Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study.
Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be
randomized to double blind treatment of either 1,000 mg twice daily (b.i.d.) ASP3291 (2,000
mg/d) or matching placebo in a 1:1 ratio for 8 weeks.
The study hypothesis is that treatment with ASP3291 compared to placebo will improve a
patient's ulcerative colitis endoscopic score from baseline to Week 8.