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Dexpramipexole for Asthma (EXHALE-2 Trial)

Phase 3
Recruiting
Led By Salman Siddiqui, 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 history of at least two asthma exacerbations requiring treatment with systemic corticosteroids within the past 12-month period prior to Screening Visit 1
Pre-bronchodilator forced expiratory volume (Pre-BD FEV₁) ≥40% and <80% (<90% for participants 12 to 17 years of age) of predicted at Screening Visit 2
Must not have
Treatment with specific prohibited medications/procedures
AEC of <0.15x10⁹/L at Screening Visit 1 for participants aged 12 to 17 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (baseline, pre-dose), weeks 4, 12, 20,28 36, 44, 52
Awards & highlights

Summary

This trial tests a medication for asthma, to see if it helps control symptoms in those with severe asthma and a history of flare-ups.

Who is the study for?
This trial is for adolescents and adults aged 12 or older with severe eosinophilic asthma that isn't well-controlled, despite current treatments. Participants must have had at least two asthma attacks in the past year requiring steroids. Women who can have children must use effective birth control.Check my eligibility
What is being tested?
The study tests Dexpramipexole as an additional oral treatment against a placebo to see if it helps people with a specific type of severe asthma. The goal is to find out if this new medicine can reduce asthma symptoms and prevent attacks.See study design
What are the potential side effects?
While the potential side effects of Dexpramipexole are not detailed here, common side effects may include headache, dizziness, gastrointestinal issues, or allergic reactions. Placebo pills typically do not cause side effects but mimic those of the tested drug due to psychological factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've needed steroids for asthma attacks at least twice in the last year.
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My lung function is between 40% and 80% of the expected value.
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I am being treated for asthma with specific medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not taken any medications or undergone procedures that are not allowed in this trial.
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My white blood cell count is low.
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I have not had a respiratory infection in the last 4 weeks.
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I have not had a bronchial thermoplasty in the last year nor plan to have one.
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My blood, kidney, and liver tests are within safe ranges.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (baseline, pre-dose), weeks 4, 12, 20,28 36, 44, 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, 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized rate of severe asthma exacerbations over 52 weeks.
Secondary outcome measures
Absolute Change in pre-bronchodilator forced expiratory volume (Pre-BD FEV)₁ from Baseline
Annualized Rate of severe exacerbations from Week 4 to Week 52
Annualized rate of severe exacerbations requiring an emergency department visit or hospitalization over 52 weeks.
+10 more

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 primarily aim to reduce inflammation and manage symptoms. Dexpramipexole, like other treatments targeting eosinophilic asthma, works by reducing eosinophil levels, thereby decreasing inflammation and preventing exacerbations. Other common treatments include inhaled corticosteroids (ICS), which reduce airway inflammation, and long-acting beta-agonists (LABAs), which relax airway muscles to improve breathing. Biologics such as mepolizumab and reslizumab specifically target and reduce eosinophils, similar to dexpramipexole. These mechanisms are crucial for asthma patients as they help control chronic inflammation, reduce the frequency and severity of asthma attacks, and improve overall lung function and quality of life.
Mepolizumab versus placebo for asthma.

Find a Location

Who is running the clinical trial?

Areteia TherapeuticsLead Sponsor
3 Previous Clinical Trials
3,080 Total Patients Enrolled
3 Trials studying Asthma
3,080 Patients Enrolled for Asthma
Salman Siddiqui, MDPrincipal InvestigatorImperial College Healthcare NHS Trust (via Imperial Consultants)

Media Library

150 mg BID Clinical Trial Eligibility Overview. Trial Name: NCT05763121 — Phase 3
150 mg BID 2023 Treatment Timeline for Medical Study. Trial Name: NCT05763121 — Phase 3
Asthma Research Study Groups: Placebo, 150 mg BID, 75 mg BID
Asthma Clinical Trial 2023: 150 mg BID Highlights & Side Effects. Trial Name: NCT05763121 — Phase 3
~767 spots leftby Jun 2026