This study is being conducted to evaluate the efficacy and safety of a medication called duvakitug in people living with Crohn’s Disease. Crohn’s Disease is a type of immune system disease that causes inflammation, or swelling, in the digestive tract. The investigation focuses on individuals experiencing moderate to severe symptoms of this condition.
Participants in the study will receive either duvakitug or a placebo through a subcutaneous injection, which is a method of delivering medication just under the skin. This is an induction study, meaning the goal is to determine how well the treatment can quickly reduce active symptoms and inflammation. The study uses a randomized and double-blind approach, which means participants are assigned to groups by chance, and neither the participants nor the researchers know which specific treatment is being administered during the course of the study.
Who Can Join the Study?
You must be at least 18 years old but no older than 80 years old. In some locations, people aged 16 to 17 may join if they have reached Tanner Stage 5, which is a medical way to describe reaching full physical maturity during puberty.
You must have a confirmed diagnosis of Crohn’s Disease, which is a type of long-term inflammation in the digestive tract, that has been moderately to severely active for at least 3 months.
You must have previously tried conventional therapies (standard treatments) or advanced therapies (more complex medications) and found that they did not work well enough, stopped working over time, or caused side effects that you could not tolerate.
Who Cannot Join the Study?
People who have Ulcerative Colitis (a type of inflammation in the large intestine) or indeterminate colitis (a condition where doctors cannot tell exactly which type of intestinal inflammation is present).
People who are missing entire sections of their intestines, specifically the terminal ileum (the end of the small intestine), the right colon, the transverse colon, the sigmoid colon, the left colon, or the rectum.
People who have had or currently have high-grade gastrointestinal dysplasia (a condition where cells in the digestive tract look abnormal and may lead to cancer).
People who are taking standard treatments but have not been on a stable dose (a regular, unchanging amount of medicine) before starting the study.
People who are using prohibited medications or therapies (medicines or treatments that are not allowed during this study).
People who have previously used anti-TL1A investigational therapy (experimental medicines that target a specific protein called TL1A in the body).
Duvakitug is an experimental medicine given as a shot under the skin. It is being tested to see if it can help reduce symptoms and treat inflammation in people with moderately to severely active Crohn’s disease.
Crohn’s disease – This is a type of chronic inflammation that affects the digestive tract. It can involve any part of the gastrointestinal tract from the mouth to the anus. The condition often progresses through periods of inflammation that can cause swelling and sores in the lining of the digestive system. Over time, this inflammation may lead to the formation of narrow areas or deep wounds in the intestinal walls. The severity and location of the inflammation can vary significantly between different individuals.
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