Clinical trial NCT05748600: A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Eosinophilic Asthma
Asthma; Eosinophilic
Asthma Attack
Keywords: FEV1
Asthma
Dexpramipexole
EXHALE
EXHALE-4
Areteia
Uncontrolled Asthma
Asthma Attack
forced expiratory volume
Lead sponsor: Areteia Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-02-28
Enrollment: 600
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. In addition, the study will further evaluate the safety and tolerability of dexpramipexole in participants with eosinophilic asthma.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent form and assent form, as appropriate.
2. Male or female ≥12 years of age at Screening Visit 1. Sites in Poland will only include participants aged ≥18 years.

   Asthma-related criteria
3. Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1.
4. 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.
5. Pre-BD FEV1 ≥40% and \<80% (\<90% for participants 12 to 17 years of age) of predicted at Screening Visit 2.
6. 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.
7. ACQ-6 ≥1.5 at Screening Visit 2.
8. 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
9. Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Screening and Baseline visits.
10. 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

1. 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.
2. 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).
3. Respiratory infection: Upper or lower respiratory tract, sinus, or middle ear infection within the 4 weeks before Screening Visit 1.

   Prohibited medications/procedures
4. 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.
5. Treatment with any of the following monoclonal antibody therapies within 120 days prior to Baseline: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab.
6. Treatment with pramipexole (Mirapex®) within 30 days of Baseline.
7. Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days prior to Screening Visit 1.
8. Bronchial thermoplasty procedure in the past 12 months prior to Screening Visit 1 or planned during the study period.

   General medical history
9. Weight \<40 kg at Screening Visit 2.
10. 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.
11. Known or suspected alcohol or drug abuse.
12. Uncontrolled severe hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to the Baseline Visit despite antihypertensive therapy.
13. 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.
14. History of human immunodeficiency virus (HIV) infection or chronic infection with hepatitis B or C.
15. 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.
16. Medical or other condition likely to interfere with participant's ability to undergo study procedures, adhere to visit schedule, or comply with study requirements.
17. Known or suspected noncompliance with medication.
18. Unwillingness or inability to follow the procedures outlined in the protocol.

    Clinical safety labs
19. Absolute neutrophil count \<2.000x10⁹/L at Screening Visit 1 or Screening Visit 2..
20. 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).
21. 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
22. History of New York Heart Association class IV heart failure or last known left ventricular ejection fraction \<25%.
23. History of major adverse cardiovascular event (MACE) within 3 months prior to the Baseline Visit.
24. History of cardiac arrhythmia within 3 months prior to the Baseline Visit that is not controlled by medication or via ablation.
25. History of long QT syndrome.
26. 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.
27. 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
28. Pregnant women or women breastfeeding.
29. 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.

Primary outcomes:
measure: Change in pre-BD FEV₁ from baseline
timeFrame: Day 1 (baseline, pre-dose), Weeks 20, 24
Secondary outcomes:
measure: Change from baseline in Asthma Control Questionnaire-6 (ACQ-6)
timeFrame: Day 1 (baseline, pre-dose), Weeks 20, 24
measure: Change in Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) from baseline to Week 24.
timeFrame: Day 1 (baseline, pre-dose) through Week 24
measure: Change from baseline absolute eosinophil count (AEC) averaged across Weeks 20 and 24.
timeFrame: Day 1 (baseline, pre-dose) through Week 24
measure: Change from baseline forced vital capacity (FVC) averaged over Weeks 20 and 24.
timeFrame: Day 1 (baseline, pre-dose), Weeks 20, 24
measure: Change from baseline forced vital capacity (FVC) at Weeks 4, 8, 12, 16, 20, and 24.
timeFrame: Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, and 24
measure: Change from baseline post-bronchodilator (post-BD) forced expiratory volume (FEV₁) at Week 24.
timeFrame: Day 1 (baseline, pre-dose) through Week 24
measure: The EuroQol 5-dimensional questionnaire (EQ-5D-5L) change from baseline to Week 24
timeFrame: Day 1 (baseline, pre-dose) through Week 24
Other outcomes:
Locations:
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facility: Research Site 40001-462
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facility: Research Site 40001-385
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facility: Research Site 40001-029
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facility: Research Site 40001-350
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city: Homestead
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city: Kissimmee
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facility: Research Site 40001-015
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city: Kissimmee
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facility: Research Site 40001-002
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city: Maitland
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facility: Research Site 40001-318
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city: Miami
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city: Orlando
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city: Plantation
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city: Saint Petersburg
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city: Sarasota
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facility: Research Site 40001-351
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city: Tallahassee
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facility: Research Site 40001-370
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city: Tampa
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facility: Research Site 40001-004
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city: Viera
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facility: Research Site 40001-319
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city: Adairsville
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city: Augusta
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facility: Research Site 40001-075
state: Georgia
city: Columbus
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facility: Research Site 40001-018
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city: Dunwoody
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facility: Research Site 40001-452
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city: East Point
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city: Lilburn
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facility: Research Site 40001-366
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city: Savannah
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city: Chicago
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facility: Research Site 40001-343
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city: Normal
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city: River Forest
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city: Skokie
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city: Louisville
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city: Owensboro
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city: Marrero
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city: Zachary
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city: Baltimore
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city: Takoma Park
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city: White Marsh
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city: Flint
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city: Flint
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city: Rochester Hills
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city: Southfield
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city: Warren
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city: Mankato
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city: Columbia
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city: Saint Charles
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city: Saint Louis
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city: Lincoln
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city: Las Vegas
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city: Brick
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city: Edison
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city: Jersey City
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city: Toms River
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city: Great Neck
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city: New York
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city: New York
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state: New York
city: Charlotte
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state: North Carolina
city: Charlotte
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state: North Carolina
city: Gastonia
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facility: Research Site 40001-039
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city: Greenville
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facility: Research Site 40001-435
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city: Raleigh
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city: Cincinnati
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facility: Research Site 40001-013
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city: Cincinnati
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city: Cleveland
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city: Dayton
country: United States
facility: Research Site 40001-017
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city: Toledo
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facility: Research Site 40001-063
state: Ohio
city: Edmond
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facility: Research Site US-40001-038
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city: Oklahoma City
country: United States
facility: Research Site 40001-386
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site 40001-079
state: Oklahoma
city: Grants Pass
country: United States
facility: Research Site 40001-027
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city: Portland
country: United States
facility: Research Site 40001-337
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city: Philadelphia
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city: Columbia
country: United States
facility: Research Site 40001-032
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city: Greenville
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facility: Research Site 40001-025
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city: Rock Hill
country: United States
facility: Research Site 40001-430
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city: Spartanburg
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facility: Research Site 40001-073
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city: Franklin
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facility: Research Site 40001-414
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facility: Research Site 40001-334
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city: Amarillo
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facility: Research Site 40001-068
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city: Dallas
country: United States
facility: Research Site 40001-023
state: Texas
city: Dallas
country: United States
facility: Research Site 40001-028
state: Texas
city: Dallas
country: United States
facility: Research Site 40001-415
state: Texas
city: DeSoto
country: United States
facility: Research Site 40001-304
state: Texas
city: Frisco
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facility: Research Site 40001-418
state: Texas
city: Houston
country: United States
facility: Research Site 40001-064
state: Texas
city: Houston
country: United States
facility: Research Site 40001-085
state: Texas
city: Kerrville
country: United States
facility: Research Site 40001-424
state: Texas
city: McKinney
country: United States
facility: Research Site 40001-295
state: Texas
city: Red Oak
country: United States
facility: Research Site 40001-304
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city: San Antonio
country: United States
facility: Research Site 40001-377
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city: Sugar Land
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facility: Research Site 40001-335
state: Texas
city: Murray
country: United States
facility: Research Site 40001-258
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city: Pleasant View
country: United States
facility: Research Site 40001-333
state: Utah
city: Burke
country: United States
facility: Research Site 40001-340
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city: Williamsburg
country: United States
facility: Research Site 40001-394
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city: Greenfield
country: United States
facility: Research Site 40001-339
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city: La Crosse
country: United States
facility: Research Site 40001-433
state: Wisconsin
city: La Crosse
country: United States
facility: Research Site 40001-443
state: Wisconsin
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country: Argentina
facility: Research Site 40054-035
city: Buenos Aires
country: Argentina
facility: Research Site 40054-044
city: Buenos Aires
country: Argentina
facility: Research Site 40054-034
city: Buenos Aires
country: Argentina
facility: Research Site 40054-017
city: Buenos Aires
country: Argentina
facility: Research Site 40054-008
city: Buenos Aires
country: Argentina
facility: Research Site 40054-043
city: Caba
country: Argentina
facility: Research Site 40054-015
city: Mendoza
country: Argentina
facility: Research Site 40054-019
city: Mendoza
country: Argentina
facility: Research Site 40054-016
city: Mendoza
country: Argentina
facility: Research Site 40054-010
city: Mendoza
country: Argentina
facility: Research Site 40054-028
city: Mendoza
country: Argentina
facility: Research Site 40054-032
city: Mendoza
country: Argentina
facility: Research Site 40054-057
city: Tucumán
country: Argentina
facility: Research Site 40054-024
city: Tucumán
country: Argentina
facility: Research Site 40054-002
city: Tucumán
country: Argentina
facility: Research Site 40054-020
city: Salzburg
country: Austria
facility: Research Site 30043-013
city: Blumenau
country: Brazil
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city: Curitiba
country: Brazil
facility: Research Site 40055-036
city: Porto Alegre
country: Brazil
facility: Research Site 40055-012
city: Porto Alegre
country: Brazil
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city: Porto Alegre
country: Brazil
facility: Research Site 40055-010
city: Rio de Janeiro
country: Brazil
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city: Salvador
country: Brazil
facility: Research Site 40055-025
city: Santo André
country: Brazil
facility: Research Site 40055-005
city: Santos
country: Brazil
facility: Research Site 40055-009
city: São Bernardo Do Campo
country: Brazil
facility: Research Site 40055-001
city: Ajax
country: Canada
facility: Research Site 40011-004
state: Ontario
city: Ajax
country: Canada
facility: Research Site 40011-016
state: Ontario
city: Burlington
country: Canada
facility: Research Site 40011-010
state: Ontario
city: Ottawa
country: Canada
facility: Research Site 40011-014
state: Ontario
city: Windsor
country: Canada
facility: Research Site 40011-005
state: Ontario
city: Windsor
country: Canada
facility: Research Site 40011-001
state: Ontario
city: Québec
country: Canada
facility: Research Site 40011-022
state: Quebec
city: Trois-Rivières
country: Canada
facility: Research Site 40011-020
state: Quebec
city: Vancouver
country: Canada
facility: Research Site 40011-011
city: Ashkelon
country: Israel
facility: Research Site 40972-010
city: Be'er Sheva
country: Israel
facility: Research Site 40972-008
city: Haifa
country: Israel
facility: Research Site 40972-005
city: Jerusalem
country: Israel
facility: Research Site 40972-001
city: Kfar Saba
country: Israel
facility: Research Site 40972-009
city: Petah tikva
country: Israel
facility: Research Site 40972-002
city: Ramat Gan
country: Israel
facility: Research Site 40972-011
city: Anyang-Si
country: Korea, Republic of
facility: Research Site 40082-003
city: Bucheon
country: Korea, Republic of
facility: Research Site 30082-024
city: Busan
country: Korea, Republic of
facility: Research Site 40082-007
city: Gwangju
country: Korea, Republic of
facility: Research Site 40082-021
city: Incheon
country: Korea, Republic of
facility: Research Site 40082-020
city: Jeonju
country: Korea, Republic of
facility: Research Site 40082-006
city: Seoul
country: Korea, Republic of
facility: Research Site 40082-019
city: Seoul
country: Korea, Republic of
facility: Research Site 40082-008
city: Seoul
country: Korea, Republic of
facility: Research Site 40082-004
city: Suwon-si
country: Korea, Republic of
facility: Research Site 40082-010
city: Kampung Kelantan
country: Malaysia
facility: Research Site 30060-006
city: Chihuahua
country: Mexico
facility: Research Site 40052-026
city: Guadalajara
country: Mexico
facility: Research Site 40052-007
city: Mexico City
country: Mexico
facility: Research Site 40052-028
city: San Juan Del Río
country: Mexico
facility: Research Site 40052-012
city: Bialystok
country: Poland
facility: Research Site 40048-032
city: Białystok
country: Poland
facility: Research Site 40048-018
city: Będzin
country: Poland
facility: Research Site 40048-001
city: Giżycko
country: Poland
facility: Research Site 40048-006
city: Katowice
country: Poland
facility: Research Site 40048-021
city: Katowice
country: Poland
facility: Research Site 40048-002
city: Krakow
country: Poland
facility: Research Site 40048-040
city: Kraków
country: Poland
facility: Research Site 40048-027
city: Kraków
country: Poland
facility: Research Site 40048-033
city: Kraków
country: Poland
facility: Research Site 40048-008
city: Lublin
country: Poland
facility: Research Site 40048-022
city: Maków Podhalański
country: Poland
facility: Research Site 40048-024
city: Ostrowiec Świętokrzyski
country: Poland
facility: Research Site 40048-031
city: Piaseczno
country: Poland
facility: Research Site 40048-010
city: Poznań
country: Poland
facility: Research Site 40048-016
city: Rzeszow
country: Poland
facility: Research Site 40048-039
city: Skierniewice
country: Poland
facility: Research Site 40048-014
city: Trzebnica
country: Poland
facility: Research Site 40048-012
city: Wrocław
country: Poland
facility: Research Site 40048-019
city: Łódź
country: Poland
facility: Research Site 40048-015
city: Łódź
country: Poland
facility: Research Site 40048-009
city: Łódź
country: Poland
facility: Research Site 40048-005
city: Guaynabo
country: Puerto Rico
facility: Research Site 40787-365
city: Ponce
country: Puerto Rico
facility: Research Site 40787-390
city: San Juan
country: Puerto Rico
facility: Research Site 40787-388
city: San Juan
country: Puerto Rico
facility: Research Site 40787-383
city: San Juan
country: Puerto Rico
facility: Research Site 40787-405
city: San Juan
country: Puerto Rico
facility: Research Site 40787-360
city: Vega Baja
country: Puerto Rico
facility: Research Site 40787-345
city: Braşov
country: Romania
facility: Research Site 40040-004
state: Brasov
city: Cluj-Napoca
country: Romania
facility: Research Site 40040-006
state: Cluj
city: Braşov
country: Romania
facility: Research Site 40040-002
city: Cluj-Napoca
country: Romania
facility: Research Site 40040-009
city: Cluj-Napoca
country: Romania
facility: Research Site 40040-007
city: Constanţa
country: Romania
facility: Research Site 40040-001
city: Sangeorgiu de Mures
country: Romania
facility: Research Site 40040-010
city: Timişoara
country: Romania
facility: Research Site 40040-003
city: Benoni
country: South Africa
facility: Research Site 40027-013
city: Cape Town
country: South Africa
facility: Research Site 40027-025
city: Cape Town
country: South Africa
facility: Research Site 40027-009
city: Cape Town
country: South Africa
facility: Research Site 40027-011
city: Cape Town
country: South Africa
facility: Research Site 40027-021
city: Durban
country: South Africa
facility: Research Site 30090-020
city: Durban
country: South Africa
facility: Research Site 40027-007
city: Johannesburg
country: South Africa
facility: Research Site 40027-026
city: KwaZulu
country: South Africa
facility: Research Site 40027-005
city: KwaZulu
country: South Africa
facility: Research Site 40027-008
city: KwaZulu
country: South Africa
facility: Research Site 40027-020
city: KwaZulu
country: South Africa
facility: Research Site 40027-023
city: KwaZulu
country: South Africa
facility: Research Site 40027-027
city: KwaZulu
country: South Africa
facility: Research Site 40027-010
city: Mpumalanga
country: South Africa
facility: Research Site 40027-006
city: Pretoria
country: South Africa
facility: Research Site 40027-004
city: Pretoria
country: South Africa
facility: Research Site 40027-019
city: Vereeniging
country: South Africa
facility: Research Site 40027-018
city: Welkom
country: South Africa
facility: Research Site 40027-017
city: Kaohsiung
country: Taiwan
facility: Research Site 40886-001
city: New Taipei City
country: Taiwan
facility: Research Site 40886-004
city: New Taipei City
country: Taiwan
facility: Research Site 40886-006
city: Taichung
country: Taiwan
facility: Research Site 40886-005
city: Taichung
country: Taiwan
facility: Research Site 40886-007
city: Taipei
country: Taiwan
facility: Research Site 40886-010
city: Taipei
country: Taiwan
facility: Research Site 40886-008
city: Taipei
country: Taiwan
facility: Research Site 40866-003
city: Taipei
country: Taiwan
facility: Research Site 40886-009
city: Pathumthani
country: Thailand
facility: Research Site 30066-004
city: Adana
country: Turkey
facility: Research Site 40090-002
city: Ankara
country: Turkey
facility: Research Site 40090-018
city: Ankara
country: Turkey
facility: Research Site 40090-021
city: Ankara
country: Turkey
facility: Research Site 40090-024
city: Ankara
country: Turkey
facility: Research Site 40090-003
city: Ankara
country: Turkey
facility: Research Site 40090-025
city: Ankara
country: Turkey
facility: Research Site 40090-008
city: Ankara
country: Turkey
facility: Research Site 40090-009
city: Bornova
country: Turkey
facility: Research Site 40090-019
city: Istanbul
country: Turkey
facility: Research Site 40090-026
city: Konak
country: Turkey
facility: Research Site 40090-012
city: Merkez
country: Turkey
facility: Research Site 40090-016
city: Mersin
country: Turkey
facility: Research Site 40090-013
city: Pendik
country: Turkey
facility: Research Site 40090-024
city: Tekirdag
country: Turkey
facility: Research Site 40090-022
city: Chernivtsi
country: Ukraine
facility: Research Site 40380-002
city: Chernivtsi
country: Ukraine
facility: Research Site 40380-021
city: Ivano-Frankivs'k
country: Ukraine
facility: Research Site 40380-009
city: Ivano-Frankivs'k
country: Ukraine
facility: Research Site 40380-004
city: Ivano-Frankivs'k
country: Ukraine
facility: Research Site 40380-017
city: Ivano-Frankivs'k
country: Ukraine
facility: Research Site 40380-014
city: Kyiv
country: Ukraine
facility: Research Site 40380-019
city: Kyiv
country: Ukraine
facility: Research Site 40380-018
city: Kyiv
country: Ukraine
facility: Research Site 40380-007
city: Kyiv
country: Ukraine
facility: Research Site 40380-010
city: Kyiv
country: Ukraine
facility: Research Site 40380-012
city: Kyiv
country: Ukraine
facility: Research Site 40380-015
city: Kyiv
country: Ukraine
facility: Research Site 40380-011
city: Kyiv
country: Ukraine
facility: Research Site 40380-013
city: Luts'k
country: Ukraine
facility: Research Site 40380-016
city: Ternopil
country: Ukraine
facility: Research Site 40380-001
city: Vinnytsia
country: Ukraine
facility: Research Site 40380-003
city: Vinnytsia
country: Ukraine
facility: Research Site 40380-020
city: Vinnytsia
country: Ukraine
facility: Research Site 40380-008
city: Vinnytsia
country: Ukraine
facility: Research Site 40380-022
city: Zhytomyr
country: Ukraine
facility: Research Site 40380-005
city: Bellshill
country: United Kingdom
facility: Research Site 40044-018
city: Birmingham
country: United Kingdom
facility: Research Site 40044-021
city: Bollington
country: United Kingdom
facility: Research Site 40044-077
city: Chorley
country: United Kingdom
facility: Research Site 40044-017
city: Enfield Town
country: United Kingdom
facility: Research Site 40044-022
city: Liverpool
country: United Kingdom
facility: Research Site 40044-019
city: London
country: United Kingdom
facility: Research Site 40044-084
city: Manchester
country: United Kingdom
facility: Research Site 40044-001
city: Manchester
country: United Kingdom
facility: Research Site 40044-020
city: Manchester
country: United Kingdom
facility: Research Site 40044-013
city: Manchester
country: United Kingdom
facility: Research Site 40044-009
city: Manchester
country: United Kingdom
facility: Research Site 40044-036
city: Manchester
country: United Kingdom
facility: Research Site 40044-006
city: Preston
country: United Kingdom
facility: Research Site 40044-024
city: Rochdale
country: United Kingdom
facility: Research Site 40044-026
city: Salford
country: United Kingdom
facility: Research Site 40044-008
city: Stockport
country: United Kingdom
facility: Research Site 40044-034
city: Wythenshawe
country: United Kingdom
facility: Research Site 40044-078
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Mona Bafadhel, MD
role: PRINCIPAL_INVESTIGATOR
References: