An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils - Full Text View

Purpose

The primary objective of the study is to determine the ability of reslizumab administered sc to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.

Condition	Intervention	Phase
Asthma Elevated Blood Eosinophils	Drug: Reslizumab Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment
Official Title:	A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

Resource links provided by NLM:

MedlinePlus related topics: Steroids

Drug Information available for: Reslizumab

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):

Primary Outcome Measures:

Percent reduction in daily OCS dose compared with baseline [ Time Frame: Week 0 through study week 24 ]

Secondary Outcome Measures:

Proportion of patients achieving ≥50% reduction in OCS dose [ Time Frame: Week 0 through study week 24 ]
Proportion of patients achieving OCS dose reduction to ≤5mg daily dose [ Time Frame: Week 0 through study week 24 ]
Percent change from baseline in OCS dose [ Time Frame: Week 0 through study week 24 ]
Proportion of patients achieving less than 5 mg decrement in OCS dose compared to the baseline OCS dose [ Time Frame: Week 0 through study week 24 ]
Annualized rate of clinical asthma exacerbations [ Time Frame: Week 0 through study week 24 ]
Annualized rate of clinical asthma exacerbations requiring a burst of systemic corticosteroid (injection, or if oral, at least a doubling from the current OCS dose for at least 3 days); an asthma-specific hospital admission; or an asthma-specific emergency department visit
Proportion of patients discontinuing OCS [ Time Frame: Week 0 through study week 24 ]
Time to first clinical asthma exacerbation [ Time Frame: Week 0 through study week 24 ]
Pre-bronchodilator FEV1: change from baseline [ Time Frame: Week 0 through study week 24 ]
Post-bronchodilator FEV1: change from baseline [ Time Frame: Week 0 through study week 24 ]
Ambulatory lung function: change in peak expiratory flow (PEF) from run-in baseline [ Time Frame: Week 0 through study week 24 ]
Asthma Quality of Life (AQLQ) + 12 score: change from baseline [ Time Frame: Week 0 through study week 24 ]
ACQ-6: change from baseline [ Time Frame: Week 0 through study week 24 ]
Change in nighttime awakenings due to asthma requiring rescue inhaler from run-in baseline [ Time Frame: Week 0 through study week 24 ]
Change in total asthma symptom scores from run-in baseline [ Time Frame: Week 0 through study week 24 ]
European Quality of Life 5-dimension health state utility index (EQ-5D) score: change from baseline [ Time Frame: Week 0 through study week 24 ]
St. George's Respiratory Questionnaire (SGRQ) score: change from baseline [ Time Frame: Week 0 through study week 24 ]
Change in total rescue inhaler use from run-in baseline [ Time Frame: Week 0 through study week 24 ]
Serum response relationships [ Time Frame: Week 0 through study week 24 ]
Serum reslizumab concentrations to characterize PK and assess exposure response relationships
Immunogenicity as assessed by anti-drug antibodies (ADA) [ Time Frame: Week 0 through study week 48 ]
Percentage of participants with adverse events [ Time Frame: Week 0 through study week 32 ]


Enrollment:	177
Study Start Date:	September 2015
Estimated Study Completion Date:	September 2017
Estimated Primary Completion Date:	August 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Reslizumab Reslizumab Subcutaneous Dosing	Drug: Reslizumab Reslizumab Subcutaneous Dosing
Placebo Comparator: Placebo Matching placebo	Drug: Placebo

Eligibility


Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma.
Written informed consent is obtained.
The patient requires daily maintenance dose of prednisone or equivalent for asthma of between 5 and 40 mg during the 3 months prior to screening.
The patient has a documented elevated blood eosinophils at screening or during the previous 12 months.
The patient has required high dose ICS plus another asthma controller for at least 6 months prior to screening.
The patient has FEV1 reversibility to inhaled SABA or historical reversibility within the previous 24 months.
- Other criteria may apply, please contact the investigator for more information.

Exclusion Criteria:

The patient has any clinically significant, uncontrolled medical condition that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient's safety.
The patient has another confounding underlying lung disorder.
The patient has a known hypereosinophilic syndrome.
The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
The patient is pregnant or intends to become pregnant during the study or is lactating.
The patient required treatment for an asthma exacerbation within 4 weeks of screening.
The patient is a current smoker or has a smoking history ≥10 pack-years.
The patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance OCS for the treatment of asthma.
The patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
The patient was previously exposed to benralizumab within 12 months of screening.
The patient was previously exposed to reslizumab.
The patient has a history of immunodeficiency disorder including human immunodeficiency virus.
The patient has current suspected drug and/or alcohol abuse.
The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.
The patient has a history of allergic reactions or hypersensitivity to any component of the study drug.
- Other criteria may apply, please contact the investigator for more information.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02501629

Show 111 Study Locations

Sponsors and Collaborators

Teva Branded Pharmaceutical Products, R&D Inc.

Investigators


Study Director:	Teva Medical Expert, MD	TEVA

More Information


Responsible Party:	Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier:	NCT02501629 History of Changes
Other Study ID Numbers:	C38072-AS-30027 2015-001580-39 ( EudraCT Number )
Study First Received:	July 14, 2015
Last Updated:	January 26, 2017

Additional relevant MeSH terms:


Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases	Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases

ClinicalTrials.gov processed this record on July 07, 2017