Phase III Long-Term Extension Study With Dexpramipexole

NCT06388889 | Terminated Phase 3 FDA Drug

• 1 other identifier: AR-DEX-22-04
• Study Type: interventional
• Target: 509
• Locations: 15 countries
• Sites: 103

Brief 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.

Conditions

Eosinophilic Asthma

Keywords

Exacerbations; Severe Asthma; EXHALE-2; EXHALE-3; EXHALE-4; Uncontrolled Asthma; Asthma Attack

Outcome Measures

Primary Outcomes (4)

• Number and Percentage of Participants with a Treatment Emergent Adverse Event

  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

  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

  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

  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 Outcomes (3)

• Severe Asthma Exacerbations

  Averaged across 52 weeks

• Change in Asthma Control Questionnaire-6 (ACQ-6)

  Day 1 (baseline), Weeks 16, 32, and 52

• Change in absolute eosinophil counts (AEC)

  Day 1 (baseline), Weeks 16, 32, and 52

Study Arms (1)

150 mg BID

EXPERIMENTAL

Dexpramipexole 150 mg oral tablet taken twice a day.

Drug: Dexpramipexole Dihydrochloride

Interventions

Dexpramipexole Dihydrochloride DRUG

Oral administration of dexpramipexole tablet

150 mg BID

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Areteia Therapeutics: lead

Study Sites (103)

Research Site 20001-374

Bakersfield, California, 93301, United States

Location

Research Site 20001-376

Northridge, California, 91324, United States

Location

Research Site 20001-029

Coral Gables, Florida, 33134, United States

Location

Research Site 20001-014

Greenacres City, Florida, 33467, United States

Location

Research Site 30001-291

Jacksonville, Florida, 32216, United States

Location

Research Site 20001-066

Miami, Florida, 33126, United States

Location

Research Site 20001-001

Miami, Florida, 33135, United States

Location

Research Site 20001-311

Miami, Florida, 33144, United States

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Research Site 20001-026

Miami, Florida, 33155, United States

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Research Site 30001-082

Miami, Florida, 33179, United States

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Research Site 20001-024

Miami, Florida, 33184, United States

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Research Site 20054-024

Miami, Florida, 33184, United States

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Research Site 30001-429

Plantation, Florida, 33137, United States

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Research Site 30001-429

Plantation, Florida, 33317, United States

Location

Research Site 20001-004

Tampa, Florida, 33607, United States

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Research Site 20001-036

Elwood, Indiana, 46036, United States

Location

Research Site 20001-044

Evansville, Indiana, 47715, United States

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Research Site 20001-006

Flint, Michigan, 48504, United States

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Research Site 20001-046

St Louis, Missouri, 63110, United States

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Research Site 20001-355

Toms River, New Jersey, 08755, United States

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Research Site 20001-047

Hawthorne, New York, 10532, United States

Location

Research Site 20001-063

Toledo, Ohio, 43617, United States

Location

Research Site 30001-297

Pearland, Texas, 77584, United States

Location

Research Site 30054-044

Buenos Aires, B1878FNR, Argentina

Location

Research Site 20054-017

Buenos Aires, C1027AAP, Argentina

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Research Site 20054-015

Buenos Aires, C1121ABE, Argentina

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Research Site 20054-022

Buenos Aires, C1414AIF, Argentina

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Research Site 20054-024

Buenos Aires, C1425BEN, Argentina

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Research Site 20054-008

Buenos Aires, C1426ABP, Argentina

Location

Research Site 20054-005

Córdoba, X5003DCE, Argentina

Location

Research Site 30054-047

Mendoza, 5509, Argentina

Location

Research Site 20054-019

Mendoza, M5500AXR, Argentina

Location

Research Site 20054-016

Mendoza, M5500CBA, Argentina

Location

Research Site 20054-010

Mendoza, M5500CCG, Argentina

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Research Site 20054-002

San Miguel de Tucumán, T4000CBC, Argentina

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Research Site 20054-020

San Miguel de Tucumán, T4000IAP, Argentina

Location

Research Site 20054-013

Santa Fe, 5509, Argentina

Location

Research Site 20055-007

Blumenau, 89030-101, Brazil

Location

Research Site 20055-004

Porto Alegre, 90610-000, Brazil

Location

Research Site 20055-010

Porto Alegre, 91010-006, Brazil

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Research Site 20055-001

São Bernardo, 09715-590, Brazil

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Research Site 20055-003

São Paulo, 05403-000, Brazil

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Research Site 20055-008

São Paulo, 09090-790, Brazil

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Research Site 20055-002

Sorocaba, 18040-425, Brazil

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Research Site 20359-016

Dimitrovgrad, 3703, Bulgaria

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Research Site 20359-008

Montana, 3400, Bulgaria

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Research Site 20359-010

Pernik, 2300, Bulgaria

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Research Site 20359-005

Rousse, 7002, Bulgaria

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Research Site 20359-009

Sliven, 8800, Bulgaria

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Research Site 20359-016

Vidin, 3703, Bulgaria

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Research Site 20995-001

Kutaisi, 4600, Georgia

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Research Site 20995-005

Tbilisi, 0102, Georgia

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Research Site 20995-006

Tbilisi, 0144, Georgia

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Research Site 20995-002

Tbilisi, 0159, Georgia

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Research Site 20995-003

Tbilisi, 0159, Georgia

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Research Site 20995-004

Tbilisi, 0159, Georgia

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Research Site 20995-009

Tbilisi, 0159, Georgia

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Research Site 20081-023

Tokyo, 140-8522, Japan

Location

Research Site 20052-002

Guadalajara, 44200, Mexico

Location

Research Site 20052-012

San Juan del Río, 76800, Mexico

Location

Research Site 20052-014

Tijuana, 22010, Mexico

Location

Research Site 20389-004

Skopje, 1000, North Macedonia

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Research Site 20389-007

Skopje, 1000, North Macedonia

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Research Site 20048-018

Bialystok, 15-044, Poland

Location

Research Site 20048-006

Giżycko, 11-500, Poland

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Research Site 20048-008

Krakow, 20-001, Poland

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Research Site 20048-027

Krakow, 30-033, Poland

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Research Site 20048-033

Krakow, 31-011, Poland

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Research Site 20048-005

Lodz, 50-549, Poland

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Research Site 20048-031

Ostrów Wielkopolski, 27-400, Poland

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Research Site 20048-010

Piaseczno, 05-500, Poland

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Research Site 20048-028

Poznan, 60-693, Poland

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Research Site 20048-016

Poznan, 61-578, Poland

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Research Site 20040-002

Brasov, 500051, Romania

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Research Site 20040-004

Brasov, 500366, Romania

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Research Site 20381-002

Belgrade, 11000, Serbia

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Research Site 20381-005

Belgrade, 11000, Serbia

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Research Site 20381-007

Belgrade, 11000, Serbia

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Research Site 20381-003

Valjevo, 14000, Serbia

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Research Site 30027-010

Durban, Kwa-ZuIu Natal, South Africa

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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, 4001, South Africa

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Research Site 30027-014

Durban, 4091, South Africa

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Research Site 30027-010

Durban, 4450, South Africa

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Research Site 20082-003

Anyang-si, 14068, South Korea

Location

Research Site 20082-009

Daegu, 42415, South Korea

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Research Site 20082-006

Jeonju, 54907, South Korea

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Research Site 20082-008

Seoul, 6591, South Korea

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Research Site 20380-002

Chernivtsi, 58001, Ukraine

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Research Site 20380-014

Ivano-Frankivsk, 76019, Ukraine

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Research Site 20380-004

Ivano-Frankivsk, Ukraine

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Research Site 20380-018

Kyiv, 03037, Ukraine

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Research Site 20380-007

Kyiv, 03038, 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, 46023, Ukraine

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Research Site 20380-003

Vinnytsia, 21001, Ukraine

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Research Site 20380-003

Zhytomyr, 10002, Ukraine

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Research Site 20380-005

Zhytomyr, 10002, Ukraine

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Research Site 20044-020

Manchester, "M15 6SE ", United Kingdom

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Research Site 20044-026

Rochdale, OL11 4AU, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Eosinophilia; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sady Alpizar, MD

  Clinical Research Trials of Florida, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 29, 2024
• Study Start: June 12, 2024
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (10); BR (7); KR (4); AR (14); GB (2); NO (2); JP (1); US (23); ZA (6); SE (4); ME (3); RO (2); UA (12); BU (6); GE (7)