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A Study to Test if TEV-48574 is Effective in Relieving Asthma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study to Test if TEV-48574 is Effective in Relieving Asthma

A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Evaluate the Efficacy and Safety of TEV-48574 in Adults With T2-low/Non-T2 Severe Uncontrolled Asthma

NCT04545385•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of the study is to evaluate the effect of TEV-48574 compared with placebo on loss of asthma control (LoAC) in adult participants with T2-low and non-T2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA). The secondary efficacy objective is to evaluate the effect of TEV-48574 compared with placebo on a range of clinical measures of asthma control. The duration of participant participation in the study is planned to be up to approximately 30 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The participant has a diagnosis of asthma for at least 12 months prior to the initial screening visit.
•The participant is able to perform technically acceptable and repeatable spirometry, including with a hand-held spirometer, after training
•The participant has had at least one documented clinical asthma exacerbation in the 18 months prior to (but not within 30 days of) the initial screening visit.
•The participant is a non-smoker for ≥6 months with lifetime history ≤10 pack-years, with no current ecigarette or marijuana use.
•NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria

•The participant has any concomitant conditions or treatments that could interfere with study conduct.
•The participant is currently pregnant or lactating or is planning to become pregnant during the study.
•The participant has received any live or attenuated vaccine within 15 days of the initial screening visit.
•NOTE- Additional criteria apply, please contact the investigator for more information

Locations (97)

Teva Investigational Site 14884

Birmingham, Alabama, United States

Teva Investigational Site 14915

Little Rock, Arkansas, United States

Teva Investigational Site 14914

Bakersfield, California, United States

Teva Investigational Site 15234

Huntington Beach, California, United States

Teva Investigational Site 14896

Los Angeles, California, United States

Teva Investigational Site 14918

Los Angeles, California, United States

Teva Investigational Site 14913

Los Angeles, California, United States

Teva Investigational Site 14910

Rolling Hills Estates, California, United States

Teva Investigational Site 14907

San Diego, California, United States

Teva Investigational Site 14891

San Jose, California, United States

Key Dates

Start Date

October 7, 2020

Primary Completion Date

January 17, 2022

Completion Date

January 17, 2022

Last Updated

March 13, 2023

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

TEV-48574

DRUG

Placebo

DRUG

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

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

View study

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: March 13, 2023Data 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.

View ClinicalTrials.gov Terms and Conditions

A Study to Test if TEV-48574 is Effective in Relieving Asthma

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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

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