Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease

• Status: Terminated
• Trial end date: 2009-02-01

Summary

The study will be conducted according to a randomized, double-blind placebo-controlled, parallel group design in up to 25 clinical sites in Europe.

Patients will be randomly assigned to two parallel treatment groups (1:1 randomization ratio) receiving either ITF2357, as hard gelatine capsule for oral administration, at the dose of 50 mg b.i.d. (total daily dose of 100 mg), or matching placebo capsules,. Treatment will be administered on an outpatient basis for 8 consecutive weeks, followed by a 4-week follow-up. During screening, in the 8-week treatment period and in the 4-week follow-up period, patients will attend scheduled visits, with physical and laboratory assessments, in order to monitor disease evolution and safety and tolerability of ITF2357.

The study will be conducted in up to 80 patients of both genders, with established diagnosis of CD, who present with ulcerations greater than aphthous ulcers in at least one of the five bowel segments investigated endoscopically, from the ileum to the rectum, with endoscopic and clinical evidence of moderate-to-severe active disease, not controlled by on-going treatment with conventional therapies such as 5-aminosalycylates, steroids or immunosuppressants.

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: Italfarmaco
• Treatments: Givinostat hydrochloride