This clinical trial studies the effectiveness and safety of tulisokibart (also known as MK-7240) in people who have Crohn’s Disease. Crohn’s Disease is a long-lasting condition that causes inflammation in the digestive tract, leading to symptoms such as stomach pain and diarrhea. The condition can range from moderate to severe, affecting daily life and overall well-being.
The study will test tulisokibart against placebo to see if it can help patients achieve remission, which means a significant reduction in disease symptoms. The medication will be given in two different ways: through intravenous infusion (delivered directly into a vein) or through subcutaneous injection (given under the skin using a pre-filled injector).
During the study, participants will receive treatment for 12 weeks. The researchers will monitor various aspects of the disease, including changes in symptoms such as abdominal pain and stool frequency. They will also examine the inside of the digestive tract to check if the treatment reduces inflammation and helps heal the intestinal lining. Throughout the study, participants will have regular check-ups to monitor their health and any potential side effects.
1Initial assessment
Your participation begins after being diagnosed with Crohn’s Disease for at least 3 months
The study accepts patients with moderate to severe Crohn’s Disease who have not responded well to previous treatments such as steroids, immunomodulators, or other therapies
2Treatment assignment
You will be randomly assigned to receive either tulisokibart or a placebo (inactive substance)
The treatment will be administered in one of two ways:
– Through an intravenous infusion (medicine given through a vein)
– Through a subcutaneous injection (injection under the skin) using a pre-filled injector
312-week treatment period
Your condition will be monitored for 12 weeks
During this period, medical staff will track:
– Changes in your stool frequency
– Level of abdominal pain
– Overall disease activity using the Crohn’s Disease Activity Index
– Your fatigue levels
– Quality of life related to inflammatory bowel disease
4Endoscopic evaluations
At week 12, you will undergo an endoscopic examination to assess:
– Response to treatment
– Presence of ulcers in your digestive tract
This procedure will help determine if the treatment has improved the condition of your digestive system
5Safety monitoring
Throughout the study, medical staff will monitor for any side effects or adverse reactions
Your safety will be continuously evaluated
The study is expected to continue until February 2033
Who Can Join the Study?
Must have been diagnosed with Crohn’s Disease for at least 3 months before the study begins
Must have moderate to severe Crohn’s Disease (meaning significant symptoms that affect daily life)
Must have had an inadequate response to, lost response to, or could not tolerate at least one of these previous treatments:
Oral locally acting steroids (medications that work mainly in the gut)
Systemic steroids (medications that affect the whole body)
Immunomodulators (medications that adjust immune system activity)
Biologics (protein-based medications) or small molecule therapies (newer types of medications)
Must be 16 years of age or older
Both men and women can participate in the study
Adolescents between 16 and 18 years old may participate if approved by their country’s health authorities
Who Cannot Join the Study?
History of extensive bowel surgery or short bowel syndrome (a condition where part of the small intestine is missing or has been removed)
Active or latent (dormant) tuberculosis
Current serious infections including hepatitis B or hepatitis C
History of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
Severe heart, lung, kidney, or liver disease
Current or recent use of other biological medications for Crohn’s Disease
Pregnant or breastfeeding women
History of severe allergic reactions to similar medications
Active intestinal infections, including C. difficile
Presence of intestinal strictures (narrowing of the intestine) with obstructive symptoms
Uncontrolled high blood pressure or diabetes
History of severe mental health conditions that could interfere with study participation
Live vaccines received within 4 weeks before study start
Tulisokibart is an investigational medication being studied for treating moderate to severe Crohn’s Disease. It is being tested to see if it can help reduce symptoms like abdominal pain and frequent bowel movements, and improve the appearance of the intestinal lining when viewed through an endoscope. This medication is being compared to a placebo to determine how well it works in achieving remission (reduction of disease symptoms) in people with Crohn’s Disease after 12 weeks of treatment.
Crohn’s Disease – A chronic inflammatory condition that can affect any part of the digestive tract, from mouth to anus. The disease typically develops in patches, where healthy parts of the intestine are found between inflamed areas. It causes inflammation of the digestive tract, which can lead to abdominal pain, severe diarrhea, fatigue, and weight loss. The inflammation often spreads deep into the layers of affected bowel tissue. Crohn’s Disease can develop at any age, but most people are diagnosed in their late teens or early 20s. The condition tends to fluctuate between periods of active disease and remission.
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