Dexpramipexole for Eosinophilic Asthma
(EXHALE-4 Trial)

Recruiting in Palo Alto (17 mi)

+138 other locations

Overseen byMona Bafadhel, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Areteia Therapeutics

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing an oral medication called dexpramipexole to help people with a type of asthma that isn't well controlled by their current treatments. The medication works by reducing specific white blood cells that cause inflammation, which may improve breathing and asthma control.

Research Team

Mona Bafadhel, MD

Principal Investigator

Guy's and St Thomas' NHS Foundation Trust

Eligibility Criteria

This trial is for adolescents and adults aged 12 or older with eosinophilic asthma that isn't well-controlled despite using daily low-dose inhaled corticosteroids and another maintenance medication. Participants should have a certain level of lung function reversibility after bronchodilator use, an eosinophil count within a specified range, and not be pregnant. Smokers or those with other complicating health issues are excluded.

Inclusion Criteria

I've been on daily asthma medication including steroids for at least 3 months.

I have been diagnosed with asthma for at least a year.

Pre-BD FEV1 ≥40% and <80% of predicted at Screening.

Exclusion Criteria

I have not taken Mirapex® in the last 30 days.

Treatment Details

Interventions

Dexpramipexole Dihydrochloride (Other)
Placebo (Other)

Trial OverviewThe study tests the effectiveness of dexpramipexole dihydrochloride as an additional oral treatment to improve lung function, control asthma symptoms, and enhance quality of life in patients with eosinophilic asthma. It's compared against a placebo to assess improvements and side effects.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 75 mg BIDExperimental Treatment1 Intervention

Dexpramipexole 75 mg oral tablet taken twice a day

Group II: 150 mg BIDExperimental Treatment1 Intervention

Dexpramipexole 150 mg oral tablet taken twice a day

Group III: PlaceboPlacebo Group1 Intervention

Placebo oral tablet taken twice a day