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Dexpramipexole for Asthma (EXHALE-5 Trial)

Phase 3
Waitlist Available
Led By Sady Alpizar, 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
Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days
Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (baseline), weeks 16, 32, and 52
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to study the safety of using dexpramipexole in the long term for individuals aged 12 years and older with severe asthma who are already on certain asthma treatments.

Who is the study for?
This trial is for people aged 12 or older with severe asthma who are already on high-level asthma treatments (GINA Step 4 or 5) and have completed the EXHALE-2 or EXHALE-3 studies. It's not specified who can't join, but typically there would be criteria to exclude those with other health issues that could affect results.
What is being tested?
The study tests the long-term safety of a drug called Dexpramipexole Dihydrochloride in individuals with severe asthma. Participants from previous Phase III trials will continue treatment to gather more data on its effects over an extended period.
What are the potential side effects?
While specific side effects aren't listed here, generally, drugs like Dexpramipexole may cause reactions at the site of administration, headaches, gastrointestinal discomforts such as nausea or diarrhea, and potential respiratory symptoms.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't taken drugs with a high risk of neutropenia in the last 30 days.
Select...
I am a male willing to use contraception during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (baseline), weeks 16, 32, and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (baseline), weeks 16, 32, 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
Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations
Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight
Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters
+1 more
Secondary study objectives
Change in Asthma Control Questionnaire-6 (ACQ-6)
Change in absolute eosinophil counts (AEC)
Severe Asthma Exacerbations

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 150 mg BIDExperimental Treatment1 Intervention
Dexpramipexole 150 mg oral tablet taken twice a day.

Find a Location

Who is running the clinical trial?

Areteia TherapeuticsLead Sponsor
4 Previous Clinical Trials
2,905 Total Patients Enrolled
3 Trials studying Asthma
2,875 Patients Enrolled for Asthma
Sady Alpizar, MDPrincipal InvestigatorClinical Research Trials of Florida, Inc.
~1067 spots leftby Jun 2027
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