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

NCT01290887 | Terminated Phase 3 Results DMC

• 2 other identifiers: C38072/30852010-024540-15
• Study Type: interventional
• Target: 1,052
• Locations: 31 countries
• Sites: 219

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.

Conditions

Eosinophilic Asthma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

  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

  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

  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

  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

  Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

Study Arms (1)

Reslizumab 3.0 mg/kg

EXPERIMENTAL

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

Drug: Reslizumab

Interventions

Reslizumab DRUG

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

Also known as: Cinquil, humanized monoclonal antibody, CEP-38072

Reslizumab 3.0 mg/kg

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (219)

Teva Investigational Site 58

Scottsdale, Arizona, United States

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Teva Investigational Site 12

Anaheim, California, United States

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Teva Investigational Site 11

Fountain Valley, California, United States

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Teva Investigational Site 41

Fresno, California, United States

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Teva Investigational Site 59

Long Beach, California, United States

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Teva Investigational Site 43

Los Angeles, California, United States

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Teva Investigational Site 4

Orange, California, United States

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Teva Investigational Site 15

Walnut Creek, California, United States

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Teva Investigational Site 2

Colorado Springs, Colorado, United States

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Teva Investigational Site 34

Colorado Springs, Colorado, United States

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Teva Investigational Site 47

Denver, Colorado, United States

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Teva Investigational Site 28

Waterbury, Connecticut, United States

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Teva Investigational Site 53

Clearwater, Florida, United States

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Teva Investigational Site 24

Largo, Florida, United States

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Teva Investigational Site 27

Miami, Florida, United States

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Teva Investigational Site 55

Miami, Florida, United States

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Teva Investigational Site 5

Miami, Florida, United States

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Teva Investigational Site 52

Orlando, Florida, United States

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Teva Investigational Site 19

Tallahassee, Florida, United States

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Teva Investigational Site 17

Trinity, Florida, United States

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Teva Investigational Site 18

Valrico, Florida, United States

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Teva Investigational Site 25

Lawrenceville, Georgia, United States

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Teva Investigational Site 6

Lilburn, Georgia, United States

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Teva Investigational Site 3

Savannah, Georgia, United States

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Teva Investigational Site 49

Lexington, Kentucky, United States

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Teva Investigational Site 46

Bangor, Maine, United States

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Teva Investigational Site 40

St Louis, Missouri, United States

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Teva Investigational Site 74

St Louis, Missouri, United States

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Teva Investigational Site 64

Boys Town, Nebraska, United States

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Teva Investigational Site 8

Omaha, Nebraska, United States

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Teva Investigational Site 26

Summit, New Jersey, United States

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Teva Investigational Site 30

Winston-Salem, North Carolina, United States

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Teva Investigational Site 20

Cincinnati, Ohio, United States

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Teva Investigational Site 31

Cincinnati, Ohio, United States

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Teva Investigational Site 50

Oklahoma City, Oklahoma, United States

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Teva Investigational Site 1

Medford, Oregon, United States

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Teva Investigational Site 66

Altoona, Pennsylvania, United States

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Teva Investigational Site 73

Lincoln, Rhode Island, United States

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Teva Investigational Site 9

Providence, Rhode Island, United States

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Teva Investigational Site 21

Charleston, South Carolina, United States

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Teva Investigational Site 32

Nashville, Tennessee, United States

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Teva Investigational Site 63

Boerne, Texas, United States

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Teva Investigational Site 44

Dallas, Texas, United States

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Teva Investigational Site 69

El Paso, Texas, United States

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Teva Investigational Site 16

Fort Worth, Texas, United States

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Teva Investigational Site 14

San Antonio, Texas, United States

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Teva Investigational Site 45

San Antonio, Texas, United States

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Teva Investigational Site 33

Madison, Wisconsin, United States

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Teva Investigational Site 121

Ciudad Autonoma de Buenos Aire, Argentina

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Teva Investigational Site 126

Ciudad Autonoma de Buenos Aire, Argentina

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Teva Investigational Site 127

Ciudad Autonoma de Buenos Aire, Argentina

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Teva Investigational Site 128

Quilmes-Buenos Aires, Argentina

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Teva Investigational Site 125

Rosario, Argentina

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Teva Investigational Site 123

Rosario-Santa Fe, Argentina

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Teva Investigational Site 120

San Miguel de Tucuman - Tucuma, Argentina

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Teva Investigational Site 122

San Miguel de Tucuman - Tucuma, Argentina

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Teva Investigational Site 641

East Bentleigh, Australia

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Teva Investigational Site 642

Frankston, Australia

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Teva Investigational Site 645

Liverpool, Australia

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Teva Investigational Site 643

Nedlands, Australia

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Teva Investigational Site 261

Brussels, Belgium

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Teva Investigational Site 264

Brussels, Belgium

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Teva Investigational Site 260

Ghent, Belgium

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Teva Investigational Site 262

Jambes, Belgium

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Teva Investigational Site 263

Liège, Belgium

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Teva Investigational Site 146

Belo Horizonte, Brazil

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Teva Investigational Site 150

Florianópolis, Brazil

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Teva Investigational Site 140

Porto Alegre, Brazil

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Teva Investigational Site 144

Porto Alegre, Brazil

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Teva Investigational Site 147

Porto Alegre - RS, Brazil

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Teva Investigational Site 143

Porto Alegre, RS, Brazil

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Teva Investigational Site 142

Santo André, Brazil

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Teva Investigational Site 103

Calgary, Canada

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Teva Investigational Site 101

Montreal, Canada

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Teva Investigational Site 104

Newmarket, Canada

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Teva Investigational Site 105

Windsor, Canada

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Teva Investigational Site 160

Rancagua, Chile

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Teva Investigational Site 164

Santiago, Chile

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Teva Investigational Site 161

Temuco, Chile

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Teva Investigational Site 162

Valdivia, Chile

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Teva Investigational Site 166

Valparaíso, Chile

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Teva Investigational Site 181

Bogotá, Colombia

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Teva Investigational Site 185

Bogotá, Colombia

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Teva Investigational Site 182

Cali, Colombia

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Teva Investigational Site 180

Floridablanca, Colombia

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Teva Investigational Site 287

Brno, Czechia

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Teva Investigational Site 284

Břeclav, Czechia

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Teva Investigational Site 286

Liberec, Czechia

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Teva Investigational Site 280

Olomouc, Czechia

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Teva Investigational Site 281

Olomouc, Czechia

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Teva Investigational Site 285

Olomouc, Czechia

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Teva Investigational Site 283

Tábor, Czechia

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Teva Investigational Site 300

Odense, Denmark

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Teva Investigational Site 342

Marseille, France

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Teva Investigational Site 341

Montpellier, France

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Teva Investigational Site 361

Berlin, Germany

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Teva Investigational Site 366

Berlin, Germany

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Teva Investigational Site 371

Bochum, Germany

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Teva Investigational Site 369

Frankfurt, Germany

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Teva Investigational Site 370

Hamburg, Germany

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Teva Investigational Site 372

Koblenz, Germany

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Teva Investigational Site 367

Leipzig, Germany

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Teva Investigational Site 363

Mainz, Germany

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Teva Investigational Site 380

Athens, Greece

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Teva Investigational Site 401

Balassagyarmat, Hungary

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Teva Investigational Site 400

Miskolc, Hungary

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Teva Investigational Site 404

Mosonmagyaróvár, Hungary

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Teva Investigational Site 403

Sopron, Hungary

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Teva Investigational Site 407

Százhalombatta, Hungary

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Teva Investigational Site 402

Tatabánya, Hungary

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Teva Investigational Site 405

Törökbálint, Hungary

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Teva Investigational Site 423

Ashkelon, Israel

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Teva Investigational Site 432

Haifa, Israel

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Teva Investigational Site 425

Jerusalem, Israel

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Teva Investigational Site 428

Jerusalem, Israel

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Teva Investigational Site 426

Kfar Saba, Israel

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Teva Investigational Site 422

Petah Tikva, Israel

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Teva Investigational Site 433

Ramat Gan, Israel

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Teva Investigational Site 421

Rehovot, Israel

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Teva Investigational Site 420

Tel Aviv, Israel

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Teva Investigational Site 705

Batu Caves, Malaysia

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Teva Investigational Site 701

George Town, Malaysia

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Teva Investigational Site 700

Kuala Lumpur, Malaysia

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Teva Investigational Site 702

Kuala Lumpur, Malaysia

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Teva Investigational Site 704

Taiping, Malaysia

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Teva Investigational Site 203

Distrito Federal, Mexico

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Teva Investigational Site 204

Guadalajara, JAL, Mexico

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Teva Investigational Site 200

Hermosillo, Sonora, Mexico

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Teva Investigational Site 205

Mexico City, Mexico

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Teva Investigational Site 207

Mexico City, Mexico

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Teva Investigational Site 209

Monterrey, Mexico

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Teva Investigational Site 202

Tijuana, B.C., Mexico

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Teva Investigational Site 460

Heerlen, Netherlands

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Teva Investigational Site 723

Auckland, New Zealand

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Teva Investigational Site 724

Dunedin, New Zealand

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Teva Investigational Site 727

Hamilton, New Zealand

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Teva Investigational Site 720

Tauranga, New Zealand

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Teva Investigational Site 721

Wellington, New Zealand

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Teva Investigational Site 223

Cercado de Lima, Lima, Peru

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Teva Investigational Site 220

Lima, Peru

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Teva Investigational Site 221

Lima, Peru

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Teva Investigational Site 222

Lima, Peru

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Teva Investigational Site 225

Lima, Peru

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Teva Investigational Site 226

Lima, Peru

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Teva Investigational Site 227

Lima, Peru

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Teva Investigational Site 229

Lima, Peru

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Teva Investigational Site 742

Manila, Philippines

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Teva Investigational Site 740

Quezon City, Philippines

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Teva Investigational Site 741

Quezon City, Philippines

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Teva Investigational Site 743

Quezon City, Philippines

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Teva Investigational Site 745

Quezon City, Philippines

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Teva Investigational Site 507

Bialystok, Poland

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Teva Investigational Site 509

Bydgoszcz, Poland

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Teva Investigational Site 513

Gdansk, Poland

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Teva Investigational Site 512

Lodz, Poland

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Teva Investigational Site 505

Lublin, Poland

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Teva Investigational Site 500

Ostrów Wielkopolski, Poland

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Teva Investigational Site 511

Poznan, Poland

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Teva Investigational Site 504

Tarnów, Poland

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Teva Investigational Site 523

Bucharest, Romania

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Teva Investigational Site 524

Bucharest, Romania

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Teva Investigational Site 520

Cluj-Napoca, Romania

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Teva Investigational Site 521

Iași, Romania

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Teva Investigational Site 522

Târgu Mureş, Romania

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Teva Investigational Site 545

Barnaul, Russia

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Teva Investigational Site 549

Kemerovo, Russia

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Teva Investigational Site 543

Moscow, Russia

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Teva Investigational Site 544

Moscow, Russia

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Teva Investigational Site 554

Moscow, Russia

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Teva Investigational Site 558

Moscow, Russia

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Teva Investigational Site 559

Moscow, Russia

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Teva Investigational Site 555

Novosibirsk, Russia

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Teva Investigational Site 557

Novosibirsk, Russia

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Teva Investigational Site 540

Saint Petersburg, Russia

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Teva Investigational Site 541

Saint Petersburg, Russia

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Teva Investigational Site 542

Saint Petersburg, Russia

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Teva Investigational Site 552

Tomsk, Russia

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Teva Investigational Site 546

Yaroslavl, Russia

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Teva Investigational Site 563

Bradejov, Slovakia

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Teva Investigational Site 561

Levice, Slovakia

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Teva Investigational Site 560

Spišská Nová Ves, Slovakia

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Teva Investigational Site 562

Topoľčany, Slovakia

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Teva Investigational Site 584

Cape Town, South Africa

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Teva Investigational Site 586

Cape Town, South Africa

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Teva Investigational Site 587

Centurion, South Africa

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Teva Investigational Site 582

Durban, South Africa

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Teva Investigational Site 585

Durban, South Africa

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Teva Investigational Site 580

Johannesburg, South Africa

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Teva Investigational Site 589

Johannesburg, South Africa

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Teva Investigational Site 583

Pretoria, South Africa

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Teva Investigational Site 588

Pretoria, South Africa

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Teva Investigational Site 682

Gwangju, South Korea

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Teva Investigational Site 680

Seoul, South Korea

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Teva Investigational Site 681

Seoul, South Korea

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Teva Investigational Site 683

Seoul, South Korea

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Teva Investigational Site 686

Seoul, South Korea

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Teva Investigational Site 685

Suwon, South Korea

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Teva Investigational Site 602

Gothenburg, Sweden

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Teva Investigational Site 604

Gothenburg, Sweden

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Teva Investigational Site 603

Linköping, Sweden

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Teva Investigational Site 600

Lund, Sweden

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Teva Investigational Site 601

Malmo, Sweden

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Teva Investigational Site 761

Taipei, Taiwan

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Teva Investigational Site 763

Taoyuan District, Taiwan

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Teva Investigational Site 780

Bangkok, Thailand

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Teva Investigational Site 782

Bangkok, Thailand

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Teva Investigational Site 784

Nakhon Ratchasima, Thailand

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Teva Investigational Site 621

Dnipropetrovsk, Ukraine

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Teva Investigational Site 629

Donetsk, Ukraine

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Teva Investigational Site 630

Ivano-Frankivsk, Ukraine

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Teva Investigational Site 620

Kharkiv, Ukraine

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Teva Investigational Site 633

Kharkiv, Ukraine

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Teva Investigational Site 622

Kyiv, Ukraine

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Teva Investigational Site 623

Kyiv, Ukraine

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Teva Investigational Site 624

Kyiv, Ukraine

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Teva Investigational Site 625

Kyiv, Ukraine

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Teva Investigational Site 626

Vinnytsia, Ukraine

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Teva Investigational Site 631

Zaporizhzhia, Ukraine

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Teva Investigational Site 632

Zaporizhzhya, Ukraine

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MeSH Terms

Conditions

Pulmonary Eosinophilia

Interventions

reslizumab; Antibodies, Monoclonal, Humanized

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

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

  Cephalon

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 7, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 6, 2016
• Results First Posted: June 6, 2016

Record last verified: 2016-04

Locations

SE (5); CL (5); GR (1); MY (5); ME (7); PH (5); NL (1); RU (14); SL (4); ZA (9); AR (8); CZ (7); BE (5); TW (2); PL (8); CO (4); DK (1); AU (4); UA (12); TH (3); US (48); NZ (5); FR (2); BR (7); CA (4); DE (8); IL (9); RO (5); PE (8); HU (7); KR (6)