Ulcerative ColitisPhase 3NCT05507216
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
A Phase 3 study testing ABX464 in people with Ulcerative Colitis, run by Abivax S.A. at 262 sites in 27 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- ABX464
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 636 participants
- Where
- 262 sitesin 27 countries
- Study dates
- 25 Jan 2023to 15 Jul 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
262 sites in 27 countries.
262 sites in 27 countries
Japan49 sites
Asahikawa City Hospital
Asahikawa-shi
Asahikawa Medical University Hospital
Asahikawa-shi
Institute of Science Tokyo Hospital
Bunkyō City
Juntendo University Hospital
Bunkyō City
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, 818-8502
Shinseikai Sai Gastroenterology, Proctology Clinic
Fujiidera, Osaka, 583-0027
Fukui Prefectural Hospital
Fukui-shi
NHO Fukuyama Medical Center
Fukuyama-shi, Hiroshima, 720-8520
Matsuaikai Matsuda Hospital
Hamamatsu, Shizuoka, 432-8061
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji-shi
NHO Hirosaki General Medical Center
Hirosaki-shi
Aso Co.,Ltd Iizuka Hospital
Iizuka-shi, Fukuoka, 820-8505
Jiaikai Izuro Imamura Hospital
Kagoshima, Kagoshima-ken, 892-0824
Kagoshima IBD Gastroenterology Clinic
Kagoshima, Kagoshima-ken, 892-0843
Sameshima Hospital
Kagoshima, Kagoshima-ken, 892-0846
NHO Kanazawa Medical Center
Kanazawa, Ishikawa-ken, 920-8650
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Chiba, 277-0871
Kawasaki Municipal Hospital
Kawasaki-shi, Kanagawa, 210-0013
Kiryu Kosei General Hospital
Kiryu-shi, Gunma, 376-0024
Aoyama Clinic
Kobe, Hyōgo, 650-0015
NHI Komatsu Municipal Hospital
Komatsu-shi
Showa University Koto Toyosu Hospital
Kōtoku, Tokyo-To, 135-8577
Kumagaya General Hospital
Kumagaya-shi, Saitama, 360-8567
Kaiseikai Hattori Clinic
Kumamoto, Kumamoto, 860-0004
NHO Kure Medical Center and Chugoku Cancer Center
Kure-shi, Hiroshima, 737-0023
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011
Our Lady of the Snow St. Mary's Hospital
Kurume-shi, Fukuoka, 830-8543
Ehime Prefectural Central Hospital
Matsuyama, Ehime, 790-0024
Kitasato University Kitasato Institute Hospital
Minatoku, Tokyo-To, 108-8642
Kyorin University Hospital
Mitaka-shi
Nagaoka Red Cross Hospital
Nagaoka-shi
Saiseikai Niigata Hospital
Niigata, Niigata, 950-1104
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
NHO Okayama Medical Center
Okayama, Okayama-ken, 701-1192
Keiaikai Nakagami Hospital
Okinawa-shi, Okinawa, 904-2195
NHO Osaka National Hospital
Osaka, Osaka, 540-0006
JCHO Osaka Hospital
Osaka, Osaka, 553-0003
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma, 373-8585
Saga-Ken Medical Centre Koseikan
Saga, Saga-ken, 840-8571
Saga University Hospital
Saga, Saga-ken, 849-8501
JCHO Hokkaido Hospital
Sapporo, Hokkaido, 062-8618
JCHO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo-To, 169-0073
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, 760-0017
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi
NHO Ureshino Medical Center
Ureshino-shi, Saga-ken, 843-0393
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, 224-8503
Keijinkai Matsushima Hospital
Yokohama
United States46 sites
University of Michigan
Ann Arbor, Michigan, 48109
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012
National Institute of Clinical Research
Bakersfield, California, 93309
Inquest Clinical Research
Baytown, Texas, 77521
University of Alabama -Birmingham
Birmingham, Alabama, 35205
NY Scientific Corp.
Brooklyn, New York, 11235
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, 33762
Citrus Valley Gastroenterology
Covina, California, 91723
Danbury Hospital
Danbury, Connecticut, 06810
Plains Clinical Research Center, LLC
Fargo, North Dakota, 58104
Gastroenterology Consultants of South Texas, PA
Harlingen, Texas, 78550
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, 17110
Digestive Health Research, LC
Hermitage, Tennessee, 37076
The University of Iowa
Iowa City, Iowa, 52242
IHS Health
Kissimmee, Florida, 34741
BVL Clinical Research
Liberty, Missouri, 64068
Research Solutions of Arizona, PC
Litchfield Park, Arizona, 85340
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
Tandem Clinical Research, LLC
Marrero, Louisiana, 70072
Research Associates of South Florida
Miami, Florida, 33134
Sanchez Clinical Research, Inc
Miami, Florida, 33157
Wellness Clinical Research
Miami Lakes, Florida, 33016
United Medical Doctors
Murrieta, California, 92563
Mount Sinai
New York, New York, 10029
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Sarkis Clinical Trials - Parent
Ocala, Florida, 34474
AdventHealth Medical Group
Orlando, Florida, 32804
Arnold Palmer Hospital For Children
Orlando, Florida, 32806
Omega Research Orlando, LLC
Orlando, Florida, 32808
Digestive System Healthcare
Pasadena, Texas, 77505
LinQ Research, LLC
Pearland, Texas, 77584
Advanced Medical Research Center
Port Orange, Florida, 32127
Rapid City Medical Center, LLC
Rapid City, South Dakota, 57701
Richmond VA Medical Center
Richmond, Virginia, 23249
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
Roanoke, Virginia, 24014
Southern Star Research Institute, LLC
San Antonio, Texas, 78229
Clinical Applications Laboratories
San Diego, California, 92103
Santa Maria Gastroenterology Medical Group
Santa Maria, California, 93458
Premier Health Research
Sparta, New Jersey, 07871
GCP Clinical Research, LLC
Tampa, Florida, 33609
University of South Florida - PARENT
Tampa, Florida, 33612
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
Tyler Research Institute, LLC
Tyler, Texas, 75703
Frontier Clinical Research, LLC
Uniontown, Pennsylvania, 15401
The Vancouver Clinic
Vancouver, Washington, 98664
Poland16 sites
NZOZ Centrum Medyczne KERmed
Bydgoszcz, 85-231
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338
ETG Kielce Zagorska
Kielce, 25-355
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
Knurów, 44-190
Centrum Medyczne Plejady
Krakow, 30-363
Centrum Medyczne Plejady
Krakow
1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Lublinie
Lublin, 20-049
NZOZ Neuromed M. i M. Nastaj Sp.P.
Lublin
ALLMEDICA sp. z o. o.
Nowy Targ, 34-400
Wojewodzki Specjalistyczny Szpital w Olsztynie
Olsztyn, 10-561
Medicome Sp. z o.o.
Oświęcim, 32-600
Trialmed CRS
Piotrkow Trybunalski, 62-800
Gabinet Lekarski Bartosz Korczowski
Rzeszów, 35-302
Nowe zdrowie-CK, Kieltucki i wspolnicy sp. j.
Staszów, 28-200
DC-MED
Swidnica, 58-100
Centrum Zdrowia Tuchow Sp. z o.o.
Wierzchosławice, 33-122
Ukraine16 sites
RCNECRCH Dept of Proctology, SHEI Ukr BSMU
Chernivtsi
Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine
Dnipro
CNCE of Kyiv Regional Council Kyiv Regional Center of Rehabilitation Medicine
Kyiv
CNCE of Kyiv Regional Council Kyiv Regional Clinical Hospital, Clinical Center of Therapeutic Profil
Kyiv
Medical Center of Limited Liability Company Arensia Exploratory Medicine
Kyiv
Medical Center Universal Clinic Oberih of Limited Liability Company Kapital
Kyiv
Railway Transport Kyiv Clinical Hospital #2 of Healthcare Center Branch of JSC Ukrainian Railway
Kyiv
Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council
Lutsk
CNCE of Lviv Regional Council Lviv Regional Clinical Hospital
Lviv
SSH St. Panteleimon of MNPE "Lviv Territorial Med Union" MC of E&I care,Th. Center D.Halytskyi LNMU
Lviv
CNE Odesa Regional Clinical Hospital of Odesa Regional Council
Odesa
M.V. Sklifosovskyi Poltava RCH Dept of Pulmonology HSEIU Ukrainian Medical Stomatological Academy
Poltava
CNE A.Novak Transcarpathian Reg Clin Hospital of Transcarpathian Reg Council
Uzhhorod
CNCE M.I.Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council
Vinnytsia
CNCE Vinnytsia City Clinical Hospital #1, Dep of Clinical Therapy #2
Vinnytsia
Communal Enterprise Hospital #1 of Zhytomyr City Council
Zhytomyr
Brazil14 sites
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, 18618-686
L2IP - Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, 70200-730
Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS)
Caxias do Sul, Rio Grande do Sul, 95070-560
CDC - Centro Digestivo de Curitiba
Curitiba, Paraná, 80430-160
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, Ceará, 60430-370
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, 17201-130
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Hospital Aliança
Salvador, Estado de Bahia, 41920-180
Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao
Salvador, Estado de Bahia
Pesquisare Saúde
Santo André, São Paulo, 09080-110
Praxis Pesquisa Medica
Santo André, São Paulo, 09090-970
Irmandade da Santa Casa da Misericórdia de Santos
Santos, São Paulo, 11075-101
Hepatogastro
São Paulo, São Paulo, 04543-011
Hospital Sirio Libanes
São Paulo
India14 sites
Vydehi Institute of Medical Sciences and Research Centre
Bengaluru
Origin Hospital
Hyderabad, Andhra Pradesh, 500048
Yashoda Super Speciality Hospital
Hyderabad, Andhra Pradesh, 500082
Gleneagles Global Hospitals
Hyderabad
Institute of Post Graduate Medical Education And Research
Kolkata, West Bengal, 700020
Lokmanya Tilak Municipal General Hospital & Medical College
Mumbai, Maharashtra, 400022
Fortis Escorts Heart Institute and Research Centre
New Delhi, National Capital Territory of Delhi, 110025
Maharaja Agrasen Hospital
New Delhi, National Capital Territory of Delhi, 110026
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Gandhi Hospital
Secunderabad, Andhra Pradesh, 500003
Surat Institute of Digestive Sciences
Surat, Gujarat, 395002
Gujarat Hospital
Surat, Gujarat, 395009
Isha Multispeciality Hospital
Vadodara, Gujarat, 390007
Datta Meghe Institute of Medical Sciences (Deemed University)
Wardha, Maharashtra, 442004
France11 sites
CHU Amiens - Hopital Sud
Amiens, Somme, 80054
CHU de Grenoble - Hôpital Nord
Grenoble, Isere, 38043
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, Vendée, 85925
CHU Lille - Hôpital Claude Huriez
Lille, Nord, 59037
Hôpital Nord - CHU Marseille
Marseille, Bouches-du-Rhône, 13915
Institut des MICI
Neuilly, Hauts De Seine, 92200
CHU Nice - Hôpital de l'Archet 2
Nice, Alpes Maritimes, 06200
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhone, 69495
CHU Rennes - Hôpital Pontchaillou
Rennes, Ille Et Vilaine, 35000
Hopital Rangueil
Toulouse, Haute Garonne, 31059
Hospital de brabois
Vandœuvre-lès-Nancy, Moselle, 57070
Israel11 sites
HaEmek Medical Center
Afula, 18101
Soroka University Medical Center
Beersheba, 84001
Carmel Medical Center
Haifa, 34362
Wolfson Medical Center
Holon
Shaare Zedek Medical Center
Jerusalem, 9103102
Meir Medical Center
Kfar Saba, 4428164
Galilee Medical Center Institute of Gastroenterology
Nahariya
Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492
Chaim Sheba Medical Center
Ramat Gan, 5265602
Kaplan Medical Center KMC Institute of Gastroenterology and Liver Diseases
Rehovot, 76100
Tel Aviv Sourasky Medical Center
Tel Aviv
Germany9 sites
Charité - Campus Charité Mitte
Berlin, 10117
DRK Kliniken Berlin Westend
Berlin, 14050
Krankenhaus Waldfriede e. V.
Berlin, 14163
Evangelisches Krankenhaus Kalk GmbH
Cologne
Hamburgisches Forschungsinstitut fure Chronische Darmerkrankungen
Hamburg, 20251
INLUGA im Haus der Gesundheit
Ludwigshafen am Rhein, Rhineland-Palatinate, 67067
Siloah St. Trudpert Klinikum
Pforzheim
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Universitaetsklinikum Ulm
Ulm
Slovakia8 sites
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, 97517
Cliniq s.r.o.
Bratislava, 82007
Endomed, s.r.o.
Košice, 04013
KM Management spol. s r.o.
Nitra, 04901
Gastro I, s.r.o.
Prešov, 08001
Gastro LM s.r.o.
Prešov, 08001
Svet zdravia a.s.
Rimavská Sobota, 97901
Accout Center s.r.o.
Šahy, 93601
Spain8 sites
Centro Medico Teknon
Barcelona, 08022
Complejo Hospitalario Universitario de Ferrol
Ferrol, La Coruña, 15405
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital General Juan Ramon Jimenez
Huelva, 21005
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Las Palmas, 35019
Hospital Montecelo
Pontevedra, 36071
Hospital Clinico Universitario de Valencia
Valencia, 46010
Hospital Universitario Miguel Servet
Zaragoza, 50009
Argentina7 sites
CEMIC
Buenos Aires, Ciudad Autonoma Buenos Aires, 1431
Hospital Britanico de Buenos Aires
Buenos Aires, Ciudad Autonoma Buenos Aires, C1280AEB
Gastroenterología Diagnóstica y Terapéutica (Gedyt)
Ciudad Autonoma Buenos Aires, C1117ABK
DIM Clinica Privada
Ramos Mejía, Buenos Aires
Centro de Investigaciones Clinicas Baigorria
Rosario, Santa Fe Province
Centro de Investigacion CICE
San Miguel de Tucumán, Tucumán Province, 4000
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province, T4000AXL
Italy6 sites
Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, 88100
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milan, 20157
Azienda Ospedale-Università di Padova
Padova
Università Campus Bio-Medico di Roma
Roma, 00128
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Romania6 sites
SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
Bucharest, 012015
Spitalul de Oncologie Monza
Bucharest, 013812
Spitalul Clinic Colentina
Bucharest, 020125
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca, 400006
S.C Pelican Impex S.R.L
Oradea, 410469
S.C Centrul Medical Valahia S.R.L
Ploieşti, 100550
Serbia6 sites
Clinical Center " Dr Dragisa Misovic Dedinje"
Belgrade, 11000
Clinical Hospital Center Zvezdara
Belgrade, 11000
Clinical Hospital Center "Bezanijska kosa
Belgrade
University Clinical Center Kragujevac
Kragujevac
General Hospital Subotica
Subotica, 24000
General Hospital "Djordje Joanovic"
Zrenjanin
Ireland5 sites
Connolly Hospital
Abbotstown, Dublin, D15 X40D
Beaumont Hospital
Dublin
St Vincents University Hospital
Dublin
Portiuncula Hospital
Galway
Midland Regional Hospital
Mullingar, Westmeath, N91
Belgium4 sites
GZA Ziekenhuizen
Antwerp, 2018
AZ Maria Middelares
Ghent, 9000
Universitair Ziekenhuis Gent
Ghent, 9000
AZ Delta
Roeselare, 8800
Canada4 sites
London Health Sciences Centre (LHSC) - Victoria Hospital
London
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, V6Z 2K5
Gordon and Leslie Diamond Health Care Centre - Vancouver General Hospital
Vancouver, British Columbia
Newfoundland and Labrador Health Services
Winnipeg, Manitoba
Hungary4 sites
Semmelweis Egyetem
Budapest, 1088
Gyongyosi Bugat Pal Korhaz
Gyöngyös, 3200
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
Clinfan Szolgaltato Kft.
Szekszárd, 7100
Mexico4 sites
Consultorio Medico, InvesclinicMX
Irapuato, Guanajuato, 36650
Accelerium S de RL de CV
Monterrey, Nuevo León, 64000
FAICIC S. de R.L. de C.V.
Veracruz, 91900
Sociedad de Metabolismo y Corazon S.C
Veracruz, 91900
Bosnia and Herzegovina3 sites
University Clinical Centre of the Republic of Srpska
Banja Luka
General Hospital Prim.dr.Abdulah Nakas
Sarajevo
University Clinical Center Tuzla
Tuzla
Bulgaria3 sites
Diagnostic Consultation Center CONVEX EOOD
Sofia, 1680
Acibadem City Clinic Mladost Eood
Sofia
MC Medica Plus
Veliko Tarnovo, 5000
Croatia2 sites
Poliklinika Borzan d.o.o
Osijek, 31000
University hospital centre Zagreb
Zagreb, 10000
Lithuania2 sites
Lithuanian University of Health Sciences Kaunas Hospital
Kaunas, 47144
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, LT-50161
United Kingdom2 sites
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Guy's Hospital
London, Greater London, SE1 9RT
About this study
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
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
- Being tested
- ABX464, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX464Drug
Also called Obefazimod
Administered once daily in the morning with food
PlaceboDrug
Administered once daily in the morning with food
| Study group | Role | What they receive |
|---|---|---|
| ABX464 50mg | Experimental | Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks Receives: Drug: ABX464 |
| ABX464 25mg | Experimental | Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks Receives: Drug: ABX464 |
| Placebo | Placebo comparator | Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (3)
Proportion of Subjects Who Achieve Endoscopic Improvement at Week 8
To compare the efficacy of ABX464 versus placebo on endoscopic improvement. Endoscopic improvement is defined as Mayo Endoscopic Score (MES) = 0 or 1 (MES of 1 modified to exclude friability).
Measured: 8 weeks
Proportion of Subjects Who Achieve Clinical Response Per MMS at Week 8
To compare the efficacy of ABX464 versus placebo on clinical response as per MMS.
MMS is the Modified Mayo Score. Modified Mayo score is a composite measure of ulcerative disease activity consisting of three components: stool frequency, rectal bleeding and endoscopic subscores. Each component is scored from 0 (normal or inactive disease) to 3 (severe activity).
The total range score ranges from 0 to 9, with higher scores indicating more severe disease activity.
Clinical Response is defined as a reduction from baseline in MMS ≥ 2 points and a relative reduction from baseline in MMS ≥ 30%, and a reduction from baseline in Rectal Bleeding Score (RBS) ≥ 1 point and/or RBS = 0 or 1.
Measured: 8 weeks
Proportion of Subjects With HEMI Per Geboes at Week 8
To compare the efficacy of ABX464 versus placebo on histologic-endoscopic mucosal improvement (HEMI).
HEMI is defined as endoscopic improvement associated with histologic improvement per Geboes score.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start25 Jan 2023
- Primary completion24 Jun 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 636 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abivax S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Severine Vermeire, MD, PhD, Principal investigator, UZ Leuven, BelgiumBruce Sands, MD, PhD, Principal investigator, Mount Sinai Health System Digestive Disease Institute, New York USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507216
- Sponsor's protocol ID
- ABX464-106
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2022
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No