Clinical trial NCT05507203: ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Abivax S.A.
Sponsor class: INDUSTRY
First posted: 2022-08-18
Enrollment: 612
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies \[corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)\] and/or advanced therapies \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].


Eligibility criteria: Inclusion Criteria:

* Men or women at least 16 years old; Adolescent subjects will only be enrolled if approved by the country regulatory/health authority. If these approvals have not been granted, only subjects ≥ 18 years old will be enrolled. To be eligible, adolescent subjects must weight ≥ 40 kg and meet the definition of Tanner Stage 5 at the screening visit.
* Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met.
* Documented diagnosis of UC confirmed by endoscopy and histology. Should endoscopy/histology results not be available at screening, results from endoscopies or biopsies taken at screening may be used.
* Active disease defined by modified Mayo score (MMS) ≥ 5 with rectal bleeding subscore (RBS) ≥ 1 and endoscopy subscore (MES) of 2 or 3 (confirmed by central reader).
* Subjects with documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids, immunosuppressant, biologic or biosimilar therapies, S1P receptor modulators and/or JAK inhibitors and/or new drugs approved during the study (note: failure to only 5-ASA or sulfasalazine is not accepted).
* Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to comply with the contraception requirements described in the protocol.
* Subjects able and willing to comply with study visits and procedures as per protocol.
* Subjects should be affiliated to a health insurance policy whenever required by a participating country or state.

Exclusion Criteria:

* Subjects with UC limited to an isolated proctitis (≤ 15cm from anal verge) determined by endoscopy central reading.
* Subjects with primary sclerosing cholangitis or autoimmune hepatitis.
* Subjects who have failed on 5-ASA or sulfasalazine therapy only.
* Subjects with CD or presence or history of fistula, indeterminate colitis, infectious/ischemic colitis or microscopic colitis (lymphocytic and collagenous colitis).
* History or current evidence of toxic megacolon, fulminant colitis, bowel perforation.
* History of colonic cancer or colonic low grade or high grade dysplasia adenomatous polyps, and/or at the screening endoscopy, evidence of colonic cancer or evidence of low grade or high grade dysplasia adenomatous polyps (fully removed or not).
* Recent or planned bowel surgery or history of proctocolectomy or partial colectomy or current stoma.
* Subjects on antidiarrheals including those working on motility (e.g., loperamide, diphenoxylate with atropine, etc.).
* Subjects on probiotics (e.g., Culturelle® \[Lactobacillus GG, i-Health, Inc.\], Saccharomyces boulardii).
* Subjects who do not meet the washout period requirements prior to the screening endoscopy
* Subjects with the following hematological and biochemical laboratory parameters obtained during the screening period:

  * Hemoglobin ≤ 8.0 g dL-1
  * Absolute neutrophil count \< 750 mm-3
  * Platelets \< 100,000 mm-3
  * Creatinine clearance \< 60 mL.min-1 (Cockroft-Gault formula)
  * Total serum bilirubin \> 1.5 x ULN
  * Alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2 x ULN
* Subjects with the following conditions (infection):

  * Subjects with chronic or recurrent grade 3 or grade 4 infection within the last 2 months prior to screening or a history of opportunistic infection while not on immunosuppressive therapy.
  * Herpes zoster reactivation within the last 2 months prior to screening.
  * Subjects with active infection at screening or any major episode of infection that required hospitalization or treatment with intravenous antibiotics within 1 month of screening or during screening. Fungal infection of nail beds is allowed.
  * Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridium difficile toxin at screening. If C. difficile is positive, subject may be treated and retested ≥ 2 weeks after completing treatment.
  * Subjects with HIV infection.
  * Subjects having acute or chronic hepatitis B infection at screening (positive for hepatitis B surface antigen \[HbsAg\], or negative for HbsAg and positive for anti-hepatitis B core antibody in conjunction with detectable HBV DNA, or detectable HBV DNA).
  * Subjects having acute or chronic hepatitis C infection at screening as defined by positive for hepatitis C antibody (subjects successfully treated and without recurrence ≥ 1 year with no detectable HCV RNA \[assessed centrally\] are eligible).
  * Active tuberculosis (TB) or untreated latent TB are ruled out. For subjects with positive or intermediate QuantiFERON test see study protocol.
* Subjects with an uncontrolled ischemic heart disease and/or a history of congestive heart failure with New York Heart Association (NYHA) class 3 or 4 symptoms.
* Subjects with a family or personal history of congenital or acquired long QT syndrome, or subjects with a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \[Fridericia or Bazett correction\] \>450 milliseconds for male and \> 460 milliseconds for female).
* Subjects with a history of torsade de pointe (TdP).
* Acute or chronic of clinically relevant pulmonary, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history (note: treated autoimmune hypothyroidy and autoimmune diabetes are allowed).
* Serious illness requiring hospitalization within 4 weeks prior to screening (except UC flare).
* Subjects previously treated with ABX464.
* Subjects with a known hypersensitivity to the active substance or to any of the excipients.
* WOCBP subject who is pregnant or breast-feeding at screening, or intends to become pregnant during the study, or male subject with WOCBP partner who intends to be pregnant during the study.
* Illicit drug or alcohol abuse or dependence.
* Subjects who received live vaccine within 3 months prior to screening and/or who's planning to receive such a vaccine during the study duration.
* Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer, and during the study.
* Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
* Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.

Primary outcomes:
measure: Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: Proportion of subjects who achieve endoscopic improvement at week 8
timeFrame: 8 weeks
measure: Proportion of subjects who achieve clinical response per MMS at week 8
timeFrame: 8 weeks
measure: Proportion of subjects with symptomatic remission at week 8
timeFrame: 8 weeks
measure: Proportion of subjects with HEMI per Geboes at week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Guntersville
country: United States
facility: Lakeview Clinical Research
state: Alabama
city: Sun City
country: United States
facility: GI Alliance
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Costa Mesa
country: United States
facility: Aurora Care Clinic
state: California
city: Lancaster
country: United States
facility: Gastro Care Institute
state: California
city: Northridge
country: United States
facility: California Medical Research Associates Inc.
state: California
city: Orange
country: United States
facility: Clinnova Research Solutions
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Brandon
country: United States
facility: Clinical Research Of Brandon, LLC
state: Florida
city: Brooksville
country: United States
facility: Access Research Institute
state: Florida
city: Lakeland
country: United States
facility: Auzmer Research
state: Florida
city: Maitland
country: United States
facility: Cfagi, Llc
state: Florida
city: Miami
country: United States
facility: MedOne Clinical Research LLC
state: Florida
city: Miami
country: United States
facility: Medical Professional Clinical Research Center
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Orlando
country: United States
facility: Endoscopic Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Pensacola
country: United States
facility: Gastroenterology Associates of Pensacola, PA
state: Florida
city: Temple Terrace
country: United States
facility: Theia Clinical Research Centers, LLC
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, P.C.
state: Georgia
city: Norcross
country: United States
facility: One Health Research Clinic Atlanta, LLC
state: Georgia
city: Chicago
country: United States
facility: Eagle Clinical Research
state: Illinois
city: Glenview
country: United States
facility: GI Alliance
state: Illinois
city: Gurnee
country: United States
facility: GI Alliance
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute, Inc.
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Research Foundation
state: Kentucky
city: Baton Rouge
country: United States
facility: GI Alliance - Baton Rouge
state: Louisiana
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: New Bedford
country: United States
facility: Lucida Clinical Trials LLC
state: Massachusetts
city: Ocean Springs
country: United States
facility: Digestive Health Center PA
state: Mississippi
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates, LLC
state: New Jersey
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology, P.L.L.C
state: North Carolina
city: Lumberton
country: United States
facility: Care Access Research Lumberton
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Health
state: North Carolina
city: Cincinnati
country: United States
facility: Gastro Health Research
state: Ohio
city: Columbus
country: United States
facility: Wexner Medical Center
state: Ohio
city: Springboro
country: United States
facility: DSI Research LLC
state: Ohio
city: Columbia
country: United States
facility: Columbia Digestive Health Research
state: South Carolina
city: Greenville
country: United States
facility: Gastroenterology Associates, PA
state: South Carolina
city: Germantown
country: United States
facility: Gastroenterology Center of the MidSouth PC
state: Tennessee
city: Austin
country: United States
facility: GI Alliance - Southlake
state: Texas
city: Austin
country: United States
facility: Central Texas Clinical Research, LLC
state: Texas
city: Cedar Park
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Dallas
country: United States
facility: Baylor Scott and White
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Garland
country: United States
facility: GI Alliance - Garland
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, Inc. Research Center
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Katy
country: United States
facility: Gastro Health & Nutrition
state: Texas
city: San Marcos
country: United States
facility: GI Alliance - San Marcos
state: Texas
city: Spring
country: United States
facility: Texas Gastroenterology Associates
state: Texas
city: Webster
country: United States
facility: GI Alliance - Webster
state: Texas
city: Ogden
country: United States
facility: Care Access Research LLC
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
city: Williamsburg
country: United States
facility: TPMG Clinical Research Williamsburg
state: Virginia
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes
state: Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: STAT Research S.A.
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Blacktown
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: North Mackay
country: Australia
facility: Coral Sea Clinical Research Institute
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Graz
country: Austria
facility: LKH - Universitaetsklinikum Graz
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Salzburg
country: Austria
facility: LKH - Universitätsklinikum der PMU Salzburg
city: St Veit an der Glan
country: Austria
facility: KH der Barmherzigen Brüder St.Veit an der Glan
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brugge
country: Belgium
facility: AZ Sint-Lucas
city: Bruxelles
country: Belgium
facility: C. H. U. St-Pierre
city: Bruxelles
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: Clinique CHC MontLégia
city: Yvoir
country: Belgium
facility: CHU UCL Namur
city: Pleven
country: Bulgaria
facility: Medical center Medconsult Pleven OOD
city: Sofia
country: Bulgaria
facility: DCC "Alexandrovska", EOOD
city: Sofia
country: Bulgaria
facility: UMHAT 'Tsaritsa Yoanna - ISUL', EAD
city: Sofia
country: Bulgaria
facility: UMHATEM 'N.I. Pirogov', EAD
city: Stara Zagora
country: Bulgaria
facility: UMHAT Prof. Dr. Stoyan Kirkovich AD
city: North Bay
country: Canada
facility: Scott Shulman Medicine Professional Corporation
state: Ontario
city: Toronto
country: Canada
facility: Kensington Screening Clinic
state: Ontario
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Wuhu
country: China
facility: Yijishan Hospital of Wannan Medical College
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Fuzhou
country: China
facility: The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Changsha
country: China
facility: The 2nd Xiangya Hospital of Central South University
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: General Hospital of Eastern Theater Command
state: Jiangsu
city: Ganzhou
country: China
facility: Jiangxi Gannan Medical College Affiliated 1 st Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Tai'an
country: China
facility: Taian City Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Chongqing
country: China
facility: Army Specialty Medical Center of The Chinese People's Liberation Army
state: Sichuan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Brno
country: Czechia
facility: CCR Brno, s.r.o.
city: Brno
country: Czechia
facility: SurGal Clinic s.r.o.
city: Hradec Králové
country: Czechia
facility: Hepato-Gastroenterologie HK s.r.o.
city: Olomouc
country: Czechia
facility: PreventaMed s.r.o.
city: Ostrava
country: Czechia
facility: CCR Ostrava s.r.o.
city: Slaný
country: Czechia
facility: Nemocnice Slany
city: Reims
country: France
facility: CHU Reims - Hôpital Robert Debré
state: Ardennes
city: Dijon
country: France
facility: CHU Dijon - Hôpital Bocage Central
state: Cote D'or
city: Besançon
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
state: Doubs
city: Pessac
country: France
facility: CHU Bordeaux - Hôpital Haut-Lévêque
state: Gironde
city: Montpellier
country: France
facility: Hopital Saint Eloi
state: Herault
city: Nantes
country: France
facility: CHU Nantes - Hôtel Dieu
state: Loire Atlantique
city: Saint-Étienne
country: France
facility: CHU Saint Etienne - Hôpital Nord
state: Loire
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand - Hopital d'Estaing
state: Puy De Dome
city: Pau
country: France
facility: Centre Hospitalier de Pau - Hôpital François Mitterrand
state: Pyrénées Atlantique
city: Créteil
country: France
facility: Hôpital Henri Mondor
state: Val De Marne
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
state: Val De Marne
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
state: Baden Wuerttemberg
city: Heidelberg
country: Germany
facility: Praxis fuer Gasroenterologie Prof. Dr. med Robert Ehehalt
state: Baden Wuerttemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
state: Bayern
city: Brandenburg an der Havel
country: Germany
facility: Staedisches Klinikum Brandenburg
state: Brandenburg
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt Goethe-Universitaet
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel
state: Schleswig Holstein
city: Berlin
country: Germany
facility: Gastroenterologie Berlin Karlshorst
city: Berlin
country: Germany
facility: Charité - Campus Benjamin Franklin
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis
city: Athens
country: Greece
facility: General Hospital of Athens "Evangelismos"
city: Corfu
country: Greece
facility: Corfu General Hospital "St. Eirini"
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Thessaloníki
country: Greece
facility: General Hospital of Thessaloniki "Hippokration"
city: Budapest
country: Hungary
facility: Clinexpert Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum
city: Békéscsaba
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz
city: Szombathely
country: Hungary
facility: Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
city: Ahmedabad
country: India
facility: Navneet Memorial Hospital 'Sushrusha'
state: Gujarat
city: Rājkot
country: India
facility: Shree Giriraj Multispeciality Hospital
state: Gujarat
city: Sūrat
country: India
facility: Unity Hospital ICU and Trauma
state: Gujarat
city: Gurgaon
country: India
facility: Fortis Memorial Research Institute
state: Haryana
city: Bangalore
country: India
facility: M. S. Ramaiah Medical College and Hospital
state: Karnataka
city: Belagave
country: India
facility: K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
state: Karnataka
city: Cochin
country: India
facility: Amrita Institute Of Medical Sciences and Research Centre
state: Kerala
city: Mumbai
country: India
facility: King Edward Memorial Hospital Research Centre
state: Maharashtra
city: Nagpur
country: India
facility: Midas Multispeciality Hospital Pvt Ltd
state: Maharashtra
city: Nashik
country: India
facility: Chopda Medicare & Research Centre
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharashtra
city: Ludhiāna
country: India
facility: Dayanand Medical College and Hospital
state: Punjab
city: Jaipur
country: India
facility: S. R. Kalla Memorial Gastro & General Hospital
state: Rajasthan
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
state: Foggia
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
state: Verona
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
city: Catania
country: Italy
facility: Presidio Ospedaliero Garibaldi Nesima
city: Milano
country: Italy
facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti "Villa Sofia-Cervello"
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Vicenza
country: Italy
facility: Ospedale San Bortolo di Vicenza
city: Wŏnju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Gangwon-do
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
state: Gyeongsangbuk-do
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon St. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Locatie AMC
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Sittard
country: Netherlands
facility: Zuyderland Medisch Centrum - Sittard-Geleen
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth
city: Uden
country: Netherlands
facility: Bernhoven Uden
city: Belchatow
country: Poland
facility: Przychodnia Specjalistyczna Insula
city: Katowice
country: Poland
facility: Szpital Zakonu Bonifratow Sp. z o.o.
city: Kraków
country: Poland
facility: Centrum Medyczne PROMED
city: Kraków
country: Poland
facility: NZOZ Centrum Medyczne ProMiMed
city: Opole
country: Poland
facility: Twoja Przychodnia Opolskie Centrum Medyczne
city: Poznań
country: Poland
facility: SOLUMED Centrum Medyczne
city: Poznań
country: Poland
facility: NSZOZ Termedica - Centrum Badan Klinicznych
city: Poznań
country: Poland
facility: Twoja Przychodnia PCM
city: Sosnowiec
country: Poland
facility: Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
city: Warsaw
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: NZOZ VIVAMED Jadwiga Miecz
city: Wrocław
country: Poland
facility: PlanetMed sp. z o.o.
city: Wrocław
country: Poland
facility: Centrum Medyczne Oporow
city: Zamość
country: Poland
facility: ETG Zamosc
city: Łódź
country: Poland
facility: AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa
city: Łęczna
country: Poland
facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej
city: Braga
country: Portugal
facility: Hospital de Braga
city: Guimarães
country: Portugal
facility: Hospital da Senhora da Oliveira Guimarães
city: Santa Maria Da Feira
country: Portugal
facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
city: Viana Do Castelo
country: Portugal
facility: Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Cordoba
city: Santiago De Compostela
country: Spain
facility: Clinica Gaias - Santiago
state: La Coruña
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Basel
country: Switzerland
facility: Claraspital
city: Bern
country: Switzerland
facility: Inselspital - Universitaetsspital Bern
city: Bern
country: Switzerland
facility: Intesto Gastroenterologische Praxis, Crohn-Colitis-Zentrum Bern
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich
city: Istanbul
country: Turkey
facility: Koc University Hospital
city: Istanbul
country: Turkey
facility: Medicana Kadikoy Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: London
country: United Kingdom
facility: King's College Hospital
state: Greater London
city: London
country: United Kingdom
facility: Hammersmith Hospital
state: Greater London
city: Bury
country: United Kingdom
facility: Bury Care Organisation
state: Greater Manchester
city: Harrow
country: United Kingdom
facility: St Mark's Hospital
state: Middlesex
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
state: Somerset
city: Huddersfield
country: United Kingdom
facility: Huddersfield Royal Infirmary
state: West Yorkshire
city: Belfast
country: United Kingdom
facility: The Ulster Hospital
Study officials:
References: