What side effects are associated with this type of intervention?

Common treatments for severe eosinophilic asthma, such as mepolizumab, benralizumab, dupilumab, and reslizumab, primarily target eosinophil levels and inflammation. Known side effects of these treatments include injection site reactions, headache, back pain, fatigue, and oropharyngeal pain. Some patients may experience more serious reactions such as hypersensitivity or anaphylaxis, although these are rare. Monitoring for these side effects is essential to ensure patient safety.

What prior FDA approvals exist?

Several drugs targeting eosinophilic inflammation in asthma have received FDA approval. Mepolizumab, an anti-IL-5 monoclonal antibody, reduces eosinophil levels and has been approved for severe eosinophilic asthma. Other similar biologics include benralizumab and reslizumab, which also target IL-5 to reduce eosinophil counts and inflammation. Dupilumab, targeting the IL-4 receptor alpha, is approved for moderate-to-severe asthma and helps reduce inflammation by inhibiting IL-4 and IL-13 signaling. These treatments aim to control severe asthma by addressing the underlying eosinophilic inflammation.

What other types of research exist?

Promising alternatives to dexpramipexole for asthma treatment include: <ol> <li>Itepekimab: A monoclonal antibody targeting IL-33, shown to reduce airway inflammation and eosinophil levels.</li> <li></li> </ol> Benralizumab: Targets the IL-5 receptor, effectively reducing eosinophil counts and inflammation. 3. Mepolizumab: An anti-IL-5 antibody that reduces eosinophil levels and is effective in severe eosinophilic asthma. 4. Reslizumab: Another anti-IL-5 antibody, effective in reducing eosinophil counts and improving asthma control.

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Other

Dexpramipexole for Asthma (EXHALE-3 Trial)

Verified Trial

Phase 3

Recruiting

Led By Michael E. Wechsler, MD

Research Sponsored by Areteia Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

A participant who experiences a severe asthma exacerbation at any time from 4 weeks prior to Screening Visit 1 up to and including the Baseline Visit

Bronchial thermoplasty procedure in the past 12 months prior to Screening Visit 1 or planned during the coming year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1(baseline, pre-dose), weeks 4, 12, 20, 28, 36, 44, and 52.

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called dexpramipexole to see if it can help people with severe eosinophilic asthma that isn't well-controlled by current treatments. The medication works by lowering the levels of certain cells in the blood that cause inflammation. The goal is to find out if this can improve asthma symptoms and be safe for patients.

Who is the study for?

This trial is for adolescents and adults over 12 years old with severe eosinophilic asthma that isn't well-controlled. They should have had at least two asthma attacks in the last year needing steroids, an eosinophil count above a certain level, and not be current smokers or have a heavy smoking history. Women who can get pregnant must use birth control.

What is being tested?

The study tests dexpramipexole's safety and effectiveness against a placebo in managing severe eosinophilic asthma. Participants will randomly receive either the actual drug or a placebo to compare outcomes between the two groups.

What are the potential side effects?

While specific side effects of dexpramipexole are not listed here, common ones may include headache, nausea, potential allergic reactions, or issues related to immune system changes due to its effect on white blood cells.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a severe asthma attack within 4 weeks before my first screening visit up to now.

Select...

I have not had a bronchial thermoplasty in the last year nor plan to have one this coming year.

Select...

I have not had a respiratory infection in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1(baseline, pre-dose), weeks 4, 12, 20, 28, 36, 44, and 52.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1(baseline, pre-dose), weeks 4, 12, 20, 28, 36, 44, and 52.

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1(baseline, pre-dose), weeks 4, 12, 20, 28, 36, 44, and 52. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Annualized rate of severe asthma exacerbations over 52 weeks.

Secondary study objectives

Absolute Change in pre-bronchodilator forced expiratory volume (Pre-BD FEV₁) from Baseline

Annualized rate of severe exacerbations (AAER) from Week 4 to Week 52.

Annualized rate of severe exacerbations requiring an emergency over 52 weeks department visit or hospitalization

+9 more

Side effects data

From 2017 Phase 4 trial • 52 Patients • NCT02033369

82%

nausea

59%

headache

50%

somnolence

45%

Lightheadedness

45%

Dry Mouth

41%

Insomnia

41%

Restlessness

36%

Dizziness

32%

Forgetfulness

32%

Vomiting

32%

Heartburn

32%

decreased libido

27%

Blurry Vision

27%

Decreased Appetite

27%

Increased Appetite

23%

Diarrhea

23%

Sleep Attacks

23%

Skin Problems

18%

Constipation

18%

Sweating

18%

Impaired Coordination

14%

Sexual Dysfunction

14%

compulsive behaviorws

Bruising

tremor

Impaired Concentration

fatigue

100%

80%

60%

40%

20%

Study treatment Arm

MDD Patients

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

0 / 3Eligibility criteria met

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 work through various mechanisms to reduce inflammation, relax airway muscles, and prevent exacerbations. Inhaled corticosteroids (ICS) reduce airway inflammation and swelling, making it easier to breathe. Long-acting beta agonists (LABAs) relax the muscles around the airways, helping to keep them open. Leukotriene modifiers block chemicals that cause inflammation and bronchoconstriction. Biologics, such as dexpramipexole, target specific pathways involved in asthma, like reducing eosinophil levels and inflammation. These mechanisms are crucial for asthma patients as they help control symptoms, improve lung function, and reduce the frequency and severity of asthma attacks.