ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1

NCT ID: NCT05507203

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 639 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2025-06-25

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].

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ABX464 50mg

Subjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks

Group Type: EXPERIMENTAL

ABX464

Intervention Type: DRUG

Administered once daily in the morning with food

ABX464 25mg

Subjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks

Group Type: EXPERIMENTAL

ABX464

Intervention Type: DRUG

Administered once daily in the morning with food

Placebo

Subjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered once daily in the morning with food

Interventions

ABX464

Administered once daily in the morning with food

Intervention Type: DRUG

Placebo

Administered once daily in the morning with food

Intervention Type: DRUG

Other Intervention Names

Obefazimod

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abivax S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

Lakeview Clinical Research

Guntersville, Alabama, United States

GI Alliance

Sun City, Arizona, United States

Del Sol Research Management, LLC

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Aurora Care Clinic

Costa Mesa, California, United States

Gastro Care Institute

Lancaster, California, United States

California Medical Research Associates Inc.

Northridge, California, United States

Clinnova Research Solutions

Orange, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Clinical Research Of Brandon, LLC

Brandon, Florida, United States

Access Research Institute

Brooksville, Florida, United States

Auzmer Research

Lakeland, Florida, United States

Cfagi, Llc

Maitland, Florida, United States

MedOne Clinical Research LLC

Miami, Florida, United States

Medical Professional Clinical Research Center

Miami, Florida, United States

Advanced Research Institute, Inc.

New Port Richey, Florida, United States

Endoscopic Research, Inc.

Orlando, Florida, United States

Advanced Research Institute, Inc.

Orlando, Florida, United States

Gastroenterology Associates of Pensacola, PA

Pensacola, Florida, United States

Theia Clinical Research Centers, LLC

Temple Terrace, Florida, United States

Digestive Healthcare of Georgia

Atlanta, Georgia, United States

Atlanta Center for Gastroenterology, P.C.

Decatur, Georgia, United States

One Health Research Clinic Atlanta, LLC

Norcross, Georgia, United States

Eagle Clinical Research

Chicago, Illinois, United States

GI Alliance

Glenview, Illinois, United States

GI Alliance

Gurnee, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, United States

University of Louisville Research Foundation

Louisville, Kentucky, United States

GI Alliance - Baton Rouge

Baton Rouge, Louisiana, United States

Boston Medical Center

Boston, Massachusetts, United States

Lucida Clinical Trials LLC

New Bedford, Massachusetts, United States

Digestive Health Center PA

Ocean Springs, Mississippi, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

AGA Clinical Research Associates, LLC

Egg Harbor, New Jersey, United States

Rochester Clinical Research

Rochester, New York, United States

Charlotte Gastroenterology and Hepatology, P.L.L.C

Charlotte, North Carolina, United States

Care Access Research Lumberton

Lumberton, North Carolina, United States

Wilmington Health

Wilmington, North Carolina, United States

Gastro Health Research

Cincinnati, Ohio, United States

Wexner Medical Center

Columbus, Ohio, United States

DSI Research LLC

Springboro, Ohio, United States

Columbia Digestive Health Research

Columbia, South Carolina, United States

Gastroenterology Associates, PA

Greenville, South Carolina, United States

Gastroenterology Center of the MidSouth PC

Germantown, Tennessee, United States

GI Alliance - Southlake

Austin, Texas, United States

Central Texas Clinical Research, LLC

Austin, Texas, United States

Texas Digestive Disease Consultants

Cedar Park, Texas, United States

Baylor Scott and White

Dallas, Texas, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

GI Alliance - Garland

Garland, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Biopharma Informatic, Inc. Research Center

Houston, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Gastro Health & Nutrition

Katy, Texas, United States

GI Alliance - San Marcos

San Marcos, Texas, United States

Texas Gastroenterology Associates

Spring, Texas, United States

GI Alliance - Webster

Webster, Texas, United States

Care Access Research LLC

Ogden, Utah, United States

University of Utah

Salt Lake City, Utah, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Blue Ridge Medical Research

Lynchburg, Virginia, United States

TPMG Clinical Research Williamsburg

Williamsburg, Virginia, United States

Instituto de Investigaciones Clinicas Quilmes

Quilmes, Buenos Aires, Argentina

STAT Research S.A.

Ciudad Autonoma Buenos Aires, , Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, , Argentina

Hospital Privado Centro Medico de Cordoba S.A

Córdoba, , Argentina

Blacktown Hospital

Blacktown, New South Wales, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Coral Sea Clinical Research Institute

North Mackay, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Footscray Hospital

Footscray, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Canberra Hospital

Canberra, , Australia

Coral Sea Clinical Research Institute

North Mackay, , Australia

Royal Perth Hospital

Perth, , Australia

Mater Misericordiae Ltd

South Brisbane, , Australia

LKH - Universitaetsklinikum Graz

Graz, , Austria

Medizinische Universität Innsbruck

Innsbruck, , Austria

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, , Austria

KH der Barmherzigen Brüder St.Veit an der Glan

Sankt Veit an der Glan, , Austria

AKH - Medizinische Universität Wien

Vienna, , Austria

AZ Klina

Brasschaat, , Belgium

AZ Sint-Lucas

Bruges, , Belgium

C. H. U. St-Pierre

Brussels, , Belgium

HUB Erasme

Brussels, , Belgium

Universitair Ziekenhuis Brussel

Brussels, , Belgium

UZ Leuven

Leuven, , Belgium

Clinique CHC MontLégia

Liège, , Belgium

CHU UCL Namur

Yvoir, , Belgium

Medical center Medconsult Pleven OOD

Pleven, , Bulgaria

DCC "Alexandrovska", EOOD

Sofia, , Bulgaria

UMHAT 'Tsaritsa Yoanna - ISUL', EAD

Sofia, , Bulgaria

UMHATEM 'N.I. Pirogov', EAD

Sofia, , Bulgaria

UMHAT Prof. Dr. Stoyan Kirkovich AD

Stara Zagora, , Bulgaria

Gastroenterology and Internal Medicine Research Institute

Edmonton, Alberta, Canada

Scott Shulman Medicine Professional Corporation

North Bay, Ontario, Canada

Kensington Screening Clinic

Toronto, Ontario, Canada

McGill University Health Centre- Montreal General Hospital

Montreal, Quebec, Canada

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force

Fuzhou, Fujian, China

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

The First People's Hospital of Foshan

Foshan, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Sun Yat-sen University

Yuexiu, Guangdong, China

Liuzhou People's Hospital

Liuzhou, Guangxi Zhuang, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi Zhuang, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Xiangya Hospital, Central South University

Changsha, Hu'nan, China

The 2nd Xiangya Hospital of Central South University

Changsha, Hu'nan, China

The First Affiliated Hospital of University of South China

Hengyang, Hu'nan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

ongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

Renmin Hospital, Wuhan University

Wuhan, Hubei, China

Changzhou No.2 People's Hospital

Changzhou, Jiangsu, China

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Jiangxi Gannan Medical College Affiliated 1 st Hospital

Ganzhou, Jiangxi, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Binzhou Medical University Hospital

Binzhou, Shandong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Jinan Central Hospital

Jinan, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Taian City Central Hospital

Tai’an, Shandong, China

Ruijin Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

Shanghai, Shanghai Municipality, China

Army Specialty Medical Center of The Chinese People's Liberation Army

Chongqing, Sichuan, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Tianjin Union Medical Center

Tianjin, Tianjin Municipality, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yun'nan, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Huzhou Central Hospital

Huzhou, Zhejiang, China

West China Hospital, Sichuan University

Sichuan, , China

CCR Brno, s.r.o.

Brno, , Czechia

SurGal Clinic s.r.o.

Brno, , Czechia

Vojenska nemocnice Brno

Brno, , Czechia

Hepato-Gastroenterologie HK s.r.o.

Hradec Králové, , Czechia

PreventaMed s.r.o.

Olomouc, , Czechia

CCR Ostrava s.r.o.

Ostrava, , Czechia

Nemocnice Slany

Slaný, , Czechia

CHU Reims - Hôpital Robert Debré

Reims, Ardennes, France

CHU Dijon - Hôpital Bocage Central

Dijon, Cote D'or, France

CHU Besançon - Hôpital Jean Minjoz

Besançon, Doubs, France

CHU Bordeaux - Hôpital Haut-Lévêque

Pessac, Gironde, France

Hopital Saint Eloi

Montpellier, Herault, France

CHU Nantes - Hôtel Dieu

Nantes, Loire Atlantique, France

CHU Saint Etienne - Hôpital Nord

Saint-Étienne-de-Montluc, Pays de la Loire Region, France

CHU Clermont Ferrand - Hopital d'Estaing

Clermont-Ferrand, Puy De Dome, France

Centre Hospitalier de Pau - Hôpital François Mitterrand

Pau, Pyrénées Atlantique, France

Hôpital Henri Mondor

Créteil, Val De Marne, France

Hôpital Bicêtre

Le Kremlin-Bicêtre, Val De Marne, France

Hôpital Saint-Louis

Paris, , France

Universitaetsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Praxis fuer Gasroenterologie Prof. Dr. med Robert Ehehalt

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Erlangen

Erlangen, Bavaria, Germany

LMU - Campus Grosshadern

Munich, Bavaria, Germany

Staedisches Klinikum Brandenburg

Brandenburg, Brandenburg, Germany

Universitaetsklinikum Frankfurt Goethe-Universitaet

Frankfurt am Main, Hesse, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Universitaetsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Schleswig-Holstein, Germany

Gastroenterologie Berlin Karlshorst

Berlin, , Germany

Charité - Campus Benjamin Franklin

Berlin, , Germany

University General Hospital of Alexandroupolis

Alexandroupoli, , Greece

General Hospital of Athens "Evangelismos"

Athens, , Greece

Corfu General Hospital "St. Eirini"

Corfu, , Greece

University General Hospital of Heraklion

Heraklion, , Greece

General Hospital of Thessaloniki "Hippokration"

Thessaloniki, , Greece

Bekes Varmegyei Kozponti Korhaz

Békéscsaba, , Hungary

Clinexpert Kft.

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Pannonia Maganorvosi Centrum

Budapest, , Hungary

Debreceni Egyetem

Debrecen, , Hungary

Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz

Szombathely, , Hungary

Navneet Memorial Hospital 'Sushrusha'

Ahmedabad, Gujarat, India

Shree Giriraj Multispeciality Hospital

Rajkot, Gujarat, India

Unity Hospital ICU and Trauma

Surat, Gujarat, India

Fortis Memorial Research Institute

Gurgaon, Haryana, India

M. S. Ramaiah Medical College and Hospital

Bangalore, Karnataka, India

K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

Belagāve, Karnataka, India

Amrita Institute Of Medical Sciences and Research Centre

Kochi, Kerala, India

King Edward Memorial Hospital Research Centre

Mumbai, Maharashtra, India

Kingsway Hospital

Nagpur, Maharashtra, India

Midas Multispeciality Hospital Pvt Ltd

Nagpur, Maharashtra, India

Chopda Medicare & Research Centre

Nashik, Maharashtra, India

Ruby Hall Clinic

Pune, Maharashtra, India

Sahyadri Specialty Hospital

Pune, Maharashtra, India

Dayanand Medical College and Hospital

Ludhiana, Punjab, India

S. R. Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan, India

Chhatrapati Shahuji Maharaj (CSM) Medical University

Lucknow, Uttar Pradesh, India

Nil Ratan Sircar Medical College

Kolkata, West Bengal, India

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

I.R.C.C.S Policlinico San Donato

San Donato Milanese, Milano, Italy

Ospedale Sacro Cuore Don Calabria

Negrar, Verona, Italy

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, , Italy

Azienda Ospedaliera Giuseppe Brotzu

Cagliari, , Italy

Presidio Ospedaliero Garibaldi Nesima

Catania, , Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Ospedale San Raffaele

Milan, , Italy

Ospedale Sacro Cuore Don Calabria

Negrar, , Italy

Azienda Ospedaliera Ospedali Riuniti "Villa Sofia-Cervello"

Palermo, , Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

Pisa, , Italy

Ospedale San Bortolo di Vicenza

Vicenza, , Italy

Amsterdam UMC, Locatie AMC

Amsterdam, , Netherlands

Radboud UMC

Nijmegen, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

Zuyderland Medisch Centrum - Sittard-Geleen

Sittard, , Netherlands

ETZ Elisabeth

Tilburg, , Netherlands

Bernhoven Uden

Uden, , Netherlands

Przychodnia Specjalistyczna Insula

Bełchatów, , Poland

Szpital Zakonu Bonifratow Sp. z o.o.

Katowice, , Poland

Centrum Medyczne PROMED

Krakow, , Poland

NZOZ Centrum Medyczne ProMiMed

Krakow, , Poland

AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa

Lodz, , Poland

Twoja Przychodnia Opolskie Centrum Medyczne

Opole, , Poland

SOLUMED Centrum Medyczne

Poznan, , Poland

NSZOZ Termedica - Centrum Badan Klinicznych

Poznan, , Poland

Twoja Przychodnia PCM

Poznan, , Poland

Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA

Sosnowiec, , Poland

Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.

Szczecin, , Poland

Centrum Zdrowia MDM

Warsaw, , Poland

NZOZ VIVAMED Jadwiga Miecz

Warsaw, , Poland

PlanetMed sp. z o.o.

Wroclaw, , Poland

Centrum Medyczne Oporow

Wroclaw, , Poland

ETG Zamosc

Zamość, , Poland

Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej

Łęczna, , Poland

Hospital de Braga

Braga, , Portugal

Hospital da Senhora da Oliveira Guimarães

Guimarães, , Portugal

Hospital da Luz

Lisbon, , Portugal

Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião

Santa Maria da Feira, , Portugal

Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE

Viana do Castelo, , Portugal

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Yeungnam University Hospital

Daegu, Gyeongsangbuk-do, South Korea

Inje University Haeundae Paik Hospital

Busan, , South Korea

Dong-A University Hospital

Busan, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

The Catholic University of Korea, Daejeon St. Mary's Hospital

Daejeon, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, , South Korea

Chung-Ang University Hospital

Seoul, , South Korea

Hospital Universitario Reina Sofia

Córdoba, Cordoba, Spain

Clinica Gaias - Santiago

Santiago de Compostela, La Coruña, Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Claraspital

Basel, , Switzerland

Inselspital - Universitaetsspital Bern

Bern, , Switzerland

Intesto Gastroenterologische Praxis, Crohn-Colitis-Zentrum Bern

Bern, , Switzerland

Universitaetsspital Zuerich

Zurich, , Switzerland

Gazi University Medical Faculty

Ankara, , Turkey (Türkiye)

Koc University Hospital

Istanbul, , Turkey (Türkiye)

Medicana Kadikoy Hospital

Istanbul, , Turkey (Türkiye)

Acibadem Kozyatagi Hospital

Istanbul, , Turkey (Türkiye)

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi

Kocaeli, , Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

Varlik Mah. Kazim Karabekir Cad.

Muratpaşa, , Turkey (Türkiye)

CNE Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, , Ukraine

RCNE Chernivtsi Regional Clinical Hospital Gastroenterology Subdivision Bukovinian SMU

Chernivtsi, , Ukraine

Dnipro Division Medical Center Clinic of Family Medicine of LLC

Dnipro, , Ukraine

CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council

Ivano-Frankivsk, , Ukraine

CNCE Khmelnytskyi Regional Hospital of Khmelnytskyi Regional Council

Khmelnytskyi, , Ukraine

CNCE Kyiv City Clinical Hospital #1 of Executive Body of Kyiv City Council

Kyiv, , Ukraine

Clinical Hospital Feofaniia of State Management of Affairs

Kyiv, , Ukraine

Medical Center of Limited Liability Company Medical Center Concilium Medical

Kyiv, , Ukraine

Medical Center of Limited Liability Company Saliutas

Lviv, , Ukraine

CNCE of Lviv Regional Council Lviv Regional Clinical Hospital

Lviv, , Ukraine

LLC Medical Center The Clinic of Hospodarskyy

Ternopil, , Ukraine

CNE Uzhhorod city MCH of UCC Dept of Therapy

Uzhhorod, , Ukraine

Limited Liability Company Medical Center Health Clinic, Medical Clinical Research Center

Vinnytsia, , Ukraine

CNE M.I. Pyrohov Vinnytsia RCH of Vinnytsia Regional Council, RSC Gastro Center

Vinnytsia, , Ukraine

Clinic of the SRI of Invalid Rehab (EST Complex) of Pirogov Memorial NMU

Vinnytsia, , Ukraine

Royal London Hospital

London, Greater London, United Kingdom

King's College Hospital

London, Greater London, United Kingdom

Hammersmith Hospital

London, Greater London, United Kingdom

Bury Care Organisation

Bury, Greater Manchester, United Kingdom

St Mark's Hospital

Harrow, Middlesex, United Kingdom

Yeovil District Hospital

Yeovil, Somerset, United Kingdom

Huddersfield Royal Infirmary

Huddersfield, West Yorkshire, United Kingdom

The Ulster Hospital

Belfast, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Bulgaria; Canada; China; Czechia; France; Germany; Greece; Hungary; India; Italy; Netherlands; Poland; Portugal; South Korea; Spain; Switzerland; Turkey (Türkiye); Ukraine; United Kingdom

Other Identifiers

ABX464-105

Identifier Type: -

Identifier Source: org_study_id