Ulcerative ColitisPhase 2NCT04023396
Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
A Phase 2 study testing ABX464 in people with Ulcerative Colitis, run by Abivax S.A. at 120 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- ABX464
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 120 sitesin 16 countries
- Study dates
- 13 Jan 2020to 23 Feb 2023
- Phase
- Phase 2
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
120 sites in 16 countries.
120 sites in 16 countries
France18 sites
CHU Amiens - Hopital Sud
Amiens
CHU Besançon - Hôpital Jean Minjoz
Besançon
CHU Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand
Hôpital Beaujon
Clichy
CHU de Grenoble - Hôpital Nord
Grenoble
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon
CHU Lille - Hôpital Claude Huriez
Lille
Hôpital Nord - CHU Marseille
Marseille
Hopital Saint Eloi
Montpellier
CHU Nantes - Hôtel Dieu
Nantes
CHU Nice - Hôpital de l'Archet 2
Nice
CHU Reims - Hôpital Robert Debré
Reims
CHU Rennes - Hôpital Pontchaillou
Rennes
CHU de Rouen - Hôpital Charles Nicolle
Rouen
CHU Saint Etienne - Hôpital Nord
Saint-Etienne
CHU Strasbourg - Hôpital Hautepierre
Strasbourg
Hopital Rangueil
Toulouse
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy
Ukraine17 sites
CNE Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy
I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
Dnipro
Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk
CHI Kharkiv City Clinical Hospital #13
Kharkiv
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
Kharkiv
Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv
CI Kherson CCH
Kherson
Khmelnytska Regional Hospital
Khmelnytskyi
Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv
Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU
Lviv
Ternopil University Hospital
Ternopil
A. Novak Transcarpathian Regional Clinical Hospital
Uzhhorod
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
Vinnytsia
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia
MCIC MC LLC Health Clinic
Vinnytsia
CI City Clinical Hospital #6 Dept of Gastroenterology
Zaporizhzhya
CNCE "City Hospital 9" Zaporizhzhia CC
Zaporizhzhya
Poland15 sites
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz
Uniwersyteckie Centrum Kliniczne
Gdansk
Centrum Medyczne Plejady
Krakow
Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz
Wojskowy Szpital Kliniczny w Lublinie
Lublin
Trialmed CRS
Piotrkow Trybunalski
Centrum Medyczne Grunwald
Poznan
KO-MED Centra Kliniczne Pulawy
Puławy
Gabinet Lekarski Bartosz Korczowski
Rzeszów
Centrum Zdrowia MDM
Warsaw
Nzoz Vivamed
Warsaw
Centrum Zdrowia Tuchow Sp. z o.o.
Wierzchosławice
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wroclaw
Centrum Medyczne Oporow
Wroclaw
LexMedica
Wroclaw
Germany10 sites
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin
Florence-Nightingale-Krankenhaus-Diakonie Kaiserswerth
Düsseldorf
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt
Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt
Halle
Universitaetsklinikum Halle (Saale)
Halle
Medizinische Hochschule Hannover
Hanover
Johanna-Etienne-Krankenhaus
Neuss
Tumorzentrum Nordthueringen MVZ GmbH
Nordhausen
Dr. Tasso Bieler
Riesa
Universitaetsklinikum Ulm
Ulm
Italy10 sites
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna
Fondazione Poliambulanza Istituto Ospedaliero
Brescia
Azienda Ospedaliero Universitaria Mater Domini
Catanzaro
I.R.C.C.S Policlinico San Donato
Milan
Ospedale Sacro Cuore Don Calabria
Negrar
Azienda Ospedaliera di Padova
Padova
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma
Istituto Clinico Humanitas
Rozzano
Czechia7 sites
Fakultni nemocnice u sv. Anny v Brne
Brno
Hepato-Gastroenterologie HK s.r.o.
Hradec Králové
MUDr. GREGAR s.r.o.
Olomouc
Fakultni nemocnice Ostrava
Ostrava-Kunčice
Nemocnice Na Bulovce
Prague
Thomayerova nemocnice
Prague
Nemocnice Slany
Slaný
Hungary7 sites
DRC Gyogyszervizsgalo Kozpont Kft.
Balatonfüred
Obudai Egeszsegugyi Centrum Kft.
Budapest
Pannonia Maganorvosi Centrum
Budapest
Semmelweis Egyetem
Budapest
Debreceni Egyetem
Debrecen
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
Debrecen
Petz Aladar Megyei Oktato Korhaz
Győr
Belarus5 sites
Gomel Regional Clinical Hospital
Homyel
Minsk city diagnostic center
Minsk
Regional Clinical Hospital
Minsk
Vitebsk Regional Clinical Hospital
Vitebsk
Vitebsk regoinal clinical specialized center
Vitebsk
Canada5 sites
Brandon Medical Arts Clinic
Brandon
South Edmonton Gastroenterology
Edmonton
LHSC - Victoria Hospital
London
The Ottawa Hospital - General Campus
Ottawa
Mount Sinai Hospital
Toronto
Slovakia5 sites
Alian s.r.o.
Bardejov
Gastromedic, s.r.o.
Nové Zámky
Gastro I, s.r.o.
Prešov
Accout Center s.r.o.
Šahy
Endomed, s.r.o.
Vranov nad Topľou
Austria4 sites
Medizinische Universität Innsbruck
Innsbruck
Klinikum Klagenfurt am Wörthersee
Klagenfurt
Ordensklinikum Linz GmbH - Barmherzige Schwestern
Linz
AKH - Medizinische Universität Wien
Vienna
Spain4 sites
Centro Médico Teknon
Barcelona
Hospital Universitario Reina Sofia
Córdoba
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria
Hospital Quironsalud Malaga
Málaga
United Kingdom4 sites
Fairfield General Hospital
Bury
Guy's Hospital
London
University College London Hospitals
London
Nottingham University Hospitals Queen's Medical Centre
Nottingham
Belgium3 sites
AZ Sint-Lucas
Bruges
C. H. U. St-Pierre
Brussels
University Hospitals Leuven - campus Gasthuisberg
Leuven, 3000
Serbia3 sites
Clinical Center " Dr Dragisa Misovic Dedinje"
Belgrade
Clinical Center Bezanijska Kosa
Belgrade
General Hospital Uzice
Užice
Slovenia3 sites
General Hospital Celje
Celje
University Medical Centre Maribor
Maribor
General Hospital Murska Sobota
Murska Sobota
About this study
Official title: A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
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.
Read the detailed description
This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-103 clinical study (induction study) and who are willing to continue their treatment. All subjects will receive ABX464 given at 50mg o.d regardless of their previous treatment and dose received in the ABX464-103 study (i.e. ABX464 100mg, ABX464 50mg, ABX464 25mg or Placebo). The enrolment in this follow-up study will be based on the willingness of the subject to carry on his/her participation. Subjects will be treated with ABX464 for an overall period of 48 weeks. Subjects will be followed up on a monthly basis.
- Conditions
- Ulcerative Colitis
- Being tested
- ABX464
- Keywords
- moderate to severe ulcerative colitis
- 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
ABX464
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ABX464 50mg | Experimental | All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks. Receives: Drug: ABX464 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 48
Secondary outcomes (10)
Proportion of Patients With Clinical Response at Weeks 48 and 96 Compared to Baseline of Induction Study
Proportion of patients with clinical response at week 48 Clinical response is defined as: a reduction in Mayo Score ≥ 3 points and ≥ 30 % from baseline with an accompanying decrease in rectal bleeding sub-score ≥ 1 point or absolute rectal bleeding sub-score ≤ 1 point.
Measured: Weeks 48 and 96
Endoscopic Improvement at Weeks 48 and 96
Proportion of patients with endoscopic improvement at week 48 among all patients.
Proportion of patients with endoscopic improvement at week 96 among all patients.
Endoscopic improvement is defined as a Mayo endoscopic sub score of ≤1 (excluding friability).
Measured: week 48 and week 96
Endoscopic Remission at Weeks 48 and 96
Proportion of patients with endoscopic remission at week 48 among all patients. Proportion of patients with endoscopic remission at week 96 among all patients. Endoscopic remission is defined as a Mayo endoscopic sub score of 0.
Measured: week 48 and week 96
Sustained Endoscopic Changes at Week 48 and Week 96
Proportion of patients with sustained endoscopic changes at week 48 and 96. Sustained endoscopic changes is defined as the number of patients with endoscopic changes at week 48 among patients who had endoscopic changes during the Induction study (at week 8 or week 16 of study ABX464-103).
Measured: weeks 48 and 96
Change in Modified Mayo Score and in Partial Modified Mayo Score
Change in Modified Mayo Score (MMS) at weeks 48 and 96 and in partial Modified Mayo Score (pMMS)
MMS is a composite score of UC disease activity calculated as the sum of the following 3 subscores:
- Stool frequency, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
- Rectal bleeding, scored from 0 (no blood seen) to 3 (blood alone passed).
- Endoscopic evaluation, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall MMS ranges from 0 to 9 where higher scores represent more severe disease.
pMMS is a composite score of UC disease activity calculed as the sum of the following 2 subscores:
- Stool frequency, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
- Rectal bleeding, scored from 0 (no blood seen) to 3 (blood alone passed). The overall pMMS ranges from 0 to 6 where higher scores represent more severe disease.
Measured: From baseline to week 96
Stool Frequency Subscore
Participants recorded stool frequency using a paper subject diary on a daily basis. The stool frequency subscore ranges from 0 to 3 according to the following scale:
Score 0: Normal number of stools Score 1: 1 to 2 stools per day more than normal Score 2: 3 to 4 stools per day more than normal Score 3: 5 or more stools per day more than normal
Measured: From baseline to week 96
Rectal Bleeding Score
Participants recorded rectal bleeding in a paper subject diary on a daily basis. Rectal bleeding score is taken as the worst subscore of the three most recent scores within 7 days prior to the visit.
The rectal bleeding subscore ranges from 0 to 3 according to the following scale:
Score 0: No blood seen Score 1: Streaks of blood with stool less than half the time Score 2: Obvious blood with stool most of the time Score 3: Blood alone passed A lower score represents an improvement in rectal bleeding.
Measured: From baseline to week 96
C-Reactive Protein
Change to baseline in C-Reactive Protein levels
Measured: baseline, week 24, week 48
miRNA-124 Expression
Change relative to baseline in miRNA-124 expression in rectal/sigmoidal biopsies at week 48 and in total blood at week 24 and week 48.
Measured: baseline, week 24 and week 48
Incidence and Description of Adverse Events
Number and rate of all adverse events, causally-related adverse events, all serious adverse events and causally-related serious adverse events classified by severity.
Incidence of treatment-emergent serious adverse events, hospitalizations, total inpatient days.
Incidence of adverse events leading to investigational product discontinuation. Number of clinically significant laboratory abnormalities.
Measured: From baseline to week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start13 Jan 2020
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label, follow-up study
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abivax S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Severine VERMEIRE, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023396
- Sponsor's protocol ID
- ABX464-104
- Status last verified
- Apr 2026
- First submitted
- 5 Jul 2019
- Last updated
- 6 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40417999Vermeire 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.
PubMed 36075249