ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
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
1 other identifier
interventional
639
23 countries
315
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 \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2022
Typical duration for phase_3
315 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2022
CompletedFirst Posted
Study publicly available on registry
August 18, 2022
CompletedStudy Start
First participant enrolled
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2025
CompletedOctober 24, 2025
October 1, 2025
2.7 years
August 17, 2022
October 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8
To compare the efficacy of ABX464 versus placebo on clinical remission
8 weeks
Secondary Outcomes (4)
Proportion of subjects who achieve endoscopic improvement at week 8
8 weeks
Proportion of subjects who achieve clinical response per MMS at week 8
8 weeks
Proportion of subjects with symptomatic remission at week 8
8 weeks
Proportion of subjects with HEMI per Geboes at week 8
8 weeks
Study Arms (3)
ABX464 50mg
EXPERIMENTALSubjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks
ABX464 25mg
EXPERIMENTALSubjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks
Placebo
PLACEBO COMPARATORSubjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abivax S.A.lead
Study Sites (320)
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305, United States
Lakeview Clinical Research
Guntersville, Alabama, 35976, United States
GI Alliance
Sun City, Arizona, 85351, United States
Del Sol Research Management, LLC
Tucson, Arizona, 85715, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205-7199, United States
Aurora Care Clinic
Costa Mesa, California, 92627, United States
Gastro Care Institute
Lancaster, California, 93534, United States
California Medical Research Associates Inc.
Northridge, California, 91324, United States
Clinnova Research Solutions
Orange, California, 92868, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Clinical Research Of Brandon, LLC
Brandon, Florida, 33511, United States
Access Research Institute
Brooksville, Florida, 34613, United States
Auzmer Research
Lakeland, Florida, 33813, United States
Cfagi, Llc
Maitland, Florida, 32751, United States
MedOne Clinical Research LLC
Miami, Florida, 33145, United States
Medical Professional Clinical Research Center
Miami, Florida, 33165, United States
Advanced Research Institute, Inc.
New Port Richey, Florida, 34653, United States
Endoscopic Research, Inc.
Orlando, Florida, 32803, United States
Advanced Research Institute, Inc.
Orlando, Florida, 32825, United States
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida, 32503, United States
Theia Clinical Research Centers, LLC
Temple Terrace, Florida, 33617, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, 30033, United States
One Health Research Clinic Atlanta, LLC
Norcross, Georgia, 30093, United States
Eagle Clinical Research
Chicago, Illinois, 60621, United States
GI Alliance
Glenview, Illinois, 60026, United States
GI Alliance
Gurnee, Illinois, 60031, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160, United States
University of Louisville Research Foundation
Louisville, Kentucky, 40202, United States
GI Alliance - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Lucida Clinical Trials LLC
New Bedford, Massachusetts, 02740, United States
Digestive Health Center PA
Ocean Springs, Mississippi, 39564, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, 08234, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, 28207, United States
Care Access Research Lumberton
Lumberton, North Carolina, 28358, United States
Wilmington Health
Wilmington, North Carolina, 28401, United States
Gastro Health Research
Cincinnati, Ohio, 45249, United States
Wexner Medical Center
Columbus, Ohio, 43210, United States
DSI Research LLC
Springboro, Ohio, 45066, United States
Columbia Digestive Health Research
Columbia, South Carolina, 29204, United States
Gastroenterology Associates, PA
Greenville, South Carolina, 29607, United States
Gastroenterology Center of the MidSouth PC
Germantown, Tennessee, 38138, United States
GI Alliance - Southlake
Austin, Texas, 76092, United States
Central Texas Clinical Research, LLC
Austin, Texas, 78705, United States
Texas Digestive Disease Consultants
Cedar Park, Texas, 78613, United States
Baylor Scott and White
Dallas, Texas, 75246, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
GI Alliance - Garland
Garland, Texas, 75044, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Biopharma Informatic, Inc. Research Center
Houston, Texas, 77043, United States
Biopharma Informatic, LLC
Houston, Texas, 77084, United States
Gastro Health & Nutrition
Katy, Texas, 78754, United States
GI Alliance - San Marcos
San Marcos, Texas, 78130, United States
Texas Gastroenterology Associates
Spring, Texas, 77386, United States
GI Alliance - Webster
Webster, Texas, 77598, United States
Care Access Research LLC
Ogden, Utah, 84403, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
TPMG Clinical Research Williamsburg
Williamsburg, Virginia, 23188, United States
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Buenos Aires, B1878GEG, Argentina
STAT Research S.A.
Ciudad Autonoma Buenos Aires, C1013AAB, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, C199AAB, Argentina
Hospital Privado Centro Medico de Cordoba S.A
Córdoba, X5016KEH, Argentina
Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Coral Sea Clinical Research Institute
North Mackay, Queensland, 4740, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Footscray Hospital
Footscray, Victoria, 3011, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Canberra Hospital
Canberra, 2605, Australia
Coral Sea Clinical Research Institute
North Mackay, 4740, Australia
Royal Perth Hospital
Perth, 6000, Australia
Mater Misericordiae Ltd
South Brisbane, 4101, Australia
LKH - Universitaetsklinikum Graz
Graz, 8036, Austria
Medizinische Universität Innsbruck
Innsbruck, 6020, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020, Austria
KH der Barmherzigen Brüder St.Veit an der Glan
Sankt Veit an der Glan, 9300, Austria
AKH - Medizinische Universität Wien
Vienna, 1090, Austria
AZ Klina
Brasschaat, 2930, Belgium
AZ Sint-Lucas
Bruges, 8310, Belgium
C. H. U. St-Pierre
Brussels, 1000, Belgium
HUB Erasme
Brussels, 1070, Belgium
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
UZ Leuven
Leuven, 3000, Belgium
Clinique CHC MontLégia
Liège, 4000, Belgium
CHU UCL Namur
Yvoir, 5530, Belgium
Medical center Medconsult Pleven OOD
Pleven, 5800, Bulgaria
DCC "Alexandrovska", EOOD
Sofia, 1431, Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia, 1527, Bulgaria
UMHATEM 'N.I. Pirogov', EAD
Sofia, 1606, Bulgaria
UMHAT Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, 6000, Bulgaria
Gastroenterology and Internal Medicine Research Institute
Edmonton, Alberta, T5R 1W2, Canada
Scott Shulman Medicine Professional Corporation
North Bay, Ontario, P1B 2H3, Canada
Kensington Screening Clinic
Toronto, Ontario, M5T 3A9, Canada
McGill University Health Centre- Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, 241001, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force
Fuzhou, Fujian, 350025, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
The First People's Hospital of Foshan
Foshan, Guangdong, 528000, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
The First Affiliated Hospital of Sun Yat-sen University
Yuexiu, Guangdong, 510080, China
Liuzhou People's Hospital
Liuchow, Guangxi Zhuang, 545006, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi Zhuang, 530021, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Xiangya Hospital, Central South University
Changsha, Hu'nan, 410008, China
The 2nd Xiangya Hospital of Central South University
Changsha, Hu'nan, 410011, China
The First Affiliated Hospital of University of South China
Hengyang, Hu'nan, 421001, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
ongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Renmin Hospital, Wuhan University
Wuhan, Hubei, 430060, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213000, China
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210002, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
Jiangxi Gannan Medical College Affiliated 1 st Hospital
Ganzhou, Jiangxi, 341000, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110022, China
Binzhou Medical University Hospital
Binzhou, Shandong, 256603, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003, China
Taian City Central Hospital
Tai’an, Shandong, 271000, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200082, China
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
Shanghai, Shanghai Municipality, 200127, China
Army Specialty Medical Center of The Chinese People's Liberation Army
Chongqing, Sichuan, 400042, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646099, China
Tianjin Union Medical Center
Tianjin, Tianjin Municipality, 300121, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yun'nan, 650032, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310018, China
Huzhou Central Hospital
Huzhou, Zhejiang, 313099, China
West China Hospital, Sichuan University
Sichuan, China
CCR Brno, s.r.o.
Brno, 60200, Czechia
SurGal Clinic s.r.o.
Brno, 60200, Czechia
Vojenska nemocnice Brno
Brno, Czechia
Hepato-Gastroenterologie HK s.r.o.
Hradec Králové, 50012, Czechia
PreventaMed s.r.o.
Olomouc, 77200, Czechia
CCR Ostrava s.r.o.
Ostrava, 70200, Czechia
Nemocnice Slany
Slaný, 27401, Czechia
CHU Reims - Hôpital Robert Debré
Reims, Ardennes, 51100, France
CHU Dijon - Hôpital Bocage Central
Dijon, Cote D'or, 21000, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, Doubs, 25000, France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, Gironde, 33604, France
Hopital Saint Eloi
Montpellier, Herault, 34295, France
CHU Nantes - Hôtel Dieu
Nantes, Loire Atlantique, 44093, France
CHU Saint Etienne - Hôpital Nord
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France
CHU Clermont Ferrand - Hopital d'Estaing
Clermont-Ferrand, Puy De Dome, 63000, France
Centre Hospitalier de Pau - Hôpital François Mitterrand
Pau, Pyrénées Atlantique, 64000, France
Hôpital Henri Mondor
Créteil, Val De Marne, 94010, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, Val De Marne, 94275, France
Hôpital Saint-Louis
Paris, 75475, France
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Praxis fuer Gasroenterologie Prof. Dr. med Robert Ehehalt
Heidelberg, Baden-Wurttemberg, 69121, Germany
Universitaetsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
LMU - Campus Grosshadern
Munich, Bavaria, 81337, Germany
Staedisches Klinikum Brandenburg
Brandenburg, Brandenburg, 14770, Germany
Universitaetsklinikum Frankfurt Goethe-Universitaet
Frankfurt am Main, Hesse, 60590, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig-Holstein, 24105, Germany
Gastroenterologie Berlin Karlshorst
Berlin, 10318, Germany
Charité - Campus Benjamin Franklin
Berlin, 12203, Germany
University General Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
General Hospital of Athens "Evangelismos"
Athens, 10676, Greece
Corfu General Hospital "St. Eirini"
Corfu, 49100, Greece
University General Hospital of Heraklion
Heraklion, 71110, Greece
General Hospital of Thessaloniki "Hippokration"
Thessaloniki, 54642, Greece
Bekes Varmegyei Kozponti Korhaz
Békéscsaba, 5600, Hungary
Clinexpert Kft.
Budapest, 1033, Hungary
Semmelweis Egyetem
Budapest, 1082, Hungary
Pannonia Maganorvosi Centrum
Budapest, 1136, Hungary
Debreceni Egyetem
Debrecen, Hungary
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Szombathely, 9700, Hungary
Navneet Memorial Hospital 'Sushrusha'
Ahmedabad, Gujarat, 380009, India
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, 360005, India
Unity Hospital ICU and Trauma
Surat, Gujarat, 395010, India
Fortis Memorial Research Institute
Gurgaon, Haryana, 122002, India
M. S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, 560054, India
K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
Belagāve, Karnataka, 590010, India
Amrita Institute Of Medical Sciences and Research Centre
Kochi, Kerala, 682041, India
King Edward Memorial Hospital Research Centre
Mumbai, Maharashtra, 400012, India
Kingsway Hospital
Nagpur, Maharashtra, 440001, India
Midas Multispeciality Hospital Pvt Ltd
Nagpur, Maharashtra, 440010, India
Chopda Medicare & Research Centre
Nashik, Maharashtra, 422005, India
Ruby Hall Clinic
Pune, Maharashtra, 411001, India
Sahyadri Specialty Hospital
Pune, Maharashtra, 411028, India
Dayanand Medical College and Hospital
Ludhiana, Punjab, 141001, India
S. R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001, India
Chhatrapati Shahuji Maharaj (CSM) Medical University
Lucknow, Uttar Pradesh, 226003, India
Nil Ratan Sircar Medical College
Kolkata, West Bengal, 700014, India
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese, Milano, 20097, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, Verona, 37024, Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, 25124, Italy
Azienda Ospedaliera Giuseppe Brotzu
Cagliari, 09134, Italy
Presidio Ospedaliero Garibaldi Nesima
Catania, 95122, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, Italy
Azienda Ospedaliera Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, 90146, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
Pisa, Italy
Ospedale San Bortolo di Vicenza
Vicenza, 36100, Italy
Amsterdam UMC, Locatie AMC
Amsterdam, 1105 AZ, Netherlands
Radboud UMC
Nijmegen, 6525 GA, Netherlands
Erasmus MC
Rotterdam, 3015 GD, Netherlands
Zuyderland Medisch Centrum - Sittard-Geleen
Sittard, 6162 BG, Netherlands
ETZ Elisabeth
Tilburg, 5022 GC, Netherlands
Bernhoven Uden
Uden, 5406 PT, Netherlands
Przychodnia Specjalistyczna Insula
Bełchatów, 97-400, Poland
Szpital Zakonu Bonifratow Sp. z o.o.
Katowice, 40-211, Poland
Centrum Medyczne PROMED
Krakow, 31-513, Poland
NZOZ Centrum Medyczne ProMiMed
Krakow, 31-637, Poland
AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa
Lodz, 90-644, Poland
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, 45-819, Poland
SOLUMED Centrum Medyczne
Poznan, 60-529, Poland
NSZOZ Termedica - Centrum Badan Klinicznych
Poznan, 60-681, Poland
Twoja Przychodnia PCM
Poznan, 61-293, Poland
Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA
Sosnowiec, 41-200, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
Szczecin, 71-434, Poland
Centrum Zdrowia MDM
Warsaw, 00-635, Poland
NZOZ VIVAMED Jadwiga Miecz
Warsaw, 03-580, Poland
PlanetMed sp. z o.o.
Wroclaw, 52-210, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
ETG Zamosc
Zamość, 22-400, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej
Łęczna, 21-010, Poland
Hospital de Braga
Braga, 4710-243, Portugal
Hospital da Senhora da Oliveira Guimarães
Guimarães, 4835-044, Portugal
Hospital da Luz
Lisbon, 1500-650, Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
Santa Maria da Feira, 4520-211, Portugal
Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE
Viana do Castelo, 4904-858, Portugal
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 13496, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Yeungnam University Hospital
Daegu, Gyeongsangbuk-do, 42415, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daejeon, 34943, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Hospital Universitario Reina Sofia
Córdoba, Cordoba, 14004, Spain
Clinica Gaias - Santiago
Santiago de Compostela, La Coruña, 15702, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Claraspital
Basel, 4058, Switzerland
Inselspital - Universitaetsspital Bern
Bern, 3010, Switzerland
Intesto Gastroenterologische Praxis, Crohn-Colitis-Zentrum Bern
Bern, 3012, Switzerland
Universitaetsspital Zuerich
Zurich, 8091, Switzerland
Gazi University Medical Faculty
Ankara, 06500, Turkey (Türkiye)
Koc University Hospital
Istanbul, 34010, Turkey (Türkiye)
Medicana Kadikoy Hospital
Istanbul, 34724, Turkey (Türkiye)
Acibadem Kozyatagi Hospital
Istanbul, 34742, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35100, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33343, Turkey (Türkiye)
Varlik Mah. Kazim Karabekir Cad.
Muratpaşa, 07100, Turkey (Türkiye)
CNE Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, 18009, Ukraine
RCNE Chernivtsi Regional Clinical Hospital Gastroenterology Subdivision Bukovinian SMU
Chernivtsi, 58001, Ukraine
Dnipro Division Medical Center Clinic of Family Medicine of LLC
Dnipro, 49000, Ukraine
CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council
Ivano-Frankivsk, 76008, Ukraine
CNCE Khmelnytskyi Regional Hospital of Khmelnytskyi Regional Council
Khmelnytskyi, 29000, Ukraine
CNCE Kyiv City Clinical Hospital #1 of Executive Body of Kyiv City Council
Kyiv, 02091, Ukraine
Clinical Hospital Feofaniia of State Management of Affairs
Kyiv, 03143, Ukraine
Medical Center of Limited Liability Company Medical Center Concilium Medical
Kyiv, 04050, Ukraine
Medical Center of Limited Liability Company Saliutas
Lviv, 79005, Ukraine
CNCE of Lviv Regional Council Lviv Regional Clinical Hospital
Lviv, Ukraine
LLC Medical Center The Clinic of Hospodarskyy
Ternopil, 46002, Ukraine
CNE Uzhhorod city MCH of UCC Dept of Therapy
Uzhhorod, 88000, Ukraine
Limited Liability Company Medical Center Health Clinic, Medical Clinical Research Center
Vinnytsia, 21009, Ukraine
CNE M.I. Pyrohov Vinnytsia RCH of Vinnytsia Regional Council, RSC Gastro Center
Vinnytsia, 21018, Ukraine
Clinic of the SRI of Invalid Rehab (EST Complex) of Pirogov Memorial NMU
Vinnytsia, 21029, Ukraine
Royal London Hospital
London, Greater London, E1 1FR, United Kingdom
King's College Hospital
London, Greater London, SE5 9NU, United Kingdom
Hammersmith Hospital
London, Greater London, W12 0HS, United Kingdom
Bury Care Organisation
Bury, Greater Manchester, BL9 7TD, United Kingdom
St Mark's Hospital
Harrow, Middlesex, HA1 3UJ, United Kingdom
Yeovil District Hospital
Yeovil, Somerset, BA21 4AT, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorkshire, HD3 3EA, United Kingdom
The Ulster Hospital
Belfast, BT16 1RH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2022
First Posted
August 18, 2022
Study Start
October 10, 2022
Primary Completion
June 24, 2025
Study Completion
June 25, 2025
Last Updated
October 24, 2025
Record last verified: 2025-10