Eosinophilic AsthmaPhase 3EXHALE-4NCT05748600
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma
A Phase 3 study testing Dexpramipexole Dihydrochloride in people with Eosinophilic Asthma and Asthma; Eosinophilic, run by Areteia Therapeutics at 335 sites in 18 countries.
Trial summary
The purpose of this study is to evaluate dexpramipexole as an add-on oral therapy in participants with inadequately controlled eosinophilic asthma to evaluate improvements in lung function, asthma control, and quality of life. Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Eosinophilic Asthma, Asthma; Eosinophilic, Asthma Attack
- 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
- 600 participants
- Where
- 335 sitesin 18 countries
- Study dates
- 30 Jan 2023to Dec 2025
- Phase
- Phase 3
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. Sites in Poland will only include participants aged ≥18 years.
- Asthma-related criteria
- Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1.
- Participants requiring at a minimum daily low dose inhaled corticosteroids (ICS; ≥100 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per GINA 2021), plus one or more additional daily maintenance asthma controller medications, eg, long-acting β2 agonist (LABA), leukotriene antagonist, theophylline, long-acting muscarinic antagonists, cromolyn/nedocromil. Note: In Poland, this will instead include participants requiring a minimum daily medium dose ICS (≥500 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per GINA 2021). Use of daily ICS must be for at least 12 weeks prior to Screening Visit 1 and the doses of all controller medications must be stable for at least 4 weeks 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.
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- 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.
- ACQ-6 ≥1.5 at Screening Visit 2.
- 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).
- 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. least 7 days prior to baseline.
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 prior to the Screening Visit 1 up to and including the Baseline 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, or 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-interleukin-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 study period.
- General medical history
- Weight <40 kg at Screening Visit 2.
- Current smoking within 12 months prior to Screening Visit 1 or a smoking history of >10 packyears. 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 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 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 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 resting 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).
- For this study, rescreening may only be permitted under specific circumstances and only after contact with a Sponsor Clinical representative.
Trial locations and contacts
335 sites in 18 countries.
335 sites in 18 countries
United States146 sites
Research Site 40001-142
Adairsville, Georgia, 30103
Research Site 40001-437
Alexandria, Louisiana, 71303
Research Site 40001-334
Allen, Texas, 75013
Research Site 40001-068
Amarillo, Texas, 79124
Research Site 40001-417
Annapolis, Maryland, 21401
Research Site 40001-075
Augusta, Georgia, 30909
Research Site 40001-425
Aurora, Colorado, 80014
Research Site 40001-048
Aventura, Florida, 33180
Research Site 40001-374
Bakersfield, California, 93301
Research Site 40001-466
Baltimore, Maryland, 21237
Research Site 40001-090
Berwyn, Illinois, 60402
Research Site 40001-005
Brandon, Florida, 33511
Research Site 40001-051
Brandon, Florida, 33511
Research Site 40001-387
Brick, New Jersey, 08724
Research Site 40001-340
Burke, Virginia, 22015
Research Site 40001-487
Chandler, Arizona, 85224
Research Site 40001-408
Charlotte, North Carolina, 28273
Research Site 40001-398
Charlotte, North Carolina, 28277
Research Site 40001-343
Chicago, Illinois, 60607
Research Site 40001-034
Cincinnati, Ohio, 45215
Research Site 40001-013
Cincinnati, Ohio, 45219
Research Site 40001-010
Cincinnati, Ohio, 45236
Research Site 40001-413
Cleveland, Ohio, 44106
Research Site 40001-353
Colorado Springs, Colorado, 80907
Research Site 40001-083
Columbia, Missouri, 65203
Research Site 40001-032
Columbia, South Carolina, 29204
Research Site 40001-018
Columbus, Georgia, 31904
Research Site 40001-029
Coral Gables, Florida, 33134
Research Site 40001-023
Dallas, Texas, 75230
Research Site 40001-028
Dallas, Texas, 75235
Research Site 40001-415
Dallas, Texas, 75246
Research Site 40001-017
Dayton, Ohio, 45424
Research Site 40001-427
Dearborn, Michigan, 48126
Research Site 40001-304
DeSoto, Texas, 75115
Research Site 40001-438
Dickson, Tennessee, 37055
Research Site 40001-452
Dunwoody, Georgia, 30350
Research Site 40001-050
East Amherst, New York, 14051
Research Site 40001-483
East Point, Georgia, 30344
Research Site 40001-363
Edison, New Jersey, 08817
Research Site US-40001-038
Edmond, Oklahoma, 73034
Research Site 40001-036
Elwood, Indiana, 46036
Research Site 40001-227
Encinitas, California, 92024
Research Site 40001-468
Fall River, Massachusetts, 02723
Research Site 40001-006
Flint, Michigan, 48504
Research Site 40001-148
Flint, Michigan, 48507
Research Site 40001-414
Franklin, Tennessee, 37067
Research Site 40001-418
Frisco, Texas, 75034
Research Site 40001-350
Gainesville, Florida, 32607
Research Site 40001-039
Gastonia, North Carolina, 28054
Research Site 40001-027
Grants Pass, Oregon, 97527
Research Site 40001-412
Great Neck, New York, 11021
Research Site 40001-014
Greenacres City, Florida, 33467
Research Site 40001-339
Greenfield, Wisconsin, 53228
Research Site 40001-435
Greenville, North Carolina, 17834
Research Site 40001-025
Greenville, South Carolina, 29651
Research Site 40001-047
Hawthorne, New York, 10532
Research Site 40001-395
Hershey, Pennsylvania, 17033
Research Site 40001-054
Hialeah, Florida, 33012
Research Site 40001-067
Hialeah, Florida, 33016
Research Site 40001-020
Homestead, Florida, 33030
Research Site 40001-064
Houston, Texas, 77074
Research Site 40001-085
Houston, Texas, 77099
Research Site 40001-111
Huntersville, North Carolina, 28078
Research Site 40001-349
Huntington Beach, California, 92647
Research Site 40001-485
Inglewood, California, 06410
Research Site 40001-457
Jersey City, New Jersey, 07304
Research Site 40001-424
Kerrville, Texas, 78028
Research Site 40001-015
Kissimmee, Florida, 34744
Research Site 40001-002
Kissimmee, Florida, 34746
Research Site 40001-433
La Crosse, Wisconsin, 54601
Research Site 40001-443
La Crosse, Wisconsin, 54601
Research Site 40001-440
La Palma, California, 90623
Research Site 40001-357
Lancaster, California, 93534
Research Site 40001-473
Las Vegas, Nevada, 89109
Research Site 40001-366
Lilburn, Georgia, 30047
Research Site 40001-448
Lincoln, Nebraska, 68510
Research Site 40001-089
Los Angeles, California, 90048
Research Site 40001-347
Louisville, Kentucky, 40202
Research Site 40001-086
Loxahatchee Groves, Florida, 33470
Research Site 40001-318
Maitland, Florida, 32751
Research Site 40001-421
Mankato, Minnesota, 56001
Research Site 40001-313
Marrero, Louisiana, 70072
Research Site 40001-295
McKinney, Texas, 75069
Research Site 40001-066
Miami, Florida, 33126
Research Site 40001-001
Miami, Florida, 33135
Research Site 40001-059
Miami, Florida, 33144
Research Site 40001-026
Miami, Florida, 33155
Research Site 40001-288
Miami, Florida, 33165
Research Site 40001-065
Miami, Florida, 33173
Research Site 40001-024
Miami, Florida, 33184
Research Site 40001-338
Miami Beach, Florida, 33169
Research Site 40001-362
Mission Viejo, California, 92691
Research Site 40001-409
Missoula, Montana, 59808
Research Site 40001-258
Murray, Utah, 84107
Research Site 40001-449
Napa, California, 94558
Research Site 40001-455
New York, New York, 10016
Research Site 40001-369
New York, New York, 10029
Research Site 40001-062
Newport Beach, California, 92660
Research Site 40001-043
Newport Beach, California, 92663
Research Site 40001-358
Normal, Illinois, 61761
Research Site 40001-348
Ocala, Florida, 34471
Research Site 40001-386
Oklahoma City, Oklahoma, 73102
Research Site 40001-079
Oklahoma City, Oklahoma, 73120
Research Site 40001-404
Omaha, Nebraska, 68798
Research Site 40001-293
Orlando, Florida, 32819
Research Site 40001-019
Owensboro, Kentucky, 42301
Research Site 40001-462
Peoria, Arizona, 85381
Research Site 40001-327
Philadelphia, Pennsylvania, 19140
Research Site 40001-429
Plantation, Florida, 33317
Research Site 40001-333
Pleasant View, Utah, 84404
Research Site 40001-337
Portland, Oregon, 97202
Research Site 40001-382
Raleigh, North Carolina, 27610
Research Site 40001-304
Red Oak, Texas, 75154
Research Site 40001-380
Redding, California, 96001
Research Site 40001-135
River Forest, Illinois, 60305
Research Site 40001-463
Rochester Hills, Michigan, 48307
Research Site 40001-430
Rock Hill, South Carolina, 29732
Research Site 40001-439
Rocky Mount, North Carolina, 27804
Research Site 40001-074
Saint Charles, Missouri, 63301
Research Site 40001-377
San Antonio, Texas, 78258
Research Site 40001-434
San Diego, California, 92123
Research Site 40001-088
San Jose, California, 95117
Research Site 40001-351
Sarasota, Florida, 34239
Research Site 40001-423
Savannah, Georgia, 31406
Research Site 40001-403
Skokie, Illinois, 60077
Research Site 40001-442
Southfield, Michigan, 48034
Research Site 40001-073
Spartanburg, South Carolina, 29303
Research Site 40001-046
St Louis, Missouri, 63110
Research Site 40001-069
St. Petersburg, Florida, 33713
Research Site 40001-335
Sugar Land, Texas, 77479
Research Site 40001-322
Surprise, Arizona, 85378
Research Site 40001-456
Takoma Park, Maryland, 20912
Research Site 40001-370
Tallahassee, Florida, 32308
Research Site 40001-004
Tampa, Florida, 33607
Research Site 40001-063
Toledo, Ohio, 43617
Research Site 40001-355
Toms River, New Jersey, 08755
Research Site 40001-359
Upland, California, 91756
Research Site 40001-319
Viera, Florida, 32940
Research Site 40001-372
Warren, Michigan, 48088
Research Site 40001-003
West Covina, California, 91790
Research Site 40001-419
Westminster, California, 92683
Research Site 40001-385
Wheat Ridge, Colorado, 80033
Research Site 40001-055
White Marsh, Maryland, 21162
Research Site 40001-394
Williamsburg, Virginia, 23188
Research Site 40001-283
Winston-Salem, North Carolina, 21704
Research Site 40001-352
Zachary, Louisiana, 70791
Poland23 sites
Research Site 40048-001
Będzin, 42-500
Research Site 40048-018
Bialystok, 15-044
Research Site 40048-032
Bialystok, 15-430
Research Site 40048-023
Gdansk, 80-214
Research Site 40048-006
Giżycko, 11-500
Research Site 40048-021
Katowice, 40-081
Research Site 40048-002
Katowice, 40-365
Research Site 40048-027
Krakow, 30-033
Research Site 40048-033
Krakow, 31-011
Research Site 40048-008
Krakow, 31-159
Research Site 40048-040
Krakow, 31-864
Research Site 40048-015
Lodz, 90-141
Research Site 40048-009
Lodz, 90-302
Research Site 40048-005
Lodz, 90-549
Research Site 40048-022
Lublin, 20-089
Research Site 40048-024
Maków Podhalański, 34-220
Research Site 40048-031
Ostrowiec Świętokrzyski, 27-400
Research Site 40048-010
Piaseczno, 05-500
Research Site 40048-016
Poznan, 61-578
Research Site 40048-039
Rzeszów, 35-205
Research Site 40048-014
Skierniewice, 96-100
Research Site 40048-012
Trzebnica, 55-100
Research Site 40048-019
Wroclaw, 51-162
Ukraine21 sites
Research Site 40380-002
Chernivtsi, 58001
Research Site 40380-021
Chernivtsi, 58022
Research Site 40380-009
Ivano-Frankivsk, 76008
Research Site 40380-004
Ivano-Frankivsk, 76018
Research Site 40380-017
Ivano-Frankivsk, 76018
Research Site 40380-014
Ivano-Frankivsk, 76019
Research Site 40380-019
Kyiv, 02002
Research Site 40380-018
Kyiv, 03037
Research Site 40380-007
Kyiv, 03038
Research Site 40380-010
Kyiv, 03038
Research Site 40380-012
Kyiv, 03038
Research Site 40380-015
Kyiv, 03049
Research Site 40380-011
Kyiv, 03057
Research Site 40380-013
Kyiv, 03115
Research Site 40380-016
Lutsk, 45634
Research Site 40380-001
Ternopil, 46023
Research Site 40380-003
Vinnytsia, 21001
Research Site 40380-020
Vinnytsia, 21018
Research Site 40380-008
Vinnytsia, 21029
Research Site 40380-022
Vinnytsia, 21029
Research Site 40380-005
Zhytomyr, 10002
South Africa19 sites
Research Site 40027-013
Benoni, 1500
Research Site 40027-025
Cape Town, 7505
Research Site 40027-009
Cape Town, 7530
Research Site 40027-011
Cape Town, 7570
Research Site 40027-021
Cape Town, 7700
Research Site 30090-020
Durban, 4001
Research Site 40027-007
Durban, 7570
Research Site 40027-026
Johannesburg, 2193
Research Site 40027-005
KwaZulu, 4001
Research Site 40027-008
KwaZulu, 4092
Research Site 40027-020
KwaZulu, 4170
Research Site 40027-023
KwaZulu, 4301
Research Site 40027-027
KwaZulu, 4301
Research Site 40027-010
KwaZulu, 4450
Research Site 40027-006
Mpumalanga, 1050
Research Site 40027-004
Pretoria, 0002
Research Site 40027-019
Pretoria, 0204
Research Site 40027-018
Vereeniging, 1935
Research Site 40027-017
Welkom, 9460
Turkey (Türkiye)18 sites
Research Site 40090-002
Adana, 01240
Research Site 40090-018
Ankara, 06230
Research Site 40090-021
Ankara, 06230
Research Site 40090-024
Ankara, 06230
Research Site 40090-003
Ankara, 06560
Research Site 40090-025
Ankara, 06560
Research Site 40090-008
Ankara, 06620
Research Site 40090-009
Ankara, 06930
Research Site 40090-017
Antalya, 07400
Research Site 40090-019
Bornova, 35100
Research Site 40090-016
Center, 17020
Research Site 40090-020
Istanbul, 34020
Research Site 40090-026
Istanbul, 34750
Research Site 40090-011
Istanbul, 34844
Research Site 40090-012
Konak, 35110
Research Site 40090-013
Mersin, 33110
Research Site 40090-024
Pendik
Research Site 40090-022
Tekirdağ, 59100
United Kingdom18 sites
Research Site 40044-018
Bellshill, ML4 3NJ
Research Site 40044-021
Birmingham, B15 2SQ
Research Site 40044-077
Bollington, SK10 5JH
Research Site 40044-017
Chorley, PR7 7NA
Research Site 40044-022
Enfield, EN3 4GS
Research Site 40044-019
Liverpool, L22 0LG
Research Site 40044-084
London, E1 1 EQ
Research Site 40044-001
Manchester, BL9 0NJ
Research Site 40044-020
Manchester, M15 6SE
Research Site 40044-013
Manchester, M22 4DH
Research Site 40044-009
Manchester, M24 4DZ
Research Site 40044-036
Manchester, M27 0EW
Research Site 40044-006
Manchester, M33 4BR
Research Site 40044-024
Preston, PR2 9RB
Research Site 40044-026
Rochdale, OL11 4AU
Research Site 40044-008
Salford, M6 5WW
Research Site 40044-034
Stockport, SK8 5LL
Research Site 40044-078
Wythenshawe, M23 9QZ
Argentina16 sites
Research Site 40054-035
Buenos Aires, B1878FNR
Research Site 40054-044
Buenos Aires, B1878FNR
Research Site 40054-034
Buenos Aires, B8000JRB
Research Site 40054-017
Buenos Aires, C1027AAP
Research Site 40054-008
Buenos Aires, C1426ABP
Research Site 40054-043
Buenos Aires, C14426ABP
Research Site 40054-015
Caba, C1121ABE
Research Site 40054-019
Mendoza, M5500AXR
Research Site 40054-016
Mendoza, M5500CBA
Research Site 40054-010
Mendoza, M5500CCG
Research Site 40054-028
Mendoza, M5501AAJ
Research Site 40054-032
Mendoza, M5501GCA
Research Site 40054-057
Mendoza, M5506BBH
Research Site 40054-024
San Miguel de Tucumán, C1425BEN
Research Site 40054-002
San Miguel de Tucumán, T4000CBC
Research Site 40054-020
San Miguel de Tucumán, T4000IAJ
Brazil13 sites
Research Site 40055-015
Belo Horizonte
Research Site 40055-007
Blumenau, 89030-101
Research Site 40055-011
Campo Largo, 83606-177
Research Site 40055-043
Curitiba, 80060-900
Research Site 40055-036
Curitiba, 80810-100
Research Site 40055-012
Porto Alegre, 90035-074
Research Site 40055-004
Porto Alegre, 90610-000
Research Site 40055-010
Porto Alegre, 91010-006
Research Site 40055-035
Rio de Janeiro, 22061-080
Research Site 40055-025
Salvador, 40060-325
Research Site 40055-005
Santo André, 09060-870
Research Site 40055-009
Santos, 11075-900
Research Site 40055-001
São Bernardo do Campo, 09715-090
South Korea12 sites
Research Site 40082-003
Anyang-si, 14068
Research Site 30082-024
Bucheon-si, 14584
Research Site 40082-007
Busan, 48108
Research Site 40082-021
Gwangju, 61469
Research Site 40082-020
Incheon, 21565
Research Site 40082-006
Jeonju, 54907
Research Site 40082-019
Seoul, 04763
Research Site 40082-012
Seoul, 05030
Research Site 40082-008
Seoul, 06591
Research Site 40082-004
Seoul, 07061
Research Site 40082-011
Seoul, 08308
Research Site 40082-010
Suwon, 16499
Canada10 sites
Research Site 40011-004
Ajax, Ontario, L1S 2J5
Research Site 40011-016
Ajax, Ontario, L1Z 0M1
Research Site 40011-010
Burlington, Ontario, L7N
Research Site 40011-018
Montreal, Quebec, H4A 3J1
Research Site 40011-014
Ottawa, Ontario, K1H 1E4
Research Site 40011-022
Québec, Quebec, G1G 3Y8
Research Site 40011-020
Trois-Rivières, Quebec, G9A 4P3
Research Site 40011-011
Vancouver, V5Z 1M9
Research Site 40011-005
Windsor, Ontario, N8X 2G1
Research Site 40011-001
Windsor, Ontario, N8X 5A6
Taiwan9 sites
Research Site 40886-001
Kaohsiung City, 807
Research Site 40886-004
New Taipei City, 220
Research Site 40886-006
New Taipei City, 23561
Research Site 40886-005
Taichung, 40403
Research Site 40886-007
Taichung, 40705
Research Site 40886-010
Taipei, 100
Research Site 40886-008
Taipei, 110
Research Site 40866-003
Taipei, 11217
Research Site 40886-009
Taipei, 11240
Israel8 sites
Research Site 40972-010
Ashkelon, 7830604
Research Site 40972-008
Beersheba, 8410101
Research Site 40972-005
Haifa, 3109601
Research Site 40972-004
Haifa, 3436212
Research Site 40972-001
Jerusalem
Research Site 40972-009
Kfar Saba, 4428164
Research Site 40972-002
Petah Tikva, 4941492
Research Site 40972-011
Ramat Gan, 5262000
Romania8 sites
Research Site 40040-004
Brasov, Brașov County, 50366
Research Site 40040-002
Brasov, 500051
Research Site 40040-006
Cluj-Napoca, Cluj, 400371
Research Site 40040-009
Cluj-Napoca, 400162
Research Site 40040-007
Cluj-Napoca, 400371
Research Site 40040-001
Constanța, 900002
Research Site 40040-010
Sângeorgiu de Mureş, 547365
Research Site 40040-003
Timișoara, 300310
Puerto Rico7 sites
Research Site 40787-365
Guaynabo, 00968
Research Site 40787-390
Ponce, 00717
Research Site 40787-388
San Juan, 00907
Research Site 40787-383
San Juan, 00918
Research Site 40787-405
San Juan, 00918
Research Site 40787-360
San Juan, 00927
Research Site 40787-345
Vega Baja, 00694
Mexico4 sites
Research Site 40052-026
Chihuahua City, 31203
Research Site 40052-007
Guadalajara, 044100
Research Site 40052-028
Mexico City, 06700
Research Site 40052-012
San Juan del Río, 76800
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 24 Weeks in Participants With Eosinophilic Asthma
The purpose of this study is to evaluate dexpramipexole as an add-on oral therapy in participants with inadequately controlled eosinophilic asthma to evaluate improvements in lung function, asthma control, and quality of life. In addition, the study will further evaluate the safety and tolerability of dexpramipexole in participants with eosinophilic asthma.
- Conditions
- Eosinophilic Asthma, Asthma; Eosinophilic, Asthma Attack
- Being tested
- Dexpramipexole Dihydrochloride, Placebo
- Keywords
- FEV1, Asthma, Dexpramipexole, EXHALE, EXHALE-4, Areteia, Uncontrolled Asthma, Asthma Attack, forced expiratory volume
- 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
administration of dexpramipexole tablet
PlaceboDrug
administration of placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| 150 mg BID | Experimental | Dexpramipexole 150 mg oral tablet taken twice a day Receives: Drug: Dexpramipexole Dihydrochloride |
| 75 mg BID | Experimental | Dexpramipexole 75 mg oral tablet taken twice a day Receives: Drug: Dexpramipexole Dihydrochloride |
| Placebo | Placebo comparator | Placebo 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.
Change in pre-BD FEV₁ from baseline
Pre-bronchodilator forced expiratory volume (pre-BD) FEV₁, absolute change from baseline, averaged over Weeks 20 and 24.
Measured: Day 1 (baseline, pre-dose), Weeks 20, 24
Secondary outcomes (7)
Change from baseline in Asthma Control Questionnaire-6 (ACQ-6)
Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) averaged over visits at Weeks 20 and 24.
Measured: Day 1 (baseline, pre-dose), Weeks 20, 24
Change in Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) from baseline to Week 24.
Measured: Day 1 (baseline, pre-dose) through Week 24
Change from baseline absolute eosinophil count (AEC) averaged across Weeks 20 and 24.
Measured: Day 1 (baseline, pre-dose) through Week 24
Change from baseline forced vital capacity (FVC) averaged over Weeks 20 and 24.
Measured: Day 1 (baseline, pre-dose), Weeks 20, 24
Change from baseline forced vital capacity (FVC) at Weeks 4, 8, 12, 16, 20, and 24.
Measured: Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, and 24
Change from baseline post-bronchodilator (post-BD) forced expiratory volume (FEV₁) at Week 24.
Measured: Day 1 (baseline, pre-dose) through Week 24
The EuroQol 5-dimensional questionnaire (EQ-5D-5L) change from baseline to Week 24
Measured: Day 1 (baseline, pre-dose) through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start30 Jan 2023
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Areteia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mona Bafadhel, MD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748600
- Sponsor's protocol ID
- AR-DEX-22-03
- Other IDs
- 2022-003005-30
- Acronym
- EXHALE-4
- Status last verified
- Aug 2025
- First submitted
- 20 Feb 2023
- Last updated
- 5 Sep 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