This clinical trial is focused on studying the effects of a medication called ABX464 on individuals with ulcerative colitis, a condition that causes inflammation and sores in the colon. The study aims to evaluate how effective and safe ABX464 is when taken once daily by people who have moderate to severe symptoms of this disease. Participants in the trial will receive either the medication or a placebo, which looks like the medication but does not contain the active ingredient.
The purpose of the study is to compare the improvement in symptoms and the healing of the colon lining between those taking ABX464 and those taking the placebo. The trial will last for a period of eight weeks, during which participants will be monitored for any changes in their condition and any side effects they might experience. The study will help determine if ABX464 can lead to better outcomes for people with ulcerative colitis.
Throughout the study, participants will have regular check-ups to assess their health and the progress of their condition. The trial will also track any adverse events, which are unexpected medical problems that occur during the study, to ensure the safety of the participants. This research is important for understanding whether ABX464 can be a beneficial treatment option for those suffering from ulcerative colitis.
1joining the study
Upon joining the study, you will be required to sign a written informed consent form. This form confirms your understanding and agreement to participate in the study.
You must meet specific criteria, such as being at least 16 years old (or 18 in certain regions) and having a documented diagnosis of moderately to severely active ulcerative colitis.
2initial assessment
An initial assessment will be conducted to confirm your eligibility. This may include an endoscopy and biopsy to verify your condition.
Your medical history and previous treatments will be reviewed to ensure you meet the study’s requirements.
3treatment phase
You will be randomly assigned to receive either the investigational medication ABX464 or a placebo. A placebo is a substance with no active medication, used for comparison.
The medication is administered in the form of a hard capsule taken orally once daily.
The treatment phase lasts for 8 weeks, during which you will be monitored for any changes in your condition.
4monitoring and follow-up
Throughout the study, regular visits will be scheduled to monitor your health and the effects of the treatment.
You will be assessed for endoscopic improvement and symptomatic remission at the end of the 8-week period.
Any side effects or adverse events will be recorded and evaluated.
5completion of the study
At the end of the study, a final assessment will be conducted to evaluate the overall impact of the treatment.
You will receive information about the study’s findings and any further steps if necessary.
Who Can Join the Study?
Must be a male or female who is at least 16 years old. In some regions, you must be at least 18 years old.
If you are a teenager, you must weigh at least 40 kg (about 88 pounds) and have reached full physical development.
You need to understand, sign, and date a written consent form before any study procedures begin. If you are underage, your country’s consent rules must be followed.
Must have a documented diagnosis of ulcerative colitis, confirmed by a procedure called endoscopy (a test that looks inside your colon) and histology (examining tissue samples).
Must have active disease, which means a modified Mayo score (MMS) of 5 or more, a rectal bleeding subscore (RBS) of 1 or more, and an endoscopy subscore (MES) of 2 or 3.
Must have tried and not responded well to at least one of the following treatments: corticosteroids, immunosuppressants, biologic or biosimilar therapies, S1P receptor modulators, JAK inhibitors, or new drugs approved during the study. Not responding to only 5-ASA or sulfasalazine is not enough.
If you are a woman who can have children or a man with a partner who can have children, you must agree to use birth control as described in the study protocol.
Must be able and willing to attend study visits and follow study procedures.
Must have health insurance if required by your country or state.
Who Cannot Join the Study?
Patients with other serious health conditions that could interfere with the study.
Patients who have had recent surgery related to the digestive system.
Patients who are currently using certain medications that might affect the study results.
Patients who have a history of severe allergic reactions.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with a history of substance abuse.
Patients who have certain infections that could affect the study.
Patients with a history of cancer, except for some types of skin cancer.
Patients who have a condition that affects their immune system.
Obefazimod is a medication being tested to see if it can help people with ulcerative colitis, which is a condition that causes inflammation and sores in the colon. This medication is taken once a day and is being studied to find out if it can improve the appearance of the colon when viewed through a camera and help reduce the symptoms that people with this condition experience. The goal is to see if it can make the symptoms go away or become less severe.
Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. The disease typically begins in the rectum and can extend to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation leads to frequent and urgent bowel movements, often with mucus or pus. Over time, the disease can cause the colon to lose its ability to function properly, leading to complications.
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