Safety Extension Study to Bora (MELTEMI)
Research type
Research Study
Full title
A Multicenter, Open-label, Safety Extension Study with Benralizumab (MEDI- 563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)
IRAS ID
202749
Contact name
Hassan Burhan
Contact email
Eudract number
2015-005396-25
Duration of Study in the UK
2 years, 5 months, 24 days
Research summary
The purpose of the MELTEMI study is to continue investigate safety and tolerability of benralizumab treatment in asthma patients who are otherwise uncontrolled on current standard of care. This study provides an option for continued treatment with benralizumab for adult patients who previously entered study D3250C00021 after 1 Oct 2015 and who have completed at least 16 up to 40 weeks of the treatment in BORA. Patients will receive benralizumab either every 4 or 8 weeks (un-blinded to the treatment regimen), as per treatment assignment in BORA.
Further information on risks and benefits of the study drug (benralizumab) will be collected with regard to asthma worsening and adverse events. In order to collect this information, administer benralizumab and monitor patients’ safety regular visits to the clinic will take place. This study will continue in each country until benralizumab is locally available on NHS prescription, or until it has been withdrawn from the approval process.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0234
Date of REC Opinion
22 Jun 2016
REC opinion
Further Information Favourable Opinion