Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

NCT ID: NCT04023396

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2024-03-15

Brief 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.

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

Study Design

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

Study Groups

ABX464 50mg

All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.

Group Type: EXPERIMENTAL

ABX464

Intervention Type: DRUG

ABX464

All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.

Interventions

ABX464

ABX464

All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.

Intervention Type: DRUG

Other Intervention Names

Obefazimod

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abivax S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Severine VERMEIRE, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

Medizinische Universität Innsbruck

Innsbruck, , Austria

Klinikum Klagenfurt am Wörthersee

Klagenfurt, , Austria

Ordensklinikum Linz GmbH - Barmherzige Schwestern

Linz, , Austria

AKH - Medizinische Universität Wien

Vienna, , Austria

Gomel Regional Clinical Hospital

Homyel, , Belarus

Minsk city diagnostic center

Minsk, , Belarus

Regional Clinical Hospital

Minsk, , Belarus

Vitebsk Regional Clinical Hospital

Vitebsk, , Belarus

Vitebsk regoinal clinical specialized center

Vitebsk, , Belarus

AZ Sint-Lucas

Bruges, , Belgium

C. H. U. St-Pierre

Brussels, , Belgium

University Hospitals Leuven - campus Gasthuisberg

Leuven, , Belgium

Brandon Medical Arts Clinic

Brandon, , Canada

South Edmonton Gastroenterology

Edmonton, , Canada

LHSC - Victoria Hospital

London, , Canada

The Ottawa Hospital - General Campus

Ottawa, , Canada

Mount Sinai Hospital

Toronto, , Canada

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Hepato-Gastroenterologie HK s.r.o.

Hradec Králové, , Czechia

MUDr. GREGAR s.r.o.

Olomouc, , Czechia

Fakultni nemocnice Ostrava

Ostrava-Kunčice, , Czechia

Nemocnice Na Bulovce

Prague, , Czechia

Thomayerova nemocnice

Prague, , Czechia

Nemocnice Slany

Slaný, , Czechia

CHU Amiens - Hopital Sud

Amiens, , France

CHU Besançon - Hôpital Jean Minjoz

Besançon, , France

CHU Clermont Ferrand - Hôpital d'Estaing

Clermont-Ferrand, , France

Hôpital Beaujon

Clichy, , France

CHU de Grenoble - Hôpital Nord

Grenoble, , France

Centre Hospitalier Départemental Les Oudairies

La Roche-sur-Yon, , France

CHU Lille - Hôpital Claude Huriez

Lille, , France

Hôpital Nord - CHU Marseille

Marseille, , France

Hopital Saint Eloi

Montpellier, , 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 de Rouen - Hôpital Charles Nicolle

Rouen, , France

CHU Saint Etienne - Hôpital Nord

Saint-Etienne, , France

CHU Strasbourg - Hôpital Hautepierre

Strasbourg, , France

Hopital Rangueil

Toulouse, , France

Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, , France

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, , Germany

Florence-Nightingale-Krankenhaus-Diakonie Kaiserswerth

Düsseldorf, , Germany

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt, , Germany

Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt

Halle, , Germany

Universitaetsklinikum Halle (Saale)

Halle, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Johanna-Etienne-Krankenhaus

Neuss, , Germany

Tumorzentrum Nordthueringen MVZ GmbH

Nordhausen, , Germany

Dr. Tasso Bieler

Riesa, , Germany

Universitaetsklinikum Ulm

Ulm, , Germany

DRC Gyogyszervizsgalo Kozpont Kft.

Balatonfüred, , Hungary

Obudai Egeszsegugyi Centrum Kft.

Budapest, , Hungary

Pannonia Maganorvosi Centrum

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Debreceni Egyetem

Debrecen, , Hungary

Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

Debrecen, , Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Bologna, , Italy

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, , Italy

Azienda Ospedaliero Universitaria Mater Domini

Catanzaro, , Italy

I.R.C.C.S Policlinico San Donato

Milan, , Italy

Ospedale Sacro Cuore Don Calabria

Negrar, , Italy

Azienda Ospedaliera di Padova

Padua, , Italy

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, , Italy

Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

Pisa, , Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Istituto Clinico Humanitas

Rozzano, , Italy

Szpital Uniwersytecki nr 2 im.dr J. Biziela

Bydgoszcz, , Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Centrum Medyczne Plejady

Krakow, , Poland

Santa Familia Centrum Badan, Profilaktyki i Leczenia

Lodz, , Poland

Wojskowy Szpital Kliniczny w Lublinie

Lublin, , Poland

Trialmed CRS

Piotrkow Trybunalski, , Poland

Centrum Medyczne Grunwald

Poznan, , Poland

KO-MED Centra Kliniczne Pulawy

Puławy, , Poland

Gabinet Lekarski Bartosz Korczowski

Rzeszów, , Poland

Centrum Zdrowia MDM

Warsaw, , Poland

Nzoz Vivamed

Warsaw, , Poland

Centrum Zdrowia Tuchow Sp. z o.o.

Wierzchosławice, , Poland

Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

Wroclaw, , Poland

Centrum Medyczne Oporow

Wroclaw, , Poland

LexMedica

Wroclaw, , Poland

Clinical Center " Dr Dragisa Misovic Dedinje"

Belgrade, , Serbia

Clinical Center Bezanijska Kosa

Belgrade, , Serbia

General Hospital Uzice

Užice, , Serbia

Alian s.r.o.

Bardejov, , Slovakia

Gastromedic, s.r.o.

Nové Zámky, , Slovakia

Gastro I, s.r.o.

Prešov, , Slovakia

Accout Center s.r.o.

Šahy, , Slovakia

Endomed, s.r.o.

Vranov nad Topľou, , Slovakia

General Hospital Celje

Celje, , Slovenia

University Medical Centre Maribor

Maribor, , Slovenia

General Hospital Murska Sobota

Murska Sobota, , Slovenia

Centro Médico Teknon

Barcelona, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, , Spain

Hospital Quironsalud Malaga

Málaga, , Spain

CNE Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, , Ukraine

I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

Dnipro, , Ukraine

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

Ivano-Frankivsk, , Ukraine

CHI Kharkiv City Clinical Hospital #13

Kharkiv, , Ukraine

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

Kharkiv, , Ukraine

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

Kharkiv, , Ukraine

CI Kherson CCH

Kherson, , Ukraine

Khmelnytska Regional Hospital

Khmelnytskyi, , Ukraine

Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

Kyiv, , Ukraine

Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU

Lviv, , Ukraine

Ternopil University Hospital

Ternopil, , Ukraine

A. Novak Transcarpathian Regional Clinical Hospital

Uzhhorod, , Ukraine

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

Vinnytsia, , Ukraine

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

Vinnytsia, , Ukraine

MCIC MC LLC Health Clinic

Vinnytsia, , Ukraine

CI City Clinical Hospital #6 Dept of Gastroenterology

Zaporizhzhia, , Ukraine

CNCE "City Hospital 9" Zaporizhzhia CC

Zaporizhzhia, , Ukraine

Fairfield General Hospital

Bury, , United Kingdom

Guy's Hospital

London, , United Kingdom

University College London Hospitals

London, , United Kingdom

Nottingham University Hospitals Queen's Medical Centre

Nottingham, , United Kingdom

Countries

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

References

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.

Reference Type: DERIVED

PMID: 40417999 (View on PubMed)

Vermeire 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.

Reference Type: DERIVED

PMID: 36075249 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABX464-104

Identifier Type: -

Identifier Source: org_study_id