Clinical trial NCT05507216: ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
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 weigh ≥ 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 and 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 the current 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: Birmingham
country: United States
facility: University of Alabama -Birmingham
state: Alabama
city: Litchfield Park
country: United States
facility: Research Solutions of Arizona, PC
state: Arizona
city: Phoenix
country: United States
facility: Valleywise Health Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Reliance Research
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Bakersfield
country: United States
facility: National Institute of Clinical Research
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: Covina
country: United States
facility: Citrus Valley Gastroenterology
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: San Diego
country: United States
facility: Clinical Applications Laboratories
state: California
city: Aurora
country: United States
facility: Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals
state: Colorado
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Clearwater
country: United States
facility: West Central Gastroenterology d/b/a Gastro Florida
state: Florida
city: Hialeah
country: United States
facility: Superior Associates in Research
state: Florida
city: Kissimmee
country: United States
facility: IHS Health
state: Florida
city: Miami
country: United States
facility: Infinite Clinical Research Inc
state: Florida
city: Miami
country: United States
facility: Research Associates of South Florida
state: Florida
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
city: Miami
country: United States
facility: Sanchez Clinical Research, Inc
state: Florida
city: Miami
country: United States
facility: Reliant Medical Research, LLC
state: Florida
city: Ocala
country: United States
facility: Ocala GI Research
state: Florida
city: Ocala
country: United States
facility: Sarkis Clinical Trials - Parent
state: Florida
city: Orlando
country: United States
facility: Arnold Palmer Hospital For Children
state: Florida
city: Orlando
country: United States
facility: Omega Research Orlando, LLC
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Guardian Angel Research Center
state: Florida
city: Tampa
country: United States
facility: Alliance Clinical Research
state: Florida
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Marrero
country: United States
facility: Tandem Clinical Research, LLC
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Fall River
country: United States
facility: NECCR Primacare Research, LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Farmington Hills
country: United States
facility: Michigan Center of Medical Research
state: Michigan
city: Flowood
country: United States
facility: Gastrointestinal Associates, PA
state: Mississippi
city: Liberty
country: United States
facility: BVL Clinical Research
state: Missouri
city: Florham Park
country: United States
facility: AIG Digestive Disease Research
state: New Jersey
city: Brooklyn
country: United States
facility: NY Scientific Corp.
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Fargo
country: United States
facility: Plains Clinical Research Center, LLC
state: North Dakota
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Oklahoma City
country: United States
facility: Board of Regents of the University of Oklahoma Health Sciences Center
state: Oklahoma
city: Harrisburg
country: United States
facility: Susquehanna Research Group, LLC
state: Pennsylvania
city: Uniontown
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Rapid City
country: United States
facility: Rapid City Medical Center, LLC
state: South Dakota
city: Hermitage
country: United States
facility: Digestive Health Research, LC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Baytown
country: United States
facility: Inquest Clinical Research
state: Texas
city: Fort Worth
country: United States
facility: Valley Institute of Research
state: Texas
city: Katy
country: United States
facility: Mt.Olympus Medical Research
state: Texas
city: Pasadena
country: United States
facility: Digestive System Healthcare
state: Texas
city: Pearland
country: United States
facility: LinQ Research, LLC
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Roanoke
country: United States
facility: Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
state: Virginia
city: Vancouver
country: United States
facility: The Vancouver Clinic
state: Washington
city: Buenos Aires
country: Argentina
facility: CEMIC
state: Ciudad Autonoma Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
state: Ciudad Autonoma Buenos Aires
city: San Miguel De Tucumán
country: Argentina
facility: Centro de Investigacion CICE
state: Tucuman
city: San Miguel De Tucumán
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
state: Tucuman
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Gastroenterología Diagnóstica y Terapéutica (Gedyt)
city: Antwerpen
country: Belgium
facility: GZA Ziekenhuizen
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Roeselare
country: Belgium
facility: AZ Delta
city: Salvador
country: Brazil
facility: Hospital Aliança
state: Bahia
city: Fortaleza
country: Brazil
facility: HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
state: Ceará
city: Brasília
country: Brazil
facility: L2IP - Instituto de Pesquisas Clínicas Ltda.
state: Distrito Federal
city: Curitiba
country: Brazil
facility: CDC - Centro Digestivo de Curitiba
state: Paraná
city: Caxias Do Sul
country: Brazil
facility: Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
state: Sao Paulo
city: Jaú
country: Brazil
facility: CECIP - Centro de Estudos Clínicos do Interior Paulista
state: Sao Paulo
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: Sao Paulo
city: Santo André
country: Brazil
facility: Pesquisare Saúde
state: Sao Paulo
city: Santo André
country: Brazil
facility: Praxis Pesquisa Medica
state: Sao Paulo
city: Santos
country: Brazil
facility: Irmandade da Santa Casa da Misericórdia de Santos
state: Sao Paulo
city: São Bernardo
country: Brazil
facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Hepatogastro
state: Sao Paulo
city: Pleven
country: Bulgaria
facility: DCC 'Sv. Pantaleymon' OOD
city: Sofia
country: Bulgaria
facility: Diagnostic Consultation Center CONVEX EOOD
city: Veliko Tarnovo
country: Bulgaria
facility: MC Medica Plus
city: Vancouver
country: Canada
facility: (G.I.R.I.) GI Research Institute
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Montréal
country: Canada
facility: Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal
state: Quebec
city: Koprivnica
country: Croatia
facility: General Hospital "Dr.Tomislav Bardek" Koprivnica
city: Osijek
country: Croatia
facility: Poliklinika Borzan d.o.o
city: Zadar
country: Croatia
facility: General Hospital Zadar
city: Zagreb
country: Croatia
facility: Solmed Polyclinic
city: Zagreb
country: Croatia
facility: University hospital centre Zagreb
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha
country: Czechia
facility: Institut klinicke a experimentalni mediciny
city: Zlín
country: Czechia
facility: Krajska nemocnice T. Bati a.s.
city: Nice
country: France
facility: CHU Nice - Hôpital de l'Archet 2
state: Alpes Maritimes
city: Marseille
country: France
facility: Hôpital Nord - CHU Marseille
state: Bouches-du-Rhône
city: Caen
country: France
facility: CHU Caen - Hôpital de la Côte de Nacre
state: Calvados
city: Toulouse
country: France
facility: Hopital Rangueil
state: Haute Garonne
city: Neuilly
country: France
facility: Institut des MICI
state: Hauts De Seine
city: Rennes
country: France
facility: CHU Rennes - Hôpital Pontchaillou
state: Ille Et Vilaine
city: Grenoble
country: France
facility: CHU de Grenoble - Hôpital Nord
state: Isere
city: Vantoux
country: France
facility: Hospital de brabois
state: Moselle
city: Lille
country: France
facility: CHU Lille - Hôpital Claude Huriez
state: Nord
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
state: Rhone
city: Amiens
country: France
facility: CHU Amiens - Hopital Sud
state: Somme
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental Les Oudairies
state: Vendée
city: Nürtingen
country: Germany
facility: Medius Klinik Nuertingen
state: Baden Wuerttemberg
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
state: Baden Wuerttemberg
city: Augsburg
country: Germany
facility: Universitaetsklinikum Augsburg
state: Bayern
city: Ludwigshafen
country: Germany
facility: INLUGA im Haus der Gesundheit
state: Rheinland Pfalz
city: Berlin
country: Germany
facility: Charité - Campus Charité Mitte
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Westend
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede e. V.
city: Hamburg
country: Germany
facility: Hamburgisches Forschungsinstitut fure Chronische Darmerkrankungen
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
city: Dunaujvaros
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Gyöngyös
country: Hungary
facility: Gyongyosi Bugat Pal Korhaz
city: Kaposvár
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz
city: Szekszárd
country: Hungary
facility: Clinfan Szolgaltato Kft.
city: Hyderabad
country: India
facility: Origin Hospital
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Yashoda Super Speciality Hospital
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Gandhi Hospital
state: Andhra Pradesh
city: New Delhi
country: India
facility: Fortis Escorts Heart Institute and Research Centre
state: Delhi
city: New Delhi
country: India
facility: Maharaja Agrasen Hospital
state: Delhi
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: Surat
country: India
facility: Surat Institute of Digestive Sciences
state: Gujarat
city: Sūrat
country: India
facility: Gujarat Hospital
state: Gujarat
city: Vadodara
country: India
facility: Isha Multispeciality Hospital
state: Gujarat
city: Mangalore
country: India
facility: Vinaya Hospital and Research Center
state: Karnataka
city: Cochin
country: India
facility: Lakeshore Hospital and Research Centre Ltd.
state: Kerala
city: Mumbai
country: India
facility: Lokmanya Tilak Municipal General Hospital & Medical College
state: Maharashtra
city: Wardha
country: India
facility: Datta Meghe Institute of Medical Sciences (Deemed University)
state: Maharashtra
city: Chennai
country: India
facility: SRM Institutes for Medical Sciences
state: Tamilnadu
city: Kolkata
country: India
facility: Institute of Post Graduate Medical Education And Research
state: West Bengal
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
city: Mullingar
country: Ireland
facility: Midland Regional Hospital
state: Westmeath
city: Dublin
country: Ireland
facility: Connolly Hospital
city: Galway
country: Ireland
facility: Portiuncula Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Louth
country: Ireland
facility: Our Lady of Lourdes
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Reẖovot
country: Israel
facility: Kaplan Medical Center KMC Institute of Gastroenterology and Liver Diseases
city: Rho
country: Italy
facility: Ospedale di Circolo
state: Milano
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero Universitaria Mater Domini
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
city: Roma
country: Italy
facility: Università Campus Bio-Medico di Roma
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Toyohashi
country: Japan
facility: Toyohashi Municipal Hospital
state: Aichi-Ken
city: Kashiwa-shi
country: Japan
facility: Kokikai Tsujinaka Hospital Kashiwanoha
state: Chiba-Ken
city: Matsuyama-shi
country: Japan
facility: Ehime Prefectural Central Hospital
state: Ehime-Ken
city: Chikushino-shi
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka-Ken
city: Iizuka-shi
country: Japan
facility: Aso Co.,Ltd Iizuka Hospital
state: Fukuoka-Ken
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka-Ken
city: Kurume-shi
country: Japan
facility: Our Lady of the Snow St. Mary's Hospital
state: Fukuoka-Ken
city: Kiryu-shi
country: Japan
facility: Kiryu Kosei General Hospital
state: Gunma-Ken
city: Ota-shi
country: Japan
facility: SUBARU Health Insurance Society Ota Memorial Hospital
state: Gunma-Ken
city: Fukuyama-shi
country: Japan
facility: NHO Fukuyama Medical Center
state: Hiroshima-Ken
city: Hatsukaichi-shi
country: Japan
facility: JA-Hiroshima General Hospital
state: Hiroshima-Ken
city: Hiroshima-shi
country: Japan
facility: Hiroshima Prefectural Hospital
state: Hiroshima-Ken
city: Kure-shi
country: Japan
facility: NHO Kure Medical Center and Chugoku Cancer Center
state: Hiroshima-Ken
city: Sapporo-shi
country: Japan
facility: JCHO Hokkaido Hospital
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Aoyama Clinic
state: Hyogo-Ken
city: Ibaraki
country: Japan
facility: NHO Mito Medical Center
state: Ibaraki-Ken
city: Kanazawa-shi
country: Japan
facility: NHO Kanazawa Medical Center
state: Ishikawa-Ken
city: Takamatsu-shi
country: Japan
facility: Takamatsu Red Cross Hospital
state: Kagawa-Ken
city: Takamatsu-shi
country: Japan
facility: Kagawa Prefectural Central Hospital
state: Kagawa-Ken
city: Kagoshima-shi
country: Japan
facility: Jiaikai Izuro Imamura Hospital
state: Kagoshima-Ken
city: Kagoshima-shi
country: Japan
facility: Kagoshima IBD Gastroenterology Clinic
state: Kagoshima-Ken
city: Kagoshima-shi
country: Japan
facility: Sameshima Hospital
state: Kagoshima-Ken
city: Kamakura-shi
country: Japan
facility: Gokeikai Ofuna Chuo Hospital
state: Kanagawa-Ken
city: Kawasaki-shi
country: Japan
facility: Kawasaki Municipal Hospital
state: Kanagawa-Ken
city: Yokohama-shi
country: Japan
facility: Showa University Northern Yokohama Hospital
state: Kanagawa-Ken
city: Kumamoto-shi
country: Japan
facility: Kaiseikai Hattori Clinic
state: Kumamoto-Ken
city: Tsu-shi
country: Japan
facility: Mie University Hospital
state: Mie-Ken
city: Niigata-shi
country: Japan
facility: Saiseikai Niigata Hospital
state: Niigata-Ken
city: Oita-shi
country: Japan
facility: Ishida Clinic of IBD and Gastroenterology
state: Oita-Ken
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
state: Okayama-Ken
city: Okayama-shi
country: Japan
facility: NHO Okayama Medical Center
state: Okayama-Ken
city: Okinawa-shi
country: Japan
facility: Keiaikai Nakagami Hospital
state: Okinawa-Ken
city: Fujiidera
country: Japan
facility: Shinseikai Sai Gastroenterology, Proctology Clinic
state: Osaka-Fu
city: Osaka-shi
country: Japan
facility: Kinshukai Infusion Clinic
state: Osaka-Fu
city: Osaka-shi
country: Japan
facility: NHO Osaka National Hospital
state: Osaka-Fu
city: Osaka-shi
country: Japan
facility: JCHO Osaka Hospital
state: Osaka-Fu
city: Saga-shi
country: Japan
facility: Saga-Ken Medical Centre Koseikan
state: Saga-Ken
city: Saga-shi
country: Japan
facility: Saga University Hospital
state: Saga-Ken
city: Ureshino-shi
country: Japan
facility: NHO Ureshino Medical Center
state: Saga-Ken
city: Kumagaya-shi
country: Japan
facility: Kumagaya General Hospital
state: Saitama-Ken
city: Hamamatsu-shi
country: Japan
facility: Matsuaikai Matsuda Hospital
state: Shizuoka-Ken
city: Koto-ku
country: Japan
facility: Showa University Koto Toyosu Hospital
state: Tokyo-To
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo-To
city: Shinjuku-ku
country: Japan
facility: JCHO Tokyo Yamate Medical Center
state: Tokyo-To
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences Kaunas Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
city: Klaipėda
country: Lithuania
facility: Klaipeda University Hospital branch "Seamen's Hospital"
city: Irapuato
country: Mexico
facility: Consultorio Medico, InvesclinicMX
state: Guanajuato
city: Monterrey
country: Mexico
facility: Accelerium S de RL de CV
state: Nuevo León
city: Monterrey
country: Mexico
facility: Inspirepharma S. de R.L. de C.V.
state: Nuevo León
city: Veracruz
country: Mexico
facility: FAICIC S. de R.L. de C.V.
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon S.C
city: Christchurch
country: New Zealand
facility: Christchurch Hospital NZ
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Grafton
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Bydgoszcz
country: Poland
facility: NZOZ Centrum Medyczne KERmed
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
city: Kalisz
country: Poland
facility: Trialmed CRS
city: Kielce
country: Poland
facility: ETG Kielce Zagorska
city: Knurów
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
city: Kraków
country: Poland
facility: Centrum Medyczne Plejady
city: Lublin
country: Poland
facility: 1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Lublinie
city: Nowy Targ
country: Poland
facility: ALLMEDICA sp. z o. o.
city: Olsztyn
country: Poland
facility: Wojewodzki Specjalistyczny Szpital w Olsztynie
city: Oswiecim
country: Poland
facility: Medicome Sp. z o.o.
city: Rzeszów
country: Poland
facility: Gabinet Lekarski Bartosz Korczowski
city: Staszów
country: Poland
facility: Nowe zdrowie-CK, Kieltucki i wspolnicy sp. j.
city: Wierzchosławice
country: Poland
facility: Centrum Zdrowia Tuchow Sp. z o.o.
city: Świdnica
country: Poland
facility: DC-MED
city: Bucharest
country: Romania
facility: Spitalul de Oncologie Monza
city: Bucuresti
country: Romania
facility: SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
city: Bucuresti
country: Romania
facility: S.C Delta Health Care S.R.L
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: S.C Policlinica CCBR S.R.L
city: Bucuresti
country: Romania
facility: Lotus Med SRL
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca
city: Craiova
country: Romania
facility: Centrul Medical Renasterea Craiova
city: Oradea
country: Romania
facility: S.C Pelican Impex S.R.L
city: Ploieşti
country: Romania
facility: S.C Centrul Medical Valahia S.R.L
city: Belgrade
country: Serbia
facility: Clinical Center " Dr Dragisa Misovic Dedinje"
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
city: Subotica
country: Serbia
facility: General Hospital Subotica
city: Banská Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta
city: Bratislava
country: Slovakia
facility: Cliniq s.r.o.
city: Košice
country: Slovakia
facility: Endomed, s.r.o.
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
city: Nitra
country: Slovakia
facility: KM Management spol. s r.o.
city: Nitra
country: Slovakia
facility: Fakultna nemocnica Nitra
city: Prešov
country: Slovakia
facility: Gastro I, s.r.o.
city: Prešov
country: Slovakia
facility: Gastro LM s.r.o.
city: Rimavská Sobota
country: Slovakia
facility: Svet zdravia a.s.
city: Šahy
country: Slovakia
facility: Accout Center s.r.o.
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol
state: La Coruña
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrin
state: Las Palmas
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Barcelona
country: Spain
facility: Centro Medico Teknon
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr Josep Trueta
city: Huelva
country: Spain
facility: Hospital General Juan Ramon Jimenez
city: Pontevedra
country: Spain
facility: Hospital Montecelo
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
state: Devon
city: London
country: United Kingdom
facility: Guy's Hospital
state: Greater London
Study officials:
affiliation: UZ Leuven, Belgium
name: Severine Vermeire, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Health System Digestive Disease Institute, New York USA
name: Bruce Sands, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: