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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04545385
Recruitment Status : Terminated (Met pre-specified criteria for futility at interim analysis)
First Posted : September 11, 2020
Results First Posted : March 13, 2023
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Asthma Drug: TEV-48574 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 7, 2020
Actual Primary Completion Date : January 17, 2022
Actual Study Completion Date : January 17, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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).
 Drug: TEV-48574
subcutaneous infusion
Placebo Comparator: Placebo
Participants will receive placebo matching to TEV-48574 SC every 2 weeks for a total of 8 doses.
 Drug: Placebo
Matching Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Who Experienced Loss of Asthma Control (LoAC) During the Treatment Period [ Time Frame: From randomization (Week 0) until Week 16 ]
    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.


Secondary Outcome Measures :
  1. Time From Randomization to LoAC During the Treatment Period [ Time Frame: From randomization (Week 0) until Week 16 ]
    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.

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

  3. Change From Baseline in Percent Predicted Forced Expiratory Volume in the First Second (FEV1) at Week 16 [ Time Frame: Baseline, 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%.

  4. Change From Baseline in Daily Average Use of Short-acting Beta-agonist (SABA) Quick Relief Medication at Week 16 [ Time Frame: Baseline, Week 16 ]
    Number of inhalations/puffs of SABA/quick relief inhaler used was recorded in the e-diary daily.

  5. Number of Participants Who Had a Clinical Asthma Exacerbation (CAE) During the Treatment Period [ Time Frame: From randomization (Week 0) until Week 16 ]

    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).


  6. Time From Randomization to First CAE During the Treatment Period for Participants With CAE [ Time Frame: From randomization (Week 0) until Week 16 ]

    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).


  7. Change From Baseline in Number of Nighttime Awakenings Due to Asthma at Week 16 [ Time Frame: Baseline, Week 16 ]
    Participants recorded the number of nighttime awakenings due to asthma in the e-diary daily, in the morning.

  8. Percent Change in ICS Dose During the Treatment Period [ Time Frame: From randomization (Week 0) until Week 16 ]
    The ICS dose was not collected in the participant diary as planned.

  9. Change From Baseline in Forced Vital Capacity (FVC) at Week 16 [ Time Frame: Baseline, 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.

  10. Change From Baseline in Forced Expiratory Flow at 25-75% of Pulmonary Volume (FEF25%-75%) at Week 16 [ Time Frame: Baseline, Week 16 ]
    The FEF25%-75% (measured by handheld spirometer) is the forced expiratory flow from 25% to 75% of FVC

  11. Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 16 [ Time Frame: Baseline, Week 16 ]
    FeNO was performed prior to the on-site spirometry.

  12. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From randomization (Week 0) until Week 24 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545385


Locations
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Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Branded Pharmaceutical Products R&D, Inc.
  Study Documents (Full-Text)

Documents provided by Teva Branded Pharmaceutical Products R&D, Inc.:
Study Protocol  [PDF] April 28, 2021
Statistical Analysis Plan  [PDF] November 22, 2021

More Information
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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT04545385    
Other Study ID Numbers: TV48574-AS-20031
2020-001927-15 ( EudraCT Number )
First Posted: September 11, 2020    Key Record Dates
Results First Posted: March 13, 2023
Last Update Posted: March 13, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.:
T2 low, non-T2 asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases