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

  • STATUS
    Recruiting
  • End date
    Aug 17, 2022
  • participants needed
    124
  • sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
Updated on 10 January 2022

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 patients 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 patient participation in the study is planned to be up to approximately 30 weeks.

Details
Condition Asthma
Treatment Placebo, TEV-48574
Clinical Study IdentifierNCT04545385
SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last Modified on10 January 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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