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Study on the Effects of Obefazimod for Patients with Moderate to Severe Ulcerative Colitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called ABX464 on individuals with moderately to severely active ulcerative colitis. Ulcerative colitis is a chronic condition that causes inflammation and sores in the lining of the large intestine. The medication being tested, ABX464, is taken in the form of a hard capsule and contains an active substance known as obefazimod. The study will also include a comparison with a placebo, which is a substance with no active medication.

The purpose of this study is to evaluate the effectiveness and safety of ABX464 in helping patients achieve clinical remission, which means a reduction or disappearance of symptoms. Participants in the study will take the medication once daily for a period of eight weeks. During this time, researchers will monitor the participants to see how well the medication works in reducing the symptoms of ulcerative colitis and to ensure it is safe for use.

Throughout the study, participants will undergo regular check-ups to assess their health and the progress of their condition. The study aims to determine the proportion of participants who experience significant improvement in their symptoms, as well as any potential side effects. This research is important for understanding how ABX464 can be used to treat ulcerative colitis and improve the quality of life for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign a written informed consent form. This document confirms your understanding and agreement to participate in the trial.

    You must meet specific criteria, such as being at least 16 years old and having a documented diagnosis of moderately to severely active ulcerative colitis.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and conducting necessary tests, such as endoscopy and histology, to confirm your condition.

  3. Step 3

    Randomization

    You will be randomly assigned to receive either the study medication, ABX464, or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

  4. Step 4

    Medication administration

    You will take the assigned medication orally in the form of a hard capsule once daily. The dosage will be either 25 mg or 50 mg, depending on the group you are assigned to.

    The treatment will last for a specified period, with regular monitoring to assess your response and any side effects.

  5. Step 5

    Regular monitoring

    Throughout the trial, you will attend regular study visits. These visits are essential for monitoring your health, assessing the effectiveness of the treatment, and identifying any side effects.

    You will undergo various assessments, including clinical evaluations and laboratory tests, to ensure your safety and the study's integrity.

  6. Step 6

    End of treatment evaluation

    At the end of the treatment period, a final evaluation will be conducted. This will include a comprehensive assessment of your condition and any changes observed during the trial.

    The primary goal is to determine the proportion of participants who achieve clinical remission at week 8, as well as other secondary outcomes.

Who can join the trial?

8 criteria

  • Men or women who are at least 16 years old. If you are under 18, you must weigh at least 40 kg (about 88 pounds) and have reached Tanner Stage 5, which means you have completed physical development.
  • You must understand and sign a written consent form before any study procedures begin. If you are under the legal age, your parent or guardian must also give consent according to national requirements.
  • You must have a documented diagnosis of ulcerative colitis (UC) for more than 90 days before starting the study. This diagnosis should be confirmed by a procedure called endoscopy and a tissue examination called histology.
  • Your disease must be active, which is measured by a modified Mayo score (MMS) of 5 or more, with a rectal bleeding subscore (RBS) of at least 1, and an endoscopy subscore (MES) of 2 or 3. These scores will be confirmed by a central reader.
  • You must have had an inadequate response, meaning your condition did not improve, got worse, or you could not tolerate at least one of the following treatments: corticosteroids, immunosuppressants, biologic therapies, S1P receptor modulators, JAK inhibitors, or any new drugs approved during the study. Note that failure to respond only to 5-ASA is not enough to qualify.
  • If you are a woman who can become pregnant or a man with a partner who can become pregnant, you must agree to use highly effective birth control methods as described in the study protocol.
  • You must be able and willing to attend study visits and follow the study procedures as outlined in the protocol.
  • You should have health insurance if it is required by the country or state where the study is taking place.

Who cannot join the trial?

10 criteria

  • Patients with any other significant health condition that could interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have a history of cancer, except for certain types of skin cancer that have been treated.
  • Patients who have a history of severe allergic reactions.
  • Patients who are currently pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have received certain medications that could affect the study results.
  • Patients who have had surgery related to ulcerative colitis within the last 6 months.
  • Patients who have a history of certain heart conditions.
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Investigated drugs

ABX464 is a medication being studied for its potential to help people with ulcerative colitis, a condition that causes inflammation and sores in the colon. This medication is taken once a day and is being tested to see if it can help reduce the symptoms of ulcerative colitis and bring about clinical remission, which means that the symptoms of the disease are reduced or disappear. The study is designed to compare the effects of ABX464 with a placebo to determine its effectiveness and safety for people with moderately to severely active ulcerative colitis.

What is already known about the treatment

ABX464 – ABX464 is an oral medication taken once daily, currently being studied in a phase III clinical trial for its effectiveness and safety in treating moderately to severely active ulcerative colitis. This medication is not yet widely used in medicine, as it is still under investigation. It is designed to help patients achieve clinical remission, meaning a reduction or disappearance of symptoms. ABX464 works at the molecular level by modulating the immune response, which helps reduce inflammation in the colon. It is classified as an anti-inflammatory agent.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine, leading to the formation of ulcers. The disease typically begins in the rectum and may extend to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation can cause frequent and urgent bowel movements. Over time, the condition can lead to complications such as severe bleeding or colon damage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500535-36-00Protocol codeABX464-105Estimated enrolment559 patientsSponsorAbivax

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