Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis

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.

Timeline

Start

2012-07

Primary completion

2014-04

Completion

2014-04

Drugs

Indications