Overview

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

Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Teva Branded Pharmaceutical Products, R&D Inc.
Treatments:
Reslizumab
Criteria
Inclusion Criteria:

- The patient is male or female, 12 through 75 years of age, with a previous diagnosis
of asthma. Patients 12 through 17 years of age are excluded from participating in
Germany, India, Argentina, and Korea; patients 66 through 75 years of age are excluded
from participating in India and Korea.

- The patient has had at least 1 asthma exacerbation requiring oral, intramuscular (im),
or intravenous (iv) corticosteroid use for at least 3 days over the past 12 months
before screening.

- The patient has a current blood eosinophil level of at least 400/μL.

- The patient has airway reversibility of at least 12% to beta-agonist administration.

- The patient has an ACQ score of at least 1.5 5 at the screening and baseline (before
the 1st dose of study drug) visits.

- The patient is taking inhaled fluticasone at a dosage of at least 440 μg, or
equivalent, daily. Chronic oral corticosteroid use (no more than 10 mg/day prednisone
or equivalent) is allowed. If a patient is on a stable dose, eg, 2 weeks or more of
oral corticosteroid treatment at the time of study enrollment, the patient must remain
on this dose throughout the study. The patient's baseline asthma therapy regimen
(including, but not limited to, inhaled corticosteroids, oral corticosteroids up to a
maximum dose of 10 mg prednisone daily or equivalent, leukotriene antagonists,
5-lipoxygenase inhibitors, or cromolyn) must be stable for 30 days prior to screening
and baseline and must continue without dosage changes throughout the study.

- All female patients must be surgically sterile, 2 years postmenopausal, or must have a
negative pregnancy test (ß-human chorionic gonadotropin [ß-HCG]) at screening (serum)
and baseline (urine).

- Female patients of childbearing potential (not surgically sterile or 2 years
postmenopausal), must use a medically accepted method of contraception and must agree
to continue use of this method for the duration of the study and for 30 days after
participation in the study. Acceptable methods of contraception include barrier method
with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive
(oral, transdermal, implanted, and injected). NOTE: Partner sterility alone is not
acceptable for inclusion in the study.

- Written informed consent is obtained. Patients 12 through 17 years old, where
participating, must provide assent.

- The patient is in reasonable health (except for diagnosis of asthma) as judged by the
investigator, and as determined by a medical history, medical examination, ECG
evaluation (at screening), serum chemistry, hematology, and urinalysis.

- The patient must be willing and able to understand and comply with study restrictions,
requirements, and procedures, as specified by the study center, and to remain at the
study center for the required duration during the study period, and willing to return
to the study center for the follow-up evaluation as specified in this protocol.

- Patients who experience an asthma exacerbation during the screening period will be
considered to have failed screening and cannot be randomly assigned to study drug.
Patients may be rescreened 1 time only.

Exclusion Criteria:

- The patient has a clinically meaningful co-morbidity that would interfere with the
study schedule or procedures, or compromise the patient's safety.

- The patient has known hypereosinophilic syndrome.

- The patient has another confounding underlying lung disorder (eg, chronic obstructive
pulmonary disease, pulmonary fibrosis, or lung cancer). Patients with pulmonary
conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome,
allergic bronchopulmonary aspergillosis) will also be excluded.

- The patient is a current smoker (ie, has smoked within the last 6 months prior to
screening).

- The patient is using systemic immunosuppressive, immunomodulating, or other biologic
agents (including, but not limited to, anti-immunoglobulin E (IgE) mAb, methotrexate,
cyclosporin, interferon-α, or anti-tumor necrosis factor [anti-TNF] mAb) within 6
months prior to screening.

- The patient has previously received an anti-hIL-5 monoclonal antibody (eg, reslizumab,
mepolizumab, or benralizumab).

- The patient has any aggravating medical factors that are inadequately controlled (eg,
rhinitis, gastroesophageal reflux disease, and uncontrolled diabetes).

- The patient has participated in any investigative drug or device study within 30 days
prior to screening.

- The patient has participated in any investigative biologics study within 6 months
prior to screening.

- Other exclusion criteria apply.