Study to evaluate the efficacy, as measured by the reduction of exacerbations, and safety of a drug called reslizumab performed by comparing simultaneously 2 groups of patients aged from 12 to 75 years suffering from eosinophilic asthma and receiving during 12 months, either reslizumab (at a dose of 3mg/kg) or a placebo (inactive substance). Treatment given to each patient will be drawn at random, without both the patient and the physician knowing which one has been attributed.

Conditions: Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Treatment for patients with eosinophilic asthma
MedDRA version: 17.0Level: LLTClassification code 10068462Term: Eosinophilic asthmaSystem Organ Class: 100000004855

Registration Number: EUCTR2010-024006-35-DE

Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 460

Inclusion Criteria

Patients are included in the study if all of the following criteria are met:
(a) Inclusion criterion (a2) is replaced by (a3).
(a2) 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.
(b) Inclusion criterion (b) is replaced by (b1).
(b1) The patient has had at least 1 asthma exacerbation requiring oral,
intramuscular, or iv corticosteroid use for at least 3 days over the past
12 months before screening.
(c) The patient has a current blood eosinophil level of at least 400/µL.
(d) The patient has airway reversibility of at least 12% to beta-agonist
administration.
(e) Inclusion criterion (e) is replaced by (e1).
(e1) The patient has an ACQ score of at least 1.5 at the screening and baseline (before the 1st dose of study drug) visits.
(f) Inclusion criterion (f2) is replaced by (f3).
(f3) 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 patients' 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, cromolyn) must be stable for 30 days prior to
screening and baseline and must continue without dosage changes throughout the study.
(g) 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).
(h) Inclusion criterion (h1) is replaced by (h2).
(h2) 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.
(i) Inclusion criteria (i) is replaced by (i1).
(i1) Written informed consent is obtained. Patients 12 through 17 years
old, where participating, must provide assent.
(j) Inclusion criterion (j) is replaced by (j1).
(j1) 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.
(k) Inclusion criterion (k) is replaced by (k1).
(k1) 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.
(l) Patients who experience an

Exclusion Criteria

Patients are excluded from participating in this study if 1 or more of the
following criteria are met:
(a) The patient has a clinically meaningful comorbidity that would
interfere with the study schedule or procedures, or compromise the
patient's safety.
(b) The patient has known hypereosinophilic syndrome.
(c) Exclusion criterion (c) is replaced by (c1). 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.
(d) The patient is a current smoker (ie, has smoked within the last 6
months prior to screening).
(e) Exclusion criterion (e2) is replaced by (e3).
(e3) The patient is using systemic immunosuppressive, 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.
(f) Exclusion criterion (f1) is replaced by (f2).
(f2) The patient has previously received an anti-hIL-5 monoclonal
antibody (eg, reslizumab, mepolizumab, or benralizumab).
(g) Exclusion criterion (g) is replaced by (g1).
(g1) The patient has any aggravating medical factors that are
inadequately controlled (eg, rhinitis, gastroesophageal reflux disease, and uncontrolled diabetes).
(h) Exclusion criterion (h) is replaced by (h1).
(h1) The patient has participated in any investigative drug or device
study within 30 days prior to screening.
(i) Exclusion criterion (i1) is replaced by (i2).
(i2) The patient has participated in any investigative biologics study within 6 months prior to screening.
(j) Exclusion criterion (j1) is replaced by (j2).
(j2) 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.
(k) The patient has concurrent infection or disease that may preclude
assessment of active asthma.
(l) Exclusion criterion (l) is replaced by (l1).
(l1) The patient has a history of concurrent immunodeficiency (human
immunodeficiency virus [HIV] or acquired immunodeficiency syndrome
or congenital immunodeficiency). Patients in Argentina must have
documented serology testing for HIV performed during screening.
(m) The patient has current suspected drug and alcohol abuse as
specified in the Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition, Text Revision (DSM-IV-TR) criteria.
(n) Exclusion criterion (n) is replaced by (n1).
(n1) The patient has had an active parasitic infection within 6 months prior to screening.
(o) Patients may not have received any live attenuated vaccine within
the 12-week period prior to screening.
(p) The patient has a history of allergic reactions to or hypersensitivity
to any component of the study drug.
(q) The patient has had an infection requiring the following:
? an admission to the hospital for at least 24 hours within 4 weeks
prior to screening or during the screening period
? treatment with iv antibiotics within 4 weeks prior to screening or