Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New daily pill aims to keep ulcerative colitis in check

NCT ID NCT04023396

Disease control Sponsor: Abivax S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a daily pill called ABX464 (obefazimod) as a long-term maintenance therapy for people with moderate to severe ulcerative colitis. 217 patients who completed a prior 16-week induction study took the drug for up to 96 weeks. The main goal was to see how many patients stayed in remission at week 48.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABX464 (obefazimod)
What this could lead to
If successful, this could provide a new oral maintenance option to keep ulcerative colitis under control and prevent flare-ups.
What could go wrong
This is a mid-stage, open-label trial with no placebo group, so results may not be definitive. Long-term safety and effectiveness are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

217 people

The number who actually took part.

Started

Jan 2020

Finished

Feb 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Ulcerative colitis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

Contacts and locations

Locations

  • A. Novak Transcarpathian Regional Clinical Hospital

    Uzhhorod, Ukraine

  • AKH - Medizinische Universität Wien

    Vienna, Austria

  • AZ Sint-Lucas

    Bruges, Belgium

  • Accout Center s.r.o.

    Šahy, Slovakia

  • Alian s.r.o.

    Bardejov, Slovakia

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, Italy

  • Azienda Ospedaliera di Padova

    Padova, Italy

  • Azienda Ospedaliero Universitaria Mater Domini

    Catanzaro, Italy

  • Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

    Pisa, Italy

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, Italy

  • Brandon Medical Arts Clinic

    Brandon, Canada

  • C. H. U. St-Pierre

    Brussels, Belgium

  • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

    Vinnytsia, Ukraine

  • CHI Kharkiv City Clinical Hospital #13

    Kharkiv, Ukraine

  • CHU Amiens - Hopital Sud

    Amiens, France

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, France

  • CHU Clermont Ferrand - Hôpital d'Estaing

    Clermont-Ferrand, France

  • CHU Lille - Hôpital Claude Huriez

    Lille, 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 Saint Etienne - Hôpital Nord

    Saint-Etienne, France

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg, France

  • CHU de Grenoble - Hôpital Nord

    Grenoble, France

  • CHU de Rouen - Hôpital Charles Nicolle

    Rouen, France

  • CI City Clinical Hospital #6 Dept of Gastroenterology

    Zaporizhzhia, Ukraine

  • CI Kherson CCH

    Kherson, Ukraine

  • CNCE "City Hospital 9" Zaporizhzhia CC

    Zaporizhzhia, Ukraine

  • CNE Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, Ukraine

  • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

    Kharkiv, Ukraine

  • Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU

    Ivano-Frankivsk, Ukraine

  • Centre Hospitalier Départemental Les Oudairies

    La Roche-sur-Yon, France

  • Centro Médico Teknon

    Barcelona, Spain

  • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

    Wroclaw, Poland

  • Centrum Medyczne Grunwald

    Poznan, Poland

  • Centrum Medyczne Oporow

    Wroclaw, Poland

  • Centrum Medyczne Plejady

    Krakow, Poland

  • Centrum Zdrowia MDM

    Warsaw, Poland

  • Centrum Zdrowia Tuchow Sp. z o.o.

    Wierzchosławice, Poland

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, Germany

  • Clinical Center " Dr Dragisa Misovic Dedinje"

    Belgrade, Serbia

  • Clinical Center Bezanijska Kosa

    Belgrade, Serbia

  • Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

    Kyiv, Ukraine

  • Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

    Kharkiv, Ukraine

  • DRC Gyogyszervizsgalo Kozpont Kft.

    Balatonfüred, Hungary

  • Debreceni Egyetem

    Debrecen, Hungary

  • Dr. Tasso Bieler

    Riesa, Germany

  • Endomed, s.r.o.

    Vranov nad Topľou, Slovakia

  • Fairfield General Hospital

    Bury, United Kingdom

  • Fakultni nemocnice Ostrava

    Ostrava-Kunčice, Czechia

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, Czechia

  • Florence-Nightingale-Krankenhaus-Diakonie Kaiserswerth

    Düsseldorf, Germany

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Italy

  • Gabinet Lekarski Bartosz Korczowski

    Rzeszów, Poland

  • Gastro I, s.r.o.

    Prešov, Slovakia

  • Gastromedic, s.r.o.

    Nové Zámky, Slovakia

  • General Hospital Celje

    Celje, Slovenia

  • General Hospital Murska Sobota

    Murska Sobota, Slovenia

  • General Hospital Uzice

    Užice, Serbia

  • Gomel Regional Clinical Hospital

    Homyel, Belarus

  • Guy's Hospital

    London, United Kingdom

  • Hepato-Gastroenterologie HK s.r.o.

    Hradec Králové, Czechia

  • Hopital Rangueil

    Toulouse, France

  • Hopital Saint Eloi

    Montpellier, France

  • Hospital Quironsalud Malaga

    Málaga, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, Spain

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, Spain

  • Hôpital Beaujon

    Clichy, France

  • Hôpital Nord - CHU Marseille

    Marseille, France

  • Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, France

  • I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

    Dnipro, Ukraine

  • I.R.C.C.S Policlinico San Donato

    Milan, Italy

  • Istituto Clinico Humanitas

    Rozzano, Italy

  • Johanna-Etienne-Krankenhaus

    Neuss, Germany

  • KO-MED Centra Kliniczne Pulawy

    Puławy, Poland

  • Khmelnytska Regional Hospital

    Khmelnytskyi, Ukraine

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, Austria

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt, Germany

  • LHSC - Victoria Hospital

    London, Canada

  • LexMedica

    Wroclaw, Poland

  • Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU

    Lviv, Ukraine

  • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

    Vinnytsia, Ukraine

  • MCIC MC LLC Health Clinic

    Vinnytsia, Ukraine

  • MUDr. GREGAR s.r.o.

    Olomouc, Czechia

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Medizinische Universität Innsbruck

    Innsbruck, Austria

  • Minsk city diagnostic center

    Minsk, Belarus

  • Mount Sinai Hospital

    Toronto, Canada

  • Nemocnice Na Bulovce

    Prague, Czechia

  • Nemocnice Slany

    Slaný, Czechia

  • Nottingham University Hospitals Queen's Medical Centre

    Nottingham, United Kingdom

  • Nzoz Vivamed

    Warsaw, Poland

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, Hungary

  • Ordensklinikum Linz GmbH - Barmherzige Schwestern

    Linz, Austria

  • Ospedale Sacro Cuore Don Calabria

    Negrar, Italy

  • Pannonia Maganorvosi Centrum

    Budapest, Hungary

  • Petz Aladar Megyei Oktato Korhaz

    Győr, Hungary

  • Regional Clinical Hospital

    Minsk, Belarus

  • Santa Familia Centrum Badan, Profilaktyki i Leczenia

    Lodz, Poland

  • Semmelweis Egyetem

    Budapest, Hungary

  • South Edmonton Gastroenterology

    Edmonton, Canada

  • Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt

    Halle, Germany

  • Szpital Uniwersytecki nr 2 im.dr J. Biziela

    Bydgoszcz, Poland

  • Ternopil University Hospital

    Ternopil, Ukraine

  • The Ottawa Hospital - General Campus

    Ottawa, Canada

  • Thomayerova nemocnice

    Prague, Czechia

  • Trialmed CRS

    Piotrkow Trybunalski, Poland

  • Tumorzentrum Nordthueringen MVZ GmbH

    Nordhausen, Germany

  • Universitaetsklinikum Halle (Saale)

    Halle, Germany

  • Universitaetsklinikum Ulm

    Ulm, Germany

  • University College London Hospitals

    London, United Kingdom

  • University Hospitals Leuven - campus Gasthuisberg

    Leuven, 3000, Belgium

  • University Medical Centre Maribor

    Maribor, Slovenia

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Poland

  • Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

    Debrecen, Hungary

  • Vitebsk Regional Clinical Hospital

    Vitebsk, Belarus

  • Vitebsk regoinal clinical specialized center

    Vitebsk, Belarus

  • Wojskowy Szpital Kliniczny w Lublinie

    Lublin, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.