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A 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

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.
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 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 of 10 mg of prednisone daily or equivalent, leukotriene antagonists, 5-lipooxygenase inhibitors, or cromolyn) must be stable for 30 days prior to screening and baseline, and must continue without dosage changes throughout 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.
Written informed consent is obtained. Patients 12 through 17 years old 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.
- Other criteria apply; please contact the investigator for more information.

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 or immunomodulating or other biologic agents (including, but not limited to, anti-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.
Female patients who are pregnant, nursing, or, if of childbearing potential, and not using a medically accepted, effective method of birth control (eg, barrier method with spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and injected]) are excluded from this study. NOTE: Partner sterility alone is not considered an acceptable form of birth control.
- Other criteria apply; please contact the investigator for more information.

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) 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. Positive change from baseline scores indicate improvement in asthma control. The during treatment (Weeks 4, 8, 12 and 16) average FEV1 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.

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) 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

Blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test at each scheduled visit, and from all patients experiencing a serious adverse event, an adverse event leading to withdrawal, or an exacerbation of asthma symptoms. The during treatment average eosinophil counts were 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 values correlate to reduced asthma severity.

Participants With Treatment-Emergent Adverse Events

An adverse event 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, and urinalysis values. Significance criteria: Blood urea nitrogen: >=10.71 mmol/L Uric acid: M>=625, F>=506 μmol/L Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L GGT = gamma-glutamyl transpeptidase: >= 3*ULN. Normal range is 5-49 U/L. Bilirubin: >=34.2 μmol/L White blood cells: <=3.0 or >20 10^9/L Hemoglobin: M<=115, F<=95 g/dL Hematocrit: M<0.37, F<0.32 L/L Neutrophils: <=1.0 10^9/L Eosinophils: >10.0 % Platelets: <75 or >=700 10^9/L Urinalysis: blood, glucose, ketones and total 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 12-17 yr: >100 and increase of >= 30 beats/minute (bpm) Sitting pulse - low >=18 yr: <50 and decrease of >=30 bpm Sitting pulse - high >=18 yr: >100 and increase of >=30 bpm Sitting systolic blood pressure - low >=18 yr: <90 and decrease of >=30 mmHg Sitting systolic blood pressure - high >=18 yr: >160 and increase of >=30 mmHg Sitting diastolic blood pressure - low 12-17 yr: <55 and decrease of >=12 mmHg Sitting diastolic blood pressure - low >=18 yr: <50 and decrease of >=12 mmHg Sitting diastolic blood pressure - high >=18 yr: >100 and increase of >=12 mmHg Respiratory rate >=18 yr: >24 and increase of >=10 breaths/minute Body temperature - low 12-17 yr: <96.5° Fahrenheit or <35.8° Celsius Body temp - low >=18 yr: <96.5° F or <35.8° C Body temp - high >=18 yr: >100.5° Fahrenheit

Participants With a Positive Anti-Reslizumab Antibody Status During Study

The immunogenicity of reslizumab was assessed by measuring for the presence of anti-reslizumab antibodies at baseline, weeks 16, 32, 48, and 52 or early withdrawal. Blood samples for anti-reslizumab antibodies assessment were also obtained from all patients (inside or outside of the US) experiencing a serious adverse event, an adverse event leading to withdrawal, or an exacerbation of asthma symptoms.

Full Information

NCT ID

NCT01287039

First Posted

January 28, 2011

Last Updated

November 5, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01287039

Brief Title

A 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

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

April 2011 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

5. Study Description

Brief Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in patients with eosinophilic asthma.

Detailed Description

Demonstrate the efficacy of reslizumab, at a dose of 3 mg/kg administered iv every 4 weeks over 12 months, as assessed by the reduction in frequency of clinical asthma exacerbations (CAEs) during 12 months. An exacerbation event will be considered a CAE if the patient meets either or both of the criteria listed below and this is 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 asthma-related emergency treatment The above criteria must be corroborated with at least 1 other measurement to indicate worsening in the clinical signs and symptoms of 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

489 (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 (20 mM sodium acetate, 7% sucrose), administered intravenously (iv) once every 4 weeks over 52 weeks, for a total of 13 doses administered. Each patient received a specific volume of placebo to match the volume of reslizumab on the basis of the patient's body weight.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Day 1 to Week 52

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 Week 52

Secondary Outcome Measure Information:

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 478 (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

Description

Time Frame

Day 1 (post-dose) to Week 65. The last postbaseline value for approximately 20 patients in each

Title

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

Description

Time Frame

Week 4 to Week 65. The last postbaseline value for approximately 20 patients in each

Title

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

Description

Time Frame

Week 4 to Week 65. The last postbaseline value for approximately 20 patients in each

Title

Participants With a Positive Anti-Reslizumab Antibody Status During Study

Description

Time Frame

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. 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 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 of 10 mg of prednisone daily or equivalent, leukotriene antagonists, 5-lipooxygenase inhibitors, or cromolyn) must be stable for 30 days prior to screening and baseline, and must continue without dosage changes throughout 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. Written informed consent is obtained. Patients 12 through 17 years old 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. Other criteria apply; please contact the investigator for more information. 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 or immunomodulating or other biologic agents (including, but not limited to, anti-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. Female patients who are pregnant, nursing, or, if of childbearing potential, and not using a medically accepted, effective method of birth control (eg, barrier method with spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and injected]) are excluded from this study. NOTE: Partner sterility alone is not considered an acceptable form of birth control. Other criteria apply; please contact the investigator for more information.

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 58

City

Scottsdale

State/Province

Arizona

Country

United States

Facility Name

Teva Investigational Site 61

City

Los Angeles

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 37

City

Orange

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 56

City

San Diego

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 34

City

Colorado Springs

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 52

City

DeBary

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 55

City

Miami

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 18

City

Valrico

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 49

City

Lexington

State/Province

Kentucky

Country

United States

Facility Name

Teva Investigational Site 65

City

Louisville

State/Province

Kentucky

Country

United States

Facility Name

Teva Investigational Site 51

City

Boston

State/Province

Massachusetts

Country

United States

Facility Name

Teva Investigational Site 74

City

Saint Louis

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 35

City

Missoula

State/Province

Montana

Country

United States

Facility Name

Teva Investigational Site 64

City

Boys Town

State/Province

Nebraska

Country

United States

Facility Name

Teva Investigational Site 60

City

Bronx

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 68

City

Rochester

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 30

City

Winston-Salem

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 31

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 62

City

Columbus

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 50

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 66

City

Altoona

State/Province

Pennsylvania

Country

United States

Facility Name

Teva Investigational Site 32

City

Nashville

State/Province

Tennessee

Country

United States

Facility Name

Teva Investigational Site 63

City

Boerne

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 72

City

Houston

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 38

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

Teva Investigational Site 33

City

Madison

State/Province

Wisconsin

Country

United States

Facility Name

Teva Investigational Site 643

City

Nedlands

State/Province

Western Australia

Country

Australia

Facility Name

Teva Investigational Site 641

City

Clayton

Country

Australia

Facility Name

Teva Investigational Site 644

City

Daw Park

Country

Australia

Facility Name

Teva Investigational Site 642

City

Frankston

Country

Australia

Facility Name

Teva Investigational Site 645

City

Liverpool

Country

Australia

Facility Name

Teva Investigational Site 261

City

Bruxelles

Country

Belgium

Facility Name

Teva Investigational Site 264

City

Bruxelles

Country

Belgium

Facility Name

Teva Investigational Site 260

City

Gent

Country

Belgium

Facility Name

Teva Investigational Site 262

City

Jambes

Country

Belgium

Facility Name

Teva Investigational Site 263

City

Liège

Country

Belgium

Facility Name

Teva Investigational Site 160

City

Rancagua

Country

Chile

Facility Name

Teva Investigational Site 163

City

Santiago

Country

Chile

Facility Name

Teva Investigational Site 164

City

Santiago

Country

Chile

Facility Name

Teva Investigational Site 165

City

Santiago

Country

Chile

Facility Name

Teva Investigational Site 161

City

Temuco

Country

Chile

Facility Name

Teva Investigational Site 162

City

Valdivia

Country

Chile

Facility Name

Teva Investigational Site 166

City

Valparaiso

Country

Chile

Facility Name

Teva Investigational Site 185

City

Bogota

Country

Colombia

Facility Name

Teva Investigational Site 181

City

Bogotá

Country

Colombia

Facility Name

Teva Investigational Site 182

City

Cali

Country

Colombia

Facility Name

Teva Investigational Site 180

City

Floridablanca

Country

Colombia

Facility Name

Teva Investigational Site 284

City

Breclav

Country

Czechia

Facility Name

Teva Investigational Site 287

City

Brno

Country

Czechia

Facility Name

Teva Investigational Site 286

City

Liberec

Country

Czechia

Facility Name

Teva Investigational Site 280

City

Olomouc

Country

Czechia

Facility Name

Teva Investigational Site 281

City

Olomouc

Country

Czechia

Facility Name

Teva Investigational Site 285

City

Olomouc

Country

Czechia

Facility Name

Teva Investigational Site 283

City

Tabor

Country

Czechia

Facility Name

Teva Investigational Site 301

City

Hvidovre

Country

Denmark

Facility Name

Teva Investigational Site 300

City

Odense

Country

Denmark

Facility Name

Teva Investigational Site 401

City

Balassagyarmat

Country

Hungary

Facility Name

Teva Investigational Site 400

City

Miskolc

Country

Hungary

Facility Name

Teva Investigational Site 404

City

Mosonmagyaróvár

Country

Hungary

Facility Name

Teva Investigational Site 403

City

Sopron

Country

Hungary

Facility Name

Teva Investigational Site 405

City

Törökbálint

Country

Hungary

Facility Name

Teva Investigational Site 423

City

Ashkelon

Country

Israel

Facility Name

Teva Investigational Site 430

City

Beer-Sheva

Country

Israel

Facility Name

Teva Investigational Site 431

City

Haifa

Country

Israel

Facility Name

Teva Investigational Site 432

City

Haifa

Country

Israel

Facility Name

Teva Investigational Site 425

City

Jerusalem

Country

Israel

Facility Name

Teva Investigational Site 428

City

Jerusalem

Country

Israel

Facility Name

Teva Investigational Site 429

City

Jerusalem

Country

Israel

Facility Name

Teva Investigational Site 426

City

Kfar Saba

Country

Israel

Facility Name

Teva Investigational Site 422

City

Petach Tikva

Country

Israel

Facility Name

Teva Investigational Site 427

City

Ramat Gan

Country

Israel

Facility Name

Teva Investigational Site 433

City

Ramat Gan

Country

Israel

Facility Name

Teva Investigational Site 421

City

Rehovot

Country

Israel

Facility Name

Teva Investigational Site 420

City

Tel-Aviv

Country

Israel

Facility Name

Teva Investigational Site 705

City

Batu Caves

Country

Malaysia

Facility Name

Teva Investigational Site 700

City

Kuala Lumpur

Country

Malaysia

Facility Name

Teva Investigational Site 702

City

Kuala Lumpur

Country

Malaysia

Facility Name

Teva Investigational Site 703

City

Kuantan

Country

Malaysia

Facility Name

Teva Investigational Site 701

City

Penang

Country

Malaysia

Facility Name

Teva Investigational Site 704

City

Taiping

Country

Malaysia

Facility Name

Teva Investigational Site 723

City

Auckland

Country

New Zealand

Facility Name

Teva Investigational Site 722

City

Christchurch

Country

New Zealand

Facility Name

Teva Investigational Site 726

City

Christchurch

Country

New Zealand

Facility Name

Teva Investigational Site 724

City

Dunedin

Country

New Zealand

Facility Name

Teva Investigational Site 727

City

Hamilton

Country

New Zealand

Facility Name

Teva Investigational Site 720

City

Tauranga

Country

New Zealand

Facility Name

Teva Investigational Site 721

City

Wellington

Country

New Zealand

Facility Name

Teva Investigational Site 744

City

Governor Mangubat Drive, Dasma

Country

Philippines

Facility Name

Teva Investigational Site 742

City

Manila

Country

Philippines

Facility Name

Teva Investigational Site 740

City

Quezon City

Country

Philippines

Facility Name

Teva Investigational Site 741

City

Quezon City

Country

Philippines

Facility Name

Teva Investigational Site 743

City

Quezon City

Country

Philippines

Facility Name

Teva Investigational Site 745

City

Quezon City

Country

Philippines

Facility Name

Teva Investigational Site 507

City

Bialystok

Country

Poland

Facility Name

Teva Investigational Site 509

City

Bydgoszcz

Country

Poland

Facility Name

Teva Investigational Site 501

City

Bystra

Country

Poland

Facility Name

Teva Investigational Site 500

City

Ostrow Wielkopolski

Country

Poland

Facility Name

Teva Investigational Site 511

City

Poznan

Country

Poland

Facility Name

Teva Investigational Site 502

City

Sopot

Country

Poland

Facility Name

Teva Investigational Site 504

City

Tarnow

Country

Poland

Facility Name

Teva Investigational Site 545

City

Barnaul

Country

Russian Federation

Facility Name

Teva Investigational Site 551

City

Kazan

Country

Russian Federation

Facility Name

Teva Investigational Site 549

City

Kemerovo

Country

Russian Federation

Facility Name

Teva Investigational Site 550

City

Nizhniy Novgorod

Country

Russian Federation

Facility Name

Teva Investigational Site 553

City

Novosibirsk

Country

Russian Federation

Facility Name

Teva Investigational Site 555

City

Novosibirsk

Country

Russian Federation

Facility Name

Teva Investigational Site 542

City

St. Petersburg

Country

Russian Federation

Facility Name

Teva Investigational Site 552

City

Tomsk

Country

Russian Federation

Facility Name

Teva Investigational Site 546

City

Yaroslavl

Country

Russian Federation

Facility Name

Teva Investigational Site 581

City

Cape Town

Country

South Africa

Facility Name

Teva Investigational Site 584

City

Cape Town

Country

South Africa

Facility Name

Teva Investigational Site 586

City

Cape Town

Country

South Africa

Facility Name

Teva Investigational Site 587

City

Centurion

Country

South Africa

Facility Name

Teva Investigational Site 582

City

Durban

Country

South Africa

Facility Name

Teva Investigational Site 585

City

Durban

Country

South Africa

Facility Name

Teva Investigational Site 580

City

Johannesburg

Country

South Africa

Facility Name

Teva Investigational Site 589

City

Johannesburg

Country

South Africa

Facility Name

Teva Investigational Site 583

City

Pretoria

Country

South Africa

Facility Name

Teva Investigational Site 588

City

Pretoria

Country

South Africa

Facility Name

Teva Investigational Site 602

City

Göteborg

Country

Sweden

Facility Name

Teva Investigational Site 604

City

Göteborg

Country

Sweden

Facility Name

Teva Investigational Site 603

City

Linköping

Country

Sweden

Facility Name

Teva Investigational Site 601

City

Malmö

Country

Sweden

Facility Name

Teva Investigational Site 780

City

Bangkok

Country

Thailand

Facility Name

Teva Investigational Site 782

City

Bangkok

Country

Thailand

Facility Name

Teva Investigational Site 783

City

Bangkok

Country

Thailand

Facility Name

Teva Investigational Site 781

City

Muang

Country

Thailand

Facility Name

Teva Investigational Site 784

City

Nakhon Ratchasima

Country

Thailand

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 (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

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A 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

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