Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis

Exclusion Criteria

• •Participants with Crohn's Disease (CD).
• •Participants with diagnosis of indeterminate colitis or microscopic colitis.
• •Participants with stool sample positive for culture for aerobic pathogens or C difficile.
• •Participants with prior colectomy or anticipated colectomy during their participation in the study.
• •Participants with presence of ileal pouch or ostomy.
• •Participants with fulminant disease or toxic megacolon.
• •Participants with colonic dysplasia except for adenoma.
• •Participants with intestinal failure or short bowel syndrome requiring Total Parenteral Nutrition (TPN).
• •Participants with history of recurrent or recent serious infection that has not resolved within 4 weeks prior to randomization.
• •Participants presenting with active malignancies or recurrence of malignancy within the 5 years before screening.
• •Participants with a history or presence of another significant illness that according to the investigator's judgment would adversely affect the subject's ability to participate in this study.
• •Participants presenting with fever (≥38°C) or persistent chronic or active recurring infection within 4 weeks prior to the Screening Visit requiring treatment with antibiotics, antivirals, or any history of frequent recurrent infections deemed unacceptable per investigator's judgment.
• •Participants who were administered any live (attenuated) vaccine within 3 months prior to the randomization Visit.
• •Participants with a history of recurrent herpes zoster.
• •Participants with uncontrolled diabetes, defined as HbA1c ≥9.0% at the Screening Visit.
• •Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated active or latent TB per local guidelines will be excluded from the study unless it is documented by a specialist that the participant has been adequately treated and can now start treatment with the RIPK1 kinase inhibitor.
• •Participants presenting with opportunistic infections within six months prior to screening or while receiving anti-TNF treatment in the last 6 months.
• •Participants undergoing hemodialysis or peritoneal dialysis.
• •Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV serology at screening.
• •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. Participants that were treated for HCV and clear the virus documented by HCV RNA by PCR below the limit of quantification can be eligible.
• •Positive COVID-19 test, suspected COVID-19 infection or known exposure to COVID-19 during the screening period.
• •History of COVID-19 infection within 4 weeks prior to Screening; history of mechanical ventilation or extracorporeal membrane oxygenation (ECMO) due to COVID-19 infection within 3 months prior to Screening or with residual significant complications from COVID-19 making it unsafe for the participant to enter this study.
• •Participants presenting alcohol or drug dependency within the 2 years prior to the Screening Visit.
• •Participants with unexplained, uncontrolled, or untreated thyroid disease or unexplained abnormal serum prolactin levels at screening.
• •Participants under cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide or tacrolimus treatment within 4 weeks prior to screening.
• •Participants with previous exposure to natalizumab (Tysabri®).
• •Participants with previous exposure to RIPK1 inhibitor.
• •Participants under antidiarrheals within 2 weeks prior to screening and during screening period.
• •Participants under prednisone \>25 mg/day (or equivalent).
• •Participants under budesonide \>9 mg/day.
• •Participants who received intravenous corticosteroids or cytapheresis therapy within 2 weeks prior to screening or during screening.
• •Participants who were rectally administered topical 5-aminosalicylate or corticosteroids within 4 weeks prior to screening.
• •Participants who received therapeutic enema or suppository, other than required for colonoscopy or flexible sigmoidoscopy within 4 weeks prior to screening or during screening.
• •Participants who received antibiotics for UC or gastrointestinal infection within 4 weeks prior to screening.
• •Participants who have taken other investigational medications within 2 months or 5 half--lives, (whichever is longer) prior to screening.
• •Presence of significant laboratory findings at the Screening Visit.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.