A study to investigate efficacy and safety of SAR442970 in patients with Crohn’s Disease (CD)
General Information:
The purpose of the CHROMA-CD study is to find out if SAR442970 is safe and effective in improving the symptoms of CD.
Eligibility:
Eligibility Criteria:
- Male or Female participants ages 18-75
- Diagnosis of Crohn’s Disease (CD) for at least 3 months that is currently active
- Have frequent soft or liquid bowel movements and abdominal pain
- Have taken certain other drug treatments for CD, but either didn’t benefit from those treatments or stopped taking them after having side effects.
- Some other medications may be allowed that you may be currently taking to treat your CD, check with the study site.
- NOT diagnosed with ulcerative colitis
Study Details:
Study description/explanation of participation:
Approximately 99 participants will join the study at research sites around the world. The main study may last up to 1 year and is followed by an optional long-term extension period of up to 2 years. During the first year of the study, 2 different doses of the study drug will be studied along with a placebo. You will have a 66% chance of receiving study the study drug.
During the optional long- term extension, every participant will receive study medication.
Description of treatment or intervention (mechanism of action):
SAR442970 is a novel, investigational medication that simultaneously targets two different known pathways of CD to potentially improve disease control. This study will help us learn more about SAR442970, how it works in people with CD, and any potential side effects it may have. The study medication is given just under the skin with a short needle (subcutaneous injection).
Patient Participation Requirements:
Participants will visit the study center every 2 weeks to receive the study drug and have various assessments, such as physical exam, blood draws, provide stool sample, etc. Participants will be asked to complete a daily electronic study diary (at home). There will also be questionnaires spread throughout the study to complete.
Possible risks and side effects:
There is no certainty that you will have any benefit from taking part in the study. The information collected during this study may help doctors better treat patients with Crohn’s disease in the future. Further details are provided on the informed consent form which the study site will provide and discuss with participants.