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

April 22, 2026 updated by: Abivax S.A.

A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
217

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Medizinische Universitat Innsbruck
      • Klagenfurt, Austria
        • Klinikum Klagenfurt am Worthersee
      • Linz, Austria
        • Ordensklinikum Linz GmbH - Barmherzige Schwestern
      • Vienna, Austria
        • AKH - Medizinische Universitat Wien
  • Belarus
      • Homyel, Belarus
        • Gomel Regional Clinical Hospital
      • Minsk, Belarus
        • Minsk city diagnostic center
      • Minsk, Belarus
        • Regional Clinical Hospital
      • Vitebsk, Belarus
        • Vitebsk Regional Clinical Hospital
      • Vitebsk, Belarus
        • Vitebsk regoinal clinical specialized center
  • Belgium
      • Bruges, Belgium
        • AZ Sint-Lucas
      • Brussels, Belgium
        • C. H. U. St-Pierre
      • Leuven, Belgium, 3000
        • University Hospitals Leuven - campus Gasthuisberg
  • Canada
      • Brandon, Canada
        • Brandon Medical Arts Clinic
      • Edmonton, Canada
        • South Edmonton Gastroenterology
      • London, Canada
        • LHSC - Victoria Hospital
      • Ottawa, Canada
        • The Ottawa Hospital - General Campus
      • Toronto, Canada
        • Mount Sinai Hospital
  • Czechia
      • Brno, Czechia
        • Fakultni nemocnice u sv. Anny v Brne
      • Hradec Králové, Czechia
        • Hepato-Gastroenterologie HK s.r.o.
      • Olomouc, Czechia
        • MUDr. Gregar s.r.o.
      • Ostrava-Kunčice, Czechia
        • Fakultni Nemocnice Ostrava
      • Prague, Czechia
        • Nemocnice Na Bulovce
      • Prague, Czechia
        • Thomayerova nemocnice
      • Slaný, Czechia
        • Nemocnice Slany
  • France
      • Amiens, France
        • CHU Amiens - Hopital Sud
      • Besançon, France
        • CHU Besancon - Hôpital Jean Minjoz
      • Clermont-Ferrand, France
        • CHU Clermont Ferrand - Hôpital d'Estaing
      • Clichy, France
        • Hopital Beaujon
      • Grenoble, France
        • CHU de Grenoble - Hôpital Nord
      • La Roche-sur-Yon, France
        • Centre Hospitalier Departemental Les Oudairies
      • Lille, France
        • CHU Lille - Hôpital Claude Huriez
      • Marseille, France
        • Hopital Nord - CHU Marseille
      • Montpellier, France
        • Hopital Saint Eloi
      • Nantes, France
        • CHU Nantes - Hotel Dieu
      • Nice, France
        • CHU Nice - Hopital de l'Archet 2
      • Reims, France
        • CHU Reims - Hôpital Robert Debré
      • Rennes, France
        • CHU Rennes - Hôpital Pontchaillou
      • Rouen, France
        • CHU de Rouen - Hôpital Charles Nicolle
      • Saint-Etienne, France
        • CHU Saint Etienne - Hopital Nord
      • Strasbourg, France
        • CHU Strasbourg - Hôpital Hautepierre
      • Toulouse, France
        • Hopital Rangueil
      • Vandœuvre-lès-Nancy, France
        • Hôpital de Brabois Adultes
  • Germany
      • Berlin, Germany
        • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
      • Düsseldorf, Germany
        • Florence-Nightingale-Krankenhaus-Diakonie Kaiserswerth
      • Frankfurt, Germany
        • Klinikum Der Johann Wolfgang Goethe-Universitaet
      • Halle, Germany
        • Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt
      • Halle, Germany
        • Universitaetsklinikum Halle (Saale)
      • Hanover, Germany
        • Medizinische Hochschule Hannover
      • Neuss, Germany
        • Johanna-Etienne-Krankenhaus
      • Nordhausen, Germany
        • Tumorzentrum Nordthueringen MVZ GmbH
      • Riesa, Germany
        • Dr. Tasso Bieler
      • Ulm, Germany
        • Universitaetsklinikum Ulm
  • Hungary
      • Balatonfüred, Hungary
        • DRC Gyogyszervizsgalo Kozpont Kft.
      • Budapest, Hungary
        • Semmelweis Egyetem
      • Budapest, Hungary
        • Obudai Egeszsegugyi Centrum Kft.
      • Budapest, Hungary
        • Pannónia Magánorvosi Centrum
      • Debrecen, Hungary
        • Debreceni Egyetem
      • Debrecen, Hungary
        • Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
      • Győr, Hungary
        • Petz Aladar Megyei Oktato Korhaz
  • Italy
      • Bologna, Italy
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
      • Brescia, Italy
        • Fondazione Poliambulanza Istituto Ospedaliero
      • Catanzaro, Italy
        • Azienda Ospedaliero Universitaria Mater Domini
      • Milan, Italy
        • I.R.C.C.S Policlinico San Donato
      • Negrar, Italy
        • Ospedale Sacro Cuore Don Calabria
      • Padova, Italy
        • Azienda Ospedaliera di Padova
      • Palermo, Italy
        • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
      • Pisa, Italy
        • Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
      • Roma, Italy
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Rozzano, Italy
        • Istituto Clinico Humanitas
  • Poland
      • Bydgoszcz, Poland
        • Szpital Uniwersytecki nr 2 im.dr J. Biziela
      • Gdansk, Poland
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Poland
        • Centrum Medyczne Plejady
      • Lodz, Poland
        • SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
      • Lublin, Poland
        • Wojskowy Szpital Kliniczny w Lublinie
      • Piotrkow Trybunalski, Poland
        • Trialmed CRS
      • Poznan, Poland
        • Centrum Medyczne Grunwald
      • Puławy, Poland
        • KO-MED Centra Kliniczne Pulawy
      • Rzeszów, Poland
        • Gabinet Lekarski Bartosz Korczowski
      • Warsaw, Poland
        • Centrum Zdrowia MDM
      • Warsaw, Poland
        • NZOZ Vivamed
      • Wierzchosławice, Poland
        • Centrum Zdrowia Tuchow Sp. z o.o.
      • Wroclaw, Poland
        • LexMedica
      • Wroclaw, Poland
        • Centrum Medyczne Oporow
      • Wroclaw, Poland
        • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
  • Serbia
      • Belgrade, Serbia
        • Clinical Center " Dr Dragisa Misovic Dedinje"
      • Belgrade, Serbia
        • Clinical Center Bezanijska kosa
      • Užice, Serbia
        • General Hospital Uzice
  • Slovakia
      • Bardejov, Slovakia
        • Alian s.r.o.
      • Nové Zámky, Slovakia
        • Gastromedic, s.r.o.
      • Prešov, Slovakia
        • Gastro I, s.r.o.
      • Vranov nad Topľou, Slovakia
        • Endomed, s.r.o.
      • Šahy, Slovakia
        • Accout Center s.r.o.
  • Slovenia
      • Celje, Slovenia
        • General Hospital Celje
      • Maribor, Slovenia
        • University Medical Centre Maribor
      • Murska Sobota, Slovenia
        • General Hospital Murska Sobota
  • Spain
      • Barcelona, Spain
        • Centro Médico Teknon
      • Córdoba, Spain
        • Hospital Universitario Reina Sofia
      • Las Palmas de Gran Canaria, Spain
        • Hospital Universitario de Gran Canaria Dr. Negrin
      • Málaga, Spain
        • Hospital Quironsalud Malaga
  • Ukraine
      • Cherkasy, Ukraine
        • CNE Cherkasy Regional Hospital of Cherkasy Regional Council
      • Dnipro, Ukraine
        • I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
      • Ivano-Frankivsk, Ukraine
        • Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
      • Kharkiv, 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
      • Kherson, Ukraine
        • CI Kherson CCH
      • Khmelnytskyi, Ukraine
        • Khmelnytska Regional Hospital
      • Kyiv, Ukraine
        • Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
      • Lviv, Ukraine
        • Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU
      • Ternopil, Ukraine
        • Ternopil University Hospital
      • Uzhhorod, Ukraine
        • A. Novak Transcarpathian Regional Clinical Hospital
      • Vinnytsia, 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
      • Zaporizhzhia, Ukraine
        • CI City Clinical Hospital #6 Dept of Gastroenterology
      • Zaporizhzhia, Ukraine
        • CNCE "City Hospital 9" Zaporizhzhia CC
  • United Kingdom
      • Bury, United Kingdom
        • Fairfield General Hospital
      • London, United Kingdom
        • Guy's Hospital
      • London, United Kingdom
        • University College London Hospitals
      • Nottingham, United Kingdom
        • Nottingham University Hospitals Queen's Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ABX464 50mg
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
Drug: ABX464

ABX464

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

Other Names:
  • Obefazimod

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Patients With Clinical Remission at Week 48 Compared to Baseline of Induction Study (ABX464-103)
Time Frame: week 48
Clinical remission (based on the Mayo scoring system) is defined as: a rectal bleeding sub-score = 0, and an endoscopy sub-score ≤1 (excluding friability), and at least 1-point decrease in stool frequency sub-score from baseline to achieve a stool frequency sub-score ≤1
week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Patients With Clinical Response at Weeks 48 and 96 Compared to Baseline of Induction Study
Time Frame: Weeks 48 and 96
Proportion of patients with clinical response at week 48 Clinical response is defined as: a reduction in Mayo Score ≥ 3 points and ≥ 30 % from baseline with an accompanying decrease in rectal bleeding sub-score ≥ 1 point or absolute rectal bleeding sub-score ≤ 1 point.
Weeks 48 and 96
Endoscopic Improvement at Weeks 48 and 96
Time Frame: week 48 and week 96

Proportion of patients with endoscopic improvement at week 48 among all patients.

Proportion of patients with endoscopic improvement at week 96 among all patients.

Endoscopic improvement is defined as a Mayo endoscopic sub score of ≤1 (excluding friability).
week 48 and week 96
Endoscopic Remission at Weeks 48 and 96
Time Frame: week 48 and week 96
Proportion of patients with endoscopic remission at week 48 among all patients. Proportion of patients with endoscopic remission at week 96 among all patients. Endoscopic remission is defined as a Mayo endoscopic sub score of 0.
week 48 and week 96
miRNA-124 Expression
Time Frame: baseline, week 24 and week 48
Change relative to baseline in miRNA-124 expression in rectal/sigmoidal biopsies at week 48 and in total blood at week 24 and week 48.
baseline, week 24 and week 48
Incidence and Description of Adverse Events
Time Frame: From baseline to week 96

Number and rate of all adverse events, causally-related adverse events, all serious adverse events and causally-related serious adverse events classified by severity.

Incidence of treatment-emergent serious adverse events, hospitalizations, total inpatient days.

Incidence of adverse events leading to investigational product discontinuation. Number of clinically significant laboratory abnormalities.
From baseline to week 96
Sustained Endoscopic Changes at Week 48 and Week 96
Time Frame: weeks 48 and 96
Proportion of patients with sustained endoscopic changes at week 48 and 96. Sustained endoscopic changes is defined as the number of patients with endoscopic changes at week 48 among patients who had endoscopic changes during the Induction study (at week 8 or week 16 of study ABX464-103).
weeks 48 and 96
Change in Modified Mayo Score and in Partial Modified Mayo Score
Time Frame: From baseline to week 96

Change in Modified Mayo Score (MMS) at weeks 48 and 96 and in partial Modified Mayo Score (pMMS)

MMS is a composite score of UC disease activity calculated as the sum of the following 3 subscores:

  1. Stool frequency, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
  2. Rectal bleeding, scored from 0 (no blood seen) to 3 (blood alone passed).
  3. Endoscopic evaluation, 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.

pMMS is a composite score of UC disease activity calculed as the sum of the following 2 subscores:

  1. Stool frequency, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
  2. Rectal bleeding, scored from 0 (no blood seen) to 3 (blood alone passed). The overall pMMS ranges from 0 to 6 where higher scores represent more severe disease.
From baseline to week 96
Stool Frequency Subscore
Time Frame: From baseline to week 96

Participants recorded stool frequency using a paper subject diary on a daily basis. The stool frequency subscore ranges from 0 to 3 according to the following scale:

Score 0: Normal number of stools Score 1: 1 to 2 stools per day more than normal Score 2: 3 to 4 stools per day more than normal Score 3: 5 or more stools per day more than normal
From baseline to week 96
Rectal Bleeding Score
Time Frame: From baseline to week 96

Participants recorded rectal bleeding in a paper subject diary on a daily basis. Rectal bleeding score is taken as the worst subscore of the three most recent scores within 7 days prior to the visit.

The rectal bleeding subscore ranges from 0 to 3 according to the following scale:

Score 0: No blood seen Score 1: Streaks of blood with stool less than half the time Score 2: Obvious blood with stool most of the time Score 3: Blood alone passed A lower score represents an improvement in rectal bleeding.
From baseline to week 96
C-Reactive Protein
Time Frame: baseline, week 24, week 48
Change to baseline in C-Reactive Protein levels
baseline, week 24, week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abivax S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Severine VERMEIRE, MD, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABX464-104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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