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Long-term treatment for ulcerative colitis with ABX464

A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Long-term Efficacy and Safety of ABX464 25 mg or 50 mg Once Daily as a Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Phase 3 Interventional Abivax S.A. · NCT05535946

This study is testing a daily medication called ABX464 to see if it can help people with moderate to severe ulcerative colitis who haven't found relief with other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1050 (estimated)
Ages16 Years and up
SexAll
SponsorAbivax S.A. Industry-sponsored
Drugs / interventionsmethotrexate
Locations554 sites (Birmingham, Alabama and 553 other locations)
Trial IDNCT05535946 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, placebo-controlled study evaluates the long-term efficacy and safety of ABX464 administered once daily as maintenance therapy for patients with moderately to severely active ulcerative colitis who have not responded adequately to conventional or advanced therapies. The study includes a 44-week maintenance phase followed by a 4-year Long Term Extension phase, allowing participants to continue treatment based on their response status. Participants who completed prior induction studies will be randomized to receive either the active treatment or a placebo, with ongoing monitoring throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates are patients who have completed prior induction studies for ulcerative colitis and have a documented clinical response.

Not a fit: Patients who have not completed the induction studies or those who do not have a clinical response status available will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new maintenance therapy option for patients with ulcerative colitis who have not responded to existing treatments.

How similar studies have performed: Other studies have shown promising results with similar maintenance therapies for ulcerative colitis, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria in maintenance phase:

* Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106), and patients' clinical response status must be available.
* Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day 1.
* Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met.
* Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to comply with contraception requirements as described in Section 4.4. (Contraception) of the protocol.
* Subjects must be able and willing to comply with study visits and procedures as per protocol.
* Subjects should be affiliated to a health insurance policy whenever required by a participating country or state

Inclusion criteria in LTE phase:

* Subject must have completed the maintenance phase
* Investigator and subject must assess and agree that the subject has received, and will continue to receive benefit from being in the study

Exclusion Criteria in maintenance phase:

* Subjects who permanently discontinued the study treatment during the induction study (either ABX464-105 or ABX464-106).
* Subjects who have developed any major illness/condition (eg. primary sclerosis cholangitis, Crohn's disease, colectomy, diverting ileostomy, colon cancer or colonic adenomas \[low or high grade dysplasia\]).
* Subjects with evidence of an unstable clinical condition (eg. toxic megacolon, fulminant colitis, bowel perforation, uncontrolled ischemic disease, congestive heart failure with NYHA class 3 or 4 symptoms) during the induction study that, in the investigator's judgment, will substantially increase the risk to the subject if he or she participates in the study.
* Subjects who plan to participate in other investigational studies during the maintenance study.
* Male or female planning a pregnancy, or pregnant female subjects
* Introduction during induction study of prohibited medications, dosages, surgical or non-medicinal procedures indicated for UC (except antidiarrheals and motility agents for acute diarrhea).
* Any changes in the laboratory values during the induction period that could jeopardize subject's safety in the opinion of the investigator. If any doubts, the investigator should contact the sponsor study medical monitor.
* Subject who is planning to receive live vaccine during the study.
* Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.

Exclusion criteria for LTE phase:

* Subject continues to satisfy exclusion criteria listed above for the maintenance phase
* Introduction during maintenance phase of prohibited medications, dosages, surgical or non-medicinal procedures indicated for UC (except antidiarrheals and motility agents for acute diarrhea).

Where this trial is running

Birmingham, Alabama and 553 other locations

+504 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative Colitis
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.