Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease

Summary

Objectives: The primary objective of the study was to determine the ability of ITF2357, administered orally at the dose of 50 mg b.i.d. for 8 consecutive weeks, to induce complete healing of mucosal ulcerations of ileum and/or colon, assessed by endoscopy, in patients with endoscopic and clinical evidence of active moderate-to-severe Crohn's disease not controlled by conventional therapies. The secondary objectives of the study were: * to evaluate the effect of ITF2357 on endoscopic disease activity assessed using both the Crohn's Disease Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score of Crohn's Disease (SES-CD); * to evaluate the effect of ITF2357 on clinical disease activity, assessed using the Crohn's Disease Activity Index (CDAI); * to assess the safety and tolerability of ITF2357; to assess the pharmacokinetic profile of ITF2357.

Timeline

Start

2007-10-22

Primary completion

2008-12

Completion

2009-03-11

Drugs

Indications