Eosinophilic AsthmaPhase 3EXHALE-5NCT06388889
Phase III Long-Term Extension Study With Dexpramipexole
A Phase 3 study testing Dexpramipexole Dihydrochloride in people with Eosinophilic Asthma, run by Areteia Therapeutics at 103 sites in 15 countries.
Trial summary
The goal of this clinical trial] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥18 years, on Global Initiative for Asthma (GINA) 2021 [GINA, 2021] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Eosinophilic Asthma
- 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
- 509 participants
- Where
- 103 sitesin 15 countries
- Study dates
- 12 Jun 2024to 8 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who completed the double-blind study intervention treatment period during either of the Phase III studies EXHALE-2 or EXHALE-3.
- Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Baseline Visit/Day 1.
- WOCBP (after menarche) must use either of the following methods of birth control, from the Baseline Visit/Day 1 through the End of Study Visit:
- A highly effective form of birth control (confirmed by the investigator). Highly effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device (IUD), IUD/intrauterine system, levonorgestrel intrauterine system, or oral contraceptive. -OR-
- Two protocol acceptable methods of contraception in tandem. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for ≥12 months prior to the planned date of the Baseline Visit/Day 1 without an alternative medical cause. The following age specific requirements apply:
- Women <50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone levels in the postmenopausal range.
- Women ≥50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
Who cannot join
- Clinically significant change in health status during either of the Phase III studies EXHALE-2 or EXHALE-3 which in the opinion of the investigator would make the participant unsuitable for participation in this study.
- Participants with allergy/intolerance to dexpramipexole or any of its excipients.
- Participants who met permanent discontinuation criteria or permanently discontinued study treatment for any reason in either of the Phase III studies EXHALE-2 or EXHALE-3..
- Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days.
- Pregnant or breastfeeding women.
- Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).
Trial locations and contacts
103 sites in 15 countries.
103 sites in 15 countries
United States23 sites
Research Site 20001-374
Bakersfield, California, 93301
Research Site 20001-029
Coral Gables, Florida, 33134
Research Site 20001-036
Elwood, Indiana, 46036
Research Site 20001-044
Evansville, Indiana, 47715
Research Site 20001-006
Flint, Michigan, 48504
Research Site 20001-014
Greenacres City, Florida, 33467
Research Site 20001-047
Hawthorne, New York, 10532
Research Site 30001-291
Jacksonville, Florida, 32216
Research Site 20001-066
Miami, Florida, 33126
Research Site 20001-001
Miami, Florida, 33135
Research Site 20001-311
Miami, Florida, 33144
Research Site 20001-026
Miami, Florida, 33155
Research Site 30001-082
Miami, Florida, 33179
Research Site 20001-024
Miami, Florida, 33184
Research Site 20054-024
Miami, Florida, 33184
Research Site 20001-376
Northridge, California, 91324
Research Site 30001-297
Pearland, Texas, 77584
Research Site 30001-429
Plantation, Florida, 33137
Research Site 30001-429
Plantation, Florida, 33317
Research Site 20001-046
St Louis, Missouri, 63110
Research Site 20001-004
Tampa, Florida, 33607
Research Site 20001-063
Toledo, Ohio, 43617
Research Site 20001-355
Toms River, New Jersey, 08755
Argentina14 sites
Research Site 30054-044
Buenos Aires, B1878FNR
Research Site 20054-017
Buenos Aires, C1027AAP
Research Site 20054-015
Buenos Aires, C1121ABE
Research Site 20054-022
Buenos Aires, C1414AIF
Research Site 20054-024
Buenos Aires, C1425BEN
Research Site 20054-008
Buenos Aires, C1426ABP
Research Site 20054-005
Córdoba, X5003DCE
Research Site 30054-047
Mendoza, 5509
Research Site 20054-019
Mendoza, M5500AXR
Research Site 20054-016
Mendoza, M5500CBA
Research Site 20054-010
Mendoza, M5500CCG
Research Site 20054-002
San Miguel de Tucumán, T4000CBC
Research Site 20054-020
San Miguel de Tucumán, T4000IAP
Research Site 20054-013
Santa Fe, 5509
Ukraine12 sites
Research Site 20380-002
Chernivtsi, 58001
Research Site 20380-014
Ivano-Frankivsk, 76019
Research Site 20380-004
Ivano-Frankivsk
Research Site 20380-018
Kyiv, 03037
Research Site 20380-007
Kyiv, 03038
Research Site 20380-010
Kyiv
Research Site 20380-012
Kyiv
Research Site 20380-013
Kyiv
Research Site 20380-001
Ternopil, 46023
Research Site 20380-003
Vinnytsia, 21001
Research Site 20380-003
Zhytomyr, 10002
Research Site 20380-005
Zhytomyr, 10002
Poland10 sites
Research Site 20048-018
Bialystok, 15-044
Research Site 20048-006
Giżycko, 11-500
Research Site 20048-008
Krakow, 20-001
Research Site 20048-027
Krakow, 30-033
Research Site 20048-033
Krakow, 31-011
Research Site 20048-005
Lodz, 50-549
Research Site 20048-031
Ostrów Wielkopolski, 27-400
Research Site 20048-010
Piaseczno, 05-500
Research Site 20048-028
Poznan, 60-693
Research Site 20048-016
Poznan, 61-578
Brazil7 sites
Research Site 20055-007
Blumenau, 89030-101
Research Site 20055-004
Porto Alegre, 90610-000
Research Site 20055-010
Porto Alegre, 91010-006
Research Site 20055-001
São Bernardo, 09715-590
Research Site 20055-003
São Paulo, 05403-000
Research Site 20055-008
São Paulo, 09090-790
Research Site 20055-002
Sorocaba, 18040-425
Georgia7 sites
Research Site 20995-001
Kutaisi, 4600
Research Site 20995-005
Tbilisi, 0102
Research Site 20995-006
Tbilisi, 0144
Research Site 20995-002
Tbilisi, 0159
Research Site 20995-003
Tbilisi, 0159
Research Site 20995-004
Tbilisi, 0159
Research Site 20995-009
Tbilisi, 0159
Bulgaria6 sites
Research Site 20359-016
Dimitrovgrad, 3703
Research Site 20359-008
Montana, 3400
Research Site 20359-010
Pernik, 2300
Research Site 20359-005
Rousse, 7002
Research Site 20359-009
Sliven, 8800
Research Site 20359-016
Vidin, 3703
South Africa6 sites
Research Site 30027-009
Cape Town, Western Cape
Research Site 30027-010
Durban, Kwa-ZuIu Natal
Research Site 30027-008
Durban, KwaZulu-Natal
Research Site 30027-005
Durban, 4001
Research Site 30027-014
Durban, 4091
Research Site 30027-010
Durban, 4450
Serbia4 sites
Research Site 20381-002
Belgrade, 11000
Research Site 20381-005
Belgrade, 11000
Research Site 20381-007
Belgrade, 11000
Research Site 20381-003
Valjevo, 14000
South Korea4 sites
Research Site 20082-003
Anyang-si, 14068
Research Site 20082-009
Daegu, 42415
Research Site 20082-006
Jeonju, 54907
Research Site 20082-008
Seoul, 6591
Mexico3 sites
Research Site 20052-002
Guadalajara, 44200
Research Site 20052-012
San Juan del Río, 76800
Research Site 20052-014
Tijuana, 22010
North Macedonia2 sites
Research Site 20389-004
Skopje, 1000
Research Site 20389-007
Skopje, 1000
Romania2 sites
Research Site 20040-002
Brasov, 500051
Research Site 20040-004
Brasov, 500366
United Kingdom2 sites
Research Site 20044-020
Manchester, "M15 6SE "
Research Site 20044-026
Rochdale, OL11 4AU
About this study
Official title: An Open-Label Long-Term Phase III Extension Study to Assess the Long-Term Safety and Tolerability of Dexpramipexole in Participants With Severe Eosinophilic Asthma
The goal of this clinical trial] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥18 years, on Global Initiative for Asthma (GINA) 2021 [GINA, 2021] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3.
- Conditions
- Eosinophilic Asthma
- Being tested
- Dexpramipexole Dihydrochloride
- Keywords
- Exacerbations, Severe Asthma, EXHALE-2, EXHALE-3, EXHALE-4, Uncontrolled Asthma, Asthma Attack
- Medical subject headings
- Pulmonary Eosinophilia, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexpramipexole DihydrochlorideDrug
Oral administration of dexpramipexole tablet
| Study group | Role | What they receive |
|---|---|---|
| 150 mg BID | Experimental | Dexpramipexole 150 mg 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.
Number and Percentage of Participants with a Treatment Emergent Adverse Event
Summary of participants from the safety population who experienced an adverse event.
Measured: 52 weeks
Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations
Summary of participants from the safety population who experienced potentially clinically significant postbaseline changes in hematology and chemistry results.
Measured: 52 weeks
Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight
Summary of participants from the safety population who experienced potentially clinically significant postbaseline changes in vital signs (blood pressure, pulse rate, respiratory rate, and temperature) or body weight.
Measured: 52 weeks
Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters
Summary of participants from the safety population who experienced potentially significant postbaseline changes in electrocardiogram parameters: heart rate, PR, QRS and QTcF intervals.
Measured: 52 weeks
Secondary outcomes (3)
Severe Asthma Exacerbations
Annualized rate of severe asthma exacerbations over 52 weeks
Measured: Averaged across 52 weeks
Change in Asthma Control Questionnaire-6 (ACQ-6)
ACQ-6 is simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. The 6-point self-administered scale has items measuring asthma symptoms and rescue inhaler use. The ACQ score is the mean of the questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
Measured: Day 1 (baseline), Weeks 16, 32, and 52
Change in absolute eosinophil counts (AEC)
Change from baseline, at Weeks 16, 32, and 52.
Measured: Day 1 (baseline), Weeks 16, 32, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start12 Jun 2024
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Why it stopped: Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic AsthmaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Areteia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sady Alpizar, MD, Principal investigator, Clinical Research Trials of Florida, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388889
- Sponsor's protocol ID
- AR-DEX-22-04
- Acronym
- EXHALE-5
- Status last verified
- Dec 2025
- First submitted
- 27 Mar 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seluk L, Davis AE, Rhoads S, Wechsler ME. Novel asthma treatments: Advancing beyond approved novel step-up therapies for asthma. Ann Allergy Asthma Immunol. 2025 Jan;134(1):9-18. doi: 10.1016/j.anai.2024.09.016. Epub 2024 Oct 10.
PubMed 39393433
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Long-Term Phase III Extension Study to Assess the Long-Term Safety and Tolerability of Dexpramipexole in Participants With Severe Eosinophilic Asthma
- ClinicalTrials.gov ID
- NCT06388889
- Acronym / sponsor ID
- EXHALE-5 / AR-DEX-22-04
- Conditions
- Eosinophilic Asthma
- Keywords
- Exacerbations, Severe Asthma, EXHALE-2, EXHALE-3, EXHALE-4, Uncontrolled Asthma, Asthma Attack
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Areteia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 29 Apr 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.
The goal of this clinical trial] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥18 years, on Global Initiative for Asthma (GINA) 2021 [GINA, 2021] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3.
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 BID | Experimental | Drug: Dexpramipexole DihydrochlorideDexpramipexole 150 mg oral tablet taken twice a day. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants who completed the double-blind study intervention treatment period during either of the Phase III studies EXHALE-2 or EXHALE-3.
- Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Baseline Visit/Day 1.
- WOCBP (after menarche) must use either of the following methods of birth control, from the Baseline Visit/Day 1 through the End of Study Visit:
Key exclusion criteria (6 listed)
- Clinically significant change in health status during either of the Phase III studies EXHALE-2 or EXHALE-3 which in the opinion of the investigator would make the participant unsuitable for participation in this study.
- Participants with allergy/intolerance to dexpramipexole or any of its excipients.
- Participants who met permanent discontinuation criteria or permanently discontinued study treatment for any reason in either of the Phase III studies EXHALE-2 or EXHALE-3..
- Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days.
- Pregnant or breastfeeding women.
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 DihydrochlorideOral administration of dexpramipexole tablet | Drug | 150 mg BID |
Primary outcome
Number and Percentage of Participants with a Treatment Emergent Adverse Event
Time frame: 52 weeks
Summary of participants from the safety population who experienced an adverse event.
Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations
Time frame: 52 weeks
Summary of participants from the safety population who experienced potentially clinically significant postbaseline changes in hematology and chemistry results.
Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight
Time frame: 52 weeks
Summary of participants from the safety population who experienced potentially clinically significant postbaseline changes in vital signs (blood pressure, pulse rate, respiratory rate, and temperature) or body weight.
Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters
Time frame: 52 weeks
Summary of participants from the safety population who experienced potentially significant postbaseline changes in electrocardiogram parameters: heart rate, PR, QRS and QTcF intervals.
3 secondary outcomes
Severe Asthma Exacerbations
Time frame: Averaged across 52 weeks
Change in Asthma Control Questionnaire-6 (ACQ-6)
Time frame: Day 1 (baseline), Weeks 16, 32, and 52
Change in absolute eosinophil counts (AEC)
Time frame: Day 1 (baseline), Weeks 16, 32, and 52
Results and safety
The study was stopped early (reason given: Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Derived from this study: PubMed 39393433Seluk L, Davis AE, Rhoads S, Wechsler ME. Novel asthma treatments: Advancing beyond approved novel step-up therapies for asthma. Ann Allergy Asthma Immunol. 2025 Jan;134(1):9-18. doi: 10.1016/j.anai.2024.09.016. Epub 2024 Oct 10.
- 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.
Sady Alpizar, MD principal investigator
Clinical Research Trials of Florida, Inc.
103 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexpramipexole Dihydrochloride in people with Eosinophilic Asthma, run by Areteia Therapeutics at 103 sites in 15 countries.
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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 103 sites in United States, Argentina, Ukraine, Poland, Brazil and 10 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.). Results are not available in the source record.
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?
Number and Percentage of Participants with a Treatment Emergent Adverse Event (time frame: 52 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06388889, which also lists 1 linked publication.
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 15 Dec 2025.