Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
1 other identifier
interventional
217
14 countries
112
Brief Summary
A phase 2b study to evaluate the long-term efficacy and safety study of ABX464 50mg as maintenance therapy in patients with moderate to severe Ulcerative Colitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2020
Typical duration for phase_2
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2019
CompletedFirst Posted
Study publicly available on registry
July 17, 2019
CompletedStudy Start
First participant enrolled
January 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2023
CompletedResults Posted
Study results publicly available
April 27, 2025
CompletedMay 6, 2026
April 1, 2026
3.1 years
July 5, 2019
September 17, 2024
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients With Clinical Remission at Week 48 Compared to Baseline of Induction Study (ABX464-103)
Clinical remission (based on the Mayo scoring system) is defined as: a rectal bleeding sub-score = 0, and an endoscopy sub-score ≤1 (excluding friability), and at least 1-point decrease in stool frequency sub-score from baseline to achieve a stool frequency sub-score ≤1
week 48
Secondary Outcomes (10)
Proportion of Patients With Clinical Response at Weeks 48 and 96 Compared to Baseline of Induction Study
Weeks 48 and 96
Endoscopic Improvement at Weeks 48 and 96
week 48 and week 96
Endoscopic Remission at Weeks 48 and 96
week 48 and week 96
Sustained Endoscopic Changes at Week 48 and Week 96
weeks 48 and 96
Change in Modified Mayo Score and in Partial Modified Mayo Score
From baseline to week 96
- +5 more secondary outcomes
Study Arms (1)
ABX464 50mg
EXPERIMENTALAll subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
Interventions
ABX464 All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
Eligibility Criteria
You may qualify if:
- Patients must have completed the 16-week induction treatment period (ABX464-103);
- Patients are able and willing to comply with study visits and procedures as per protocol;
- Patients should understand, sign and date the written voluntary informed consent form prior to any protocol-specific procedures are performed;
- Patients should be affiliated to a social security regimen (for French sites only);
- Females and males receiving the study treatment (potentially in combination with immunosuppressant) and their partners must agree to use a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Contraception should be in place at least 2 weeks prior to screening. Women must be surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) or in the postmenopausal state (no menses for 12 months without an alternative medical cause) or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male patients must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male patients should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male patients must not donate sperm as long as contraception is required.
- Criteria that should be met by patients at week 48 to be eligible for 48 additional weeks of study treatment.
- Patients should be in clinical response. Clinical response is defined as: a reduction in Modified Mayo Score ≥ 2 points and ≥ 30 % from baseline (induction) with an accompanying decrease in rectal bleeding sub-score ≥ 1 point or absolute rectal bleeding sub-score ≤ 1 point.
- Patients able and willing to continue the study treatment and who are compliant with study visits and procedures and who signed the update of the written voluntary informed consent.
You may not qualify if:
- Patients who had major protocol deviation(s) in the induction study;
- Patients who permanently discontinued study the treatment in induction study (ABX464-103) because of an adverse event (AE) regardless of relatedness to investigational product;
- Patients who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study;
- Patients with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study;
- Patients who are participating or plan to participate in other investigational studies (other than induction study) during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abivax S.A.lead
Study Sites (120)
Medizinische Universität Innsbruck
Innsbruck, Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria
Ordensklinikum Linz GmbH - Barmherzige Schwestern
Linz, Austria
AKH - Medizinische Universität Wien
Vienna, Austria
Gomel Regional Clinical Hospital
Homyel, Belarus
Minsk city diagnostic center
Minsk, Belarus
Regional Clinical Hospital
Minsk, Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, Belarus
Vitebsk regoinal clinical specialized center
Vitebsk, Belarus
AZ Sint-Lucas
Bruges, Belgium
C. H. U. St-Pierre
Brussels, Belgium
University Hospitals Leuven - campus Gasthuisberg
Leuven, 3000, Belgium
Brandon Medical Arts Clinic
Brandon, Canada
South Edmonton Gastroenterology
Edmonton, Canada
LHSC - Victoria Hospital
London, Canada
The Ottawa Hospital - General Campus
Ottawa, Canada
Mount Sinai Hospital
Toronto, Canada
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia
Hepato-Gastroenterologie HK s.r.o.
Hradec Králové, Czechia
MUDr. GREGAR s.r.o.
Olomouc, Czechia
Fakultni nemocnice Ostrava
Ostrava-Kunčice, Czechia
Nemocnice Na Bulovce
Prague, Czechia
Thomayerova nemocnice
Prague, Czechia
Nemocnice Slany
Slaný, Czechia
CHU Amiens - Hopital Sud
Amiens, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, France
CHU Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand, France
Hôpital Beaujon
Clichy, France
CHU de Grenoble - Hôpital Nord
Grenoble, France
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, France
CHU Lille - Hôpital Claude Huriez
Lille, France
Hôpital Nord - CHU Marseille
Marseille, France
Hopital Saint Eloi
Montpellier, France
CHU Nantes - Hôtel Dieu
Nantes, France
CHU Nice - Hôpital de l'Archet 2
Nice, France
CHU Reims - Hôpital Robert Debré
Reims, France
CHU Rennes - Hôpital Pontchaillou
Rennes, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, France
CHU Saint Etienne - Hôpital Nord
Saint-Etienne, France
CHU Strasbourg - Hôpital Hautepierre
Strasbourg, France
Hopital Rangueil
Toulouse, France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, France
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany
Florence-Nightingale-Krankenhaus-Diakonie Kaiserswerth
Düsseldorf, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, Germany
Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt
Halle, Germany
Universitaetsklinikum Halle (Saale)
Halle, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Johanna-Etienne-Krankenhaus
Neuss, Germany
Tumorzentrum Nordthueringen MVZ GmbH
Nordhausen, Germany
Dr. Tasso Bieler
Riesa, Germany
Universitaetsklinikum Ulm
Ulm, Germany
DRC Gyogyszervizsgalo Kozpont Kft.
Balatonfüred, Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest, Hungary
Pannonia Maganorvosi Centrum
Budapest, Hungary
Semmelweis Egyetem
Budapest, Hungary
Debreceni Egyetem
Debrecen, Hungary
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
Debrecen, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, Hungary
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy
Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, Italy
I.R.C.C.S Policlinico San Donato
Milan, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, Italy
Azienda Ospedaliera di Padova
Padova, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
Pisa, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Centrum Medyczne Plejady
Krakow, Poland
Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, Poland
Wojskowy Szpital Kliniczny w Lublinie
Lublin, Poland
Trialmed CRS
Piotrkow Trybunalski, Poland
Centrum Medyczne Grunwald
Poznan, Poland
KO-MED Centra Kliniczne Pulawy
Puławy, Poland
Gabinet Lekarski Bartosz Korczowski
Rzeszów, Poland
Centrum Zdrowia MDM
Warsaw, Poland
Nzoz Vivamed
Warsaw, Poland
Centrum Zdrowia Tuchow Sp. z o.o.
Wierzchosławice, Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wroclaw, Poland
Centrum Medyczne Oporow
Wroclaw, Poland
LexMedica
Wroclaw, Poland
Clinical Center " Dr Dragisa Misovic Dedinje"
Belgrade, Serbia
Clinical Center Bezanijska Kosa
Belgrade, Serbia
General Hospital Uzice
Užice, Serbia
Alian s.r.o.
Bardejov, Slovakia
Gastromedic, s.r.o.
Nové Zámky, Slovakia
Gastro I, s.r.o.
Prešov, Slovakia
Accout Center s.r.o.
Šahy, Slovakia
Endomed, s.r.o.
Vranov nad Topľou, Slovakia
General Hospital Celje
Celje, Slovenia
University Medical Centre Maribor
Maribor, Slovenia
General Hospital Murska Sobota
Murska Sobota, Slovenia
Centro Médico Teknon
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Spain
Hospital Quironsalud Malaga
Málaga, Spain
CNE Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, Ukraine
I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
Dnipro, Ukraine
Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, Ukraine
CHI Kharkiv City Clinical Hospital #13
Kharkiv, Ukraine
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
Kharkiv, Ukraine
Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv, Ukraine
CI Kherson CCH
Kherson, Ukraine
Khmelnytska Regional Hospital
Khmelnytskyi, Ukraine
Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, Ukraine
Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU
Lviv, Ukraine
Ternopil University Hospital
Ternopil, Ukraine
A. Novak Transcarpathian Regional Clinical Hospital
Uzhhorod, Ukraine
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
Vinnytsia, Ukraine
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia, Ukraine
MCIC MC LLC Health Clinic
Vinnytsia, Ukraine
CI City Clinical Hospital #6 Dept of Gastroenterology
Zaporizhzhia, Ukraine
CNCE "City Hospital 9" Zaporizhzhia CC
Zaporizhzhia, Ukraine
Fairfield General Hospital
Bury, United Kingdom
Guy's Hospital
London, United Kingdom
University College London Hospitals
London, United Kingdom
Nottingham University Hospitals Queen's Medical Centre
Nottingham, United Kingdom
Related Publications (2)
Vermeire S, Nitcheu J, Gineste P, Flatres A, Santo J, Scherrer D, Peyrin-Biroulet L, Dulai PS, Danese S, Dubinsky M, Tilg H, Siegmund B, Hisamatsu T, Shan K, Rabbat CJ, Sands BE. Obefazimod in patients with moderate-to-severely active ulcerative colitis: efficacy and safety analysis from the 96-week open-label maintenance phase 2b study. J Crohns Colitis. 2025 May 8;19(5):jjaf074. doi: 10.1093/ecco-jcc/jjaf074.
PMID: 40417999DERIVEDVermeire S, Sands BE, Tilg H, Tulassay Z, Kempinski R, Danese S, Bunganic I, Nitcheu J, Santo J, Scherrer D, Biguenet S, Ehrlich HJ, Steens JM, Gineste P, Sandborn WJ. ABX464 (obefazimod) for moderate-to-severe, active ulcerative colitis: a phase 2b, double-blind, randomised, placebo-controlled induction trial and 48 week, open-label extension. Lancet Gastroenterol Hepatol. 2022 Nov;7(11):1024-1035. doi: 10.1016/S2468-1253(22)00233-3. Epub 2022 Sep 6.
PMID: 36075249DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director Clinical Operations
- Organization
- Abivax
Study Officials
- PRINCIPAL INVESTIGATOR
Severine VERMEIRE, MD
Universitaire Ziekenhuizen KU Leuven
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2019
First Posted
July 17, 2019
Study Start
January 13, 2020
Primary Completion
February 23, 2023
Study Completion
February 23, 2023
Last Updated
May 6, 2026
Results First Posted
April 27, 2025
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share