How long is the study?
For each participant, the study will last approximately 58 weeks (around 13,5 months) including up to 12 months of study treatment with investigational medication or placebo.
Complete this brief questionnaire
Check eligibilityLearn more about a Clinical Study for Ulcerative Colitis
This study is looking for adults with active moderate to severe ulcerative colitis (UC) for whom either their symptoms are not well controlled by current treatment or they cannot tolerate the current treatment.
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 this study, we encourage you to complete a brief questionnaire to help determine if you may qualify to participate and be referred to a site recruiting in your area for further evaluation.
If you are interested in learning more about this study, we encourage you to complete a brief questionnaire to help determine if you may qualify to participate and be referred to a site recruiting in your area for further evaluation.
What is the purpose of this study?
This study is to evaluate how effective and safe different doses of the investigational medication are to treat moderate to severe UC.
What is the investigational medication?
- The investigational medication is intended to influence your immune system to reduce inflammation and help return your colon to a more normal and healthy state, which can improve signs and symptoms of UC.
- The investigational medication can only be used in a research study, like this one, and it is not yet approved for treating people with UC.
- The investigational medication is randomly assigned (like flipping a coin) for you to receive one of the 3 doses of investigational medication or placebo. There is a 50% or greater chance of getting investigational medication. Regardless of the treatment group to which you are assigned, you will be taking 3 capsules by mouth twice a day.
Study Information
Terms to know
What is an investigational medication?
It is the medication being studied to see if patient symptoms improve while taking it. The drug is not yet approved for general use by regulatory authorities.
What is a placebo?
A placebo is an inactive substance or treatment that looks the same and is given in the same way as the investigational medication that is being studied.
What is a double-blind clinical study?
Neither the participant nor the study doctor will know which treatment the participant is receiving.
What is expected if I qualify and decide to participate?
Every patient has their right to stop the participation whenever they like and without the need to give an explanation.
- Attend the scheduled visits and allow the tests or procedures to be performed as planned.
- Complete the electronic and paper diaries every day, which allows the study doctor to monitor your symptoms and confirm your investigational medication usage.
- Follow the study doctor’s instructions regarding the how the investigational medication should be taken.
- Inform the study doctor or study staff before stopping or modifying your medication(s) or before starting any new medications(s).
- Complete 3 endoscopies during the study to assess your disease (1 at the beginning, at 3 months and at 12 months).
FAQ
If you have more questions about clinical studies, click here
What type of study-related medical care is provided during the study?
All study-related medical care is provided, including study-related exams and study-related medications. There is no insurance required to participate. All study-related medical care will be explained.
Studies may also offer compensation in return for travel.
Can I speak with someone if I have questions?
Yes, after you complete the online questionnaire and give permission to be contacted, a study representative will contact with you. You can ask any questions you may want at the time before deciding to participate, or at any time during the study.
Am I eligible?
Complete this brief questionnaire (approximately 5 to 10 minutes) to determine if you are eligible to participate in this clinical study and be referred to a site recruiting in near your area.
You can also add your contact information to be notified of future Sanofi studies.
V1.0 - October 10, 2023