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New hope for ulcerative colitis sufferers: experimental drug shows promise

NCT ID NCT03760003

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested an experimental drug called ABX464 in 355 adults with moderate to severe ulcerative colitis who had not responded well to other treatments. The goal was to see if the drug could reduce symptoms like diarrhea, bleeding, and colon inflammation. Participants received different doses of ABX464 or a placebo daily, and their disease activity was measured using a standard scoring system.

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

355 people

The number who actually took part.

Started

Aug 2019

Finished

Apr 2021

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 to 75 years

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: * 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: i. Hemoglobin \> 9.0 g dL-1; ii. Absolute neutrophil count ≥ 750 mm-3; iii. Platelets ≥ 100,000 mm-3; iv. Total serum creatinine ≤ 1.3 x ULN (upper limit of normal); v. Creatinine clearance \> 90 mL min-1 by the Cockcroft-Gault equation within 60 days prior to baseline; vi. Total serum bilirubin \< 1.5 x ULN; vii. Alkaline phosphatase, AST (SGOT) and ALT (SGPT) \< 2 x ULN; * 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 at the screening visit 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 after end of study or early termination. Contraception should be in place at least 2 Weeks prior to study participation. 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 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 an 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 participants should use condoms and not donate sperm as long as contraception is required. Exclusion Criteria: * 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.

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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

  • A. Novak Transcarpathian Regional Clinical Hospital

    Uzhhorod, Ukraine

  • AKH - Medizinische Universität Wien

    Vienna, Austria

  • AZ Sint-Lucas

    Bruges, Belgium

  • Accout Center s.r.o.

    Šahy, Slovakia

  • Alian s.r.o.

    Bardejov, Slovakia

  • Allen Whey Khye Lim Professional Corporation

    Saskatoon, Canada

  • Atlanta Center for Gastroenterology, P.C

    Decatur, Georgia, 30033, United States

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, Italy

  • Azienda Ospedaliera di Padova

    Padova, Italy

  • Azienda Ospedaliero Universitaria Mater Domini

    Catanzaro, Italy

  • Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

    Pisa, Italy

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, Italy

  • Brandon Medical Arts Clinic

    Brandon, Canada

  • C. H. U. St-Pierre

    Brussels, Belgium

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

    Vinnytsia, Ukraine

  • CHI Kharkiv City Clinical Hospital #13

    Kharkiv, Ukraine

  • CHU Amiens - Hopital Sud

    Amiens, France

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, France

  • CHU Clermont Ferrand - Hôpital d'Estaing

    Clermont-Ferrand, France

  • CHU Lille - Hôpital Claude Huriez

    Lille, 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 Saint Etienne - Hôpital Nord

    Saint-Etienne, France

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg, France

  • CHU de Grenoble - Hôpital Nord

    Grenoble, France

  • CHU de Rouen - Hôpital Charles Nicolle

    Rouen, France

  • CI City Clinical Hospital #6 Dept of Gastroenterology

    Zaporizhzhia, Ukraine

  • CI Kherson CCH

    Kherson, Ukraine

  • CNCE "City Hospital 9" Zaporizhzhia CC

    Zaporizhzhia, Ukraine

  • CNE Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, Ukraine

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

    Kharkiv, Ukraine

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

    Ivano-Frankivsk, Ukraine

  • Central Texas Clinical Research, LLC

    Austin, Texas, 78705, United States

  • Centre Hospitalier Départemental Les Oudairies

    La Roche-sur-Yon, France

  • Centro Médico Teknon

    Barcelona, Spain

  • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

    Wroclaw, Poland

  • Centrum Medyczne Grunwald

    Poznan, Poland

  • Centrum Medyczne Oporow

    Wroclaw, Poland

  • Centrum Medyczne Plejady

    Krakow, Poland

  • Centrum Zdrowia MDM

    Warsaw, Poland

  • Centrum Zdrowia Tuchow Sp. z o.o.

    Wierzchosławice, Poland

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, Germany

  • Clinical Center " Dr Dragisa Misovic Dedinje"

    Belgrade, Serbia

  • Clinical Center Bezanijska Kosa

    Belgrade, Serbia

  • Clinical Center Zvezdara

    Belgrade, Serbia

  • Cliniq s.r.o.

    Bratislava, Slovakia

  • Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

    Kyiv, Ukraine

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

    Kharkiv, Ukraine

  • DRC Gyogyszervizsgalo Kozpont Kft.

    Balatonfüred, Hungary

  • Debreceni Egyetem

    Debrecen, Hungary

  • Dr. Tasso Bieler

    Riesa, Germany

  • Endomed, s.r.o.

    Vranov nad Topľou, Slovakia

  • Fairfield General Hospital

    Bury, United Kingdom

  • Fakultni nemocnice Ostrava

    Ostrava-Kunčice, Czechia

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, Czechia

  • Florence-Nightingale-Krankenhaus-Diakonie Kaiserswerth

    Düsseldorf, Germany

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Italy

  • Gabinet Lekarski Bartosz Korczowski

    Rzeszów, Poland

  • Gastro I, s.r.o.

    Prešov, Slovakia

  • Gastromedic, s.r.o.

    Nové Zámky, Slovakia

  • General Hospital "Djordje Joanovic"

    Zrenjanin, Serbia

  • General Hospital Celje

    Celje, Slovenia

  • General Hospital Murska Sobota

    Murska Sobota, Slovenia

  • General Hospital Uzice

    Užice, Serbia

  • Gomel Regional Clinical Hospital

    Homyel, Belarus

  • Guy's Hospital

    London, United Kingdom

  • Hepato-Gastroenterologie HK s.r.o.

    Hradec Králové, Czechia

  • Hopital Rangueil

    Toulouse, France

  • Hopital Saint Eloi

    Montpellier, France

  • Hospital Quironsalud Malaga

    Málaga, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, Spain

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, Spain

  • Hôpital Beaujon

    Clichy, France

  • Hôpital Nord - CHU Marseille

    Marseille, France

  • Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, France

  • I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

    Dnipro, Ukraine

  • I.R.C.C.S Policlinico San Donato

    Milan, Italy

  • Istituto Clinico Humanitas

    Rozzano, Italy

  • Johanna-Etienne-Krankenhaus

    Neuss, Germany

  • KO-MED Centra Kliniczne Pulawy

    Puławy, Poland

  • Khmelnytska Regional Hospital

    Khmelnytskyi, Ukraine

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, Austria

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt, Germany

  • LHSC - Victoria Hospital

    London, Canada

  • LexMedica

    Wroclaw, Poland

  • Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU

    Lviv, Ukraine

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

    Vinnytsia, Ukraine

  • MCIC MC LLC Health Clinic

    Vinnytsia, Ukraine

  • MUDr. GREGAR s.r.o.

    Olomouc, Czechia

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Medizinische Universität Innsbruck

    Innsbruck, Austria

  • Minsk city diagnostic center

    Minsk, Belarus

  • Mount Sinai Hospital

    Toronto, Canada

  • Nemocnice Na Bulovce

    Prague, Czechia

  • Nemocnice Slany

    Slaný, Czechia

  • Nottingham University Hospitals Queen's Medical Centre

    Nottingham, United Kingdom

  • Nzoz Vivamed

    Warsaw, Poland

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, Hungary

  • Ordensklinikum Linz GmbH - Barmherzige Schwestern

    Linz, Austria

  • Ospedale Sacro Cuore Don Calabria

    Negrar, Italy

  • Pannonia Maganorvosi Centrum

    Budapest, Hungary

  • Petz Aladar Megyei Oktato Korhaz

    Győr, Hungary

  • Regional Clinical Hospital

    Minsk, Belarus

  • Santa Familia Centrum Badan, Profilaktyki i Leczenia

    Lodz, Poland

  • Semmelweis Egyetem

    Budapest, Hungary

  • South Edmonton Gastroenterology

    Edmonton, Canada

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78212, United States

  • Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt

    Halle, Germany

  • Szpital Uniwersytecki nr 2 im.dr J. Biziela

    Bydgoszcz, Poland

  • Ternopil University Hospital

    Ternopil, Ukraine

  • The Ottawa Hospital - General Campus

    Ottawa, Canada

  • Thomayerova nemocnice

    Prague, Czechia

  • Trialmed CRS

    Piotrkow Trybunalski, Poland

  • Tumorzentrum Nordthueringen MVZ GmbH

    Nordhausen, Germany

  • UCSD Health System

    San Diego, California, 92103, United States

  • UZ Leuven

    Leuven, Belgium

  • UZA

    Edegem, Belgium

  • Universitaetsklinikum Halle (Saale)

    Halle, Germany

  • Universitaetsklinikum Ulm

    Ulm, Germany

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

  • University College London Hospitals

    London, United Kingdom

  • University Medical Centre Maribor

    Maribor, Slovenia

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Poland

  • Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

    Debrecen, Hungary

  • Vitebsk Regional Clinical Hospital

    Vitebsk, Belarus

  • Vitebsk regoinal clinical specialized center

    Vitebsk, Belarus

  • Wojskowy Szpital Kliniczny w Lublinie

    Lublin, Poland

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