This study involves people with ulcerative colitis that is moderately to severely active. Ulcerative colitis is a long-term condition where the inner lining of the large intestine becomes inflamed and develops sores, leading to symptoms such as diarrhea, abdominal pain, bleeding from the rectum, and urgent need to have bowel movements. The study will test a medication called Duvakitug, which is also known by its code name SAR447189. This medication is given as an injection under the skin and works by targeting a specific protein in the body that is involved in inflammation. Some people in the study will receive Duvakitug while others will receive placebo. The purpose of the study is to see how well Duvakitug works as a maintenance treatment compared to placebo in keeping the disease under control.
The study is divided into different parts. People who join this particular part of the study will be those who have already shown improvement after earlier treatment and have completed certain examinations. The study will look at whether Duvakitug can help keep the condition in a state where symptoms are minimal or absent, which is called remission. During the study, doctors will check the condition of the intestine using an examination that looks inside the bowel, and they will also assess symptoms such as bowel movements, bleeding, and abdominal pain. The study will also look at whether people can stop using steroid medications while maintaining good control of their condition.
Throughout the study, participants will be monitored for any side effects or unwanted reactions to the treatment. The study will measure various aspects of the disease and how it affects daily life, including fatigue levels, quality of life, and the need for hospital care related to ulcerative colitis. Blood samples will be taken to measure the amount of Duvakitug in the body and to check if the body develops any immune response to the medication. The study will also include a longer extension period for people who complete the main part of the study, allowing for continued observation of the medication’s effects and safety over time.
1Entry into the maintenance study
This study is designed for individuals who have moderately to severely active ulcerative colitis. Ulcerative colitis is a condition where the large intestine becomes inflamed and develops sores.
To be eligible, your age should be between 18 and 80 years at the start of the study.
You must have completed a previous study called SUNSCAPE-1 and shown improvement in your symptoms, which is referred to as clinical response. You should have also undergone an examination of the inside of your intestine using a camera, called an endoscopy, at the end of that previous study.
2Random assignment to treatment group
You will be randomly assigned to receive either duvakitug or a placebo. A placebo is an inactive substance that looks like the real medication but contains no active ingredient.
Neither you nor the study staff will know which treatment you are receiving. This is called a double-blind study design.
The purpose of this approach is to ensure that the results are measured fairly and without bias.
3Receiving study medication
The medication duvakitug or the matching placebo will be given as an injection under the skin, which is called a subcutaneous injection.
The medication is provided as a solution for injection.
Specific details about how often you will receive the injections and for how long will be provided by the study staff based on the study protocol.
4Monitoring and assessments during the study
Throughout the study, your condition will be monitored to see how well the treatment is working. This includes checking if you achieve clinical remission, which means your symptoms have significantly improved or disappeared.
Your symptoms will be assessed using a scoring system called the modified Mayo Score. This score evaluates the frequency of bowel movements, bleeding, and the appearance of the intestine lining.
You may undergo additional endoscopy procedures to examine the inside of your intestine and check for endoscopic improvement, which means the inflammation and sores have reduced.
Tissue samples may be taken during endoscopy to check for histologic endoscopic mucosal improvement, which means the tissue structure has improved under a microscope.
You will be asked about specific symptoms such as bowel urgency, which is the sudden need to have a bowel movement, and abdominal pain.
Your fatigue level will be measured using a questionnaire called PROMIS-Fatigue Short Form 7a.
Your overall quality of life will be assessed using the Inflammatory Bowel Disease Questionnaire, which asks about how the condition affects your daily activities.
Blood samples will be collected to measure the amount of duvakitug in your bloodstream and to check if your body has developed any immune response to the medication, known as anti-drug antibodies.
5Safety monitoring
Throughout the study, you will be monitored for any side effects or unwanted reactions to the medication. These are called adverse events.
Particular attention will be paid to serious side effects, known as serious adverse events, and any side effects that are of special interest for this type of medication.
If you experience any side effects that are concerning, the study staff will assess whether you need to stop taking the study medication.
Any hospitalizations related to ulcerative colitis will be recorded.
6Possible continuation in open-label extension
After completing the main part of the maintenance study, you may have the option to continue in an open-label extension sub-study.
In this phase, all participants will know they are receiving duvakitug, not placebo. This is called open-label because the treatment is no longer blinded.
The purpose of this extension is to gather additional long-term safety information about duvakitug.
During this phase, safety monitoring will continue in the same way as in the main study.
7Completion of the study
The study is expected to continue until approximately August 2033.
At the end of your participation, final assessments will be conducted to evaluate your condition and any effects of the treatment.
Information collected throughout the study will be used to determine whether duvakitug is effective and safe for treating ulcerative colitis.
Who Can Join the Study?
You must be between 18 and 80 years old at the start of the study. In some locations, people aged 16 to under 18 years may participate if they have reached full physical maturity, which doctors measure using something called Tanner stage 5, meaning their body has completed its development into adulthood.
For the Pivotal Maintenance Sub-Study: You must have completed a previous study called SUNSCAPE-1, achieved a clinical response, which means your symptoms improved with treatment, and had an endoscopy, which is a procedure where a doctor uses a thin tube with a camera to look inside your intestines at the end of that study.
For the OLE Sub-Study, which stands for Open-Label Extension Sub-Study where all participants know they are receiving the study medication: You must have finished either the Pivotal Maintenance Sub-Study or another study called TV48574-IMM-20038.
Who Cannot Join the Study?
The specific exclusion criteria (reasons why you cannot participate) have not been provided in the available study information
Generally, clinical trials have rules about who cannot join to ensure participant safety and study accuracy
Common reasons people may not be able to join studies include having certain other medical conditions, taking specific medications, being pregnant or breastfeeding, or having recently participated in other research studies
Your doctor will review all requirements with you to determine if this study is appropriate for your situation
Duvakitug is an investigational medication being studied as a maintenance treatment for people with ulcerative colitis, which is a condition that causes inflammation and sores in the digestive tract. This medicine is being tested to see if it can help control the symptoms of ulcerative colitis and keep the disease under control over time.
Placebo is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare against duvakitug to help researchers determine if duvakitug is truly effective in treating ulcerative colitis.
Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory bowel disease that affects the colon and rectum. The condition causes inflammation and ulcers in the inner lining of the large intestine. People with this disease typically experience symptoms such as abdominal pain, diarrhea with blood or pus, rectal bleeding, and urgent need to have bowel movements. The inflammation usually begins in the rectum and can spread continuously through the colon. During active periods, patients may also experience fatigue and reduced quality of life. The disease progresses through cycles of flare-ups and periods of remission, where symptoms may temporarily improve or disappear.
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