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Dexpramipexole for COPD (SUSPIRE-1 Trial)

Phase 2
Recruiting
Led By Gerard J Criner, MD
Research Sponsored by Areteia Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female aged 40 to 80 years at Screening Visit
Background ICS-based therapy for at least 12 weeks prior to enrollment with a stable dose of medication for at least 4 weeks prior to the Screening Visit
Must not have
Treatment with selected drugs known to have a substantial risk of neutropenia or QT prolongation in the past 30 days prior to the Screening Visit
History of New York Heart Association class IV heart failure or low left ventricular ejection fraction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 16
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a drug called dexpramipexole in participants with eosinophilic COPD. The study aims to see how well the drug can reduce blood eosinophil counts and

Who is the study for?
This trial is for adults aged 40-80 with eosinophilic COPD, a history of smoking, and recent exacerbations. They must have been on stable ICS-based therapy for at least 12 weeks. Exclusions include significant heart or liver disease, certain infections, other lung diseases besides COPD, recent use of drugs affecting blood cells or QT interval, pregnancy/breastfeeding women, and those not using birth control.
What is being tested?
The study tests the effects of Dexpramipexole Dihydrochloride (150 mg twice daily) on people with eosinophilic COPD to see how it affects their blood eosinophil counts. It's an open-label Phase II trial where all participants know they're receiving the medication.
What are the potential side effects?
While specific side effects are not listed here, common ones may include potential risks like neutropenia (low white blood cell count), issues related to heart rhythm (QT prolongation), and general drug-related reactions such as fatigue or gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 80 years old.
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I've been on a stable dose of inhaled corticosteroids for at least 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken drugs with a high risk of neutropenia or QT prolongation in the last 30 days.
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I have had severe heart failure or a weak heart pump.
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My liver isn't working properly.
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I am a male and willing to use birth control during the study.
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I have a history of HIV or chronic hepatitis B or C.
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I have asthma or was diagnosed with it after turning 40.
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I have a serious lung condition that is not COPD.
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I haven't had monoclonal antibody therapy in the last 4 months.
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I have not taken Mirapex® in the last 30 days.
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My kidney function is reduced, with a filtration rate below 60 mL/min.
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I am currently in an active pulmonary rehab program.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
COPD Assessment Test (CAT)
Post-BD FEV1
Pre-BD FEV1
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

Areteia TherapeuticsLead Sponsor
4 Previous Clinical Trials
4,475 Total Patients Enrolled
Gerard J Criner, MDPrincipal InvestigatorTemple University
6 Previous Clinical Trials
2,124 Total Patients Enrolled
~15 spots leftby Apr 2025
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