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Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils

A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils

NCT02452190•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent is obtained.
•The participant is male or female, 12 years of age and older, with a diagnosis of asthma.
•The participant has Forced Expiratory Volume in 1 Second (FEV1) reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol.
•The participant has required an inhaled corticosteroid.
•The participant has required an additional asthma controller medication besides inhaled corticosteroids.
•The participant has a history of asthma exacerbation.
•The participant must be willing and able to comply with study restrictions, perform requisite procedures and 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.
•* Additional criteria may apply, please contact the investigator for more information

Exclusion Criteria

•The participant has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient's safety.
•The participant has another confounding underlying lung disorder
•The participant has a known hypereosinophilic syndrome.
•The participant has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
•The participant is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study.
•The participant is a current smoker or has a smoking history.
•The participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
•The participant was previously exposed to reslizumab.
•The participant has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).
•The participant has current or suspected drug and alcohol abuse.
+3 more criteria

Locations (226)

Teva Investigational Site 13212

Birmingham, Alabama, United States

Teva Investigational Site 13241

Flagstaff, Arizona, United States

Teva Investigational Site 13194

Glendale, Arkansas, United States

Teva Investigational Site 13215

Bakersfield, California, United States

Teva Investigational Site 13181

Canoga Park, California, United States

Teva Investigational Site 13254

Fresno, California, United States

Teva Investigational Site 13216

Huntington Beach, California, United States

Teva Investigational Site 13247

Long Beach, California, United States

Teva Investigational Site 13205

Napa, California, United States

Teva Investigational Site 13764

San Jose, California, United States

Key Dates

Start Date

September 28, 2015

Primary Completion Date

December 4, 2017

Completion Date

January 31, 2018

Last Updated

November 9, 2021

Enrollment

468

ACTUAL participants

Conditions

Asthma

Interventions

Reslizumab

DRUG

Placebo

DRUG

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NCT07219173

Asthma

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RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma