Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis

NCT03760003 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ABX464-103
• Study Type: interventional
• Target: 355
• Locations: 15 countries
• Sites: 119

Brief Summary

Phase 2b study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.

Conditions

Ulcerative Colitis

Keywords

ABX464; Refractory patients; Phase 2b; Dose Ranging

Outcome Measures

Primary Outcomes (1)

• Reduction From Baseline in Modified Mayo Score (MMS) at Week 8

  Reduction from baseline in Modified Mayo Score (MMS) MMS is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall MMS ranges from 0 to 9 where higher scores represent more severe disease.

  Week 8

Secondary Outcomes (27)

• Reduction From Baseline in MMS at Week 16

  Week 16

• Number of Participants in Clinical Remission Per MMS at Week 8

  Week 8

• Number of Participants in Clinical Remission Per MMS at Week 16

  Week 16

• Number of Participants With Clinical Response at Week 8

  Week 8

• Number of Participants With Clinical Response at Week 16

  Week 16

Study Arms (4)

ABX464 100 mg

EXPERIMENTAL

ABX464 100 mg was administered orally (capsules) once daily for 16 weeks

Drug: ABX464 100 mg

ABX464 50 mg

EXPERIMENTAL

ABX464 50 mg was administered orally (capsules) once daily for 16 weeks

Drug: ABX464 50 mg

ABX464 25 mg

EXPERIMENTAL

ABX464 25 mg was administered orally (capsules) once daily for 16 weeks

Drug: ABX464 25 mg

Matching Placebo

PLACEBO COMPARATOR

Matching placebo was administered orally (capsules) once daily for 16 weeks

Drug: Placebo

Interventions

ABX464 100 mg DRUG

ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks

Also known as: Obefazimod 100 mg

ABX464 100 mg

ABX464 50 mg DRUG

ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks

Also known as: Obefazimod 50 mg

ABX464 50 mg

ABX464 25 mg DRUG

ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks

Also known as: Obefazimod 25 mg

ABX464 25 mg

Placebo DRUG

Two capsules of placebo once daily for 16 weeks

Also known as: Obefazimod placebo control

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women age 18 - 75 years;
• Diagnosis of moderate to severe active UC (including ulcerative proctitis if proximal extension of disease occurs beyond 10 cm) confirmed by endoscopy and histology at least 12 Weeks prior to screening visit. Moderate to severe active UC defined by Modified Mayo Score (MMS) of 5 to 9 inclusive (on a scale of 0-9). Moderate to severe active UC should be confirmed at screening visit with a centrally read endoscopy sub-score of at least 2 (on a scale of 0-3);
• Patients having either a documented inadequate response, no response, a loss of response, or an intolerance (defined as the occurrence of at least one Adverse Reaction leading to treatment discontinuation) to either immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor \[TNF\] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Inadequate response, no response, loss of response is defined as:
• i. Active disease or relapse in spite of thiopurines or methotrexate given at an appropriate dose for at least 3 months (i.e. azathioprine 2-2.5 mg/kg/day or mercaptopurine 1-1.5 mg/kg/day in the absence of leukopenia), and/or ii. Active disease despite corticosteroids treatment (prednisolone up to 0.75 mg/kg/day) over a period of 4 Weeks, and/or iii. Active disease or relapse in spite of adequate treatment (as defined in the SmPC) with tumor necrosis factor \[TNF\] inhibitors or vedolizumab, and/or iv. Active disease or relapse in spite of adequate treatment with JAK inhibitors over a period of at least 6 Weeks.
• Patients receiving oral corticosteroids must have been on a stable dose of prednisone or prednisone equivalent (≤20 mg/day) or on beclomethasone diproprionate (≤5mg/day) or on budesonide MMX (≤9 mg/day) for at least 2 Weeks prior to the screening visit;
• Topical corticosteroids and topical 5-aminosalicylic acid preparations must have been withdrawn at least 2 Weeks prior to the screening visit;
• Patients who are on oral 5-aminosalicylic acid must have been on a stable dose for at least 4 Weeks prior to the screening visit;
• Patients who are receiving immunosuppressants in the form of azathioprine, 6-mercaptopurine, or methotrexate needed to be on a stable dose for at least 4 Weeks prior to screening visit. Patients taking methotrexate also are advised to take folic acid 1 mg/day (or equivalent) supplementation if there is no contraindication;
• Patients on probiotics (e.g., Culturelle® \[Lactobacillus GG, i-Health, Inc.\], Saccharomyces boulardii) must be on stable doses for at least 2 Weeks prior to the screening visit;
• Patients on antidiarrheals (e.g., loperamide, diphenoxylate with atropine) must be on stable doses for at least 2 Weeks prior to the screening visit;
• Patients who have received tumor necrosis factor \[TNF\] inhibitors, vedolizumab or other biologics must have discontinued therapy at least 8 Weeks prior to the screening visit due to lack or insufficient efficacy or intolerance;
• Patients previously treated with cyclosporine, tacrolimus or JAK inhibitors must have discontinued therapy at least 4 Weeks prior to the screening visit due to lack or insufficient efficacy or intolerance;
• Patients previously treated with tube feeding, defined formula diets, or parenteral alimentation/nutrition must have discontinued treatment 3 Weeks before the screening visit and must be able to take, orally, appropriate amount of food (calories) and liquids to maintain body weight;
• Patients with surveillance colonoscopy defined as per ECCO guidelines;
• Patients with the following hematological and biochemical laboratory parameters obtained at screening:

You may not qualify if:

• Patients with Crohn's Disease (CD) or presence or history of fistula, indeterminate colitis (IC), infectious/ischemic colitis or microscopic colitis (lymphocytic and collagenous colitis);
• History of toxic megacolon, abdominal abscess, symptomatic colonic stricture or stoma; history or imminent colectomy, colonic malignancy;
• History or current evidence of colonic dysplasia or adenomatous colonic polyps. Patient with severe gastrointestinal complications; e.g., short bowel syndromes, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation;
• History of more than one episode of herpes zoster or a history (single episode) of disseminated zoster;
• Patients with active infections at screening such as infected abdominal abscess, Clostridium difficile (stool antigen and toxin required), CMV (positive IgM), TB and recent infectious hospitalization;
• Patients previously treated with ABX464;
• Acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable CNS pathology such as seizure disorder, angina or cardiac arrhythmias, active malignancy or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history;
• Acute, chronic or history of immunodeficiency or autoimmune disease;
• History of malignancy excluding patients considered cured (5 years disease free survivors);
• Serious illness requiring systemic treatment and/or hospitalization within 3 Weeks prior to baseline;
• Pregnant or breast-feeding women;
• Illicit drug or alcohol abuse or dependence;
• Patients who received live vaccine 30 days or fewer before first dose of study treatment and/or who's planning to receive such a vaccine during the study duration;
• Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer and during the study;
• Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.

Sponsors & Collaborators

• Abivax S.A.: lead

Study Sites (130)

UCSD Health System

San Diego, California, 92103, United States

Location

Atlanta Center for Gastroenterology, P.C

Decatur, Georgia, 30033, United States

Location

Central Texas Clinical Research, LLC

Austin, Texas, 78705, United States

Location

Southern Star Research Institute, LLC

San Antonio, Texas, 78212, United States

Location

Medizinische Universität Innsbruck

Innsbruck, Austria

Location

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Austria

Location

Ordensklinikum Linz GmbH - Barmherzige Schwestern

Linz, Austria

Location

AKH - Medizinische Universität Wien

Vienna, Austria

Location

Gomel Regional Clinical Hospital

Homyel, Belarus

Location

Minsk city diagnostic center

Minsk, Belarus

Location

Regional Clinical Hospital

Minsk, Belarus

Location

Vitebsk Regional Clinical Hospital

Vitebsk, Belarus

Location

Vitebsk regoinal clinical specialized center

Vitebsk, Belarus

Location

AZ Sint-Lucas

Bruges, Belgium

Location

C. H. U. St-Pierre

Brussels, Belgium

Location

UZA

Edegem, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

Brandon Medical Arts Clinic

Brandon, Canada

Location

South Edmonton Gastroenterology

Edmonton, Canada

Location

LHSC - Victoria Hospital

London, Canada

Location

The Ottawa Hospital - General Campus

Ottawa, Canada

Location

Allen Whey Khye Lim Professional Corporation

Saskatoon, Canada

Location

Mount Sinai Hospital

Toronto, Canada

Location

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

Location

Hepato-Gastroenterologie HK s.r.o.

Hradec Králové, Czechia

Location

MUDr. GREGAR s.r.o.

Olomouc, Czechia

Location

Fakultni nemocnice Ostrava

Ostrava-Kunčice, Czechia

Location

Nemocnice Na Bulovce

Prague, Czechia

Location

Thomayerova nemocnice

Prague, Czechia

Location

Nemocnice Slany

Slaný, Czechia

Location

CHU Amiens - Hopital Sud

Amiens, France

Location

CHU Besançon - Hôpital Jean Minjoz

Besançon, France

Location

CHU Clermont Ferrand - Hôpital d'Estaing

Clermont-Ferrand, France

Location

Hôpital Beaujon

Clichy, France

Location

CHU de Grenoble - Hôpital Nord

Grenoble, France

Location

Centre Hospitalier Départemental Les Oudairies

La Roche-sur-Yon, France

Location

CHU Lille - Hôpital Claude Huriez

Lille, France

Location

Hôpital Nord - CHU Marseille

Marseille, France

Location

Hopital Saint Eloi

Montpellier, France

Location

CHU Nantes - Hôtel Dieu

Nantes, France

Location

CHU Nice - Hôpital de l'Archet 2

Nice, France

Location

CHU Reims - Hôpital Robert Debré

Reims, France

Location

CHU Rennes - Hôpital Pontchaillou

Rennes, France

Location

CHU de Rouen - Hôpital Charles Nicolle

Rouen, France

Location

CHU Saint Etienne - Hôpital Nord

Saint-Etienne, France

Location

CHU Strasbourg - Hôpital Hautepierre

Strasbourg, France

Location

Hopital Rangueil

Toulouse, France

Location

Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, France

Location

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, Germany

Location

Florence-Nightingale-Krankenhaus-Diakonie Kaiserswerth

Düsseldorf, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt, Germany

Location

Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt

Halle, Germany

Location

Universitaetsklinikum Halle (Saale)

Halle, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Johanna-Etienne-Krankenhaus

Neuss, Germany

Location

Tumorzentrum Nordthueringen MVZ GmbH

Nordhausen, Germany

Location

Dr. Tasso Bieler

Riesa, Germany

Location

Universitaetsklinikum Ulm

Ulm, Germany

Location

DRC Gyogyszervizsgalo Kozpont Kft.

Balatonfüred, Hungary

Location

Obudai Egeszsegugyi Centrum Kft.

Budapest, Hungary

Location

Pannonia Maganorvosi Centrum

Budapest, Hungary

Location

Semmelweis Egyetem

Budapest, Hungary

Location

Debreceni Egyetem

Debrecen, Hungary

Location

Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

Debrecen, Hungary

Location

Petz Aladar Megyei Oktato Korhaz

Győr, Hungary

Location

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Bologna, Italy

Location

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Italy

Location

Azienda Ospedaliero Universitaria Mater Domini

Catanzaro, Italy

Location

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

Milan, Italy

Location

Ospedale Sacro Cuore Don Calabria

Negrar, Italy

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, Italy

Location

Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

Pisa, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Location

Istituto Clinico Humanitas

Rozzano, Italy

Location

Szpital Uniwersytecki nr 2 im.dr J. Biziela

Bydgoszcz, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Location

Centrum Medyczne Plejady

Krakow, Poland

Location

Santa Familia Centrum Badan, Profilaktyki i Leczenia

Lodz, Poland

Location

Wojskowy Szpital Kliniczny w Lublinie

Lublin, Poland

Location

Trialmed CRS

Piotrkow Trybunalski, Poland

Location

Centrum Medyczne Grunwald

Poznan, Poland

Location

KO-MED Centra Kliniczne Pulawy

Puławy, Poland

Location

Gabinet Lekarski Bartosz Korczowski

Rzeszów, Poland

Location

Centrum Zdrowia MDM

Warsaw, Poland

Location

Nzoz Vivamed

Warsaw, Poland

Location

Centrum Zdrowia Tuchow Sp. z o.o.

Wierzchosławice, Poland

Location

Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

Wroclaw, Poland

Location

Centrum Medyczne Oporow

Wroclaw, Poland

Location

LexMedica

Wroclaw, Poland

Location

Clinical Center " Dr Dragisa Misovic Dedinje"

Belgrade, Serbia

Location

Clinical Center Bezanijska Kosa

Belgrade, Serbia

Location

Clinical Center Zvezdara

Belgrade, Serbia

Location

General Hospital Uzice

Užice, Serbia

Location

General Hospital "Djordje Joanovic"

Zrenjanin, Serbia

Location

Alian s.r.o.

Bardejov, Slovakia

Location

Cliniq s.r.o.

Bratislava, Slovakia

Location

Gastromedic, s.r.o.

Nové Zámky, Slovakia

Location

Gastro I, s.r.o.

Prešov, Slovakia

Location

Accout Center s.r.o.

Šahy, Slovakia

Location

Endomed, s.r.o.

Vranov nad Topľou, Slovakia

Location

General Hospital Celje

Celje, Slovenia

Location

University Medical Centre Maribor

Maribor, Slovenia

Location

General Hospital Murska Sobota

Murska Sobota, Slovenia

Location

Centro Médico Teknon

Barcelona, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, Spain

Location

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, Spain

Location

Hospital Quironsalud Malaga

Málaga, Spain

Location

CNE Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, Ukraine

Location

I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

Dnipro, Ukraine

Location

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

Ivano-Frankivsk, Ukraine

Location

CHI Kharkiv City Clinical Hospital #13

Kharkiv, Ukraine

Location

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

Kharkiv, Ukraine

Location

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

Kharkiv, Ukraine

Location

CI Kherson CCH

Kherson, Ukraine

Location

Khmelnytska Regional Hospital

Khmelnytskyi, Ukraine

Location

Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

Kyiv, Ukraine

Location

Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU

Lviv, Ukraine

Location

Ternopil University Hospital

Ternopil, Ukraine

Location

A. Novak Transcarpathian Regional Clinical Hospital

Uzhhorod, Ukraine

Location

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

Vinnytsia, Ukraine

Location

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

Vinnytsia, Ukraine

Location

MCIC MC LLC Health Clinic

Vinnytsia, Ukraine

Location

CI City Clinical Hospital #6 Dept of Gastroenterology

Zaporizhzhia, Ukraine

Location

CNCE "City Hospital 9" Zaporizhzhia CC

Zaporizhzhia, Ukraine

Location

Fairfield General Hospital

Bury, United Kingdom

Location

Guy's Hospital

London, United Kingdom

Location

University College London Hospitals

London, United Kingdom

Location

Nottingham University Hospitals Queen's Medical Centre

Nottingham, United Kingdom

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

Results Point of Contact

• Title: Fabio Cataldi
• Organization: ABIVAX

clinicaltrials@abivax.com

+33 (0) 1 53 83 08 41

Study Officials

• Séverine VERMEIRE, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double blind, placebo controlled, parallel groups

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: November 30, 2018
• Study Start: August 13, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 16, 2021
• Last Updated: November 28, 2025
• Results First Posted: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (7); UA (17); BE (5); US (4); CA (6); HU (7); SL (3); FR (18); SE (5); GB (4); PL (15); IT (10); DE (10); ES (4); AU (4)