This clinical trial is focused on studying the effects of a medication called ABX464, which contains the active substance obefazimod. The study is aimed at individuals with ulcerative colitis, a condition that causes inflammation and sores in the colon and rectum. The trial will evaluate the effectiveness and safety of taking ABX464 once daily in capsule form. Participants will be randomly assigned to receive either the medication or a placebo, which looks like the medication but does not contain the active substance.
The purpose of the study is to compare how well obefazimod works against a placebo in improving the condition of the colon as seen through an endoscope, a tool used to look inside the body, and in reducing symptoms. The study will last for a period of eight weeks, during which participants will take the medication or placebo daily. The trial will monitor the participants’ health and any changes in their symptoms throughout this period.
Participants will be assessed for improvements in their condition, such as reduced inflammation and fewer symptoms, by the end of the study. The trial will also keep track of any side effects or adverse events that may occur. This research aims to provide more information on the potential benefits and risks of using ABX464 for treating ulcerative colitis.
1joining 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 (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 includes reviewing your medical history and conducting necessary tests, such as endoscopy and biopsies, to confirm your condition.
3treatment assignment
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 to compare the effects of the actual drug.
The medication is administered in the form of a hard capsule taken orally once daily.
4treatment period
The treatment period lasts for 8 weeks. During this time, you will take the assigned capsule daily as instructed.
You will be monitored for any changes in your condition and any side effects you may experience.
5follow-up visits
Regular follow-up visits will be scheduled to assess your progress. These visits will include evaluations of your symptoms and overall health.
The primary goal is to determine the proportion of participants who achieve endoscopic improvement and symptomatic remission by the end of the 8-week period.
6final assessment
At the end of the 8-week treatment period, a final assessment will be conducted. This will include a review of your response to the treatment and any side effects experienced.
The study aims to evaluate the safety and effectiveness of the medication compared to the placebo.
Who Can Join the Study?
Must be a male or female who is at least 16 years old. In some countries, 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 (known as Tanner Stage 5).
You need to understand, sign, and date a written consent form before any study procedures. 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 and tissue examination (histology).
Must have active disease, shown by a specific score (called the modified Mayo score) of 5 or more, with certain subscores for symptoms like rectal bleeding and endoscopy results.
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.
Women who can have children and men with partners who can have children must agree to follow birth control requirements.
Must be able and willing to attend study visits and follow study procedures.
Must have health insurance if required by the country or state where the study is conducted.
Who Cannot Join the Study?
Patients with any other significant health condition that might interfere with the study.
Patients who have had a recent surgery related to the digestive system.
Patients who are currently using other medications that might affect the study results.
Patients with 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 been diagnosed with cancer in the past five years.
Patients with active infections that require treatment.
Patients with a history of heart disease or stroke.
Obefazimod 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 improve the appearance of the colon when viewed through a camera (endoscopic improvement) and help reduce the symptoms of the disease, such as diarrhea and abdominal pain, leading to a state where the symptoms are minimal or gone (symptomatic remission). The goal of the trial is to determine if obefazimod is more effective than a placebo, which is a substance with no active medication, in achieving these improvements.
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, often with mucus or pus. Over time, the disease can lead to complications such as colon narrowing or increased risk of colon cancer.
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