Dexpramipexole for Eosinophilic Asthma

(EXHALE-4 Trial)

Recruiting at 138 trial locations

Overseen By EXHALE Recruiting

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Areteia Therapeutics

Must be taking: Inhaled corticosteroids

Must not be taking: Monoclonal antibodies, Pramipexole

Disqualifiers: Severe asthma, COPD, Smoking, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 20

Duration: 24 weeks

550 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that your asthma medications be stable for at least 4 weeks before starting. Some specific medications, like certain monoclonal antibodies and pramipexole, must not be taken close to the trial start.

What data supports the effectiveness of the drug Dexpramipexole for Eosinophilic Asthma?

Dexpramipexole has shown promise in reducing eosinophil levels in other conditions like hypereosinophilic syndromes, where it helped lower the need for steroids and improved symptoms. It has also been observed to consistently lower eosinophil counts in clinical studies, suggesting potential benefits for eosinophilic asthma. ^{1 2 3 4 5}

Is Dexpramipexole safe for humans?

Dexpramipexole has been tested in clinical trials for conditions like amyotrophic lateral sclerosis and hypereosinophilic syndromes, showing an excellent safety profile. It was well tolerated with no significant increase in adverse events compared to placebo, and any side effects were self-limited and did not lead to stopping the treatment. ^{1 2 3 4 6}

How does the drug dexpramipexole differ from other treatments for eosinophilic asthma?

Dexpramipexole is unique because it is an oral drug specifically designed to lower eosinophil levels, which are white blood cells involved in inflammation, and it has shown promise in reducing the need for corticosteroids (steroid medications) in related conditions. Unlike many current asthma treatments that rely heavily on steroids, dexpramipexole offers a potential alternative with fewer side effects. ^{1 2 4 5 7}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dexpramipexole or placebo orally twice a day to evaluate improvements in lung function, asthma control, and quality of life

24 weeks

Visits at baseline, Weeks 20, and 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dexpramipexole Dihydrochloride
• Placebo

Trial Overview The 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

Group I: 75 mg BID Experimental Treatment 1 Intervention

Dexpramipexole 75 mg oral tablet taken twice a day

Group II: 150 mg BID Experimental Treatment 1 Intervention

Dexpramipexole 150 mg oral tablet taken twice a day

Group III: Placebo Placebo Group 1 Intervention

Placebo oral tablet taken twice a day

Who Is Running the Clinical Trial?

Areteia Therapeutics

Lead Sponsor

Trials

5

Recruited

4,500+

Findings from Research

Fevipiprant, an oral DP2 receptor antagonist, showed a significant improvement in lung function (measured by forced expiratory volume in 1 second) in patients with allergic asthma who were not well-controlled on low-dose inhaled corticosteroids, particularly at a dose of 150 mg once daily.

The treatment was generally well-tolerated with mild to moderate adverse events, indicating that fevipiprant could be a safe and effective option for managing asthma in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fevipiprant, an oral prostaglandin DP2 receptor (CRTh2) antagonist, in allergic asthma uncontrolled on low-dose inhaled corticosteroids. Bateman, ED., Guerreros, AG., Brockhaus, F., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Dexpramipexole in Eosinophilic Asthma (EXHALE): A randomized controlled trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Dexpramipexole as an oral steroid-sparing agent in hypereosinophilic syndromes. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of fevipiprant in reducing exacerbations in patients with severe asthma (LUSTER-1 and LUSTER-2): two phase 3 randomised controlled trials. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The targeted eosinophil-lowering effects of dexpramipexole in clinical studies. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Fevipiprant in the treatment of asthma. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Fevipiprant, an oral prostaglandin DP2 receptor (CRTh2) antagonist, in allergic asthma uncontrolled on low-dose inhaled corticosteroids. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Clinical pharmacology study of the corticosteroid nasal spray dexamethasone cipecilate (NS-126): examination of the durability of efficacy in the nasal induction test. [2010]