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A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma

Primary Purpose

Eosinophilic Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Reslizumab

Placebo

About this trial

This is an interventional treatment trial for Eosinophilic Asthma

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma. Patients 12 through 17 years of age are excluded from participating in Germany, India, Argentina, and Korea; patients 66 through 75 years of age are excluded from participating in India and Korea.
The patient has had at least 1 asthma exacerbation requiring oral, intramuscular (im), or intravenous (iv) corticosteroid use for at least 3 days over the past 12 months before screening.
The patient has a current blood eosinophil level of at least 400/μL.
The patient has airway reversibility of at least 12% to beta-agonist administration.
The patient has an ACQ score of at least 1.5 5 at the screening and baseline (before the 1st dose of study drug) visits.
The patient is taking inhaled fluticasone at a dosage of at least 440 μg, or equivalent, daily. Chronic oral corticosteroid use (no more than 10 mg/day prednisone or equivalent) is allowed. If a patient is on a stable dose, eg, 2 weeks or more of oral corticosteroid treatment at the time of study enrollment, the patient must remain on this dose throughout the study. The patient's baseline asthma therapy regimen (including, but not limited to, inhaled corticosteroids, oral corticosteroids up to a maximum dose of 10 mg prednisone daily or equivalent, leukotriene antagonists, 5-lipoxygenase inhibitors, or cromolyn) must be stable for 30 days prior to screening and baseline and must continue without dosage changes throughout the study.
All female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test (ß-human chorionic gonadotropin [ß-HCG]) at screening (serum) and baseline (urine).
Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected). NOTE: Partner sterility alone is not acceptable for inclusion in the study.
Written informed consent is obtained. Patients 12 through 17 years old, where participating, must provide assent.
The patient is in reasonable health (except for diagnosis of asthma) as judged by the investigator, and as determined by a medical history, medical examination, ECG evaluation (at screening), serum chemistry, hematology, and urinalysis.
The patient must be willing and able to understand and comply with study restrictions, requirements, and procedures, as specified by the study center, and to remain at the study center for the required duration during the study period, and willing to return to the study center for the follow-up evaluation as specified in this protocol.
Patients who experience an asthma exacerbation during the screening period will be considered to have failed screening and cannot be randomly assigned to study drug. Patients may be rescreened 1 time only.

Exclusion Criteria:

The patient has a clinically meaningful co-morbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
The patient has known hypereosinophilic syndrome.
The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). Patients with pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) will also be excluded.
The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
The patient is using systemic immunosuppressive, immunomodulating, or other biologic agents (including, but not limited to, anti-immunoglobulin E (IgE) mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis factor [anti-TNF] mAb) within 6 months prior to screening.
The patient has previously received an anti-hIL-5 monoclonal antibody (eg, reslizumab, mepolizumab, or benralizumab).
The patient has any aggravating medical factors that are inadequately controlled (eg, rhinitis, gastroesophageal reflux disease, and uncontrolled diabetes).
The patient has participated in any investigative drug or device study within 30 days prior to screening.
The patient has participated in any investigative biologics study within 6 months prior to screening.
Other exclusion criteria apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Reslizumab 3.0 mg/kg

Arm Description

Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.

Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.

Outcomes

Primary Outcome Measures

Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment

An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma: use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids. asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization. CAEs were adjudicated by committee to assure consistency. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors. Results are offered as adjusted means.

Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs)

An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma: use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids. asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization CAEs were adjudicated by committee to assure consistency. Adjusted CAE rate and confidence intervals for the two criteria were based on Negative Binomial regression model adjusted for stratification factors. Results are offered as adjusted means.

Secondary Outcome Measures

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) At Week 16

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures

FEV1 is a standard measurement of air movement in the lungs of patients 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. During study (Weeks 4, 8, 12 and 16) average value used a mixed effect model for repeated measures (MMRM) with treatment group, visit, treatment and visit interaction, and stratification factors as fixed effects and participant as a random effect. Covariates for baseline values were also included in the model; for pulmonary function test analyses, covariates for height and sex were included as well. Positive change from baseline scores indicate improvement in asthma control.

Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) to Week 16

The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were "patient-specific," which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits. Positive change from baseline scores indicate improvement in quality of life.

Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures

The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (Weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. Negative change from baseline scores indicate improvement in asthma control.

Kaplan-Meier Estimates for Time to First Clinical Asthma Exacerbation (CAE)

An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma: use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids. asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization. CAEs were adjudicated by committee to assure consistency. The distributions were compared by a log rank test stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).

Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures

The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms. The during treatment (Weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms.

Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures

SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3. The during treatment (Weeks 4, 8, 12 and 16) average SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. Negative change from baseline scores indicate improvement in asthma control.

Change From Baseline in Blood Eosinophil Count Over 16 Weeks and 52 Weeks Using Mixed Model for Repeated Measures

The blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test. Results of all differential blood tests conducted after randomization were blinded. The during treatment average eosinophil count was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. The 'over 16 weeks' value used data from Weeks 4, 8, 12 and 16. The 'over 52 weeks' value used all the during study time points listed in the Time Frame field. Negative change from baseline values correlate to reduced asthma severity.

Participants With Treatment-Emergent Adverse Events TEAE)

An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. 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.

Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values

Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology (except for eosinophil values), and urinalysis values. Significance criteria: Blood urea nitrogen: >=10.71 mmol/L Creatinine: >=177 μmol/L Urate: M>=625, F>=506 μmol/L Aspartate aminotransferase (AST): >=3*upper limit of normal (ULN) Alanine aminotransferase (ALT): >=3*ULN GGT = gamma-glutamyl transpeptidase: >= 3*ULN Total bilirubin: >=34.2 μmol/L White blood cells (low): <=3.0*10^9/L White blood cells (high): >=20*10^9/L Hemoglobin (age >=18 years): M<=115, F<=95 g/dL Hematocrit (age >=18 years): M<0.37, F<0.32 L/L Eosinophils/leukocytes: >=10.0% Platelets: <=75*10^9/L Neutrophils: <=1.0*10^9/L Urinalysis: blood, ketones, glucose, and protein: >=2 unit increase from baseline

Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values

Data represents participants with potentially clinically significant (PCS) vital sign values. Significance criteria Sitting pulse (high): >100 and increase of >= 30 beats/minute Sitting systolic blood pressure (low): <90 and decrease of >= 30 mmHg Sitting systolic blood pressure (high): >160 and increase of >= 30 mmHg Sitting diastolic blood pressure (low): <50 and decrease of >=12 mmHg (if 12-17 years old: <55 and decrease of >=12 mmHg 0 Sitting diastolic blood pressure (high): >100 and increase of >=12 mmHg Respiratory rate (low): <6 breaths/minute Respiratory rate (high): >24 and increase of >=10 breaths/minute Body temperature (low): <35.8° Celsius Body temperature (high): >=38.1 and increase of >=1.1° Celsius

Participants With a Positive Anti-Reslizumab Antibody Status During Study

Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the experimental treatment arm. Blood samples were collected for determination of ADAs before study drug infusion.

Full Information

NCT ID

NCT01285323

First Posted

January 25, 2011

Last Updated

November 6, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01285323

Brief Title

A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma

Official Title

A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.

6. Conditions and Keywords

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

Eosinophilic Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

464 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.

Arm Title

Reslizumab 3.0 mg/kg

Arm Type

Experimental

Arm Description

Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.

Intervention Type

Drug

Intervention Name(s)

Reslizumab

Other Intervention Name(s)

Cinquil, humanized monoclonal antibody, CEP-38072

Intervention Description

Patients were administered intravenously over 15 to 30 minutes reslizumab at a dosage of 3.0 mg/kg at baseline and once every 4 weeks relative to baseline over 48 weeks for a total of 13 doses.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo (acetate sucrose buffer), administered intravenously (iv) once every 4 weeks for a total of 13 doses.

Primary Outcome Measure Information:

Title

Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment

Description

Time Frame

Day 1 to Month 12

Title

Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs)

Description

An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma: use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids. asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization CAEs were adjudicated by committee to assure consistency. Adjusted CAE rate and confidence intervals for the two criteria were based on Negative Binomial regression model adjusted for stratification factors. Results are offered as adjusted means.

Time Frame

Day 1 to Month 12

Secondary Outcome Measure Information:

Title

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) At Week 16

Description

Time Frame

Day 1 (baseline, pre-dose), Week 16

Title

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures

Description

Time Frame

Day 1 (baseline, pre-dose), Weeks 4, 8, 12 and 16

Title

Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) to Week 16

Description

Time Frame

Day 1 (baseline, pre-dose), Week 16

Title

Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures

Description

Time Frame

Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16

Title

Kaplan-Meier Estimates for Time to First Clinical Asthma Exacerbation (CAE)

Description

An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma: use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids. asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization. CAEs were adjudicated by committee to assure consistency. The distributions were compared by a log rank test stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).

Time Frame

Day 1 to Day 526 (longest treatment time plus 2 weeks)

Title

Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures

Description

Time Frame

Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16

Title

Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures

Description

Time Frame

Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16

Title

Change From Baseline in Blood Eosinophil Count Over 16 Weeks and 52 Weeks Using Mixed Model for Repeated Measures

Description

Time Frame

Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 or early withdrawal

Title

Participants With Treatment-Emergent Adverse Events TEAE)

Description

Time Frame

Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.

Title

Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values

Description

Time Frame

Week 4 to Week 52

Title

Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values

Description

Time Frame

Week 4 to Week 52

Title

Participants With a Positive Anti-Reslizumab Antibody Status During Study

Description

Time Frame

Baseline visit (prior to reslizumab exposure), Weeks 16, 32, 48 and 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma. Patients 12 through 17 years of age are excluded from participating in Germany, India, Argentina, and Korea; patients 66 through 75 years of age are excluded from participating in India and Korea. The patient has had at least 1 asthma exacerbation requiring oral, intramuscular (im), or intravenous (iv) corticosteroid use for at least 3 days over the past 12 months before screening. The patient has a current blood eosinophil level of at least 400/μL. The patient has airway reversibility of at least 12% to beta-agonist administration. The patient has an ACQ score of at least 1.5 5 at the screening and baseline (before the 1st dose of study drug) visits. The patient is taking inhaled fluticasone at a dosage of at least 440 μg, or equivalent, daily. Chronic oral corticosteroid use (no more than 10 mg/day prednisone or equivalent) is allowed. If a patient is on a stable dose, eg, 2 weeks or more of oral corticosteroid treatment at the time of study enrollment, the patient must remain on this dose throughout the study. The patient's baseline asthma therapy regimen (including, but not limited to, inhaled corticosteroids, oral corticosteroids up to a maximum dose of 10 mg prednisone daily or equivalent, leukotriene antagonists, 5-lipoxygenase inhibitors, or cromolyn) must be stable for 30 days prior to screening and baseline and must continue without dosage changes throughout the study. All female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test (ß-human chorionic gonadotropin [ß-HCG]) at screening (serum) and baseline (urine). Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected). NOTE: Partner sterility alone is not acceptable for inclusion in the study. Written informed consent is obtained. Patients 12 through 17 years old, where participating, must provide assent. The patient is in reasonable health (except for diagnosis of asthma) as judged by the investigator, and as determined by a medical history, medical examination, ECG evaluation (at screening), serum chemistry, hematology, and urinalysis. The patient must be willing and able to understand and comply with study restrictions, requirements, and procedures, as specified by the study center, and to remain at the study center for the required duration during the study period, and willing to return to the study center for the follow-up evaluation as specified in this protocol. Patients who experience an asthma exacerbation during the screening period will be considered to have failed screening and cannot be randomly assigned to study drug. Patients may be rescreened 1 time only. Exclusion Criteria: The patient has a clinically meaningful co-morbidity that would interfere with the study schedule or procedures, or compromise the patient's safety. The patient has known hypereosinophilic syndrome. The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). Patients with pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) will also be excluded. The patient is a current smoker (ie, has smoked within the last 6 months prior to screening). The patient is using systemic immunosuppressive, immunomodulating, or other biologic agents (including, but not limited to, anti-immunoglobulin E (IgE) mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis factor [anti-TNF] mAb) within 6 months prior to screening. The patient has previously received an anti-hIL-5 monoclonal antibody (eg, reslizumab, mepolizumab, or benralizumab). The patient has any aggravating medical factors that are inadequately controlled (eg, rhinitis, gastroesophageal reflux disease, and uncontrolled diabetes). The patient has participated in any investigative drug or device study within 30 days prior to screening. The patient has participated in any investigative biologics study within 6 months prior to screening. Other exclusion criteria apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Expert, MD

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 48

City

Mobile

State/Province

Alabama

Country

United States

Facility Name

Teva Investigational Site 41

City

Fresno

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 59

City

Long Beach

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 47

City

Denver

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 28

City

Waterbury

State/Province

Connecticut

Country

United States

Facility Name

Teva Investigational Site 53

City

Clearwater

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 27

City

Miami

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 25

City

Lawrenceville

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 57

City

Metairie

State/Province

Louisiana

Country

United States

Facility Name

Teva Investigational Site 46

City

Bangor

State/Province

Maine

Country

United States

Facility Name

Teva Investigational Site 40

City

Saint Louis

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 67

City

Fort Mill

State/Province

South Carolina

Country

United States

Facility Name

Teva Investigational Site 44

City

Dallas

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 69

City

El Paso

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 45

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 121

City

Ciudad Autonoma de Buenos Aire

Country

Argentina

Facility Name

Teva Investigational Site 126

City

Ciudad Autonoma de Buenos Aire

Country

Argentina

Facility Name

Teva Investigational Site 123

City

Rosario-Santa Fe

Country

Argentina

Facility Name

Teva Investigational Site 120

City

San Miguel De Tucuman - Tucuma

Country

Argentina

Facility Name

Teva Investigational Site 150

City

Florianopolis

Country

Brazil

Facility Name

Teva Investigational Site 143

City

Porto Alegre, RS

Country

Brazil

Facility Name

Teva Investigational Site 140

City

Porto Alegre

Country

Brazil

Facility Name

Teva Investigational Site 144

City

Porto Alegre

Country

Brazil

Facility Name

Teva Investigational Site 145

City

Porto Alegre

Country

Brazil

Facility Name

Teva Investigational Site 142

City

Santo André, São Paulo

Country

Brazil

Facility Name

Teva Investigational Site 104

City

Newmarket

Country

Canada

Facility Name

Teva Investigational Site 102

City

Pointe-Claire

Country

Canada

Facility Name

Teva Investigational Site 105

City

Windsor

Country

Canada

Facility Name

Teva Investigational Site 343

City

Grenoble

Country

France

Facility Name

Teva Investigational Site 342

City

Marseille

Country

France

Facility Name

Teva Investigational Site 341

City

Montpellier

Country

France

Facility Name

Teva Investigational Site 360

City

Bad Wörishofen

Country

Germany

Facility Name

Teva Investigational Site 361

City

Berlin

Country

Germany

Facility Name

Teva Investigational Site 362

City

Berlin

Country

Germany

Facility Name

Teva Investigational Site 366

City

Berlin

Country

Germany

Facility Name

Teva Investigational Site 371

City

Bochum

Country

Germany

Facility Name

Teva Investigational Site 365

City

Dresden

Country

Germany

Facility Name

Teva Investigational Site 369

City

Frankfurt

Country

Germany

Facility Name

Teva Investigational Site 370

City

Hamburg

Country

Germany

Facility Name

Teva Investigational Site 372

City

Koblenz

Country

Germany

Facility Name

Teva Investigational Site 367

City

Leipzig

Country

Germany

Facility Name

Teva Investigational Site 368

City

Leipzig

Country

Germany

Facility Name

Teva Investigational Site 363

City

Mainz

Country

Germany

Facility Name

Teva Investigational Site 364

City

Mainz

Country

Germany

Facility Name

Teva Investigational Site 381

City

Alexandroupolis

Country

Greece

Facility Name

Teva Investigational Site 380

City

Athens

Country

Greece

Facility Name

Teva Investigational Site 382

City

Heraklion, Crete

Country

Greece

Facility Name

Teva Investigational Site 682

City

Gwangju

Country

Korea, Republic of

Facility Name

Teva Investigational Site 680

City

Seoul

Country

Korea, Republic of

Facility Name

Teva Investigational Site 681

City

Seoul

Country

Korea, Republic of

Facility Name

Teva Investigational Site 683

City

Seoul

Country

Korea, Republic of

Facility Name

Teva Investigational Site 686

City

Seoul

Country

Korea, Republic of

Facility Name

Teva Investigational Site 685

City

Suwon

Country

Korea, Republic of

Facility Name

Teva Investigational Site 205

City

Ciudad De México

Country

Mexico

Facility Name

Teva Investigational Site 203

City

Distrito Federal

Country

Mexico

Facility Name

Teva Investigational Site 204

City

Guadalajara, JAL

Country

Mexico

Facility Name

Teva Investigational Site 207

City

Mexico City

Country

Mexico

Facility Name

Teva Investigational Site 209

City

Monterrey

Country

Mexico

Facility Name

Teva Investigational Site 202

City

Tijuana, B.C.

Country

Mexico

Facility Name

Teva Investigational Site 223

City

Cercado De Lima, Lima

Country

Peru

Facility Name

Teva Investigational Site 220

City

Lima

Country

Peru

Facility Name

Teva Investigational Site 221

City

Lima

Country

Peru

Facility Name

Teva Investigational Site 222

City

Lima

Country

Peru

Facility Name

Teva Investigational Site 225

City

Lima

Country

Peru

Facility Name

Teva Investigational Site 226

City

Lima

Country

Peru

Facility Name

Teva Investigational Site 227

City

Lima

Country

Peru

Facility Name

Teva Investigational Site 229

City

Lima

Country

Peru

Facility Name

Teva Investigational Site 523

City

Bucharest

Country

Romania

Facility Name

Teva Investigational Site 524

City

Bucharest

Country

Romania

Facility Name

Teva Investigational Site 520

City

Cluj-Napoca

Country

Romania

Facility Name

Teva Investigational Site 521

City

Iasi

Country

Romania

Facility Name

Teva Investigational Site 522

City

Targu Mures

Country

Romania

Facility Name

Teva Investigational Site 543

City

Moscow

Country

Russian Federation

Facility Name

Teva Investigational Site 544

City

Moscow

Country

Russian Federation

Facility Name

Teva Investigational Site 554

City

Moscow

Country

Russian Federation

Facility Name

Teva Investigational Site 556

City

Moscow

Country

Russian Federation

Facility Name

Teva Investigational Site 558

City

Moscow

Country

Russian Federation

Facility Name

Teva Investigational Site 559

City

Moscow

Country

Russian Federation

Facility Name

Teva Investigational Site 557

City

Novosibirsk

Country

Russian Federation

Facility Name

Teva Investigational Site 541

City

St. Petersburg

Country

Russian Federation

Facility Name

Teva Investigational Site 540

City

St.Petersburg

Country

Russian Federation

Facility Name

Teva Investigational Site 563

City

Bradejov

Country

Slovakia

Facility Name

Teva Investigational Site 561

City

Levice

Country

Slovakia

Facility Name

Teva Investigational Site 560

City

Spisska Nova Ves

Country

Slovakia

Facility Name

Teva Investigational Site 562

City

Topolcany

Country

Slovakia

Facility Name

Teva Investigational Site 764

City

Kaohsiung

Country

Taiwan

Facility Name

Teva Investigational Site 765

City

Taichung

Country

Taiwan

Facility Name

Teva Investigational Site 760

City

Taipei

Country

Taiwan

Facility Name

Teva Investigational Site 761

City

Taipei

Country

Taiwan

Facility Name

Teva Investigational Site 763

City

Taoyuan

Country

Taiwan

Facility Name

Teva Investigational Site 621

City

Dnipropetrovsk

Country

Ukraine

Facility Name

Teva Investigational Site 629

City

Donetsk

Country

Ukraine

Facility Name

Teva Investigational Site 635

City

Donetsk

Country

Ukraine

Facility Name

Teva Investigational Site 630

City

Ivano-Frankivsk

Country

Ukraine

Facility Name

Teva Investigational Site 620

City

Kharkiv

Country

Ukraine

Facility Name

Teva Investigational Site 633

City

Kharkiv

Country

Ukraine

Facility Name

Teva Investigational Site 622

City

Kyiv

Country

Ukraine

Facility Name

Teva Investigational Site 623

City

Kyiv

Country

Ukraine

Facility Name

Teva Investigational Site 624

City

Kyiv

Country

Ukraine

Facility Name

Teva Investigational Site 625

City

Kyiv

Country

Ukraine

Facility Name

Teva Investigational Site 628

City

Ternopil

Country

Ukraine

Facility Name

Teva Investigational Site 626

City

Vinnytsya

Country

Ukraine

Facility Name

Teva Investigational Site 631

City

Zaporizhzhia

Country

Ukraine

Facility Name

Teva Investigational Site 632

City

Zaporizhzhia

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

31626990

Citation

Nair P, Bardin P, Humbert M, Murphy KR, Hickey L, Garin M, Vanlandingham R, Chanez P. Efficacy of Intravenous Reslizumab in Oral Corticosteroid-Dependent Asthma. J Allergy Clin Immunol Pract. 2020 Feb;8(2):555-564. doi: 10.1016/j.jaip.2019.09.036. Epub 2019 Oct 15.

Results Reference

derived

PubMed Identifier

31262379

Citation

Carr WW, McDonald M, Meizlik P. Effect of intravenously administered reslizumab on spirometric lung age in patients with moderate-to-severe eosinophilic asthma. Allergy Asthma Proc. 2019 Jul 1;40(4):240-249. doi: 10.2500/aap.2019.40.4225.

Results Reference

derived

PubMed Identifier

30964365

Citation

Han S, Kim S, Kim H, Suh HS. Cost-utility analysis of reslizumab for patients with severe eosinophilic asthma inadequately controlled with high-dose inhaled corticosteroids and long-acting beta2-agonists in South Korea. Curr Med Res Opin. 2019 Sep;35(9):1597-1605. doi: 10.1080/03007995.2019.1605159. Epub 2019 May 16.

Results Reference

derived

PubMed Identifier

30346831

Citation

Bateman ED, Djukanovic R, Castro M, Canvin J, Germinaro M, Noble R, Garin M, Buhl R. Predicting Responders to Reslizumab after 16 Weeks of Treatment Using an Algorithm Derived from Clinical Studies of Patients with Severe Eosinophilic Asthma. Am J Respir Crit Care Med. 2019 Feb 15;199(4):489-495. doi: 10.1164/rccm.201708-1668OC.

Results Reference

derived

PubMed Identifier

30193936

Citation

Weinstein SF, Katial RK, Bardin P, Korn S, McDonald M, Garin M, Bateman ED, Hoyte FCL, Germinaro M. Effects of Reslizumab on Asthma Outcomes in a Subgroup of Eosinophilic Asthma Patients with Self-Reported Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2019 Feb;7(2):589-596.e3. doi: 10.1016/j.jaip.2018.08.021. Epub 2018 Sep 5.

Results Reference

derived

PubMed Identifier

28159511

Citation

Brusselle G, Germinaro M, Weiss S, Zangrilli J. Reslizumab in patients with inadequately controlled late-onset asthma and elevated blood eosinophils. Pulm Pharmacol Ther. 2017 Apr;43:39-45. doi: 10.1016/j.pupt.2017.01.011. Epub 2017 Jan 31.

Results Reference

derived

PubMed Identifier

25736990

Citation

Castro M, Zangrilli J, Wechsler ME, Bateman ED, Brusselle GG, Bardin P, Murphy K, Maspero JF, O'Brien C, Korn S. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015 May;3(5):355-66. doi: 10.1016/S2213-2600(15)00042-9. Epub 2015 Feb 23. Erratum In: Lancet Respir Med. 2015 Apr;3(4):e15. Lancet Respir Med. 2016 Oct;4(10 ):e50.

Results Reference

derived

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma

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A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma

Eosinophilic 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