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

Sponsored by Cephalon

Phase Quota
Phase 3

The primary objective of this study is to determine whether reslizumab, at a dose of 3 mg/kg administered intravenously (iv) every 4 weeks over 12 months, is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.

Study Start Date: March 2011

Estimated Completion Date: May 2014

Specialties: Internal Medicine: Pulmonology Nursing: Pulmonology Pulmonology: Asthma/Atopy,Clinical Pharmacology Allergy/Immunology: Cardiovascular/Pulm

Interventions

  • Drug: Placebo
  • Drug: Reslizumab

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 India and Argentina; patients 66 through 75 years of age are excluded from participating in India
  • The patient has had at least 1 asthma exacerbation requiring oral 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
  • 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 must be stable for 30 days prior to screening, and continue without dosage changes throughout 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
  • Written informed consent is obtained. Patients 12 through 17 years old, where participating, must provide assent

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 or immunomodulating drugs agents (anti-IgE mAb, systemic corticosteroids greater than 10 mg/day daily dose, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis factor [anti-TNF] mAb) within 6 months prior screening
  • The patient has participated in an anti-interleukin-5 (IL-5) study for asthma
  • 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
  • The patient has concurrent infection or disease that may preclude assessment of active asthma
  • The patient has a history of concurrent immunodeficiency (human immunodeficiency or acquired immunodeficiency syndrome or congenital immunodeficiency). Patients in Argentina must have documented serology testing for HIV performed during screening
  • Presence of or suspected parasitic infestation/infection
  • Patients may not have received any live attenuated vaccine within the 12-week period prior to screening

Study Locations And Contact Information

  • Teva Investigational Site 204, Guadalajara, JAL
  • Teva Investigational Site 104, Newmarket
  • Teva Investigational Site 121, Ciudad Autonoma de Buenos Aire
  • Teva Investigational Site 67, Fort Mill South Carolina
  • Teva Investigational Site 763, Taoyuan
  • Teva Investigational Site 48, Mobile Alabama
  • Teva Investigational Site 372, Koblenz
  • Teva Investigational Site 625, Kyiv
  • Teva Investigational Site 543, Moscow
  • Teva Investigational Site 760, Taipei
  • Teva Investigational Site 369, Frankfurt
  • Teva Investigational Site 554, Moscow
  • Teva Investigational Site 633, Kharkiv
  • Teva Investigational Site 540, St.Petersburg
  • Teva Investigational Site 631, Zaporizhzhia
  • Teva Investigational Site 145, Porto Alegre
  • Teva Investigational Site 144, Porto Alegre
  • Teva Investigational Site 623, Kyiv
  • Teva Investigational Site 53, Clearwater Florida
  • Teva Investigational Site 556, Moscow
  • Teva Investigational Site 382, Heraklion, Crete
  • Teva Investigational Site 123, Rosario-Santa Fe
  • Teva Investigational Site 541, St. Petersburg
  • Teva Investigational Site 622, Kyiv
  • Teva Investigational Site 562, Topolcany
  • Teva Investigational Site 628, Ternopil
  • Teva Investigational Site 558, Moscow
  • Teva Investigational Site 25, Lawrenceville Georgia
  • Teva Investigational Site 367, Leipzig
  • Teva Investigational Site 59, Long Beach California
  • Teva Investigational Site 686, Seoul
  • Teva Investigational Site 380, Athens
  • Teva Investigational Site 682, Gwangju
  • Teva Investigational Site 202, Tijuana, B.C.
  • Teva Investigational Site 560, Spisska Nova Ves
  • Teva Investigational Site 685, Suwon
  • Teva Investigational Site 143, Porto Alegre, RS
  • Teva Investigational Site 209, Monterrey
  • Teva Investigational Site 57, Metairie Louisiana
  • Teva Investigational Site 561, Levice
  • Teva Investigational Site 120, San Miguel de Tucuman - Tucuma
  • Teva Investigational Site 620, Kharkiv
  • Teva Investigational Site 371, Bochum
  • Teva Investigational Site 626, Vinnytsya
  • Teva Investigational Site 363, Mainz
  • Teva Investigational Site 366, Berlin
  • Teva Investigational Site 524, Bucharest
  • Teva Investigational Site 680, Seoul
  • Teva Investigational Site 362, Berlin
  • Teva Investigational Site 41, Fresno California
  • Teva Investigational Site 223, Cercado de Lima, Lima
  • Teva Investigational Site 365, Dresden
  • Teva Investigational Site 368, Leipzig
  • Teva Investigational Site 341, Montpellier
  • Teva Investigational Site 140, Porto Alegre
  • Teva Investigational Site 227, Lima
  • Teva Investigational Site 381, Alexandroupolis
  • Teva Investigational Site 205, Ciudad De México
  • Teva Investigational Site 40, St. Louis Missouri
  • Teva Investigational Site 221, Lima
  • Teva Investigational Site 635, Donetsk
  • Teva Investigational Site 150, Florianopolis
  • Teva Investigational Site 222, Lima
  • Teva Investigational Site 370, Hamburg
  • Teva Investigational Site 47, Denver Colorado
  • Teva Investigational Site 621, Dnipropetrovsk
  • Teva Investigational Site 46, Bangor Maine
  • Teva Investigational Site 220, Lima
  • Teva Investigational Site 27, Miami Florida
  • Teva Investigational Site 207, Mexico City
  • Teva Investigational Site 683, Seoul
  • Teva Investigational Site 681, Seoul
  • Teva Investigational Site 360, Bad Wörishofen
  • Teva Investigational Site 521, Iasi
  • Teva Investigational Site 630, Ivano-Frankivsk
  • Teva Investigational Site 629, Donetsk
  • Teva Investigational Site 102, Pointe-Claire
  • Teva Investigational Site 364, Mainz
  • Teva Investigational Site 632, Zaporizhzhia
  • Teva Investigational Site 69, El Paso Texas
  • Teva Investigational Site 520, Cluj-Napoca
  • Teva Investigational Site 624, Kyiv
  • Teva Investigational Site 226, Lima
  • Teva Investigational Site 44, Dallas Texas
  • Teva Investigational Site 142, Santo André, São Paulo
  • Teva Investigational Site 765, Taichung
  • Teva Investigational Site 126, Ciudad Autonoma de Buenos Aire
  • Teva Investigational Site 522, Targu Mures
  • Teva Investigational Site 761, Taipei
  • Teva Investigational Site 225, Lima
  • Teva Investigational Site 342, Marseille
  • Teva Investigational Site 764, Kaohsiung
  • Teva Investigational Site 229, Lima
  • Teva Investigational Site 557, Novosibirsk
  • Teva Investigational Site 28, Waterbury Connecticut
  • Teva Investigational Site 559, Moscow
  • Teva Investigational Site 203, Distrito Federal
  • Teva Investigational Site 45, San Antonio Texas
  • Teva Investigational Site 523, Bucharest
  • Teva Investigational Site 544, Moscow
  • Teva Investigational Site 361, Berlin
  • Teva Investigational Site 343, Grenoble
  • Teva Investigational Site 563, Bradejov
  • Teva Investigational Site 105, Windsor

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