Efficacy, safety & tolerability of dexpramipexole orally in eosinophilic severe asthma (EXHALE-3)
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of dexpramipexole administered orally for 52 weeks in participants with severe eosinophilic asthma (EXHALE-3)
IRAS ID
1007345
Contact name
Tara Richardson
Contact email
Sponsor organisation
Areteia Therapeutics
Eudract number
2023-503693-20
Research summary
About half of people with asthma have “eosinophilic asthma”, which is a type of asthma with high levels of eosinophils, a type of white blood cell. These eosinophils can be measured in the blood and identify patients in which these cells play a role in their asthma and whose asthma improves with the eosinophil-lowering treatments below. In patients with eosinophilic asthma, eosinophils in the lung can release chemicals that lead to asthma symptoms and severe asthma attacks. Over the past several years, a few new drugs that lower eosinophils were approved by the U.S., UK and European medicines regulators (FDA, MHRA, EMA) for the treatment of asthma (for example, mepolizumab/Nucala; reslizumab/Cinqair; benralizumab/Fasenra). All of these approved drugs are injected using a needle.
Dexpramipexole is an experimental drug that is an oral tablet that is taken by mouth twice a day but is not approved in any country. Dexpramipexole also works by lowering the number of eosinophils in the blood. In a Phase 2 study, dexpramipexole lowered blood eosinophils and patients also experienced some improvement in their lung function.
The Phase III program for dexpramipexole includes three studies - EXHALE-2, EXHALE-3 and EXHALE-4.
EXHALE-3. is a 52-week study testing whether adding a new drug called dexpramipexole, on top of standard inhaled medications, reduces the number of asthma attacks in people with severe eosinophilic asthma. Dexpramipexole will be compared to an inactive pill called a placebo. The purpose of this study is to understand more about the safety of dexpramipexole and how well it works for the treatment of severe eosinophilic asthma.REC name
London - Central Research Ethics Committee
REC reference
23/LO/0281
Date of REC Opinion
24 Jul 2023
REC opinion
Further Information Favourable Opinion