A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.

Launched by SANOFI · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called SAR441566 for adults with moderate to severe Crohn's Disease, a condition that causes inflammation in the digestive tract. The goal is to see how effective and safe this medication is compared to a placebo, which is an inactive substance given to some participants. The study will last a total of 52 weeks, including a 12-week period where participants will receive the treatment and then a 40-week period to see how well it works over time. Some participants may also have the chance to continue in the study for up to 92 weeks after the main treatment period.

To join the trial, participants need to be between 18 and 75 years old and have had Crohn's Disease for at least three months. They should also have tried other treatments for their condition without much success. However, those with certain complications or infections, or who have had recent surgeries, may not be eligible. Throughout the study, participants will receive regular check-ups to monitor their health and the effects of the treatment. This trial is a great opportunity for those looking for new options to manage their Crohn's Disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Participants are eligible to be included in the study only if all of the following criteria apply:
• • 1. Male or female participants aged 18 to 75 years at the time of signing the ICF
• • 2. Confirmed diagnosis of CD for at least 3 months prior to Baseline
• 3. Confirmed diagnosis of moderate to severe CD as assessed by:
• • Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader
• • stool frequency (SF), abdominal pain (AP) score
• • 4. History of prior exposure to standard treatment (5-ASA, steroids, immunomodulators or antibiotics) or advanced therapies (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies
• • 5. On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, AZA, 6-MP, or MTX ..)
• • 6. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding.
• Exclusion Criteria:
• Participants are excluded from the study if any of the following criteria apply:
• • 1. Participants with active UC, indeterminate colitis or short bowel syndrome
• • 2. Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement
• • 3. Participants with following ongoing known complications of CD: fistula, abscess, symptomatic stricture/stenosis, fulminant colitis, toxic megacolon, recent bowel resection within 3 months of screening or history of \> 3 bowel resections
• • 4. Participants with stool sample positive for infectious pathogens
• • 5. Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines
• • 6. Participants with Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit
• • 7. Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
• • 8. Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
• • 9. Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
• • 10. Participants with adenomatous colonic polyps or colonic mucosal dysplasia (low- or high grade) not excised or incompletely excised
• • 11. Infection(s) requiring treatment with IV anti infectives within 30 days or oral/intramuscular anti-infectives within 14 days prior to the screening visit
• • 12. Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
• • 13. Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
• • 14. Participants who received fecal microbial transplantation within 30 days prior to screening
• • 15. Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
• • 16. Participants who received IV corticosteroids within 14 days prior to screening or during screening period
• • 17. Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening
• • 18. Screening laboratory and other analyses show abnormal results