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(904) 244-0411

A 52-week study assessing exacerbation rate, asthma control and safety in adult severe eosinophilic asthmatics treated with depemokimab compared with mepolizumab or benralizumab

  • Status
    Accepting Candidates
  • Age
    N/A
  • Sexes
    All
  • Healthy Volunteers
I'm interested
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Description

This is a multi-centre, randomised, double-blind, double-dummy, parallel group noninferiority trial of GSK3511294 (depemokimab) 100 mg SC compared with continuation of mepolizumab

or benralizumab treatment in participants with severe asthma with an eosinophilic

phenotype. At Visit 2 (Week 0) those participants who meet the randomisation eligibility criteria will be randomised in a 1:1 ratio to either remain on their existing anti-IL-5/5R therapy (mepolizumab or benralizumab) or switch to GSK3511294 100 mg.

Throughout the study, all participants will continue their baseline standard of care (SoC)

asthma treatment. Assessments will include the rate of clinically significant exacerbations and measures of lung function, asthma control, and safety.

Details

Protocol number 20204289

Eligibility

Have eosinophilic asthma that has been controlled with mepolizumab

or benralizumab for at least 12 months. On medium to high dose inhaled corticosteroid treatment  Have never smoked or have less than 20 pack years smoking history (number of pack years = (number of cigarettes per day / 20) x number of years smoked).

Lead researcher

  • James D Cury, MD
    Pulmonologist, Critical Care Medicine Physician

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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