A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma (EXHALE-4)

August 29, 2025 updated by: Areteia Therapeutics

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, B1878FNR
    - Research Site 40054-035
  - Buenos Aires, Argentina, B1878FNR
    - Research Site 40054-044
  - Buenos Aires, Argentina, B8000JRB
    - Research Site 40054-034
  - Buenos Aires, Argentina, C1027AAP
    - Research Site 40054-017
  - Buenos Aires, Argentina, C1426ABP
    - Research Site 40054-008
  - Buenos Aires, Argentina, C14426ABP
    - Research Site 40054-043
  - Caba, Argentina, C1121ABE
    - Research Site 40054-015
  - Mendoza, Argentina, M5500AXR
    - Research Site 40054-019
  - Mendoza, Argentina, M5500CBA
    - Research Site 40054-016
  - Mendoza, Argentina, M5500CCG
    - Research Site 40054-010
  - Mendoza, Argentina, M5501AAJ
    - Research Site 40054-028
  - Mendoza, Argentina, M5501GCA
    - Research Site 40054-032
  - Mendoza, Argentina, M5506BBH
    - Research Site 40054-057
  - San Miguel de Tucumán, Argentina, C1425BEN
    - Research Site 40054-024
  - San Miguel de Tucumán, Argentina, T4000CBC
    - Research Site 40054-002
  - San Miguel de Tucumán, Argentina, T4000IAJ
    - Research Site 40054-020
Austria
- - Salzburg, Austria, 5020
    - Research Site 30043-013
Brazil
- - Belo Horizonte, Brazil
    - Research Site 40055-015
  - Blumenau, Brazil, 89030-101
    - Research Site 40055-007
  - Campo Largo, Brazil, 83606-177
    - Research Site 40055-011
  - Curitiba, Brazil, 80810-100
    - Research Site 40055-036
  - Curitiba, Brazil, 80060-900
    - Research Site 40055-043
  - Porto Alegre, Brazil, 90035-074
    - Research Site 40055-012
  - Porto Alegre, Brazil, 90610-000
    - Research Site 40055-004
  - Porto Alegre, Brazil, 91010-006
    - Research Site 40055-010
  - Rio de Janeiro, Brazil, 22061-080
    - Research Site 40055-035
  - Salvador, Brazil, 40060-325
    - Research Site 40055-025
  - Santo André, Brazil, 09060-870
    - Research Site 40055-005
  - Santos, Brazil, 11075-900
    - Research Site 40055-009
  - São Bernardo do Campo, Brazil, 09715-090
    - Research Site 40055-001
Canada
- - Vancouver, Canada, V5Z 1M9
    - Research Site 40011-011
- Ontario
  - Ajax, Ontario, Canada, L1S 2J5
    - Research Site 40011-004
  - Ajax, Ontario, Canada, L1Z 0M1
    - Research Site 40011-016
  - Burlington, Ontario, Canada, L7N
    - Research Site 40011-010
  - Ottawa, Ontario, Canada, K1H 1E4
    - Research Site 40011-014
  - Windsor, Ontario, Canada, N8X 5A6
    - Research Site 40011-001
  - Windsor, Ontario, Canada, N8X 2G1
    - Research Site 40011-005
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - Research Site 40011-018
  - Québec, Quebec, Canada, G1G 3Y8
    - Research Site 40011-022
  - Trois-Rivières, Quebec, Canada, G9A 4P3
    - Research Site 40011-020
Israel
- - Ashkelon, Israel, 7830604
    - Research Site 40972-010
  - Beersheba, Israel, 8410101
    - Research Site 40972-008
  - Haifa, Israel, 3109601
    - Research Site 40972-005
  - Haifa, Israel, 3436212
    - Research Site 40972-004
  - Jerusalem, Israel
    - Research Site 40972-001
  - Kfar Saba, Israel, 4428164
    - Research Site 40972-009
  - Petah Tikva, Israel, 4941492
    - Research Site 40972-002
  - Ramat Gan, Israel, 5262000
    - Research Site 40972-011
Malaysia
- - Kampung Kelantan, Malaysia
    - Research Site 30060-006
Mexico
- - Chihuahua City, Mexico, 31203
    - Research Site 40052-026
  - Guadalajara, Mexico, 044100
    - Research Site 40052-007
  - Mexico City, Mexico, 06700
    - Research Site 40052-028
  - San Juan del Río, Mexico, 76800
    - Research Site 40052-012
Poland
- - Bialystok, Poland, 15-430
    - Research Site 40048-032
  - Bialystok, Poland, 15-044
    - Research Site 40048-018
  - Będzin, Poland, 42-500
    - Research Site 40048-001
  - Gdansk, Poland, 80-214
    - Research Site 40048-023
  - Giżycko, Poland, 11-500
    - Research Site 40048-006
  - Katowice, Poland, 40-081
    - Research Site 40048-021
  - Katowice, Poland, 40-365
    - Research Site 40048-002
  - Krakow, Poland, 31-864
    - Research Site 40048-040
  - Krakow, Poland, 30-033
    - Research Site 40048-027
  - Krakow, Poland, 31-011
    - Research Site 40048-033
  - Krakow, Poland, 31-159
    - Research Site 40048-008
  - Lodz, Poland, 90-141
    - Research Site 40048-015
  - Lodz, Poland, 90-302
    - Research Site 40048-009
  - Lodz, Poland, 90-549
    - Research Site 40048-005
  - Lublin, Poland, 20-089
    - Research Site 40048-022
  - Maków Podhalański, Poland, 34-220
    - Research Site 40048-024
  - Ostrowiec Świętokrzyski, Poland, 27-400
    - Research Site 40048-031
  - Piaseczno, Poland, 05-500
    - Research Site 40048-010
  - Poznan, Poland, 61-578
    - Research Site 40048-016
  - Rzeszów, Poland, 35-205
    - Research Site 40048-039
  - Skierniewice, Poland, 96-100
    - Research Site 40048-014
  - Trzebnica, Poland, 55-100
    - Research Site 40048-012
  - Wroclaw, Poland, 51-162
    - Research Site 40048-019
Puerto Rico
- - Guaynabo, Puerto Rico, 00968
    - Research Site 40787-365
  - Ponce, Puerto Rico, 00717
    - Research Site 40787-390
  - San Juan, Puerto Rico, 00907
    - Research Site 40787-388
  - San Juan, Puerto Rico, 00918
    - Research Site 40787-405
  - San Juan, Puerto Rico, 00927
    - Research Site 40787-360
  - San Juan, Puerto Rico, 00918
    - Research Site 40787-383
  - Vega Baja, Puerto Rico, 00694
    - Research Site 40787-345
Romania
- - Brasov, Romania, 500051
    - Research Site 40040-002
  - Cluj-Napoca, Romania, 400371
    - Research Site 40040-007
  - Cluj-Napoca, Romania, 400162
    - Research Site 40040-009
  - Constanța, Romania, 900002
    - Research Site 40040-001
  - Sângeorgiu de Mureş, Romania, 547365
    - Research Site 40040-010
  - Timișoara, Romania, 300310
    - Research Site 40040-003
- Brașov County
  - Brasov, Brașov County, Romania, 50366
    - Research Site 40040-004
- Cluj
  - Cluj-Napoca, Cluj, Romania, 400371
    - Research Site 40040-006
South Africa
- - Benoni, South Africa, 1500
    - Research Site 40027-013
  - Cape Town, South Africa, 7570
    - Research Site 40027-011
  - Cape Town, South Africa, 7505
    - Research Site 40027-025
  - Cape Town, South Africa, 7530
    - Research Site 40027-009
  - Cape Town, South Africa, 7700
    - Research Site 40027-021
  - Durban, South Africa, 7570
    - Research Site 40027-007
  - Durban, South Africa, 4001
    - Research Site 30090-020
  - Johannesburg, South Africa, 2193
    - Research Site 40027-026
  - KwaZulu, South Africa, 4001
    - Research Site 40027-005
  - KwaZulu, South Africa, 4092
    - Research Site 40027-008
  - KwaZulu, South Africa, 4170
    - Research Site 40027-020
  - KwaZulu, South Africa, 4301
    - Research Site 40027-023
  - KwaZulu, South Africa, 4301
    - Research Site 40027-027
  - KwaZulu, South Africa, 4450
    - Research Site 40027-010
  - Mpumalanga, South Africa, 1050
    - Research Site 40027-006
  - Pretoria, South Africa, 0002
    - Research Site 40027-004
  - Pretoria, South Africa, 0204
    - Research Site 40027-019
  - Vereeniging, South Africa, 1935
    - Research Site 40027-018
  - Welkom, South Africa, 9460
    - Research Site 40027-017
South Korea
- - Anyang-si, South Korea, 14068
    - Research Site 40082-003
  - Bucheon-si, South Korea, 14584
    - Research Site 30082-024
  - Busan, South Korea, 48108
    - Research Site 40082-007
  - Gwangju, South Korea, 61469
    - Research Site 40082-021
  - Incheon, South Korea, 21565
    - Research Site 40082-020
  - Jeonju, South Korea, 54907
    - Research Site 40082-006
  - Seoul, South Korea, 04763
    - Research Site 40082-019
  - Seoul, South Korea, 05030
    - Research Site 40082-012
  - Seoul, South Korea, 06591
    - Research Site 40082-008
  - Seoul, South Korea, 07061
    - Research Site 40082-004
  - Seoul, South Korea, 08308
    - Research Site 40082-011
  - Suwon, South Korea, 16499
    - Research Site 40082-010
Taiwan
- - Kaohsiung City, Taiwan, 807
    - Research Site 40886-001
  - New Taipei City, Taiwan, 23561
    - Research Site 40886-006
  - New Taipei City, Taiwan, 220
    - Research Site 40886-004
  - Taichung, Taiwan, 40403
    - Research Site 40886-005
  - Taichung, Taiwan, 40705
    - Research Site 40886-007
  - Taipei, Taiwan, 11217
    - Research Site 40866-003
  - Taipei, Taiwan, 100
    - Research Site 40886-010
  - Taipei, Taiwan, 110
    - Research Site 40886-008
  - Taipei, Taiwan, 11240
    - Research Site 40886-009
Thailand
- - Pathum Thani, Thailand, 12120
    - Research Site 30066-004
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 01240
    - Research Site 40090-002
  - Ankara, Turkey (Türkiye), 06230
    - Research Site 40090-018
  - Ankara, Turkey (Türkiye), 06230
    - Research Site 40090-021
  - Ankara, Turkey (Türkiye), 06230
    - Research Site 40090-024
  - Ankara, Turkey (Türkiye), 06560
    - Research Site 40090-003
  - Ankara, Turkey (Türkiye), 06560
    - Research Site 40090-025
  - Ankara, Turkey (Türkiye), 06620
    - Research Site 40090-008
  - Ankara, Turkey (Türkiye), 06930
    - Research Site 40090-009
  - Antalya, Turkey (Türkiye), 07400
    - Research Site 40090-017
  - Bornova, Turkey (Türkiye), 35100
    - Research Site 40090-019
  - Istanbul, Turkey (Türkiye), 34020
    - Research Site 40090-020
  - Istanbul, Turkey (Türkiye), 34750
    - Research Site 40090-026
  - Istanbul, Turkey (Türkiye), 34844
    - Research Site 40090-011
  - Konak, Turkey (Türkiye), 35110
    - Research Site 40090-012
  - Merkez, Turkey (Türkiye), 17020
    - Research Site 40090-016
  - Mersin, Turkey (Türkiye), 33110
    - Research Site 40090-013
  - Pendik, Turkey (Türkiye)
    - Research Site 40090-024
  - Tekirdağ, Turkey (Türkiye), 59100
    - Research Site 40090-022
Ukraine
- - Chernivtsi, Ukraine, 58001
    - Research Site 40380-002
  - Chernivtsi, Ukraine, 58022
    - Research Site 40380-021
  - Ivano-Frankivsk, Ukraine, 76008
    - Research Site 40380-009
  - Ivano-Frankivsk, Ukraine, 76018
    - Research Site 40380-004
  - Ivano-Frankivsk, Ukraine, 76018
    - Research Site 40380-017
  - Ivano-Frankivsk, Ukraine, 76019
    - Research Site 40380-014
  - Kyiv, Ukraine, 02002
    - Research Site 40380-019
  - Kyiv, Ukraine, 03038
    - Research Site 40380-010
  - Kyiv, Ukraine, 03038
    - Research Site 40380-012
  - Kyiv, Ukraine, 03057
    - Research Site 40380-011
  - Kyiv, Ukraine, 03115
    - Research Site 40380-013
  - Kyiv, Ukraine, 03037
    - Research Site 40380-018
  - Kyiv, Ukraine, 03038
    - Research Site 40380-007
  - Kyiv, Ukraine, 03049
    - Research Site 40380-015
  - Lutsk, Ukraine, 45634
    - Research Site 40380-016
  - Ternopil, Ukraine, 46023
    - Research Site 40380-001
  - Vinnytsia, Ukraine, 21001
    - Research Site 40380-003
  - Vinnytsia, Ukraine, 21018
    - Research Site 40380-020
  - Vinnytsia, Ukraine, 21029
    - Research Site 40380-008
  - Vinnytsia, Ukraine, 21029
    - Research Site 40380-022
  - Zhytomyr, Ukraine, 10002
    - Research Site 40380-005
United Kingdom
- - Bellshill, United Kingdom, ML4 3NJ
    - Research Site 40044-018
  - Birmingham, United Kingdom, B15 2SQ
    - Research Site 40044-021
  - Bollington, United Kingdom, SK10 5JH
    - Research Site 40044-077
  - Chorley, United Kingdom, PR7 7NA
    - Research Site 40044-017
  - Enfield, United Kingdom, EN3 4GS
    - Research Site 40044-022
  - Liverpool, United Kingdom, L22 0LG
    - Research Site 40044-019
  - London, United Kingdom, E1 1 EQ
    - Research Site 40044-084
  - Manchester, United Kingdom, BL9 0NJ
    - Research Site 40044-001
  - Manchester, United Kingdom, M15 6SE
    - Research Site 40044-020
  - Manchester, United Kingdom, M22 4DH
    - Research Site 40044-013
  - Manchester, United Kingdom, M24 4DZ
    - Research Site 40044-009
  - Manchester, United Kingdom, M33 4BR
    - Research Site 40044-006
  - Manchester, United Kingdom, M27 0EW
    - Research Site 40044-036
  - Preston, United Kingdom, PR2 9RB
    - Research Site 40044-024
  - Rochdale, United Kingdom, OL11 4AU
    - Research Site 40044-026
  - Salford, United Kingdom, M6 5WW
    - Research Site 40044-008
  - Stockport, United Kingdom, SK8 5LL
    - Research Site 40044-034
  - Wythenshawe, United Kingdom, M23 9QZ
    - Research Site 40044-078
United States
- Arizona
  - Chandler, Arizona, United States, 85224
    - Research Site 40001-487
  - Peoria, Arizona, United States, 85381
    - Research Site 40001-462
  - Surprise, Arizona, United States, 85378
    - Research Site 40001-322
- California
  - Bakersfield, California, United States, 93301
    - Research Site 40001-374
  - Encinitas, California, United States, 92024
    - Research Site 40001-227
  - Huntington Beach, California, United States, 92647
    - Research Site 40001-349
  - Inglewood, California, United States, 06410
    - Research Site 40001-485
  - La Palma, California, United States, 90623
    - Research Site 40001-440
  - Lancaster, California, United States, 93534
    - Research Site 40001-357
  - Los Angeles, California, United States, 90048
    - Research Site 40001-089
  - Mission Viejo, California, United States, 92691
    - Research Site 40001-362
  - Napa, California, United States, 94558
    - Research Site 40001-449
  - Newport Beach, California, United States, 92660
    - Research Site 40001-062
  - Newport Beach, California, United States, 92663
    - Research Site 40001-043
  - Redding, California, United States, 96001
    - Research Site 40001-380
  - San Diego, California, United States, 92123
    - Research Site 40001-434
  - San Jose, California, United States, 95117
    - Research Site 40001-088
  - Upland, California, United States, 91756
    - Research Site 40001-359
  - West Covina, California, United States, 91790
    - Research Site 40001-003
  - Westminster, California, United States, 92683
    - Research Site 40001-419
- Colorado
  - Aurora, Colorado, United States, 80014
    - Research Site 40001-425
  - Colorado Springs, Colorado, United States, 80907
    - Research Site 40001-353
  - Wheat Ridge, Colorado, United States, 80033
    - Research Site 40001-385
- Florida
  - Aventura, Florida, United States, 33180
    - Research Site 40001-048
  - Brandon, Florida, United States, 33511
    - Research Site 40001-005
  - Brandon, Florida, United States, 33511
    - Research Site 40001-051
  - Coral Gables, Florida, United States, 33134
    - Research Site 40001-029
  - Gainesville, Florida, United States, 32607
    - Research Site 40001-350
  - Greenacres City, Florida, United States, 33467
    - Research Site 40001-014
  - Hialeah, Florida, United States, 33012
    - Research Site 40001-054
  - Hialeah, Florida, United States, 33016
    - Research Site 40001-067
  - Homestead, Florida, United States, 33030
    - Research Site 40001-020
  - Kissimmee, Florida, United States, 34744
    - Research Site 40001-015
  - Kissimmee, Florida, United States, 34746
    - Research Site 40001-002
  - Loxahatchee Groves, Florida, United States, 33470
    - Research Site 40001-086
  - Maitland, Florida, United States, 32751
    - Research Site 40001-318
  - Miami, Florida, United States, 33126
    - Research Site 40001-066
  - Miami, Florida, United States, 33135
    - Research Site 40001-001
  - Miami, Florida, United States, 33144
    - Research Site 40001-059
  - Miami, Florida, United States, 33155
    - Research Site 40001-026
  - Miami, Florida, United States, 33165
    - Research Site 40001-288
  - Miami, Florida, United States, 33173
    - Research Site 40001-065
  - Miami, Florida, United States, 33184
    - Research Site 40001-024
  - Miami Beach, Florida, United States, 33169
    - Research Site 40001-338
  - Ocala, Florida, United States, 34471
    - Research Site 40001-348
  - Orlando, Florida, United States, 32819
    - Research Site 40001-293
  - Plantation, Florida, United States, 33317
    - Research Site 40001-429
  - Sarasota, Florida, United States, 34239
    - Research Site 40001-351
  - St. Petersburg, Florida, United States, 33713
    - Research Site 40001-069
  - Tallahassee, Florida, United States, 32308
    - Research Site 40001-370
  - Tampa, Florida, United States, 33607
    - Research Site 40001-004
  - Viera, Florida, United States, 32940
    - Research Site 40001-319
- Georgia
  - Adairsville, Georgia, United States, 30103
    - Research Site 40001-142
  - Augusta, Georgia, United States, 30909
    - Research Site 40001-075
  - Columbus, Georgia, United States, 31904
    - Research Site 40001-018
  - Dunwoody, Georgia, United States, 30350
    - Research Site 40001-452
  - East Point, Georgia, United States, 30344
    - Research Site 40001-483
  - Lilburn, Georgia, United States, 30047
    - Research Site 40001-366
  - Savannah, Georgia, United States, 31406
    - Research Site 40001-423
- Illinois
  - Berwyn, Illinois, United States, 60402
    - Research Site 40001-090
  - Chicago, Illinois, United States, 60607
    - Research Site 40001-343
  - Normal, Illinois, United States, 61761
    - Research Site 40001-358
  - River Forest, Illinois, United States, 60305
    - Research Site 40001-135
  - Skokie, Illinois, United States, 60077
    - Research Site 40001-403
- Indiana
  - Elwood, Indiana, United States, 46036
    - Research Site 40001-036
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Research Site 40001-347
  - Owensboro, Kentucky, United States, 42301
    - Research Site 40001-019
- Louisiana
  - Alexandria, Louisiana, United States, 71303
    - Research Site 40001-437
  - Marrero, Louisiana, United States, 70072
    - Research Site 40001-313
  - Zachary, Louisiana, United States, 70791
    - Research Site 40001-352
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Research Site 40001-417
  - Baltimore, Maryland, United States, 21237
    - Research Site 40001-466
  - Takoma Park, Maryland, United States, 20912
    - Research Site 40001-456
  - White Marsh, Maryland, United States, 21162
    - Research Site 40001-055
- Massachusetts
  - Fall River, Massachusetts, United States, 02723
    - Research Site 40001-468
- Michigan
  - Dearborn, Michigan, United States, 48126
    - Research Site 40001-427
  - Flint, Michigan, United States, 48504
    - Research Site 40001-006
  - Flint, Michigan, United States, 48507
    - Research Site 40001-148
  - Rochester Hills, Michigan, United States, 48307
    - Research Site 40001-463
  - Southfield, Michigan, United States, 48034
    - Research Site 40001-442
  - Warren, Michigan, United States, 48088
    - Research Site 40001-372
- Minnesota
  - Mankato, Minnesota, United States, 56001
    - Research Site 40001-421
- Missouri
  - Columbia, Missouri, United States, 65203
    - Research Site 40001-083
  - Saint Charles, Missouri, United States, 63301
    - Research Site 40001-074
  - St Louis, Missouri, United States, 63110
    - Research Site 40001-046
- Montana
  - Missoula, Montana, United States, 59808
    - Research Site 40001-409
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Research Site 40001-448
  - Omaha, Nebraska, United States, 68798
    - Research Site 40001-404
- Nevada
  - Las Vegas, Nevada, United States, 89109
    - Research Site 40001-473
- New Jersey
  - Brick, New Jersey, United States, 08724
    - Research Site 40001-387
  - Edison, New Jersey, United States, 08817
    - Research Site 40001-363
  - Jersey City, New Jersey, United States, 07304
    - Research Site 40001-457
  - Toms River, New Jersey, United States, 08755
    - Research Site 40001-355
- New York
  - East Amherst, New York, United States, 14051
    - Research Site 40001-050
  - Great Neck, New York, United States, 11021
    - Research Site 40001-412
  - Hawthorne, New York, United States, 10532
    - Research Site 40001-047
  - New York, New York, United States, 10029
    - Research Site 40001-369
  - New York, New York, United States, 10016
    - Research Site 40001-455
- North Carolina
  - Charlotte, North Carolina, United States, 28277
    - Research Site 40001-398
  - Charlotte, North Carolina, United States, 28273
    - Research Site 40001-408
  - Gastonia, North Carolina, United States, 28054
    - Research Site 40001-039
  - Greenville, North Carolina, United States, 17834
    - Research Site 40001-435
  - Huntersville, North Carolina, United States, 28078
    - Research Site 40001-111
  - Raleigh, North Carolina, United States, 27610
    - Research Site 40001-382
  - Rocky Mount, North Carolina, United States, 27804
    - Research Site 40001-439
  - Winston-Salem, North Carolina, United States, 21704
    - Research Site 40001-283
- Ohio
  - Cincinnati, Ohio, United States, 45215
    - Research Site 40001-034
  - Cincinnati, Ohio, United States, 45236
    - Research Site 40001-010
  - Cincinnati, Ohio, United States, 45219
    - Research Site 40001-013
  - Cleveland, Ohio, United States, 44106
    - Research Site 40001-413
  - Dayton, Ohio, United States, 45424
    - Research Site 40001-017
  - Toledo, Ohio, United States, 43617
    - Research Site 40001-063
- Oklahoma
  - Edmond, Oklahoma, United States, 73034
    - Research Site US-40001-038
  - Oklahoma City, Oklahoma, United States, 73120
    - Research Site 40001-079
  - Oklahoma City, Oklahoma, United States, 73102
    - Research Site 40001-386
- Oregon
  - Grants Pass, Oregon, United States, 97527
    - Research Site 40001-027
  - Portland, Oregon, United States, 97202
    - Research Site 40001-337
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Research Site 40001-395
  - Philadelphia, Pennsylvania, United States, 19140
    - Research Site 40001-327
- South Carolina
  - Columbia, South Carolina, United States, 29204
    - Research Site 40001-032
  - Greenville, South Carolina, United States, 29651
    - Research Site 40001-025
  - Rock Hill, South Carolina, United States, 29732
    - Research Site 40001-430
  - Spartanburg, South Carolina, United States, 29303
    - Research Site 40001-073
- Tennessee
  - Dickson, Tennessee, United States, 37055
    - Research Site 40001-438
  - Franklin, Tennessee, United States, 37067
    - Research Site 40001-414
- Texas
  - Allen, Texas, United States, 75013
    - Research Site 40001-334
  - Amarillo, Texas, United States, 79124
    - Research Site 40001-068
  - Dallas, Texas, United States, 75230
    - Research Site 40001-023
  - Dallas, Texas, United States, 75235
    - Research Site 40001-028
  - Dallas, Texas, United States, 75246
    - Research Site 40001-415
  - DeSoto, Texas, United States, 75115
    - Research Site 40001-304
  - Frisco, Texas, United States, 75034
    - Research Site 40001-418
  - Houston, Texas, United States, 77074
    - Research Site 40001-064
  - Houston, Texas, United States, 77099
    - Research Site 40001-085
  - Kerrville, Texas, United States, 78028
    - Research Site 40001-424
  - McKinney, Texas, United States, 75069
    - Research Site 40001-295
  - Red Oak, Texas, United States, 75154
    - Research Site 40001-304
  - San Antonio, Texas, United States, 78258
    - Research Site 40001-377
  - Sugar Land, Texas, United States, 77479
    - Research Site 40001-335
- Utah
  - Murray, Utah, United States, 84107
    - Research Site 40001-258
  - Pleasant View, Utah, United States, 84404
    - Research Site 40001-333
- Virginia
  - Burke, Virginia, United States, 22015
    - Research Site 40001-340
  - Williamsburg, Virginia, United States, 23188
    - Research Site 40001-394
- Wisconsin
  - Greenfield, Wisconsin, United States, 53228
    - Research Site 40001-339
  - La Crosse, Wisconsin, United States, 54601
    - Research Site 40001-433
  - La Crosse, Wisconsin, United States, 54601
    - Research Site 40001-443

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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.
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:
1. A highly effective form of birth control (confirmed by the investigator). Highly effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device (IUD), IUD/intrauterine system (IUS), Levonorgestrel Intrauterine system, or oral contraceptive.
  Or
2. Two protocol acceptable methods of contraception in tandem.
  - Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of the Baseline Visit without an alternative medical cause. The following age specific requirements apply:
3. Women <50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone levels in the postmenopausal range.
4. Women ≥50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. least 7 days prior to baseline.

Exclusion Criteria:

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
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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 150 mg BID Dexpramipexole 150 mg oral tablet taken twice a day	Drug: Dexpramipexole Dihydrochloride administration of dexpramipexole tablet
Experimental: 75 mg BID Dexpramipexole 75 mg oral tablet taken twice a day	Drug: Dexpramipexole Dihydrochloride administration of dexpramipexole tablet
Placebo Comparator: Placebo Placebo oral tablet taken twice a day	Drug: Placebo administration of placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pre-BD FEV₁ from baseline Time Frame: Day 1 (baseline, pre-dose), Weeks 20, 24	Pre-bronchodilator forced expiratory volume (pre-BD) FEV₁, absolute change from baseline, averaged over Weeks 20 and 24.	Day 1 (baseline, pre-dose), Weeks 20, 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) Time Frame: Day 1 (baseline, pre-dose), Weeks 20, 24	Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) averaged over visits at Weeks 20 and 24.	Day 1 (baseline, pre-dose), Weeks 20, 24
Change from baseline forced vital capacity (FVC) averaged over Weeks 20 and 24. Time Frame: Day 1 (baseline, pre-dose), Weeks 20, 24		Day 1 (baseline, pre-dose), Weeks 20, 24
Change from baseline forced vital capacity (FVC) at Weeks 4, 8, 12, 16, 20, and 24. Time Frame: Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, and 24		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. Time Frame: Day 1 (baseline, pre-dose) through Week 24		Day 1 (baseline, pre-dose) through Week 24
The EuroQol 5-dimensional questionnaire (EQ-5D-5L) change from baseline to Week 24 Time Frame: Day 1 (baseline, pre-dose) through Week 24		Day 1 (baseline, pre-dose) through Week 24
Change in Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) from baseline to Week 24. Time Frame: Day 1 (baseline, pre-dose) through Week 24		Day 1 (baseline, pre-dose) through Week 24
Change from baseline absolute eosinophil count (AEC) averaged across Weeks 20 and 24. Time Frame: Day 1 (baseline, pre-dose) through Week 24		Day 1 (baseline, pre-dose) through Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Areteia Therapeutics

Investigators

Principal Investigator: Mona Bafadhel, MD, Guy's and St Thomas' NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

AR-DEX-22-03
2022-003005-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Asthma Attack

Clinical Trials on Dexpramipexole Dihydrochloride

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