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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

509

Phase

  • 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

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
Intervention / Treatment
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

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

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

Areteia Therapeutics

Investigators

  • 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)

June 12, 2024

Primary Completion (Actual)

December 8, 2025

Study Completion (Actual)

December 8, 2025

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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