Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
With
Healios K.K.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 or adalimumab.
Subjects must be on stable steroid doses.
You may not be if
Subjects who have abnormal organ and marrow function.
Subjects with a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
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.
