AzTrials
AzTrials

Eosinophilic AsthmaPhase 3EXHALE-2NCT05763121

A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.

A Phase 3 study testing Dexpramipexole Dihydrochloride in people with Eosinophilic Asthma and Asthma; Eosinophilic, run by Areteia Therapeutics at 401 sites in 20 countries.

Terminated

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

Official record
Search all trials

Trial summary

This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations. 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
1,061 participants
Where
401 sitesin 20 countries
Study dates
30 Jan 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.
  • Treatment of asthma, participants must satisfy all the below (items a to c):
  • 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 Global Initiative for Asthma (GINA) 2021) on a regular basis for at least 12 months prior to Screening Visit 1.
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  • Documented treatment with a stable dose of either medium or high dose ICS for at least 3 months prior to Screening Visit 1. The ICS may be contained within an ICS/LABA (long-acting β2 agonist) 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-bronchodilator forced expiratory volume (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 to17). 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.
  • Peak flow variation of ≥20% over a 2-week period, documented in the past 24 months prior to Screening Visit 1.
  • 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) documented in the past past 24 months prior to Screening Visit 1.
  • 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 Visit 2 and Baseline Visit.
  • 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 would 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 would 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.
  • 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, 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.
  • For participants aged 12 to 17 years old, AEC of <0.15x10⁹/L at Screening Visit 1.
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  • Prohibited medications/procedures
  • 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 Visit: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab.
  • Treatment with pramipexole (Mirapex®) within 30 days of Baseline Visit.
  • 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 2.
  • Current smoking within the 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 the Baseline Visit despite antihypertensive 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 the 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 to 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 (ANC) <2.000x10⁹/L 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 for age ≥18 years at screening; using the Bedside Schwartz eGFR formula).
  • 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 the 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).

Trial locations and contacts

401 sites in 20 countries.

401 sites in 20 countries

United States89 sites

  • Research Site 20001-068

    Amarillo, Texas, 79124

  • Research Site 20001-075

    Augusta, Georgia, 30909

  • Research Site 20001-048

    Aventura, Florida, 33180

  • Research Site 20001-374

    Bakersfield, California, 93301

  • Research Site 20001-466

    Baltimore, Maryland, 21237

  • Research Site 20001-480

    Barboursville, West Virginia, 25504

  • Research Site 20001-090

    Berwyn, Illinois, 60402

  • Research Site 20001-005

    Brandon, Florida, 33511

  • Research Site 20001-051

    Brandon, Florida, 33511

  • Research Site 20001-340

    Burke, Virginia, 22015

  • Research Site 20001-408

    Charlotte, North Carolina, 28273

  • Research Site 20001-370

    Chesterfield, Missouri, 63005

  • Research Site 20001-476

    Chicago, Illinois, 60611

  • Research Site 20001-034

    Cincinnati, Ohio, 45215

  • Research Site 20001-013

    Cincinnati, Ohio, 45219

  • Research Site 20001-032

    Columbia, South Carolina, 29204

  • Research Site 20001-018

    Columbus, Georgia, 31904

  • Research Site 20001-029

    Coral Gables, Florida, 33134

  • Research Site 20001-023

    Dallas, Texas, 75230

  • Research Site 20001-028

    Dallas, Texas, 75235

  • Research Site 20001-017

    Dayton, Ohio, 45424

  • Research Site 20001-438

    Dickson, Tennessee, 37055

  • Research Site 20001-050

    East Amherst, New York, 14051

  • Research Site 20001-038

    Edmond, Oklahoma, 73034

  • Research Site 20001-036

    Elwood, Indiana, 46036

  • Research Site 20001-044

    Evansville, Indiana, 47715

  • Research Site 20001-468

    Fall River, Massachusetts, 02723

  • Research Site 20001-006

    Flint, Michigan, 48504

  • Research Site 20001-148

    Flint, Michigan, 48507

  • Research Site 20001-350

    Gainesville, Florida, 32607

  • Research Site 20001-039

    Gastonia, North Carolina, 28054

  • Research Site 20001-014

    Green Acres, Florida, 33467

  • Research Site 20001-435

    Greenville, North Carolina, 27834

  • Research Site 20001-025

    Greenville, South Carolina, 29615

  • Research Site 20001-047

    Hawthorne, New York, 10532

  • Research Site 20001-486

    Henderson, Nevada, 89052

  • Research Site 20001-395

    Hershey, Pennsylvania, 17033

  • Research Site 20001-054

    Hialeah, Florida, 33012

  • Research Site 20001-067

    Hialeah, Florida, 33016

  • Research Site 20001-471

    Highland Park, New Jersey, 08904

  • Research Site 20001-020

    Homestead, Florida, 33030

  • Research Site 20001-064

    Houston, Texas, 77074

  • Research Site 20001-085

    Houston, Texas, 77099

  • Research Site 20001-021

    Iowa City, Iowa, 52242

  • Research Site 20001-457

    Jersey City, New Jersey, 07304

  • Research Site 20001-015

    Kissimmee, Florida, 34744

  • Research Site 20001-002

    Kissimmee, Florida, 34746

  • Research Site 20001-433

    La Crosse, Wisconsin, 54601

  • Research Site 20001-440

    La Palma, California, 90623

  • Research Site 20001-473

    Las Vegas, Nevada, 89109

  • Research Site 20001-086

    Loxahatchee Groves, Florida, 33470

  • Research Site 20001-057

    Madison, Wisconsin, 53792

  • Research Site 20001-066

    Miami, Florida, 33126

  • Research Site 20001-001

    Miami, Florida, 33135

  • Research Site 20001-059

    Miami, Florida, 33144

  • Research Site 20001-026

    Miami, Florida, 33155

  • Research Site 20001-065

    Miami, Florida, 33173

  • Research Site 20001-024

    Miami, Florida, 33184

  • Research Site 20001-409

    Missoula, Montana, 59808

  • Research Site 20001-258

    Murray, Utah, 84107

  • Research Site 20001-420

    New Brunswick, New Jersey, 08901

  • Research Site 20001-062

    Newport Beach, California, 92660

  • Research Site 20001-043

    Newport Beach, California, 92663

  • Research Site 20001-358

    Normal, Illinois, 61761

  • Research Site 20001-079

    Oklahoma City, Oklahoma, 73120

  • Research Site 20001-019

    Owensboro, Kentucky, 42301

  • Research Site 20001-478

    Plano, Texas, 75093

  • Research Site 20001-382

    Raleigh, North Carolina, 27610

  • Research Site 20001-380

    Redding, California, 96001

  • Research Site 20001-135

    River Forest, Illinois, 60305

  • Research Site 20001-422

    Rochester, New York, 14607

  • Research Site 20001-463

    Rochester Hills, Michigan, 48307

  • Research Site 20001-074

    Saint Charles, Missouri, 63301

  • Research Site 20001-477

    Salt Lake City, Utah, 84107

  • Research Site US-20001-488

    San Diego, California, 92108

  • Research Site 20001-403

    Skokie, Illinois, 60077

  • Research Site 20001-073

    Spartanburg, South Carolina, 29303

  • Research Site 20001-046

    St Louis, Missouri, 63110

  • Research Site 20001-069

    St. Petersburg, Florida, 33713

  • Research Site 20001-459

    Sugar Hill, Georgia, 30518

  • Research Site 20001-456

    Takoma Park, Maryland, 20912

  • Research Site 20001-004

    Tampa, Florida, 33607

  • Research Site 20001-368

    The Bronx, New York, 10455

  • Research Site 20001-072

    The Woodlands, Texas, 77380

  • Research Site 20001-063

    Toledo, Ohio, 43617

  • Research Site 20001-479

    Vienna, Virginia, 22180

  • Research Site 20001-003

    West Covina, California, 91790

  • Research Site 20001-419

    Westminster, California, 92683

  • Research Site 20001-055

    White Marsh, Maryland, 21162

Other trials in United States

Japan51 sites

  • Research Site 20081-080

    Asahikawa, 078-8510

  • Research Site 20081-046

    Fukuoka, 806-8501

  • Research Site 20081-003

    Fukuoka, 807-8556

  • Research Site 20081-044

    Fukuoka, 811-1394

  • Research Site 20081-025

    Fukuoka

  • Research Site 20081-015

    Gifu, 509-6134

  • Research Site 20081-077

    Himeji, 670-0849

  • Research Site 20081-078

    Hiroshima, 734-8530

  • Research Site 20081-071

    Hokkaido, 006-0832

  • Research Site 20081-042

    Ibaraki, 319-1113

  • Research Site 20081-069

    Isehara, 259-1193

  • Research Site 20081-050

    Kagoshima, 890-8520

  • Research Site 20081-079

    Kobe, 650-0017

  • Research Site 20081-039

    Kobe, 653-0013

  • Research Site 20081-072

    Kochi, 783-8505

  • Research Site 20081-052

    Kochi, 783-8509

  • Research Site 20081-090

    Maebashi, 371-8511

  • Research Site 20081-030

    Matsusaka, 515-8544

  • Research Site 20081-083

    Miura, 238-0111

  • Research Site 20081-021

    Nagoya, 454-8509

  • Research Site 20081-073

    Nagoya, 67-8602

  • Research Site 20081-056

    Niigata, 951-8520

  • Research Site 20081-037

    Okayama, 102-3055

  • Research Site 20081-088

    Ono, 675-1392

  • Research Site 20081-086

    Osaka, 545-8586

  • Research Site 20081-024

    Osaka, 560-8552

  • Research Site 20081-068

    Osaka, 589-8511

  • Research Site 20081-041

    Saga, 849-8501

  • Research Site 20081-076

    Saitama, 350-0495

  • Research Site 20081-009

    Shibuya-ku, 150-8935

  • Research Site 20081-032

    Shimane, 693-8501

  • Research Site 20081-031

    Shizuoka, 420-8527

  • Research Site 20081-061

    Shizuoka, 426-8677

  • Research Site 20081-076

    Tarumi, 350-0495

  • Research Site 20081-034

    Tokyo, 104-0031

  • Research Site 20081-028

    Tokyo, 105-8470

  • Research Site 20081-023

    Tokyo, 140-8522

  • Research Site 20081-026

    Tokyo, 160-0023

  • Research Site 20081-066

    Tokyo, 160-8582

  • Research Site 20081-019

    Tokyo, 162-8655

  • Research Site 20081-074

    Tokyo, 162-8666

  • Research Site 20081-065

    Tokyo, 173-8610

  • Research Site 20081-029

    Tokyo, 204-8585

  • Research Site 20081-062

    Toyama, 930-0194

  • Research Site 20081-038

    Toyama, 930-8550

  • Research Site 20081-049

    Tsuchiura, 300-8585

  • Research Site 20081-016

    Yamaguchi, 755-8505

  • Research Site 20081-011

    Yokohama, 236-0004

  • Research Site 20081-051

    Yokohama, 245-8575

  • Research Site 20081-087

    Yonago, 683-8504

  • Research Site 20081-043

    Yoshida, 910-1193

Other trials in Japan

China38 sites

  • Research Site 20086-011

    Baoding, 07100

  • Research Site 20086-037

    Beijing, 100020

  • Research Site 20086-056

    Beijing, 100034

  • Research Site 20086-012

    Beijing, 100044

  • Research Site 20086-036

    Beijing, 100191

  • Research Site 20086-057

    Beijing, 100191

  • Research Site 20086-068

    Beijing, 100730

  • Research Site 20086-002

    Beijing, 101199

  • Research Site 20086-029

    Beijing, 102218

  • Research Site 20086-076

    Chengdu, 611130

  • Research Site 20086-072

    Guandong, 518020

  • Research Site 20086-060

    Guangdong, 510080

  • Research Site 20086-075

    Guangxi, 541002

  • Research Site 20086-069

    Guangzhou, 510140

  • Research Site 20086-039

    Guizhou, 550002

  • Research Site 20086-050

    Hangzhou, 310005

  • Research Site 20086-051

    Hangzhou, 310006

  • Research Site 20086-059

    Hangzhou, 310009

  • Research Site 20086-007

    Hangzhou, 310014

  • Research Site 20086-071

    Jilin City, Jilin, 132011

  • Research Site 20086-022

    Jinan, 250012

  • Research Site 20086-048

    Luoyang, 471003

  • Research Site 20086-030

    Nanchang, 330006

  • Research Site 20086-009

    Nanchang, 330038

  • Research Site 20086-040

    Ningbo, 315040

  • Research Site 20086-021

    Pudong, 201299

  • Research Site 20086-019

    Qingdao, 266071

  • Research Site 20086-061

    Shanghai, 200032

  • Research Site 20086-063

    Shanghai, 200080

  • Research Site 20086-052

    Shanghai, 200123

  • Research Site 20086-041

    Shanghai, 200433

  • Research Site 20086-053

    Shenyang, 100004

  • Research Site 20086-064

    Taiyuan, 030001

  • Research Site 20086-001

    Taizhou, Zhejang, 318000

  • Research Site 20086-032

    Weifang, 261000

  • Research Site 20086-032

    Weifang

  • Research Site 20086-066

    Wuxi, 214023

  • Research Site 20086-017

    Zhejiang, 325000

Other trials in China

United Kingdom32 sites

  • Research Site 20044-010

    Altrincham, WA14 1PF

  • Research Site 20044-079

    Bedford, BD9 6RJ

  • Research Site 20044-018

    Bellshill, ML4 3NJ

  • Research Site 20044-083

    Birmingham, B15 2GW

  • Research Site 20044-021

    Birmingham, B15 2SQ

  • Research Site 20044-077

    Bollington, SK10 5JH

  • Research Site 20044-017

    Chorley, PR7 7NA

  • Research Site 20044-022

    Enfield, EN3 4GS

  • Research Site 20044-019

    Liverpool, L22 0LG

  • Research Site 20044-084

    London, E11 EQ

  • Research Site 20044-081

    London, EC1M 6BQ

  • Research Site 20044-036

    London, SE1 7EH

  • Research Site 20044-042

    London, W12 0HS

  • Research Site 20044-001

    Manchester, Greater Manchester, BL9 0NJ

  • Research Site 20044-033

    Manchester, Greater Manchester, M20 2RN

  • Research Site 20044-046

    Manchester, Greater Manchester, M27 0EW

  • Research Site 20044-013

    Manchester, Greater Manchester, SK8 4NQ

  • Research Site 20044-020

    Manchester, M15 6SE

  • Research Site 20044-031

    Manchester, M20 6BA

  • Research Site 20044-032

    Manchester, M23 2SY

  • Research Site 20044-009

    Manchester, M24 4DZ

  • Research Site 20044-005

    Manchester, M27 8HP

  • Research Site 20044-030

    Manchester, M41 8AA

  • Research Site 20044-012

    Manchester, M42 7WJ

  • Research Site 20044-004

    Manchester, OL6 6HD

  • Research Site 20044-082

    Nottingham, NG5 1PB

  • Research Site 20044-024

    Preston, PR2 9RB

  • Research Site 20044-026

    Rochdale, OL11 4AU

  • Research Site 20044-008

    Salford, Greater Manchester, M6 5WW

  • Research Site 20044-029

    Stockport, SK3 9NX

  • Research Site 20044-034

    Stockport, SK8 5LL

  • Research Site 20044-078

    Wythenshawe, M23 9QZ

Other trials in United Kingdom

Poland27 sites

  • Research Site 20048-001

    Będzin, 42-500

  • Research Site 20048-018

    Bialystok, 15-044

  • Research Site 20048-032

    Bialystok, 15-430

  • Research Site 20048-006

    Giżycko, 11-500

  • Research Site 20048-021

    Katowice, 40-081

  • Research Site 20048-002

    Katowice, 40-365

  • Research Site 20048-036

    Kielce, 25-355

  • Research Site 20048-027

    Krakow, 30-033

  • Research Site 20048-033

    Krakow, 31-011

  • Research Site 20048-008

    Krakow, 31-159

  • Research Site 20048-040

    Krakow, 31-864

  • Research Site 20048-005

    Lodz, 50-549

  • Research Site 20048-009

    Lodz, 90-302

  • Research Site 20048-015

    Lodz, 902-141

  • Research Site 20048-022

    Lublin, 20-289

  • Research Site 20048-024

    Maków Podhalański, 34-220

  • Research Site 20048-031

    Ostrowiec Świętokrzyski, 27-400

  • Research Site 20048-010

    Piaseczno, 05-500

  • Research Site 20048-028

    Poznan, 60-693

  • Research Site 20048-016

    Poznan, 61-578

  • Research Site 20048-039

    Rzeszów, 35-205

  • Research Site 20048-014

    Skierniewice, 96-100

  • Research Site 20048-037

    Torun, Torun 87-100

  • Research Site 20048-012

    Trzebnica, 55-100

  • Research Site 20048-034

    Warsaw, 02-793

  • Research Site 20048-019

    Wroclaw, 51-162

  • Research Site 20048-029

    Wroclaw, 53-301

Other trials in Poland

Bulgaria22 sites

  • Research Site 20359-017

    Dimitrovgrad, 3703

  • Research Site 20359-022

    Kozloduy, 3320

  • Research Site 20359-027

    Lovech, 3500

  • Research Site 20359-008

    Montana, 3400

  • Research Site 20359-029

    Montana, 3400

  • Research Site 20359-010

    Pernik, 2300

  • Research Site 20359-023

    Pleven, 5800

  • Research Site 20359-026

    Plovdiv, 4000

  • Research Site 20359-024

    Plovdiv, 4002

  • Research Site 20359-005

    Rousse, 7002

  • Research Site 20359-009

    Sliven, 8800

  • Research Site 20359-033

    Sliven, 8800

  • Research Site 20359-025

    Smolyan, 4700

  • Research Site 20359-014

    Sofia, 1000

  • Research Site 20359-030

    Sofia, 1000

  • Research Site 20359-020

    Sofia, 1142

  • Research Site 20359-006

    Sofia, 1510

  • Research Site 20359-015

    Sofia, 1612

  • Research Site 20359-003

    Stara Zagora, 6000

  • Research Site 20359-019

    Stara Zagora, 6000

  • Research Site 20359-021

    Velingrad, 4600

  • Research Site 20359-016

    Vidin, 3703

Other trials in Bulgaria

Ukraine21 sites

  • Research Site 20380-002

    Chernivtsi, 58001

  • Research Site 20380-021

    Chernivtsi, 58022

  • Research Site 20380-017

    Ivano-Frankivsk, 76008

  • Research Site 20380-004

    Ivano-Frankivsk, 76019

  • Research Site 20380-009

    Ivano-Frankivsk, 76019

  • Research Site 20380-014

    Ivano-Frankivsk, 76019

  • Research Site 20380-015

    Kyiv, 02002

  • Research Site 20380-019

    Kyiv, 02002

  • Research Site 20380-007

    Kyiv, 03038

  • Research Site 20380-010

    Kyiv, 03038

  • Research Site 20380-012

    Kyiv, 03038

  • Research Site 20380-011

    Kyiv, 03115

  • Research Site 20380-013

    Kyiv, 03115

  • Research Site 20380-018

    Kyiv, 3037

  • Research Site 20380-016

    Lutsk, 45634

  • Research Site 20380-001

    Ternopil, 46023

  • Research Site 20380-003

    Vinnytsia, 21001

  • Research Site 20380-020

    Vinnytsia, 21018

  • Research Site 20380-022

    Vinnytsia, 21028

  • Research Site 20380-008

    Vinnytsia, 21029

  • Research Site 20380-005

    Zhytomyr, 10002

Other trials in Ukraine

Argentina16 sites

  • Research Site 20054-054

    Buenos Aires, B1602DQD

  • Research Site -20054-021

    Buenos Aires, B7600FYK

  • Research Site 20054-023

    Buenos Aires, B7602DCK

  • Research Site 20054-011

    Buenos Aires, Bl60IDQD

  • Research Site 20054-017

    Buenos Aires, C1027AAP

  • Research Site 20054-015

    Buenos Aires, C1121ABE

  • Research Site 20054-022

    Buenos Aires, C1414AIF

  • Research Site 20054-024

    Buenos Aires, C1425BEN

  • Research Site 20054-008

    Buenos Aires, C1426ABP

  • Research Site 20054-005

    Córdoba, X5003DCE

  • Research Site 20054-019

    Mendoza, M5500AXR

  • Research Site 20054-016

    Mendoza, M5500CBA

  • Research Site 20054-010

    Mendoza, M5500CCG

  • Research Site 20054-013

    Rosario, S2000DEJ

  • Research Site 20054-002

    San Miguel de Tucumán, T4000CBC

  • Research Site 20054-020

    San Miguel de Tucumán, T4000IAP

Other trials in Argentina

Brazil12 sites

  • Research Site 20055-007

    Blumenau, 89030-101

  • Research Site 20055-011

    Campo Largo, 83606

  • Research Site 20055-012

    Porto Alegre, Rio Grande do Sul, 90035-074

  • Research Site 20055-004

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Research Site 20055-010

    Porto Alegre, 91010-006

  • Research Site 20055-014

    Ribeirão Preto, São Paulo, 14048-900

  • Research Site 20055-005

    Santo André, 09060-870

  • Research Site 20055-009

    Santos, São Paulo, 11075-900

  • Research Site 20055-001

    São Bernardo do Campo, São Paulo, 09715-590

  • Research Site 20055-003

    São Paulo, 05403

  • Research Site 20055-008

    São Paulo, 09090-790

  • Research Site 20055-002

    Sorocaba, São Paulo, 18040-425

Other trials in Brazil

Peru12 sites

  • Research Site 20051-009

    Lima, 15023

  • Researcdh Site 20051-014

    Lima, 15046

  • Research Site 20051-012

    Lima, 15046

  • Research Site 20051-013

    Lima, 15046

  • Research Site 20051-030

    Lima, 15073

  • Research Site 20051-003

    Lima, 15076

  • Research Site 20051-007

    Lima, 15082

  • Research Site 20051-006

    Lima, 15088

  • Research Site 20051-010

    Lima, 15102

  • Research Site 20051-001

    Lima, 15131

  • Research Site20051-002

    Lima, 15131

  • Research Site 20051-008

    Piura, 20001

Other trials in Peru

Serbia12 sites

  • Research Site 20381-002

    Belgrade, 11000

  • Research Site 20381-007

    Belgrade, 11000

  • Research Site 20381-010

    Belgrade, 11000

  • Research Site 20381-012

    Belgrade, 11000

  • Research Site 20381-005

    Belgrade, 11080

  • Research Site 20381-006

    Belgrade, 11080

  • Research Site 20381-008

    Kamenitz, 21204

  • Research Site 20381-001

    Kragujevac, 3400

  • Research Site 20381-004

    Niš, 18000

  • Research Site 20381-009

    Novi Sad, 21000

  • Research Site 20381-011

    Užice, 31000

  • Research Site 20381-003

    Valjevo, 14000

Other trials in Serbia

South Korea12 sites

  • Research Site 20082-003

    Anyang, 14068

  • Research Site 20082-007

    Busan, 48108

  • Research Site 20082-009

    Daegu, 42415

  • Research Site 20381-009

    Incheon, 21565

  • Research Site 20082-006

    Jeonju, 54907

  • Research Site 20082-013

    Seoul, 03080

  • Research Site 20082-019

    Seoul, 04763

  • Research Site 20082-008

    Seoul, 06591

  • Research Site 20082-004

    Seoul, 07061

  • Research Site 20082-014

    Seoul, 07345

  • Research Site 20082-011

    Seoul, 08308

  • Research Site 20082-010

    Suwon, 16499

Other trials in South Korea

Mexico11 sites

  • Research Site 20052-011

    Benito Juárez, 03100

  • Research Site 20052-008

    Córdoba, 94550

  • Research Site 20052-035

    Cuernavaca, 62250

  • Research Site 20052-002

    Guadalajara, 44200

  • Research Site 20052-034

    Guadalajara, 44950

  • Research Site 20052-013

    Mérida, 97070

  • Research Site 20052-004

    Mérida, 97217

  • Research Site 20052-012

    San Juan del Río, 76800

  • Research Site 20052-037

    San Nicolás de los Garza, 66465

  • Research Site 20052-006

    Veracruz, 91851

  • Research Site 20052-009

    Zapopan, 45138

Other trials in Mexico

Canada10 sites

  • Research Site 20011-016

    Ajax, Ontario, L1Z 0M1

  • Research Site 20011-004

    Ajax, Ontario, LIS 2J5

  • Research Site 20011-010

    Burlington, Ontario, L7N 3V2

  • Research Site 20011-024

    Guelph, N1H 6J2

  • Research Site 20011-018

    Montreal, Quebec, H4A 3J1

  • Research Site 20011-022

    Québec, Quebec, G1G 3Y8

  • Research Site 20011-020

    Trois-Rivières, Quebec, G9A 4P3

  • Research Site 20011-011

    Vancouver, British Columbia, V5Z 1M9

  • Research Site 20011-001

    Windsor, Ontario, N8X 5A6

  • Research Site 20011-019

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Georgia10 sites

  • Research Site 20995-007

    Batumi, 6010

  • Research Site 20995-001

    Kutaisi, 4600

  • Research Site 20995-005

    Tbilisi, 0102

  • Research Site 20995-010

    Tbilisi, 0112

  • Research Site 20995-006

    Tbilisi, 0144

  • Research Site 20995-002

    Tbilisi, 0159

  • Research Site 20995-003

    Tbilisi, 0159

  • Research Site 20995-004

    Tbilisi, 0159

  • Research Site 20995-009

    Tbilisi, 0159

  • Research Site 20995-008

    Tbilisi, 0186

Other trials in Georgia

Lebanon7 sites

  • Research Site 20961-007

    Aïn Ouzaïn

  • Research Site 20961-003

    Beirut

  • Research Site 20961-004

    Beirut

  • Research Site 20961-009

    Beirut

  • Research Site 20961-010

    Beirut

  • Research Site 20961-012

    Beirut

  • Research Site 20961-005

    Tripoli

Other trials in Lebanon

North Macedonia6 sites

  • Research Site 20389-006

    Shtip, 2000

  • Research Site 20389-003

    Skopje, 1000

  • Research Site 20389-004

    Skopje, 1000

  • Research Site 20389-007

    Skopje, 1000

  • Research Site 20389-005

    Strumica, 2400

  • Research Site 20389-001

    Veles, 1400

Other trials in North Macedonia

Romania6 sites

  • Research Site 20040-008

    Bragadiru, 077025

  • Research Site 20040-004

    Brasov, Brașov County, 500366

  • Research Site 20040-002

    Brasov, 500051

  • Research Site 20040-004

    Brasov, 500366

  • Research Site 20040-006

    Cluj-Napoca, Cluj, 400371

  • Research Site 20040-011

    Timișoara, 300566

Other trials in Romania

Colombia5 sites

  • Research Site 20057-008

    Barranquilla, 080020

  • Research Site 20057-006

    Bogotá, 110111

  • Research Site 20057-007

    Ibague, 730000001

  • Research Site 20057-009

    Santander, 681004

  • Research Site 20057-001

    Zipaquirá, 250252

Other trials in Colombia

Puerto Rico2 sites

  • Research Site 20787-365

    Guaynabo, 00968

  • Research Site 20787-390

    Ponce, 00717

Other trials in Puerto Rico

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

This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of dexpramipexole in adults and adolescents with severe, inadequately controlled asthma with eosinophilic phenotype on medium to high-dose inhaled corticosteroids (ICS )and at least one additional asthma controller medication with or without oral corticosteroids (OCS). Approximately 1400 participants will be randomized globally. Participants will receive dexpramipexole, or placebo, administered orally, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 4 weeks.

Being tested
Dexpramipexole Dihydrochloride, Placebo
Keywords
Exacerbations, Severe Asthma, Dexpramipexole, EXHALE, Areteia, EXHALE-2, 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 NCT05763121
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 (13)

  1. Absolute Change in pre-bronchodilator forced expiratory volume (Pre-BD FEV)₁ 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. Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6)

    Asthma Control Questionnaire-6 (ACQ-6), change from baseline, averaged across visits at Weeks 36, 44, and 52.

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

  3. Change in Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) from baseline to Week 52.

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

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

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

  5. Annualized Rate of severe exacerbations from Week 4 to Week 52

    Measured: Week 4 through Week 52

  6. Average change in absolute eosinophil count (AEC)

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

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

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

  8. Change from baseline in forced vital capacity (FVC)

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

  9. Change from baseline in Post-bronchodilator FEV₁

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

  10. Change from baseline in peak expiratory flow (PEF)

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

  11. Time to first severe asthma exacerbation

    Measured: Up to Week 52

  12. Change from baseline in total asthma symptom score

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

  13. Change from baseline in the EuroQol five-dimensional questionnaire (EQ-5D-5L)

    Measured: Day 1 (baseline, pre-dose) through 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 posted10 Mar 2023
  2. Study start30 Jan 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
1,061 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05763121
Sponsor's protocol ID
AR-DEX-22-01
Other IDs
2022-003004-33, 2023049491
Acronym
EXHALE-2
Status last verified
Dec 2025
First submitted
20 Feb 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 401 sites in 20 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 26 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 401 sites in United States, Japan, China, United Kingdom, Poland and 15 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 NCT05763121, 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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