Participants
Approximately 204 adults between 18-75 years of age
Check your eligibility now & get in touch with a study center
CHECK ELIGIBILITYAre you between the ages of 18-75?
Have you been diagnosed with ulcerative colitis (UC) for at least three (3) months?
What is ulcerative colitis?
Ulcerative colitis (UC) is a long-lasting condition that causes inflammation in the large intestine (also called the colon). The exact cause is unknown, but many believe it involves problems with the immune system.
- Your immune system is like your body's defense team. It usually fights off harmful invaders, like bad bacteria or viruses.
- In ulcerative colitis, the immune system is overactive (working too much), even when there's no real threat.
- This overactivity leads to inflammation in the colon, causing the symptoms of ulcerative colitis.
Symptoms can vary depending on how much of the colon is infected and how severe the inflammation. Individuals with moderate to severe UC may have symptoms such as abdominal pain (pain in the belly) and daily loose stool with blood. Currently, there's no medications that can cure ulcerative colitis. There are treatments available to help manage the flare-ups (when symptoms get worse) and improve your quality of life.
To find out more, visit the Crohn's & Colitis Foundation.
What is the study medication?
In people with UC there is too much inflammation, which may be caused by a protein in your body called tumor necrosis factor alpha (TNFα). The study medication blocks this protein, which may reduce the chronic inflammation and may lead to fewer UC symptoms.
The study medication is a tablet and is still being tested, so it's not available for general use yet. During this study, you have a 5 in 6 chance of receiving the study medication or 1 in 6 chance of receiving a placebo. A placebo looks like the medicine being tested and is also given in the same way as the medication that is being studied, but it does not have any medicine in it. If your symptoms are worsening or not improving during the study there is also the option to switch to the study medication.
What can you expect during the study?
At your appointments several checks to monitor your health are included:
Physical exam / vital signs
A physical exam, including checking your height, weight, and vital signs
Colonoscopies / sigmoidoscopies & biopsies
Up to three (3) colonoscopies or sigmoidoscopies (a long flexible tube with a light and camera that is inserted into the rectum to view the entire inside the colon or parts of the colon) with biopsies
Heart activity
An ECG test (checks your heart's electrical activity using electrodes placed on your skin)
Blood, urine and stool tests
Pregnancy test
Electronic Diary
Short, daily electronic questionnaires about number of stools and blood loss, quality of life (how you're feeling or daily activities) and medication usage
Is there a cost to participate?
There is no cost to participate. All study-related exams, study-related medications and study-related medical care are provided. There is no insurance required to take part in this study. You may be compensated for time and travel.
Find a site near you
Am I Eligible?
Sanofi believes that everyone should have the opportunity to take part in clinical trials. It is important to include people who have been historically under-represented in clinical trials. Sanofi is committed to inclusivity in our studies.
If you are interested in learning more about these studies, we encourage you to complete this brief questionnaire to help determine if you may qualify to participate and be referred to a site recruiting in your area for further evaluation.
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Version 1.0, 19DEC2024
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