This study is being conducted to evaluate the efficacy and safety of duvakitug in individuals with Crohn’s disease. Crohn’s disease is a type of immune system disease that causes inflammation in the digestive tract. The investigation focuses on how well duvakitug works as a maintenance therapy, which is a treatment used to keep symptoms under control and prevent flares of the disease over a long period.
Participants in the study will receive either duvakitug or a placebo through a subcutaneous injection, which is a shot administered just under the skin. This is a randomized study, meaning participants are assigned to a group by chance, and it is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The study involves monitoring the condition over a period of time to observe how the body responds to the medication.
Who Can Join the Study?
You must be at least 18 years old and no more than 80 years old at the start of the study. In some locations, people aged 16 to 17 may participate if they have reached Tanner stage 5, which is a term used to describe reaching the final stage of physical development during puberty.
For the maintenance part of the study, you must have shown a clinical response, meaning your symptoms improved, and you must have finished an endoscopy, which is a medical procedure where a doctor uses a small camera on a flexible tube to look inside your body.
For the open-label extension (OLE) part of the study, you must have finished either the maintenance part of this study or a previous specific study.
You must have Crohn’s Disease (CD), which is a type of long-term inflammation in the digestive tract, that is considered moderately to severely active.
Who Cannot Join the Study?
People who have a medical condition or difficulty following the study rules that the investigator (the doctor leading the study) decides makes them unsuitable to participate.
People who have a known hypersensitivity (an extreme allergic reaction) to the study medicine, duvakitug.
Duvakitug is a medication given as an injection under the skin. It is being studied to see if it can help maintain health and manage symptoms in people living with moderately to severely active Crohn’s disease.
Crohn’s disease – This is a type of inflammatory bowel disease that causes chronic inflammation in the digestive tract. The inflammation can affect any part of the gastrointestinal tract from the mouth to the anus. It often progresses through periods of active symptoms followed by periods of remission. During active stages, the inflammation can lead to the development of ulcers or sores in the lining of the digestive system. Over time, this persistent inflammation may affect the thickness and function of the intestinal walls.
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