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An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

Primary Purpose

Asthma, Elevated Blood Eosinophils, Oral Corticosteroid Dependence

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Reslizumab

Placebo

Non-Oral Corticosteroid (non-OCS) Asthma Medication

Oral Corticosteroid (OCS)

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Elevated Blood Eosinophils, Oral corticosteroid dependence, Reslizumab

Eligibility Criteria

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

Inclusion Criteria:

The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma.
Written informed consent is obtained.
The patient requires daily maintenance dose of prednisone or equivalent for asthma of between 5 and 40 mg during the 3 months prior to screening.
The patient has a documented elevated blood eosinophils at screening or during the previous 12 months.
The patient has required high dose ICS plus another asthma controller for at least 6 months prior to screening.
The patient has FEV1 reversibility to inhaled SABA or historical reversibility within the previous 24 months.
- Other criteria may apply, please contact the investigator for more information.

Exclusion Criteria:

The patient has any clinically significant, uncontrolled medical condition that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient's safety.
The patient has another confounding underlying lung disorder.
The patient has a known hypereosinophilic syndrome.
The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
The patient is pregnant or intends to become pregnant during the study or is lactating.
The patient required treatment for an asthma exacerbation within 4 weeks of screening.
The patient is a current smoker or has a smoking history ≥10 pack-years.
The patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance OCS for the treatment of asthma.
The patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
The patient was previously exposed to benralizumab within 12 months of screening.
The patient was previously exposed to reslizumab.
The patient has a history of immunodeficiency disorder including human immunodeficiency virus.
The patient has current suspected drug and/or alcohol abuse.
The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.
The patient has a history of allergic reactions or hypersensitivity to any component of the study drug.
- Other 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 110 mg

Placebo

Arm Description

Reslizumab was administered by subcutaneous injection (sc) in a dosage of 110 mg (1.0 mL) every 4 weeks for a total of six doses.

Matching placebo was administered by subcutaneous injection (sc) 1.0 mL every 4 weeks for a total of six doses.

Outcomes

Primary Outcome Measures

Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline

The primary endpoint was the 5-level categorized percent reduction in OCS dose during weeks 20 to 24 compared with the optimized dose at baseline. The primary analysis incorporated data from all randomized patients. Analysis of the primary and secondary variables related to categorical OCS dose reduction incorporated missing data as non-responders. No decrease indicates there was no decrease in OCS, loss of baseline asthma control during weeks 20 to 24, or discontinuation from study drug.

Secondary Outcome Measures

Percentage of Participants Achieving a >=50% Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control

Percentage of patients whose OCS dose at weeks 20-24 was reduced >=50% compared to baseline while maintaining asthma control. Patients listed as "no" did not achieve the 50% reduction in baseline OCS dose goal, or did achieve that goal but lost asthma control during weeks 20 to 24, or discontinued from study drug.

Percentage of Participants Achieving an OCS Dose of <=5 mg at Weeks 20-24 While Maintaining Asthma Control

Percentage of participants whose OCS dose at weeks 20-24 was <=5 mg and they maintained asthma control. Patients listed as "no" had a week 20-24 OCS dose > 5 mg, or whose OCS dose was <=5 mg at weeks 20-24 but did not maintain asthma control, or they discontinued from study drug.

Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 Using a Mixed Model for Repeated Measures

The baseline OCS dose is the prescribed optimized OCS dose following the OCS optimization period. Endpoint data are presented using an on-treatment approach. In this context, 'endpoint' was defined as the last observation obtained at a scheduled or qualified early termination visit during the treatment period. Weeks 20-24 data is included between the Week 20 dose and Week 24 for completed patients; last dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early. Measurements collected outside of these defined timeframes are excluded from the analyses. The mixed model repeated measures (MMRM) included fixed effects for treatment, visit, treatment by visit interaction, age group, and OCS dose group, duration of OCS use and baseline value as covariates, and patient as a random effect. Unstructured covariance was assumed for the repeated measures.

Percentage of Participants Achieving a >=5 mg Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control

Percentage of participants whose OCS dose at weeks 20-24 was reduced by at least 5mg from baseline and maintained asthma control. Patients listed as "no" had a week 20-24 OCS dose that did not meet the threshold of a 5mg reduction, or whose OCS dose met the threshold but did not maintain asthma control, or discontinued from study drug.

Annualized Rate of Clinical Asthma Exacerbations (CAEs)

The annual exacerbation rate is based on clinical asthma exacerbations reported by the investigator in the eCRF.

Percentage of Participants Achieving an OCS Dose of 0 mg at Weeks 20-24 While Maintaining Asthma Control

Percentage of participants who discontinue use of OCS during weeks 20-24 while maintaining asthma control. Patients listed as "no" continued to use OCS during weeks 20-24, or who discontinued use of OCS during weeks 20-24 but lost control of their asthma, or discontinued from study drug.

Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses

Treatment-emergent responses were defined as a positive sample post-baseline (negative baseline) OR a titer increase of >=4-fold relative to a positive baseline sample. Two types of antibody assay were performed, an immunogenicity status assay (ADA) and neutralizing assay (NAb). The ADA assay produces a positive or negative result. For samples with a positive result, a neutralizing assay was performed, which also produces a positive or negative result.

Participants With Adverse Events

An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product, regardless of whether it has a causal relationship with this treatment. In this study, asthma exacerbations (which are efficacy parameters) should not be recorded as adverse events unless assessed by the investigator as more severe than the patient's usual disease course. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. Treatment-related adverse events or adverse events related to OCS use included events with missing relationship to study drug or OCS use, respectively.

Full Information

NCT ID

NCT02501629

First Posted

July 14, 2015

Last Updated

November 5, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02501629

Brief Title

An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

Official Title

A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

September 29, 2015 (Actual)

Primary Completion Date

June 19, 2017 (Actual)

Study Completion Date

December 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.

6. Conditions and Keywords

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

Asthma, Elevated Blood Eosinophils, Oral Corticosteroid Dependence

Keywords

Asthma, Elevated Blood Eosinophils, Oral corticosteroid dependence, Reslizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

177 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reslizumab 110 mg

Arm Type

Experimental

Arm Description

Reslizumab was administered by subcutaneous injection (sc) in a dosage of 110 mg (1.0 mL) every 4 weeks for a total of six doses.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo was administered by subcutaneous injection (sc) 1.0 mL every 4 weeks for a total of six doses.

Intervention Type

Drug

Intervention Name(s)

Reslizumab

Other Intervention Name(s)

CEP38072

Intervention Description

Reslizumab 110 mg was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.

Intervention Type

Drug

Intervention Name(s)

Non-Oral Corticosteroid (non-OCS) Asthma Medication

Intervention Description

Participants continue using their non-OCS background asthma medications without change during the study's treatment period.

Intervention Type

Drug

Intervention Name(s)

Oral Corticosteroid (OCS)

Intervention Description

After screening and prior to study start, the participant's OCS dose was adjusted to determine the minimal effective OCS requirement.

Primary Outcome Measure Information:

Title

Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline

Description

Time Frame

Baseline (Day 1), Weeks 20-24

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving a >=50% Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control

Description

Time Frame

Baseline (Day 1), Weeks 20-24

Title

Percentage of Participants Achieving an OCS Dose of <=5 mg at Weeks 20-24 While Maintaining Asthma Control

Description

Time Frame

Weeks 20-24

Title

Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 Using a Mixed Model for Repeated Measures

Description

Time Frame

Baseline (Day 1), Weeks 20-24

Title

Percentage of Participants Achieving a >=5 mg Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control

Description

Time Frame

Baseline (Day 1), Weeks 20-24

Title

Annualized Rate of Clinical Asthma Exacerbations (CAEs)

Description

The annual exacerbation rate is based on clinical asthma exacerbations reported by the investigator in the eCRF.

Time Frame

Day 1 through Week 24

Title

Percentage of Participants Achieving an OCS Dose of 0 mg at Weeks 20-24 While Maintaining Asthma Control

Description

Time Frame

Weeks 20-24

Title

Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses

Description

Time Frame

Weeks 4, 8, 12, 24 or early withdrawal.

Title

Participants With Adverse Events

Description

Time Frame

Day 1 up to Week 24 (end of treatment visit); Data were included between Day 1 and Week 24 for completed patients, and Day 1 and 4 weeks after the last dose of study drug for patients who discontinued treatment early.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma. Written informed consent is obtained. The patient requires daily maintenance dose of prednisone or equivalent for asthma of between 5 and 40 mg during the 3 months prior to screening. The patient has a documented elevated blood eosinophils at screening or during the previous 12 months. The patient has required high dose ICS plus another asthma controller for at least 6 months prior to screening. The patient has FEV1 reversibility to inhaled SABA or historical reversibility within the previous 24 months. Other criteria may apply, please contact the investigator for more information. Exclusion Criteria: The patient has any clinically significant, uncontrolled medical condition that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient's safety. The patient has another confounding underlying lung disorder. The patient has a known hypereosinophilic syndrome. The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers. The patient is pregnant or intends to become pregnant during the study or is lactating. The patient required treatment for an asthma exacerbation within 4 weeks of screening. The patient is a current smoker or has a smoking history ≥10 pack-years. The patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance OCS for the treatment of asthma. The patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer. The patient was previously exposed to benralizumab within 12 months of screening. The patient was previously exposed to reslizumab. The patient has a history of immunodeficiency disorder including human immunodeficiency virus. The patient has current suspected drug and/or alcohol abuse. The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening. The patient has a history of allergic reactions or hypersensitivity to any component of the study drug. Other 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 13357

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Teva Investigational Site 13365

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

Teva Investigational Site 13371

City

Clermont

State/Province

Florida

ZIP/Postal Code

73034

Country

United States

Facility Name

Teva Investigational Site 13351

City

Homestead

State/Province

Florida

ZIP/Postal Code

33030

Country

United States

Facility Name

Teva Investigational Site 13342

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34741

Country

United States

Facility Name

Teva Investigational Site 13344

City

Miami

State/Province

Florida

ZIP/Postal Code

33015

Country

United States

Facility Name

Teva Investigational Site 13372

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

Facility Name

Teva Investigational Site 13354

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33029

Country

United States

Facility Name

Teva Investigational Site 13343

City

Saint Cloud

State/Province

Florida

ZIP/Postal Code

34769

Country

United States

Facility Name

Teva Investigational Site 13368

City

Sebring

State/Province

Florida

ZIP/Postal Code

33870

Country

United States

Facility Name

Teva Investigational Site 13346

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

Teva Investigational Site 13367

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Teva Investigational Site 13363

City

Normal

State/Province

Illinois

ZIP/Postal Code

61761

Country

United States

Facility Name

Teva Investigational Site 13345

City

Michigan City

State/Province

Indiana

ZIP/Postal Code

46360

Country

United States

Facility Name

Teva Investigational Site 13348

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

Teva Investigational Site 13362

City

Biloxi

State/Province

Mississippi

ZIP/Postal Code

39531

Country

United States

Facility Name

Teva Investigational Site 13350

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63106

Country

United States

Facility Name

Teva Investigational Site 13352

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63143

Country

United States

Facility Name

Teva Investigational Site 13356

City

New York

State/Province

New York

ZIP/Postal Code

10016-9196

Country

United States

Facility Name

Teva Investigational Site 13349

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Facility Name

Teva Investigational Site 13370

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73034

Country

United States

Facility Name

Teva Investigational Site 13347

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Teva Investigational Site 13366

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

Teva Investigational Site 13377

City

Dallas

State/Province

Texas

ZIP/Postal Code

75225

Country

United States

Facility Name

Teva Investigational Site 13369

City

Houston

State/Province

Texas

ZIP/Postal Code

77099

Country

United States

Facility Name

Teva Investigational Site 13358

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22030

Country

United States

Facility Name

Teva Investigational Site 20059

City

Buenos Aires

ZIP/Postal Code

C1028AAP

Country

Argentina

Facility Name

Teva Investigational Site 20058

City

Buenos Aires

ZIP/Postal Code

C1425BEN

Country

Argentina

Facility Name

Teva Investigational Site 20056

City

Buenos Aires

ZIP/Postal Code

C1426ABP

Country

Argentina

Facility Name

Teva Investigational Site 20057

City

Buenos Aires

Country

Argentina

Facility Name

Teva Investigational Site 20052

City

Cordoba

ZIP/Postal Code

X5003DCE

Country

Argentina

Facility Name

Teva Investigational Site 20055

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Teva Investigational Site 20050

City

Mendoza

ZIP/Postal Code

M5500CCG

Country

Argentina

Facility Name

Teva Investigational Site 20087

City

Rosario

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Teva Investigational Site 20051

City

San Miguel de Tucuman

ZIP/Postal Code

T4000CHE

Country

Argentina

Facility Name

Teva Investigational Site 20066

City

San Rafael

Country

Argentina

Facility Name

Teva Investigational Site 78089

City

Bedford Park

ZIP/Postal Code

5042

Country

Australia

Facility Name

Teva Investigational Site 78092

City

Box Hill

ZIP/Postal Code

3128

Country

Australia

Facility Name

Teva Investigational Site 78097

City

Frankston

ZIP/Postal Code

3199

Country

Australia

Facility Name

Teva Investigational Site 78093

City

Kent Town

ZIP/Postal Code

5067

Country

Australia

Facility Name

Teva Investigational Site 78090

City

Nedlands

ZIP/Postal Code

6009

Country

Australia

Facility Name

Teva Investigational Site 78091

City

New Lambton

ZIP/Postal Code

2305

Country

Australia

Facility Name

Teva Investigational Site 37059

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Teva Investigational Site 37058

City

Gembloux

ZIP/Postal Code

5030

Country

Belgium

Facility Name

Teva Investigational Site 54133

City

Breclav

ZIP/Postal Code

690 74

Country

Czechia

Facility Name

Teva Investigational Site 54132

City

Jindrichuv Hradec

ZIP/Postal Code

377 38

Country

Czechia

Facility Name

Teva Investigational Site 35186

City

Le Kremlin-bicetre

ZIP/Postal Code

94275 Cedex

Country

France

Facility Name

Teva Investigational Site 35185

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Teva Investigational Site 35189

City

Lyon Cedex 04

ZIP/Postal Code

69317

Country

France

Facility Name

Teva Investigational Site 35187

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Teva Investigational Site 32621

City

Bad Worishofen

ZIP/Postal Code

86825

Country

Germany

Facility Name

Teva Investigational Site 32576

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

Teva Investigational Site 32573

City

Berlin

ZIP/Postal Code

12159

Country

Germany

Facility Name

Teva Investigational Site 32578

City

Berlin

ZIP/Postal Code

13187

Country

Germany

Facility Name

Teva Investigational Site 32622

City

Frankfurt

ZIP/Postal Code

60389

Country

Germany

Facility Name

Teva Investigational Site 32579

City

Hannover

ZIP/Postal Code

30173

Country

Germany

Facility Name

Teva Investigational Site 32574

City

Leipzig

ZIP/Postal Code

4275

Country

Germany

Facility Name

Teva Investigational Site 32580

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Teva Investigational Site 51254

City

Csorna

ZIP/Postal Code

9300

Country

Hungary

Facility Name

Teva Investigational Site 51232

City

Dombovar

ZIP/Postal Code

7200

Country

Hungary

Facility Name

Teva Investigational Site 51233

City

Hatvan

ZIP/Postal Code

3000

Country

Hungary

Facility Name

Teva Investigational Site 51253

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Teva Investigational Site 80085

City

Haifa

ZIP/Postal Code

3436212

Country

Israel

Facility Name

Teva Investigational Site 80083

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Teva Investigational Site 80091

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Teva Investigational Site 80084

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Teva Investigational Site 80082

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Teva Investigational Site 30152

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

Facility Name

Teva Investigational Site 30154

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Teva Investigational Site 87020

City

Goyang-si

ZIP/Postal Code

411-706

Country

Korea, Republic of

Facility Name

Teva Investigational Site 87024

City

Jeonju

ZIP/Postal Code

561-712

Country

Korea, Republic of

Facility Name

Teva Investigational Site 87025

City

Seongnam-si

ZIP/Postal Code

463-707

Country

Korea, Republic of

Facility Name

Teva Investigational Site 87023

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

Teva Investigational Site 87022

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Teva Investigational Site 87021

City

Seoul

ZIP/Postal Code

143-729

Country

Korea, Republic of

Facility Name

Teva Investigational Site 21106

City

Chihuahua

ZIP/Postal Code

31203

Country

Mexico

Facility Name

Teva Investigational Site 21102

City

Distrito Federal

ZIP/Postal Code

07020

Country

Mexico

Facility Name

Teva Investigational Site 21104

City

Durango

ZIP/Postal Code

34080

Country

Mexico

Facility Name

Teva Investigational Site 21094

City

Guadalajara

ZIP/Postal Code

44100

Country

Mexico

Facility Name

Teva Investigational Site 21091

City

Guadalajara

ZIP/Postal Code

44130

Country

Mexico

Facility Name

Teva Investigational Site 21100

City

Guadalajara

ZIP/Postal Code

44160

Country

Mexico

Facility Name

Teva Investigational Site 21093

City

Guadalajara

ZIP/Postal Code

44220

Country

Mexico

Facility Name

Teva Investigational Site 21090

City

Mexico City

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Teva Investigational Site 21103

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Teva Investigational Site 21101

City

Monterrey

ZIP/Postal Code

64718

Country

Mexico

Facility Name

Teva Investigational Site 21105

City

Queretaro

ZIP/Postal Code

76800

Country

Mexico

Facility Name

Teva Investigational Site 38084

City

Leeuwarden

ZIP/Postal Code

8901 BR

Country

Netherlands

Facility Name

Teva Investigational Site 38085

City

Zwolle

ZIP/Postal Code

8025-AB

Country

Netherlands

Facility Name

Teva Investigational Site 53316

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Teva Investigational Site 53318

City

Krakow

ZIP/Postal Code

31-624

Country

Poland

Facility Name

Teva Investigational Site 53319

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Teva Investigational Site 53321

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Teva Investigational Site 53322

City

Lubin

ZIP/Postal Code

59-300

Country

Poland

Facility Name

Teva Investigational Site 53320

City

Ostrow Wielkopolski

ZIP/Postal Code

63-400

Country

Poland

Facility Name

Teva Investigational Site 53358

City

Rzeszow

ZIP/Postal Code

35-612

Country

Poland

Facility Name

Teva Investigational Site 53317

City

Tarnow

ZIP/Postal Code

33-100

Country

Poland

Facility Name

Teva Investigational Site 53323

City

Wroclaw

ZIP/Postal Code

54-239

Country

Poland

Facility Name

Teva Investigational Site 50356

City

Barnaul

ZIP/Postal Code

656024

Country

Russian Federation

Facility Name

Teva Investigational Site 50417

City

Chelyabinsk

ZIP/Postal Code

454021

Country

Russian Federation

Facility Name

Teva Investigational Site 50419

City

Ekaterinburg

ZIP/Postal Code

620039

Country

Russian Federation

Facility Name

Teva Investigational Site 50385

City

Kemerovo

ZIP/Postal Code

650002

Country

Russian Federation

Facility Name

Teva Investigational Site 50382

City

Kemerovo

ZIP/Postal Code

650099

Country

Russian Federation

Facility Name

Teva Investigational Site 50384

City

Moscow

ZIP/Postal Code

129090

Country

Russian Federation

Facility Name

Teva Investigational Site 50383

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

Teva Investigational Site 50386

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

Teva Investigational Site 50357

City

St. Petersburg

ZIP/Postal Code

197089

Country

Russian Federation

Facility Name

Teva Investigational Site 50418

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

Teva Investigational Site 50358

City

Tomsk

ZIP/Postal Code

634063

Country

Russian Federation

Facility Name

Teva Investigational Site 31159

City

Barcelona

ZIP/Postal Code

?08025

Country

Spain

Facility Name

Teva Investigational Site 31161

City

Girona

ZIP/Postal Code

17004

Country

Spain

Facility Name

Teva Investigational Site 31160

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

Teva Investigational Site 31158

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Teva Investigational Site 58245

City

Dnepropetrovsk

ZIP/Postal Code

49044

Country

Ukraine

Facility Name

Teva Investigational Site 58238

City

Dnipropetrovsk

ZIP/Postal Code

49074

Country

Ukraine

Facility Name

Teva Investigational Site 58240

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Teva Investigational Site 58244

City

Kharkiv

ZIP/Postal Code

61002

Country

Ukraine

Facility Name

Teva Investigational Site 58235

City

Kharkiv

ZIP/Postal Code

61007

Country

Ukraine

Facility Name

Teva Investigational Site 58239

City

Kharkiv

ZIP/Postal Code

61035

Country

Ukraine

Facility Name

Teva Investigational Site 58241

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Teva Investigational Site 58249

City

Kremenchuk

ZIP/Postal Code

39617

Country

Ukraine

Facility Name

Teva Investigational Site 58248

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Teva Investigational Site 58251

City

Kyiv

ZIP/Postal Code

2091

Country

Ukraine

Facility Name

Teva Investigational Site 58237

City

Kyiv

ZIP/Postal Code

3049

Country

Ukraine

Facility Name

Teva Investigational Site 58250

City

Kyiv

ZIP/Postal Code

?03680

Country

Ukraine

Facility Name

Teva Investigational Site 58243

City

Sumy

ZIP/Postal Code

40022

Country

Ukraine

Facility Name

Teva Investigational Site 58246

City

Vinnytsya

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

Teva Investigational Site 58242

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

An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

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An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

Asthma, Elevated Blood Eosinophils, Oral Corticosteroid Dependence

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