Actively Recruiting
A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating SAR441566 in Adults with Moderate-to-severe Ulcerative Colitis
Led by Sanofi · Updated on 2026-05-28
204
Participants Needed
115
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SAR441566 in adults aged 18 to 75 years with moderate-to-severe ulcerative colitis UC in this Phase 2 multinational, randomized, double-blind, placebo-controlled study. The main goal is to assess how different doses of SAR441566 affect clinical remission in participants with active UC. The study includes a screening period of up to 28 days plus an additional 7 days if needed. Participants will receive one of three dose regimens of SAR441566 or a matching placebo, given orally as tablets. The study treatment period lasts up to 52 weeks, with a 12-week induction phase followed by a 40-week maintenance phase and a 2-week follow-up after treatment ends. An optional open-label period of up to 40 weeks is also offered to eligible participants not enrolling in a long-term safety study. During the study, participants will attend 12 visits in the main treatment period and up to 8 visits during the open-label phase. Researchers will monitor clinical remission using the modified Mayo Score at week 12 and evaluate other outcomes such as clinical response, endoscopic remission, patient-reported outcomes, and adverse events. Safety will be closely followed throughout the study, which may last up to 59 weeks in total for each participant.
CONDITIONS
Brief Title
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 75 years
- Clinical evidence of active ulcerative colitis for at least 3 months confirmed by endoscopy
- Moderate-to-severe ulcerative colitis at screening defined by modified Mayo Score 5 to 9 with specific subscore requirements
- Prior treatment for ulcerative colitis with either standard therapies or approved advanced therapies
- Use of contraception consistent with local regulations for participants of childbearing potential
You will not qualify if you...
- Diagnosis of active Crohn's disease, indeterminate colitis, ischemic colitis, or microscopic colitis
- Complications such as fulminant colitis, toxic megacolon, or conditions requiring bowel surgery during the study
- Prior colectomy, ostomy, ileoanal pouch, or anticipated colectomy during participation
- Positive tests for ova, parasites, bacterial pathogens, or Clostridium difficile toxin in stool
- Active tuberculosis or incompletely treated latent tuberculosis
- Positive hepatitis B surface antigen or core antibody, or hepatitis C virus antibody
- Active, chronic, or recurrent infections including herpes zoster or herpes simplex
- Known HIV infection or positive HIV serology
- Active malignancies or lymphoproliferative disease within 5 years prior to screening
- Gastrointestinal dysplasia not completely removed or presence of adenomatous polyps not removed by screening
- Pregnancy, breastfeeding, or planning pregnancy during study and 3 months post last dose
- Recent treatment with IV or oral anti-infectives within specified timeframes
- Use of parenteral nutrition or exclusive enteral nutrition
- Recent use of cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, fecal microbial transplantation, or IV corticosteroids
- Exposure to natalizumab or oral carotegrast methyl
- Abnormal laboratory or screening results preventing safe participation
Research Team
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