Clinical trial NCT01290887: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Eosinophilic Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-07
Enrollment: 1052
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Study patients deemed eligible based on activities from the preceding Teva sponsored double blind study of reslizumab in eosinophilic asthma. Specifically, as per inclusion criterion c, patients must have either completed treatment in a previous Teva-sponsored study or have received at least 2 doses of study drug treatment in a pulmonary function study.

Eligible patients could enroll in this study only after completion of the end of treatment visit in a Teva sponsored, randomized, placebo controlled, double blind study of reslizumab in eosinophilic asthma, which served as the screening/baseline visit for participation in this open label extension study. The use of systemic corticosteroids for asthma in any of the previous Teva sponsored double blind studies of reslizumab did not exclude patients from this study. The previous Teva studies were C38072/3081 (NCT01270464), C38072/3082 (NCT01287039), and C38072/3083 (NCT01285323).

Eligibility 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.

Primary outcomes:
measure: Participants With Treatment-Emergent Adverse Events
timeFrame: Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
measure: Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values
timeFrame: Weeks 4, 8, 24 and 48
measure: Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values
timeFrame: Week 4 to Week 65
Secondary outcomes:
measure: Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint
timeFrame: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
measure: Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint
timeFrame: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
measure: Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint
timeFrame: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
measure: Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint
timeFrame: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
measure: Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint
timeFrame: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
measure: Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint
timeFrame: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
measure: Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint
timeFrame: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
measure: Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint
timeFrame: Weeks 24, 48, 72, 96, End of Study and Endpoint
measure: Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall
timeFrame: Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Teva Investigational Site 58
state: Arizona
city: Anaheim
country: United States
facility: Teva Investigational Site 12
state: California
city: Fountain Valley
country: United States
facility: Teva Investigational Site 11
state: California
city: Fresno
country: United States
facility: Teva Investigational Site 41
state: California
city: Long Beach
country: United States
facility: Teva Investigational Site 59
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 43
state: California
city: Orange
country: United States
facility: Teva Investigational Site 4
state: California
city: Walnut Creek
country: United States
facility: Teva Investigational Site 15
state: California
city: Colorado Springs
country: United States
facility: Teva Investigational Site 2
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Investigational Site 34
state: Colorado
city: Denver
country: United States
facility: Teva Investigational Site 47
state: Colorado
city: Waterbury
country: United States
facility: Teva Investigational Site 28
state: Connecticut
city: Clearwater
country: United States
facility: Teva Investigational Site 53
state: Florida
city: Largo
country: United States
facility: Teva Investigational Site 24
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 27
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 55
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 5
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 52
state: Florida
city: Tallahassee
country: United States
facility: Teva Investigational Site 19
state: Florida
city: Trinity
country: United States
facility: Teva Investigational Site 17
state: Florida
city: Valrico
country: United States
facility: Teva Investigational Site 18
state: Florida
city: Lawrenceville
country: United States
facility: Teva Investigational Site 25
state: Georgia
city: Lilburn
country: United States
facility: Teva Investigational Site 6
state: Georgia
city: Savannah
country: United States
facility: Teva Investigational Site 3
state: Georgia
city: Lexington
country: United States
facility: Teva Investigational Site 49
state: Kentucky
city: Bangor
country: United States
facility: Teva Investigational Site 46
state: Maine
city: St. Louis
country: United States
facility: Teva Investigational Site 40
state: Missouri
city: St. Louis
country: United States
facility: Teva Investigational Site 74
state: Missouri
city: Boys Town
country: United States
facility: Teva Investigational Site 64
state: Nebraska
city: Omaha
country: United States
facility: Teva Investigational Site 8
state: Nebraska
city: Summit
country: United States
facility: Teva Investigational Site 26
state: New Jersey
city: Winston-Salem
country: United States
facility: Teva Investigational Site 30
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 20
state: Ohio
city: Cincinnati
country: United States
facility: Teva Investigational Site 31
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 50
state: Oklahoma
city: Medford
country: United States
facility: Teva Investigational Site 1
state: Oregon
city: Altoona
country: United States
facility: Teva Investigational Site 66
state: Pennsylvania
city: Lincoln
country: United States
facility: Teva Investigational Site 73
state: Rhode Island
city: Providence
country: United States
facility: Teva Investigational Site 9
state: Rhode Island
city: Charleston
country: United States
facility: Teva Investigational Site 21
state: South Carolina
city: Nashville
country: United States
facility: Teva Investigational Site 32
state: Tennessee
city: Boerne
country: United States
facility: Teva Investigational Site 63
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 44
state: Texas
city: El Paso
country: United States
facility: Teva Investigational Site 69
state: Texas
city: Fort Worth
country: United States
facility: Teva Investigational Site 16
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 14
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 45
state: Texas
city: Madison
country: United States
facility: Teva Investigational Site 33
state: Wisconsin
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Teva Investigational Site 121
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Teva Investigational Site 126
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Teva Investigational Site 127
city: Quilmes-Buenos Aires
country: Argentina
facility: Teva Investigational Site 128
city: Rosario-Santa Fe
country: Argentina
facility: Teva Investigational Site 123
city: Rosario
country: Argentina
facility: Teva Investigational Site 125
city: San Miguel de Tucuman - Tucuma
country: Argentina
facility: Teva Investigational Site 120
city: San Miguel de Tucuman - Tucuma
country: Argentina
facility: Teva Investigational Site 122
city: East Bentleigh
country: Australia
facility: Teva Investigational Site 641
city: Frankston
country: Australia
facility: Teva Investigational Site 642
city: Liverpool
country: Australia
facility: Teva Investigational Site 645
city: Nedlands
country: Australia
facility: Teva Investigational Site 643
city: Bruxelles
country: Belgium
facility: Teva Investigational Site 261
city: Bruxelles
country: Belgium
facility: Teva Investigational Site 264
city: Gent
country: Belgium
facility: Teva Investigational Site 260
city: Jambes
country: Belgium
facility: Teva Investigational Site 262
city: Liège
country: Belgium
facility: Teva Investigational Site 263
city: Belo Horizonte
country: Brazil
facility: Teva Investigational Site 146
city: Florianopolis
country: Brazil
facility: Teva Investigational Site 150
city: Porto Alegre - RS
country: Brazil
facility: Teva Investigational Site 147
city: Porto Alegre, RS
country: Brazil
facility: Teva Investigational Site 143
city: Porto Alegre
country: Brazil
facility: Teva Investigational Site 140
city: Porto Alegre
country: Brazil
facility: Teva Investigational Site 144
city: Santo André, São Paulo
country: Brazil
facility: Teva Investigational Site 142
city: Calgary
country: Canada
facility: Teva Investigational Site 103
city: Montreal
country: Canada
facility: Teva Investigational Site 101
city: Newmarket
country: Canada
facility: Teva Investigational Site 104
city: Windsor
country: Canada
facility: Teva Investigational Site 105
city: Rancagua
country: Chile
facility: Teva Investigational Site 160
city: Santiago
country: Chile
facility: Teva Investigational Site 164
city: Temuco
country: Chile
facility: Teva Investigational Site 161
city: Valdivia
country: Chile
facility: Teva Investigational Site 162
city: Valparaiso
country: Chile
facility: Teva Investigational Site 166
city: Bogota
country: Colombia
facility: Teva Investigational Site 185
city: Bogotá
country: Colombia
facility: Teva Investigational Site 181
city: Cali
country: Colombia
facility: Teva Investigational Site 182
city: Floridablanca
country: Colombia
facility: Teva Investigational Site 180
city: Breclav
country: Czech Republic
facility: Teva Investigational Site 284
city: Brno
country: Czech Republic
facility: Teva Investigational Site 287
city: Liberec
country: Czech Republic
facility: Teva Investigational Site 286
city: Olomouc
country: Czech Republic
facility: Teva Investigational Site 280
city: Olomouc
country: Czech Republic
facility: Teva Investigational Site 281
city: Olomouc
country: Czech Republic
facility: Teva Investigational Site 285
city: Tabor
country: Czech Republic
facility: Teva Investigational Site 283
city: Odense
country: Denmark
facility: Teva Investigational Site 300
city: Marseille
country: France
facility: Teva Investigational Site 342
city: Montpellier
country: France
facility: Teva Investigational Site 341
city: Berlin
country: Germany
facility: Teva Investigational Site 361
city: Berlin
country: Germany
facility: Teva Investigational Site 366
city: Bochum
country: Germany
facility: Teva Investigational Site 371
city: Frankfurt
country: Germany
facility: Teva Investigational Site 369
city: Hamburg
country: Germany
facility: Teva Investigational Site 370
city: Koblenz
country: Germany
facility: Teva Investigational Site 372
city: Leipzig
country: Germany
facility: Teva Investigational Site 367
city: Mainz
country: Germany
facility: Teva Investigational Site 363
city: Athens
country: Greece
facility: Teva Investigational Site 380
city: Balassagyarmat
country: Hungary
facility: Teva Investigational Site 401
city: Miskolc
country: Hungary
facility: Teva Investigational Site 400
city: Mosonmagyaróvár
country: Hungary
facility: Teva Investigational Site 404
city: Sopron
country: Hungary
facility: Teva Investigational Site 403
city: Szazhalombatta
country: Hungary
facility: Teva Investigational Site 407
city: Tatabánya
country: Hungary
facility: Teva Investigational Site 402
city: Törökbálint
country: Hungary
facility: Teva Investigational Site 405
city: Ashkelon
country: Israel
facility: Teva Investigational Site 423
city: Haifa
country: Israel
facility: Teva Investigational Site 432
city: Jerusalem
country: Israel
facility: Teva Investigational Site 425
city: Jerusalem
country: Israel
facility: Teva Investigational Site 428
city: Kfar Saba
country: Israel
facility: Teva Investigational Site 426
city: Petach Tikva
country: Israel
facility: Teva Investigational Site 422
city: Ramat Gan
country: Israel
facility: Teva Investigational Site 433
city: Rehovot
country: Israel
facility: Teva Investigational Site 421
city: Tel-Aviv
country: Israel
facility: Teva Investigational Site 420
city: Gwangju
country: Korea, Republic of
facility: Teva Investigational Site 682
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 680
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 681
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 683
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 686
city: Suwon
country: Korea, Republic of
facility: Teva Investigational Site 685
city: Batu Caves
country: Malaysia
facility: Teva Investigational Site 705
city: Kuala Lumpur
country: Malaysia
facility: Teva Investigational Site 700
city: Kuala Lumpur
country: Malaysia
facility: Teva Investigational Site 702
city: Penang
country: Malaysia
facility: Teva Investigational Site 701
city: Taiping
country: Malaysia
facility: Teva Investigational Site 704
city: Ciudad De México
country: Mexico
facility: Teva Investigational Site 205
city: Distrito Federal
country: Mexico
facility: Teva Investigational Site 203
city: Guadalajara, JAL
country: Mexico
facility: Teva Investigational Site 204
city: Hermosillo, Sonora
country: Mexico
facility: Teva Investigational Site 200
city: Mexico City
country: Mexico
facility: Teva Investigational Site 207
city: Monterrey
country: Mexico
facility: Teva Investigational Site 209
city: Tijuana, B.C.
country: Mexico
facility: Teva Investigational Site 202
city: Heerlen
country: Netherlands
facility: Teva Investigational Site 460
city: Auckland
country: New Zealand
facility: Teva Investigational Site 723
city: Dunedin
country: New Zealand
facility: Teva Investigational Site 724
city: Hamilton
country: New Zealand
facility: Teva Investigational Site 727
city: Tauranga
country: New Zealand
facility: Teva Investigational Site 720
city: Wellington
country: New Zealand
facility: Teva Investigational Site 721
city: Cercado de Lima, Lima
country: Peru
facility: Teva Investigational Site 223
city: Lima
country: Peru
facility: Teva Investigational Site 220
city: Lima
country: Peru
facility: Teva Investigational Site 221
city: Lima
country: Peru
facility: Teva Investigational Site 222
city: Lima
country: Peru
facility: Teva Investigational Site 225
city: Lima
country: Peru
facility: Teva Investigational Site 226
city: Lima
country: Peru
facility: Teva Investigational Site 227
city: Lima
country: Peru
facility: Teva Investigational Site 229
city: Manila
country: Philippines
facility: Teva Investigational Site 742
city: Quezon City
country: Philippines
facility: Teva Investigational Site 740
city: Quezon City
country: Philippines
facility: Teva Investigational Site 741
city: Quezon City
country: Philippines
facility: Teva Investigational Site 743
city: Quezon City
country: Philippines
facility: Teva Investigational Site 745
city: Bialystok
country: Poland
facility: Teva Investigational Site 507
city: Bydgoszcz
country: Poland
facility: Teva Investigational Site 509
city: Gdansk
country: Poland
facility: Teva Investigational Site 513
city: Lodz
country: Poland
facility: Teva Investigational Site 512
city: Lublin
country: Poland
facility: Teva Investigational Site 505
city: Ostrow Wielkopolski
country: Poland
facility: Teva Investigational Site 500
city: Poznan
country: Poland
facility: Teva Investigational Site 511
city: Tarnow
country: Poland
facility: Teva Investigational Site 504
city: Bucharest
country: Romania
facility: Teva Investigational Site 523
city: Bucharest
country: Romania
facility: Teva Investigational Site 524
city: Cluj-Napoca
country: Romania
facility: Teva Investigational Site 520
city: Iasi
country: Romania
facility: Teva Investigational Site 521
city: Targu Mures
country: Romania
facility: Teva Investigational Site 522
city: Barnaul
country: Russian Federation
facility: Teva Investigational Site 545
city: Kemerovo
country: Russian Federation
facility: Teva Investigational Site 549
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 543
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 544
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 554
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 558
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 559
city: Novosibirsk
country: Russian Federation
facility: Teva Investigational Site 555
city: Novosibirsk
country: Russian Federation
facility: Teva Investigational Site 557
city: St. Petersburg
country: Russian Federation
facility: Teva Investigational Site 541
city: St. Petersburg
country: Russian Federation
facility: Teva Investigational Site 542
city: St.Petersburg
country: Russian Federation
facility: Teva Investigational Site 540
city: Tomsk
country: Russian Federation
facility: Teva Investigational Site 552
city: Yaroslavl
country: Russian Federation
facility: Teva Investigational Site 546
city: Bradejov
country: Slovakia
facility: Teva Investigational Site 563
city: Levice
country: Slovakia
facility: Teva Investigational Site 561
city: Spisska Nova Ves
country: Slovakia
facility: Teva Investigational Site 560
city: Topolcany
country: Slovakia
facility: Teva Investigational Site 562
city: Cape Town
country: South Africa
facility: Teva Investigational Site 584
city: Cape Town
country: South Africa
facility: Teva Investigational Site 586
city: Centurion
country: South Africa
facility: Teva Investigational Site 587
city: Durban
country: South Africa
facility: Teva Investigational Site 582
city: Durban
country: South Africa
facility: Teva Investigational Site 585
city: Johannesburg
country: South Africa
facility: Teva Investigational Site 580
city: Johannesburg
country: South Africa
facility: Teva Investigational Site 589
city: Pretoria
country: South Africa
facility: Teva Investigational Site 583
city: Pretoria
country: South Africa
facility: Teva Investigational Site 588
city: Göteborg
country: Sweden
facility: Teva Investigational Site 602
city: Göteborg
country: Sweden
facility: Teva Investigational Site 604
city: Linköping
country: Sweden
facility: Teva Investigational Site 603
city: Lund
country: Sweden
facility: Teva Investigational Site 600
city: Malmö
country: Sweden
facility: Teva Investigational Site 601
city: Taipei
country: Taiwan
facility: Teva Investigational Site 761
city: Taoyuan
country: Taiwan
facility: Teva Investigational Site 763
city: Bangkok
country: Thailand
facility: Teva Investigational Site 780
city: Bangkok
country: Thailand
facility: Teva Investigational Site 782
city: Nakhon Ratchasima
country: Thailand
facility: Teva Investigational Site 784
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 621
city: Donetsk
country: Ukraine
facility: Teva Investigational Site 629
city: Ivano-Frankivsk
country: Ukraine
facility: Teva Investigational Site 630
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 620
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 633
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 622
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 623
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 624
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 625
city: Vinnytsya
country: Ukraine
facility: Teva Investigational Site 626
city: Zaporizhzhia
country: Ukraine
facility: Teva Investigational Site 631
city: Zaporizhzhya
country: Ukraine
facility: Teva Investigational Site 632
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Expert, Senior Director - Worldwide Clinical Research
role: STUDY_DIRECTOR
References: