AzTrials
AzTrials

Eosinophilic AsthmaPhase 3EXHALE-3NCT05813288

A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma (EXHALE-3)

A Phase 3 study testing Dexpramipexole Dihydrochloride in people with Eosinophilic Asthma and Asthma; Eosinophilic, run by Areteia Therapeutics at 282 sites in 26 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The objective of this clinical study is to investigate the safety, tolerability, and efficacy of dexpramipexole in participants with inadequately controlled severe eosinophilic asthma. Read more about this study

Who is it for?
Ages 12 to 99 years
Conditions the study is for
Eosinophilic Asthma, Asthma; Eosinophilic, Asthma
What is being tested?
Dexpramipexole Dihydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
654 participants
Where
282 sitesin 26 countries
Study dates
27 Mar 2023to 8 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Signed informed consent form and assent form, as appropriate.
  • Male or female ≥12 years of age at Screening Visit 1.
  • Asthma-related criteria
  • Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1.
  • Eosinophil count of ≥0.30x10⁹/L at Screening Visit 1. If the initial value is between 0.250x10⁹/L to 0.299x10⁹/L, then this may be repeated once at an unscheduled visit (prior to Screening Visit 2).
  • Treatment of asthma, participants must satisfy all the below (items a to c):
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  • Participants who have received asthma controller medication with medium or high dose inhaled corticosteroids (ICS ≥500 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per GINA 2021) on a regular basis for at least 12 months prior to Screening Visit 1.
  • Documented treatment with a stable dose of either medium or high dose ICS for at least 3 months prior to Visit 1. The ICS may be contained within an ICS/long-acting β2 agonist (LABA) combination product. Daily oral corticosteroids are an allowed concomitant medication; participants on daily oral corticosteroids must be on a stable dose for 3 months before Screening Visit 1.
  • Use of one of more additional daily maintenance asthma controller medications according to standard practice of care is required. Use of a stable dose of any additional asthma controller medications must be documented for at least 3 months prior to Screening Visit 1.
  • Pre-BD FEV₁ ≥40% and <80% (<90% for participants 12 to 17 years of age) of predicted at Screening Visit 2.
  • Variable airflow obstruction documented with at least one of the following criteria:
  • Bronchodilator reversibility at Screening Visit 2, as evidenced by ≥12% and ≥200 mL improvement in FEV₁, 15 to 30 minutes following inhalation of 400 µg (four puffs) of albuterol/salbutamol (≥12% and ≥160 mL for ages 12 to 17). Participants who do not meet the bronchodilator reversibility inclusion criterion but have ≥10% and ≥160 mL reversibility, may repeat the reversibility spirometry assessment once during the Screening period, at an unscheduled visit at least 7 days prior to baseline.
  • Bronchodilator reversibility, using the criteria above, documented in the past 24 months prior to Screening Visit 1 or during Screening.
  • Peak flow variation of ≥20% over a 2-week period, documented in the past 24 months prior to Screening Visit 1 or during Screening.
  • Airflow variability in clinic FEV₁ ≥20% between two consecutive clinic visits, documented in the past 24 months prior to Screening Visit 1.
  • Airway hyperresponsiveness (provocative concentration causing a 20% fall in FEV₁ of methacholine <8 mg/mL or other clinically relevant bronchoprovocation testing) documented in the past 24 months prior to Screening Visit 1 or during Screening.
  • ACQ-6 ≥1.5 at Screening Visit 2.
  • Documented history of at least two asthma exacerbations requiring treatment with systemic corticosteroids (intramuscular, intravenous, or oral) within the past 12-month period prior to Screening Visit 1.
  • General medical history
  • Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Screening and Baseline visits.
  • WOCBP must use either of the following methods of birth control, from Screening Visit 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 (IUS), 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 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.

Who cannot join

  • Asthma-related criteria
  • A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids) at any time from 4 weeks prior to Screening Visit 1.
  • Participants who experience an asthma exacerbation during the Screening/Run-in Period may remain in screening and proceed with study visits 14 days after they have completed their course of oral steroids or returned to their pre-Screening Visit maintenance dose of oral steroids and the investigator considers participant has returned to baseline status.
  • Current diagnosis of diseases which may confound interpretation of this study's findings such as allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis with polyangiitis, eosinophilic gastrointestinal diseases, hypereosinophilic syndrome, or lung diseases (eg, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis).
  • Respiratory infection: Upper or lower respiratory tract, sinus, or middle ear infection within the 4 weeks before Screening Visit 1.
  • Prohibited medications/procedures
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  • Treatment with a biologic investigational drug in the last 5 months prior to Screening Visit 1. Treatment with non-biologic investigational drugs in the previous 30 days or five-half-lives prior to Screening Visit 1, whichever is longer. Treatment with GSK3511294 (long-acting anti-IL-5) in the past 12 months.
  • Treatment with any of the following monoclonal antibody therapies within 120 days prior to Baseline: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab.
  • Treatment with pramipexole (Mirapex®) within 30 days of Baseline.
  • Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days prior to Screening Visit 1.
  • Bronchial thermoplasty procedure in the past 12 months prior to Screening Visit 1 or planned during the coming year.
  • General medical history
  • Weight <40 kg at Screening Visit 1.
  • Current smoking within 12 months prior to Screening Visit 1 or a smoking history of >10 pack-years. Smoking includes tobacco, vaping, and/or marijuana use.
  • Known or suspected alcohol or drug abuse
  • Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to Baseline Visit despite anti-hypertensive therapy.
  • History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the 5 years prior to Baseline Visit.
  • History of human immunodeficiency virus (HIV) infection or chronic infection with hepatitis B or C.
  • A helminth parasitic infection diagnosed within 24 weeks prior Screening Visit 1 that has not been treated with or has failed to respond to standard of care (SoC) therapy.
  • Medical or other condition likely to interfere with participant's ability to undergo study procedures, adhere to visit schedule, or comply with study requirements.
  • Known or suspected noncompliance with medication.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Clinical safety labs
  • Absolute neutrophil count <2.000x10⁹/L at screening at Screening Visit 1 or Screening Visit 2.
  • Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m² at Screening Visit 2 (using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula [Levey et al, 2009] for age ≥18 years at screening; using the Bedside Schwartz [Schwartz and Work, 2009] eGFR formula for age <18).
  • Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), >3x the upper limit of normal (ULN), or total bilirubin >2x ULN at Screening Visit 2 confirmed by a repeat abnormal measurement of the relevant value(s), at least 1 week apart.
  • Cardiac safety
  • History of New York Heart Association class IV heart failure or last known left ventricular ejection fraction <25%.
  • History of major adverse cardiovascular event (MACE) within 3 months prior to the Baseline Visit.
  • History of cardiac arrhythmia within 3 months prior to Baseline Visit that is not controlled by medication or via ablation.
  • History of long QT syndrome.
  • Corrected QT interval by Fridericia (QTcF) interval >450 ms for males and >470 ms for females at Screening Visit 2 or QTcF ≥480 ms for participants with bundle branch block.
  • Clinically important abnormalities in resting ECG that may interfere with the interpretation of QTcF interval changes at Screening Visit 2, including heart rate <45 beats per minute (bpm) or >100 bpm.
  • Pregnancy/Lactation
  • Pregnant women or women breastfeeding.
  • Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).
  • Allergy or hypersensitivity to dexpramipexole or any of its components.

Trial locations and contacts

282 sites in 26 countries.

282 sites in 26 countries

United States76 sites

  • Research Site 30001-437

    Alexandria, Louisiana, 71303

  • Research Site 30001-334

    Allen, Texas, 60607

  • Research Site 30001-414

    Annapolis, Maryland, 37067

  • Research Site 30001-090

    Austin, Texas, 78726

  • Research Site 30001-502

    Canoga Park, California, 91303

  • Research Site 30001-487

    Chandler, Arizona, 85224

  • Research Site 30001-398

    Charlotte, North Carolina, 28277

  • Research Site 30001-413

    Cleveland, Ohio, 44106

  • Research Site 30001-495

    Columbus, Ohio, 43235

  • Research Site 30001-415

    Dallas, Texas, 75246

  • Research Site 30001-452

    Dunwoody, Georgia, 30350

  • Research Site 30001-483

    East Point, Georgia, 30344

  • Research Site 30001-363

    Edison, New Jersey, 08817

  • Research Site 30001-472

    Farmington Hills, Michigan, 48336

  • Research Site 30001-414

    Franklin, Tennessee, 37067

  • Research Site US-30001-418

    Frisco, Texas, 75034

  • Research Site 30001-499

    Hamilton, New Jersey, 08619

  • Research Site 30001-299

    Houston, Texas, 77063

  • Research Site 30001-485

    Inglewood, California, 96410

  • Research Site 30001-291

    Jacksonville, Florida, 32216

  • Research Site 30001-315

    Katy, Texas, 77494

  • Research Site 30001-286

    Lafayette, Louisiana, 70508

  • Research Site 30001-362

    Laguna Niguel, California, 92677

  • Research Site 30001-366

    Lilburn, Georgia, 30047

  • Research Site 30001-010

    Little Rock, Arkansas, 72212

  • Research Site 30001-497

    Los Angeles, California, 90017

  • Research Site 30001-347

    Louisville, Kentucky, 40202

  • Research Site 30001-318

    Maitland, Florida, 32751

  • Research Site 30001-421

    Mankato, Minnesota, 56001

  • Research Site 30001-313

    Marrero, Louisiana, 70072

  • Research Site 30001-474

    Massena, New York, 13662

  • Research Site 30001-328

    Maywood, Illinois, 60153

  • Research Site 30001-295

    McKinney, Texas, 75069

  • Research Site 30001-364

    Memphis, Tennessee, 38105

  • Research Site 30001-373

    Mesquite, Texas, 75150

  • Research Site 30001-311

    Miami, Florida, 33144

  • Research Site 30001-288

    Miami, Florida, 33165

  • Research Site 30001-310

    Miami, Florida, 33165

  • Research Site 30001-329

    Miami, Florida, 33165

  • Research Site 30001-082

    Miami, Florida, 33179

  • Research Site 30001-287

    Mobile, Alabama, 36608

  • Research Site 30001-301

    Naples, Florida, 34103

  • Research Site 30001-481

    Nederland, Texas, 71627

  • Research Site 30001-455

    New York, New York, 10016

  • Research Site US-30001-369

    New York, New York, 10029

  • Research Site 30001-522

    North Las Vegas, Nevada, 89030

  • Research Site 30001-500

    Northridge, California, 91324

  • Research Site 30001-348

    Ocala, Florida, 34471

  • Research Site 30001-331

    Orlando, Florida, 32807

  • Research Site 30001-293

    Orlando, Florida, 32819

  • Research Site 30001-489

    Pasadena, California, 91105

  • Research Site 30001-297

    Pearland, Texas, 77584

  • Research Site 30001-312

    Pembroke Pines, Florida, 33026

  • Research Site 30001-462

    Peoria, Arizona, 85381

  • Research Site 30001-327

    Philadelphia, Pennsylvania, 19140

  • Research Site 30001-429

    Plantation, Florida, 33317

  • Research Site 30001-333

    Pleasant View, Utah, 84404

  • Research Site 30001-406

    Rochester, Minnesota, 55905

  • Research Site 30001-439

    Rocky Mount, North Carolina, 27804

  • Research Site 30001-238

    San Antonio, Texas, 78258

  • Research Site 30001-377

    San Antonio, Texas, 78258

  • Research Site 30001-501

    San Diego, California, 92120

  • Research Site 30001-434

    San Diego, California, 92123

  • Research Site 30001-484

    Santa Monica, California, 90424

  • Research Site 30001-300

    Schenectady, New York, 12304

  • Research Site 30001-442

    Southfield, Michigan, 48034

  • Research Site 30001-335

    Sugar Land, Texas, 77479

  • Research Site 30001-322

    Surprise, Arizona, 85378

  • Research Site 30001-458

    Tucson, Arizona, 85724

  • Research Site 30001-304

    Valencia, California, 91355

  • Research Site 30001-305

    Valencia, California, 97355

  • Research Site 30001-319

    Viera, Florida, 32940

  • Research Site 30001-372

    Warren, Michigan, 48088

  • Research Site 30001-515

    West Valley City, Utah, 84120

  • Research Site 30001-535

    Westchester, Illinois, 60154

  • Research Site 30001-352

    Zachary, Louisiana, 70791

Other trials in United States

Argentina23 sites

  • Research Site 30054-035

    Buenos Aires, 30054-035

  • Research Site 30054-031

    Buenos Aires, 4190

  • Research Site 30054-048

    Buenos Aires, 8000

  • Research Site 30054-045

    Buenos Aires, B1646EBJ

  • Research Site 30054-026

    Buenos Aires, B1824KAJ

  • Research Site 30054-049

    Buenos Aires, B1842

  • Research Site 30054-050

    Buenos Aires, B1842

  • Research Site 30054-044

    Buenos Aires, B1878FNR

  • Research Site 30054-012

    Buenos Aires, B1900BNN

  • Research Site 30054-021

    Buenos Aires, B7600FYK

  • Research Site 30054-034

    Buenos Aires, B8000JRB

  • Research Site 30054-015

    Buenos Aires, C1121ABE

  • Research Site 30054-024

    Buenos Aires, C1425BEN

  • Research Site 30054-008

    Buenos Aires, C1426ABP

  • Research Site -30054-043

    Buenos Aires, Cl426ABP

  • Research Site 30054-054

    Concepción del Uruguay, E3260EPD

  • Research Site 30054-051

    Córdoba, 5000

  • Research Site 30054-052

    Córdoba, 5000

  • Research Site 30054-047

    Mendoza, 5509

  • Research Site 30054-010

    Mendoza, M5500CCG

  • Research Site 30054-032

    Mendoza, M5501GCA

  • Research Site 30054-028

    Mendoza, M550JIAAJ

  • Research Site 30054-042

    Santa Fe, 2128

Other trials in Argentina

South Africa21 sites

  • Research Site 30027-013

    Benoni, 1501

  • Research Site 30027-009

    Cape Town, 7530

  • Research Site 30027-011

    Cape Town, 7570

  • Research Site 30027-012

    Cape Town, 7700

  • Research Site 30027-021

    Cape Town, 7700

  • Research Site 30027-007

    Durban, 3630

  • Research Site 30027-001

    Durban, 4000

  • Research Site 30027-014

    Durban, 4091

  • Research Site 30027-023

    Durban, 4301

  • Research Site 30027-010

    Durban, 4450

  • Research Site 30027-030

    Johannesburg, 1827

  • Research Site 30027-026

    Johannesburg, 2193

  • Research Site 30027-031

    Krugersdorp, 1739

  • Research Site 30027-008

    KwaZulu, 4092

  • Research Site 30027-032

    Plettenberg Bay, 6600

  • Research Site 30027-029

    Polokwane, 0699

  • Research Site 30027-004

    Pretoria, 0002

  • Research Site 30027-019

    Pretoria, 0204

  • Research Site 30027-015

    Thabazimbi, 0380

  • Research Site 30027-018

    Vereeniging, 1935

  • Research Site 30027-017

    Welkom, 9460

Other trials in South Africa

Turkey (Türkiye)18 sites

  • Research Site 30090-017

    Alanya, 07400

  • Research Site 30090-018

    Ankara, 06230

  • Research Site 30090-021

    Ankara, 06230

  • Research Site 30090-008

    Ankara, 06620

  • Research Site 30090-009

    Ankara, 06930

  • Research Site 30090-029

    Antalya, 07070

  • Research Site 30090-019

    Bornova, 35100

  • Research Site 30090-016

    Çanakkale, 17020

  • Research Site 30090-027

    Gaziantep, 27410

  • Research Site 30030-024

    Istanbul, 34020

  • Research Site 30090-020

    Istanbul, 34020

  • Research Site 30090-026

    Istanbul, 34750

  • Research Site 30090-011

    Istanbul, 34844

  • Research Site 30090-012

    Izmir, 35170

  • Research Site 30090-013

    Mersin, 33110

  • Research Site 30090-010

    Nilufer, 16059

  • Research Site 30090-022

    Tekirdağ, 59100

  • Research Site 30090-002

    Yüreğir, 01240

Other trials in Turkey (Türkiye)

Germany16 sites

  • Research Site 30049-081

    Augsburg, 86150

  • Research Site 30049-060

    Berlin, 10717

  • Research Site 30049-005

    Berlin, 10961

  • Research Site 30049-004

    Cottbus, 03050

  • Research Site 30049-082

    Delitzsch, 04509

  • Research Site 30049-059

    Frankfurt, 63089

  • Research Site 30049-019

    Frankfurt, 95606

  • Research Site 30049-006

    Fürstenwalde, 15517

  • Research Site 30049-035

    Hanover, 30625

  • Research Site 30049-073

    Homburg, 66421

  • Research Site 30049-061

    Leipzig, 04275

  • Research Site 30049-056

    Leipzig, 04357

  • Research Site 30049-038

    Magdeburg, 39120

  • Research Site 30049-051

    Munich, 80539

  • Research Site 30049-028

    Munich, 81241

  • Research Site 30049-029

    Witten, 58456

Other trials in Germany

France12 sites

  • Research Site 30033-012

    Cholet, 49300

  • Research Site 30033-005

    Grenoble, 38043

  • Research Site 30033-013

    Libourne, 33500

  • Research Site 30033-014

    Lille, 59037

  • Research Site 30033-002

    Lyon, 69317

  • Research Site 30033-001

    Marseille, 13003

  • Research Site 30033-006

    Marseille, 13015

  • Research Site 30033-007

    Montpellier, 34295

  • Research Site 30033-003

    Paris, 75018

  • Research Site 30033-015

    Reims, 51100

  • Research Site 30033-004

    Saint-Herblain, 44800

  • Research Site 30033-018

    Strasbourg, 67091

Other trials in France

Spain12 sites

  • Research Site 30034-046

    A Coruña, 15006

  • Research Site 30034-052

    A Coruña, 15706

  • Research Site 30034-011

    Barcelona, 08017

  • Research Site 30034-049

    Barcelona, 08025

  • Research Site 30034-013

    Barcelona, 08036

  • Research Site 30034-021

    Lugo, 27003

  • Research Site 30034-053

    Madrid, 28040

  • Research Site 30034-037

    Madrid, 28046

  • Research Site 30034-045

    Madrid, 28046

  • Research Site 30034-050

    Santander, 39008

  • Research Site 30034-043

    Valencia, 46017

  • Research Site 30034-041

    Vigo, 36211

Other trials in Spain

India11 sites

  • Research Site 30091-006

    Ahmedabad, Gujarat, 382345

  • Research Site 30091-010

    Ahmedabad, Gujarat, 382350

  • Research Site 30091-043

    Chhatrapati Sambhajinagar, Maharashta, 431001

  • Research Site 30091-011

    Himmatnagar, Gujarat, 383001

  • Research Site 30091-018

    Jaipur, Rajasthan, 302039

  • Research Site 30091-021

    Kanpur, 208002

  • Research Site 30091-004

    Nagpur, Maharashta, 440010

  • Research Site 30091-023

    Nagpur, Maharashta, 440010

  • Research Site 30091-033

    Pune, Maharashta, 411057

  • Research Site 30091-024

    Rohtak, Haryana, 124001

  • Research Site 30091-001

    Surat, Gujarat, 395006

Other trials in India

Chile10 sites

  • Research Site 30056-009

    Curicó, 3341643

  • Research Site 30056-013

    Santiago, Providencia, 7501126

  • Research Site 30056-007

    Santiago, 7500657

  • Research Site 30056-013

    Santiago, 7501126

  • Research Site 30056-011

    Santiago, 7510000

  • Research Site 30056-010

    Santiago, 7630226

  • Research Site 30056-006

    Santiago, 8330034

  • Research Site 30056-012

    Santiago, 8389001

  • Research Site 30056-005

    Temuco, 4781151

  • Research Site 30056-014

    Viña del Mar, 2520598

Other trials in Chile

Taiwan10 sites

  • Research Site 30886-013

    Douliu, 640

  • Research Site 30886-004

    New Taipei City, 220

  • Research Site 30886-006

    New Taipei City, 23561

  • Research Site 30886-005

    Taichung, 404327

  • Research Site 30886-007

    Taichung, 40705

  • Research Site 30886-011

    Tainan

  • Research Site 30886-010

    Taipei, 100

  • Research Site 30886-008

    Taipei, 11031

  • Research Site 30886-003

    Taipei, 112

  • Research Site 30886-009

    Taipei, 112

Other trials in Taiwan

Czechia7 sites

  • Research Site 30420-018

    Brno, 61 800

  • Research Site 30420-012

    Brno, 62 500

  • Research Site 30420-003

    Jindřichův Hradec, 37 701

  • Research Site 30420-007

    Lovosice, 41 002

  • Research Site 30420-014

    Olomouc, 77 900

  • Research Site 30420-010

    Strakonice, 38 601

  • Research Site 30420-009

    Teplice, 41 501

Other trials in Czechia

Hungary7 sites

  • Research Site 30036-005

    Balassagyarmat, 2660

  • Research Site 30036-001

    Budapest, 1122

  • Research Site 30036-014

    Debrecen, 4027

  • Research Site 30036-017

    Edelény, 3780

  • Research Site 30036-013

    Gödöllő, 2100

  • Research Site 30036-006

    Szeged, 6720

  • Research Site 30036-018

    Szigetvár, 7900

Other trials in Hungary

Italy7 sites

  • Research Site 30039-004

    Bergamo, 24127

  • Research Site 30039-012

    Ferrara, 44124

  • Research Site 30039-020

    Genova, 16132

  • Research Site 30039-013

    Naples, 80131

  • Research Site 30039-002

    Padova, 35128

  • Research Site 30039-017

    Reggio Emilia, 42123

  • Research Site 30039-011

    Roma, 00168

Other trials in Italy

Mexico7 sites

  • Research Site 30052-026

    Chihuahua City, 31203

  • Research Site 30052-030

    Durango, 34080

  • Research Site 30052-024

    Guadalajara, Jalisco, 44100

  • Research Site 30052-033

    León, 37160

  • Research Site 30052-028

    Mexico City, 6700

  • Research Site 30052-023

    Monterrey, 64718

  • Research Site 30052-025

    Morelia, Michoacon, 58260

Other trials in Mexico

Peru7 sites

  • Research Site -30051-023

    Arequipa, 04017

  • Research Site 30051-022

    Lima, 15023

  • Research Site 30051-026

    Lima, 15023

  • Research Site 30051-020

    Lima, 15046

  • Research Site -30051-028

    Lima, 15072

  • Research Site 30051-017

    Lima, 15072

  • Research Site 30051-021

    Lima, 15801

Other trials in Peru

Israel6 sites

  • Research Site 30972-008

    Beersheba

  • Research Site 30972-001

    Jerusalem, 9112026851

  • Research Site 30972-009

    Kfar Saba, 4428164

  • Research Site 30972-011

    Ramat Gan, 5262000

  • Research Site 30972-012

    Rehovot, 7661041

  • Research Site 30972-005

    Sha‘ar Ha‘Aliya, 3109601

Other trials in Israel

South Korea6 sites

  • Research Site 30082-019

    Gwangju, 61469

  • Research Site 30082-022

    Seoul, 02841

  • Research Site 30082-018

    Seoul, 03312

  • Research Site 20082-028

    Seoul, 05278

  • Research Site 30082-010

    Suwon, 16499

  • Research Site 30082-017

    Wŏnju, 26426

Other trials in South Korea

Brazil5 sites

  • Research Site 30055-036

    Curitiba, 808101-00

  • Research Site 30055-021

    Porto Alegre, 90410-000

  • Research Site 30055-035

    Rio de Janeiro, 22061-080

  • Research Site 30055-025

    Salvador, 40060-325

  • Research Site 30055-025

    São Paulo, 03164-000

Other trials in Brazil

Puerto Rico4 sites

  • Research Site 30787-388

    Rio Piedras, 00918

  • Research Site 30001-383

    San Juan, 00918

  • Research Site 30787-405

    San Juan, 00918

  • Research Site 30001-345

    Vega Baja, 00694

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United Kingdom4 sites

  • Research Site 30044-027

    Glasgow, G20 7BE

  • Research Site 30044-059

    High Wycombe, HP11 2QW

  • Research Site 30044-039

    Leicester, LE3 9QP

  • Research Site 30044-025

    Sheffield, S25FX

Other trials in United Kingdom

Austria3 sites

  • Research Site 30043-013

    Salzburg, 5020

  • Research Site 30043-012

    Vienna, 1130

  • Research Site 30043-001

    Weiz, 1090

Other trials in Austria

Croatia3 sites

  • Research Site 30385-008

    Zadar, 23000

  • Research Site 30385-002

    Zagreb, 10000

  • Research Site 30385-007

    Zagreb, 10000

Other trials in Croatia

Lithuania3 sites

  • Research Site 30370-016

    Kaunas, 50161

  • Research Site 30370-017

    Klaipėda, 92231

  • Research Site 30370-002

    Vilnius, 06256

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Ukraine2 sites

  • Research Site 30380-002

    Chernivtsi, 58001

  • Research Site 30380-011

    Kyiv, 03057

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China1 site

  • Research Site 30086-021

    Shanghai, 201299

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Japan1 site

  • Research Site 20081-010

    Kanazawa, 920-8650

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About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Dexpramipexole Administered Orally for 52 Weeks in Participants With Severe Eosinophilic Asthma

The objective of this clinical study is to investigate the safety, tolerability, and efficacy of dexpramipexole in participants with inadequately controlled severe eosinophilic asthma.

Being tested
Dexpramipexole Dihydrochloride, Placebo
Keywords
Exacerbations, Severe Asthma, Dexpramipexole, EXHALE, Areteia, EXHALE-3, Uncontrolled Asthma, Asthma Attack
Medical subject headings
Pulmonary Eosinophilia, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexpramipexole DihydrochlorideDrug

    Oral administration of dexpramipexole tablet

  • PlaceboDrug

    Oral administration of placebo tablet

Study groups in NCT05813288
Study groupRoleWhat they receive
150 mg BIDExperimentalDexpramipexole 150 mg oral tablet taken twice a day
Receives: Drug: Dexpramipexole Dihydrochloride
75 mg BIDExperimentalDexpramipexole 75 mg oral tablet taken twice a day
Receives: Drug: Dexpramipexole Dihydrochloride
PlaceboPlacebo comparatorPlacebo oral tablet taken twice a day
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized rate of severe asthma exacerbations over 52 weeks.

    A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids; or death due to asthma.

    Measured: Day 1 (baseline, pre-dose) through Week 52

Secondary outcomes (12)

  1. Absolute Change in pre-bronchodilator forced expiratory volume (Pre-BD FEV₁) from Baseline

    The absolute change from baseline in pre-bronchodilator forced expiratory volume, averaged across visits at Weeks 36, 44, and 52.

    Measured: Day 1 (baseline, pre-dose), Weeks 36, 44, 52

  2. Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6 (ACQ-6) (Key Secondary Endpoint)

    Change from baseline in ACQ-6 as compared to placebo at Week 52. The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses

    Measured: From randomization to Study Week 52

  3. Mean Change From Baseline at Week 52 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Total Score (Key Secondary Endpoint)

    Mean change from baseline in AQLQ+12 as compared to placebo at Week 52. The AQLQ+12 is a questionnaire that measures the health-related quality of life experienced by asthma subjects. The total score is defined as the average of all 32 questions in the AQLQ+12 questionnaire. AQLQ+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).

    Measured: From randomization to Study Week 52

  4. Annualized rate of severe exacerbations requiring an emergency over 52 weeks department visit or hospitalization

    Measured: Day 1 (baseline, pre-dose), Week 52

  5. Annualized rate of severe exacerbations (AAER) from Week 4 to Week 52.

    Measured: Week 4 through Week 52

  6. Change in absolute eosinophil count (AEC)

    Measured: Day 1 (baseline, pre-dose), Weeks 35, 44, and 52

  7. Average change from baseline in forced vital capacity (FVC)

    Measured: Day 1(baseline, pre-dose), Weeks 36, 44, and 52

  8. FVC, change from baseline at Weeks 4, 12, 20, 28, 36, 44, and 52.

    Measured: Day 1(baseline, pre-dose), Weeks 4, 12, 20, 28, 36, 44, and 52.

  9. Post-bronchodilator FEV₁, change from baseline to Week 52

    Measured: Day 1 (baseline, pre-dose) through Week 52

  10. Time to first severe asthma exacerbation

    Measured: Up to Week 52

  11. Mean Change From Baseline at Week 52 in Asthma Symptom Diary (ASD)

    The Asthma Symptom Diary comprises of 10 items (5 items in the morning; 5 items in the evening). Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the daily diary. A daily ASD score is the mean of the 10 items. Responses for all 10 items are required to calculate the daily ASD score; otherwise, it is treated as missing. For the 7-day average asthma symptom score, scoring is done with no imputation using the mean of at least 4 of the 7 daily ASD scores as a mean weekly item score. The 7-day average ASD score ranges from 0 to 4, where 0 indicates no asthma symptoms.

    Measured: From randomization to Study Week 52

  12. Mean Change From Baseline at Week 52 in EQ-5D-5L

    EQ-5D-5L allows subjects to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.

    Measured: At Study Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2023
  2. Study start27 Mar 2023
  3. Primary completion8 Dec 2025
  4. Study completion8 Dec 2025

Why it stopped: Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
654 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05813288
Sponsor's protocol ID
AR-DEX-22-02
Other IDs
2023-503693-20, 2023
Acronym
EXHALE-3
Status last verified
Dec 2025
First submitted
27 Mar 2023
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Seluk L, Davis AE, Rhoads S, Wechsler ME. Novel asthma treatments: Advancing beyond approved novel step-up therapies for asthma. Ann Allergy Asthma Immunol. 2025 Jan;134(1):9-18. doi: 10.1016/j.anai.2024.09.016. Epub 2024 Oct 10.

    PubMed 39393433

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexpramipexole Dihydrochloride in people with Eosinophilic Asthma and Asthma; Eosinophilic, run by Areteia Therapeutics at 282 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 282 sites in United States, Argentina, South Africa, Turkey (Türkiye), Germany and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized rate of severe asthma exacerbations over 52 weeks. (time frame: Day 1 (baseline, pre-dose) through Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05813288, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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