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

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

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.

Study Overview

• Status: Terminated
• Conditions: Eosinophilic Asthma
• Intervention / Treatment: Drug: Reslizumab

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).

• Study Type: Interventional
• Enrollment (Actual): 1052
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma de Buenos Aire, Argentina
    • Teva Investigational Site 121
  • Ciudad Autonoma de Buenos Aire, Argentina
    • Teva Investigational Site 126
  • Ciudad Autonoma de Buenos Aire, Argentina
    • Teva Investigational Site 127
  • Quilmes-Buenos Aires, Argentina
    • Teva Investigational Site 128
  • Rosario, Argentina
    • Teva Investigational Site 125
  • Rosario-Santa Fe, Argentina
    • Teva Investigational Site 123
  • San Miguel de Tucuman - Tucuma, Argentina
    • Teva Investigational Site 120
  • San Miguel de Tucuman - Tucuma, Argentina
    • Teva Investigational Site 122
• Australia
  • East Bentleigh, Australia
    • Teva Investigational Site 641
  • Frankston, Australia
    • Teva Investigational Site 642
  • Liverpool, Australia
    • Teva Investigational Site 645
  • Nedlands, Australia
    • Teva Investigational Site 643
• Belgium
  • Bruxelles, Belgium
    • Teva Investigational Site 261
  • Bruxelles, Belgium
    • Teva Investigational Site 264
  • Gent, Belgium
    • Teva Investigational Site 260
  • Jambes, Belgium
    • Teva Investigational Site 262
  • Liège, Belgium
    • Teva Investigational Site 263
• Brazil
  • Belo Horizonte, Brazil
    • Teva Investigational Site 146
  • Florianopolis, Brazil
    • Teva Investigational Site 150
  • Porto Alegre, Brazil
    • Teva Investigational Site 140
  • Porto Alegre, Brazil
    • Teva Investigational Site 144
  • Porto Alegre - RS, Brazil
    • Teva Investigational Site 147
  • Porto Alegre, RS, Brazil
    • Teva Investigational Site 143
  • Santo André, São Paulo, Brazil
    • Teva Investigational Site 142
• Canada
  • Calgary, Canada
    • Teva Investigational Site 103
  • Montreal, Canada
    • Teva Investigational Site 101
  • Newmarket, Canada
    • Teva Investigational Site 104
  • Windsor, Canada
    • Teva Investigational Site 105
• Chile
  • Rancagua, Chile
    • Teva Investigational Site 160
  • Santiago, Chile
    • Teva Investigational Site 164
  • Temuco, Chile
    • Teva Investigational Site 161
  • Valdivia, Chile
    • Teva Investigational Site 162
  • Valparaiso, Chile
    • Teva Investigational Site 166
• Colombia
  • Bogota, Colombia
    • Teva Investigational Site 185
  • Bogotá, Colombia
    • Teva Investigational Site 181
  • Cali, Colombia
    • Teva Investigational Site 182
  • Floridablanca, Colombia
    • Teva Investigational Site 180
• Czech Republic
  • Breclav, Czech Republic
    • Teva Investigational Site 284
  • Brno, Czech Republic
    • Teva Investigational Site 287
  • Liberec, Czech Republic
    • Teva Investigational Site 286
  • Olomouc, Czech Republic
    • Teva Investigational Site 280
  • Olomouc, Czech Republic
    • Teva Investigational Site 281
  • Olomouc, Czech Republic
    • Teva Investigational Site 285
  • Tabor, Czech Republic
    • Teva Investigational Site 283
• Denmark
  • Odense, Denmark
    • Teva Investigational Site 300
• France
  • Marseille, France
    • Teva Investigational Site 342
  • Montpellier, France
    • Teva Investigational Site 341
• Germany
  • Berlin, Germany
    • Teva Investigational Site 361
  • Berlin, Germany
    • Teva Investigational Site 366
  • Bochum, Germany
    • Teva Investigational Site 371
  • Frankfurt, Germany
    • Teva Investigational Site 369
  • Hamburg, Germany
    • Teva Investigational Site 370
  • Koblenz, Germany
    • Teva Investigational Site 372
  • Leipzig, Germany
    • Teva Investigational Site 367
  • Mainz, Germany
    • Teva Investigational Site 363
• Greece
  • Athens, Greece
    • Teva Investigational Site 380
• Hungary
  • Balassagyarmat, Hungary
    • Teva Investigational Site 401
  • Miskolc, Hungary
    • Teva Investigational Site 400
  • Mosonmagyaróvár, Hungary
    • Teva Investigational Site 404
  • Sopron, Hungary
    • Teva Investigational Site 403
  • Szazhalombatta, Hungary
    • Teva Investigational Site 407
  • Tatabánya, Hungary
    • Teva Investigational Site 402
  • Törökbálint, Hungary
    • Teva Investigational Site 405
• Israel
  • Ashkelon, Israel
    • Teva Investigational Site 423
  • Haifa, Israel
    • Teva Investigational Site 432
  • Jerusalem, Israel
    • Teva Investigational Site 425
  • Jerusalem, Israel
    • Teva Investigational Site 428
  • Kfar Saba, Israel
    • Teva Investigational Site 426
  • Petach Tikva, Israel
    • Teva Investigational Site 422
  • Ramat Gan, Israel
    • Teva Investigational Site 433
  • Rehovot, Israel
    • Teva Investigational Site 421
  • Tel-Aviv, Israel
    • Teva Investigational Site 420
• Korea, Republic of
  • Gwangju, Korea, Republic of
    • Teva Investigational Site 682
  • 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
  • Suwon, Korea, Republic of
    • Teva Investigational Site 685
• Malaysia
  • Batu Caves, Malaysia
    • Teva Investigational Site 705
  • Kuala Lumpur, Malaysia
    • Teva Investigational Site 700
  • Kuala Lumpur, Malaysia
    • Teva Investigational Site 702
  • Penang, Malaysia
    • Teva Investigational Site 701
  • Taiping, Malaysia
    • Teva Investigational Site 704
• Mexico
  • Ciudad De México, Mexico
    • Teva Investigational Site 205
  • Distrito Federal, Mexico
    • Teva Investigational Site 203
  • Guadalajara, JAL, Mexico
    • Teva Investigational Site 204
  • Hermosillo, Sonora, Mexico
    • Teva Investigational Site 200
  • Mexico City, Mexico
    • Teva Investigational Site 207
  • Monterrey, Mexico
    • Teva Investigational Site 209
  • Tijuana, B.C., Mexico
    • Teva Investigational Site 202
• Netherlands
  • Heerlen, Netherlands
    • Teva Investigational Site 460
• New Zealand
  • Auckland, New Zealand
    • Teva Investigational Site 723
  • Dunedin, New Zealand
    • Teva Investigational Site 724
  • Hamilton, New Zealand
    • Teva Investigational Site 727
  • Tauranga, New Zealand
    • Teva Investigational Site 720
  • Wellington, New Zealand
    • Teva Investigational Site 721
• Peru
  • Cercado de Lima, Lima, Peru
    • Teva Investigational Site 223
  • Lima, Peru
    • Teva Investigational Site 220
  • Lima, Peru
    • Teva Investigational Site 221
  • Lima, Peru
    • Teva Investigational Site 222
  • Lima, Peru
    • Teva Investigational Site 225
  • Lima, Peru
    • Teva Investigational Site 226
  • Lima, Peru
    • Teva Investigational Site 227
  • Lima, Peru
    • Teva Investigational Site 229
• Philippines
  • Manila, Philippines
    • Teva Investigational Site 742
  • Quezon City, Philippines
    • Teva Investigational Site 740
  • Quezon City, Philippines
    • Teva Investigational Site 741
  • Quezon City, Philippines
    • Teva Investigational Site 743
  • Quezon City, Philippines
    • Teva Investigational Site 745
• Poland
  • Bialystok, Poland
    • Teva Investigational Site 507
  • Bydgoszcz, Poland
    • Teva Investigational Site 509
  • Gdansk, Poland
    • Teva Investigational Site 513
  • Lodz, Poland
    • Teva Investigational Site 512
  • Lublin, Poland
    • Teva Investigational Site 505
  • Ostrow Wielkopolski, Poland
    • Teva Investigational Site 500
  • Poznan, Poland
    • Teva Investigational Site 511
  • Tarnow, Poland
    • Teva Investigational Site 504
• Romania
  • Bucharest, Romania
    • Teva Investigational Site 523
  • Bucharest, Romania
    • Teva Investigational Site 524
  • Cluj-Napoca, Romania
    • Teva Investigational Site 520
  • Iasi, Romania
    • Teva Investigational Site 521
  • Targu Mures, Romania
    • Teva Investigational Site 522
• Russian Federation
  • Barnaul, Russian Federation
    • Teva Investigational Site 545
  • Kemerovo, Russian Federation
    • Teva Investigational Site 549
  • Moscow, Russian Federation
    • Teva Investigational Site 543
  • Moscow, Russian Federation
    • Teva Investigational Site 544
  • Moscow, Russian Federation
    • Teva Investigational Site 554
  • Moscow, Russian Federation
    • Teva Investigational Site 558
  • Moscow, Russian Federation
    • Teva Investigational Site 559
  • Novosibirsk, Russian Federation
    • Teva Investigational Site 555
  • Novosibirsk, Russian Federation
    • Teva Investigational Site 557
  • St. Petersburg, Russian Federation
    • Teva Investigational Site 542
  • St. Petersburg, Russian Federation
    • Teva Investigational Site 541
  • St.Petersburg, Russian Federation
    • Teva Investigational Site 540
  • Tomsk, Russian Federation
    • Teva Investigational Site 552
  • Yaroslavl, Russian Federation
    • Teva Investigational Site 546
• Slovakia
  • Bradejov, Slovakia
    • Teva Investigational Site 563
  • Levice, Slovakia
    • Teva Investigational Site 561
  • Spisska Nova Ves, Slovakia
    • Teva Investigational Site 560
  • Topolcany, Slovakia
    • Teva Investigational Site 562
• South Africa
  • Cape Town, South Africa
    • Teva Investigational Site 584
  • Cape Town, South Africa
    • Teva Investigational Site 586
  • Centurion, South Africa
    • Teva Investigational Site 587
  • Durban, South Africa
    • Teva Investigational Site 582
  • Durban, South Africa
    • Teva Investigational Site 585
  • Johannesburg, South Africa
    • Teva Investigational Site 580
  • Johannesburg, South Africa
    • Teva Investigational Site 589
  • Pretoria, South Africa
    • Teva Investigational Site 583
  • Pretoria, South Africa
    • Teva Investigational Site 588
• Sweden
  • Göteborg, Sweden
    • Teva Investigational Site 602
  • Göteborg, Sweden
    • Teva Investigational Site 604
  • Linköping, Sweden
    • Teva Investigational Site 603
  • Lund, Sweden
    • Teva Investigational Site 600
  • Malmö, Sweden
    • Teva Investigational Site 601
• Taiwan
  • Taipei, Taiwan
    • Teva Investigational Site 761
  • Taoyuan, Taiwan
    • Teva Investigational Site 763
• Thailand
  • Bangkok, Thailand
    • Teva Investigational Site 780
  • Bangkok, Thailand
    • Teva Investigational Site 782
  • Nakhon Ratchasima, Thailand
    • Teva Investigational Site 784
• Ukraine
  • Dnipropetrovsk, Ukraine
    • Teva Investigational Site 621
  • Donetsk, Ukraine
    • Teva Investigational Site 629
  • Ivano-Frankivsk, Ukraine
    • Teva Investigational Site 630
  • Kharkiv, Ukraine
    • Teva Investigational Site 620
  • Kharkiv, Ukraine
    • Teva Investigational Site 633
  • Kyiv, Ukraine
    • Teva Investigational Site 622
  • Kyiv, Ukraine
    • Teva Investigational Site 623
  • Kyiv, Ukraine
    • Teva Investigational Site 624
  • Kyiv, Ukraine
    • Teva Investigational Site 625
  • Vinnytsya, Ukraine
    • Teva Investigational Site 626
  • Zaporizhzhia, Ukraine
    • Teva Investigational Site 631
  • Zaporizhzhya, Ukraine
    • Teva Investigational Site 632
• United States
  • Arizona
    • Scottsdale, Arizona, United States
      • Teva Investigational Site 58
  • California
    • Anaheim, California, United States
      • Teva Investigational Site 12
    • Fountain Valley, California, United States
      • Teva Investigational Site 11
    • Fresno, California, United States
      • Teva Investigational Site 41
    • Long Beach, California, United States
      • Teva Investigational Site 59
    • Los Angeles, California, United States
      • Teva Investigational Site 43
    • Orange, California, United States
      • Teva Investigational Site 4
    • Walnut Creek, California, United States
      • Teva Investigational Site 15
  • Colorado
    • Colorado Springs, Colorado, United States
      • Teva Investigational Site 34
    • Colorado Springs, Colorado, United States
      • Teva Investigational Site 2
    • Denver, Colorado, United States
      • Teva Investigational Site 47
  • Connecticut
    • Waterbury, Connecticut, United States
      • Teva Investigational Site 28
  • Florida
    • Clearwater, Florida, United States
      • Teva Investigational Site 53
    • Largo, Florida, United States
      • Teva Investigational Site 24
    • Miami, Florida, United States
      • Teva Investigational Site 55
    • Miami, Florida, United States
      • Teva Investigational Site 27
    • Miami, Florida, United States
      • Teva Investigational Site 5
    • Orlando, Florida, United States
      • Teva Investigational Site 52
    • Tallahassee, Florida, United States
      • Teva Investigational Site 19
    • Trinity, Florida, United States
      • Teva Investigational Site 17
    • Valrico, Florida, United States
      • Teva Investigational Site 18
  • Georgia
    • Lawrenceville, Georgia, United States
      • Teva Investigational Site 25
    • Lilburn, Georgia, United States
      • Teva Investigational Site 6
    • Savannah, Georgia, United States
      • Teva Investigational Site 3
  • Kentucky
    • Lexington, Kentucky, United States
      • Teva Investigational Site 49
  • Maine
    • Bangor, Maine, United States
      • Teva Investigational Site 46
  • Missouri
    • St. Louis, Missouri, United States
      • Teva Investigational Site 40
    • St. Louis, Missouri, United States
      • Teva Investigational Site 74
  • Nebraska
    • Boys Town, Nebraska, United States
      • Teva Investigational Site 64
    • Omaha, Nebraska, United States
      • Teva Investigational Site 8
  • New Jersey
    • Summit, New Jersey, United States
      • Teva Investigational Site 26
  • North Carolina
    • Winston-Salem, North Carolina, United States
      • Teva Investigational Site 30
  • Ohio
    • Cincinnati, Ohio, United States
      • Teva Investigational Site 31
    • Cincinnati, Ohio, United States
      • Teva Investigational Site 20
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Teva Investigational Site 50
  • Oregon
    • Medford, Oregon, United States
      • Teva Investigational Site 1
  • Pennsylvania
    • Altoona, Pennsylvania, United States
      • Teva Investigational Site 66
  • Rhode Island
    • Lincoln, Rhode Island, United States
      • Teva Investigational Site 73
    • Providence, Rhode Island, United States
      • Teva Investigational Site 9
  • South Carolina
    • Charleston, South Carolina, United States
      • Teva Investigational Site 21
  • Tennessee
    • Nashville, Tennessee, United States
      • Teva Investigational Site 32
  • Texas
    • Boerne, Texas, United States
      • Teva Investigational Site 63
    • Dallas, Texas, United States
      • Teva Investigational Site 44
    • El Paso, Texas, United States
      • Teva Investigational Site 69
    • Fort Worth, Texas, United States
      • Teva Investigational Site 16
    • San Antonio, Texas, United States
      • Teva Investigational Site 14
    • San Antonio, Texas, United States
      • Teva Investigational Site 45
  • Wisconsin
    • Madison, Wisconsin, United States
      • Teva Investigational Site 33

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reslizumab 3.0 mg/kg; Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.	Drug: Reslizumab; Reslizumab (3.0 mg/kg) administered intravenously by infusion every 28 days (±7 days), for approximately 24 months; Other Names: Cinquil; humanized monoclonal antibody; CEP-38072

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Treatment-Emergent Adverse Events	An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.	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.
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values	Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values on any of the during treatment lab analyses. Significance criteria: Blood urea nitrogen: >=10.71 mmol/L; Creatinine: >=177 μmol/L; Uric acid: M>=625, F>=506 μmol/L; Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L; Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L; GGT = gamma-glutamyl transpeptidase: >= 3*upper limit of normal. Normal range is 5-49 U/L.; Total bilirubin: >=34.2 μmol/L; White blood cells- low: <=3.0*10^9/L; White blood cells-high: >=20*10^9/L; Hemoglobin: M<=115, F<=95 g/dL; Hematocrit: M<0.37, F<0.32 L/L; Platelets: >=700*10^9/L; Absolute neutrophil count: <=1.0*10^9/L; Eosinophils: >=10; Urinalysis: ketones, blood, glucose, and total protein: >=2 unit increase from baseline	Weeks 4, 8, 24 and 48
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values	Data represents participants with PCS vital sign values during any of the during treatment visits or the follow-up visit. Significance criteria; Sitting heart rate-high: >100 and increase of >= 30 beats/min (all ages); Sitting heart rate-low: <50 and decrease of >=30 beats/min; Sitting systolic blood pressure (BP)-high: >130 and increase of >=30 mmHg (ages 12-17); Systolic BP-low: <90 and decrease of >=30 mmHg (ages >=18); Systolic BP-high: >160 and increase of >=30 mmHg (ages >=18); Sitting diastolic BP-low: <55 and decrease of >=12 mmHg (ages 12-17); Diastolic BP-high: >85 and increase of >=12 mmHg (ages 12-17); Diastolic BP-low: <50 and decrease of >=12 mmHg (ages >=18); Diastolic BP-high: >100 and increase of >=12 mmHg (ages >=18); Respiration rate: >20 and increase of >=10 breaths/minute (ages 12-17); Respiration rate: >24 and increase of >=10 breaths/minute (ages >=18); Body temperature-low: <96.5° Fahrenheit (all ages); Body temp-high: >100.5° F (all ages)	Week 4 to Week 65

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.	Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
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	The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva.	Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint	The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters. .	Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
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	The FEF 25%-75% is the force expiratory flow at 25% to 75% of the Forced Vital Capacity (FVC), measured in liters/second .	Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
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	SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit participants were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3. .	Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint	The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control. .	Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint	The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control.	Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint
Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint	The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were "patient-specific," which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.	Weeks 24, 48, 72, 96, End of Study and Endpoint
Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall	Blood samples were collected for the determination of anti-drug antibody (ADAs) before study drug infusion at baseline and every 24 weeks until end of treatment visit or early withdrawal. Serum samples were analyzed by Teva (Teva Biopharmaceuticals USA, Rockville, Maryland, USA) using a validated homogeneous solution based bridging enzyme linked immune sorbent assay (Mikulsis et al 2011, Qui et al 2010). The analysis of anti-reslizumab antibody in patient serum consists of 3 tiers of assays for screening, confirmation, and titer analysis. If a participant had a treatment-emergent ADA response (ie, ADA positive at any of the postdose time points but negative at the predose time point) or if there was a treatment-boosted ADA response (defined as a greater than 4-fold increase from a positive baseline ADA response (Shankar et at 2014), the participant was classified as overall ADA positive. Predose samples for the reslizumab-experienced participants came from the previous studies.	Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Director: Sponsor's Medical Expert, Senior Director - Worldwide Clinical Research, Cephalon

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: February 4, 2011
• First Posted (Estimate): February 7, 2011

Study Record Updates

• Last Update Posted (Estimate): June 6, 2016
• Last Update Submitted That Met QC Criteria: April 28, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Leukocyte Disorders; Eosinophilia; Hypereosinophilic Syndrome; Asthma; Pulmonary Eosinophilia; Anti-Asthmatic Agents; Respiratory System Agents; Reslizumab
• Other Study ID Numbers: C38072/3085; 2010-024540-15 (EudraCT Number)