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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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)
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
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
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
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)
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
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
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
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
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
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
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
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
Sex
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
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
489
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
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
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North Carolina
Country [12] 0 0
United States of America
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Ohio
Country [13] 0 0
United States of America
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Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Belgium
State/province [19] 0 0
Bruxelles
Country [20] 0 0
Belgium
State/province [20] 0 0
Gent
Country [21] 0 0
Belgium
State/province [21] 0 0
Jambes
Country [22] 0 0
Belgium
State/province [22] 0 0
Liège
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Chile
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Rancagua
Country [24] 0 0
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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Hungary
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Miskolc
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Hungary
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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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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
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Philippines
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Governor Mangubat Drive, Dasma
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Philippines
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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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Bydgoszcz
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Bystra
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Ostrow Wielkopolski
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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
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Russian Federation
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Novosibirsk
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Yaroslavl
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South Africa
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Cape Town
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South Africa
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Centurion
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South Africa
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Durban
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South Africa
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Johannesburg
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South Africa
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Pretoria
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Sweden
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Göteborg
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Sweden
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Linköping
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01287039