal Code

930-0194

Country

Japan

Facility Name

Teva Investigational Site 84046

City

Toyama

ZIP/Postal Code

930-8550

Country

Japan

Facility Name

Teva Investigational Site 84035

City

Toyoake-shi

ZIP/Postal Code

470-1192

Country

Japan

Facility Name

Teva Investigational Site 84040

City

Yokohama-shi

ZIP/Postal Code

231-8682

Country

Japan

Facility Name

Teva Investigational Site 87015

City

Bucheon

ZIP/Postal Code

420-767

Country

Korea, Republic of

Facility Name

Teva Investigational Site 87016

City

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Facility Name

Teva Investigational Site 87014

City

Seoul

ZIP/Postal Code

152703

Country

Korea, Republic of

Facility Name

Teva Investigational Site 21084

City

Guadalajara

ZIP/Postal Code

44100

Country

Mexico

Facility Name

Teva Investigational Site 21085

City

Guadalajara

ZIP/Postal Code

44130

Country

Mexico

Facility Name

Teva Investigational Site 21088

City

Guadalajara

ZIP/Postal Code

44160

Country

Mexico

Facility Name

Teva Investigational Site 21089

City

Guadalajara

ZIP/Postal Code

44220

Country

Mexico

Facility Name

Teva Investigational Site 21087

City

Monterrey

ZIP/Postal Code

64718

Country

Mexico

Facility Name

Teva Investigational Site 21086

City

Zapopan

ZIP/Postal Code

45070

Country

Mexico

Facility Name

Teva Investigational Site 79047

City

Auckland

ZIP/Postal Code

1640

Country

New Zealand

Facility Name

Teva Investigational Site 79046

City

Auckland

Country

New Zealand

Facility Name

Teva Investigational Site 53310

City

Bialystok

ZIP/Postal Code

15-044

Country

Poland

Facility Name

Teva Investigational Site 53315

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

Teva Investigational Site 53308

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Teva Investigational Site 53311

City

Krakow

ZIP/Postal Code

31-624

Country

Poland

Facility Name

Teva Investigational Site 53314

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Teva Investigational Site 53312

City

Lodz

ZIP/Postal Code

90-329

Country

Poland

Facility Name

Teva Investigational Site 53313

City

Poznan

ZIP/Postal Code

60-214

Country

Poland

Facility Name

Teva Investigational Site 53309

City

Tarnow

ZIP/Postal Code

33-100

Country

Poland

Facility Name

Teva Investigational Site 52108

City

Brasov

ZIP/Postal Code

500051

Country

Romania

Facility Name

Teva Investigational Site 52109

City

Brasov

ZIP/Postal Code

500086

Country

Romania

Facility Name

Teva Investigational Site 52107

City

Bucharest

ZIP/Postal Code

11461

Country

Romania

Facility Name

Teva Investigational Site 52105

City

Bucharest

ZIP/Postal Code

50159

Country

Romania

Facility Name

Teva Investigational Site 52104

City

Cluj-Napoca

ZIP/Postal Code

400371

Country

Romania

Facility Name

Teva Investigational Site 52111

City

Deva

Country

Romania

Facility Name

Teva Investigational Site 52106

City

Targu Mures

ZIP/Postal Code

540136

Country

Romania

Facility Name

Teva Investigational Site 52110

City

Timisoara

ZIP/Postal Code

300310

Country

Romania

Facility Name

Teva Investigational Site 50350

City

Barnaul

ZIP/Postal Code

656024

Country

Russian Federation

Facility Name

Teva Investigational Site 50354

City

Kemerovo

ZIP/Postal Code

650099

Country

Russian Federation

Facility Name

Teva Investigational Site 50348

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Teva Investigational Site 50351

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

Teva Investigational Site 50347

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

Teva Investigational Site 50355

City

Saint Petersburg

ZIP/Postal Code

194356

Country

Russian Federation

Facility Name

Teva Investigational Site 50352

City

St. Petersburg

ZIP/Postal Code

197089

Country

Russian Federation

Facility Name

Teva Investigational Site 50349

City

Tomsk

ZIP/Postal Code

634063

Country

Russian Federation

Facility Name

Teva Investigational Site 90027

City

Benoni

ZIP/Postal Code

1500

Country

South Africa

Facility Name

Teva Investigational Site 90028

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Teva Investigational Site 90026

City

Cape Town

ZIP/Postal Code

7505

Country

South Africa

Facility Name

Teva Investigational Site 90031

City

Cape Town

ZIP/Postal Code

7570

Country

South Africa

Facility Name

Teva Investigational Site 90029

City

Cape Town

ZIP/Postal Code

7937

Country

South Africa

Facility Name

Teva Investigational Site 90032

City

Durban

ZIP/Postal Code

4091

Country

South Africa

Facility Name

Teva Investigational Site 90030

City

Durban

ZIP/Postal Code

4170

Country

South Africa

Facility Name

Teva Investigational Site 31149

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Teva Investigational Site 31147

City

Esplugues de Llobregat

ZIP/Postal Code

08950

Country

Spain

Facility Name

Teva Investigational Site 31152

City

Girona

ZIP/Postal Code

17005

Country

Spain

Facility Name

Teva Investigational Site 31154

City

Vitoria-Gasteiz

ZIP/Postal Code

01009

Country

Spain

Facility Name

Teva Investigational Site 82042

City

Ankara

ZIP/Postal Code

06290

Country

Turkey

Facility Name

Teva Investigational Site 82041

City

Izmir

ZIP/Postal Code

35120

Country

Turkey

Facility Name

Teva Investigational Site 82040

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Teva Investigational Site 82039

City

Konya

Country

Turkey

Facility Name

Teva Investigational Site 82043

City

Mersin

ZIP/Postal Code

33169

Country

Turkey

Facility Name

Teva Investigational Site 58216

City

Chernivtsi

ZIP/Postal Code

58023

Country

Ukraine

Facility Name

Teva Investigational Site 58219

City

Dnipropetrovsk

ZIP/Postal Code

49074

Country

Ukraine

Facility Name

Teva Investigational Site 58225

City

Dnipropetrovsk

ZIP/Postal Code

49101

Country

Ukraine

Facility Name

Teva Investigational Site 58222

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Teva Investigational Site 58227

City

Kharkiv

ZIP/Postal Code

61002

Country

Ukraine

Facility Name

Teva Investigational Site 58213

City

Kharkiv

ZIP/Postal Code

61007

Country

Ukraine

Facility Name

Teva Investigational Site 58221

City

Kharkiv

ZIP/Postal Code

61035

Country

Ukraine

Facility Name

Teva Investigational Site 58223

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Teva Investigational Site 58214

City

Kremenchuk

ZIP/Postal Code

39617

Country

Ukraine

Facility Name

Teva Investigational Site 58228

City

Kryvyi Rih

ZIP/Postal Code

50082

Country

Ukraine

Facility Name

Teva Investigational Site 58220

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Teva Investigational Site 58230

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Teva Investigational Site 58218

City

Kyiv

ZIP/Postal Code

04107

Country

Ukraine

Facility Name

Teva Investigational Site 58226

City

Kyiv

ZIP/Postal Code

04201

Country

Ukraine

Facility Name

Teva Investigational Site 58253

City

Kyiv

ZIP/Postal Code

?03680

Country

Ukraine

Facility Name

Teva Investigational Site 58234

City

Sumy

ZIP/Postal Code

40022

Country

Ukraine

Facility Name

Teva Investigational Site 58233

City

Vinnytsia

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

Teva Investigational Site 58229

City

Vinnytsya

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

Teva Investigational Site 58231

City

Zaporizhzhya

ZIP/Postal Code

69063

Country

Ukraine

Facility Name

Teva Investigational Site 58224

City

Zhaporizhzhya

ZIP/Postal Code

69035

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

32066536

Citation

Bernstein JA, Virchow JC, Murphy K, Maspero JF, Jacobs J, Adir Y, Humbert M, Castro M, Marsteller DA, McElhattan J, Hickey L, Garin M, Vanlandingham R, Brusselle G. Effect of fixed-dose subcutaneous reslizumab on asthma exacerbations in patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma: results from two phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2020 May;8(5):461-474. doi: 10.1016/S2213-2600(19)30372-8. Epub 2020 Feb 14.

Results Reference

derived

Learn more about this trial

Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils

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Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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