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

NCT ID: NCT04545385

Last Updated: 2023-03-13

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-07

Study Completion Date

2022-01-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TEV-48574

Participants will receive the investigational medicinal product (IMP) loading doses on the day of randomization and the subsequent corresponding IMP maintenance doses every 2 weeks for a total of 8 doses (1 loading dose and 7 maintenance doses).

Group Type EXPERIMENTAL

TEV-48574

Intervention Type DRUG

subcutaneous infusion

Placebo

Participants will receive placebo matching to TEV-48574 SC every 2 weeks for a total of 8 doses.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo

Interventions

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TEV-48574

subcutaneous infusion

Intervention Type DRUG

Placebo

Matching Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Site 14884

Birmingham, Alabama, United States

Site Status

Teva Investigational Site 14915

Little Rock, Arkansas, United States

Site Status

Teva Investigational Site 14914

Bakersfield, California, United States

Site Status

Teva Investigational Site 15234

Huntington Beach, California, United States

Site Status

Teva Investigational Site 14896

Los Angeles, California, United States

Site Status

Teva Investigational Site 14918

Los Angeles, California, United States

Site Status

Teva Investigational Site 14913

Los Angeles, California, United States

Site Status

Teva Investigational Site 14910

Rolling Hills Estates, California, United States

Site Status

Teva Investigational Site 14907

San Diego, California, United States

Site Status

Teva Investigational Site 14891

San Jose, California, United States

Site Status

Teva Investigational Site 15231

Stockton, California, United States

Site Status

Teva Investigational Site 14916

Walnut Creek, California, United States

Site Status

Teva Investigational Site 14878

Westminster, California, United States

Site Status

Teva Investigational Site 14895

Colorado Springs, Colorado, United States

Site Status

Teva Investigational Site 14917

Denver, Colorado, United States

Site Status

Teva Investigational Site 15222

Coral Gables, Florida, United States

Site Status

Teva Investigational Site 15223

Cutler Bay, Florida, United States

Site Status

Teva Investigational Site 14911

Hialeah, Florida, United States

Site Status

Teva Investigational Site 15225

Hialeah, Florida, United States

Site Status

Teva Investigational Site 14900

Miami, Florida, United States

Site Status

Teva Investigational Site 14883

Miami, Florida, United States

Site Status

Teva Investigational Site 14908

Panama City, Florida, United States

Site Status

Teva Investigational Site 14894

Tallahassee, Florida, United States

Site Status

Teva Investigational Site 15224

Tampa, Florida, United States

Site Status

Teva Investigational Site 14924

Evansville, Indiana, United States

Site Status

Teva Investigational Site 14897

Kansas City, Kansas, United States

Site Status

Teva Investigational Site 15220

Baltimore, Maryland, United States

Site Status

Teva Investigational Site 14877

North Dartmouth, Massachusetts, United States

Site Status

Teva Investigational Site 14922

St Louis, Missouri, United States

Site Status

Teva Investigational Site 14893

St Louis, Missouri, United States

Site Status

Teva Investigational Site 14904

Missoula, Montana, United States

Site Status

Teva Investigational Site 14912

Bellevue, Nebraska, United States

Site Status

Teva Investigational Site 14903

Lincoln, Nebraska, United States

Site Status

Teva Investigational Site 15227

Skillman, New Jersey, United States

Site Status

Teva Investigational Site 15221

Charlotte, North Carolina, United States

Site Status

Teva Investigational Site 15226

Monroe, North Carolina, United States

Site Status

Teva Investigational Site 14882

Raleigh, North Carolina, United States

Site Status

Teva Investigational Site 14887

Wilmington, North Carolina, United States

Site Status

Teva Investigational Site 14889

Cincinnati, Ohio, United States

Site Status

Teva Investigational Site 14886

Dublin, Ohio, United States

Site Status

Teva Investigational Site 14901

Toledo, Ohio, United States

Site Status

Teva Investigational Site 14888

Edmond, Oklahoma, United States

Site Status

Teva Investigational Site 14880

Oklahoma City, Oklahoma, United States

Site Status

Teva Investigational Site 14923

Philadelphia, Pennsylvania, United States

Site Status

Teva Investigational Site 14890

Charleston, South Carolina, United States

Site Status

Teva Investigational Site 14925

Allen, Texas, United States

Site Status

Teva Investigational Site 15230

Austin, Texas, United States

Site Status

Teva Investigational Site 14909

Dallas, Texas, United States

Site Status

Teva Investigational Site 14902

El Paso, Texas, United States

Site Status

Teva Investigational Site 14919

Fort Worth, Texas, United States

Site Status

Teva Investigational Site 14921

Houston, Texas, United States

Site Status

Teva Investigational Site 14905

McKinney, Texas, United States

Site Status

Teva Investigational Site 14879

San Antonio, Texas, United States

Site Status

Teva Investigational Site 14920

Spokane, Washington, United States

Site Status

Teva Investigational Site 14881

Greenfield, Wisconsin, United States

Site Status

Teva Investigational Site 59159

Kozloduy, , Bulgaria

Site Status

Teva Investigational Site 59166

Montana, , Bulgaria

Site Status

Teva Investigational Site 59163

Plovdiv, , Bulgaria

Site Status

Teva Investigational Site 59189

Plovdiv, , Bulgaria

Site Status

Teva Investigational Site 59190

Plovdiv, , Bulgaria

Site Status

Teva Investigational Site 59164

Rousse, , Bulgaria

Site Status

Teva Investigational Site 59168

Sofia, , Bulgaria

Site Status

Teva Investigational Site 59167

Sofia, , Bulgaria

Site Status

Teva Investigational Site 59160

Stara Zagora, , Bulgaria

Site Status

Teva Investigational Site 59161

Stara Zagora, , Bulgaria

Site Status

Teva Investigational Site 59165

Varna, , Bulgaria

Site Status

Teva Investigational Site 59162

Veliko Tarnovo, , Bulgaria

Site Status

Teva Investigational Site 59192

Vratsa, , Bulgaria

Site Status

Teva Investigational Site 54197

Brandýs nad Labem, , Czechia

Site Status

Teva Investigational Site 54194

Jindřichův Hradec, , Czechia

Site Status

Teva Investigational Site 54193

Miroslav, , Czechia

Site Status

Teva Investigational Site 54195

Prague, , Czechia

Site Status

Teva Investigational Site 54203

Strakonice, , Czechia

Site Status

Teva Investigational Site 54196

Teplice, , Czechia

Site Status

Teva Investigational Site 32747

Berlin, , Germany

Site Status

Teva Investigational Site 32759

Frankfurt am Main, , Germany

Site Status

Teva Investigational Site 32741

Frankfurt am Main, , Germany

Site Status

Teva Investigational Site 32744

Geesthacht, , Germany

Site Status

Teva Investigational Site 32739

Hamburg, , Germany

Site Status

Teva Investigational Site 32746

Hanover, , Germany

Site Status

Teva Investigational Site 32757

Leipzig, , Germany

Site Status

Teva Investigational Site 32758

Leipzig, , Germany

Site Status

Teva Investigational Site 32756

Leipzig, , Germany

Site Status

Teva Investigational Site 32742

Lübeck, , Germany

Site Status

Teva Investigational Site 32743

München, , Germany

Site Status

Teva Investigational Site 32745

Rheine, , Germany

Site Status

Teva Investigational Site 53461

Bydgoszcz, , Poland

Site Status

Teva Investigational Site 53458

Krakaw, , Poland

Site Status

Teva Investigational Site 53457

Krakow, , Poland

Site Status

Teva Investigational Site 53455

Lodz, , Poland

Site Status

Teva Investigational Site 53483

Poznan, , Poland

Site Status

Teva Investigational Site 53459

Poznan, , Poland

Site Status

Teva Investigational Site 53486

Sucha Beskidzka, , Poland

Site Status

Teva Investigational Site 53462

Tarnów, , Poland

Site Status

Teva Investigational Site 53485

Warsaw, , Poland

Site Status

Teva Investigational Site 53460

Wroclaw, , Poland

Site Status

Teva Investigational Site 53456

Wroclaw, , Poland

Site Status

Countries

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United States Bulgaria Czechia Germany Poland

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2020-001927-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TV48574-AS-20031

Identifier Type: -

Identifier Source: org_study_id

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