The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy variable for this study is the change from baseline to
endpoint in FEV1.
Secondary outcome
The secondary efficacy variables and endpoints for this study are as follows:
* change in lung function as measured by %FEV1, FVC, and FEV25-75% from
baseline to weeks 4, 8, 12, 16, and endpoint (endpoint is week 16 or early
withdrawal)
* change in beta-agonist use from baseline to weeks 4, 8, 12, 16, and endpoint
* change in blood eosinophil count from baseline to weeks 4, 8, 12, 16, and
endpoint
* change in asthma symptom score from baseline to weeks 4, 8, 12, 16, and
endpoint
* change in ACQ score from baseline to weeks 4, 8, 12, 16, and endpoint
* change in AQLQ score from baseline to week 16 and endpoint
* change in sputum eosinophil levels from baseline to endpoint
* change in biomarkers from baseline to endpoint
* change in the presence or absence of nasal polyps
* adverse events throughout the study
* clinical laboratory tests assessed at weeks 4, 8, 12, 16, and 90 days after
the end-of-treatment evaluation
* vital signs (blood pressure, pulse, body temperature, and respiratory rate)
measurements at weeks 4, 8, 12, 16, and 90 days after the end-of-treatment
evaluation
* physical examinations at weeks 4, 8, 12, 16, and endpoint
* ECG recording at week 16 and endpoint
* concomitant medication usage throughout the study
* measurement of anti-drug antibodies at week 16 and endpoint
Background summary
Some individuals have a type of asthma made worse by an unusual increase in
white blood cells in their lungs which may cause chronic airway inflammation.
These cells are called eosinophils and may be caused by high levels of a normal
protein called interleukin 5 (IL 5). Researchers hope that reslizumab blocks
the action of the IL 5 protein and therefore lowers the level of these white
blood cells in the lungs.
Reslizumab is an investigational drug, a drug that is being tested and is not
approved for sale yet. Researchers hope that Reslizumab improves asthma control
in subjects with active asthma and eosinophilic airway inflammation. This will
be studied in this research.
Study objective
The primary objective of this study is to determine whether reslizumab, at a
dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4
doses, is more effective than placebo in improving lung function in patients
with eosinophilic asthma as assessed by the change from baseline in forced
expiratory volume in 1 second (FEV1). The secondary objectives of the study are
as follows:
* to evaluate the efficacy of reslizumab treatment compared with placebo
treatment in patients with eosinophilic asthma as assessed by the effect of
reslizumab on the following:
* lung function as measured by percent predicted forced expiratory volume in 1
second (%FEV1), forced vital capacity (FVC), and forced expiratory flow at 25%
to 75% of FVC (FEF25-75%)
* beta-agonist use
* blood eosinophil count
* asthma symptoms as measured by the Asthma Symptom Utility Index (ASUI)
* asthma control as measured by the Asthma Control Questionnaire (ACQ)
* quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ)
* to characterize the pharmacokinetics of reslizumab using serum concentrations
obtained prior to and after each infusion
* to characterize the relationship between serum concentrations of reslizumab
and measures of efficacy and safety
* to evaluate the safety and tolerability of reslizumab treatment as assessed
by the following:
* occurrence of adverse events throughout the study
* clinical laboratory (serum chemistry, hematology, urinalysis) test results at
specified times throughout the treatment period or early withdrawal
* vital signs (systolic and diastolic blood pressures, pulse, body temperature,
and respiratory rate) measurements at weeks 4, 8, 12, and 16 or early withdrawal
* physical examination findings at weeks 4, 8, 12, and 16 or early withdrawal
* 12-lead electrocardiography (ECG) findings at week 16 or early withdrawal
* concomitant medication usage throughout the study
* measurement of anti-drug antibodies at weeks 8 and 16 or early withdrawal
* as an exploratory objective, to characterize potential biomarkers in sputum
and/or blood that may more effectively identify patients who have this
phenotype of asthma.
Study design
Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study.
Intervention
Reslizumab administered intravenously at 0.3 mg/kg or 3 mg/kg once every 4
weeks, or placebo.
Study burden and risks
Reslizumab can give the following side effects:
Headache; fatigue; nausea; upper respiratory tract infection; myalgia .
Summary of study procedures:
- complete or short physical exam (every visit)
- lung function tests (every visit, except screening)
- 1x "airway reversibility test" (screening)
- questionnaires regarding asthma symptoms (every visit)
- blood samples for lab study (every visit)
- urine analysis (every visit)
- pregnancy test (every visit, at screening by serum, thereafter by urine)
- 12-lead ECG (screening)
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PA 19355 Frazer
US
Listed location countries
Age
Inclusion criteria
- The patient is a male or female 12 through 75 years of age with a previous diagnosis of asthma.
- The patient has an ACQ score of at least 1.5.
- The patient has airway reversibility of at least 12% to beta-agonist administration at screening.
- The patient is currently taking fluticasone at a dosage of at least 440 *g daily (or equivalent).
- The patient has a blood eosinophil count of at least 400/*L.
Exclusion criteria
- The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient*s safety.
- The patient has known HES.
- The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
- The patient is a current smoker.
- The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-IgE mAb, methotrexate, cyclosporin, interferon-*, or anti-tumor necrosis factor mAb) within 6 months prior to study entry (randomization).
- The patient is currently using systemic corticosteroids (includes use of oral corticosteroids).
prior to screening.
- The patient has previously received anti-hIL-5 monoclonal antibody.
- The patient has a current infection or disease that may preclude assessment of asthma.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-023342-67-NL |
| ClinicalTrials.gov | NCT01270464 |
| CCMO | NL35307.096.11 |