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Phase III Long-Term Extension Study With Dexpramipexole

NCT ID: NCT06388889

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

509 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-12

Study Completion Date

2025-12-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Eosinophilic Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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150 mg BID

Dexpramipexole 150 mg oral tablet taken twice a day.

Group Type EXPERIMENTAL

Dexpramipexole Dihydrochloride

Intervention Type DRUG

Oral administration of dexpramipexole tablet

Interventions

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Dexpramipexole Dihydrochloride

Oral administration of dexpramipexole tablet

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Areteia Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sady Alpizar, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Trials of Florida, Inc.

Locations

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Research Site 20001-374

Bakersfield, California, United States

Site Status

Research Site 20001-376

Northridge, California, United States

Site Status

Research Site 20001-029

Coral Gables, Florida, United States

Site Status

Research Site 20001-014

Greenacres City, Florida, United States

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Research Site 30001-291

Jacksonville, Florida, United States

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Research Site 20001-066

Miami, Florida, United States

Site Status

Research Site 20001-001

Miami, Florida, United States

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Research Site 20001-311

Miami, Florida, United States

Site Status

Research Site 20001-026

Miami, Florida, United States

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Research Site 30001-082

Miami, Florida, United States

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Research Site 20001-024

Miami, Florida, United States

Site Status

Research Site 20054-024

Miami, Florida, United States

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Research Site 30001-429

Plantation, Florida, United States

Site Status

Research Site 30001-429

Plantation, Florida, United States

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Research Site 20001-004

Tampa, Florida, United States

Site Status

Research Site 20001-036

Elwood, Indiana, United States

Site Status

Research Site 20001-044

Evansville, Indiana, United States

Site Status

Research Site 20001-006

Flint, Michigan, United States

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Research Site 20001-046

St Louis, Missouri, United States

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Research Site 20001-355

Toms River, New Jersey, United States

Site Status

Research Site 20001-047

Hawthorne, New York, United States

Site Status

Research Site 20001-063

Toledo, Ohio, United States

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Research Site 30001-297

Pearland, Texas, United States

Site Status

Research Site 30054-044

Buenos Aires, , Argentina

Site Status

Research Site 20054-017

Buenos Aires, , Argentina

Site Status

Research Site 20054-015

Buenos Aires, , Argentina

Site Status

Research Site 20054-022

Buenos Aires, , Argentina

Site Status

Research Site 20054-024

Buenos Aires, , Argentina

Site Status

Research Site 20054-008

Buenos Aires, , Argentina

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Research Site 20054-005

Córdoba, , Argentina

Site Status

Research Site 30054-047

Mendoza, , Argentina

Site Status

Research Site 20054-019

Mendoza, , Argentina

Site Status

Research Site 20054-016

Mendoza, , Argentina

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Research Site 20054-010

Mendoza, , Argentina

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Research Site 20054-002

San Miguel de Tucumán, , Argentina

Site Status

Research Site 20054-020

San Miguel de Tucumán, , Argentina

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Research Site 20054-013

Santa Fe, , Argentina

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Research Site 20055-007

Blumenau, , Brazil

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Research Site 20055-004

Porto Alegre, , Brazil

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Research Site 20055-010

Porto Alegre, , Brazil

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Research Site 20055-001

São Bernardo, , Brazil

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Research Site 20055-003

São Paulo, , Brazil

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Research Site 20055-008

São Paulo, , Brazil

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Research Site 20055-002

Sorocaba, , Brazil

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Research Site 20359-016

Dimitrovgrad, , Bulgaria

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Research Site 20359-008

Montana, , Bulgaria

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Research Site 20359-010

Pernik, , Bulgaria

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Research Site 20359-005

Rousse, , Bulgaria

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Research Site 20359-009

Sliven, , Bulgaria

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Research Site 20359-016

Vidin, , Bulgaria

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Research Site 20995-001

Kutaisi, , Georgia

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Research Site 20995-005

Tbilisi, , Georgia

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Research Site 20995-006

Tbilisi, , Georgia

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Research Site 20995-002

Tbilisi, , Georgia

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Research Site 20995-003

Tbilisi, , Georgia

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Research Site 20995-004

Tbilisi, , Georgia

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Research Site 20995-009

Tbilisi, , Georgia

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Research Site 20081-023

Tokyo, , Japan

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Research Site 20052-002

Guadalajara, , Mexico

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Research Site 20052-012

San Juan del Río, , Mexico

Site Status

Research Site 20052-014

Tijuana, , Mexico

Site Status

Research Site 20389-004

Skopje, , North Macedonia

Site Status

Research Site 20389-007

Skopje, , North Macedonia

Site Status

Research Site 20048-018

Bialystok, , Poland

Site Status

Research Site 20048-006

Giżycko, , Poland

Site Status

Research Site 20048-008

Krakow, , Poland

Site Status

Research Site 20048-027

Krakow, , Poland

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Research Site 20048-033

Krakow, , Poland

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Research Site 20048-005

Lodz, , Poland

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Research Site 20048-031

Ostrów Wielkopolski, , Poland

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Research Site 20048-010

Piaseczno, , Poland

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Research Site 20048-028

Poznan, , Poland

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Research Site 20048-016

Poznan, , Poland

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Research Site 20040-002

Brasov, , Romania

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Research Site 20040-004

Brasov, , Romania

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Research Site 20381-002

Belgrade, , Serbia

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Research Site 20381-005

Belgrade, , Serbia

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Research Site 20381-007

Belgrade, , Serbia

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Research Site 20381-003

Valjevo, , Serbia

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Research Site 30027-010

Durban, Kwa-ZuIu Natal, South Africa

Site Status

Research Site 30027-008

Durban, KwaZulu-Natal, South Africa

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Research Site 30027-009

Cape Town, Western Cape, South Africa

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Research Site 30027-005

Durban, , South Africa

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Research Site 30027-014

Durban, , South Africa

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Research Site 30027-010

Durban, , South Africa

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Research Site 20082-003

Anyang-si, , South Korea

Site Status

Research Site 20082-009

Daegu, , South Korea

Site Status

Research Site 20082-006

Jeonju, , South Korea

Site Status

Research Site 20082-008

Seoul, , South Korea

Site Status

Research Site 20380-002

Chernivtsi, , Ukraine

Site Status

Research Site 20380-014

Ivano-Frankivsk, , Ukraine

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Research Site 20380-004

Ivano-Frankivsk, , Ukraine

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Research Site 20380-018

Kyiv, , Ukraine

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Research Site 20380-007

Kyiv, , Ukraine

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Research Site 20380-010

Kyiv, , Ukraine

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Research Site 20380-012

Kyiv, , Ukraine

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Research Site 20380-013

Kyiv, , Ukraine

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Research Site 20380-001

Ternopil, , Ukraine

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Research Site 20380-003

Vinnytsia, , Ukraine

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Research Site 20380-003

Zhytomyr, , Ukraine

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Research Site 20380-005

Zhytomyr, , Ukraine

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Research Site 20044-020

Manchester, , United Kingdom

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Research Site 20044-026

Rochdale, , United Kingdom

Site Status

Countries

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United States Argentina Brazil Bulgaria Georgia Japan Mexico North Macedonia Poland Romania Serbia South Africa South Korea Ukraine United Kingdom

Other Identifiers

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AR-DEX-22-04

Identifier Type: -

Identifier Source: org_study_id

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