This clinical trial is focused on studying the effects of a new treatment for two types of inflammatory bowel diseases: Ulcerative Colitis and Crohn’s Disease. These conditions cause inflammation in the digestive tract, leading to symptoms like abdominal pain, diarrhea, and fatigue. The treatment being tested is called TEV-48574, which is a solution for injection. It contains an active substance known as Duvakitug, a type of protein designed to help reduce inflammation by targeting specific pathways in the body. The study will also use a placebo, which looks like the treatment but does not contain the active substance.
The purpose of the study is to evaluate how effective and safe TEV-48574 is for patients with moderate to severe forms of these diseases. Participants will receive the treatment or placebo through subcutaneous injections, which means the solution is injected under the skin. The study will last for 14 weeks, during which the treatment will be administered every two weeks. Researchers will monitor the participants to see if the treatment helps achieve clinical remission, which means a significant reduction or disappearance of symptoms, and an endoscopic response, which is an improvement seen during a medical examination of the intestines.
Throughout the study, the safety and tolerability of TEV-48574 will be closely observed. This includes checking for any side effects, changes in laboratory test results, and overall health indicators like blood pressure and heart rate. The study aims to provide valuable information on whether TEV-48574 can be a beneficial treatment option for people living with Ulcerative Colitis and Crohn’s Disease.



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