- Subjects must have a documented diagnosis of ulcerative colitis at least 6 months
prior to screening.
- Subjects must have active moderate-to-severe ulcerative colitis based on Mayo score.
- Subjects must have Modified Baron endoscopic score of at least 2 determined within 7
days of first dosing.
- Subjects must have failed or be intolerant (as determined by the investigator) of at
least one of the following treatments for UC: Oral corticosteroids, azathioprine or
6-mercaptopurine (6-MP), or anti-tumor necrosis factor (TNF) therapy, eg, infliximab
- Subjects must be on stable steroid doses.
- Subjects who have abnormal organ and marrow function.
- Subjects with a diagnosis of indeterminate colitis, or clinical findings suggestive of
- Subjects who meet Truelove-Witts criteria for severe ulcerative colitis.
- Subjects receiving or who are expected to receive Infliximab or other biologic
treatment within 8 weeks of the Day 1 study visit.
- Subjects receiving or who are expected to receive Cyclosporine, mycophenolate, or
tacrolimus within 4 weeks of the Day 1 study visit.