Status:
TERMINATED
Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease
Lead Sponsor:
Italfarmaco
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
The study was conducted according to a randomized, double-blind placebo-controlled, parallel group design in up to 25 clinical sites in Europe. Eligible patients were randomly assigned to two paralle...
Eligibility Criteria
Inclusion
- 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 ileum to rectum
- If any on-going treatment with corticosteroids (prednisone, prednisolone or budesonide), it must be at a dose equivalent to or less than 30 mg/day prednisone, or 9 mg of budesonide, and 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), it must be in use for at least 3 months before patient enrolment
- If any on-going treatment with 5-aminosalicylates, it must be in place 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
- Treatment in the 2 months with anti-TNF-alfa antibodies and in the previous 3 months with cytokines inhibitors or experimental drugs
- Primary failure to previous treatment with anti-TNF-alfa antibodies-
- Current bowel obstruction or any condition that may predispose to its development (e.g. clinically significant unresolved intestinal stricture, adhesions or any other condition that would place the patient at risk for developing overt bowel obstruction) 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 anti-HIV testing and positive testing for active HBV replication, e.g. HBV-DNA or HBsAg or HBeAg (to be performed at screening)
- 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
- Any previous evidence, irrespective of its severity, of coronary disease, cardiac rhythm abnormalities or congestive heart failure
- QTc interval \> 450 msec at pre-treatment evaluation
- Serum magnesium and potassium below the LLN at pre-treatment evaluation
- Platelet counts below 200 x 10\^9/L at pre-treatment evaluation
- Any previous evidence, irrespective of its severity, of renal function impairment
- Unavoidable concomitant treatment with any drug known for potential risk of causing Torsades de Pointes
- Presence of a transplanted organ
- History of cancer with less than 5 years documentation of a disease-free state
- History of tuberculosis
- Severe lactose intolerance
- Pregnant or nursing women
- Female of childbearing potential without using a safe contraceptive measure
- Participation in a clinical trial within 30 days prior to initiation of study treatment.
Key Trial Info
Start Date :
October 22 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2009
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00792740
Start Date
October 22 2007
End Date
March 11 2009
Last Update
July 19 2023
Active Locations (10)
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1
AZ Sint Lucas Gastro-enterologie
Assebroek, Belgium, 8310
2
Imelda Hospital Gastro-enterology dept.
Bonheiden, Belgium, 2820
3
CHU Saint-Pierre Médecine Interne
Brussels, Belgium, 1000
4
UZ Gent Gastro-enterologie 1K12IE
Ghent, Belgium, 9000