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A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

Primary Purpose

Eosinophils, Asthma

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

reslizumab

About this trial

This is an interventional treatment trial for Eosinophils, Asthma

Eligibility Criteria

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

Inclusion Criteria:

• Patient with eosinophilic asthma who completed the treatment period of a double-blind, placebo controlled sc reslizumab study (Study C38072-AS-30025 or C38072-AS-30027)

~~ Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

Patient has received any reslizumab administration in any previous clinical trial other than Studies C38072-AS-30025 and C38072-AS-30027.
The patient has any clinically significant, uncontrolled medical condition
The patient has another confounding underlying lung disorder
The patient has a known/diagnosed hypereosinophilic syndrome.
The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
The patient is a pregnant or lactating woman
The patient is a current smoker (ie, has smoked within the last 6 months before screening) or has a smoking history ≥10 pack-years.
The patient is currently using any systemic immunosuppressive or immunomodulatory agents other than OCS
The patient has a history of allergic reaction or hypersensitivity to any component of the study drug.
The patient has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).
- Additional criteria apply, please contact the investigator for more information

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

reslizumab 110 mg

Arm Description

Reslizumab was administered as 110 mg subcutaneous (sc) injection in the thigh, abdomen, or upper arm(s) once every 4 weeks for a total of 9 doses.

Outcomes

Primary Outcome Measures

Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event is any untoward medical occurrence, regardless of whether it has a causal relationship with study treatment. In this study, asthma exacerbations should not be recorded as adverse events unless assessed by the investigator as more severe than the patient's usual disease course. The period for reporting treatment-emergent adverse events was defined as the period after the first dose of study drug was administered until the end of treatment visit. 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.

Secondary Outcome Measures

Participants With Potentially Clinically Significant Abnormal Hematology Values

Participants are included in the counts if the worst study value reaches the following clinically significant levels: Eosinophils (high): >=1.5*10^9/L and increase >0 Hematocrit (low): >=18 years old: <0.32 L/L for females; <0.37 L/L for males plus a decrease >0 for both or 12 to <18 years old: <0.30 L/L and a decrease >0 for both females and males Hemoglobin (low): >=18 years old: <=95 g/L and decrease >0; 12 to <18 years old: <=100 g/L and decrease >0 Leukocytes (high): >=20*10^9/L and increase >0 Leukocytes (low): <=3*10^9/L and decrease >0 Neutrophils (low): <=1*10^9/L and decrease >0 Platelets (low): <=75*10^9/L and decrease >0

Participants With Potentially Clinically Significant Abnormal Serum Chemistry Values

Participants are included in the counts if the worst study value reaches the following clinically significant levels: Alanine Aminotransferase (high): >=3* upper limit of normal (ULN) and increase >0 Aspartate Aminotransferase (high): >=3* upper limit of normal (ULN) and increase >0 Bilirubin (high): >=34.2 micromol/L and increase >0 Blood Urea Nitrogen (high): >=10.71 mmol/L and increase >0 Creatine Phosphokinase (high): >10* ULN and increase >0 Creatine Phosphokinase (medium high): >=3.1*ULN and <=10*ULN and increase >0 Creatinine (high): >=177 micromol/L and increase >0

Participants' Tolerability and Injection Site Reactions by Domain and Worst Overall Severity

The worst finding for participants in each tolerability and injection site domain from all treatment weeks is summarized. Local tolerability at the injection site was assessed approximately 1 hour after study drug administration. Severity was rated on a 4-level scale of none, mild, moderate and severe.

Participants With Potentially Clinically Significant Abnormal Vital Sign Values

Participants are included in the counts if the worst study value reaches the following clinically significant levels: Diastolic blood pressure (high): >100 mmHg and increase >=12 for participants >=18 years; >85 mmHg and increase >=12 for participants 12 - < 18 years Pulse rate (high): >100 beats/minute and increase >=12 Respiratory rate (high): >24 breaths/minute and increase >=10 for participants >=18 years >20 breaths/minute and increase >=10 for participants 12 - < 18 years Systolic blood pressure (high): >160 mmHg and increase >=30 for participants >=18 years; >130 mmHg and increase >=30 for participants 12 - < 18 years Temperature (high): >38.1 celsius and increase >=1.1 Temperature (low): <35.8 celsius

Annualized Rate of Clinical Asthma Exacerbations (CAEs)

Data is included between the first dose of study drug to the end of treatment visit for completed participants, and the first dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early. Annual rate is defined as the number of events/(duration of treatment [days]/365.25). Participants with zero events are included.

Annualized Rate of Clinical Asthma Exacerbations (CAEs) Requiring Asthma-Specific Hospital Admissions or Emergency Room Visits

Mean Number of Days of Hospital Stay During the Treatment Period

Participants with no hospitalizations are included.

Mean Number of School/Work Days Missed Due to Asthma During the Treatment Period

Participants with no school or work days missed due to asthma are included in the counts.

Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36

The FEV1 is the volume of air that can be forcibly exhaled from the lungs in the first second, measured in liters. Pre-bronchodilator spirometry assessments at designated clinic visits (weeks 0, 8, and 24, and 36) should only be performed after withholding short-acting bronchodilators (ie, inhaled short-acting beta-adrenergic agonists and/or short-acting anticholinergics) for at least 6 hours and long-acting bronchodilators ie, inhaled long-acting beta-adrenergic agonists and long acting anticholinergic agents) for at least 12 or 24 hours, according to their labeled dose schedule.

Morning Ambulatory Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36

A weekly average of daily morning ambulatory FEV1 (measured by the handheld spirometry device) was derived using 7-day window intervals. The average was calculated as the sum of all values divided by the number of non-missing assessments. There will be no imputation of missing data. At least 4 of the 7 measurements need to be recorded for a week to be included in the analysis; otherwise the week was treated as missing.

Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 16-20 and Weeks 32-36

Daily OCS dose is defined as total OCS dose in a day (accounting for reported dose and dose frequency) and converting the total daily dose to a prednisone-equivalent dose. Baseline dose is the prescribed OCS dose on the day of first dose of study drug in this study. Dose at Weeks 16-20 and 32-36 is the mean of all daily OCS doses during the week range. Percent change = 100 * (absolute change / baseline dose)

Total Inhalations of Reliever Bronchodilator Medication: Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36

Total inhalations of reliever bronchodilator medication (eg, short-acting beta-agonist [SABA]) measured using weekly averages. The average was calculated as the sum of all values divided by the number of non-missing assessments. There was no imputation of missing data. At least 4 of the 7 measurements need to be recorded for a week to be included in the analysis; otherwise the week was treated as missing.

Asthma Control Questionnaire-6 (ACQ-6) Total Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36

The ACQ-6 is a validated asthma assessment tool that has been widely used. There are 6 self-assessment questions. Each item on the ACQ-6 has a possible score ranging from 0 to 6 and the total score is the mean of all responses. The seven-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Negative change from baseline values indicate improved asthma control.

Asthma Quality of Life Questionnaire Administered to Participants Ages 12-70 Years (AQLQ +12) Overall Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36

The AQLQ +12 is a modified version of the standardized AQLQ, which was developed to measure functional impairments experienced by adults ≥17 years of age. The AQLQ +12 is valid for patients 12 to 70 years of age and includes 32 questions in 4 domains (symptoms, activity limitation, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and score each of the questions on a 7-point scale, where 7=not at all limited and 1=totally limited. The overall score of the AQLQ +12 was derived as the average of the 32 questions, thus, the total score ranges from 1 (indicates "total impairment") to 7 (indicates "no impairment"). Positive change from baseline values indicate improved quality of life.

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 Treatment-Emergent Anti-Drug Antibody (ADA) At the End-0f-Study Visit (Week 51)

The endpoint was defined to evaluate immunogenicity after study drug washout since the end of study visit on Week 51 was to be 19 weeks after the final dose of study drug. Due to the early termination of the study no participants had an end of study visit.

Full Information

NCT ID

NCT03052725

First Posted

February 7, 2017

Last Updated

December 9, 2022

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03052725

Brief Title

A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

Official Title

An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Terminated

Why Stopped

Parent Studies didn't meet their primary endpoint so study was terminated.

Study Start Date

March 10, 2017 (Actual)

Primary Completion Date

February 22, 2018 (Actual)

Study Completion Date

February 22, 2018 (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

5. Study Description

Brief Summary

This is a multicenter, open-label (OL) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The study consists of a screening/baseline visit followed by a 36-week OL treatment period and a 15-week follow-up period.

6. Conditions and Keywords

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

Eosinophils, Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

391 (Actual)

8. Arms, Groups, and Interventions

Arm Title

reslizumab 110 mg

Arm Type

Experimental

Arm Description

Reslizumab was administered as 110 mg subcutaneous (sc) injection in the thigh, abdomen, or upper arm(s) once every 4 weeks for a total of 9 doses.

Intervention Type

Drug

Intervention Name(s)

reslizumab

Other Intervention Name(s)

CEP38072

Intervention Description

Reslizumab was provided in a pre-filled syringe.

Primary Outcome Measure Information:

Title

Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.

Secondary Outcome Measure Information:

Title

Participants With Potentially Clinically Significant Abnormal Hematology Values

Description

Time Frame

Week 0 (baseline), Weeks 8, 24, 36 plus any unscheduled visits

Title

Participants With Potentially Clinically Significant Abnormal Serum Chemistry Values

Description

Time Frame

Week 0 (baseline), Weeks 4, 8, 24, 36 plus any unscheduled visits

Title

Participants' Tolerability and Injection Site Reactions by Domain and Worst Overall Severity

Description

Time Frame

Weeks 4, 8, 12, 16, 20, 24, 28, and 36

Title

Participants With Potentially Clinically Significant Abnormal Vital Sign Values

Description

Time Frame

Week 0 (baseline), Weeks 4, 8, 12, 16,20, 24, 28, 32, 36 plus any unscheduled visits

Title

Annualized Rate of Clinical Asthma Exacerbations (CAEs)

Description

Time Frame

Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.

Title

Annualized Rate of Clinical Asthma Exacerbations (CAEs) Requiring Asthma-Specific Hospital Admissions or Emergency Room Visits

Description

Time Frame

Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.

Title

Mean Number of Days of Hospital Stay During the Treatment Period

Description

Participants with no hospitalizations are included.

Time Frame

Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug

Title

Mean Number of School/Work Days Missed Due to Asthma During the Treatment Period

Description

Participants with no school or work days missed due to asthma are included in the counts.

Time Frame

Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug

Title

Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36

Description

Time Frame

Week 0 (baseline), Weeks 8, 24, 36

Title

Morning Ambulatory Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36

Description

Time Frame

Week 0 (baseline), Weeks 1, 4, 8, 24, 36

Title

Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 16-20 and Weeks 32-36

Description

Time Frame

Week 0 (baseline), Weeks 16-20, Weeks 32-36

Title

Total Inhalations of Reliever Bronchodilator Medication: Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36

Description

Time Frame

Baseline (Week 0), Weeks 1, 4, 8, 24, 36

Title

Asthma Control Questionnaire-6 (ACQ-6) Total Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36

Description

Time Frame

Baseline (Week 0), Weeks 8, 24, 36

Title

Asthma Quality of Life Questionnaire Administered to Participants Ages 12-70 Years (AQLQ +12) Overall Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36

Description

Time Frame

Baseline (Week 0), Weeks 8, 24, 36

Title

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

Description

Time Frame

Baseline - date of randomization in the previous study (C38072-AS-30025 or C38072-AS-30027), Weeks 8, 24, 36 or early withdrawal

Title

Participants With Treatment-Emergent Anti-Drug Antibody (ADA) At the End-0f-Study Visit (Week 51)

Description

Time Frame

Week 51

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: • Patient with eosinophilic asthma who completed the treatment period of a double-blind, placebo controlled sc reslizumab study (Study C38072-AS-30025 or C38072-AS-30027) ~~ Additional criteria apply, please contact the investigator for more information Exclusion Criteria: Patient has received any reslizumab administration in any previous clinical trial other than Studies C38072-AS-30025 and C38072-AS-30027. The patient has any clinically significant, uncontrolled medical condition The patient has another confounding underlying lung disorder The patient has a known/diagnosed hypereosinophilic syndrome. The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers. The patient is a pregnant or lactating woman The patient is a current smoker (ie, has smoked within the last 6 months before screening) or has a smoking history ≥10 pack-years. The patient is currently using any systemic immunosuppressive or immunomodulatory agents other than OCS The patient has a history of allergic reaction or hypersensitivity to any component of the study drug. The patient has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV). Additional criteria 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 14647

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Teva Investigational Site 14631

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Teva Investigational Site 14648

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647

Country

United States

Facility Name

Teva Investigational Site 14637

City

Napa

State/Province

California

ZIP/Postal Code

94558

Country

United States

Facility Name

Teva Investigational Site 14654

City

Stockton

State/Province

California

ZIP/Postal Code

95207

Country

United States

Facility Name

Teva Investigational Site 14636

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Teva Investigational Site 14626

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Teva Investigational Site 14634

City

Homestead

State/Province

Florida

ZIP/Postal Code

33030

Country

United States

Facility Name

Teva Investigational Site 14650

City

Miami

State/Province

Florida

ZIP/Postal Code

33015

Country

United States

Facility Name

Teva Investigational Site 14629

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Teva Investigational Site 14619

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

Teva Investigational Site 14624

City

Orlando

State/Province

Florida

ZIP/Postal Code

32819

Country

United States

Facility Name

Teva Investigational Site 14638

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

Teva Investigational Site 14642

City

Buford

State/Province

Georgia

ZIP/Postal Code

30518

Country

United States

Facility Name

Teva Investigational Site 14651

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Teva Investigational Site 14645

City

Michigan City

State/Province

Indiana

ZIP/Postal Code

46360

Country

United States

Facility Name

Teva Investigational Site 14620

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42301

Country

United States

Facility Name

Teva Investigational Site 14623

City

Lafayette

State/Province

Louisiana

ZIP/Postal Code

70508

Country

United States

Facility Name

Teva Investigational Site 14627

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

Teva Investigational Site 14644

City

Boys Town

State/Province

Nebraska

ZIP/Postal Code

68010

Country

United States

Facility Name

Teva Investigational Site 14652

City

Ocean City

State/Province

New Jersey

ZIP/Postal Code

07712

Country

United States

Facility Name

Teva Investigational Site 14632

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Teva Investigational Site 14646

City

New York

State/Province

New York

ZIP/Postal Code

10016-9196

Country

United States

Facility Name

Teva Investigational Site 14633

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45221

Country

United States

Facility Name

Teva Investigational Site 14653

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Teva Investigational Site 14621

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73034

Country

United States

Facility Name

Teva Investigational Site 14625

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73034

Country

United States

Facility Name

Teva Investigational Site 14643

City

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Facility Name

Teva Investigational Site 14622

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

Teva Investigational Site 14630

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

Facility Name

Teva Investigational Site 14649

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02909

Country

United States

Facility Name

Teva Investigational Site 14655

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37919

Country

United States

Facility Name

Teva Investigational Site 14639

City

Corsicana

State/Province

Texas

ZIP/Postal Code

75110

Country

United States

Facility Name

Teva Investigational Site 14640

City

Dallas

State/Province

Texas

ZIP/Postal Code

75225

Country

United States

Facility Name

Teva Investigational Site 14641

City

Provo

State/Province

Utah

ZIP/Postal Code

84604

Country

United States

Facility Name

Teva Investigational Site 14628

City

Abingdon

State/Province

Virginia

ZIP/Postal Code

24210

Country

United States

Facility Name

Teva Investigational Site 14635

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22044

Country

United States

Facility Name

Teva Investigational Site 37082

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Teva Investigational Site 37081

City

Erpent

ZIP/Postal Code

5101

Country

Belgium

Facility Name

Teva Investigational Site 37083

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Teva Investigational Site 11133

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E1

Country

Canada

Facility Name

Teva Investigational Site 11134

City

Etobicoke

State/Province

Ontario

ZIP/Postal Code

M9V 4B4

Country

Canada

Facility Name

Teva Investigational Site 54151

City

Breclav

ZIP/Postal Code

690 74

Country

Czechia

Facility Name

Teva Investigational Site 54150

City

Jablonec nad Nisou

ZIP/Postal Code

46601

Country

Czechia

Facility Name

Teva Investigational Site 54148

City

Jindrichuv Hradec

ZIP/Postal Code

377 38

Country

Czechia

Facility Name

Teva Investigational Site 54149

City

Tabor

ZIP/Postal Code

39001

Country

Czechia

Facility Name

Teva Investigational Site 35229

City

Le Kremlin-bicetre

ZIP/Postal Code

94275 Cedex

Country

France

Facility Name

Teva Investigational Site 35227

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Teva Investigational Site 35228

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Teva Investigational Site 32676

City

Berlin-Tempelhof

ZIP/Postal Code

12099

Country

Germany

Facility Name

Teva Investigational Site 32670

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

Teva Investigational Site 32680

City

Berlin

ZIP/Postal Code

10969

Country

Germany

Facility Name

Teva Investigational Site 32673

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Teva Investigational Site 32675

City

Frankfurt/Main

ZIP/Postal Code

60389

Country

Germany

Facility Name

Teva Investigational Site 32679

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Teva Investigational Site 32678

City

Hamburg

ZIP/Postal Code

22299

Country

Germany

Facility Name

Teva Investigational Site 32681

City

Hannover

ZIP/Postal Code

30173

Country

Germany

Facility Name

Teva Investigational Site 32677

City

Koblenz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Teva Investigational Site 32672

City

Leipzig

ZIP/Postal Code

4357

Country

Germany

Facility Name

Teva Investigational Site 32671

City

Leipzig

ZIP/Postal Code

?04275

Country

Germany

Facility Name

Teva Investigational Site 32674

City

Lubeck

ZIP/Postal Code

23552

Country

Germany

Facility Name

Teva Investigational Site 32682

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Teva Investigational Site 51291

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Teva Investigational Site 51290

City

Budapest

ZIP/Postal Code

H-1036

Country

Hungary

Facility Name

Teva Investigational Site 51293

City

Csorna

ZIP/Postal Code

9300

Country

Hungary

Facility Name

Teva Investigational Site 51292

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Teva Investigational Site 51283

City

Debrecen

ZIP/Postal Code

4043

Country

Hungary

Facility Name

Teva Investigational Site 51286

City

Godollo

ZIP/Postal Code

2100

Country

Hungary

Facility Name

Teva Investigational Site 51284

City

Gyor

ZIP/Postal Code

9023

Country

Hungary

Facility Name

Teva Investigational Site 51285

City

Hajdunanas

ZIP/Postal Code

4080

Country

Hungary

Facility Name

Teva Investigational Site 51282

City

Kapuvar

ZIP/Postal Code

9330

Country

Hungary

Facility Name

Teva Investigational Site 51288

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Teva Investigational Site 51289

City

Szigetvar

ZIP/Postal Code

7900

Country

Hungary

Facility Name

Teva Investigational Site 51280

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Teva Investigational Site 51281

City

Tatabanya

ZIP/Postal Code

2800

Country

Hungary

Facility Name

Teva Investigational Site 51287

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Teva Investigational Site 80136

City

Ashkelon

ZIP/Postal Code

7830604

Country

Israel

Facility Name

Teva Investigational Site 80129

City

Haifa

ZIP/Postal Code

3436212

Country

Israel

Facility Name

Teva Investigational Site 80131

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Teva Investigational Site 80135

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Teva Investigational Site 80134

City

Kfar Saba

ZIP/Postal Code

4428164

Country

Israel

Facility Name

Teva Investigational Site 80132

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Teva Investigational Site 80133

City

Ramat Gan

ZIP/Postal Code

5262100

Country

Israel

Facility Name

Teva Investigational Site 80130

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Teva Investigational Site 53405

City

Bialystok

ZIP/Postal Code

15-044

Country

Poland

Facility Name

Teva Investigational Site 53402

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Teva Investigational Site 53399

City

Krakow

ZIP/Postal Code

31-624

Country

Poland

Facility Name

Teva Investigational Site 53408

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Teva Investigational Site 53400

City

Lodz

ZIP/Postal Code

90-329

Country

Poland

Facility Name

Teva Investigational Site 53403

City

Lubin

ZIP/Postal Code

59-300

Country

Poland

Facility Name

Teva Investigational Site 53407

City

Ostrow Wielkopolski

ZIP/Postal Code

63-400

Country

Poland

Facility Name

Teva Investigational Site 53401

City

Poznan

ZIP/Postal Code

60-214

Country

Poland

Facility Name

Teva Investigational Site 53404

City

Tarnow

ZIP/Postal Code

33-100

Country

Poland

Facility Name

Teva Investigational Site 53406

City

Wroclaw

ZIP/Postal Code

54-239

Country

Poland

Facility Name

Teva Investigational Site 52115

City

Brasov

ZIP/Postal Code

500051

Country

Romania

Facility Name

Teva Investigational Site 52116

City

Brasov

ZIP/Postal Code

500086

Country

Romania

Facility Name

Teva Investigational Site 52113

City

Cluj-Napoca

ZIP/Postal Code

400371

Country

Romania

Facility Name

Teva Investigational Site 52114

City

Targu Mures

ZIP/Postal Code

540136

Country

Romania

Facility Name

Teva Investigational Site 52117

City

Timisoara

ZIP/Postal Code

300310

Country

Romania

Facility Name

Teva Investigational Site 50460

City

Barnaul

ZIP/Postal Code

656024

Country

Russian Federation

Facility Name

Teva Investigational Site 50453

City

Kemerovo

ZIP/Postal Code

650002

Country

Russian Federation

Facility Name

Teva Investigational Site 50461

City

Kemerovo

ZIP/Postal Code

650099

Country

Russian Federation

Facility Name

Teva Investigational Site 50456

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Teva Investigational Site 50459

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

Teva Investigational Site 50455

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

Teva Investigational Site 50454

City

Saint-Petersburg

ZIP/Postal Code

194223

Country

Russian Federation

Facility Name

Teva Investigational Site 50457

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Teva Investigational Site 50458

City

Tomsk

ZIP/Postal Code

634063

Country

Russian Federation

Facility Name

Teva Investigational Site 31219

City

Barcelona

ZIP/Postal Code

8041

Country

Spain

Facility Name

Teva Investigational Site 31218

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

Teva Investigational Site 31217

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Teva Investigational Site 58283

City

Chernivtsi

ZIP/Postal Code

58023

Country

Ukraine

Facility Name

Teva Investigational Site 58304

City

Dnipropetrovsk

ZIP/Postal Code

49074

Country

Ukraine

Facility Name

Teva Investigational Site 58287

City

Dnipropetrovsk

ZIP/Postal Code

49101

Country

Ukraine

Facility Name

Teva Investigational Site 58295

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Teva Investigational Site 58293

City

Kharkiv

ZIP/Postal Code

61002

Country

Ukraine

Facility Name

Teva Investigational Site 58289

City

Kharkiv

ZIP/Postal Code

61007

Country

Ukraine

Facility Name

Teva Investigational Site 58284

City

Kharkiv

ZIP/Postal Code

61035

Country

Ukraine

Facility Name

Teva Investigational Site 58288

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Teva Investigational Site 58302

City

Kremenchuk

ZIP/Postal Code

39617

Country

Ukraine

Facility Name

Teva Investigational Site 58292

City

Kryvyi Rih

ZIP/Postal Code

50082

Country

Ukraine

Facility Name

Teva Investigational Site 58303

City

Kyiv

ZIP/Postal Code

2091

Country

Ukraine

Facility Name

Teva Investigational Site 58282

City

Kyiv

ZIP/Postal Code

3049

Country

Ukraine

Facility Name

Teva Investigational Site 58285

City

Kyiv

ZIP/Postal Code

3680

Country

Ukraine

Facility Name

Teva Investigational Site 58286

City

Kyiv

ZIP/Postal Code

3680

Country

Ukraine

Facility Name

Teva Investigational Site 58290

City

Kyiv

ZIP/Postal Code

3680

Country

Ukraine

Facility Name

Teva Investigational Site 58291

City

Kyiv

ZIP/Postal Code

4050

Country

Ukraine

Facility Name

Teva Investigational Site 58296

City

Kyiv

ZIP/Postal Code

4107

Country

Ukraine

Facility Name

Teva Investigational Site 58299

City

Kyiv

ZIP/Postal Code

4201

Country

Ukraine

Facility Name

Teva Investigational Site 58297

City

Sumy

ZIP/Postal Code

40022

Country

Ukraine

Facility Name

Teva Investigational Site 58301

City

Vinnytsia

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

Teva Investigational Site 58294

City

Vinnytsya

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

Teva Investigational Site 58298

City

Zaporizhzhya

ZIP/Postal Code

69063

Country

Ukraine

Facility Name

Teva Investigational Site 58300

City

Zaporizhzhya

ZIP/Postal Code

69118

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

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A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

Eosinophils, Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial