Phase III Long-Term Extension Study With Dexpramipexole (EXHALE-5)

December 10, 2025 updated by: Areteia Therapeutics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
509

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1027AAP
        • Research Site 20054-017
      • Buenos Aires, Argentina, C1121ABE
        • Research Site 20054-015
      • Buenos Aires, Argentina, C1414AIF
        • Research Site 20054-022
      • Buenos Aires, Argentina, C1425BEN
        • Research Site 20054-024
      • Buenos Aires, Argentina, C1426ABP
        • Research Site 20054-008
      • Buenos Aires, Argentina, B1878FNR
        • Research Site 30054-044
      • Córdoba, Argentina, X5003DCE
        • Research Site 20054-005
      • Mendoza, Argentina, M5500AXR
        • Research Site 20054-019
      • Mendoza, Argentina, M5500CBA
        • Research Site 20054-016
      • Mendoza, Argentina, M5500CCG
        • Research Site 20054-010
      • Mendoza, Argentina, 5509
        • Research Site 30054-047
      • San Miguel de Tucumán, Argentina, T4000CBC
        • Research Site 20054-002
      • San Miguel de Tucumán, Argentina, T4000IAP
        • Research Site 20054-020
      • Santa Fe, Argentina, 5509
        • Research Site 20054-013
  • Brazil
      • Blumenau, Brazil, 89030-101
        • Research Site 20055-007
      • Porto Alegre, Brazil, 90610-000
        • Research Site 20055-004
      • Porto Alegre, Brazil, 91010-006
        • Research Site 20055-010
      • Sorocaba, Brazil, 18040-425
        • Research Site 20055-002
      • São Bernardo, Brazil, 09715-590
        • Research Site 20055-001
      • São Paulo, Brazil, 05403-000
        • Research Site 20055-003
      • São Paulo, Brazil, 09090-790
        • Research Site 20055-008
  • Bulgaria
      • Dimitrovgrad, Bulgaria, 3703
        • Research Site 20359-016
      • Montana, Bulgaria, 3400
        • Research Site 20359-008
      • Pernik, Bulgaria, 2300
        • Research Site 20359-010
      • Rousse, Bulgaria, 7002
        • Research Site 20359-005
      • Sliven, Bulgaria, 8800
        • Research Site 20359-009
      • Vidin, Bulgaria, 3703
        • Research Site 20359-016
  • Georgia
      • Kutaisi, Georgia, 4600
        • Research Site 20995-001
      • Tbilisi, Georgia, 0102
        • Research Site 20995-005
      • Tbilisi, Georgia, 0144
        • Research Site 20995-006
      • Tbilisi, Georgia, 0159
        • Research Site 20995-002
      • Tbilisi, Georgia, 0159
        • Research Site 20995-003
      • Tbilisi, Georgia, 0159
        • Research Site 20995-004
      • Tbilisi, Georgia, 0159
        • Research Site 20995-009
  • Japan
      • Tokyo, Japan, 140-8522
        • Research Site 20081-023
  • Mexico
      • Guadalajara, Mexico, 44200
        • Research Site 20052-002
      • San Juan del Río, Mexico, 76800
        • Research Site 20052-012
      • Tijuana, Mexico, 22010
        • Research Site 20052-014
  • North Macedonia
      • Skopje, North Macedonia, 1000
        • Research Site 20389-004
      • Skopje, North Macedonia, 1000
        • Research Site 20389-007
  • Poland
      • Bialystok, Poland, 15-044
        • Research Site 20048-018
      • Giżycko, Poland, 11-500
        • Research Site 20048-006
      • Krakow, Poland, 20-001
        • Research Site 20048-008
      • Krakow, Poland, 30-033
        • Research Site 20048-027
      • Krakow, Poland, 31-011
        • Research Site 20048-033
      • Lodz, Poland, 50-549
        • Research Site 20048-005
      • Ostrów Wielkopolski, Poland, 27-400
        • Research Site 20048-031
      • Piaseczno, Poland, 05-500
        • Research Site 20048-010
      • Poznan, Poland, 61-578
        • Research Site 20048-016
      • Poznan, Poland, 60-693
        • Research Site 20048-028
  • Romania
      • Brasov, Romania, 500051
        • Research Site 20040-002
      • Brasov, Romania, 500366
        • Research Site 20040-004
  • Serbia
      • Belgrade, Serbia, 11000
        • Research Site 20381-002
      • Belgrade, Serbia, 11000
        • Research Site 20381-007
      • Belgrade, Serbia, 11000
        • Research Site 20381-005
      • Valjevo, Serbia, 14000
        • Research Site 20381-003
  • South Africa
      • Durban, South Africa, 4001
        • Research Site 30027-005
      • Durban, South Africa, 4091
        • Research Site 30027-014
      • Durban, South Africa, 4450
        • Research Site 30027-010
    • Kwa-ZuIu Natal
      • Durban, Kwa-ZuIu Natal, South Africa
        • Research Site 30027-010
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa
        • Research Site 30027-008
    • Western Cape
      • Cape Town, Western Cape, South Africa
        • Research Site 30027-009
  • South Korea
      • Anyang-si, South Korea, 14068
        • Research Site 20082-003
      • Daegu, South Korea, 42415
        • Research Site 20082-009
      • Jeonju, South Korea, 54907
        • Research Site 20082-006
      • Seoul, South Korea, 6591
        • Research Site 20082-008
  • Ukraine
      • Chernivtsi, Ukraine, 58001
        • Research Site 20380-002
      • Ivano-Frankivsk, Ukraine, 76019
        • Research Site 20380-014
      • Ivano-Frankivsk, Ukraine
        • Research Site 20380-004
      • Kyiv, Ukraine
        • Research Site 20380-010
      • Kyiv, Ukraine
        • Research Site 20380-012
      • Kyiv, Ukraine
        • Research Site 20380-013
      • Kyiv, Ukraine, 03038
        • Research Site 20380-007
      • Kyiv, Ukraine, 03037
        • Research Site 20380-018
      • Ternopil, Ukraine, 46023
        • Research Site 20380-001
      • Vinnytsia, Ukraine, 21001
        • Research Site 20380-003
      • Zhytomyr, Ukraine, 10002
        • Research Site 20380-005
      • Zhytomyr, Ukraine, 10002
        • Research Site 20380-003
  • United Kingdom
      • Manchester, United Kingdom, "M15 6SE "
        • Research Site 20044-020
      • Rochdale, United Kingdom, OL11 4AU
        • Research Site 20044-026
  • United States
    • California
      • Bakersfield, California, United States, 93301
        • Research Site 20001-374
      • Northridge, California, United States, 91324
        • Research Site 20001-376
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Research Site 20001-029
      • Greenacres City, Florida, United States, 33467
        • Research Site 20001-014
      • Jacksonville, Florida, United States, 32216
        • Research Site 30001-291
      • Miami, Florida, United States, 33126
        • Research Site 20001-066
      • Miami, Florida, United States, 33155
        • Research Site 20001-026
      • Miami, Florida, United States, 33144
        • Research Site 20001-311
      • Miami, Florida, United States, 33179
        • Research Site 30001-082
      • Miami, Florida, United States, 33184
        • Research Site 20054-024
      • Miami, Florida, United States, 33135
        • Research Site 20001-001
      • Miami, Florida, United States, 33184
        • Research Site 20001-024
      • Plantation, Florida, United States, 33137
        • Research Site 30001-429
      • Plantation, Florida, United States, 33317
        • Research Site 30001-429
      • Tampa, Florida, United States, 33607
        • Research Site 20001-004
    • Indiana
      • Elwood, Indiana, United States, 46036
        • Research Site 20001-036
      • Evansville, Indiana, United States, 47715
        • Research Site 20001-044
    • Michigan
      • Flint, Michigan, United States, 48504
        • Research Site 20001-006
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Research Site 20001-046
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Research Site 20001-355
    • New York
      • Hawthorne, New York, United States, 10532
        • Research Site 20001-047
    • Ohio
      • Toledo, Ohio, United States, 43617
        • Research Site 20001-063
    • Texas
      • Pearland, Texas, United States, 77584
        • Research Site 30001-297

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants who completed the double-blind study intervention treatment period during either of the Phase III studies EXHALE-2 or EXHALE-3.
  2. 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.
  3. Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Baseline Visit/Day 1.

  4. 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:

    1. 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-
    2. 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:
    3. 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.
    4. 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.

Exclusion Criteria:

  1. 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.
  2. Participants with allergy/intolerance to dexpramipexole or any of its excipients.
  3. 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..
  4. Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days.
  5. Pregnant or breastfeeding women.
  6. Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 150 mg BID
Dexpramipexole 150 mg oral tablet taken twice a day.
Drug: Dexpramipexole Dihydrochloride
Oral administration of dexpramipexole tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
52 weeks
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.
52 weeks
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.
52 weeks
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.
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severe Asthma Exacerbations
Time Frame: Averaged across 52 weeks
Annualized rate of severe asthma exacerbations over 52 weeks
Averaged across 52 weeks
Change in Asthma Control Questionnaire-6 (ACQ-6)
Time Frame: Day 1 (baseline), Weeks 16, 32, and 52
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).
Day 1 (baseline), Weeks 16, 32, and 52
Change in absolute eosinophil counts (AEC)
Time Frame: Day 1 (baseline), Weeks 16, 32, and 52
Change from baseline, at Weeks 16, 32, and 52.
Day 1 (baseline), Weeks 16, 32, and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Areteia Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sady Alpizar, MD, Clinical Research Trials of Florida, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AR-DEX-22-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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