EXHALE-5
Research type
Research Study
Full title
An Open-Label Long-Term Phase III Extension Study to Assess the Long-Term Safety and Tolerability of Dexpramipexole in Participants with Severe Eosinophilic Asthma (EXHALE-5)
IRAS ID
1009622
Contact name
Anesa Moyer
Contact email
Sponsor organisation
Areteia Therapeutics, LLC
Eudract number
2024-510810-33
Clinicaltrials.gov Identifier
Research summary
This study is limited to people that completed either EXHALE-2 or EXHALE-3 (also known as the parent studies). These studies included participants with severe asthma that was not well controlled, most of whom had increased numbers of eosinophils (a type of white blood cell) in their blood. The purpose of the parent studies was to see if Dexpramipexole, when added to participants regular asthma medications, would decrease asthma exacerbations (asthma attacks) and improve lung function. The purpose of this study (EXHALE-5) is to learn more about the safety of dexpramipexole over a long period of time. Everyone in EXHALE-5 will receive Dexpramipexole 150 mg twice a day, regardless of what treatment they were assigned to in the parent studies. People that were assigned to Dexpramipexole in the parent studies will receive Dexpramipexole for a total of 24 months (12 months in the parent study + 12 months in EXHALE-5) while people that were assigned to placebo in the parent studies will receive Dexpramipexole for 12 months (only during the 12 months of EXHALE-5). About 1,600 people, aged 12 and over, will take part in this study at approximately 650 global research centres.
REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0445
Date of REC Opinion
16 Aug 2024
REC opinion
Further Information Favourable Opinion