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: Treatment for patients with eosinophilic asthma; MedDRA version: 13.1Level: LLTClassification code 10068462Term: Eosinophilic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-024006-35-GR
• Lead Sponsor: Cephalon Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-10
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patients are included in the study if all of the following criteria are met:
(a) The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma.
(b) The patient has had at least 1 asthma exacerbation requiring oral 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/?L.
(d) The patient has airway reversibility of at least 12% to beta-agonist administration.
(e) The patient has an ACQ score of at least 1.5.
(f) Inclusion criterion (f) is replaced by (f1). 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. Patients’ baseline asthma therapy regimen (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipooxegnase inhibitors, cromolyn) must be stable for 30 days prior to screening, and continue without dosage changes throughout 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) 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) in conjunction with a barrier method.
(i) Written informed consent is obtained. Patients 12 through 17 years old must provide assent.
(j) 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, serum chemistry, hematology, and urinalysis.
(k) The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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) The patient is using systemic immunosuppressive or immunomodulating drugs eg, systemic corticosteroids greater than 10 mg/day daily dose, methotrexate, cyclosporine, antibody 6 months prior to study entry (randomization).
(f) The patient has participated in an anti-interleukin-5 (IL-5) study for asthma.
(g) The patient has any aggravating medical factors that are inadequately controlled (eg, rhinitis, gastroesophageal reflux disease).
(h) The patient has participated in any investigative drug or device study within 30 days prior to study enrollment (randomization).
(i) The patient has participated in any investigative biologics study within 3 months prior to study enrollment (randomization).
(j) 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] in conjunction with a barrier method) are excluded from this study.
(k) The patient has concurrent infection or disease that may preclude assessment of active asthma.
(l) The patient has a history of concurrent immunodeficiency (human immunodeficiency or acquired immunodeficiency syndrome or congenital immunodeficiency).
(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) Presence of or suspected parasitic infestation /infection.
(o) Patients may not have received any live attenuated vaccine within the 12-week period prior to screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified