Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - "Choosebetweenamab".

Sponsor
University of Newcastle, Australia
Study ID
NCT04585997
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Mepolizumab — DRUG
    Mepolizumab 100mg subcutaneous injection monthly for 6 months
  • Omalizumab — DRUG
    Omalizumab subcutaneous injection every 2-4 weeks (dosage determined by the Omalizumab nomogram).

Study Details

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.

Key Dates

Start date
Nov 3, 2018
Status verified
Oct 2020
Primary completion
Jun 30, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Mepolizumab
    Mepolizumab
  • Active Comparator: Omalizumab
    Omalizumab

Primary Outcome Measure

ACQ5 [ Time Frame: Assessed after 6 months treatment ]

Central Contacts

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