Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma

NCT01508936 | Completed Phase 3 Results DMC

• 1 other identifier: C38072/3084
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 66

Brief Summary

The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to baseline blood eosinophil levels in patients with moderate to severe asthma, as assessed by the change from baseline to week 16 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) at Week 16 in Full Analysis Set

  FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10\^9/liter) by treatment group.

  Baseline (Day 1), Week 16

Secondary Outcomes (15)

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

  Baseline (Day 1), Weeks 4, 8, 12, 16

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

  Baseline (Day 1), Weeks 4, 8, 12, 16

• Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in FEV1 Subpopulation

  Baseline (Day 1), Week 16

• Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 4, 8, 12, and 16

  Baseline (Day 1), Weeks 4, 8, 12, and 16

• Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16 and Endpoint

  Baseline (Day 1), Weeks 4, 8, 12, and 16

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo intravenous injection every 4 weeks for a total of 4 doses.

Drug: Placebo

Reslizumab 3.0 mg/kg

EXPERIMENTAL

Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.

Drug: Reslizumab

Interventions

Reslizumab DRUG

Reslizumab administered at a dosage of 3.0 mg/kg by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).

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

Reslizumab 3.0 mg/kg

Placebo DRUG

Matching placebo administered by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients are included in the study if all of the following criteria are met:
• The patient is a man or woman, 18 through 65 years of age, with a diagnosis of asthma.
• The patient has an ACQ score of at least 1.5.
• At screening, the patient has airway reversibility of at least 12% to beta-agonist administration.
• 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.
• Female patients must be surgically sterile, 2 years postmenopausal, or must have a negative beta-human chorionic gonadotropin (ßHCG) result for a pregnancy test 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 participation in the study. 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.
• The patient is in reasonable health (except for diagnosis of asthma) as judged by the investigator, and as determined by a medical history, medical examination, electrocardiogram (ECG) evaluation, serum chemistry, hematology, urinalysis, and serology.
• 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 be willing to return to the clinic for the follow-up evaluation as specified in this protocol.

You may not qualify if:

• Patients are excluded from participating in this study if 1 or more of the following criteria are met:
• The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer). The patient has other pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis).
• 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 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-immunoglobulin E \[anti-IgE\] mAb, methotrexate, cyclosporin, interferon-α, anti-tumor necrosis factor mAb, or omalizumab) within 6 months prior to study entry (randomization).
• The patient is currently using or has used systemic corticosteroids (includes use of oral corticosteroids) within 30 days prior to the screening visit.
• 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, and thus would aggravate asthma symptoms (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 reslizumab or other anti-hIL-5 mAbs (eg, mepolizumab).
• The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the 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).

Sponsors & Collaborators

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

Study Sites (66)

Investigational Site 861

Birmingham, Alabama, United States

Location

Investigational Site 842

Homewood, Alabama, United States

Location

Investigational Site 887

Jasper, Alabama, United States

Location

Investigational Site 809

Tucson, Arizona, United States

Location

Investigational Site 892

Tucson, Arizona, United States

Location

Investigational Site 846

Little Rock, Arkansas, United States

Location

Investigational Site 828

Anaheim, California, United States

Location

Investigational Site 900

Fresno, California, United States

Location

Investigational Site 862

Huntington Beach, California, United States

Location

Investigational Site 852

Los Angeles, California, United States

Location

Investigational Site 909

Los Angeles, California, United States

Location

Investigational Site 864

Newport Beach, California, United States

Location

Investigational Site 812

Rancho Mirage, California, United States

Location

Investigational Site 808

Riverside, California, United States

Location

Investigational Site 804

Sacramento, California, United States

Location

Investigational Site 837

Centennial, Colorado, United States

Location

Investigational Site 851

Denver, Colorado, United States

Location

Investigational Site 832

Wheat Ridge, Colorado, United States

Location

Investigational Site 855

Jacksonville, Florida, United States

Location

Investigational Site 865

Miami, Florida, United States

Location

Investigational Site 881

Miami, Florida, United States

Location

Investigational Site 805

Albany, Georgia, United States

Location

Investigational Site 870

Stockbridge, Georgia, United States

Location

Investigational Site 816

Chicago, Illinois, United States

Location

Investigational Site 824

Shiloh, Illinois, United States

Location

Investigational Site 883

Evansville, Indiana, United States

Location

Investigational Site 878

Fort Wayne, Indiana, United States

Location

Investigational Site 820

Lenexa, Kansas, United States

Location

Investigational Site 873

Owensboro, Kentucky, United States

Location

Investigational Site 801

Lafayette, Louisiana, United States

Location

Investigational Site 877

Mandeville, Louisiana, United States

Location

Investigational Site 875

White Marsh, Maryland, United States

Location

Investigational Site 871

Fall River, Massachusetts, United States

Location

Investigational Site 834

North Dartmouth, Massachusetts, United States

Location

Investigational Site 889

Troy, Michigan, United States

Location

Investigational Site 838

Rolla, Missouri, United States

Location

Investigational Site 818

St Louis, Missouri, United States

Location

Investigational Site 841

St Louis, Missouri, United States

Location

Investigational Site 857

Albuquerque, New Mexico, United States

Location

Investigational Site 819

Newburgh, New York, United States

Location

Investigational Site 844

Charlotte, North Carolina, United States

Location

Investigational Site 845

Middleburg Heights, Ohio, United States

Location

Investigational Site 810

Tulsa, Oklahoma, United States

Location

Investigational Site 859

Ashland, Oregon, United States

Location

Investigational Site 859

Portland, Oregon, United States

Location

Investigational Site 854

Jenkintown, Pennsylvania, United States

Location

Investigational Site 843

Providence, Rhode Island, United States

Location

Investigational Site 802

Florence, South Carolina, United States

Location

Investigational Site 814

Orangeburg, South Carolina, United States

Location

Investigational Site 821

Spartanburg, South Carolina, United States

Location

Investigational Site 829

Spartanburg, South Carolina, United States

Location

Investigational Site 850

Knoxville, Tennessee, United States

Location

Investigational Site 803

Nashville, Tennessee, United States

Location

Investigational Site 880

Dallas, Texas, United States

Location

Investigational Site 858

Dickinson, Texas, United States

Location

Investigational Site 869

Live Oak, Texas, United States

Location

Investigational Site 879

Plano, Texas, United States

Location

Investigational Site 847

Salt Lake City, Utah, United States

Location

Investigational Site 876

West Jordan, Utah, United States

Location

Investigational Site 840

Fairfax, Virginia, United States

Location

Investigational Site 836

Richmond, Virginia, United States

Location

Investigational Site 867

Seattle, Washington, United States

Location

Investigational Site 833

Spokane, Washington, United States

Location

Investigational Site 904

Vancouver, Washington, United States

Location

Investigational Site 806

Greenfield, Wisconsin, United States

Location

Investigational Site 823

La Crosse, Wisconsin, United States

Location

Related Publications (1)

• Corren J, Weinstein S, Janka L, Zangrilli J, Garin M. Phase 3 Study of Reslizumab in Patients With Poorly Controlled Asthma: Effects Across a Broad Range of Eosinophil Counts. Chest. 2016 Oct;150(4):799-810. doi: 10.1016/j.chest.2016.03.018. Epub 2016 Mar 25.

  PMID: 27018175 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

• Global Respiratory Clinical Research, M.D.

  Sponsor's Medical Expert

  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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 12, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 27, 2016
• Results First Posted: June 27, 2016

Record last verified: 2016-05

Locations

US (66)