Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: SAR441566: Dose formulation: Oral Unit dose strength(s): 100 mg Intervention description: For each dose arm, the participant will take 2 tablets in the morning and 2 in the evening (4 t
Sponsors
Sanofi Healthcare India Pvt Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent. 2. Participants who have clinical evidence of active UC for more than equal to 3 months before screening and confirmed by endoscopy during the screening period. 3. Active moderate-to-severe UC at screening as defined by a mMS of 5 to 9 (without the PGA, with a minimum RB subscore more than equal to 1, a minimum SF subscore more than equal to 1, a mMES more than equal to 2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent more than 15 cm from the anal verge. 4. Must have received prior treatment for UC (either a or b below or combination of both)- a-No prior exposure to AT, but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds- 5-ASA, 6-MP, AZA, MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of UC). OR b-Inadequate response to, loss of response to or intolerance to treatment with more than equal to 1 approved 5. AT such as a biologic agent (such as TNF antagonists, anti-integrin other than natalizumab, anti-IL-12/23, anti-IL-23, or experimental biologic UC therapeutics), or a small molecule (such as a JAKi or S1PRm) for UC. The treatment must have been discontinued according to the following timeline- -anti-TNF, anti-IL12/23 and anti-IL23 therapies at least 8 weeks before randomization. -vedolizumab, ustekinumab or rizankizumab treatment at least 8 weeks before randomization. -experimental biologic UC therapy at least 8 weeks before randomization or 5 times the terminal half-life of the investigational drug, whichever is longer. -JAKi or S1PRm at least 2 weeks before randomization. -experimental biologic small molecule at least 2 weeks before randomization or 5 times the terminal half-life of the IMP, whichever is longer. 6. Participant may be receiving a therapeutic dosage of at least 1 of the following drugs- -Oral 5-ASA compounds- prescribed dose must be stable for at least 2 weeks before screening colonoscopy or stopped treatment at least 2 weeks prior to screening colonoscopy. -Oral corticosteroids must be at a prednisone-equivalent dose of 25 mg/day, or 9 mg/day of budesonide, and have been at a stable dose for at least 2 weeks prior to the screening colonoscopy or stopped at least 2 weeks prior to screening colonoscopy. -AZA, 6-MP, or MTX- if the prescribed dose has been stable for at least 4 weeks before screening endoscopy, or, if stopped, medication must have been discontinued or at least 4 weeks prior to screening endoscopy to be considered eligible for enrollment. Sex, contraceptive/barrier method and pregnancy testing requirements/breastfeeding Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a-Male participants Male participants who are sexually active with female partner(s) of childbearing potential must agree to practice the protocol-specified contraception during the study and for up to 3 months, after the last dose of study intervention which will allow for one complete cycle of spermatogenesis following study drug discontinu
Exclusion criteria
Exclusion criteria: Medical conditions 1. Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitis. 2. Participants with the following ongoing known complications of UC: -Fulminant colitis -Toxic megacolon -Or any other manifestation that might require bowel surgery while enrolled in the study -Participant with ostomy or ileoanal pouch 3. Participants with prior colectomy or anticipated colectomy during their participation in the study. 4. Participants with fecal sample positive for ova or parasites, or any aerobic pathogens at screening including: Aeromonas, Plesiomonas, Shigella, Salmonella, Yersinia, Campylobacter, or E. coli sp. or positive for Clostridium difficile B toxin in stools. 5. At the screening visits, participants with positive- - Hepatitis B surface antigen (HBsAg), or Hepatitis B core antibody immunoglobulin M (HBcAb IgM) or HBcAb total, or Hepatitis C virus antibody (HCVAb) confirmed by positive HCV-RNA. (Participants with a positive HCVAb and negative HCV-RNA who have documented evidence of completing HCV anti-virals with cure may be included) - Any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex. 6. Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening. 7. Participants with active tuberculosis or who meet tuberculosis exclusionary parameters: - Active TB or a history of incompletely treated TB. - Undergoing treatment for latent TB infection (LTBI). - Positive QuantiFERON-TB test at Screening visit. Indeterminate QuantiFERON-TB may be repeated once during screening period and will be considered positive if retest results are positive or indeterminate. - Current household contacts with active TB. - Received BCG-vaccination within 12 months prior to screening. -Participants meeting all the following TB-related criteria would not be excluded: - documented completed appropriate LTBI treatment, OR treated for active TB infection (with a treatment regimen as per local guidelines), AND - have obtained consultation with a specialist to rule out or treat active TB infection AND - for whom review and approval from Sponsor have been granted are eligible. Note- TB testing is mandatory to rule out active/latent TB and a blood sample for QuantiFERON-Tuberculosis Gold Interferon- Gamma Release Assay (IGRA) testing should be sent to the central laboratory. 8. Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening (with the exception of the following treated malignancies that are allowed in the study- basal cell carcinoma, adequately squamous cell carcinoma in situ of the skin or cervical carcinoma in situ). 9. Participants with adenomatous colonic polyps or colonic mucosal dysplasia (low- or high-grade) not excised or incompletely excised. 10. History of colonic mucosal dysplasia or presence of adenomatous colonic polyps not removed OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit. 11. If the participant has extensive colitis for more than equal to 8 years or disease limited to left side of colon (ie, dista
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe UCTimepoint: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of different doses of SAR441566 on clinical response in participants with moderate-to-severe UCTimepoint: 52 weeks | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, New Zealand, Poland, South Africa, Spain, Turkey, United States of America
Contacts
Public ContactMr Laxman Deshmukh
Sanofi Healthcare India Private Limited
Outcome results
None listed