Clinical trial NCT04281472: A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
Official title: A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2020-02-24
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.


Eligibility criteria: Inclusion Criteria:

1. Ability to understand the requirements of the trial, provide written informed consent (include consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits)
2. Male or female patient aged 18 years or older, at the time of signing the informed consent.
3. Diagnosed with probable or definite CIDP according to criteria of the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS 2010), progressing or relapsing forms.
4. CIDP Disease Activity Status (CDAS) score ≥2 at screening.
5. INCAT score ≥2 at the first run-in visit (for patients entering run-in) or stage A baseline (for treatment-naïve patients with documented evidence for worsening on the total adjusted INCAT disability score within 3 months prior to screening). Patients with an INCAT score of 2 at trial entry must have this score exclusively from the leg disability score; for patients with an INCAT score of ≥3 at trial entry, there are no specific requirements for arm or leg scores.
6. Fulfilling any of the following treatment conditions:

   * Currently treated with pulsed corticosteroids, oral corticosteroids equivalent to prednisolone/prednisone ≤10mg/day, and/or IVIg or SCIg, if this treatment has been started within the last 5 years before screening, and the patient is willing to discontinue this treatment at the first run-in visit; or
   * Without previous treatment (treatment-naive); or
   * Treatment with corticosteroids and/or IVIg or SCIg discontinued at least 6 months prior to screening Note: Patients not treated with monthly or daily corticosteroids, IVIg or SCIg for at least 6 months prior to screening are considered as equal to treatment-naïve patients.
7. Women of childbearing potential who have a negative pregnancy test at screening and a negative urine pregnancy test up to Stage A baseline.
8. Women of childbearing potential must use an acceptable method of contraception from signing the ICF until the date of the last dose of IMP

Exclusion Criteria:

1. Pure sensory atypical CIDP (EFNS/PNS definition).
2. Polyneuropathy of other causes, including the following: Multifocal motor neuropathy; Monoclonal gammopathy of uncertain significance with anti-myelin associated, glycoprotein immunoglobulin M (IgM) antibodies; Hereditary demyelinating neuropathy; Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due to diabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- or toxin-induced polyneuropathy.
3. Any other disease that could better explain the patient's signs and symptoms.
4. Any history of myelopathy or evidence of central demyelination.
5. Current or past history (within 12 months of screening) of alcohol, drug or medication abuse.
6. Severe psychiatric disorder (such as severe depression, psychosis, bipolar disorder), history of suicide attempt, or current suicidal ideation that in the opinion of the investigator could create undue risk to the patient or could affect adherence with the trial protocol.
7. Patients with clinically significant active or chronic uncontrolled bacterial, viral, or fungal infection at screening, including patients who test positive for an active viral infection at screening with: Active Hepatitis B Virus (HBV): serologic panel test results indicative of an active (acute or chronic) infection; Active Hepatitis C Virus (HCV): serology positive for HCV-Ab; Human Immunodeficiency Virus (HIV) positive serology associated with an Acquired Immune Deficiency Syndrome (AIDS)-defining condition or with a cluster of differentiation 4 (CD4) count ≤200 cells/mm3.
8. Total IgG level \<6 g/L at screening.
9. Treatment with the following: Within 3 months (or 5 half-lives of the drug, whichever is longer) before screening: plasma exchange or immunoadsorption, any concomitant Fc-containing therapeutic agents or other biological, or any other investigational product; Within 6 months before screening: rituximab, alemtuzumab, any other monoclonal antibody, cyclophosphamide, interferon, tumor necrosis factor-alpha inhibitors, fingolimod, methotrexate, azathioprine, mycophenolate, any other immunomodulating or immunosuppressive medications, and oral daily corticosteroids \>10 mg/day. Note: Patients using IVIg, SCIg, pulsed corticosteroids, and oral daily corticosteroids ≤10 mg/day can be included.

   Patients who (intend to) use prohibited medications and therapies (see protocol) during the trial.
10. Pregnant and lactating women and those intending to become pregnant during the trial or within 90 days after last IMP administration.
11. Patients with any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of CIDP.
12. Patients who received a live-attenuated vaccine fewer than 28 days before screening. Receiving an inactivated, sub-unit, polysaccharide, or conjugate vaccine any time before screening is not exclusionary.
13. Patients who have a history of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before the first IMP administration. Patients with the following cancer can be included anytime: Adequately treated basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, or Incidental histological finding of Prostate cancer (TNM \[tumor, nodes, and metastases classification\] stage T1a or T1b).
14. Patients who previously participated in a trial with efgartigimod and have received at least one administration of IMP.
15. Patients with known medical history of hypersensitivity to any of the ingredients of IMP.
16. Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or any other reason which could confound the results of the trial or put the patient at undue risk.

Primary outcomes:
measure: Stage A: Percentage of Participants With Confirmed Evidence of Clinical Improvement(ECI)
timeFrame: Up to 12 weeks during the open-label stage A
measure: Stage B: Time to First Adjusted INCAT Deterioration Compared to Stage B Baseline
timeFrame: Up to 48 weeks during the randomized placebo-controlled stage B
Secondary outcomes:
measure: Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI)
timeFrame: Up to 12 weeks during the open-label stage A
measure: Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in Adjusted INCAT Score
timeFrame: Up to 12 weeks during the open-label stage A
measure: Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in Medical Research Council (MRC) Sum Score
timeFrame: Up to 12 weeks during the open-label stage A
measure: Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in I-RODS Disability Scores
timeFrame: Up to 12 weeks during the open-label stage A
measure: Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in TUG Score
timeFrame: Up to 12 weeks during the open-label stage A
measure: Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in Mean Grip Strength
timeFrame: Up to 12 weeks during the open-label stage A
measure: Stage A: Exposure Adjusted Occurrence of Treatment-emergent Adverse Events and Serious Adverse Events
timeFrame: Up to 12 weeks during the open-label stage A
measure: Stage A: Pre-dosing Efgartigimod Serum Concentrations Over Time
timeFrame: Up to 13 weeks during the open-label stage A (12 weeks + optional 1 additional week to confirm evidence of clinical improvement (ECI))
measure: Stage A: Percent Changes From Stage A Baseline of Serum IgG Levels Over Time
timeFrame: Up to 13 weeks during the open-label stage A (12 weeks + optional 1 additional week to confirm evidence of clinical improvement (ECI))
measure: Stage A: Number of Participants With Binding Antidrug Antibodies (ADA) Towards Efgartigimod or Antibodies (Ab) Against rHuPH20 and Neutralizing Antibodies (NAb) Against Efgartigimod and/or rHuPH20
timeFrame: Up to 12 weeks during the open-label stage A
measure: Stage A: Changes From Stage A Baseline to Last Assessment in Stage A, in EQ-5D-5L Visual Analog Scale (VAS) Over Time
timeFrame: Up to 12 weeks during the open-label stage A
measure: Stage B: Time to CIDP Disease Progression
timeFrame: Up to 48 weeks during the randomized placebo-controlled stage B
measure: Stage B: Number of Participants With Improved Functional Level Compared to Stage B Baseline
timeFrame: Up to 48 weeks during the randomized placebo-controlled stage B
measure: Stage B: Change From Stage B Baseline to Last Assessment in Stage B, in Adjusted INCAT Score
timeFrame: Up to 48 weeks during the randomized placebo-controlled stage B
measure: Stage B: Change From Stage B Baseline to Last Assessment in Stage B, in MRC Sum Score
timeFrame: Up to 48 weeks during the randomized placebo-controlled stage B
measure: Stage B: Change From Stage B Baseline to Last Assessment in Stage B, in 24-item I-RODS Disability Score
timeFrame: Up to 48 weeks during the randomized placebo-controlled stage B
measure: Stage B: Change From Stage B Baseline to Last Assessment in Stage B, in TUG Score
timeFrame: Up to 48 weeks during the randomized placebo-controlled stage B
measure: Stage B: Change From Stage B Baseline to Last Assessment in Stage B, in Mean Grip Strength
timeFrame: Up to 48 weeks during the randomized placebo-controlled stage B
measure: Stage B: Time to 10% Decrease in the 24-item I-RODS
timeFrame: Up to 48 weeks during the randomized placebo-controlled stage B
measure: Stage B: Exposure Adjusted Occurrence of Treatment-emergent Adverse Events and Serious Adverse Events
timeFrame: Up to 48 weeks during the randomized placebo-controlled stage B
measure: Stage B: Pre-dosing Efgartigimod Serum Concentrations Over Time
timeFrame: Up to 48 weeks during the randomized placebo-controlled stage B
measure: Stage B: Percent Changes of Serum IgG Levels Over Time
timeFrame: Up to 48 weeks during the randomized placebo-controlled stage B
measure: Stage B: Number of Participants With Binding Antidrug Antibodies (ADA) Towards Efgartigimod or Antibodies (Ab) Against rHuPH20 and Neutralizing Antibodies (NAb) Against Efgartigimod and/or rHuPH20
timeFrame: Up to 48 weeks during the randomized placebo-controlled stage B
measure: Stage B: Changes From Stage B Baseline to Last Assessment in Stage B, in EQ-5D-5L Visual Analog Scale (VAS) Over Time
timeFrame: Up to 48 weeks during the randomized placebo-controlled stage B
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigator site 0010065
state: Alabama
city: Phoenix
country: United States
facility: Investigator site 0010013
state: Arizona
city: Scottsdale
country: United States
facility: Investigator site 0010055
state: Arizona
city: Carlsbad
country: United States
facility: Investigator Site 0010032
state: California
city: Orange
country: United States
facility: Investigator site 0010004
state: California
city: Pomona
country: United States
facility: Investigator site 0010190
state: California
city: Rancho Mirage
country: United States
facility: Investigator site 0010160
state: California
city: San Francisco
country: United States
facility: Investigator site 0010071
state: California
city: Centennial
country: United States
facility: Investigator site 0010057
state: Colorado
city: New Haven
country: United States
facility: Investigator site 0010026
state: Connecticut
city: Boca Raton
country: United States
facility: Investigator site 0010072
state: Florida
city: Coral Springs
country: United States
facility: Investigator site 0010144
state: Florida
city: Jacksonville
country: United States
facility: Investigator site 0010023
state: Florida
city: Maitland
country: United States
facility: Investigator Site 0010068
state: Florida
city: Miami
country: United States
facility: Investigator site 0010059
state: Florida
city: Orlando
country: United States
facility: Investigator site 0010050
state: Florida
city: Ormond Beach
country: United States
facility: Investigator site 0010172
state: Florida
city: Tampa
country: United States
facility: Investigator site 0010006
state: Florida
city: Augusta
country: United States
facility: Investigator site 0010125
state: Georgia
city: Iowa City
country: United States
facility: Investigator site 0010011
state: Iowa
city: Fairway
country: United States
facility: Investigator site 0010015
state: Kansas
city: Lexington
country: United States
facility: Investigator site 0010147
state: Kentucky
city: Detroit
country: United States
facility: Investigator site 0010014
state: Michigan
city: East Lansing
country: United States
facility: Investigator site 0010063
state: Michigan
city: Minneapolis
country: United States
facility: Investigator site 0010052
state: Minnesota
city: Columbia
country: United States
facility: Investigator site 0010028
state: Missouri
city: New Brunswick
country: United States
facility: Investigator site 0010070
state: New Jersey
city: New York
country: United States
facility: Investigator site 0010069
state: New York
city: New York
country: United States
facility: Investigator site 0010168
state: New York
city: New York
country: United States
facility: Investigator site 0010191
state: New York
city: New York
country: United States
facility: Investigator site 0010074
state: New York
city: Patchogue
country: United States
facility: Investigator site 0010075
state: New York
city: Chapel Hill
country: United States
facility: Investigator site 0010003
state: North Carolina
city: Durham
country: United States
facility: Investigator site 0010077
state: North Carolina
city: Cincinnati
country: United States
facility: Investigator site 0010051
state: Ohio
city: Columbus
country: United States
facility: Investigator site 0010064
state: Ohio
city: Philadelphia
country: United States
facility: Investigator site 0010047
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigator site 0010007
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigator site 0010067
state: Pennsylvania
city: Austin
country: United States
facility: Investigator site 0010066
state: Texas
city: Houston
country: United States
facility: Investigator site 0010026
state: Texas
city: San Antonio
country: United States
facility: Investigator site 0010009
state: Texas
city: Burlington
country: United States
facility: Investigator site 0010076
state: Vermont
city: Charlottesville
country: United States
facility: Investigator site 0010007
state: Virginia
city: Richmond
country: United States
facility: Investigator site 0010061
state: Virginia
city: Graz
country: Austria
facility: Investigator site 0430009
city: Innsbruck
country: Austria
facility: Investigator site 0430007
city: Linz
country: Austria
facility: Investigator site 0430008
city: Salzburg
country: Austria
facility: Investigator site 0430006
city: Wien
country: Austria
facility: Investigator site 0430005
city: Brussel
country: Belgium
facility: Investigator site 0320017
city: Brussel
country: Belgium
facility: Investigator site 0320019
city: Edegem
country: Belgium
facility: Investigator site 0320016
city: Leuven
country: Belgium
facility: Investigator site 0320009
city: Liège
country: Belgium
facility: Investigator site 0320024
city: Woluwe-Saint-Lambert
country: Belgium
facility: Investigator site 0320022
city: Pleven
country: Bulgaria
facility: Investigator site 3590007
city: Sofia
country: Bulgaria
facility: Investigator site 3590008
city: Sofia
country: Bulgaria
facility: Investigator site 3590009
city: Sofia
country: Bulgaria
facility: Investigator site 3590005
city: Beijing
country: China
facility: Investigator site 0860033
city: Changchun
country: China
facility: Investigator site 0860030
city: Changsha
country: China
facility: Investigator site 0860041
city: Chengdu
country: China
facility: Investigator site 0860036
city: Chifeng
country: China
facility: Investigator site 0860049
city: Fuzhou
country: China
facility: Investigator site 0860038
city: Guanzhou
country: China
facility: Investigator site 0860050
city: Guanzhou
country: China
facility: Investigator site 0860032
city: Guiyang
country: China
facility: Investigator site 0860045
city: Hangzhou
country: China
facility: Investigator site 0860046
city: Hanzhou
country: China
facility: Investigator site 0860035
city: Jinan
country: China
facility: Investigator site 0860031
city: Jining
country: China
facility: Investigator site 0860063
city: Nanchang
country: China
facility: Investigator site 0860044
city: Nanchang
country: China
facility: Investigator Site 0860040
city: Nanchang
country: China
facility: Investigator site 0860051
city: Nanjing
country: China
facility: Investigator site 0860043
city: Nanjing
country: China
facility: Investigator site 0860043
city: Shangai
country: China
facility: Investigator site 0860028
city: Shanghai
country: China
facility: Investigator site 0860047
city: Shanghai
country: China
facility: Investigator site 0860052
city: Taiyuan
country: China
facility: Investigator site 0860042
city: Wuhan
country: China
facility: Investigator site 0860029
city: Wuhan
country: China
facility: Investigator site 0860034
city: Xi'an
country: China
facility: Investigator site 0860048
city: Xi'an
country: China
facility: Investigator site 0860037
city: Xiangyang
country: China
facility: Investigator site 0860054
city: Hradec Králové
country: Czechia
facility: Investigator site 4200010
city: Aarhus
country: Denmark
facility: Investigator site 0450002
city: Copenhagen
country: Denmark
facility: Investigator site 0450001
city: Odense
country: Denmark
facility: Investigator site 0450003
city: Angers
country: France
facility: Investigator site 0330034
city: Bordeaux
country: France
facility: Investigator site 0330013
city: Clermont-Ferrand
country: France
facility: Investigator site 0330033
city: Garches
country: France
facility: Investigator site 0330025
city: Le Kremlin-Bicêtre
country: France
facility: Investigator site 0330023
city: Limoges
country: France
facility: Investigator site 0330024
city: Nantes
country: France
facility: Investigator site 0330022
city: Nice
country: France
facility: Investigator site 0330021
city: Paris
country: France
facility: Investigator site 0330035
city: Strasbourg
country: France
facility: Investigator site 0330020
city: Kutaisi
country: Georgia
facility: Investigator site 9950020
city: Tbilisi
country: Georgia
facility: Investigator site 9950005
city: Tbilisi
country: Georgia
facility: Investigator Site 9950002
city: Tbilisi
country: Georgia
facility: Investigator Site 9950003
city: Tbilisi
country: Georgia
facility: Investigator Site 9950004
city: Berlin
country: Germany
facility: Investigator site 0490018
city: Berlin
country: Germany
facility: Investigator site 0490017
city: Bochum
country: Germany
facility: Investigator site 0490044
city: Essen
country: Germany
facility: Investigator site 0490045
city: Göttingen
country: Germany
facility: Investigator site 0490021
city: Hannover
country: Germany
facility: Investigator site 0490014
city: Kiel
country: Germany
facility: Investigator site 0490016
city: Köln
country: Germany
facility: Investigator site 0490013
city: Leipzig
country: Germany
facility: Investigator site 0490020
city: Potsdam
country: Germany
facility: Investigator site 0490019
city: Regensburg
country: Germany
facility: Investigator site 0490015
city: Budapest
country: Hungary
facility: Investigator site 0360017
city: Kistarcsa
country: Hungary
facility: Investigator site 0360018
city: H̱olon
country: Israel
facility: Investigator site 9720006
city: Ramat Gan
country: Israel
facility: Investigator site 9720005
city: Tel Aviv
country: Israel
facility: Investigator site 9720004
city: Brescia
country: Italy
facility: Investigator site 0390022
city: Firenze
country: Italy
facility: Investigator site 0390029
city: Genova
country: Italy
facility: Investigator site 0390024
city: Messina
country: Italy
facility: Investigator site 0390027
city: Milano
country: Italy
facility: Investigator site 0390003
city: Milano
country: Italy
facility: Investigator site 0390026
city: Napoli
country: Italy
facility: Investigator site 0390007
city: Pisa
country: Italy
facility: Investigator site 0390023
city: Roma
country: Italy
facility: Investigator site 0390008
city: Siena
country: Italy
facility: Investigator site 0390028
city: Torino
country: Italy
facility: Investigator site 0390042
city: Bunkyō-Ku
country: Japan
facility: Investigator site 0810035
city: Chiba
country: Japan
facility: Investigator site 0810002
city: Chuo Ku
country: Japan
facility: Investigator site 0810034
city: Fuchū
country: Japan
facility: Investigator site 0810030
city: Fukuoka
country: Japan
facility: Investigator site 0810031
city: Ginowan
country: Japan
facility: Investigator site 0810065
city: Hakodate
country: Japan
facility: Investigator site 0810066
city: Hiroshima
country: Japan
facility: Investigator site 0810058
city: Itabashi
country: Japan
facility: Investigator site 0810036
city: Kawaguchi
country: Japan
facility: Investigator site 0810029
city: Kawasaki
country: Japan
facility: Investigator site 0810062
city: Kodaira
country: Japan
facility: Investigator site 0810026
city: Kyoto
country: Japan
facility: Investigator site 0810061
city: Mibu
country: Japan
facility: Investigator site 0810027
city: Nagoya
country: Japan
facility: Investigator site 0810032
city: Osaka
country: Japan
facility: Investigator site 0810003
city: Osaka
country: Japan
facility: Investigator site 0810007
city: Sagamihara
country: Japan
facility: Investigator site 0810028
city: Sapporo
country: Japan
facility: Investigator site 0810033
city: Shinjuku-Ku
country: Japan
facility: Investigator site 0810037
city: Suita
country: Japan
facility: Investigator site 0810063
city: Tokushima
country: Japan
facility: Investigator site 0810064
city: Yokohama
country: Japan
facility: Investigator site 0810060
city: Riga
country: Latvia
facility: Investigator site 3710001
city: Amsterdam
country: Netherlands
facility: Investigator site 0310010
city: Rotterdam
country: Netherlands
facility: Investigator site 0310011
city: Białystok
country: Poland
facility: Investigator site 0480019
city: Katowice
country: Poland
facility: Investigator site 0480023
city: Kraków
country: Poland
facility: Investigator site 0480017
city: Kraków
country: Poland
facility: Investigator site 0480024
city: Lublin
country: Poland
facility: Investigator site 0480018
city: Warsaw
country: Poland
facility: Investigator site 0480022
city: Łódź
country: Poland
facility: Investigator site 0480020
city: Braşov
country: Romania
facility: Investigation site 0400002
city: Bucharest
country: Romania
facility: Investigator site 0400001
city: Constanţa
country: Romania
facility: Investigator site 0400004
city: Timişoara
country: Romania
facility: Investigator site 0400003
city: Kazan
country: Russian Federation
facility: Investigator site 0070017
city: Kazan
country: Russian Federation
facility: Investigator site 0070023
city: Moscow
country: Russian Federation
facility: Investigator site 0070016
city: Moscow
country: Russian Federation
facility: Investigator site 0070020
city: Perm
country: Russian Federation
facility: Investigator site 0070018
city: Rostov-on-Don
country: Russian Federation
facility: Investigator site 0070019
city: Saint Petersburg
country: Russian Federation
facility: Investigator site 0070014
city: Saransk
country: Russian Federation
facility: Investigator site 0070021
city: Belgrad
country: Serbia
facility: Investigator site 3810001
city: Belgrad
country: Serbia
facility: Investigator site 3810003
city: Kragujevac
country: Serbia
facility: Investigator site 3810004
city: Alicante
country: Spain
facility: Investigator site 0340020
city: Badalona
country: Spain
facility: Investigator site 0340021
city: Barcelona
country: Spain
facility: Investigator site 0340038
city: Córdoba
country: Spain
facility: Investigator site 0340019
city: Madrid
country: Spain
facility: Investigator site 0340017
city: Madrid
country: Spain
facility: Investigator site 0340018
city: Sevilla
country: Spain
facility: Investigator site 0340016
city: Kaohsiung
country: Taiwan
facility: Investigator site 8860014
city: Taichung
country: Taiwan
facility: Investigator site 8860015
city: Tainan
country: Taiwan
facility: Investigator site 8860013
city: Taipei
country: Taiwan
facility: Investigator site 8860011
city: Taipei
country: Taiwan
facility: Investigator site 8860012
city: Taipei
country: Taiwan
facility: Investigator site 8860016
city: Taoyuan
country: Taiwan
facility: Investigator site 8860017
city: Bursa
country: Turkey
facility: Investigator site 0900025
city: Istanbul
country: Turkey
facility: Investigator site 0900023
city: İzmir
country: Turkey
facility: Investigator site 0900021
city: Samsun
country: Turkey
facility: Investigator site 0900022
city: Sarıçam
country: Turkey
facility: Investigator site 0900024
city: Dnipropetrovs'k
country: Ukraine
facility: Investigator site 3800014
city: Dnipro
country: Ukraine
facility: Investigator site 3800012
city: Ivano-Frankivs'k
country: Ukraine
facility: Investigator site 3800010
city: Kharkiv
country: Ukraine
facility: Investigator site 3800015
city: Kyiv
country: Ukraine
facility: Investigator site 3800013
city: Luts'k
country: Ukraine
facility: Investigator site 380008
city: Vinnytsia
country: Ukraine
facility: Investigator site 380009
city: Vinnytsia
country: Ukraine
facility: Investigator site 3800015
city: Zaporizhzhya
country: Ukraine
facility: Investigator site 3800011
city: Glasgow
country: United Kingdom
facility: Investigator site 0440017
city: Inverness
country: United Kingdom
facility: Investigator site 0440015
city: London
country: United Kingdom
facility: Investigator site 0440026
city: Oxford
country: United Kingdom
facility: Investigator site 0440016
city: Sheffield
country: United Kingdom
facility: Investigator site 0440018
city: Stoke-on-Trent
country: United Kingdom
facility: Investigator site 0440019
city: Tooting
country: United Kingdom
facility: Investigator site 0440028
Study officials:
References: