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.

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Age: ><=18 years
- Diagnosis of CD, (re)-established by endoscopy and/or X-ray and/or surgery in the last 36 months
- CD in active phase since at least 2 weeks before screening
- CDAI between 220 and 450
- CDEIS > 8
- ulcerations greater than aphthous ulcers in at least 1 of the bowel segments from the ileum to the rectum
- If any on-going treatment with corticosteroids (prednisone, prednisolone or budesonide), at a dose equivalent to or less than 30 mg/day prednisone, or 9 mg of budesonide, in use for at least one month and at a stable dose for at least two weeks before patient enrolment
- If any on-going treatment with immunosuppressant (azathioprine, 6-mercaptopurine, methotrexate), in use for at least 3 months before patient enrolment
- If any on-going treatment with 5-aminosalicilates, in use for at least 4 weeks before patient enrolment, at a dose ><= 2 g
- Females of childbearing potential with negative pregnancy tests
- Signed written informed consent to participate in this trial

Exclusion Criteria

- Treatment in the previous 2 months with anti-TNFa antibodies
- Primary failure to previous treatment with anti-TNFa antibodies-
- Current bowel obstruction or any condition that may predispose to its development (or intestinal perforation or significant GI hemorrhage
- Expected surgery for the duration of the study
- Any ostomy or extensive bowel resection
- Positive serological anti-HCV and HBV and anti-HIV testing
- Other on-going clinical relevant viral infections (e.g. herpes zoster, Epstein-Barr, CMV), systemic fungal infections or history of recurrent serious bacterial infections
- Signs and symptoms of severe, progressive or uncontrolled renal, hepatic, haematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease
- QTc interval > 450 msec at pre-treatment evaluation
- Serum magnesium and potassium below the LLN at pre-treatment evaluation
- Platelet counts below 200 x 109/L at pre-treatment evaluation
- Unavoidable concomitant treatment with any drug known for potential risk of causing Torsades de Pointes (see list in Appendix F)
- History of cancer with less than 5 years documentation of a disease-free state
- History of tuberculosis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Rate of complete mucosal healing at week 8.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. to evaluate the effect of ITF2357 on endoscopic disease activity assessed<br /><br>using both the Crohns Disease Endoscopic Index of Severity (CDEIS) and the<br /><br>Simple Endoscopic Score of Crohns Disease (SES-CD)<br /><br>2. to evaluate the effect of ITF2357 on clinical disease activity, assessed<br /><br>using the Crohn*s Disease Activity Index (CDAI)<br /><br>3. to assess safety and tolerability of ITF2357<br /><br>4. to assess pharmacokinetic properties of ITF2357</p><br>

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