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

NCT05177835 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: ABX464-108
• Study Type: interventional
• Target: 203
• Locations: 13 countries
• Sites: 43

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

Keywords

Moderate to severe ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Number of adverse events in ABX464 treated subjects

  To evaluate the long-term safety of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.

  From Baseline to a maximum period of 78 months

Secondary Outcomes (4)

• Percentage of subjects reaching clinical remission at yearly visits.

  From Baseline to a maximum period of 78 months

• Percentage of subjects reaching endoscopic remission at yearly visits

  From Baseline to a maximum period of 78 months

• Percentage of subjects reaching clinical response at yearly visits

  From Baseline to a maximum period of 78 months

• Percentage of subjects reaching endoscopic improvement at yearly visits

  From Baseline to a maximum period of 78 months

Study Arms (1)

ABX464 -25mg

EXPERIMENTAL

All subjects will receive ABX464 given at 25 mg QD.

Drug: ABX464

Interventions

ABX464 DRUG

All subjects will receive ABX464 given at 25 mg QD.

ABX464 -25mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• \. 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abivax S.A.: lead

Study Sites (46)

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Location

Medical University of Vienna

Vienna, Austria

Location

Antwerp University Hospital

Antwerp, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

South Edmonton Gastroenterology

Edmonton, Canada

Location

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

Location

Nemocnice Slany

Slaný, Czechia

Location

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, France

Location

Centre Hospitalier Universitaire De Montpellier

Montpellier, France

Location

CHU Nantes - Hôtel Dieu

Nantes, France

Location

Institut des MICI

Neuilly-sur-Seine, France

Location

CHU Saint Etienne - Hôpital Nord

Saint-Etienne, France

Location

Goethe University Frankfurt

Frankfurt, Germany

Location

Studiengesellschaft BSF UG (haftungsbeschraenkt)

Halle, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

DRC Gyogyszervizsgalo Kozpont Kft.

Balatonfüred, Hungary

Location

Semmelweis University

Budapest, Hungary

Location

Vasutegeszseguegyi Nonprofit Koezhasznu Kft.

Debrecen, Hungary

Location

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

Győr, Hungary

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Location

Humanitas Mirasole S.p.A.

Rozzano, Italy

Location

IRCCS Ospedale Sacro Cuore Don Calabria

Verona, Italy

Location

Centrum Medyczne Plejady

Krakow, Poland

Location

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

Lublin, Poland

Location

Wojskowy Szpital Kliniczny w Lublinie

Lublin, Poland

Location

Medicome Sp. z o. o.

Oświęcim, Poland

Location

Trialmed CRS

Piotrkow Trybunalski, Poland

Location

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

Poznan, Poland

Location

Ośrodek Badań Klinicznych "METABOLICA"

Tarnów, Poland

Location

Medical Network Sp. z o.o.

Warsaw, Poland

Location

Santa Sp. z o.o.

Warsaw, Poland

Location

Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

Wroclaw, Poland

Location

Centrum Medyczne Oporow

Wroclaw, Poland

Location

LexMedica

Wroclaw, Poland

Location

Samodzielny PZOZ w Lecznej

Łęczna, 21-010, Poland

Location

Kliničko bolnički centar Zvezdara

Belgrade, Serbia

Location

Opšta bolnica "Đorđe Joanović" Zrenjanin Odsek za gastroenterologiju

Zrenjanin, Serbia

Location

Cliniq s.r.o.

Bratislava, Slovakia

Location

GASTRO I, s.r.o.

Prešov, Slovakia

Location

Endomed s.r.o

Vranov nad Topľou, Slovakia

Location

Splošna bolnišnica Celje

Celje, Slovenia

Location

Univerzitetni klinični center Maribor

Maribor, Slovenia

Location

Splosna Bolnisnica Murska Sobota

Murska Sobota, Slovenia

Location

Centro Medico Teknon

Barcelona, Spain

Location

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

Cherkasy, Ukraine

Location

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

Khmelnytskyi, Ukraine

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

ABX464

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Bram Verstockt, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label Follow-up Study

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 5, 2022
• Study Start: December 3, 2021
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); UA (2); BE (2); CZ (2); HU (4); FR (5); ES (1); PL (13); SL (3); IT (3); DE (3); SE (2); AU (2)