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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01287039




Registration number
NCT01287039
Ethics application status
Date submitted
28/01/2011
Date registered
1/02/2011
Date last updated
9/11/2021

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
C38072/3082
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eosinophilic Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Blood 0 0 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Reslizumab
Treatment: Drugs - Placebo

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

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


Treatment: Drugs: Reslizumab
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.

Treatment: Drugs: Placebo
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 1 to Week 52
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Day 1 to Week 52
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 1 (baseline, pre-dose), Weeks 4, 8, 12 and 16
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Day 1 (baseline, pre-dose), Week 16
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16
Secondary outcome [4] 0 0
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).
Timepoint [4] 0 0
Day 1 to Day 478 (longest treatment time plus 2 weeks)
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 or early withdrawal
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Day 1 (post-dose) to Week 65. The last postbaseline value for approximately 20 patients in each
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Week 4 to Week 65. The last postbaseline value for approximately 20 patients in each
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Week 4 to Week 65. The last postbaseline value for approximately 20 patients in each
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Weeks 16, 32, 48 and 52

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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-a, 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Teva Investigational Site 643 - Nedlands
Recruitment hospital [2] 0 0
Teva Investigational Site 641 - Clayton
Recruitment hospital [3] 0 0
Teva Investigational Site 644 - Daw Park
Recruitment hospital [4] 0 0
Teva Investigational Site 642 - Frankston
Recruitment hospital [5] 0 0
Teva Investigational Site 645 - Liverpool
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Daw Park
Recruitment postcode(s) [4] 0 0
- Frankston
Recruitment postcode(s) [5] 0 0
- Liverpool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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Florida
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Kentucky
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Massachusetts
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United States of America
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Missouri
Country [8] 0 0
United States of America
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Montana
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United States of America
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Nebraska
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United States of America
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Wisconsin
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Jambes
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Belgium
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Liège
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Chile
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Rancagua
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Chile
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Santiago
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Chile
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Temuco
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Chile
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Valdivia
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Chile
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Valparaiso
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Colombia
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Bogota
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Colombia
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Bogotá
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Colombia
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Cali
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Colombia
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Floridablanca
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Czechia
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Breclav
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Czechia
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Brno
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Czechia
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Liberec
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Czechia
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Olomouc
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Czechia
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Tabor
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Denmark
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Hvidovre
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Denmark
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Odense
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Hungary
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Balassagyarmat
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Miskolc
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Mosonmagyaróvár
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Hungary
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Sopron
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Hungary
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Törökbálint
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Israel
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Ashkelon
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Israel
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Beer-Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Rehovot
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Israel
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Tel-Aviv
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Malaysia
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Batu Caves
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuantan
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Malaysia
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Penang
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Malaysia
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Taiping
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Hamilton
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New Zealand
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Tauranga
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New Zealand
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Wellington
Country [64] 0 0
Philippines
State/province [64] 0 0
Governor Mangubat Drive, Dasma
Country [65] 0 0
Philippines
State/province [65] 0 0
Manila
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Philippines
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Quezon City
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Bystra
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Poland
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Ostrow Wielkopolski
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Poland
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Poznan
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Poland
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Sopot
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Poland
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Tarnow
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Russian Federation
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Barnaul
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Nizhniy Novgorod
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Novosibirsk
Country [79] 0 0
Russian Federation
State/province [79] 0 0
St. Petersburg
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Tomsk
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Russian Federation
State/province [81] 0 0
Yaroslavl
Country [82] 0 0
South Africa
State/province [82] 0 0
Cape Town
Country [83] 0 0
South Africa
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Centurion
Country [84] 0 0
South Africa
State/province [84] 0 0
Durban
Country [85] 0 0
South Africa
State/province [85] 0 0
Johannesburg
Country [86] 0 0
South Africa
State/province [86] 0 0
Pretoria
Country [87] 0 0
Sweden
State/province [87] 0 0
Göteborg
Country [88] 0 0
Sweden
State/province [88] 0 0
Linköping
Country [89] 0 0
Sweden
State/province [89] 0 0
Malmö
Country [90] 0 0
Thailand
State/province [90] 0 0
Bangkok
Country [91] 0 0
Thailand
State/province [91] 0 0
Muang
Country [92] 0 0
Thailand
State/province [92] 0 0
Nakhon Ratchasima

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Teva Branded Pharmaceutical Products R&D, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01287039
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Expert, MD
Address 0 0
Teva Branded Pharmaceutical Products R&D, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications