ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
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
636
27 countries
262
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 Jan 2023
262 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
January 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2025
CompletedResults Posted
Study results publicly available
September 10, 2026
CompletedSeptember 10, 2026
August 1, 2026
2.4 years
August 17, 2022
July 3, 2026
August 18, 2026
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. Clinical remission is defined as stool frequency subscore (SFS) = 0 or 1 and rectal bleeding subscore (RBS) = 0, and Mayo Endoscopic Score (MES) = 0 or 1 (MES of 1 modified to exclude friability).
8 weeks
Secondary Outcomes (3)
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 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 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.
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 (262)
University of Alabama -Birmingham
Birmingham, Alabama, 35205, United States
Research Solutions of Arizona, PC
Litchfield Park, Arizona, 85340, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212, United States
National Institute of Clinical Research
Bakersfield, California, 93309, United States
Citrus Valley Gastroenterology
Covina, California, 91723, United States
United Medical Doctors
Murrieta, California, 92563, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Clinical Applications Laboratories
San Diego, California, 92103, United States
Santa Maria Gastroenterology Medical Group
Santa Maria, California, 93458, United States
Danbury Hospital
Danbury, Connecticut, 06810, United States
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, 33762, United States
IHS Health
Kissimmee, Florida, 34741, United States
Research Associates of South Florida
Miami, Florida, 33134, United States
Sanchez Clinical Research, Inc
Miami, Florida, 33157, United States
Wellness Clinical Research
Miami Lakes, Florida, 33016, United States
Sarkis Clinical Trials - Parent
Ocala, Florida, 34474, United States
AdventHealth Medical Group
Orlando, Florida, 32804, United States
Arnold Palmer Hospital For Children
Orlando, Florida, 32806, United States
Omega Research Orlando, LLC
Orlando, Florida, 32808, United States
Advanced Medical Research Center
Port Orange, Florida, 32127, United States
GCP Clinical Research, LLC
Tampa, Florida, 33609, United States
University of South Florida - PARENT
Tampa, Florida, 33612, United States
The University of Iowa
Iowa City, Iowa, 52242, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
Tandem Clinical Research, LLC
Marrero, Louisiana, 70072, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
BVL Clinical Research
Liberty, Missouri, 64068, United States
Premier Health Research
Sparta, New Jersey, 07871, United States
NY Scientific Corp.
Brooklyn, New York, 11235, United States
Mount Sinai
New York, New York, 10029, United States
Plains Clinical Research Center, LLC
Fargo, North Dakota, 58104, United States
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, 17110, United States
Frontier Clinical Research, LLC
Uniontown, Pennsylvania, 15401, United States
Rapid City Medical Center, LLC
Rapid City, South Dakota, 57701, United States
Digestive Health Research, LC
Hermitage, Tennessee, 37076, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
Inquest Clinical Research
Baytown, Texas, 77521, United States
Gastroenterology Consultants of South Texas, PA
Harlingen, Texas, 78550, United States
Digestive System Healthcare
Pasadena, Texas, 77505, United States
LinQ Research, LLC
Pearland, Texas, 77584, United States
Southern Star Research Institute, LLC
San Antonio, Texas, 78229, United States
Tyler Research Institute, LLC
Tyler, Texas, 75703, United States
Richmond VA Medical Center
Richmond, Virginia, 23249, United States
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
Roanoke, Virginia, 24014, United States
The Vancouver Clinic
Vancouver, Washington, 98664, United States
DIM Clinica Privada
Ramos Mejía, Buenos Aires, Argentina
CEMIC
Buenos Aires, Ciudad Autonoma Buenos Aires, 1431, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, Ciudad Autonoma Buenos Aires, C1280AEB, Argentina
Centro de Investigaciones Clinicas Baigorria
Rosario, Santa Fe Province, Argentina
Centro de Investigacion CICE
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Gastroenterología Diagnóstica y Terapéutica (Gedyt)
Ciudad Autonoma Buenos Aires, C1117ABK, Argentina
GZA Ziekenhuizen
Antwerp, 2018, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
AZ Delta
Roeselare, 8800, Belgium
University Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina
General Hospital Prim.dr.Abdulah Nakas
Sarajevo, Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla, Bosnia and Herzegovina
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, Ceará, 60430-370, Brazil
Hospital Aliança
Salvador, Estado de Bahia, 41920-180, Brazil
Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao
Salvador, Estado de Bahia, Brazil
L2IP - Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, 70200-730, Brazil
CDC - Centro Digestivo de Curitiba
Curitiba, Paraná, 80430-160, Brazil
Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS)
Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, 18618-686, Brazil
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, 17201-130, Brazil
Pesquisare Saúde
Santo André, São Paulo, 09080-110, Brazil
Praxis Pesquisa Medica
Santo André, São Paulo, 09090-970, Brazil
Irmandade da Santa Casa da Misericórdia de Santos
Santos, São Paulo, 11075-101, Brazil
Hepatogastro
São Paulo, São Paulo, 04543-011, Brazil
Hospital Sirio Libanes
São Paulo, Brazil
Diagnostic Consultation Center CONVEX EOOD
Sofia, 1680, Bulgaria
Acibadem City Clinic Mladost Eood
Sofia, Bulgaria
MC Medica Plus
Veliko Tarnovo, 5000, Bulgaria
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
Gordon and Leslie Diamond Health Care Centre - Vancouver General Hospital
Vancouver, British Columbia, Canada
Newfoundland and Labrador Health Services
Winnipeg, Manitoba, Canada
London Health Sciences Centre (LHSC) - Victoria Hospital
London, Canada
Poliklinika Borzan d.o.o
Osijek, 31000, Croatia
University hospital centre Zagreb
Zagreb, 10000, Croatia
Institut klinicke a experimentalni mediciny
Prague, 14021, Czechia
CHU Nice - Hôpital de l'Archet 2
Nice, Alpes Maritimes, 06200, France
Hôpital Nord - CHU Marseille
Marseille, Bouches-du-Rhône, 13915, France
Hopital Rangueil
Toulouse, Haute Garonne, 31059, France
Institut des MICI
Neuilly, Hauts De Seine, 92200, France
CHU Rennes - Hôpital Pontchaillou
Rennes, Ille Et Vilaine, 35000, France
CHU de Grenoble - Hôpital Nord
Grenoble, Isere, 38043, France
Hospital de brabois
Vandœuvre-lès-Nancy, Moselle, 57070, France
CHU Lille - Hôpital Claude Huriez
Lille, Nord, 59037, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhone, 69495, France
CHU Amiens - Hopital Sud
Amiens, Somme, 80054, France
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, Vendée, 85925, France
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, 72076, Germany
INLUGA im Haus der Gesundheit
Ludwigshafen am Rhein, Rhineland-Palatinate, 67067, Germany
Charité - Campus Charité Mitte
Berlin, 10117, Germany
DRK Kliniken Berlin Westend
Berlin, 14050, Germany
Krankenhaus Waldfriede e. V.
Berlin, 14163, Germany
Evangelisches Krankenhaus Kalk GmbH
Cologne, Germany
Hamburgisches Forschungsinstitut fure Chronische Darmerkrankungen
Hamburg, 20251, Germany
Siloah St. Trudpert Klinikum
Pforzheim, Germany
Universitaetsklinikum Ulm
Ulm, Germany
Semmelweis Egyetem
Budapest, 1088, Hungary
Gyongyosi Bugat Pal Korhaz
Gyöngyös, 3200, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Clinfan Szolgaltato Kft.
Szekszárd, 7100, Hungary
Origin Hospital
Hyderabad, Andhra Pradesh, 500048, India
Yashoda Super Speciality Hospital
Hyderabad, Andhra Pradesh, 500082, India
Gandhi Hospital
Secunderabad, Andhra Pradesh, 500003, India
Surat Institute of Digestive Sciences
Surat, Gujarat, 395002, India
Gujarat Hospital
Surat, Gujarat, 395009, India
Isha Multispeciality Hospital
Vadodara, Gujarat, 390007, India
Lokmanya Tilak Municipal General Hospital & Medical College
Mumbai, Maharashtra, 400022, India
Datta Meghe Institute of Medical Sciences (Deemed University)
Wardha, Maharashtra, 442004, India
Fortis Escorts Heart Institute and Research Centre
New Delhi, National Capital Territory of Delhi, 110025, India
Maharaja Agrasen Hospital
New Delhi, National Capital Territory of Delhi, 110026, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029, India
Institute of Post Graduate Medical Education And Research
Kolkata, West Bengal, 700020, India
Vydehi Institute of Medical Sciences and Research Centre
Bengaluru, India
Gleneagles Global Hospitals
Hyderabad, India
Connolly Hospital
Abbotstown, Dublin, D15 X40D, Ireland
Midland Regional Hospital
Mullingar, Westmeath, N91, Ireland
Beaumont Hospital
Dublin, Ireland
St Vincents University Hospital
Dublin, Ireland
Portiuncula Hospital
Galway, Ireland
HaEmek Medical Center
Afula, 18101, Israel
Soroka University Medical Center
Beersheba, 84001, Israel
Carmel Medical Center
Haifa, 34362, Israel
Wolfson Medical Center
Holon, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Galilee Medical Center Institute of Gastroenterology
Nahariya, Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492, Israel
Chaim Sheba Medical Center
Ramat Gan, 5265602, Israel
Kaplan Medical Center KMC Institute of Gastroenterology and Liver Diseases
Rehovot, 76100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, 88100, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milan, 20157, Italy
Azienda Ospedale-Università di Padova
Padova, Italy
Università Campus Bio-Medico di Roma
Roma, 00128, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Chiba, 277-0871, Japan
Ehime Prefectural Central Hospital
Matsuyama, Ehime, 790-0024, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, 818-8502, Japan
Aso Co.,Ltd Iizuka Hospital
Iizuka-shi, Fukuoka, 820-8505, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011, Japan
Our Lady of the Snow St. Mary's Hospital
Kurume-shi, Fukuoka, 830-8543, Japan
Kiryu Kosei General Hospital
Kiryu-shi, Gunma, 376-0024, Japan
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma, 373-8585, Japan
NHO Fukuyama Medical Center
Fukuyama-shi, Hiroshima, 720-8520, Japan
NHO Kure Medical Center and Chugoku Cancer Center
Kure-shi, Hiroshima, 737-0023, Japan
JCHO Hokkaido Hospital
Sapporo, Hokkaido, 062-8618, Japan
Aoyama Clinic
Kobe, Hyōgo, 650-0015, Japan
NHO Kanazawa Medical Center
Kanazawa, Ishikawa-ken, 920-8650, Japan
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, 760-0017, Japan
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557, Japan
Jiaikai Izuro Imamura Hospital
Kagoshima, Kagoshima-ken, 892-0824, Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, Kagoshima-ken, 892-0843, Japan
Sameshima Hospital
Kagoshima, Kagoshima-ken, 892-0846, Japan
Kawasaki Municipal Hospital
Kawasaki-shi, Kanagawa, 210-0013, Japan
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, 224-8503, Japan
Kaiseikai Hattori Clinic
Kumamoto, Kumamoto, 860-0004, Japan
Saiseikai Niigata Hospital
Niigata, Niigata, 950-1104, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
NHO Okayama Medical Center
Okayama, Okayama-ken, 701-1192, Japan
Keiaikai Nakagami Hospital
Okinawa-shi, Okinawa, 904-2195, Japan
Shinseikai Sai Gastroenterology, Proctology Clinic
Fujiidera, Osaka, 583-0027, Japan
NHO Osaka National Hospital
Osaka, Osaka, 540-0006, Japan
JCHO Osaka Hospital
Osaka, Osaka, 553-0003, Japan
Saga-Ken Medical Centre Koseikan
Saga, Saga-ken, 840-8571, Japan
Saga University Hospital
Saga, Saga-ken, 849-8501, Japan
NHO Ureshino Medical Center
Ureshino-shi, Saga-ken, 843-0393, Japan
Kumagaya General Hospital
Kumagaya-shi, Saitama, 360-8567, Japan
Matsuaikai Matsuda Hospital
Hamamatsu, Shizuoka, 432-8061, Japan
Showa University Koto Toyosu Hospital
Kōtoku, Tokyo-To, 135-8577, Japan
Kitasato University Kitasato Institute Hospital
Minatoku, Tokyo-To, 108-8642, Japan
JCHO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo-To, 169-0073, Japan
Asahikawa City Hospital
Asahikawa-shi, Japan
Asahikawa Medical University Hospital
Asahikawa-shi, Japan
Institute of Science Tokyo Hospital
Bunkyō City, Japan
Juntendo University Hospital
Bunkyō City, Japan
Fukui Prefectural Hospital
Fukui-shi, Japan
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji-shi, Japan
NHO Hirosaki General Medical Center
Hirosaki-shi, Japan
NHI Komatsu Municipal Hospital
Komatsu-shi, Japan
Kyorin University Hospital
Mitaka-shi, Japan
Nagaoka Red Cross Hospital
Nagaoka-shi, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi, Japan
Keijinkai Matsushima Hospital
Yokohama, Japan
Lithuanian University of Health Sciences Kaunas Hospital
Kaunas, 47144, Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, LT-50161, Lithuania
Consultorio Medico, InvesclinicMX
Irapuato, Guanajuato, 36650, Mexico
Accelerium S de RL de CV
Monterrey, Nuevo León, 64000, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, 91900, Mexico
Sociedad de Metabolismo y Corazon S.C
Veracruz, 91900, Mexico
Waikato Hospital
Hamilton, 3200, New Zealand
NZOZ Centrum Medyczne KERmed
Bydgoszcz, 85-231, Poland
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338, Poland
ETG Kielce Zagorska
Kielce, 25-355, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
Knurów, 44-190, Poland
Centrum Medyczne Plejady
Krakow, 30-363, Poland
Centrum Medyczne Plejady
Krakow, Poland
1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Lublinie
Lublin, 20-049, Poland
NZOZ Neuromed M. i M. Nastaj Sp.P.
Lublin, Poland
ALLMEDICA sp. z o. o.
Nowy Targ, 34-400, Poland
Wojewodzki Specjalistyczny Szpital w Olsztynie
Olsztyn, 10-561, Poland
Medicome Sp. z o.o.
Oświęcim, 32-600, Poland
Trialmed CRS
Piotrkow Trybunalski, 62-800, Poland
Gabinet Lekarski Bartosz Korczowski
Rzeszów, 35-302, Poland
Nowe zdrowie-CK, Kieltucki i wspolnicy sp. j.
Staszów, 28-200, Poland
DC-MED
Swidnica, 58-100, Poland
Centrum Zdrowia Tuchow Sp. z o.o.
Wierzchosławice, 33-122, Poland
SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
Bucharest, 012015, Romania
Spitalul de Oncologie Monza
Bucharest, 013812, Romania
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca, 400006, Romania
S.C Pelican Impex S.R.L
Oradea, 410469, Romania
S.C Centrul Medical Valahia S.R.L
Ploieşti, 100550, Romania
Clinical Center " Dr Dragisa Misovic Dedinje"
Belgrade, 11000, Serbia
Clinical Hospital Center Zvezdara
Belgrade, 11000, Serbia
Clinical Hospital Center "Bezanijska kosa
Belgrade, Serbia
University Clinical Center Kragujevac
Kragujevac, Serbia
General Hospital Subotica
Subotica, 24000, Serbia
General Hospital "Djordje Joanovic"
Zrenjanin, Serbia
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, 97517, Slovakia
Cliniq s.r.o.
Bratislava, 82007, Slovakia
Endomed, s.r.o.
Košice, 04013, Slovakia
KM Management spol. s r.o.
Nitra, 04901, Slovakia
Gastro I, s.r.o.
Prešov, 08001, Slovakia
Gastro LM s.r.o.
Prešov, 08001, Slovakia
Svet zdravia a.s.
Rimavská Sobota, 97901, Slovakia
Accout Center s.r.o.
Šahy, 93601, Slovakia
Complejo Hospitalario Universitario de Ferrol
Ferrol, La Coruña, 15405, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Las Palmas, 35019, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
Centro Medico Teknon
Barcelona, 08022, Spain
Hospital General Juan Ramon Jimenez
Huelva, 21005, Spain
Hospital Montecelo
Pontevedra, 36071, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
RCNECRCH Dept of Proctology, SHEI Ukr BSMU
Chernivtsi, Ukraine
Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine
Dnipro, Ukraine
CNCE of Kyiv Regional Council Kyiv Regional Center of Rehabilitation Medicine
Kyiv, Ukraine
CNCE of Kyiv Regional Council Kyiv Regional Clinical Hospital, Clinical Center of Therapeutic Profil
Kyiv, Ukraine
Medical Center of Limited Liability Company Arensia Exploratory Medicine
Kyiv, Ukraine
Medical Center Universal Clinic Oberih of Limited Liability Company Kapital
Kyiv, Ukraine
Railway Transport Kyiv Clinical Hospital #2 of Healthcare Center Branch of JSC Ukrainian Railway
Kyiv, Ukraine
Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council
Lutsk, Ukraine
CNCE of Lviv Regional Council Lviv Regional Clinical Hospital
Lviv, Ukraine
SSH St. Panteleimon of MNPE "Lviv Territorial Med Union" MC of E&I care,Th. Center D.Halytskyi LNMU
Lviv, Ukraine
CNE Odesa Regional Clinical Hospital of Odesa Regional Council
Odesa, Ukraine
M.V. Sklifosovskyi Poltava RCH Dept of Pulmonology HSEIU Ukrainian Medical Stomatological Academy
Poltava, Ukraine
CNE A.Novak Transcarpathian Reg Clin Hospital of Transcarpathian Reg Council
Uzhhorod, Ukraine
CNCE M.I.Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council
Vinnytsia, Ukraine
CNCE Vinnytsia City Clinical Hospital #1, Dep of Clinical Therapy #2
Vinnytsia, Ukraine
Communal Enterprise Hospital #1 of Zhytomyr City Council
Zhytomyr, Ukraine
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Guy's Hospital
London, Greater London, SE1 9RT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Abivax
Study Officials
- PRINCIPAL INVESTIGATOR
Severine Vermeire, MD, PhD
UZ Leuven, Belgium
- PRINCIPAL INVESTIGATOR
Bruce Sands, MD, PhD
Mount Sinai Health System Digestive Disease Institute, New York USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
January 25, 2023
Primary Completion
June 24, 2025
Study Completion
July 15, 2025
Last Updated
September 10, 2026
Results First Posted
September 10, 2026
Record last verified: 2026-08