This study is looking at Ulcerative Colitis, which is a condition affecting the immune system that causes inflammation and sores in the lining of the large intestine and rectum. The disease being studied is described as moderately to severely active, which means patients are experiencing significant symptoms. The study will test a medication called Duvakitug, which is also known by its code name SAR447189. This medication is a type of antibody that targets a specific protein involved in inflammation. Some participants will receive Duvakitug while others will receive placebo. The medication will be given as a subcutaneous injection, which means it is injected under the skin using a syringe.
The purpose of this study is to assess how well Duvakitug works as an initial treatment for moderately to severely active Ulcerative Colitis compared to placebo. The study will look at whether the medication can help reduce symptoms and inflammation in the intestines. This is called an induction study, which means it focuses on the first phase of treatment to see if the medication can bring the disease under control.
The study will measure several outcomes to determine if the treatment is working. The main outcome will be the proportion of participants who achieve clinical remission, which means their symptoms have improved significantly or disappeared. Other outcomes include improvements in the appearance of the intestine lining as seen during examination, reduction in symptoms like bowel urgency and abdominal pain, improvements in quality of life, and whether participants need to be hospitalized due to their condition. The study will also monitor any side effects and measure the levels of the medication in the blood over time. The treatment period will last up to 24 weeks.
1Baseline and treatment start
At the beginning of the study, your current health status will be assessed. This includes evaluating the severity of your ulcerative colitis, which is an inflammatory condition affecting the large intestine.
You will be randomly assigned to receive either duvakitug or a placebo. A placebo is an inactive substance that looks identical to the actual medication but contains no active ingredients. Neither you nor your doctor will know which one you are receiving during the study.
If you are assigned to receive duvakitug, you will receive it as a subcutaneous injection, which means the medication is injected under the skin.
2Treatment period
You will continue receiving your assigned treatment throughout the induction phase of the study. An induction phase is the initial treatment period designed to bring the disease under control.
The study medication will be administered according to a specific schedule determined by the study protocol. The exact dosage, frequency, and duration of administration will be provided to you by the study staff.
During this period, your symptoms will be regularly monitored, including stool frequency (how often you have bowel movements), rectal bleeding (bleeding from the rectum), bowel urgency (the sudden need to have a bowel movement), nocturnal bowel movements (bowel movements during the night), and abdominal pain.
3Regular assessments
Throughout the study, various assessments will be performed to evaluate how the treatment is affecting your condition.
These assessments will include endoscopic examinations, which involve using a thin, flexible tube with a camera to look inside your large intestine and assess inflammation.
Your symptoms will be evaluated using scoring systems such as the modified Mayo Score, which measures the severity of ulcerative colitis based on stool frequency, rectal bleeding, appearance of the intestinal lining, and overall physician assessment.
You will be asked to complete questionnaires about your quality of life, fatigue levels, and how the disease affects your daily activities. These include the PROMIS-Fatigue questionnaire and the Inflammatory Bowel Disease Questionnaire.
Blood samples will be taken to measure the levels of duvakitug in your bloodstream and to check whether your body has developed any immune response to the medication, known as anti-drug antibodies.
4Safety monitoring
Your safety will be continuously monitored throughout the study. Any new health problems or worsening of existing conditions that occur during the study will be recorded as adverse events.
Particular attention will be paid to serious adverse events, which are health problems that require hospitalization or are life-threatening, and to specific adverse events of special interest related to the study medication.
If you experience any side effects or health concerns during the study, these will be documented and managed appropriately.
Any hospitalizations related to ulcerative colitis will be recorded.
5Study completion
At the end of the induction period, final assessments will be performed to determine how well the treatment worked.
The results will be evaluated based on whether you achieved clinical remission, which means your symptoms have significantly improved or disappeared, and whether there is improvement in the appearance of your intestinal lining.
Additional outcomes will include whether you achieved clinical response (improvement in symptoms), endoscopic improvement (improvement in the appearance of the intestinal lining), and histological improvement (improvement in tissue samples examined under a microscope).
If you were taking steroids at the start of the study, the results will also consider whether you were able to stop using them while maintaining symptom control.
Who Can Join the Study?
You must be between 18 and 80 years old at the time of screening. In some locations, participants between 16 and 18 years old may be included if they have reached full physical development, which is called Tanner Stage 5, meaning their body has completed puberty-related growth and changes.
You must have a confirmed diagnosis of moderately to severely active ulcerative colitis, which is a condition causing inflammation and sores in the lining of the large intestine and rectum, for at least 3 months before starting the study.
You must have shown that previous treatments did not work well enough for you, stopped working over time, or caused side effects you could not tolerate. These previous treatments include conventional therapies, which are standard medications like steroids or immunosuppressants that reduce inflammation, or advanced therapies, which are newer biological medications that target specific parts of the immune system.
Who Cannot Join the Study?
The source data does not provide specific exclusion criteria for this clinical trial
Exclusion criteria are reasons why someone cannot join a study, such as having certain other medical conditions, taking specific medications, or having test results outside the required range
Without detailed exclusion criteria listed in the trial information, it is not possible to specify which patients would not be eligible to participate
The trial is studying a treatment called duvakitug for ulcerative colitis, which is a condition that causes inflammation and sores in the digestive tract
The study accepts both male and female participants across different age groups
Duvakitug is an investigational medication being studied as a treatment for people with moderately to severely active ulcerative colitis. Ulcerative colitis is a condition that causes inflammation and sores in the lining of the large intestine and rectum. This medication is being tested to see if it can help reduce the symptoms and inflammation during the initial treatment period, known as induction therapy. In this study, duvakitug will be compared to a placebo to determine how well it works and how safe it is for patients with this condition.
Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory bowel disease that affects the inner lining of the large intestine and rectum. The condition causes long-lasting inflammation and sores called ulcers in the digestive tract. Symptoms typically include abdominal pain, diarrhea often with blood or pus, rectal bleeding, urgent need to have bowel movements, and inability to have a bowel movement despite urgency. Many patients also experience fatigue, weight loss, and fever during active periods of the disease. The disease usually develops gradually and progresses over time with periods of flare-ups when symptoms worsen and periods of remission when symptoms improve or disappear. Ulcerative colitis is classified as an immune system disease where the body’s immune system mistakenly attacks the tissues of the colon.
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