This clinical trial is focused on studying the long-term effects and safety of a medication called ABX464 for people 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 study will compare the effects of taking either 25 mg or 50 mg of ABX464 once daily to a placebo, which is a substance with no active medication.
The purpose of the study is to evaluate how well ABX464 works in maintaining clinical remission, which means reducing or eliminating the symptoms of ulcerative colitis over time. Participants in the study will take the medication or placebo for a period of 44 weeks. During this time, they will have regular check-ups to monitor their health and the effects of the treatment.
The study aims to determine the proportion of participants who achieve clinical remission by the end of the study period. It will also look at other factors such as endoscopic improvement, which involves examining the inside of the colon to see if there are fewer signs of inflammation, and whether participants can maintain remission without the use of corticosteroids, a type of medication often used to reduce inflammation. The safety of the treatment will be assessed by tracking any adverse events or side effects that occur during the study.
1initial visit
Upon joining the study, you will have an initial visit. During this visit, you will be asked to sign a written informed consent form. This form confirms that you understand the study and agree to participate.
You will need to have completed a previous treatment study and have your clinical response status available. An endoscopy, which is a procedure to look inside your digestive tract, must have been performed at the end of the previous study, and the results should be available.
2medication administration
You will be randomly assigned to receive either the study medication, ABX464, or a placebo. A placebo looks like the real medication but does not contain the active substance.
The study medication will be in the form of hard capsules. You will take either 25 mg or 50 mg of ABX464 once daily by mouth.
3regular follow-up visits
Throughout the study, you will have regular follow-up visits. These visits are important to monitor your health and the effects of the medication.
During these visits, various assessments will be conducted, including checking your vital signs, performing laboratory tests, and possibly repeating endoscopy procedures.
4end of study evaluation
The study aims to evaluate the long-term efficacy and safety of the medication over a period of 44 weeks.
At the end of the study, your health and response to the treatment will be thoroughly evaluated. This includes checking for clinical remission, which means the absence of symptoms, and any improvements in your condition.
Who Can Join the Study?
Participants must have completed the initial treatment study (ABX464-105 or ABX464-106), and their response to the treatment must be available.
Participants must have had a valid endoscopy (a procedure to look inside the digestive tract) at the end of the initial study, with results available on the first day of this study.
Participants must understand, sign, and date a written consent form before any study-specific procedures. If the participant is under-aged, national consent requirements must also be met.
Women of childbearing potential (women who can become pregnant) and male participants with partners who can become pregnant must agree to use highly effective birth control methods as described in the study protocol.
Participants must be able and willing to attend study visits and follow study procedures as outlined in the protocol.
Participants should 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 could interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics.
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 are unable to comply with the study procedures.
Patients who have a known sensitivity to the study medication or its ingredients.
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 maintain remission, which means keeping the symptoms of ulcerative colitis under control over a long period. The goal of the trial is to see if ABX464 can effectively reduce the symptoms and improve the quality of life for people with this condition.
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. Over time, the inflammation can cause the colon to lose its ability to absorb water, leading to frequent and urgent bowel movements. The progression of the disease can vary, with periods of exacerbation and remission.
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