Clinical Research Details

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

Study 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.

Inclusion/Exclusion Criteria

  • 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).

Open Enrollment

Contact Name: Brandi Wells
Contact Phone: (904) 244-4693
Contact Email: brandi.wells@jax.ufl.edu

Investigators