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Dexpramipexole for Eosinophilic Asthma (EXHALE-4 Trial)
Verified Trial
Phase 3
Recruiting
Led By Mona Bafadhel, MD
Research Sponsored by Areteia Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented physician diagnosis of asthma for ≥12 months.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (baseline, pre-dose), weeks 20, 24
Awards & highlights
Pivotal Trial
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects for dexpramipexole in this context aren't detailed here, common ones may include digestive discomfort, potential blood disorders like neutropenia (low white blood cell count), liver enzyme changes, heart-related issues such as arrhythmias or QT interval changes on ECGs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with asthma for at least a year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 (baseline, pre-dose), weeks 20, 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (baseline, pre-dose), weeks 20, 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in pre-BD FEV₁ from baseline
Secondary study objectives
Change from baseline in Asthma Control Questionnaire-6 (ACQ-6)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Asthma treatments often target the underlying inflammation and bronchoconstriction that characterize the disease. Eosinophils, a type of white blood cell, play a significant role in the inflammation seen in eosinophilic asthma.
Dexpramipexole, an investigational drug, aims to reduce eosinophil levels, thereby decreasing inflammation and improving lung function. Other common treatments include inhaled corticosteroids (ICS) that reduce overall airway inflammation, long-acting beta-agonists (LABAs) that relax bronchial muscles to improve airflow, and leukotriene receptor antagonists like montelukast that block inflammatory pathways.
These treatments are crucial for asthma patients as they help control symptoms, prevent exacerbations, and improve quality of life.
Mepolizumab versus placebo for asthma.
Mepolizumab versus placebo for asthma.
Find a Location
Who is running the clinical trial?
Areteia TherapeuticsLead Sponsor
4 Previous Clinical Trials
3,955 Total Patients Enrolled
3 Trials studying Asthma
3,925 Patients Enrolled for Asthma
Mona Bafadhel, MDPrincipal InvestigatorGuy's and St Thomas' NHS Foundation Trust
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have not taken Mirapex® in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: 150 mg BID
- Group 2: 75 mg BID
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.