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Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.
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The goal of this clinical trial] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥18 years, on Global Initiative for Asthma (GINA) 2021 [GINA, 2021] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150 mg BID | Experimental | Dexpramipexole 150 mg oral tablet taken twice a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexpramipexole Dihydrochloride | Drug | Oral administration of dexpramipexole tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants with a Treatment Emergent Adverse Event | Summary of participants from the safety population who experienced an adverse event. | 52 weeks |
| Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations | Summary of participants from the safety population who experienced potentially clinically significant postbaseline changes in hematology and chemistry results. | 52 weeks |
| Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight | Summary of participants from the safety population who experienced potentially clinically significant postbaseline changes in vital signs (blood pressure, pulse rate, respiratory rate, and temperature) or body weight. | 52 weeks |
| Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters | Summary of participants from the safety population who experienced potentially significant postbaseline changes in electrocardiogram parameters: heart rate, PR, QRS and QTcF intervals. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Severe Asthma Exacerbations | Annualized rate of severe asthma exacerbations over 52 weeks | Averaged across 52 weeks |
| Change in Asthma Control Questionnaire-6 (ACQ-6) | ACQ-6 is simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. The 6-point self-administered scale has items measuring asthma symptoms and rescue inhaler use. The ACQ score is the mean of the questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). |
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Inclusion Criteria:
Participants who completed the double-blind study intervention treatment period during either of the Phase III studies EXHALE-2 or EXHALE-3.
Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Baseline Visit/Day 1.
WOCBP (after menarche) must use either of the following methods of birth control, from the Baseline Visit/Day 1 through the End of Study Visit:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sady Alpizar, MD | Clinical Research Trials of Florida, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site 20001-374 | Bakersfield | California | 93301 | United States | ||
| Research Site 20001-376 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39393433 | Derived | 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. |
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| Day 1 (baseline), Weeks 16, 32, and 52 |
| Change in absolute eosinophil counts (AEC) | Change from baseline, at Weeks 16, 32, and 52. | Day 1 (baseline), Weeks 16, 32, and 52 |
| Northridge |
| California |
| 91324 |
| United States |
| Research Site 20001-029 | Coral Gables | Florida | 33134 | United States |
| Research Site 20001-014 | Greenacres City | Florida | 33467 | United States |
| Research Site 30001-291 | Jacksonville | Florida | 32216 | United States |
| Research Site 20001-066 | Miami | Florida | 33126 | United States |
| Research Site 20001-001 | Miami | Florida | 33135 | United States |
| Research Site 20001-311 | Miami | Florida | 33144 | United States |
| Research Site 20001-026 | Miami | Florida | 33155 | United States |
| Research Site 30001-082 | Miami | Florida | 33179 | United States |
| Research Site 20001-024 | Miami | Florida | 33184 | United States |
| Research Site 20054-024 | Miami | Florida | 33184 | United States |
| Research Site 30001-429 | Plantation | Florida | 33137 | United States |
| Research Site 30001-429 | Plantation | Florida | 33317 | United States |
| Research Site 20001-004 | Tampa | Florida | 33607 | United States |
| Research Site 20001-036 | Elwood | Indiana | 46036 | United States |
| Research Site 20001-044 | Evansville | Indiana | 47715 | United States |
| Research Site 20001-006 | Flint | Michigan | 48504 | United States |
| Research Site 20001-046 | St Louis | Missouri | 63110 | United States |
| Research Site 20001-355 | Toms River | New Jersey | 08755 | United States |
| Research Site 20001-047 | Hawthorne | New York | 10532 | United States |
| Research Site 20001-063 | Toledo | Ohio | 43617 | United States |
| Research Site 30001-297 | Pearland | Texas | 77584 | United States |
| Research Site 30054-044 | Buenos Aires | B1878FNR | Argentina |
| Research Site 20054-017 | Buenos Aires | C1027AAP | Argentina |
| Research Site 20054-015 | Buenos Aires | C1121ABE | Argentina |
| Research Site 20054-022 | Buenos Aires | C1414AIF | Argentina |
| Research Site 20054-024 | Buenos Aires | C1425BEN | Argentina |
| Research Site 20054-008 | Buenos Aires | C1426ABP | Argentina |
| Research Site 20054-005 | Córdoba | X5003DCE | Argentina |
| Research Site 30054-047 | Mendoza | 5509 | Argentina |
| Research Site 20054-019 | Mendoza | M5500AXR | Argentina |
| Research Site 20054-016 | Mendoza | M5500CBA | Argentina |
| Research Site 20054-010 | Mendoza | M5500CCG | Argentina |
| Research Site 20054-002 | San Miguel de Tucumán | T4000CBC | Argentina |
| Research Site 20054-020 | San Miguel de Tucumán | T4000IAP | Argentina |
| Research Site 20054-013 | Santa Fe | 5509 | Argentina |
| Research Site 20055-007 | Blumenau | 89030-101 | Brazil |
| Research Site 20055-004 | Porto Alegre | 90610-000 | Brazil |
| Research Site 20055-010 | Porto Alegre | 91010-006 | Brazil |
| Research Site 20055-001 | São Bernardo | 09715-590 | Brazil |
| Research Site 20055-003 | São Paulo | 05403-000 | Brazil |
| Research Site 20055-008 | São Paulo | 09090-790 | Brazil |
| Research Site 20055-002 | Sorocaba | 18040-425 | Brazil |
| Research Site 20359-016 | Dimitrovgrad | 3703 | Bulgaria |
| Research Site 20359-008 | Montana | 3400 | Bulgaria |
| Research Site 20359-010 | Pernik | 2300 | Bulgaria |
| Research Site 20359-005 | Rousse | 7002 | Bulgaria |
| Research Site 20359-009 | Sliven | 8800 | Bulgaria |
| Research Site 20359-016 | Vidin | 3703 | Bulgaria |
| Research Site 20995-001 | Kutaisi | 4600 | Georgia |
| Research Site 20995-005 | Tbilisi | 0102 | Georgia |
| Research Site 20995-006 | Tbilisi | 0144 | Georgia |
| Research Site 20995-002 | Tbilisi | 0159 | Georgia |
| Research Site 20995-003 | Tbilisi | 0159 | Georgia |
| Research Site 20995-004 | Tbilisi | 0159 | Georgia |
| Research Site 20995-009 | Tbilisi | 0159 | Georgia |
| Research Site 20081-023 | Tokyo | 140-8522 | Japan |
| Research Site 20052-002 | Guadalajara | 44200 | Mexico |
| Research Site 20052-012 | San Juan del Río | 76800 | Mexico |
| Research Site 20052-014 | Tijuana | 22010 | Mexico |
| Research Site 20389-004 | Skopje | 1000 | North Macedonia |
| Research Site 20389-007 | Skopje | 1000 | North Macedonia |
| Research Site 20048-018 | Bialystok | 15-044 | Poland |
| Research Site 20048-006 | Giżycko | 11-500 | Poland |
| Research Site 20048-008 | Krakow | 20-001 | Poland |
| Research Site 20048-027 | Krakow | 30-033 | Poland |
| Research Site 20048-033 | Krakow | 31-011 | Poland |
| Research Site 20048-005 | Lodz | 50-549 | Poland |
| Research Site 20048-031 | Ostrów Wielkopolski | 27-400 | Poland |
| Research Site 20048-010 | Piaseczno | 05-500 | Poland |
| Research Site 20048-028 | Poznan | 60-693 | Poland |
| Research Site 20048-016 | Poznan | 61-578 | Poland |
| Research Site 20040-002 | Brasov | 500051 | Romania |
| Research Site 20040-004 | Brasov | 500366 | Romania |
| Research Site 20381-002 | Belgrade | 11000 | Serbia |
| Research Site 20381-005 | Belgrade | 11000 | Serbia |
| Research Site 20381-007 | Belgrade | 11000 | Serbia |
| Research Site 20381-003 | Valjevo | 14000 | Serbia |
| Research Site 30027-010 | Durban | Kwa-ZuIu Natal | South Africa |
| Research Site 30027-008 | Durban | KwaZulu-Natal | South Africa |
| Research Site 30027-009 | Cape Town | Western Cape | South Africa |
| Research Site 30027-005 | Durban | 4001 | South Africa |
| Research Site 30027-014 | Durban | 4091 | South Africa |
| Research Site 30027-010 | Durban | 4450 | South Africa |
| Research Site 20082-003 | Anyang-si | 14068 | South Korea |
| Research Site 20082-009 | Daegu | 42415 | South Korea |
| Research Site 20082-006 | Jeonju | 54907 | South Korea |
| Research Site 20082-008 | Seoul | 6591 | South Korea |
| Research Site 20380-002 | Chernivtsi | 58001 | Ukraine |
| Research Site 20380-014 | Ivano-Frankivsk | 76019 | Ukraine |
| Research Site 20380-004 | Ivano-Frankivsk | Ukraine |
| Research Site 20380-018 | Kyiv | 03037 | Ukraine |
| Research Site 20380-007 | Kyiv | 03038 | Ukraine |
| Research Site 20380-010 | Kyiv | Ukraine |
| Research Site 20380-012 | Kyiv | Ukraine |
| Research Site 20380-013 | Kyiv | Ukraine |
| Research Site 20380-001 | Ternopil | 46023 | Ukraine |
| Research Site 20380-003 | Vinnytsia | 21001 | Ukraine |
| Research Site 20380-003 | Zhytomyr | 10002 | Ukraine |
| Research Site 20380-005 | Zhytomyr | 10002 | Ukraine |
| Research Site 20044-020 | Manchester | "M15 6SE " | United Kingdom |
| Research Site 20044-026 | Rochdale | OL11 4AU | United Kingdom |
| ID | Term |
|---|---|
| D011657 | Pulmonary Eosinophilia |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017681 | Hypereosinophilic Syndrome |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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