Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04585997
Status:
UNKNOWN
Last Update Posted:
2020-10-14
First Post:
2020-09-30
Brief Title:
Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - Choosebetweenamab
Sponsor:
University of Newcastle Australia
Organization:
University of Newcastle Australia
Study Overview
Official Title:
How to Choosebetweenamab for Severe Asthma Comparing Treatment With Mepolizumab and Omalizumab for Patients With Severe Allergic and Eosinophilic Asthma
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None