Study Stopped
Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.
EXHALE-2
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
3 other identifiers
interventional
1,061
20 countries
401
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2023
Typical duration for phase_3
401 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2023
CompletedFirst Submitted
Initial submission to the registry
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
March 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2025
CompletedDecember 15, 2025
December 1, 2025
2.9 years
February 20, 2023
December 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Day 1 (baseline, pre-dose) through Week 52
Secondary Outcomes (13)
Absolute Change in pre-bronchodilator forced expiratory volume (Pre-BD FEV)₁ from Baseline
Day 1 (baseline, pre-dose), Weeks 36, 44, 52
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6)
Day 1 (baseline, pre-dose), Weeks 36, 44, 52
Change in Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) from baseline to Week 52.
Day 1 (baseline, pre-dose) through Week 52
Annualized rate of severe exacerbations requiring an emergency department visit or hospitalization over 52 weeks.
Day 1 (baseline, pre-dose) through Week 52
Annualized Rate of severe exacerbations from Week 4 to Week 52
Week 4 through Week 52
- +8 more secondary outcomes
Study Arms (3)
150 mg BID
EXPERIMENTALDexpramipexole 150 mg oral tablet taken twice a day
75 mg BID
EXPERIMENTALDexpramipexole 75 mg oral tablet taken twice a day
Placebo
PLACEBO COMPARATORPlacebo oral tablet taken twice a day
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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, 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.
- +9 more criteria
You may not qualify if:
- 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.
- 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.
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (401)
Research Site 20001-374
Bakersfield, California, 93301, United States
Research Site 20001-440
La Palma, California, 90623, United States
Research Site 20001-062
Newport Beach, California, 92660, United States
Research Site 20001-043
Newport Beach, California, 92663, United States
Research Site 20001-380
Redding, California, 96001, United States
Research Site US-20001-488
San Diego, California, 92108, United States
Research Site 20001-003
West Covina, California, 91790, United States
Research Site 20001-419
Westminster, California, 92683, United States
Research Site 20001-048
Aventura, Florida, 33180, United States
Research Site 20001-005
Brandon, Florida, 33511, United States
Research Site 20001-051
Brandon, Florida, 33511, United States
Research Site 20001-029
Coral Gables, Florida, 33134, United States
Research Site 20001-350
Gainesville, Florida, 32607, United States
Research Site 20001-014
Green Acres, Florida, 33467, United States
Research Site 20001-054
Hialeah, Florida, 33012, United States
Research Site 20001-067
Hialeah, Florida, 33016, United States
Research Site 20001-020
Homestead, Florida, 33030, United States
Research Site 20001-015
Kissimmee, Florida, 34744, United States
Research Site 20001-002
Kissimmee, Florida, 34746, United States
Research Site 20001-086
Loxahatchee Groves, Florida, 33470, United States
Research Site 20001-066
Miami, Florida, 33126, United States
Research Site 20001-001
Miami, Florida, 33135, United States
Research Site 20001-059
Miami, Florida, 33144, United States
Research Site 20001-026
Miami, Florida, 33155, United States
Research Site 20001-065
Miami, Florida, 33173, United States
Research Site 20001-024
Miami, Florida, 33184, United States
Research Site 20001-069
St. Petersburg, Florida, 33713, United States
Research Site 20001-004
Tampa, Florida, 33607, United States
Research Site 20001-075
Augusta, Georgia, 30909, United States
Research Site 20001-018
Columbus, Georgia, 31904, United States
Research Site 20001-459
Sugar Hill, Georgia, 30518, United States
Research Site 20001-090
Berwyn, Illinois, 60402, United States
Research Site 20001-476
Chicago, Illinois, 60611, United States
Research Site 20001-358
Normal, Illinois, 61761, United States
Research Site 20001-135
River Forest, Illinois, 60305, United States
Research Site 20001-403
Skokie, Illinois, 60077, United States
Research Site 20001-036
Elwood, Indiana, 46036, United States
Research Site 20001-044
Evansville, Indiana, 47715, United States
Research Site 20001-021
Iowa City, Iowa, 52242, United States
Research Site 20001-019
Owensboro, Kentucky, 42301, United States
Research Site 20001-466
Baltimore, Maryland, 21237, United States
Research Site 20001-456
Takoma Park, Maryland, 20912, United States
Research Site 20001-055
White Marsh, Maryland, 21162, United States
Research Site 20001-468
Fall River, Massachusetts, 02723, United States
Research Site 20001-006
Flint, Michigan, 48504, United States
Research Site 20001-148
Flint, Michigan, 48507, United States
Research Site 20001-463
Rochester Hills, Michigan, 48307, United States
Research Site 20001-370
Chesterfield, Missouri, 63005, United States
Research Site 20001-074
Saint Charles, Missouri, 63301, United States
Research Site 20001-046
St Louis, Missouri, 63110, United States
Research Site 20001-409
Missoula, Montana, 59808, United States
Research Site 20001-486
Henderson, Nevada, 89052, United States
Research Site 20001-473
Las Vegas, Nevada, 89109, United States
Research Site 20001-471
Highland Park, New Jersey, 08904, United States
Research Site 20001-457
Jersey City, New Jersey, 07304, United States
Research Site 20001-420
New Brunswick, New Jersey, 08901, United States
Research Site 20001-050
East Amherst, New York, 14051, United States
Research Site 20001-047
Hawthorne, New York, 10532, United States
Research Site 20001-422
Rochester, New York, 14607, United States
Research Site 20001-368
The Bronx, New York, 10455, United States
Research Site 20001-408
Charlotte, North Carolina, 28273, United States
Research Site 20001-039
Gastonia, North Carolina, 28054, United States
Research Site 20001-435
Greenville, North Carolina, 27834, United States
Research Site 20001-382
Raleigh, North Carolina, 27610, United States
Research Site 20001-034
Cincinnati, Ohio, 45215, United States
Research Site 20001-013
Cincinnati, Ohio, 45219, United States
Research Site 20001-017
Dayton, Ohio, 45424, United States
Research Site 20001-063
Toledo, Ohio, 43617, United States
Research Site 20001-038
Edmond, Oklahoma, 73034, United States
Research Site 20001-079
Oklahoma City, Oklahoma, 73120, United States
Research Site 20001-395
Hershey, Pennsylvania, 17033, United States
Research Site 20001-032
Columbia, South Carolina, 29204, United States
Research Site 20001-025
Greenville, South Carolina, 29615, United States
Research Site 20001-073
Spartanburg, South Carolina, 29303, United States
Research Site 20001-438
Dickson, Tennessee, 37055, United States
Research Site 20001-068
Amarillo, Texas, 79124, United States
Research Site 20001-023
Dallas, Texas, 75230, United States
Research Site 20001-028
Dallas, Texas, 75235, United States
Research Site 20001-064
Houston, Texas, 77074, United States
Research Site 20001-085
Houston, Texas, 77099, United States
Research Site 20001-478
Plano, Texas, 75093, United States
Research Site 20001-072
The Woodlands, Texas, 77380, United States
Research Site 20001-258
Murray, Utah, 84107, United States
Research Site 20001-477
Salt Lake City, Utah, 84107, United States
Research Site 20001-340
Burke, Virginia, 22015, United States
Research Site 20001-479
Vienna, Virginia, 22180, United States
Research Site 20001-480
Barboursville, West Virginia, 25504, United States
Research Site 20001-433
La Crosse, Wisconsin, 54601, United States
Research Site 20001-057
Madison, Wisconsin, 53792, United States
Research Site 20054-054
Buenos Aires, B1602DQD, Argentina
Research Site -20054-021
Buenos Aires, B7600FYK, Argentina
Research Site 20054-023
Buenos Aires, B7602DCK, Argentina
Research Site 20054-011
Buenos Aires, Bl60IDQD, 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 20054-019
Mendoza, M5500AXR, Argentina
Research Site 20054-016
Mendoza, M5500CBA, Argentina
Research Site 20054-010
Mendoza, M5500CCG, Argentina
Research Site 20054-013
Rosario, S2000DEJ, Argentina
Research Site 20054-002
San Miguel de Tucumán, T4000CBC, Argentina
Research Site 20054-020
San Miguel de Tucumán, T4000IAP, Argentina
Research Site 20055-012
Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
Research Site 20055-004
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Research Site 20055-014
Ribeirão Preto, São Paulo, 14048-900, Brazil
Research Site 20055-009
Santos, São Paulo, 11075-900, Brazil
Research Site 20055-001
São Bernardo do Campo, São Paulo, 09715-590, Brazil
Research Site 20055-002
Sorocaba, São Paulo, 18040-425, Brazil
Research Site 20055-007
Blumenau, 89030-101, Brazil
Research Site 20055-011
Campo Largo, 83606, Brazil
Research Site 20055-010
Porto Alegre, 91010-006, Brazil
Research Site 20055-005
Santo André, 09060-870, Brazil
Research Site 20055-003
São Paulo, 05403, Brazil
Research Site 20055-008
São Paulo, 09090-790, Brazil
Research Site 20359-017
Dimitrovgrad, 3703, Bulgaria
Research Site 20359-022
Kozloduy, 3320, Bulgaria
Research Site 20359-027
Lovech, 3500, Bulgaria
Research Site 20359-008
Montana, 3400, Bulgaria
Research Site 20359-029
Montana, 3400, Bulgaria
Research Site 20359-010
Pernik, 2300, Bulgaria
Research Site 20359-023
Pleven, 5800, Bulgaria
Research Site 20359-026
Plovdiv, 4000, Bulgaria
Research Site 20359-024
Plovdiv, 4002, Bulgaria
Research Site 20359-005
Rousse, 7002, Bulgaria
Research Site 20359-009
Sliven, 8800, Bulgaria
Research Site 20359-033
Sliven, 8800, Bulgaria
Research Site 20359-025
Smolyan, 4700, Bulgaria
Research Site 20359-014
Sofia, 1000, Bulgaria
Research Site 20359-030
Sofia, 1000, Bulgaria
Research Site 20359-020
Sofia, 1142, Bulgaria
Research Site 20359-006
Sofia, 1510, Bulgaria
Research Site 20359-015
Sofia, 1612, Bulgaria
Research Site 20359-003
Stara Zagora, 6000, Bulgaria
Research Site 20359-019
Stara Zagora, 6000, Bulgaria
Research Site 20359-021
Velingrad, 4600, Bulgaria
Research Site 20359-016
Vidin, 3703, Bulgaria
Research Site 20011-011
Vancouver, British Columbia, V5Z 1M9, Canada
Research Site 20011-019
Winnipeg, Manitoba, R2H 2A6, Canada
Research Site 20011-016
Ajax, Ontario, L1Z 0M1, Canada
Research Site 20011-004
Ajax, Ontario, LIS 2J5, Canada
Research Site 20011-010
Burlington, Ontario, L7N 3V2, Canada
Research Site 20011-001
Windsor, Ontario, N8X 5A6, Canada
Research Site 20011-018
Montreal, Quebec, H4A 3J1, Canada
Research Site 20011-022
Québec, Quebec, G1G 3Y8, Canada
Research Site 20011-020
Trois-Rivières, Quebec, G9A 4P3, Canada
Research Site 20011-024
Guelph, N1H 6J2, Canada
Research Site 20086-071
Jilin, Jilin, 132011, China
Research Site 20086-001
Taizhou, Zhejang, 318000, China
Research Site 20086-011
Baoding, 07100, China
Research Site 20086-037
Beijing, 100020, China
Research Site 20086-056
Beijing, 100034, China
Research Site 20086-012
Beijing, 100044, China
Research Site 20086-036
Beijing, 100191, China
Research Site 20086-057
Beijing, 100191, China
Research Site 20086-068
Beijing, 100730, China
Research Site 20086-002
Beijing, 101199, China
Research Site 20086-029
Beijing, 102218, China
Research Site 20086-076
Chengdu, 611130, China
Research Site 20086-072
Guandong, 518020, China
Research Site 20086-060
Guangdong, 510080, China
Research Site 20086-075
Guangxi, 541002, China
Research Site 20086-069
Guangzhou, 510140, China
Research Site 20086-039
Guizhou, 550002, China
Research Site 20086-050
Hangzhou, 310005, China
Research Site 20086-051
Hangzhou, 310006, China
Research Site 20086-059
Hangzhou, 310009, China
Research Site 20086-007
Hangzhou, 310014, China
Research Site 20086-022
Jinan, 250012, China
Research Site 20086-048
Luoyang, 471003, China
Research Site 20086-030
Nanchang, 330006, China
Research Site 20086-009
Nanchang, 330038, China
Research Site 20086-040
Ningbo, 315040, China
Research Site 20086-021
Pudong, 201299, China
Research Site 20086-019
Qingdao, 266071, China
Research Site 20086-061
Shanghai, 200032, China
Research Site 20086-063
Shanghai, 200080, China
Research Site 20086-052
Shanghai, 200123, China
Research Site 20086-041
Shanghai, 200433, China
Research Site 20086-053
Shenyang, 100004, China
Research Site 20086-064
Taiyuan, 030001, China
Research Site 20086-032
Weifang, 261000, China
Research Site 20086-032
Weifang, China
Research Site 20086-066
Wuxi, 214023, China
Research Site 20086-017
Zhejiang, 325000, China
Research Site 20057-008
Barranquilla, 080020, Colombia
Research Site 20057-006
Bogotá, 110111, Colombia
Research Site 20057-007
Ibagué, 730000001, Colombia
Research Site 20057-009
Santander, 681004, Colombia
Research Site 20057-001
Zipaquirá, 250252, Colombia
Research Site 20995-007
Batumi, 6010, Georgia
Research Site 20995-001
Kutaisi, 4600, Georgia
Research Site 20995-005
Tbilisi, 0102, Georgia
Research Site 20995-010
Tbilisi, 0112, 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 20995-008
Tbilisi, 0186, Georgia
Research Site 20081-080
Asahikawa, 078-8510, Japan
Research Site 20081-046
Fukuoka, 806-8501, Japan
Research Site 20081-003
Fukuoka, 807-8556, Japan
Research Site 20081-044
Fukuoka, 811-1394, Japan
Research Site 20081-025
Fukuoka, Japan
Research Site 20081-015
Gifu, 509-6134, Japan
Research Site 20081-077
Himeji, 670-0849, Japan
Research Site 20081-078
Hiroshima, 734-8530, Japan
Research Site 20081-071
Hokkaido, 006-0832, Japan
Research Site 20081-042
Ibaraki, 319-1113, Japan
Research Site 20081-069
Isehara, 259-1193, Japan
Research Site 20081-050
Kagoshima, 890-8520, Japan
Research Site 20081-079
Kobe, 650-0017, Japan
Research Site 20081-039
Kobe, 653-0013, Japan
Research Site 20081-072
Kochi, 783-8505, Japan
Research Site 20081-052
Kochi, 783-8509, Japan
Research Site 20081-090
Maebashi, 371-8511, Japan
Research Site 20081-030
Matsusaka, 515-8544, Japan
Research Site 20081-083
Miura, 238-0111, Japan
Research Site 20081-021
Nagoya, 454-8509, Japan
Research Site 20081-073
Nagoya, 67-8602, Japan
Research Site 20081-056
Niigata, 951-8520, Japan
Research Site 20081-037
Okayama, 102-3055, Japan
Research Site 20081-088
Ono, 675-1392, Japan
Research Site 20081-086
Osaka, 545-8586, Japan
Research Site 20081-024
Osaka, 560-8552, Japan
Research Site 20081-068
Osaka, 589-8511, Japan
Research Site 20081-041
Saga, 849-8501, Japan
Research Site 20081-076
Saitama, 350-0495, Japan
Research Site 20081-009
Shibuya-ku, 150-8935, Japan
Research Site 20081-032
Shimane, 693-8501, Japan
Research Site 20081-031
Shizuoka, 420-8527, Japan
Research Site 20081-061
Shizuoka, 426-8677, Japan
Research Site 20081-076
Tarumi, 350-0495, Japan
Research Site 20081-034
Tokyo, 104-0031, Japan
Research Site 20081-028
Tokyo, 105-8470, Japan
Research Site 20081-023
Tokyo, 140-8522, Japan
Research Site 20081-026
Tokyo, 160-0023, Japan
Research Site 20081-066
Tokyo, 160-8582, Japan
Research Site 20081-019
Tokyo, 162-8655, Japan
Research Site 20081-074
Tokyo, 162-8666, Japan
Research Site 20081-065
Tokyo, 173-8610, Japan
Research Site 20081-029
Tokyo, 204-8585, Japan
Research Site 20081-062
Toyama, 930-0194, Japan
Research Site 20081-038
Toyama, 930-8550, Japan
Research Site 20081-049
Tsuchiura, 300-8585, Japan
Research Site 20081-016
Yamaguchi, 755-8505, Japan
Research Site 20081-011
Yokohama, 236-0004, Japan
Research Site 20081-051
Yokohama, 245-8575, Japan
Research Site 20081-087
Yonago, 683-8504, Japan
Research Site 20081-043
Yoshida, 910-1193, Japan
Research Site 20961-007
Aïn Ouzaïn, Lebanon
Research Site 20961-003
Beirut, Lebanon
Research Site 20961-004
Beirut, Lebanon
Research Site 20961-009
Beirut, Lebanon
Research Site 20961-010
Beirut, Lebanon
Research Site 20961-012
Beirut, Lebanon
Research Site 20961-005
Tripoli, Lebanon
Research Site 20052-011
Benito Juárez, 03100, Mexico
Research Site 20052-008
Córdoba, 94550, Mexico
Research Site 20052-035
Cuernavaca, 62250, Mexico
Research Site 20052-002
Guadalajara, 44200, Mexico
Research Site 20052-034
Guadalajara, 44950, Mexico
Research Site 20052-013
Mérida, 97070, Mexico
Research Site 20052-004
Mérida, 97217, Mexico
Research Site 20052-012
San Juan del Río, 76800, Mexico
Research Site 20052-037
San Nicolás de los Garza, 66465, Mexico
Research Site 20052-006
Veracruz, 91851, Mexico
Research Site 20052-009
Zapopan, 45138, Mexico
Research Site 20389-006
Shtip, 2000, North Macedonia
Research Site 20389-003
Skopje, 1000, North Macedonia
Research Site 20389-004
Skopje, 1000, North Macedonia
Research Site 20389-007
Skopje, 1000, North Macedonia
Research Site 20389-005
Strumica, 2400, North Macedonia
Research Site 20389-001
Veles, 1400, North Macedonia
Research Site 20051-009
Lima, 15023, Peru
Researcdh Site 20051-014
Lima, 15046, Peru
Research Site 20051-012
Lima, 15046, Peru
Research Site 20051-013
Lima, 15046, Peru
Research Site 20051-030
Lima, 15073, Peru
Research Site 20051-003
Lima, 15076, Peru
Research Site 20051-007
Lima, 15082, Peru
Research Site 20051-006
Lima, 15088, Peru
Research Site 20051-010
Lima, 15102, Peru
Research Site 20051-001
Lima, 15131, Peru
Research Site20051-002
Lima, 15131, Peru
Research Site 20051-008
Piura, 20001, Peru
Research Site 20048-001
Będzin, 42-500, Poland
Research Site 20048-018
Bialystok, 15-044, Poland
Research Site 20048-032
Bialystok, 15-430, Poland
Research Site 20048-006
Giżycko, 11-500, Poland
Research Site 20048-021
Katowice, 40-081, Poland
Research Site 20048-002
Katowice, 40-365, Poland
Research Site 20048-036
Kielce, 25-355, Poland
Research Site 20048-027
Krakow, 30-033, Poland
Research Site 20048-033
Krakow, 31-011, Poland
Research Site 20048-008
Krakow, 31-159, Poland
Research Site 20048-040
Krakow, 31-864, Poland
Research Site 20048-005
Lodz, 50-549, Poland
Research Site 20048-009
Lodz, 90-302, Poland
Research Site 20048-015
Lodz, 902-141, Poland
Research Site 20048-022
Lublin, 20-289, Poland
Research Site 20048-024
Maków Podhalański, 34-220, Poland
Research Site 20048-031
Ostrowiec Świętokrzyski, 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 20048-039
Rzeszów, 35-205, Poland
Research Site 20048-014
Skierniewice, 96-100, Poland
Research Site 20048-037
Torun, Torun 87-100, Poland
Research Site 20048-012
Trzebnica, 55-100, Poland
Research Site 20048-034
Warsaw, 02-793, Poland
Research Site 20048-019
Wroclaw, 51-162, Poland
Research Site 20048-029
Wroclaw, 53-301, Poland
Research Site 20787-365
Guaynabo, 00968, Puerto Rico
Research Site 20787-390
Ponce, 00717, Puerto Rico
Research Site 20040-004
Brasov, Brașov County, 500366, Romania
Research Site 20040-006
Cluj-Napoca, Cluj, 400371, Romania
Research Site 20040-008
Bragadiru, 077025, Romania
Research Site 20040-002
Brasov, 500051, Romania
Research Site 20040-004
Brasov, 500366, Romania
Research Site 20040-011
Timișoara, 300566, Romania
Research Site 20381-002
Belgrade, 11000, Serbia
Research Site 20381-007
Belgrade, 11000, Serbia
Research Site 20381-010
Belgrade, 11000, Serbia
Research Site 20381-012
Belgrade, 11000, Serbia
Research Site 20381-005
Belgrade, 11080, Serbia
Research Site 20381-006
Belgrade, 11080, Serbia
Research Site 20381-008
Kamenitz, 21204, Serbia
Research Site 20381-001
Kragujevac, 3400, Serbia
Research Site 20381-004
Niš, 18000, Serbia
Research Site 20381-009
Novi Sad, 21000, Serbia
Research Site 20381-011
Užice, 31000, Serbia
Research Site 20381-003
Valjevo, 14000, Serbia
Research Site 20082-003
Anyang, 14068, South Korea
Research Site 20082-007
Busan, 48108, South Korea
Research Site 20082-009
Daegu, 42415, South Korea
Research Site 20381-009
Incheon, 21565, South Korea
Research Site 20082-006
Jeonju, 54907, South Korea
Research Site 20082-013
Seoul, 03080, South Korea
Research Site 20082-019
Seoul, 04763, South Korea
Research Site 20082-008
Seoul, 06591, South Korea
Research Site 20082-004
Seoul, 07061, South Korea
Research Site 20082-014
Seoul, 07345, South Korea
Research Site 20082-011
Seoul, 08308, South Korea
Research Site 20082-010
Suwon, 16499, South Korea
Research Site 20380-002
Chernivtsi, 58001, Ukraine
Research Site 20380-021
Chernivtsi, 58022, Ukraine
Research Site 20380-017
Ivano-Frankivsk, 76008, Ukraine
Research Site 20380-004
Ivano-Frankivsk, 76019, Ukraine
Research Site 20380-009
Ivano-Frankivsk, 76019, Ukraine
Research Site 20380-014
Ivano-Frankivsk, 76019, Ukraine
Research Site 20380-015
Kyiv, 02002, Ukraine
Research Site 20380-019
Kyiv, 02002, Ukraine
Research Site 20380-007
Kyiv, 03038, Ukraine
Research Site 20380-010
Kyiv, 03038, Ukraine
Research Site 20380-012
Kyiv, 03038, Ukraine
Research Site 20380-011
Kyiv, 03115, Ukraine
Research Site 20380-013
Kyiv, 03115, Ukraine
Research Site 20380-018
Kyiv, 3037, Ukraine
Research Site 20380-016
Lutsk, 45634, Ukraine
Research Site 20380-001
Ternopil, 46023, Ukraine
Research Site 20380-003
Vinnytsia, 21001, Ukraine
Research Site 20380-020
Vinnytsia, 21018, Ukraine
Research Site 20380-022
Vinnytsia, 21028, Ukraine
Research Site 20380-008
Vinnytsia, 21029, Ukraine
Research Site 20380-005
Zhytomyr, 10002, Ukraine
Research Site 20044-001
Manchester, Greater Manchester, BL9 0NJ, United Kingdom
Research Site 20044-033
Manchester, Greater Manchester, M20 2RN, United Kingdom
Research Site 20044-046
Manchester, Greater Manchester, M27 0EW, United Kingdom
Research Site 20044-013
Manchester, Greater Manchester, SK8 4NQ, United Kingdom
Research Site 20044-008
Salford, Greater Manchester, M6 5WW, United Kingdom
Research Site 20044-010
Altrincham, WA14 1PF, United Kingdom
Research Site 20044-079
Bedford, BD9 6RJ, United Kingdom
Research Site 20044-018
Bellshill, ML4 3NJ, United Kingdom
Research Site 20044-083
Birmingham, B15 2GW, United Kingdom
Research Site 20044-021
Birmingham, B15 2SQ, United Kingdom
Research Site 20044-077
Bollington, SK10 5JH, United Kingdom
Research Site 20044-017
Chorley, PR7 7NA, United Kingdom
Research Site 20044-022
Enfield, EN3 4GS, United Kingdom
Research Site 20044-019
Liverpool, L22 0LG, United Kingdom
Research Site 20044-084
London, E11 EQ, United Kingdom
Research Site 20044-081
London, EC1M 6BQ, United Kingdom
Research Site 20044-036
London, SE1 7EH, United Kingdom
Research Site 20044-042
London, W12 0HS, United Kingdom
Research Site 20044-020
Manchester, M15 6SE, United Kingdom
Research Site 20044-031
Manchester, M20 6BA, United Kingdom
Research Site 20044-032
Manchester, M23 2SY, United Kingdom
Research Site 20044-009
Manchester, M24 4DZ, United Kingdom
Research Site 20044-005
Manchester, M27 8HP, United Kingdom
Research Site 20044-030
Manchester, M41 8AA, United Kingdom
Research Site 20044-012
Manchester, M42 7WJ, United Kingdom
Research Site 20044-004
Manchester, OL6 6HD, United Kingdom
Research Site 20044-082
Nottingham, NG5 1PB, United Kingdom
Research Site 20044-024
Preston, PR2 9RB, United Kingdom
Research Site 20044-026
Rochdale, OL11 4AU, United Kingdom
Research Site 20044-029
Stockport, SK3 9NX, United Kingdom
Research Site 20044-034
Stockport, SK8 5LL, United Kingdom
Research Site 20044-078
Wythenshawe, M23 9QZ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Salman Siddiqui, MD
Imperial College Healthcare NHS Trust (via Imperial Consultants)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2023
First Posted
March 10, 2023
Study Start
January 30, 2023
Primary Completion
December 8, 2025
Study Completion
December 8, 2025
Last Updated
December 15, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share