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AsthmaPhase 2NCT04545385

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

A Phase 2 study testing TEV-48574 in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 97 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
TEV-48574
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
97 sitesin 5 countries
Study dates
7 Oct 2020to 17 Jan 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

97 sites in 5 countries.

97 sites in 5 countries

United States55 sites

  • Teva Investigational Site 14925

    Allen, Texas, 75013

  • Teva Investigational Site 15230

    Austin, Texas, 78759

  • Teva Investigational Site 14914

    Bakersfield, California, 93301

  • Teva Investigational Site 15220

    Baltimore, Maryland, 21236

  • Teva Investigational Site 14912

    Bellevue, Nebraska, 68123-4303

  • Teva Investigational Site 14884

    Birmingham, Alabama, 35209

  • Teva Investigational Site 14890

    Charleston, South Carolina, 29406

  • Teva Investigational Site 15221

    Charlotte, North Carolina, 28277

  • Teva Investigational Site 14889

    Cincinnati, Ohio, 45231

  • Teva Investigational Site 14895

    Colorado Springs, Colorado, 80907

  • Teva Investigational Site 15222

    Coral Gables, Florida, 33134

  • Teva Investigational Site 15223

    Cutler Bay, Florida, 33189

  • Teva Investigational Site 14909

    Dallas, Texas, 75231

  • Teva Investigational Site 14917

    Denver, Colorado, 80246

  • Teva Investigational Site 14886

    Dublin, Ohio, 43016

  • Teva Investigational Site 14888

    Edmond, Oklahoma, 73034

  • Teva Investigational Site 14902

    El Paso, Texas, 79903-3508

  • Teva Investigational Site 14924

    Evansville, Indiana, 47713

  • Teva Investigational Site 14919

    Fort Worth, Texas, 76244

  • Teva Investigational Site 14881

    Greenfield, Wisconsin, 53228

  • Teva Investigational Site 14911

    Hialeah, Florida, 33012

  • Teva Investigational Site 15225

    Hialeah, Florida, 33015

  • Teva Investigational Site 14921

    Houston, Texas, 77030

  • Teva Investigational Site 15234

    Huntington Beach, California, 92647

  • Teva Investigational Site 14897

    Kansas City, Kansas, 66160

  • Teva Investigational Site 14903

    Lincoln, Nebraska, 68505-2343

  • Teva Investigational Site 14915

    Little Rock, Arkansas, 72205

  • Teva Investigational Site 14896

    Los Angeles, California, 90025

  • Teva Investigational Site 14918

    Los Angeles, California, 90025

  • Teva Investigational Site 14913

    Los Angeles, California, 90048

  • Teva Investigational Site 14905

    McKinney, Texas, 75069

  • Teva Investigational Site 14900

    Miami, Florida, 33134

  • Teva Investigational Site 14883

    Miami, Florida, 33173

  • Teva Investigational Site 14904

    Missoula, Montana, 59808

  • Teva Investigational Site 15226

    Monroe, North Carolina, 28112

  • Teva Investigational Site 14877

    North Dartmouth, Massachusetts, 02747-3322

  • Teva Investigational Site 14880

    Oklahoma City, Oklahoma, 73112-4432

  • Teva Investigational Site 14908

    Panama City, Florida, 32405

  • Teva Investigational Site 14923

    Philadelphia, Pennsylvania, 19140

  • Teva Investigational Site 14882

    Raleigh, North Carolina, 27607

  • Teva Investigational Site 14910

    Rolling Hills Estates, California, 90274-7604

  • Teva Investigational Site 14879

    San Antonio, Texas, 78229

  • Teva Investigational Site 14907

    San Diego, California, 92123

  • Teva Investigational Site 14891

    San Jose, California, 95117

  • Teva Investigational Site 15227

    Skillman, New Jersey, 08558

  • Teva Investigational Site 14920

    Spokane, Washington, 99204

  • Teva Investigational Site 14922

    St Louis, Missouri, 63110

  • Teva Investigational Site 14893

    St Louis, Missouri, 63141

  • Teva Investigational Site 15231

    Stockton, California, 95207

  • Teva Investigational Site 14894

    Tallahassee, Florida, 32308-4355

  • Teva Investigational Site 15224

    Tampa, Florida, 33607

  • Teva Investigational Site 14901

    Toledo, Ohio, 43617

  • Teva Investigational Site 14916

    Walnut Creek, California, 94598

  • Teva Investigational Site 14878

    Westminster, California, 92683

  • Teva Investigational Site 14887

    Wilmington, North Carolina, 28401

Other trials in United States

Bulgaria13 sites

  • Teva Investigational Site 59159

    Kozloduy, 999999

  • Teva Investigational Site 59166

    Montana, 3400

  • Teva Investigational Site 59163

    Plovdiv, 4002

  • Teva Investigational Site 59189

    Plovdiv, 4003

  • Teva Investigational Site 59190

    Plovdiv, 4003

  • Teva Investigational Site 59164

    Rousse, 7002

  • Teva Investigational Site 59168

    Sofia, 1000

  • Teva Investigational Site 59167

    Sofia, 1606

  • Teva Investigational Site 59160

    Stara Zagora, 6001

  • Teva Investigational Site 59161

    Stara Zagora, 999999

  • Teva Investigational Site 59165

    Varna, 9020

  • Teva Investigational Site 59162

    Veliko Tarnovo, 5000

  • Teva Investigational Site 59192

    Vratsa, 3001

Other trials in Bulgaria

Germany12 sites

  • Teva Investigational Site 32747

    Berlin, 10787

  • Teva Investigational Site 32759

    Frankfurt am Main, 60389

  • Teva Investigational Site 32741

    Frankfurt am Main, 60596

  • Teva Investigational Site 32744

    Geesthacht, 21502

  • Teva Investigational Site 32739

    Hamburg, 22299

  • Teva Investigational Site 32746

    Hanover, 30173

  • Teva Investigational Site 32757

    Leipzig, 04537

  • Teva Investigational Site 32758

    Leipzig, 4157

  • Teva Investigational Site 32756

    Leipzig, ?04275

  • Teva Investigational Site 32742

    Lübeck, 23552

  • Teva Investigational Site 32743

    München, 81241

  • Teva Investigational Site 32745

    Rheine, 48431

Other trials in Germany

Poland11 sites

  • Teva Investigational Site 53461

    Bydgoszcz, 85-231

  • Teva Investigational Site 53458

    Krakaw, 31-033

  • Teva Investigational Site 53457

    Krakow, 31-559

  • Teva Investigational Site 53455

    Lodz, 90-302

  • Teva Investigational Site 53483

    Poznan, 60 - 823

  • Teva Investigational Site 53459

    Poznan, 60-214

  • Teva Investigational Site 53486

    Sucha Beskidzka, 34200

  • Teva Investigational Site 53462

    Tarnów, 33-100

  • Teva Investigational Site 53485

    Warsaw, 01-868

  • Teva Investigational Site 53460

    Wroclaw, 53-201

  • Teva Investigational Site 53456

    Wroclaw, 53-301

Other trials in Poland

Czechia6 sites

  • Teva Investigational Site 54197

    Brandýs nad Labem, 25001

  • Teva Investigational Site 54194

    Jindřichův Hradec, 999999

  • Teva Investigational Site 54193

    Miroslav, 671 721

  • Teva Investigational Site 54195

    Prague, 182 00

  • Teva Investigational Site 54203

    Strakonice, 999999

  • Teva Investigational Site 54196

    Teplice, 415 01

Other trials in Czechia

About this study

Official title: 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

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
Being tested
TEV-48574, Placebo
Keywords
T2 low, non-T2 asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEV-48574Drug

    subcutaneous infusion

  • PlaceboDrug

    Matching Placebo

Study groups in NCT04545385
Study groupRoleWhat they receive
TEV-48574ExperimentalParticipants 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).
Receives: Drug: TEV-48574
PlaceboPlacebo comparatorParticipants will receive placebo matching to TEV-48574 SC every 2 weeks for a total of 8 doses.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From randomization (Week 0) until Week 16

Secondary outcomes (12)

  1. Time From Randomization to LoAC During the Treatment Period

    Time (in days) from randomization to LoAC during the treatment period is the interval from randomization to the occurrence of the LoAC. The LoAC was defined as any 1 of the following during the treatment period: - morning PEF decrease ≥30% from baseline on 2 consecutive days or morning handheld FEV1 decrease ≥20% from baseline on 2 consecutive days; - increase in SABA/quick-relief medication ≥6 puffs over baseline use in 24 hours on 2 consecutive days; increase in ICS dose ≥4 × most recent dose; - systemic corticosteroid use; - asthma ER visit or hospitalization.

    Measured: From randomization (Week 0) until Week 16

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

    The ACQ-6 is a 6-item validated asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ-6 has a possible score ranges from 0 to 6, and the total score is the mean of all responses. The total score ranging from 0-6 (0=totally controlled and 6=severely uncontrolled). A higher score indicated poorer asthma control.

    Measured: Baseline, Week 16

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

    FEV1 (measured by handheld spirometer) is the volume of air that can be forcibly exhaled from the lungs in the first second. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%.

    Measured: Baseline, Week 16

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

    Number of inhalations/puffs of SABA/quick relief inhaler used was recorded in the e-diary daily.

    Measured: Baseline, Week 16

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

    The CAEs during the study were defined as a worsening of asthma symptoms resulting in any 1 of the following: - the use of systemic corticosteroids (oral or injectable); - an emergency department visit due to asthma treated with systemic corticosteroids; - an inpatient hospitalization due to asthma.

    Worsening asthma included new or increased symptoms or signs that either worried the participant or were related to an asthma-specific alert (if available through the e-diary/handheld spirometer).

    Measured: From randomization (Week 0) until Week 16

  6. Time From Randomization to First CAE During the Treatment Period for Participants With CAE

    The CAEs during the study were defined as a worsening of asthma symptoms resulting in any 1 of the following: - the use of systemic corticosteroids (oral or injectable); - an emergency department visit due to asthma treated with systemic corticosteroids; - an inpatient hospitalization due to asthma.

    Worsening asthma included new or increased symptoms or signs that either worried the participant or were related to an asthma-specific alert (if available through the e-diary/handheld spirometer).

    Measured: From randomization (Week 0) until Week 16

  7. Change From Baseline in Number of Nighttime Awakenings Due to Asthma at Week 16

    Participants recorded the number of nighttime awakenings due to asthma in the e-diary daily, in the morning.

    Measured: Baseline, Week 16

  8. Percent Change in ICS Dose During the Treatment Period

    The ICS dose was not collected in the participant diary as planned.

    Measured: From randomization (Week 0) until Week 16

  9. Change From Baseline in Forced Vital Capacity (FVC) at Week 16

    FVC (measured by handheld spirometer) is the volume of air that can be forcibly and completely blown out after full inspiration, measured in liters.

    Measured: Baseline, Week 16

  10. Change From Baseline in Forced Expiratory Flow at 25-75% of Pulmonary Volume (FEF25%-75%) at Week 16

    The FEF25%-75% (measured by handheld spirometer) is the forced expiratory flow from 25% to 75% of FVC

    Measured: Baseline, Week 16

  11. Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 16

    FeNO was performed prior to the on-site spirometry.

    Measured: Baseline, Week 16

  12. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered treatment emergent (TEAEs) if onset occurred on or after the first dose date. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. AEs include clinically significant changes from baseline in any one of the following categories: clinical laboratory test results, vital signs, ECG findings.

    Measured: From randomization (Week 0) until Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2020
  2. Study start7 Oct 2020
  3. Primary completion17 Jan 2022
  4. Study completion17 Jan 2022

Why it stopped: Met pre-specified criteria for futility at interim analysis

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04545385
Sponsor's protocol ID
TV48574-AS-20031
Other IDs
2020-001927-15
Status last verified
Mar 2023
First submitted
24 Aug 2020
Last updated
13 Mar 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TEV-48574 in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 97 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Bulgaria, Germany, Poland, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced Loss of Asthma Control (LoAC) During the Treatment Period (time frame: From randomization (Week 0) until Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04545385.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.

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Clinical Trial NCT04545385 | AzTrials