Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

NCT ID: NCT05177835

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-03
• Study Completion Date: 2026-04-30

Brief Summary

This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (QD) at 25 mg in subjects who have been previously enrolled in the ABX464-102 or ABX464-104 studies (OLE and maintenance studies) and who are willing to continue their treatment.

All subjects will receive ABX464 given at 25 mg QD. The enrolment in this long-term study will be based on the endoscopic improvement, the willingness of the subject to carry on his/her participation and also based on investigator's judgement.

Subjects will be treated with ABX464 for a maximum period of 54 months. Subjects will be followed up quarterly. After the treatment period, subjects will be followed for 4 additional weeks for safety purposes.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABX464 -25mg

All subjects will receive ABX464 given at 25 mg QD.

Group Type: EXPERIMENTAL

ABX464

Intervention Type: DRUG

All subjects will receive ABX464 given at 25 mg QD.

Interventions

ABX464

All subjects will receive ABX464 given at 25 mg QD.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abivax S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bram Verstockt, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

Medizinische Universitaet Innsbruck

Innsbruck, , Austria

Medical University of Vienna

Vienna, , Austria

Antwerp University Hospital

Antwerp, , Belgium

UZ Leuven

Leuven, , Belgium

South Edmonton Gastroenterology

Edmonton, , Canada

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Nemocnice Slany

Slaný, , Czechia

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, , France

Centre Hospitalier Universitaire De Montpellier

Montpellier, , France

CHU Nantes - Hôtel Dieu

Nantes, , France

Institut des MICI

Neuilly-sur-Seine, , France

CHU Saint Etienne - Hôpital Nord

Saint-Etienne, , France

Goethe University Frankfurt

Frankfurt, , Germany

Studiengesellschaft BSF UG (haftungsbeschraenkt)

Halle, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

DRC Gyogyszervizsgalo Kozpont Kft.

Balatonfüred, , Hungary

Semmelweis University

Budapest, , Hungary

Vasutegeszseguegyi Nonprofit Koezhasznu Kft.

Debrecen, , Hungary

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

Győr, , Hungary

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Humanitas Mirasole S.p.A.

Rozzano, , Italy

IRCCS Ospedale Sacro Cuore Don Calabria

Verona, , Italy

Centrum Medyczne Plejady

Krakow, , Poland

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

Lublin, , Poland

Wojskowy Szpital Kliniczny w Lublinie

Lublin, , Poland

Medicome Sp. z o. o.

Oświęcim, , Poland

Trialmed CRS

Piotrkow Trybunalski, , Poland

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

Poznan, , Poland

Ośrodek Badań Klinicznych "METABOLICA"

Tarnów, , Poland

Medical Network Sp. z o.o.

Warsaw, , Poland

Santa Sp. z o.o.

Warsaw, , Poland

Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

Wroclaw, , Poland

Centrum Medyczne Oporow

Wroclaw, , Poland

LexMedica

Wroclaw, , Poland

Samodzielny PZOZ w Lecznej

Łęczna, , Poland

Kliničko bolnički centar Zvezdara

Belgrade, , Serbia

Opšta bolnica "Đorđe Joanović" Zrenjanin Odsek za gastroenterologiju

Zrenjanin, , Serbia

Cliniq s.r.o.

Bratislava, , Slovakia

GASTRO I, s.r.o.

Prešov, , Slovakia

Endomed s.r.o

Vranov nad Topľou, , Slovakia

Splošna bolnišnica Celje

Celje, , Slovenia

Univerzitetni klinični center Maribor

Maribor, , Slovenia

Splosna Bolnisnica Murska Sobota

Murska Sobota, , Slovenia

Centro Medico Teknon

Barcelona, , Spain

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

Countries

Austria; Belgium; Canada; Czechia; France; Germany; Hungary; Italy; Poland; Serbia; Slovakia; Slovenia; Spain; Ukraine

Other Identifiers

ABX464-108

Identifier Type: -

Identifier Source: org_study_id