Clinical trial NCT05763121: A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe 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 52 Weeks in Participants With Severe Eosinophilic Asthma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Eosinophilic Asthma
Asthma; Eosinophilic
Asthma
Keywords: Exacerbations
Severe Asthma
Dexpramipexole
EXHALE
Areteia
EXHALE-2
Uncontrolled Asthma
Asthma Attack
Lead sponsor: Areteia Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-03-10
Enrollment: 1395
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: 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.

Detailed description: This is a multicenter, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of dexpramipexole in adults and adolescents with severe, inadequately controlled asthma with eosinophilic phenotype on medium to high-dose inhaled corticosteroids (ICS )and at least one additional asthma controller medication with or without oral corticosteroids (OCS). Approximately 1400 participants will be randomized globally. Participants will receive dexpramipexole, or placebo, administered orally, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 4 weeks.

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

   Asthma-related criteria
3. Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1.
4. Treatment of asthma, participants must satisfy all the below (items a to c):

   1. 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.
   2. 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.
   3. 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.
5. 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.
6. Variable airflow obstruction documented with at least one of the following criteria:

   1. 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 to17). 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.
   2. Bronchodilator reversibility, using the criteria above, documented in the past 24 months prior to Screening Visit 1.
   3. Peak flow variation of ≥20% over a 2-week period, documented in the past 24 months prior to Screening Visit 1.
   4. Airflow variability in clinic FEV₁ ≥20% between two consecutive clinic visits, documented in the past 24 months prior to Screening Visit 1.
   5. 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.
7. ACQ-6 ≥1.5 at Screening Visit 2.
8. Documented history of at least two asthma exacerbations requiring treatment with systemic corticosteroids (intramuscular, intravenous, or oral) within the past 12-month period prior to Screening Visit 1.

   General medical history
9. Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Screening Visit 2 and Baseline Visit.
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 would 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 would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.

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 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.
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, hypereosinophilic syndrome, 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.
4. For participants aged 12 to 17 years old, AEC of \<0.15x10⁹/L at Screening Visit 1.

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

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

    Clinical safety labs
20. Absolute neutrophil count (ANC) \<2.000x10⁹/L at Screening Visit 1 or Screening Visit 2.
21. 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 for age ≥18 years at screening; using the Bedside Schwartz eGFR formula).
22. 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
23. History of New York Heart Association class IV heart failure or last known left ventricular ejection fraction \<25%.
24. History of major adverse cardiovascular event (MACE) within 3 months prior to the Baseline Visit.
25. History of cardiac arrhythmia within 3 months prior to the Baseline Visit that is not controlled by medication or via ablation.
26. History of long QT syndrome.
27. 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.
28. Clinically important abnormalities in resting ECG that may interfere with the interpretation of QTcF interval changes at Screening Visit 2, including heart rate \<45 beats per minute (bpm) or \>100 bpm.

    Pregnancy/Lactation
29. Pregnant women or women breastfeeding
30. Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).

Primary outcomes:
measure: Annualized rate of severe asthma exacerbations over 52 weeks.
timeFrame: Day 1 (baseline, pre-dose) through Week 52
Secondary outcomes:
measure: Absolute Change in pre-bronchodilator forced expiratory volume (Pre-BD FEV)₁ from Baseline
timeFrame: Day 1 (baseline, pre-dose), Weeks 36, 44, 52
measure: Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6)
timeFrame: Day 1 (baseline, pre-dose), Weeks 36, 44, 52
measure: Change in Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) from baseline to Week 52.
timeFrame: Day 1 (baseline, pre-dose) through Week 52
measure: Annualized rate of severe exacerbations requiring an emergency department visit or hospitalization over 52 weeks.
timeFrame: Day 1 (baseline, pre-dose) through Week 52
measure: Annualized Rate of severe exacerbations from Week 4 to Week 52
timeFrame: Week 4 through Week 52
measure: Average change in absolute eosinophil count (AEC)
timeFrame: Day 1 (baseline, pre-dose) Weeks 36, 44, 52
measure: Average change from baseline in forced vital capacity (FVC)
timeFrame: Day 1 (baseline, pre-dose), Weeks 36, 44, 52
measure: Change from baseline in forced vital capacity (FVC)
timeFrame: Day 1 (baseline, pre-dose), Weeks 4, 12, 20,28 36, 44, 52
measure: Change from baseline in Post-bronchodilator FEV₁
timeFrame: Day 1 (baseline, pre-dose) through Week 52
measure: Change from baseline in peak expiratory flow (PEF)
timeFrame: Day 1 (baseline, pre-dose) through Week 52
measure: Time to first severe asthma exacerbation
timeFrame: Up to Week 52
measure: Change from baseline in total asthma symptom score
timeFrame: Day 1 (baseline, pre-dose) through Week 52
measure: Change from baseline in the EuroQol five-dimensional questionnaire (EQ-5D-5L)
timeFrame: Day 1 (baseline, pre-dose) through Week 52
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Research Site 20001-374
state: California
city: La Palma
country: United States
facility: Research Site 20001-440
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city: Newport Beach
country: United States
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facility: Research Site US-20001-488
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facility: Research Site 20001-350
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city: Hialeah
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city: Homestead
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city: Kissimmee
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city: Kissimmee
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city: Loxahatchee Groves
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state: West Virginia
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state: Wisconsin
city: Madison
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city: Buenos Aires
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city: Dimitrovgrad
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city: Vancouver
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state: British Columbia
city: Winnipeg
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state: Manitoba
city: Ajax
country: Canada
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state: Ontario
city: Ajax
country: Canada
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state: Ontario
city: Burlington
country: Canada
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city: Windsor
country: Canada
facility: Research Site 20011-001
state: Ontario
city: Montréal
country: Canada
facility: Research Site 20011-018
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Research Site 20011-020
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city: Guelph
country: Canada
facility: Research Site 20011-024
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country: Canada
facility: Research Site 20011-022
city: Taizhou
country: China
facility: Research Site 20086-001
state: Zhejang
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city: Beijing
country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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city: Hangzhou
country: China
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country: China
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country: China
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country: China
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city: Nanchang
country: China
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country: China
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country: China
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country: China
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country: China
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city: Santander
country: Colombia
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country: Georgia
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country: Georgia
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country: Georgia
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city: Tbilisi
country: Georgia
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country: Georgia
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city: Gifu
country: Japan
facility: Research Site 20081-015
city: Himeji
country: Japan
facility: Research Site 20081-077
city: Hiroshima
country: Japan
facility: Research Site 20081-078
city: Hokkaido
country: Japan
facility: Research Site 20081-071
city: Ibaraki
country: Japan
facility: Research Site 20081-042
city: Isehara
country: Japan
facility: Research Site 20081-069
city: Kagoshima
country: Japan
facility: Research Site 20081-050
city: Kobe
country: Japan
facility: Research Site 20081-079
city: Kobe
country: Japan
facility: Research Site 20081-039
city: Kochi
country: Japan
facility: Research Site 20081-072
city: Kochi
country: Japan
facility: Research Site 20081-052
city: Maebashi
country: Japan
facility: Research Site 20081-090
city: Matsusaka
country: Japan
facility: Research Site 20081-030
city: Miura
country: Japan
facility: Research Site 20081-083
city: Nagoya
country: Japan
facility: Research Site 20081-021
city: Nagoya
country: Japan
facility: Research Site 20081-073
city: Niigata
country: Japan
facility: Research Site 20081-056
city: Okayama
country: Japan
facility: Research Site 20081-037
city: Ono
country: Japan
facility: Research Site 20081-088
city: Osaka
country: Japan
facility: Research Site 20081-086
city: Osaka
country: Japan
facility: Research Site 20081-024
city: Osaka
country: Japan
facility: Research Site 20081-068
city: Saga
country: Japan
facility: Research Site 20081-041
city: Saitama
country: Japan
facility: Research Site 20081-076
city: Shibuya-ku
country: Japan
facility: Research Site 20081-009
city: Shimane
country: Japan
facility: Research Site 20081-032
city: Shizuoka
country: Japan
facility: Research Site 20081-031
city: Shizuoka
country: Japan
facility: Research Site 20081-061
city: Tarumi
country: Japan
facility: Research Site 20081-076
city: Tokyo
country: Japan
facility: Research Site 20081-034
city: Tokyo
country: Japan
facility: Research Site 20081-028
city: Tokyo
country: Japan
facility: Research Site 20081-023
city: Tokyo
country: Japan
facility: Research Site 20081-026
city: Tokyo
country: Japan
facility: Research Site 20081-066
city: Tokyo
country: Japan
facility: Research Site 20081-019
city: Tokyo
country: Japan
facility: Research Site 20081-074
city: Tokyo
country: Japan
facility: Research Site 20081-065
city: Tokyo
country: Japan
facility: Research Site 20081-029
city: Toyama
country: Japan
facility: Research Site 20081-062
city: Toyama
country: Japan
facility: Research Site 20081-038
city: Tsuchiura
country: Japan
facility: Research Site 20081-049
city: Yamaguchi
country: Japan
facility: Research Site 20081-016
city: Yokohama
country: Japan
facility: Research Site 20081-011
city: Yokohama
country: Japan
facility: Research Site 20081-051
city: Yonago
country: Japan
facility: Research Site 20081-087
city: Yoshida
country: Japan
facility: Research Site 20081-043
city: Anyang
country: Korea, Republic of
facility: Research Site 20082-003
city: Busan
country: Korea, Republic of
facility: Research Site 20082-007
city: Daegu
country: Korea, Republic of
facility: Research Site 20082-009
city: Incheon
country: Korea, Republic of
facility: Research Site 20381-009
city: Jeonju
country: Korea, Republic of
facility: Research Site 20082-006
city: Seoul
country: Korea, Republic of
facility: Research Site 20082-013
city: Seoul
country: Korea, Republic of
facility: Research Site 20082-019
city: Seoul
country: Korea, Republic of
facility: Research Site 20082-008
city: Seoul
country: Korea, Republic of
facility: Research Site 20082-004
city: Seoul
country: Korea, Republic of
facility: Research Site 20082-014
city: Seoul
country: Korea, Republic of
facility: Research Site 20082-011
city: Suwon
country: Korea, Republic of
facility: Research Site 20082-010
city: Aïn Ouzaïn
country: Lebanon
facility: Research Site 20961-007
city: Beirut
country: Lebanon
facility: Research Site 20961-003
city: Beirut
country: Lebanon
facility: Research Site 20961-004
city: Beirut
country: Lebanon
facility: Research Site 20961-009
city: Beirut
country: Lebanon
facility: Research Site 20961-012
city: Tripoli
country: Lebanon
facility: Research Site 20961-005
city: Benito Juarez
country: Mexico
facility: Research Site 20052-011
city: Córdoba
country: Mexico
facility: Research Site 20052-008
city: Guadalajara
country: Mexico
facility: Research Site 20052-002
city: Guadalajara
country: Mexico
facility: Research Site 20052-034
city: Merida
country: Mexico
facility: Research Site 20052-004
city: Mérida
country: Mexico
facility: Research Site 20052-013
city: San Juan del Rio
country: Mexico
facility: Research Site 20052-012
city: San Nicolás De Los Garza
country: Mexico
facility: Research Site 20052-037
city: Veracruz
country: Mexico
facility: Research Site 20052-006
city: Zapopan
country: Mexico
facility: Research Site 20052-009
city: Skopje
country: North Macedonia
facility: Research Site 20389-003
city: Skopje
country: North Macedonia
facility: Research Site 20389-004
city: Skopje
country: North Macedonia
facility: Research Site 20389-007
city: Stip
country: North Macedonia
facility: Research Site 20389-006
city: Strumica
country: North Macedonia
facility: Research Site 20389-005
city: Veles
country: North Macedonia
facility: Research Site 20389-001
city: Lima
country: Peru
facility: Research Site 20051-009
city: Lima
country: Peru
facility: Researcdh Site 20051-014
city: Lima
country: Peru
facility: Research Site 20051-012
city: Lima
country: Peru
facility: Research Site 20051-013
city: Lima
country: Peru
facility: Research Site 20051-030
city: Lima
country: Peru
facility: Research Site 20051-003
city: Lima
country: Peru
facility: Research Site 20051-007
city: Lima
country: Peru
facility: Research Site 20051-006
city: Lima
country: Peru
facility: Research Site 20051-010
city: Lima
country: Peru
facility: Research Site 20051-001
city: Lima
country: Peru
facility: Research Site20051-002
city: Piura
country: Peru
facility: Research Site 20051-008
city: Bialystok
country: Poland
facility: Research Site 20048-018
city: Bialystok
country: Poland
facility: Research Site 20048-032
city: Będzin
country: Poland
facility: Research Site 20048-001
city: Gizycko
country: Poland
facility: Research Site 20048-006
city: Katowice
country: Poland
facility: Research Site 20048-021
city: Katowice
country: Poland
facility: Research Site 20048-002
city: Kielce
country: Poland
facility: Research Site 20048-036
city: Krakow
country: Poland
facility: Research Site 20048-027
city: Krakow
country: Poland
facility: Research Site 20048-033
city: Kraków
country: Poland
facility: Research Site 20048-008
city: Kraków
country: Poland
facility: Research Site 20048-040
city: Lodz
country: Poland
facility: Research Site 20048-009
city: Lublin
country: Poland
facility: Research Site 20048-022
city: Makow Podhalanski
country: Poland
facility: Research Site 20048-024
city: Ostrowiec Swietokrzyski
country: Poland
facility: Research Site 20048-031
city: Piaseczno
country: Poland
facility: Research Site 20048-010
city: Poznan
country: Poland
facility: Research Site 20048-028
city: Poznań
country: Poland
facility: Research Site 20048-016
city: Rzeszow
country: Poland
facility: Research Site 20048-039
city: Skierniewice
country: Poland
facility: Research Site 20048-014
city: Torun
country: Poland
facility: Research Site 20048-037
city: Trzebnica
country: Poland
facility: Research Site 20048-012
city: Warsaw
country: Poland
facility: Research Site 20048-034
city: Wroclaw
country: Poland
facility: Research Site 20048-019
city: Wroclaw
country: Poland
facility: Research Site 20048-029
city: Łódź
country: Poland
facility: Research Site 20048-005
city: Łódź
country: Poland
facility: Research Site 20048-015
city: Guaynabo
country: Puerto Rico
facility: Research Site 20787-365
city: Braşov
country: Romania
facility: Research Site 20040-004
state: Brasov
city: Cluj-Napoca
country: Romania
facility: Research Site 20040-006
state: Cluj
city: Bragadiru
country: Romania
facility: Research Site 20040-008
city: Braşov
country: Romania
facility: Research Site 20040-002
city: Braşov
country: Romania
facility: Research Site 20040-004
city: Timisoara
country: Romania
facility: Research Site 20040-011
city: Belgrade
country: Serbia
facility: Research Site 20381-002
city: Belgrade
country: Serbia
facility: Research Site 20381-010
city: Belgrade
country: Serbia
facility: Research Site 20381-012
city: Belgrade
country: Serbia
facility: Research Site 20381-006
city: Belgrad
country: Serbia
facility: Research Site 20381-007
city: Belgrad
country: Serbia
facility: Research Site 20381-005
city: Kragujevac
country: Serbia
facility: Research Site 20381-001
city: Niš
country: Serbia
facility: Research Site 20381-004
city: Novi Sad
country: Serbia
facility: Research Site 20381-009
city: Sremska Kamenica
country: Serbia
facility: Research Site 20381-008
city: Uzice
country: Serbia
facility: Research Site 20381-011
city: Valjevo
country: Serbia
facility: Research Site 20381-003
city: Chernivtsi
country: Ukraine
facility: Research Site 20380-002
city: Chernivtsi
country: Ukraine
facility: Research Site 20380-021
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site 20380-017
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site 20380-004
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site 20380-009
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site 20380-014
city: Kyiv
country: Ukraine
facility: Research Site 20380-015
city: Kyiv
country: Ukraine
facility: Research Site 20380-019
city: Kyiv
country: Ukraine
facility: Research Site 20380-007
city: Kyiv
country: Ukraine
facility: Research Site 20380-010
city: Kyiv
country: Ukraine
facility: Research Site 20380-012
city: Kyiv
country: Ukraine
facility: Research Site 20380-011
city: Kyiv
country: Ukraine
facility: Research Site 20380-013
city: Kyiv
country: Ukraine
facility: Research Site 20380-018
city: Luts'k
country: Ukraine
facility: Research Site 20380-016
city: Ternopil'
country: Ukraine
facility: Research Site 20380-001
city: Vinnytsia
country: Ukraine
facility: Research Site 20380-003
city: Vinnytsia
country: Ukraine
facility: Research Site 20380-020
city: Vinnytsia
country: Ukraine
facility: Research Site 20380-008
city: Vinnytsya
country: Ukraine
facility: Research Site 20380-022
city: Zhytomyr
country: Ukraine
facility: Research Site 20380-005
city: Manchester
country: United Kingdom
facility: Research Site 20044-001
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: Research Site 20044-033
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: Research Site 20044-046
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: Research Site 20044-013
state: Greater Manchester
city: Salford
country: United Kingdom
facility: Research Site 20044-008
state: Greater Manchester
city: Altrincham
country: United Kingdom
facility: Research Site 20044-010
city: Bedford
country: United Kingdom
facility: Research Site 20044-079
city: Bellshill
country: United Kingdom
facility: Research Site 20044-018
city: Birmingham
country: United Kingdom
facility: Research Site 20044-083
city: Birmingham
country: United Kingdom
facility: Research Site 20044-021
city: Bollington
country: United Kingdom
facility: Research Site 20044-077
city: Chorley
country: United Kingdom
facility: Research Site 20044-017
city: Enfield Town
country: United Kingdom
facility: Research Site 20044-022
city: Liverpool
country: United Kingdom
facility: Research Site 20044-019
city: London
country: United Kingdom
facility: Research Site 20044-084
city: London
country: United Kingdom
facility: Research Site 20044-081
city: London
country: United Kingdom
facility: Research Site 20044-036
city: London
country: United Kingdom
facility: Research Site 20044-042
city: Manchester
country: United Kingdom
facility: Research Site 20044-020
city: Manchester
country: United Kingdom
facility: Research Site 20044-031
city: Manchester
country: United Kingdom
facility: Research Site 20044-032
city: Manchester
country: United Kingdom
facility: Research Site 20044-009
city: Manchester
country: United Kingdom
facility: Research Site 20044-005
city: Manchester
country: United Kingdom
facility: Research Site 20044-030
city: Manchester
country: United Kingdom
facility: Research Site 20044-012
city: Manchester
country: United Kingdom
facility: Research Site 20044-004
city: Nottingham
country: United Kingdom
facility: Research Site 20044-082
city: Preston
country: United Kingdom
facility: Research Site 20044-024
city: Rochdale
country: United Kingdom
facility: Research Site 20044-026
city: Stockport
country: United Kingdom
facility: Research Site 20044-029
city: Stockport
country: United Kingdom
facility: Research Site 20044-034
city: Wythenshawe
country: United Kingdom
facility: Research Site 20044-078
Study officials:
affiliation: Imperial College Healthcare NHS Trust (via Imperial Consultants)
name: Salman Siddiqui, MD
role: PRINCIPAL_INVESTIGATOR
References: