Asthma Clinical Trial
Official title:
How to "Choosebetweenamab" for Severe Asthma, Comparing Treatment With Mepolizumab and Omalizumab for Patients With Severe Allergic and Eosinophilic Asthma.
Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and
reduces eosinophil counts in both sputum and blood. Omalizumab is an anti-immunoglobulin E
(IgE) monoclonal antibody (mAb) used in the treatment of severe allergic eosinophilic asthma
The investigators propose that in patients with the dual phenotypes of severe allergic and
eosinophilic asthma, that Mepolizumab is as effective as Omalizumab. However, this trial will
also identify key clinical biomarkers that will clarify which patients will respond best to
each of these interventions.
This study will be the first direct clinical comparison of these agents and will apply expert
clinical characterization, along with cutting edge biotechnology to better inform treatment
choices for severe asthma. This is an important and urgent management problem facing the
Australian pharmaceutical scheme, where imprecision in prescribing will result in reduced
clinical effectiveness as well as substantial and sustained costs.
'Choosebetweenamab' will compare active treatment arms (Mepolizumab and Omalizumab) for
efficacy and adverse events in a Phase 4, parallel arm, randomized controlled trail setting
with computer generated randomization (permuted block randomization, with block sizes of 4 or
6, stratified by baseline eosinophil count using a median split). There is no placebo
control. Particpants will not be blinded but masking will be used for people assessing
outcomes and analyzing data.
'Chossebetweenamab' will also include a secondary outcome substudy (ISS 11066) to assess
biomarkers of efficacy response to treatment using single cell sequencing of peripheral blood
cells. Blood samples are taken from the randomized patients in each treatment arm
(Mepolizumab and Omalizumab) at baseline and gene expression changes assessed using
transcriptomic single cell sequencing of patient white blood cells. The data generated from
this will be compared to the clinical outcomes of 'Choosebetweenamab' at all follow-up time
points. Single cell gene expression and cell type cluster patterning will be compared to the
primary and secondary outcomes to identify baseline predictors (gene and cell type) of
treatment efficacy.
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