NL-OMON36320CompletedPhase 3
A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) with Eosinophilic Asthma. - Cephalon C38072/3081
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Cephalon Inc
- Enrollment
- 6
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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.
Investigators
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