*The efficacy, safety & tolerability of oral dexpramipexole in eosinophilic asthma (EXHALE-4)
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 24 weeks in participants with eosinophilic asthma (EXHALE-4)
IRAS ID
1006597
Contact name
Tara Richardson
Contact email
Sponsor organisation
Areteia Therapeutics
Eudract number
2022-003005-30
Clinicaltrials.gov Identifier
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-4 is a 24-week study is testing whether adding a new drug called dexpramipexole, on top of standard inhaled medications, reduces the number of asthma attacks in people with 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 eosinophilic asthma.REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0778
Date of REC Opinion
6 Feb 2023
REC opinion
Further Information Favourable Opinion