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

NCT04545385 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: TV48574-AS-200312020-001927-15
• Study Type: interventional
• Target: 65
• Locations: 5 countries
• Sites: 97

Brief 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.

Conditions

Asthma

Keywords

T2 low, non-T2 asthma

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced Loss of Asthma Control (LoAC) During the Treatment Period

  The LoAC was defined as any 1 of the following during the treatment period: - morning peak expiratory flow (PEF) decrease ≥30% from baseline on 2 consecutive days or morning handheld forced expiratory volume in the first second of exhalation (FEV1) decrease ≥20% from baseline on 2 consecutive days; - increase in short-acting beta-agonist (SABA)/quick-relief medication ≥6 puffs over baseline use in 24 hours on 2 consecutive days; increase in inhaled corticosteroids (ICS) dose ≥4 × most recent dose; - systemic corticosteroid use; - asthma emergency room (ER) visit or hospitalization.

  From randomization (Week 0) until Week 16

Secondary Outcomes (12)

• Time From Randomization to LoAC During the Treatment Period

  From randomization (Week 0) until Week 16

• Change From Baseline in Asthma Control Questionnaire 6-Question Version (ACQ-6) Score at Week 16

  Baseline, Week 16

• Change From Baseline in Percent Predicted Forced Expiratory Volume in the First Second (FEV1) at Week 16

  Baseline, Week 16

• Change From Baseline in Daily Average Use of Short-acting Beta-agonist (SABA) Quick Relief Medication at Week 16

  Baseline, Week 16

• Number of Participants Who Had a Clinical Asthma Exacerbation (CAE) During the Treatment Period

  From randomization (Week 0) until Week 16

Study Arms (2)

TEV-48574

EXPERIMENTAL

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).

Drug: TEV-48574

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

TEV-48574 DRUG

subcutaneous infusion

TEV-48574

Placebo DRUG

Matching Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (97)

Teva Investigational Site 14884

Birmingham, Alabama, 35209, United States

Location

Teva Investigational Site 14915

Little Rock, Arkansas, 72205, United States

Location

Teva Investigational Site 14914

Bakersfield, California, 93301, United States

Location

Teva Investigational Site 15234

Huntington Beach, California, 92647, United States

Location

Teva Investigational Site 14896

Los Angeles, California, 90025, United States

Location

Teva Investigational Site 14918

Los Angeles, California, 90025, United States

Location

Teva Investigational Site 14913

Los Angeles, California, 90048, United States

Location

Teva Investigational Site 14910

Rolling Hills Estates, California, 90274-7604, United States

Location

Teva Investigational Site 14907

San Diego, California, 92123, United States

Location

Teva Investigational Site 14891

San Jose, California, 95117, United States

Location

Teva Investigational Site 15231

Stockton, California, 95207, United States

Location

Teva Investigational Site 14916

Walnut Creek, California, 94598, United States

Location

Teva Investigational Site 14878

Westminster, California, 92683, United States

Location

Teva Investigational Site 14895

Colorado Springs, Colorado, 80907, United States

Location

Teva Investigational Site 14917

Denver, Colorado, 80246, United States

Location

Teva Investigational Site 15222

Coral Gables, Florida, 33134, United States

Location

Teva Investigational Site 15223

Cutler Bay, Florida, 33189, United States

Location

Teva Investigational Site 14911

Hialeah, Florida, 33012, United States

Location

Teva Investigational Site 15225

Hialeah, Florida, 33015, United States

Location

Teva Investigational Site 14900

Miami, Florida, 33134, United States

Location

Teva Investigational Site 14883

Miami, Florida, 33173, United States

Location

Teva Investigational Site 14908

Panama City, Florida, 32405, United States

Location

Teva Investigational Site 14894

Tallahassee, Florida, 32308-4355, United States

Location

Teva Investigational Site 15224

Tampa, Florida, 33607, United States

Location

Teva Investigational Site 14924

Evansville, Indiana, 47713, United States

Location

Teva Investigational Site 14897

Kansas City, Kansas, 66160, United States

Location

Teva Investigational Site 15220

Baltimore, Maryland, 21236, United States

Location

Teva Investigational Site 14877

North Dartmouth, Massachusetts, 02747-3322, United States

Location

Teva Investigational Site 14922

St Louis, Missouri, 63110, United States

Location

Teva Investigational Site 14893

St Louis, Missouri, 63141, United States

Location

Teva Investigational Site 14904

Missoula, Montana, 59808, United States

Location

Teva Investigational Site 14912

Bellevue, Nebraska, 68123-4303, United States

Location

Teva Investigational Site 14903

Lincoln, Nebraska, 68505-2343, United States

Location

Teva Investigational Site 15227

Skillman, New Jersey, 08558, United States

Location

Teva Investigational Site 15221

Charlotte, North Carolina, 28277, United States

Location

Teva Investigational Site 15226

Monroe, North Carolina, 28112, United States

Location

Teva Investigational Site 14882

Raleigh, North Carolina, 27607, United States

Location

Teva Investigational Site 14887

Wilmington, North Carolina, 28401, United States

Location

Teva Investigational Site 14889

Cincinnati, Ohio, 45231, United States

Location

Teva Investigational Site 14886

Dublin, Ohio, 43016, United States

Location

Teva Investigational Site 14901

Toledo, Ohio, 43617, United States

Location

Teva Investigational Site 14888

Edmond, Oklahoma, 73034, United States

Location

Teva Investigational Site 14880

Oklahoma City, Oklahoma, 73112-4432, United States

Location

Teva Investigational Site 14923

Philadelphia, Pennsylvania, 19140, United States

Location

Teva Investigational Site 14890

Charleston, South Carolina, 29406, United States

Location

Teva Investigational Site 14925

Allen, Texas, 75013, United States

Location

Teva Investigational Site 15230

Austin, Texas, 78759, United States

Location

Teva Investigational Site 14909

Dallas, Texas, 75231, United States

Location

Teva Investigational Site 14902

El Paso, Texas, 79903-3508, United States

Location

Teva Investigational Site 14919

Fort Worth, Texas, 76244, United States

Location

Teva Investigational Site 14921

Houston, Texas, 77030, United States

Location

Teva Investigational Site 14905

McKinney, Texas, 75069, United States

Location

Teva Investigational Site 14879

San Antonio, Texas, 78229, United States

Location

Teva Investigational Site 14920

Spokane, Washington, 99204, United States

Location

Teva Investigational Site 14881

Greenfield, Wisconsin, 53228, United States

Location

Teva Investigational Site 59159

Kozloduy, 999999, Bulgaria

Location

Teva Investigational Site 59166

Montana, 3400, Bulgaria

Location

Teva Investigational Site 59163

Plovdiv, 4002, Bulgaria

Location

Teva Investigational Site 59189

Plovdiv, 4003, Bulgaria

Location

Teva Investigational Site 59190

Plovdiv, 4003, Bulgaria

Location

Teva Investigational Site 59164

Rousse, 7002, Bulgaria

Location

Teva Investigational Site 59168

Sofia, 1000, Bulgaria

Location

Teva Investigational Site 59167

Sofia, 1606, Bulgaria

Location

Teva Investigational Site 59160

Stara Zagora, 6001, Bulgaria

Location

Teva Investigational Site 59161

Stara Zagora, 999999, Bulgaria

Location

Teva Investigational Site 59165

Varna, 9020, Bulgaria

Location

Teva Investigational Site 59162

Veliko Tarnovo, 5000, Bulgaria

Location

Teva Investigational Site 59192

Vratsa, 3001, Bulgaria

Location

Teva Investigational Site 54197

Brandýs nad Labem, 25001, Czechia

Location

Teva Investigational Site 54194

Jindřichův Hradec, 999999, Czechia

Location

Teva Investigational Site 54193

Miroslav, 671 721, Czechia

Location

Teva Investigational Site 54195

Prague, 182 00, Czechia

Location

Teva Investigational Site 54203

Strakonice, 999999, Czechia

Location

Teva Investigational Site 54196

Teplice, 415 01, Czechia

Location

Teva Investigational Site 32747

Berlin, 10787, Germany

Location

Teva Investigational Site 32759

Frankfurt am Main, 60389, Germany

Location

Teva Investigational Site 32741

Frankfurt am Main, 60596, Germany

Location

Teva Investigational Site 32744

Geesthacht, 21502, Germany

Location

Teva Investigational Site 32739

Hamburg, 22299, Germany

Location

Teva Investigational Site 32746

Hanover, 30173, Germany

Location

Teva Investigational Site 32757

Leipzig, 04537, Germany

Location

Teva Investigational Site 32758

Leipzig, 4157, Germany

Location

Teva Investigational Site 32756

Leipzig, ?04275, Germany

Location

Teva Investigational Site 32742

Lübeck, 23552, Germany

Location

Teva Investigational Site 32743

München, 81241, Germany

Location

Teva Investigational Site 32745

Rheine, 48431, Germany

Location

Teva Investigational Site 53461

Bydgoszcz, 85-231, Poland

Location

Teva Investigational Site 53458

Krakaw, 31-033, Poland

Location

Teva Investigational Site 53457

Krakow, 31-559, Poland

Location

Teva Investigational Site 53455

Lodz, 90-302, Poland

Location

Teva Investigational Site 53483

Poznan, 60 - 823, Poland

Location

Teva Investigational Site 53459

Poznan, 60-214, Poland

Location

Teva Investigational Site 53486

Sucha Beskidzka, 34200, Poland

Location

Teva Investigational Site 53462

Tarnów, 33-100, Poland

Location

Teva Investigational Site 53485

Warsaw, 01-868, Poland

Location

Teva Investigational Site 53460

Wroclaw, 53-201, Poland

Location

Teva Investigational Site 53456

Wroclaw, 53-301, Poland

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

USMedInfo@tevapharm.com

888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: August 24, 2020
• First Posted: September 11, 2020
• Study Start: October 7, 2020
• Primary Completion: January 17, 2022
• Study Completion: January 17, 2022
• Last Updated: March 13, 2023
• Results First Posted: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

PL (11); DE (12); CZ (6); BU (13); US (55)