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New pill shows promise for Long-Term ulcerative colitis control

NCT ID NCT05177835

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests the long-term safety and effectiveness of an experimental drug called ABX464 in people with moderate to severe ulcerative colitis. Participants who previously improved on ABX464 in earlier studies will continue taking it daily for up to 54 months. Researchers will track side effects and how many patients stay in remission over time.

What this could mean

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

Active substance
ABX464 (an experimental oral drug)
What this could lead to
If successful, this could provide a long-term treatment option for people with moderate to severe ulcerative colitis, helping maintain remission.
What could go wrong
This is an early-phase, open-label study with no placebo group, so results may be less reliable. Long-term safety is still being evaluated, and the drug may not work for everyone.

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

About 203 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Apr 2028

An estimate. End dates often move.

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 years and older

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: * Subjects who previously completed the ABX464-102 or ABX464-104 clinical studies * Subjects should be in endoscopic improvement with a rectal bleeding sub-score = 0 point at the end of treatment period in the previous study (ABX464-102 or ABX464-104). Endoscopic improvement is defined as: a Mayo endoscopic sub score of ≤1 ; * Subjects able and willing to comply with study visits and procedures; * Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures; * 5\. Women of childbearing potential and men receiving the study treatment and their partners must agree to continue a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Women must be surgically sterile 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 subject. 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 subjects must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male subjects should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male subjects must not donate sperm as long as contraception is required. For the purpose of this protocol, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. Finally, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy; * Subjects should be affiliated to a social security regimen (for French sites only). Exclusion Criteria: * Subjects 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 * Subjects 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 subject inappropriate for entry into this study * Subjects who are participating or plan to participate in other investigational studies (other than induction study) during the study.

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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

  • Antwerp University Hospital

    Antwerp, Belgium

  • CHU Nantes - Hôtel Dieu

    Nantes, France

  • CHU Saint Etienne - Hôpital Nord

    Saint-Etienne, France

  • Centre Hospitalier Universitaire De Montpellier

    Montpellier, France

  • Centre Hospitalier Universitaire Grenoble Alpes

    Grenoble, France

  • Centro Medico Teknon

    Barcelona, Spain

  • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

    Wroclaw, Poland

  • Centrum Medyczne Oporow

    Wroclaw, Poland

  • Centrum Medyczne Plejady

    Krakow, Poland

  • Cliniq s.r.o.

    Bratislava, Slovakia

  • Communal non-commercial enterprise "Cherkasy Regional Hospital of Cherkasy regional council"

    Cherkasy, Ukraine

  • Communal non-commercial enterprise "Khmelnytska Regional Hospital" of Khmelnytskiy regional council

    Khmelnytskyi, Ukraine

  • DRC Gyogyszervizsgalo Kozpont Kft.

    Balatonfüred, Hungary

  • Endomed s.r.o

    Vranov nad Topľou, Slovakia

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, Czechia

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Italy

  • GASTRO I, s.r.o.

    Prešov, Slovakia

  • Goethe University Frankfurt

    Frankfurt, Germany

  • Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház I. Belgyógyászat

    Győr, Hungary

  • Humanitas Mirasole S.p.A.

    Rozzano, Italy

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Verona, Italy

  • Institut des MICI

    Neuilly-sur-Seine, France

  • Kliničko bolnički centar Zvezdara

    Belgrade, Serbia

  • LexMedica

    Wroclaw, Poland

  • Medical Network Sp. z o.o.

    Warsaw, Poland

  • Medical University of Vienna

    Vienna, Austria

  • Medicome Sp. z o. o.

    Oświęcim, Poland

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Medizinische Universitaet Innsbruck

    Innsbruck, Austria

  • Nemocnice Slany

    Slaný, Czechia

  • Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. i M. Nastaj sp. p

    Lublin, Poland

  • Opšta bolnica "Đorđe Joanović" Zrenjanin Odsek za gastroenterologiju

    Zrenjanin, Serbia

  • Ośrodek Badań Klinicznych "METABOLICA"

    Tarnów, Poland

  • Samodzielny PZOZ w Lecznej

    Łęczna, 21-010, Poland

  • Santa Sp. z o.o.

    Warsaw, Poland

  • Semmelweis University

    Budapest, Hungary

  • South Edmonton Gastroenterology

    Edmonton, Canada

  • Splosna Bolnisnica Murska Sobota

    Murska Sobota, Slovenia

  • Splošna bolnišnica Celje

    Celje, Slovenia

  • Studiengesellschaft BSF UG (haftungsbeschraenkt)

    Halle, Germany

  • Termedia Sp. z o.o (NSZOZ Termedica - Centrum Badan Klinicznych)

    Poznan, Poland

  • Trialmed CRS

    Piotrkow Trybunalski, Poland

  • UZ Leuven

    Leuven, Belgium

  • Univerzitetni klinični center Maribor

    Maribor, Slovenia

  • Vasutegeszseguegyi Nonprofit Koezhasznu Kft.

    Debrecen, Hungary

  • Wojskowy Szpital Kliniczny w Lublinie

    Lublin, Poland

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