Crohn's disease
Conditions
Interventions
Product Name: ITF2357
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ITF2357
Other descriptive name: Diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphtalen-2-ylmethyl]-ammonium c
Sponsors
Italfarmaco S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Crohn’s disease with an endoscopical confirmation of ileocolitis or ileitis and a histological proof of activity within the previous 12 months - Moderate to severe activity demonstrated by a CDAI score between 220 and 450 - Age >= 18 years - Duration of disease activity: at least 3 months - Disease uncontrolled by oral corticosteroids for at least 2 months - Treatment with oral corticosteroids for at least 4 weeks on a stable dose equivalent to 40 mg/day of prednisone or less, or 9 mg/day of budesonide, with/without concomitant treatment with immunosuppressants - If receiving immunosuppressants, the dose must have been stable for at least 8 weeks - A CRP value equal to or greater than twice the upper laboratory norm (2XULN) as defined at each local laboratory - Females with negative pregnancy test - Signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Females of childbearing potential without using a safe contraceptive measure - Treatment in the previous 6 months with cytokines or cytokine inhibitors - Platelet counts below 200 x 109/L - Acute or chronic infections - Current bowel obstruction, intestinal perforation, significant GI hemorrhage - Ostomy or extensive bowel resection - Expected surgery - History of cancer or tuberculosis - Lactose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify one or more effective doses of ITF 2357 in the management of Crohn’s disease suitable for further evaluation in phase III studies;Secondary Objective: To assess safety and tolerability of the 8-week oral treatment with ITF 2357 To investigate pharmacokinetics of the administered ITF 2357 doses ;Primary end point(s): The percent change in CRP value at week 8 compared to study day -1 | — |
Countries
Slovakia
Outcome results
None listed