A Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma

NCT ID: NCT01270464

Last Updated: 2016-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-09-30

Brief Summary

The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma as assessed by the overall change from baseline in forced expiratory volume in 1 second (FEV1).

Conditions

Eosinophilic Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo administered by iv infusion by qualified study personnel every 4 weeks for a total of 4 doses.

Reslizumab - 0.3 mg/kg

0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses

Group Type: EXPERIMENTAL

Reslizumab

Intervention Type: DRUG

3.0 mg/kg or 0.3 mg/kg doses administered intravenously (iv) by qualified site personnel once every 4 weeks, for a total of 4 doses.

Reslizumab - 3.0 mg/kg

3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.

Group Type: EXPERIMENTAL

Reslizumab

Intervention Type: DRUG

3.0 mg/kg or 0.3 mg/kg doses administered intravenously (iv) by qualified site personnel once every 4 weeks, for a total of 4 doses.

Interventions

Reslizumab

3.0 mg/kg or 0.3 mg/kg doses administered intravenously (iv) by qualified site personnel once every 4 weeks, for a total of 4 doses.

Intervention Type: DRUG

Placebo

Placebo administered by iv infusion by qualified study personnel every 4 weeks for a total of 4 doses.

Intervention Type: DRUG

Other Intervention Names

Cinquil; humanized monoclonal antibody; CEP-38072

Eligibility Criteria

Inclusion Criteria

• The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma. Patients 12 through 17 years of age are excluded from participating in Argentina.
• The patient has an ACQ score of at least 1.5.
• The patient has airway reversibility of at least 12% to beta-agonist administration at screening.
• The patient is currently taking fluticasone at a dosage of at least 440 μg daily (or equivalent). Patients' baseline asthma therapy regimens (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, cromolyn) must be stable for 30 days before screening, and continue without dosage changes throughout study.
• The patient has a blood eosinophil count of at least 400/μL.
• Female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test ßHCG at screening (serum) and baseline (urine).
• Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after the end-of-treatment visit. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected).
• Written informed consent is obtained. Patients 12 through 17 years old, where participating, need to provide assent in accordance with local standards.

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 known hypereosinophilic syndrome (HES).
• The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). The patient has other pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis).
• The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
• The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-IgE mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis factor mAb) within 6 months prior to study entry (screening).
• The patient is currently using systemic corticosteroids (includes use of oral corticosteroids).
• The patient has a current infection or disease that may preclude assessment of asthma.
• 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 (eg, gastroesophageal reflux disease).
• The patient has participated in any investigative drug or device study within 30 days prior to screening.
• The patient has participated in any investigative biologics study within 90 days prior to screening.
• The patient has previously received anti-hIL-5 monoclonal antibody (eg, mepolizumab).
• Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (e.g. spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and injected]) are excluded from this study.
• The patient has a current infection or disease that may preclude assessment of asthma.
• The patient has a history of concurrent immunodeficiency (human immunodeficiency, acquired immunodeficiency syndrome, or congenital immunodeficiency). Patients in Argentina must have documented serology testing for HIV performed during screening.

• 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, MD

Role: STUDY_DIRECTOR

Cephalon

Locations

Teva Investigational Site 12

Anaheim, California, United States

Teva Investigational Site 11

Fountain Valley, 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 24

Largo, Florida, United States

Teva Investigational Site 27

Miami, Florida, United States

Teva Investigational Site 5

Miami, Florida, United States

Teva Investigational Site 19

Tallahassee, Florida, United States

Teva Investigational Site 17

Trinity, Florida, United States

Teva Investigational Site 18

Valrico, Florida, United States

Teva Investigational Site 6

Lilburn, Georgia, United States

Teva Investigational Site 3

Savannah, Georgia, United States

Teva Investigational Site 7

Iowa City, Iowa, United States

Teva Investigational Site 8

Omaha, Nebraska, United States

Teva Investigational Site 26

Summit, New Jersey, United States

Teva Investigational Site 20

Cincinnati, Ohio, United States

Teva Investigational Site 1

Medford, Oregon, 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 16

Fort Worth, Texas, United States

Teva Investigational Site 10

Houston, Texas, United States

Teva Investigational Site 14

San Antonio, Texas, United States

Teva Investigational Site 45

San Antonio, Texas, 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 124

San Miguel de Tucuman - Tucuma, , Argentina

Teva Investigational Site 261

Brussels, , Belgium

Teva Investigational Site 264

Brussels, , Belgium

Teva Investigational Site 260

Ghent, , 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 143

Porto Alegre, , Brazil

Teva Investigational Site 144

Porto Alegre, , Brazil

Teva Investigational Site 145

Porto Alegre, , Brazil

Teva Investigational Site 147

Porto Alegre - RS, , Brazil

Teva Investigational Site 142

Santo André, , Brazil

Teva Investigational Site 141

São Paulo, , 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 181

Bogotá, , Colombia

Teva Investigational Site 184

Bogotá, , Colombia

Teva Investigational Site 185

Bogotá, , Colombia

Teva Investigational Site 182

Cali, , Colombia

Teva Investigational Site 180

Floridablanca, , Colombia

Teva Investigational Site 183

Medellín, , Colombia

Teva Investigational Site 343

Grenoble, , France

Teva Investigational Site 342

Marseille, , France

Teva Investigational Site 341

Montpellier, , France

Teva Investigational Site 340

Nantes, , France

Teva Investigational Site 344

Pessac, , France

Teva Investigational Site 401

Balassagyarmat, , Hungary

Teva Investigational Site 406

Edelény, , Hungary

Teva Investigational Site 400

Miskolc, , Hungary

Teva Investigational Site 404

Mosonmagyaróvár, , Hungary

Teva Investigational Site 403

Sopron, , Hungary

Teva Investigational Site 407

Százhalombatta, , Hungary

Teva Investigational Site 402

Tatabánya, , Hungary

Teva Investigational Site 422

Petah Tikva, , Israel

Teva Investigational Site 421

Rehovot, , Israel

Teva Investigational Site 420

Tel Aviv, , Israel

Teva Investigational Site 203

Distrito Federal, , Mexico

Teva Investigational Site 205

Distrito Federal, , Mexico

Teva Investigational Site 204

Guadalajara, JAL, , Mexico

Teva Investigational Site 200

Hermosillo, Sonora, , Mexico

Teva Investigational Site 202

Tijuana, B.C., , Mexico

Teva Investigational Site 460

Heerlen, , Netherlands

Teva Investigational Site 507

Bialystok, , 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 502

Sopot, , Poland

Teva Investigational Site 504

Tarnów, , Poland

Teva Investigational Site 602

Gothenburg, , Sweden

Teva Investigational Site 600

Lund, , Sweden

Teva Investigational Site 601

Malmo, , Sweden

Countries

United States; Argentina; Belgium; Brazil; Canada; Colombia; France; Hungary; Israel; Mexico; Netherlands; Poland; Sweden

References

Bjermer L, Lemiere C, Maspero J, Weiss S, Zangrilli J, Germinaro M. Reslizumab for Inadequately Controlled Asthma With Elevated Blood Eosinophil Levels: A Randomized Phase 3 Study. Chest. 2016 Oct;150(4):789-798. doi: 10.1016/j.chest.2016.03.032. Epub 2016 Apr 4.

Reference Type: DERIVED

PMID: 27056586 (View on PubMed)

Other Identifiers

2010-023342-67

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C38072/3081

Identifier Type: -

Identifier Source: org_study_id