This study focuses on Ulcerative Colitis, a disease that causes long-lasting inflammation and sores in the lining of the large intestine. The purpose of the study is to evaluate the efficacy and safety of the drug tulisokibart, also known as MK-7240, in people with moderate to severe symptoms of this condition. Participants may receive the study drug through intravenous use, which is an infusion through a vein, or via subcutaneous use, which involves an injection under the skin. Some individuals will receive a placebo.
During the study, the effectiveness of tulisokibart will be monitored over a period of time. The investigation looks at how many people reach clinical remission, a state where the symptoms of the disease are significantly reduced or absent. Researchers will also observe endoscopic improvement, which refers to visible healing of the intestinal lining during a procedure where a camera is used to look inside the body, and histologic-endoscopic mucosal improvement, which means the tissue appears healthy both under a microscope and during a visual examination.
Who Can Join the Study?
You must have had ulcerative colitis, which is a type of long-term swelling and sores in the digestive tract, for at least 3 months before joining the study.
Your ulcerative colitis must be moderately to severely active, meaning your symptoms are medium to very strong.
Your weight must be at least 40 kg (about 88 pounds).
You must meet at least one of the following: your current ulcerative colitis treatments are not working well enough, you rely on corticosteroids (a type of steroid medicine used to reduce swelling) to manage symptoms, or you cannot tolerate the medicines used for this condition.
You must be taking allowed medications and have kept your dose levels stable as required by the study rules.
You can be any gender and must be between 18 and 80 years old.
If you are female and could become pregnant, you must use an approved contraceptive method (a way to prevent pregnancy) or follow a lifestyle of abstinence (not having sexual intercourse) for at least 14 weeks after your last study dose.
If you are female and could become pregnant, you must have a negative pregnancy test within 24 to 72 hours before your first dose, and a doctor must review your medical and menstrual history to ensure there is no risk of early pregnancy.
Who Cannot Join the Study?
You have been diagnosed with Crohn’s Disease (a type of long-term inflammation in the digestive tract), indeterminate colitis (inflammation of the colon that cannot be specifically classified), or other types of colitis or enteritis (inflammation of the intestines) that might make it hard to measure how well the medicine works.
You had a cytomegalovirus infection (a common type of virus) that went away less than 4 weeks before the start of the study.
You have had an organ transplant and need to continue taking immunosuppression (medicines that lower your body’s immune system response).
You have a history of cancer within the last 5 years, though you can participate if you had certain skin cancers or early-stage cervical cancer that were completely removed by surgery.
You are known to be infected with hepatitis B, hepatitis C, or HIV (viruses that affect the liver or the immune system).
You have active tuberculosis (a serious bacterial infection that usually affects the lungs) or latent TB (a dormant form of the infection) that has not been treated successfully.
You have a confirmed or suspected case of COVID-19.
You have a history of drug or alcohol abuse within the 6 months before the study begins.
You have had major surgery (surgery requiring general anesthesia, which is medicine that puts you to sleep) within the last 3 months, or you have a major surgery planned during the study.
You are currently using or plan to use total parenteral nutrition (a method of feeding that provides nutrients directly into a vein rather than through the digestive tract).
You have used antibiotics for ulcerative colitis and have not been on a steady dose for at least 14 days, or you stopped taking them within 14 days of starting the study.
You have been diagnosed with fulminant colitis (a severe, sudden onset of colon inflammation) or toxic megacolon (a life-threatening complication where the colon becomes very swollen).
You are using a treatment that does not follow the specific rules or protocol (the official plan for the study) provided.
You have taken any prohibited medications (medicines that are not allowed during this study).
You have previously used tulisokibart or other TL1A antibodies (a specific type of medicine used to block certain parts of the immune system).
Your ulcerative colitis is only located in the rectum (the very end of the large intestine); the inflammation must extend further up into the colon.
You currently need or are about to have a colostomy or ileostomy (surgical procedures that create an opening in the abdomen to allow waste to leave the body).
You have previously had a total proctocolectomy (surgical removal of the rectum and colon) or a partial colectomy (removal of part of the colon).
You have had a fecal microbial transplantation (a procedure where healthy stool is transferred into a patient) within 4 weeks before starting the study.
You were hospitalized for a flare-up of ulcerative colitis within 2 weeks before the study begins.
You have colonic dysplasia (abnormal cell growth in the colon) that is not low-grade (mild) and completely removed.
You have any active or serious infections that have not cleared up after receiving proper treatment.
Tulisokibart is a medication being tested to see how well it works and how safe it is for people with moderate to severe ulcerative colitis. It is administered either as an infusion through a vein or as an injection under the skin.
Ulcerative colitis – This is a condition characterized by inflammation and sores in the lining of the large intestine and rectum. The inflammation typically occurs in a continuous pattern along the affected area. As the condition progresses, the lining of the intestine can become swollen and irritated. This can lead to symptoms such as frequent bowel movements and abdominal discomfort. The inflammation may stay in one area or spread throughout the colon.
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