Acute haemorrhagic ulcerative colitis – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Fri, 12 Jun 2026 10:36:45 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Acute haemorrhagic ulcerative colitis – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Study Comparing AVT16 and Vedolizumab for Adults with Moderate to Severe Ulcerative Colitis https://clinicaltrials.eu/trial/study-comparing-avt16-and-vedolizumab-for-adults-with-moderate-to-severe-ulcerative-colitis/ Wed, 29 Apr 2026 15:00:28 +0000 https://clinicaltrials.eu/trial/study-comparing-avt16-and-vedolizumab-for-adults-with-moderate-to-severe-ulcerative-colitis/ This clinical trial is focused on studying the effects of two treatments for ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. The study involves two medications: AVT16, a proposed biosimilar, and Entyvio (also known as vedolizumab). Both medications are given as a solution through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to compare the effectiveness, safety, and immune response of AVT16 and Entyvio in people aged 18 to 80 who have moderate to severe active ulcerative colitis. Participants will receive either AVT16 or Entyvio, and some may receive a placebo. The study will last for about 46 weeks, during which participants will have regular check-ups to monitor their health and the effects of the treatment.

Throughout the study, participants will be assessed at various intervals to see how well the treatment is working. This includes checking for clinical responses, which are improvements in symptoms, and clinical remission, which is when symptoms are reduced or disappear. The study will also look at mucosal healing, which is the healing of the lining of the colon, and other health markers like albumin and CRP levels. Safety will be monitored by looking at any side effects or reactions to the infusion. The goal is to determine if AVT16 is as effective and safe as Entyvio for treating ulcerative colitis.

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