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

NCT ID: NCT01290887

Last Updated: 2016-06-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1052 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2015-01-31

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).

Conditions

Eosinophilic Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reslizumab 3.0 mg/kg

Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.

Group Type: EXPERIMENTAL

Reslizumab

Intervention Type: DRUG

Reslizumab (3.0 mg/kg) administered intravenously by infusion every 28 days (±7 days), for approximately 24 months

Interventions

Reslizumab

Reslizumab (3.0 mg/kg) administered intravenously by infusion every 28 days (±7 days), for approximately 24 months

Intervention Type: DRUG

Other Intervention Names

Cinquil; humanized monoclonal antibody; CEP-38072

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sponsor's Medical Expert, Senior Director - Worldwide Clinical Research

Role: STUDY_DIRECTOR

Cephalon

Locations

Teva Investigational Site 58

Scottsdale, Arizona, United States

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 15

Walnut Creek, California, United States

Teva Investigational Site 2

Colorado Springs, Colorado, United States

Teva Investigational Site 34

Colorado Springs, Colorado, United States

Teva Investigational Site 47

Denver, Colorado, United States

Teva Investigational Site 28

Waterbury, Connecticut, United States

Teva Investigational Site 53

Clearwater, Florida, United States

Teva Investigational Site 24

Largo, Florida, United States

Teva Investigational Site 27

Miami, Florida, United States

Teva Investigational Site 55

Miami, Florida, United States

Teva Investigational Site 5

Miami, Florida, United States

Teva Investigational Site 52

Orlando, 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

Teva Investigational Site 25

Lawrenceville, Georgia, United States

Teva Investigational Site 6

Lilburn, Georgia, United States

Teva Investigational Site 3

Savannah, Georgia, United States

Teva Investigational Site 49

Lexington, Kentucky, United States

Teva Investigational Site 46

Bangor, Maine, United States

Teva Investigational Site 40

St Louis, Missouri, United States

Teva Investigational Site 74

St Louis, Missouri, United States

Teva Investigational Site 64

Boys Town, Nebraska, United States

Teva Investigational Site 8

Omaha, Nebraska, United States

Teva Investigational Site 26

Summit, New Jersey, United States

Teva Investigational Site 30

Winston-Salem, North Carolina, United States

Teva Investigational Site 20

Cincinnati, Ohio, United States

Teva Investigational Site 31

Cincinnati, Ohio, United States

Teva Investigational Site 50

Oklahoma City, Oklahoma, United States

Teva Investigational Site 1

Medford, Oregon, United States

Teva Investigational Site 66

Altoona, Pennsylvania, United States

Teva Investigational Site 73

Lincoln, Rhode Island, United States

Teva Investigational Site 9

Providence, Rhode Island, United States

Teva Investigational Site 21

Charleston, South Carolina, United States

Teva Investigational Site 32

Nashville, Tennessee, United States

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 14

San Antonio, Texas, United States

Teva Investigational Site 45

San Antonio, Texas, United States

Teva Investigational Site 33

Madison, Wisconsin, United States

Teva Investigational Site 121

Ciudad Autonoma de Buenos Aire, , Argentina

Teva Investigational Site 126

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 120

San Miguel de Tucuman - Tucuma, , Argentina

Teva Investigational Site 122

San Miguel de Tucuman - Tucuma, , Argentina

Teva Investigational Site 641

East Bentleigh, , Australia

Teva Investigational Site 642

Frankston, , Australia

Teva Investigational Site 645

Liverpool, , Australia

Teva Investigational Site 643

Nedlands, , Australia

Teva Investigational Site 261

Brussels, , Belgium

Teva Investigational Site 264

Brussels, , Belgium

Teva Investigational Site 260

Ghent, , Belgium

Teva Investigational Site 262

Jambes, , Belgium

Teva Investigational Site 263

Liège, , Belgium

Teva Investigational Site 146

Belo Horizonte, , Brazil

Teva Investigational Site 150

Florianópolis, , Brazil

Teva Investigational Site 140

Porto Alegre, , Brazil

Teva Investigational Site 144

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, , Brazil

Teva Investigational Site 103

Calgary, , Canada

Teva Investigational Site 101

Montreal, , Canada

Teva Investigational Site 104

Newmarket, , Canada

Teva Investigational Site 105

Windsor, , Canada

Teva Investigational Site 160

Rancagua, , Chile

Teva Investigational Site 164

Santiago, , Chile

Teva Investigational Site 161

Temuco, , Chile

Teva Investigational Site 162

Valdivia, , Chile

Teva Investigational Site 166

Valparaíso, , Chile

Teva Investigational Site 181

Bogotá, , Colombia

Teva Investigational Site 185

Bogotá, , Colombia

Teva Investigational Site 182

Cali, , Colombia

Teva Investigational Site 180

Floridablanca, , Colombia

Teva Investigational Site 287

Brno, , Czechia

Teva Investigational Site 284

Břeclav, , Czechia

Teva Investigational Site 286

Liberec, , Czechia

Teva Investigational Site 280

Olomouc, , Czechia

Teva Investigational Site 281

Olomouc, , Czechia

Teva Investigational Site 285

Olomouc, , Czechia

Teva Investigational Site 283

Tábor, , Czechia

Teva Investigational Site 300

Odense, , Denmark

Teva Investigational Site 342

Marseille, , France

Teva Investigational Site 341

Montpellier, , France

Teva Investigational Site 361

Berlin, , Germany

Teva Investigational Site 366

Berlin, , Germany

Teva Investigational Site 371

Bochum, , 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 363

Mainz, , Germany

Teva Investigational Site 380

Athens, , Greece

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 407

Százhalombatta, , Hungary

Teva Investigational Site 402

Tatabánya, , Hungary

Teva Investigational Site 405

Törökbálint, , Hungary

Teva Investigational Site 423

Ashkelon, , Israel

Teva Investigational Site 432

Haifa, , Israel

Teva Investigational Site 425

Jerusalem, , Israel

Teva Investigational Site 428

Jerusalem, , Israel

Teva Investigational Site 426

Kfar Saba, , Israel

Teva Investigational Site 422

Petah Tikva, , Israel

Teva Investigational Site 433

Ramat Gan, , Israel

Teva Investigational Site 421

Rehovot, , Israel

Teva Investigational Site 420

Tel Aviv, , Israel

Teva Investigational Site 705

Batu Caves, , Malaysia

Teva Investigational Site 701

George Town, , Malaysia

Teva Investigational Site 700

Kuala Lumpur, , Malaysia

Teva Investigational Site 702

Kuala Lumpur, , Malaysia

Teva Investigational Site 704

Taiping, , Malaysia

Teva Investigational Site 203

Distrito Federal, , Mexico

Teva Investigational Site 204

Guadalajara, JAL, , Mexico

Teva Investigational Site 200

Hermosillo, Sonora, , Mexico

Teva Investigational Site 205

Mexico City, , Mexico

Teva Investigational Site 207

Mexico City, , Mexico

Teva Investigational Site 209

Monterrey, , Mexico

Teva Investigational Site 202

Tijuana, B.C., , Mexico

Teva Investigational Site 460

Heerlen, , Netherlands

Teva Investigational Site 723

Auckland, , 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

Teva Investigational Site 223

Cercado de Lima, Lima, , Peru

Teva Investigational Site 220

Lima, , Peru

Teva Investigational Site 221

Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

Teva Investigational Site 229

Lima, , Peru

Teva Investigational Site 742

Manila, , 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

Quezon City, , Philippines

Teva Investigational Site 507

Bialystok, , Poland

Teva Investigational Site 509

Bydgoszcz, , Poland

Teva Investigational Site 513

Gdansk, , Poland

Teva Investigational Site 512

Lodz, , Poland

Teva Investigational Site 505

Lublin, , Poland

Teva Investigational Site 500

Ostrów Wielkopolski, , Poland

Teva Investigational Site 511

Poznan, , Poland

Teva Investigational Site 504

Tarnów, , Poland

Teva Investigational Site 523

Bucharest, , Romania

Teva Investigational Site 524

Bucharest, , Romania

Teva Investigational Site 520

Cluj-Napoca, , Romania

Teva Investigational Site 521

Iași, , Romania

Teva Investigational Site 522

Târgu Mureş, , Romania

Teva Investigational Site 545

Barnaul, , Russia

Teva Investigational Site 549

Kemerovo, , Russia

Teva Investigational Site 543

Moscow, , Russia

Teva Investigational Site 544

Moscow, , Russia

Teva Investigational Site 554

Moscow, , Russia

Teva Investigational Site 558

Moscow, , Russia

Teva Investigational Site 559

Moscow, , Russia

Teva Investigational Site 555

Novosibirsk, , Russia

Teva Investigational Site 557

Novosibirsk, , Russia

Teva Investigational Site 540

Saint Petersburg, , Russia

Teva Investigational Site 541

Saint Petersburg, , Russia

Teva Investigational Site 542

Saint Petersburg, , Russia

Teva Investigational Site 552

Tomsk, , Russia

Teva Investigational Site 546

Yaroslavl, , Russia

Teva Investigational Site 563

Bradejov, , Slovakia

Teva Investigational Site 561

Levice, , Slovakia

Teva Investigational Site 560

Spišská Nová Ves, , Slovakia

Teva Investigational Site 562

Topoľčany, , Slovakia

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

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Pretoria, , South Africa

Teva Investigational Site 588

Pretoria, , South Africa

Teva Investigational Site 682

Gwangju, , South Korea

Teva Investigational Site 680

Seoul, , South Korea

Teva Investigational Site 681

Seoul, , South Korea

Teva Investigational Site 683

Seoul, , South Korea

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Seoul, , South Korea

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Suwon, , South Korea

Teva Investigational Site 602

Gothenburg, , Sweden

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Gothenburg, , Sweden

Teva Investigational Site 603

Linköping, , Sweden

Teva Investigational Site 600

Lund, , Sweden

Teva Investigational Site 601

Malmo, , Sweden

Teva Investigational Site 761

Taipei, , Taiwan

Teva Investigational Site 763

Taoyuan District, , Taiwan

Teva Investigational Site 780

Bangkok, , Thailand

Teva Investigational Site 782

Bangkok, , Thailand

Teva Investigational Site 784

Nakhon Ratchasima, , Thailand

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 633

Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

Teva Investigational Site 624

Kyiv, , Ukraine

Teva Investigational Site 625

Kyiv, , Ukraine

Teva Investigational Site 626

Vinnytsia, , Ukraine

Teva Investigational Site 631

Zaporizhzhia, , Ukraine

Teva Investigational Site 632

Zaporizhzhya, , Ukraine

Countries

United States; Argentina; Australia; Belgium; Brazil; Canada; Chile; Colombia; Czechia; Denmark; France; Germany; Greece; Hungary; Israel; Malaysia; Mexico; Netherlands; New Zealand; Peru; Philippines; Poland; Romania; Russia; Slovakia; South Africa; South Korea; Sweden; Taiwan; Thailand; Ukraine

Other Identifiers

2010-024540-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C38072/3085

Identifier Type: -

Identifier Source: org_study_id