Date

2025-02-27

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

1. Males and females 2. Aged 18 to 80 years (Minimum 18 years and Maximum 80 years). 3. Female participants not pregnant or breastfeeding and using effective contraception if of childbearing potential. 4. Male participants using effective contraception or abstaining if they have female partners of childbearing potential. 5. Diagnosis of ulcerative colitis (UC) established at least 3 months prior to baseline endoscopy, confirmed by clinical, endoscopic, and histopathological evidence. 6. Moderate to severe UC with a Mayo Score of 6 to 12 with an endoscopic subscore greater than or equal to 2 within 14 days prior to the first dose of IP. 7. Evidence of UC extending beyond the rectum (greater than or equal to 15 cm from the anal verge) confirmed by endoscopy at least 3 months prior the baseline endoscopy 8. Documented surveillance colonoscopy for those with long-standing colitis for those of >8 years duration or left-sided colitis of >12 years or colorectal cancer risk factors. 9. History of inadequate response, loss of response, or intolerance to corticosteroids or immunomodulators.

Next Version

1. Males and females 2. Aged 18 to 80 years (Minimum 18 years and Maximum 80 years). 3. Female participants not pregnant or breastfeeding and using effective contraception if of childbearing potential. 4. Male participants using effective contraception or abstaining if they have female partners of childbearing potential. 5. Diagnosis of ulcerative colitis (UC) established at least 3 months prior to baseline endoscopy by clinical and endoscopic evidence and corroborated by a histopathology report at baseline. 6. Moderate to severe UC with a Mayo Score of 6 to 12 with an endoscopic subscore greater than or equal to 2 within 14 days prior to the first dose of IP. 7. Evidence of UC extending beyond the rectum (greater than or equal to 15 cm from the anal verge) confirmed by endoscopy at least 3 months prior the baseline endoscopy 8. Documented surveillance colonoscopy for those with long-standing colitis for those of >8 years duration or left-sided colitis of >12 years or colorectal cancer risk factors. 9. History of inadequate response, loss of response, or intolerance to corticosteroids or immunomodulators.