Chronic Obstructive Pulmonary DiseasePhase 2SUSPIRE-1NCT06533553
A Study to Assess the Effects of Dexpramipexole in Participants With Eosinophilic COPD
A Phase 2 study testing Dexpramipexole Dihydrochloride in people with Chronic Obstructive Pulmonary Disease, run by Areteia Therapeutics at 23 sites in United States.
Trial summary
This is an open-label Phase II study assessing the PD of dexpramipexole 150 mg twice daily (BID) in participants with eosinophilic COPD. This study will help characterize the profile and duration of reductions of blood absolute eosinophil counts (AEC). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Dexpramipexole Dihydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 23 sitesUnited States
- Study dates
- 9 Jul 2024to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form prior to any study-specific procedures.
- Male or female ≥40 to ≤80 years of age at Screening Visit.
- Physician diagnosis of COPD for at least 2 years prior to the Screening Visit in accordance with the definition by the American Thoracic Society/European Respiratory Society
- Current or former smokers with a cigarette smoking history of ≥10 pack years at the Screening Visit calculated as (number of pack years = [number of cigarettes per day/20] multiplied by number of years smoked). Former smokers are defined as those who meet the pack-year history but have stopped smoking for at least 6 months prior to the Screening Visit.
- Spirometry: post-BD FEV1/FVC <0.70 and post-BD FEV1 >20% and ≤60% of predicted normal values at the Screening Visit.
- Documented history of exacerbation risk defined as exacerbation history of ≥1 moderate* or ≥1 severe** within 2 years prior to the Screening Visit.
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- Background ICS-based therapy (ICS+ long-acting β2 agonist [LABA], or ICS + long-acting muscarinic antagonist [LAMA], or ICS + LAMA + LABA) for ≥12 weeks prior to enrollment with a stable dose of medication for ≥4 weeks prior to the Screening Visit.
- Evidence of an eosinophilic phenotype: Participants with blood eosinophils ≥0.30x109/L at the Screening Visit.
- Negative urine pregnancy test for women of childbearing potential (WOCBP) at the Screening and Baseline Visits.
- WOCBP (after menarche) must use e methods of birth control from the Screening Visit through the End of Study Visit..
Who cannot join
- A current diagnosis of asthma or any history of asthma diagnosis when ≥40 years of age.
- Significant pulmonary disease other than COPD (eg, α-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, lung cancer, clinically significant bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated eosinophil counts.
- Pneumonia, upper or lower respiratory tract infection or acute exacerbation of COPD within 4 weeks prior to or during the Screening Phase.
- Treatment with a biologic investigational drug in the last 5 months prior to the Screening Visit. Treatment with non-biologic investigational drugs in the previous 30 days or five-half-lives prior to the Screening Visit, whichever is longer. Treatment with GSK3511294 (long-acting anti-interleukin-5) in the past 12 months.
- Treatment with any of the following monoclonal antibody therapies within 120 days prior to the Baseline Visit: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab.
- Treatment with pramipexole (Mirapex®) within 30 days of the Baseline Visit.
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- Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days prior to the Screening Visit.
- Treatment with selected drugs known to have a substantial risk of QT prolongation in the past 30 days prior to the Screening Visit.
- Participants who are participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation.
- History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the 2 years prior to the Baseline Visit.
- History of human immunodeficiency virus infection or chronic infection with hepatitis B or C.
- Neutrophil count <2.000x109/L at the Screening Visit.
- Renal dysfunction, defined as an estimated glomerular filtration rate <60 mL/min/1.73m2 at the Screening Visit (using the Chronic Kidney Disease Epidemiology Collaboration) formula.
- Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), >3x the upper limit of normal (ULN), or total bilirubin >2x ULN at the Screening Visit confirmed by a repeat abnormal measurement of the relevant value(s), at least 1 week apart.
- History of New York Heart Association class IV heart failure or last known left ventricular ejection fraction <25%.
- Corrected QT interval by Fridericia (QTcF) interval >450 ms for males and >470 ms for females at the Screening Visit or QTcF ≥480 ms for participants with bundle branch block.
- Pregnant women or women breastfeeding.
- Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Research Site US-10001-020
Baltimore, Maryland, 21224
Research Site 10001-032
Champaign, Illinois, 61820
Research US-10001-010
Charlotte, North Carolina, 28277
Research Site US-10001-025
Charlotte, North Carolina, 28293
Research Site US-10001-004
Columbus, Ohio, 43215
Research Site US-10001-017
Conway, Arkansas, 72032
Research Site US-10001-009
Corsicana, Texas, 75110
Research Site US-10001-033
Des Moines, Iowa, 50266
Research Site US-10001-002
DuBois, Pennsylvania, 15801
Research Site US-10001-023
East Providence, Rhode Island, 02914
Research Site US-10001-024
Farmington Hills, Michigan, 48336
Research Site US-10001-007
Gastonia, North Carolina, 28054
Research Site US-10001-021
Hammond, Indiana, 46324
Research Site US-10001-038
Houston, Texas, 77030
Research Site 10001-026
McKinney, Texas, 75069
Research Site US-10001-008
Newport Beach, California, 92663
Research Site US-10001-022
Northridge, California, 91324
Research Site US-10001-030
Orlando, Florida, 32803
Research Site US-10001-013
Philadelphia, Pennsylvania, 19140
Research Site US-10001-012
Rock Hill, South Carolina, 29732
Research Site US-10001-005
Saint Charles, Missouri, 63301
Research Site US-10001-001
St Louis, Missouri, 63110
Research Site US-10001-016
Westminster, California, 92683
About this study
Official title: An Open-label Phase II Study to Assess the Pharmacodynamic (PD) Effects of Dexpramipexole in Participants With Eosinophilic Chronic Obstructive Pulmonary Disease (COPD)
This is an open-label Phase II study assessing the PD of dexpramipexole 150 mg twice daily (BID) in participants with eosinophilic COPD. This study will help characterize the profile and duration of reductions of blood absolute eosinophil counts (AEC).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Dexpramipexole Dihydrochloride
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexpramipexole DihydrochlorideDrug
Administration of dexpramipexole tablet
| Study group | Role | What they receive |
|---|---|---|
| 150 mg dexpramipexole BID | Experimental | 150 mg dexpramipexole oral tablet taken twice a day Receives: Drug: Dexpramipexole Dihydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean change in the blood AEC from baseline to Week 16
Measured: Baseline, Week 16
Secondary outcomes (4)
Pre-BD FEV1
Change in pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1) from baseline to Week 16
Measured: Baseline, Week 16
Post-BD FEV1
Change in post-bronchodilator forced expiratory volume in 1 second (Pre-BD FEV1) from baseline to Week 16
Measured: Baseline, Week 16
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C)
Change from baseline to Week 16. SGRQ-C total scores range from 0 to 100, with higher scores indicating more limitations.
Measured: Baseline, Week 16
COPD Assessment Test (CAT)
Change from baseline to Week 16
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start9 Jul 2024
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Areteia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard J Criner, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533553
- Sponsor's protocol ID
- AR-DEX-23-05
- Acronym
- SUSPIRE-1
- Status last verified
- May 2025
- First submitted
- 30 Jul 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase II Study to Assess the Pharmacodynamic (PD) Effects of Dexpramipexole in Participants With Eosinophilic Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT06533553
- Acronym / sponsor ID
- SUSPIRE-1 / AR-DEX-23-05
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Areteia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label Phase II study assessing the PD of dexpramipexole 150 mg twice daily (BID) in participants with eosinophilic COPD. This study will help characterize the profile and duration of reductions of blood absolute eosinophil counts (AEC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 150 mg dexpramipexole BID | Experimental | Drug: Dexpramipexole Dihydrochloride150 mg dexpramipexole oral tablet taken twice a day |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent form prior to any study-specific procedures.
- Male or female ≥40 to ≤80 years of age at Screening Visit.
- Physician diagnosis of COPD for at least 2 years prior to the Screening Visit in accordance with the definition by the American Thoracic Society/European Respiratory Society
- Current or former smokers with a cigarette smoking history of ≥10 pack years at the Screening Visit calculated as (number of pack years = [number of cigarettes per day/20] multiplied by number of years smoked). Former smokers are defined as those who meet the pack-year history but have stopped smoking for at least 6 months prior to the Screening Visit.
- Spirometry: post-BD FEV1/FVC <0.70 and post-BD FEV1 >20% and ≤60% of predicted normal values at the Screening Visit.
Key exclusion criteria (19 listed)
- A current diagnosis of asthma or any history of asthma diagnosis when ≥40 years of age.
- Significant pulmonary disease other than COPD (eg, α-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, lung cancer, clinically significant bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated eosinophil counts.
- Pneumonia, upper or lower respiratory tract infection or acute exacerbation of COPD within 4 weeks prior to or during the Screening Phase.
- Treatment with a biologic investigational drug in the last 5 months prior to the Screening Visit. Treatment with non-biologic investigational drugs in the previous 30 days or five-half-lives prior to the Screening Visit, whichever is longer. Treatment with GSK3511294 (long-acting anti-interleukin-5) in the past 12 months.
- Treatment with any of the following monoclonal antibody therapies within 120 days prior to the Baseline Visit: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexpramipexole DihydrochlorideAdministration of dexpramipexole tablet | Drug | 150 mg dexpramipexole BID |
Primary outcome
Geometric mean change in the blood AEC from baseline to Week 16
Time frame: Baseline, Week 16
4 secondary outcomes
Pre-BD FEV1
Time frame: Baseline, Week 16
Post-BD FEV1
Time frame: Baseline, Week 16
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C)
Time frame: Baseline, Week 16
COPD Assessment Test (CAT)
Time frame: Baseline, Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard J Criner, MD principal investigator
Temple University
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexpramipexole Dihydrochloride in people with Chronic Obstructive Pulmonary Disease, run by Areteia Therapeutics at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean change in the blood AEC from baseline to Week 16 (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.