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Asthma drug safety check: dexpramipexole under Long-Term review

NCT ID NCT06388889

Disease control Sponsor: Areteia Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of dexpramipexole in adults with severe eosinophilic asthma. Participants had already completed earlier phase 3 trials. The goal was to track side effects and asthma control over time. However, the study was terminated early, which may limit what we can learn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dexpramipexole
What this could lead to
If successful, this could confirm dexpramipexole as a safe long-term treatment option for severe eosinophilic asthma.
What could go wrong
The study was terminated early, so results may be limited. It only included people who already tolerated the drug in earlier trials, which may not reflect broader patient experiences.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

509 people

The number who actually took part.

Started

Jun 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

asthma pulmonary eosinophilia T2-high asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eosinophilic asthma

Contacts and locations

Locations

  • Research Site 20001-001

    Miami, Florida, 33135, United States

  • Research Site 20001-004

    Tampa, Florida, 33607, United States

  • Research Site 20001-006

    Flint, Michigan, 48504, United States

  • Research Site 20001-014

    Greenacres City, Florida, 33467, United States

  • Research Site 20001-024

    Miami, Florida, 33184, United States

  • Research Site 20001-026

    Miami, Florida, 33155, United States

  • Research Site 20001-029

    Coral Gables, Florida, 33134, United States

  • Research Site 20001-036

    Elwood, Indiana, 46036, United States

  • Research Site 20001-044

    Evansville, Indiana, 47715, United States

  • Research Site 20001-046

    St Louis, Missouri, 63110, United States

  • Research Site 20001-047

    Hawthorne, New York, 10532, United States

  • Research Site 20001-063

    Toledo, Ohio, 43617, United States

  • Research Site 20001-066

    Miami, Florida, 33126, United States

  • Research Site 20001-311

    Miami, Florida, 33144, United States

  • Research Site 20001-355

    Toms River, New Jersey, 08755, United States

  • Research Site 20001-374

    Bakersfield, California, 93301, United States

  • Research Site 20001-376

    Northridge, California, 91324, United States

  • Research Site 20040-002

    Brasov, 500051, Romania

  • Research Site 20040-004

    Brasov, 500366, Romania

  • Research Site 20044-020

    Manchester, "M15 6SE ", United Kingdom

  • Research Site 20044-026

    Rochdale, OL11 4AU, United Kingdom

  • Research Site 20048-005

    Lodz, 50-549, Poland

  • Research Site 20048-006

    Giżycko, 11-500, Poland

  • Research Site 20048-008

    Krakow, 20-001, Poland

  • Research Site 20048-010

    Piaseczno, 05-500, Poland

  • Research Site 20048-016

    Poznan, 61-578, Poland

  • Research Site 20048-018

    Bialystok, 15-044, Poland

  • Research Site 20048-027

    Krakow, 30-033, Poland

  • Research Site 20048-028

    Poznan, 60-693, Poland

  • Research Site 20048-031

    Ostrów Wielkopolski, 27-400, Poland

  • Research Site 20048-033

    Krakow, 31-011, Poland

  • Research Site 20052-002

    Guadalajara, 44200, Mexico

  • Research Site 20052-012

    San Juan del Río, 76800, Mexico

  • Research Site 20052-014

    Tijuana, 22010, Mexico

  • Research Site 20054-002

    San Miguel de Tucumán, T4000CBC, Argentina

  • Research Site 20054-005

    Córdoba, X5003DCE, Argentina

  • Research Site 20054-008

    Buenos Aires, C1426ABP, Argentina

  • Research Site 20054-010

    Mendoza, M5500CCG, Argentina

  • Research Site 20054-013

    Santa Fe, 5509, Argentina

  • Research Site 20054-015

    Buenos Aires, C1121ABE, Argentina

  • Research Site 20054-016

    Mendoza, M5500CBA, Argentina

  • Research Site 20054-017

    Buenos Aires, C1027AAP, Argentina

  • Research Site 20054-019

    Mendoza, M5500AXR, Argentina

  • Research Site 20054-020

    San Miguel de Tucumán, T4000IAP, Argentina

  • Research Site 20054-022

    Buenos Aires, C1414AIF, Argentina

  • Research Site 20054-024

    Miami, Florida, 33184, United States

  • Research Site 20054-024

    Buenos Aires, C1425BEN, Argentina

  • Research Site 20055-001

    São Bernardo, 09715-590, Brazil

  • Research Site 20055-002

    Sorocaba, 18040-425, Brazil

  • Research Site 20055-003

    São Paulo, 05403-000, Brazil

  • Research Site 20055-004

    Porto Alegre, 90610-000, Brazil

  • Research Site 20055-007

    Blumenau, 89030-101, Brazil

  • Research Site 20055-008

    São Paulo, 09090-790, Brazil

  • Research Site 20055-010

    Porto Alegre, 91010-006, Brazil

  • Research Site 20081-023

    Tokyo, 140-8522, Japan

  • Research Site 20082-003

    Anyang-si, 14068, South Korea

  • Research Site 20082-006

    Jeonju, 54907, South Korea

  • Research Site 20082-008

    Seoul, 6591, South Korea

  • Research Site 20082-009

    Daegu, 42415, South Korea

  • Research Site 20359-005

    Rousse, 7002, Bulgaria

  • Research Site 20359-008

    Montana, 3400, Bulgaria

  • Research Site 20359-009

    Sliven, 8800, Bulgaria

  • Research Site 20359-010

    Pernik, 2300, Bulgaria

  • Research Site 20359-016

    Dimitrovgrad, 3703, Bulgaria

  • Research Site 20359-016

    Vidin, 3703, Bulgaria

  • Research Site 20380-001

    Ternopil, 46023, Ukraine

  • Research Site 20380-002

    Chernivtsi, 58001, Ukraine

  • Research Site 20380-003

    Vinnytsia, 21001, Ukraine

  • Research Site 20380-003

    Zhytomyr, 10002, Ukraine

  • Research Site 20380-004

    Ivano-Frankivsk, Ukraine

  • Research Site 20380-005

    Zhytomyr, 10002, Ukraine

  • Research Site 20380-007

    Kyiv, 03038, Ukraine

  • Research Site 20380-010

    Kyiv, Ukraine

  • Research Site 20380-012

    Kyiv, Ukraine

  • Research Site 20380-013

    Kyiv, Ukraine

  • Research Site 20380-014

    Ivano-Frankivsk, 76019, Ukraine

  • Research Site 20380-018

    Kyiv, 03037, Ukraine

  • Research Site 20381-002

    Belgrade, 11000, Serbia

  • Research Site 20381-003

    Valjevo, 14000, Serbia

  • Research Site 20381-005

    Belgrade, 11000, Serbia

  • Research Site 20381-007

    Belgrade, 11000, Serbia

  • Research Site 20389-004

    Skopje, 1000, North Macedonia

  • Research Site 20389-007

    Skopje, 1000, North Macedonia

  • Research Site 20995-001

    Kutaisi, 4600, Georgia

  • Research Site 20995-002

    Tbilisi, 0159, Georgia

  • Research Site 20995-003

    Tbilisi, 0159, Georgia

  • Research Site 20995-004

    Tbilisi, 0159, Georgia

  • Research Site 20995-005

    Tbilisi, 0102, Georgia

  • Research Site 20995-006

    Tbilisi, 0144, Georgia

  • Research Site 20995-009

    Tbilisi, 0159, Georgia

  • Research Site 30001-082

    Miami, Florida, 33179, United States

  • Research Site 30001-291

    Jacksonville, Florida, 32216, United States

  • Research Site 30001-297

    Pearland, Texas, 77584, United States

  • Research Site 30001-429

    Plantation, Florida, 33137, United States

  • Research Site 30001-429

    Plantation, Florida, 33317, United States

  • Research Site 30027-005

    Durban, 4001, South Africa

  • Research Site 30027-008

    Durban, KwaZulu-Natal, South Africa

  • Research Site 30027-009

    Cape Town, Western Cape, South Africa

  • Research Site 30027-010

    Durban, Kwa-ZuIu Natal, South Africa

  • Research Site 30027-010

    Durban, 4450, South Africa

  • Research Site 30027-014

    Durban, 4091, South Africa

  • Research Site 30054-044

    Buenos Aires, B1878FNR, Argentina

  • Research Site 30054-047

    Mendoza, 5509, Argentina

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