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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether dexpramipexole, taken as a pill, can improve the lives of people with eosinophilic asthma, a type of asthma that doesn't respond well to regular treatments. The main goal is to determine if this new medication can boost lung function, make asthma easier to manage, and enhance overall quality of life. Participants will receive either dexpramipexole or a placebo (a pill with no active medicine) to compare results. This trial might suit those who have had asthma for over a year and still struggle with symptoms despite using daily inhalers and other asthma medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that dexpramipexole is likely to be safe for humans?

Research shows that dexpramipexole can reduce eosinophils, white blood cells involved in allergies and asthma. Previous studies have shown that patients tolerated it well, with no major side effects reported. However, researchers suggest larger studies to fully understand its safety. The study's later stage indicates that earlier trials found the treatment safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eosinophilic asthma?

Dexpramipexole is unique because it targets eosinophilic asthma by potentially reducing the number of eosinophils, which are inflammatory cells that play a key role in this condition. Unlike standard treatments like corticosteroids and biologics that suppress inflammation more generally or block specific pathways, Dexpramipexole offers a novel approach by aiming to directly decrease eosinophil count. Researchers are excited about this treatment because it may lead to improved asthma control with fewer side effects, offering an alternative for patients who don't respond well to current therapies.

What evidence suggests that dexpramipexole could be an effective treatment for eosinophilic asthma?

Research has shown that dexpramipexole can reduce eosinophils, a type of white blood cell linked to asthma, in individuals with eosinophilic asthma. In earlier studies, dexpramipexole significantly improved lung function for participants and was well-tolerated, with most experiencing no serious side effects. This trial will evaluate different dosages of dexpramipexole, specifically 150 mg and 75 mg taken twice daily, compared to a placebo. These findings suggest that dexpramipexole could be a useful treatment for those with eosinophilic asthma who struggle with current treatments. ^{1 2 6 7 8}

Who Is on the Research Team?

Mona Bafadhel, MD

Principal Investigator

Guy's and St Thomas' NHS Foundation Trust

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37277072/

Safety and Efficacy of Dexpramipexole in Eosinophilic ... Conclusions: Dexpramipexole demonstrated effective eosinophil lowering and was well tolerated. Additional larger clinical trials are needed to understand the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05763121

NCT05763121 | A Study to Assess the Effect of ... This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an ...

3. jacionline.org jacionline.org/article/S0091-6749(23)00709-1/fulltext

Safety and Efficacy of Dexpramipexole in Eosinophilic ... We sought to evaluate the safety and efficacy of dexpramipexole in lowering blood and airway eosinophilia in subjects with eosinophilic asthma.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05813288

NCT05813288 | A Study to Assess the Effect of ... The objective of this clinical study is to investigate the safety, tolerability, and efficacy of dexpramipexole in participants with inadequately controlled ...

5. biospace.com biospace.com/press-releases/areteia-therapeutics-announces-positive-topline-results-from-the-first-phase-iii-study-of-oral-dexpramipexole-in-eosinophilic-asthma

Areteia Therapeutics Announces Positive Topline Results ... In the EXHALE-4 study, dexpramipexole met the primary endpoint with statistically significant improvement in lung function compared with ...

6. areteiatx.com areteiatx.com/documents/PIIS0091674923007091-3.pdf

Safety and Efficacy of Dexpramipexole in Eosinophilic ... Objective: We sought to evaluate the safety and efficacy of dexpramipexole in lowering blood and airway eosinophilia in subjects with eosinophilic asthma.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05748600

NCT05748600 | A Study to Assess the Effect of ... The purpose of this study is to evaluate dexpramipexole as an add-on oral therapy in participants with inadequately controlled eosinophilic asthma to ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0091674923007091

Safety and Efficacy of Dexpramipexole in Eosinophilic ... Dexpramipexole demonstrated effective eosinophil lowering and was well tolerated. Additional larger clinical trials are needed to understand the clinical ...