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

NCT01270464 | Completed Phase 3 Results DMC

• 2 other identifiers: C38072/30812010-023342-67
• Study Type: interventional
• Target: 315
• Locations: 13 countries
• Sites: 89

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline In Forced Expiratory Volume In 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures

  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. The during treatment (weeks 4, 8, 12 and 16) average FEV1 was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. Positive change from baseline scores indicate improvement in asthma control.

  Day 0 (baseline, pre-dose), Weeks 4, 8, 12 and 16

Secondary Outcomes (13)

• Change From Baseline in Forced Vital Capacity (FVC) Over 16 Weeks Using Mixed Model for Repeated Measures

  Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16

• Change From Baseline in Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) Over 16 Weeks Using Mixed Model for Repeated Measures

  Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16

• Change From Baseline in % Predicted Expiratory Volume In 1 Second (FEV1) at Week 16 and at Endpoint

  Day 1 (baseline, pre-dose), Week 16, endpoint

• Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures

  Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16

• Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) at Week 16 or at Last Observed Value

  Day 1 (baseline, pre-dose), Week 16 or last observed value

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Reslizumab - 0.3 mg/kg

EXPERIMENTAL

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

Drug: Reslizumab

Reslizumab - 3.0 mg/kg

EXPERIMENTAL

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

Drug: Reslizumab

Interventions

Reslizumab 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.

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

Reslizumab - 0.3 mg/kg; Reslizumab - 3.0 mg/kg

Placebo DRUG

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

Placebo

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:

• 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.

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 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.

Sponsors & Collaborators

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

Study Sites (89)

Teva Investigational Site 12

Anaheim, California, United States

Location

Teva Investigational Site 11

Fountain Valley, 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 24

Largo, Florida, United States

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Teva Investigational Site 27

Miami, Florida, United States

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Teva Investigational Site 5

Miami, 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 6

Lilburn, Georgia, United States

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Teva Investigational Site 3

Savannah, Georgia, United States

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Teva Investigational Site 7

Iowa City, Iowa, 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 20

Cincinnati, Ohio, United States

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Teva Investigational Site 1

Medford, Oregon, 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 16

Fort Worth, Texas, United States

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Teva Investigational Site 10

Houston, 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 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 124

San Miguel de Tucuman - Tucuma, Argentina

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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 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 143

Porto Alegre, Brazil

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Teva Investigational Site 144

Porto Alegre, Brazil

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Teva Investigational Site 145

Porto Alegre, Brazil

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Teva Investigational Site 147

Porto Alegre - RS, Brazil

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Teva Investigational Site 142

Santo André, Brazil

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Teva Investigational Site 141

São Paulo, 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 181

Bogotá, Colombia

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Teva Investigational Site 184

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 183

Medellín, Colombia

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Teva Investigational Site 343

Grenoble, France

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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 340

Nantes, France

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Teva Investigational Site 344

Pessac, France

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Teva Investigational Site 401

Balassagyarmat, Hungary

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Teva Investigational Site 406

Edelény, 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 422

Petah Tikva, 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 203

Distrito Federal, Mexico

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Teva Investigational Site 205

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 202

Tijuana, B.C., Mexico

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Teva Investigational Site 460

Heerlen, Netherlands

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Teva Investigational Site 507

Bialystok, 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 502

Sopot, Poland

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Teva Investigational Site 504

Tarnów, Poland

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Teva Investigational Site 602

Gothenburg, Sweden

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Teva Investigational Site 600

Lund, Sweden

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Teva Investigational Site 601

Malmo, Sweden

Location

Related Publications (1)

• 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.

  PMID: 27056586 DERIVED

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, MD

  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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: January 5, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 6, 2016
• Results First Posted: June 6, 2016

Record last verified: 2016-04

Locations

FR (5); US (26); AR (9); HU (7); CA (4); CO (6); NL (1); ME (5); PL (7); BE (4); BR (9); IL (3); SE (3)