A Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01287039
First received: January 28, 2011
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in patients with eosinophilic asthma.


Condition Intervention Phase
Eosinophilic Asthma
Drug: Reslizumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Frequency of clinical asthma exacerbations (CAE) [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lung function as measured by Forced Expiratory Volume (FEV1) [ Time Frame: Baseline to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52, or early withdrawal ] [ Designated as safety issue: No ]
  • Time to first clinical asthma exacerbation (CAE) [ Time Frame: Baseline through week 52 or early withdrawal ] [ Designated as safety issue: No ]
  • Short-acting Beta-agonist usage [ Time Frame: Baseline to weeks 4, 8, 12, 16, 20, 24, 28, 32,36, 40,44,48, and 52, or early withdrawal ] [ Designated as safety issue: No ]
  • Blood eosinophil count [ Time Frame: Baseline to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52, or early withdrawal ] [ Designated as safety issue: No ]
  • Asthma Symptom Utility Index (ASUI) [ Time Frame: Baseline to weeks 4, 8, 12, 16, 20, 24, 28 , 32, 36, 40, 44, 48, and 52 or early withdrawal ] [ Designated as safety issue: No ]
  • Asthma Control Questionnaire (ACQ) [ Time Frame: Baseline to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 or early withdrawal ] [ Designated as safety issue: No ]
  • Asthma Quality of Life Questionnaire [ Time Frame: Baseline to weeks 16, 32, and 52, or early withdrawal ] [ Designated as safety issue: No ]
    Quality of life will be measured by the Asthma Quality of Life Questionnaire (AQLQ).

  • Summary of Participants with Adverse Events [ Time Frame: From signing of the informed consent form (ICF) through the end of the follow-up period. (approximately 64 weeks) ] [ Designated as safety issue: Yes ]

Enrollment: 489
Study Start Date: March 2011
Study Completion Date: April 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reslizumab Drug: Reslizumab
3.0 mg/kg, administered intravenously (iv) once every 4 weeks over 52 weeks (a total of 13 doses administered)
Placebo Comparator: Placebo Drug: Placebo
Matching placebo (20 mM sodium acetate, 7% sucrose), administered intravenously (iv) once every 4 weeks over 52 weeks, for a total of 13 doses administered

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma.
  • 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 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 of 10 mg of prednisone daily or equivalent, leukotriene antagonists, 5-lipooxygenase inhibitors, or cromolyn) must be stable for 30 days prior to screening and baseline, and must 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 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.

    • Other criteria apply; please contact the investigator for more information.

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 or other biologic agents (including, but not limited to, anti-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.
  • 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.

    • Other criteria apply; please contact the investigator for more information.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287039

  Hide Study Locations
Locations
United States, Arizona
Teva Investigational Site 58
Scottsdale, Arizona, United States
United States, California
Teva Investigational Site 61
Los Angeles, California, United States
Teva Investigational Site 37
Orange, California, United States
Teva Investigational Site 56
San Diego, California, United States
United States, Colorado
Teva Investigational Site 34
Colorado Springs, Colorado, United States
United States, Florida
Teva Investigational Site 52
Debary, Florida, United States
Teva Investigational Site 55
Miami, Florida, United States
Teva Investigational Site 18
Valrico, Florida, United States
United States, Kentucky
Teva Investigational Site 49
Lexington, Kentucky, United States
Teva Investigational Site 65
Louisville, Kentucky, United States
United States, Massachusetts
Teva Investigational Site 51
Boston, Massachusetts, United States
United States, Missouri
Teva Investigational Site 74
St. Louis, Missouri, United States
United States, Montana
Teva Investigational Site 35
Missoula, Montana, United States
United States, Nebraska
Teva Investigational Site 64
Boys Town, Nebraska, United States
United States, New York
Teva Investigational Site 60
Bronx, New York, United States
Teva Investigational Site 68
Rochester, New York, United States
United States, North Carolina
Teva Investigational Site 30
Winston-Salem, North Carolina, United States
United States, Ohio
Teva Investigational Site 31
Cincinnati, Ohio, United States
Teva Investigational Site 62
Columbus, Ohio, United States
United States, Oklahoma
Teva Investigational Site 50
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Teva Investigational Site 66
Altoona, Pennsylvania, United States
United States, Tennessee
Teva Investigational Site 32
Nashville, Tennessee, United States
United States, Texas
Teva Investigational Site 63
Boerne, Texas, United States
Teva Investigational Site 72
Houston, Texas, United States
United States, Virginia
Teva Investigational Site 38
Richmond, Virginia, United States
United States, Wisconsin
Teva Investigational Site 33
Madison, Wisconsin, United States
Australia, Western Australia
Teva Investigational Site 643
Nedlands, Western Australia, Australia
Australia
Teva Investigational Site 641
Clayton, Australia
Teva Investigational Site 644
Daw Park, Australia
Teva Investigational Site 642
Frankston, Australia
Teva Investigational Site 645
Liverpool, Australia
Belgium
Teva Investigational Site 261
Bruxelles, Belgium
Teva Investigational Site 264
Bruxelles, Belgium
Teva Investigational Site 260
Gent, Belgium
Teva Investigational Site 262
Jambes, Belgium
Teva Investigational Site 263
Liège, Belgium
Chile
Teva Investigational Site 160
Rancagua, Chile
Teva Investigational Site 164
Santiago, Chile
Teva Investigational Site 165
Santiago, Chile
Teva Investigational Site 163
Santiago, Chile
Teva Investigational Site 161
Temuco, Chile
Teva Investigational Site 162
Valdivia, Chile
Teva Investigational Site 166
Valparaiso, Chile
Colombia
Teva Investigational Site 185
Bogota, Colombia
Teva Investigational Site 181
Bogotá, Colombia
Teva Investigational Site 182
Cali, Colombia
Teva Investigational Site 180
Floridablanca, Colombia
Czech Republic
Teva Investigational Site 284
Breclav, Czech Republic
Teva Investigational Site 287
Brno, Czech Republic
Teva Investigational Site 286
Liberec, Czech Republic
Teva Investigational Site 280
Olomouc, Czech Republic
Teva Investigational Site 281
Olomouc, Czech Republic
Teva Investigational Site 285
Olomouc, Czech Republic
Teva Investigational Site 283
Tabor, Czech Republic
Denmark
Teva Investigational Site 301
Hvidovre, Denmark
Teva Investigational Site 300
Odense, Denmark
Hungary
Teva Investigational Site 401
Balassagyarmat, Hungary
Teva Investigational Site 400
Miskolc, Hungary
Teva Investigational Site 404
Mosonmagyaróvár, Hungary
Teva Investigational Site 403
Sopron, Hungary
Teva Investigational Site 405
Törökbálint, Hungary
Israel
Teva Investigational Site 423
Ashkelon, Israel
Teva Investigational Site 430
Beer-Sheva, Israel
Teva Investigational Site 431
Haifa, Israel
Teva Investigational Site 432
Haifa, Israel
Teva Investigational Site 429
Jerusalem, Israel
Teva Investigational Site 428
Jerusalem, Israel
Teva Investigational Site 425
Jerusalem, Israel
Teva Investigational Site 426
Kfar Saba, Israel
Teva Investigational Site 422
Petach Tikva, Israel
Teva Investigational Site 433
Ramat Gan, Israel
Teva Investigational Site 427
Ramat Gan, Israel
Teva Investigational Site 421
Rehovot, Israel
Teva Investigational Site 420
Tel-Aviv, Israel
Malaysia
Teva Investigational Site 705
Batu Caves, Malaysia
Teva Investigational Site 702
Kuala Lumpur, Malaysia
Teva Investigational Site 700
Kuala Lumpur, Malaysia
Teva Investigational Site 703
Kuantan, Malaysia
Teva Investigational Site 701
Penang, Malaysia
Teva Investigational Site 704
Taiping, Malaysia
New Zealand
Teva Investigational Site 723
Auckland, New Zealand
Teva Investigational Site 722
Christchurch, New Zealand
Teva Investigational Site 726
Christchurch, New Zealand
Teva Investigational Site 724
Dunedin, New Zealand
Teva Investigational Site 727
Hamilton, New Zealand
Teva Investigational Site 720
Tauranga, New Zealand
Teva Investigational Site 721
Wellington, New Zealand
Philippines
Teva Investigational Site 744
Governor Mangubat Drive, Dasma, Philippines
Teva Investigational Site 742
Manila, Philippines
Teva Investigational Site 745
Quezon City, Philippines
Teva Investigational Site 743
Quezon City, Philippines
Teva Investigational Site 741
Quezon City, Philippines
Teva Investigational Site 740
Quezon City, Philippines
Poland
Teva Investigational Site 507
Bialystok, Poland
Teva Investigational Site 509
Bydgoszcz, Poland
Teva Investigational Site 501
Bystra, Poland
Teva Investigational Site 500
Ostrow Wielkopolski, Poland
Teva Investigational Site 511
Poznan, Poland
Teva Investigational Site 502
Sopot, Poland
Teva Investigational Site 504
Tarnow, Poland
Russian Federation
Teva Investigational Site 545
Barnaul, Russian Federation
Teva Investigational Site 551
Kazan, Russian Federation
Teva Investigational Site 549
Kemerovo, Russian Federation
Teva Investigational Site 550
Nizhniy Novgorod, Russian Federation
Teva Investigational Site 555
Novosibirsk, Russian Federation
Teva Investigational Site 553
Novosibirsk, Russian Federation
Teva Investigational Site 542
St. Petersburg, Russian Federation
Teva Investigational Site 552
Tomsk, Russian Federation
Teva Investigational Site 546
Yaroslavl, Russian Federation
South Africa
Teva Investigational Site 581
Cape Town, South Africa
Teva Investigational Site 584
Cape Town, South Africa
Teva Investigational Site 586
Cape Town, South Africa
Teva Investigational Site 587
Centurion, South Africa
Teva Investigational Site 582
Durban, South Africa
Teva Investigational Site 585
Durban, South Africa
Teva Investigational Site 580
Johannesburg, South Africa
Teva Investigational Site 589
Johannesburg, South Africa
Teva Investigational Site 588
Pretoria, South Africa
Teva Investigational Site 583
Pretoria, South Africa
Sweden
Teva Investigational Site 602
Göteborg, Sweden
Teva Investigational Site 604
Göteborg, Sweden
Teva Investigational Site 603
Linköping, Sweden
Teva Investigational Site 601
Malmö, Sweden
Thailand
Teva Investigational Site 780
Bangkok, Thailand
Teva Investigational Site 782
Bangkok, Thailand
Teva Investigational Site 783
Bangkok, Thailand
Teva Investigational Site 781
Muang, Thailand
Teva Investigational Site 784
Nakhon Ratchasima, Thailand
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Medical Expert, MD TEVA
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01287039     History of Changes
Other Study ID Numbers: C38072/3082
Study First Received: January 28, 2011
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Chile: Ministry of Health
Colombia: National Institutes of Health
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Hungary: National Institute of Pharmacy
Israel: Israeli Health Ministry Pharmaceutical Administration
Malaysia: Ministry of Health
New Zealand: Ministry of Health
Norway: Norwegian Medicines Agency
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Pharmacological Committee, Ministry of Health
South Africa: Medicines Control Council
Sweden: Medical Products Agency
Thailand: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Pulmonary Eosinophilia
Bronchial Diseases
Eosinophilia
Hematologic Diseases
Hypereosinophilic Syndrome
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Leukocyte Disorders
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014