Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01290887
First received: February 4, 2011
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant medication usage throughout the study (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.


Condition Intervention Phase
Eosinophilic Asthma
Drug: Reslizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophilic Asthma Who Completed a Prior Teva-Sponsored Study in Eosinophilic Asthma

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Summary of participants with adverse events [ Time Frame: up to 104 weeks of treatment and a 90-day follow-up evaluation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lung function as measured by Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Lung function as measured by percent predicted Forced Expiratory Volume in 1 second (%FEV1) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Lung function as measured by Forced Vital Capacity (FVC) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Lung function as measured by Forced Expiratory Flow at 25% to 75% FVC (FEF25-75%) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Short-acting Beta-agonist usage [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Asthma symptoms as measured by the Asthma Symptom Utility Index (ASUI) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Asthma control as measured by the Asthma Control Questionnaire (ACQ) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: 116 weeks ] [ Designated as safety issue: No ]

Enrollment: 1052
Study Start Date: June 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reslizumab Drug: Reslizumab
Reslizumab (3.0 mg/kg) will be administered intravenously by infusion every 28 days (±7 days), for approximately 24 months

  Eligibility

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

Inclusion Criteria:

  • Written informed consent is obtained.
  • Patient must have completed treatment in a previous Cephalon-sponsored double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.
  • 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.
  • other criteria may apply; please contact the investigator for more information.

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 another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
  • The patient is a current smoker.
  • The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
  • The patient has any aggravating factors that are inadequately controlled (e.g., gastroesophageal reflux disease [GERD]).
  • Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (eg, spermicide, abstinence, intrauterine device [IUD], or steroidal contraceptive [oral, transdermal, implanted, and injected] in conjunction with a barrier method) are excluded from this study.
  • The patient has a current infection or disease that may preclude assessment of asthma.
  • other criteria may 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: NCT01290887

  Hide Study Locations
Locations
United States, Arizona
Teva Investigational Site 58
Scottsdale, Arizona, United States
United States, California
Teva Investigational Site 12
Anaheim, California, United States
Teva Investigational Site 11
Fountain Valley, California, United States
Teva Investigational Site 41
Fresno, California, United States
Teva Investigational Site 59
Long Beach, California, United States
Teva Investigational Site 43
Los Angeles, California, United States
Teva Investigational Site 4
Orange, California, United States
Teva Investigational Site 29
San Fransisco, California, United States
Teva Investigational Site 15
Walnut Creek, California, United States
United States, Colorado
Teva Investigational Site 2
Colorado Springs, Colorado, United States
Teva Investigational Site 47
Denver, Colorado, United States
United States, Connecticut
Teva Investigational Site 28
Waterbury, Connecticut, United States
United States, Florida
Teva Investigational Site 53
Clearwater, Florida, United States
Teva Investigational Site 24
Largo, Florida, United States
Teva Investigational Site 5
Miami, Florida, United States
Teva Investigational Site 55
Miami, Florida, United States
Teva Investigational Site 27
Miami, Florida, United States
Teva Investigational Site 19
Tallahassee, Florida, United States
Teva Investigational Site 17
Trinity, Florida, United States
Teva Investigational Site 18
Valrico, Florida, United States
United States, Georgia
Teva Investigational Site 25
Lawrenceville, Georgia, United States
Teva Investigational Site 6
Lilburn, Georgia, United States
Teva Investigational Site 3
Savannah, Georgia, United States
United States, Kentucky
Teva Investigational Site 49
Lexington, Kentucky, United States
United States, Maine
Teva Investigational Site 46
Bangor, Maine, United States
United States, Missouri
Teva Investigational Site 74
St. Louis, Missouri, United States
Teva Investigational Site 40
St. Louis, Missouri, United States
United States, Nebraska
Teva Investigational Site 64
Boys Town, Nebraska, United States
Teva Investigational Site 8
Omaha, Nebraska, United States
United States, New Jersey
Teva Investigational Site 26
Summit, New Jersey, United States
United States, North Carolina
Teva Investigational Site 30
Winston-Salem, North Carolina, United States
United States, Ohio
Teva Investigational Site 20
Cincinnati, Ohio, United States
Teva Investigational Site 31
Cincinnati, Ohio, United States
United States, Oklahoma
Teva Investigational Site 50
Oklahoma City, Oklahoma, United States
United States, Oregon
Teva Investigational Site 1
Medford, Oregon, United States
United States, Pennsylvania
Teva Investigational Site 66
Altoona, Pennsylvania, United States
United States, Rhode Island
Teva Investigational Site 73
Lincoln, Rhode Island, United States
Teva Investigational Site 9
Providence, Rhode Island, United States
United States, South Carolina
Teva Investigational Site 21
Charleston, South Carolina, 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 44
Dallas, Texas, United States
Teva Investigational Site 69
El Paso, Texas, United States
Teva Investigational Site 16
Fort Worth, Texas, United States
Teva Investigational Site 45
San Antonio, Texas, United States
Teva Investigational Site 14
San Antonio, Texas, United States
United States, Wisconsin
Teva Investigational Site 33
Madison, Wisconsin, United States
Argentina
Teva Investigational Site 126
Ciudad Autonoma de Buenos Aire, Argentina
Teva Investigational Site 121
Ciudad Autonoma de Buenos Aire, Argentina
Teva Investigational Site 127
Ciudad Autonoma de Buenos Aire, Argentina
Teva Investigational Site 128
Quilmes-Buenos Aires, Argentina
Teva Investigational Site 125
Rosario, Argentina
Teva Investigational Site 123
Rosario-Santa Fe, Argentina
Teva Investigational Site 124
San Miguel de Tucuman - Tucuma, Argentina
Teva Investigational Site 122
San Miguel de Tucuman - Tucuma, Argentina
Teva Investigational Site 120
San Miguel de Tucuman - Tucuma, Argentina
Australia, Western Australia
Teva Investigational Site 643
Nedlands, Western Australia, Australia
Australia
Teva Investigational Site 641
East Bentleigh, Australia
Teva Investigational Site 642
Frankston, Australia
Teva Investigational Site 645
Liverpool, Australia
Teva Investigational Site 640
Melbourne, 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
Brazil
Teva Investigational Site 146
Belo Horizonte, Brazil
Teva Investigational Site 150
Florianopolis, Brazil
Teva Investigational Site 144
Porto Alegre, Brazil
Teva Investigational Site 140
Porto Alegre, Brazil
Teva Investigational Site 145
Porto Alegre, Brazil
Teva Investigational Site 147
Porto Alegre - RS, Brazil
Teva Investigational Site 143
Porto Alegre, RS, Brazil
Teva Investigational Site 142
Santo André, São Paulo, Brazil
Teva Investigational Site 141
Sao Paulo, Brazil
Canada
Teva Investigational Site 103
Calgary, Canada
Teva Investigational Site 101
Montreal, Canada
Teva Investigational Site 104
Newmarket, Canada
Teva Investigational Site 105
Windsor, Canada
Chile
Teva Investigational Site 160
Rancagua, Chile
Teva Investigational Site 165
Santiago, Chile
Teva Investigational Site 164
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 184
Bogota, Colombia
Teva Investigational Site 181
Bogotá, Colombia
Teva Investigational Site 182
Cali, Colombia
Teva Investigational Site 180
Floridablanca, Colombia
Teva Investigational Site 183
Medellin, 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 281
Olomouc, Czech Republic
Teva Investigational Site 280
Olomouc, Czech Republic
Teva Investigational Site 285
Olomouc, Czech Republic
Teva Investigational Site 283
Tabor, Czech Republic
Denmark
Teva Investigational Site 302
Hellerup, Denmark
Teva Investigational Site 301
Hvidovre, Denmark
Teva Investigational Site 300
Odense, Denmark
France
Teva Investigational Site 343
Grenoble, France
Teva Investigational Site 342
Marseille, France
Teva Investigational Site 341
Montpellier, France
Teva Investigational Site 340
Nantes, France
Teva Investigational Site 344
Pessac, France
Germany
Teva Investigational Site 360
Bad Wörishofen, Germany
Teva Investigational Site 361
Berlin, Germany
Teva Investigational Site 362
Berlin, Germany
Teva Investigational Site 366
Berlin, Germany
Teva Investigational Site 371
Bochum, Germany
Teva Investigational Site 365
Dresden, Germany
Teva Investigational Site 369
Frankfurt, Germany
Teva Investigational Site 370
Hamburg, Germany
Teva Investigational Site 372
Koblenz, Germany
Teva Investigational Site 367
Leipzig, Germany
Teva Investigational Site 368
Leipzig, Germany
Teva Investigational Site 364
Mainz, Germany
Teva Investigational Site 363
Mainz, Germany
Greece
Teva Investigational Site 380
Athens, Greece
Teva Investigational Site 382
Heraklion, Crete, Greece
Teva Investigational Site 383
Larissa, Greece
Hungary
Teva Investigational Site 401
Balassagyarmat, Hungary
Teva Investigational Site 406
Edelény, Hungary
Teva Investigational Site 400
Miskolc, Hungary
Teva Investigational Site 404
Mosonmagyaróvár, Hungary
Teva Investigational Site 403
Sopron, Hungary
Teva Investigational Site 407
Szazhalombatta, Hungary
Teva Investigational Site 402
Tatabánya, Hungary
Teva Investigational Site 405
Törökbálint, Hungary
Israel
Teva Investigational Site 423
Ashkelon, Israel
Teva Investigational Site 430
Beer-Sheva, Israel
Teva Investigational Site 432
Haifa, Israel
Teva Investigational Site 431
Haifa, Israel
Teva Investigational Site 428
Jerusalem, Israel
Teva Investigational Site 425
Jerusalem, Israel
Teva Investigational Site 429
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 421
Rehovot, Israel
Teva Investigational Site 420
Tel-Aviv, Israel
Korea, Republic of
Teva Investigational Site 682
Gwangju, Korea, Republic of
Teva Investigational Site 684
Seoul, Korea, Republic of
Teva Investigational Site 680
Seoul, Korea, Republic of
Teva Investigational Site 681
Seoul, Korea, Republic of
Teva Investigational Site 683
Seoul, Korea, Republic of
Teva Investigational Site 686
Seoul, Korea, Republic of
Teva Investigational Site 685
Suwon, Korea, Republic of
Malaysia
Teva Investigational Site 705
Batu Caves, Malaysia
Teva Investigational Site 700
Kuala Lumpur, Malaysia
Teva Investigational Site 702
Kuala Lumpur, Malaysia
Teva Investigational Site 703
Kuantan, Malaysia
Teva Investigational Site 701
Penang, Malaysia
Teva Investigational Site 704
Taiping, Malaysia
Mexico
Teva Investigational Site 205
Ciudad De México, Mexico
Teva Investigational Site 203
Distrito Federal, Mexico
Teva Investigational Site 204
Guadalajara, JAL, Mexico
Teva Investigational Site 200
Hermosillo, Sonora, Mexico
Teva Investigational Site 209
Monterrey, Mexico
Teva Investigational Site 206
Puebla, Mexico
Teva Investigational Site 202
Tijuana, B.C., Mexico
Netherlands
Teva Investigational Site 460
Heerlen, Netherlands
New Zealand
Teva Investigational Site 723
Auckland, New Zealand
Teva Investigational Site 726
Christchurch, New Zealand
Teva Investigational Site 722
Christchurch, New Zealand
Teva Investigational Site 724
Dunedin, New Zealand
Teva Investigational Site 720
Tauranga, New Zealand
Teva Investigational Site 721
Wellington, New Zealand
Peru
Teva Investigational Site 224
Callao, Peru
Teva Investigational Site 228
Callao, Peru
Teva Investigational Site 223
Cercado de Lima, Lima, Peru
Teva Investigational Site 222
Lima, Peru
Teva Investigational Site 220
Lima, Peru
Teva Investigational Site 227
Lima, Peru
Teva Investigational Site 226
Lima, Peru
Teva Investigational Site 225
Lima, Peru
Teva Investigational Site 221
Lima, Peru
Teva Investigational Site 229
Lima, Peru
Philippines
Teva Investigational Site 744
Governor Mangubat Drive, Dasma, Philippines
Teva Investigational Site 742
Manila, Philippines
Teva Investigational Site 743
Quezon City, Philippines
Teva Investigational Site 745
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 513
Gdansk, Poland
Teva Investigational Site 512
Lodz, Poland
Teva Investigational Site 505
Lublin, 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
Romania
Teva Investigational Site 524
Bucharest, Romania
Teva Investigational Site 523
Bucharest, Romania
Teva Investigational Site 520
Cluj-Napoca, Romania
Teva Investigational Site 521
Iasi, Romania
Teva Investigational Site 522
Targu Mures, Romania
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 558
Moscow, Russian Federation
Teva Investigational Site 544
Moscow, Russian Federation
Teva Investigational Site 556
Moscow, Russian Federation
Teva Investigational Site 559
Moscow, Russian Federation
Teva Investigational Site 543
Moscow, Russian Federation
Teva Investigational Site 554
Moscow, Russian Federation
Teva Investigational Site 550
Nizhniy Novgorod, Russian Federation
Teva Investigational Site 553
Novosibirsk, Russian Federation
Teva Investigational Site 557
Novosibirsk, Russian Federation
Teva Investigational Site 555
Novosibirsk, Russian Federation
Teva Investigational Site 548
Samara, Russian Federation
Teva Investigational Site 542
St. Petersburg, Russian Federation
Teva Investigational Site 541
St. Petersburg, Russian Federation
Teva Investigational Site 540
St.Petersburg, Russian Federation
Teva Investigational Site 552
Tomsk, Russian Federation
Teva Investigational Site 547
Vsevolozhsk, Russian Federation
Teva Investigational Site 546
Yaroslavl, Russian Federation
Slovakia
Teva Investigational Site 563
Bradejov, Slovakia
Teva Investigational Site 561
Levice, Slovakia
Teva Investigational Site 560
Spisska Nova Ves, Slovakia
Teva Investigational Site 562
Topolcany, Slovakia
South Africa
Teva Investigational Site 586
Cape Town, South Africa
Teva Investigational Site 581
Cape Town, South Africa
Teva Investigational Site 584
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 583
Pretoria, South Africa
Teva Investigational Site 588
Pretoria, South Africa
Sweden
Teva Investigational Site 604
Göteborg, Sweden
Teva Investigational Site 602
Göteborg, Sweden
Teva Investigational Site 603
Linköping, Sweden
Teva Investigational Site 600
Lund, Sweden
Teva Investigational Site 601
Malmö, Sweden
Taiwan
Teva Investigational Site 761
Taipei, Taiwan
Teva Investigational Site 763
Taoyuan, Taiwan
Thailand
Teva Investigational Site 780
Bangkok, Thailand
Teva Investigational Site 783
Bangkok, Thailand
Teva Investigational Site 785
Bangkok, Thailand
Teva Investigational Site 782
Bangkok, Thailand
Teva Investigational Site 781
Muang, Thailand
Teva Investigational Site 784
Nakhon Ratchasima, Thailand
Ukraine
Teva Investigational Site 621
Dnipropetrovsk, Ukraine
Teva Investigational Site 629
Donetsk, Ukraine
Teva Investigational Site 630
Ivano-Frankivsk, Ukraine
Teva Investigational Site 620
Kharkiv, Ukraine
Teva Investigational Site 623
Kyiv, Ukraine
Teva Investigational Site 622
Kyiv, Ukraine
Teva Investigational Site 624
Kyiv, Ukraine
Teva Investigational Site 625
Kyiv, Ukraine
Teva Investigational Site 626
Vinnytsya, Ukraine
Teva Investigational Site 631
Zaporizhzhia, Ukraine
Teva Investigational Site 632
Zaporizhzhya, Ukraine
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Sponsor's Medical Expert, Senior Director - Worldwide Clinical Research Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01290887     History of Changes
Other Study ID Numbers: C38072/3085, 2010-024540-15
Study First Received: February 4, 2011
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belarus: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
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
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Greece: Ministry of Health and Welfare
Hungary: National Institute of Pharmacy
India: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Malaysia: Ministry of Health
Mexico: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
New Zealand: Ministry of Health
Norway: Norwegian Medicines Agency
Peru: Ministry of Health
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Sweden: Medical Products Agency
Thailand: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health

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