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
- Conditions
- Moderate-to-severe active Crohn’s DiseaseMedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease
- Registration Number
- EUCTR2007-000189-19-BE
- Lead Sponsor
- Italfarmaco S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
- Age: above 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-aminosalicilates, 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
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
- Treatment in the 2 months with anti-TNF? antibodies and in the previous 3 months with cytokines inhibitors or experimental drugs
- Primary failure to previous treatment with anti-TNF? 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 109/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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the ability of ITF2357 to induce complete healing of mucosal ulcerations of ileum and/or colon, assessed by endoscopy;Primary end point(s): Rate of complete mucosal healing at week 8;Secondary Objective: - 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)<br>- to evaluate the effect of ITF2357 on clinical disease activity, assessed using the Crohn’s Disease Activity Index (CDAI) <br>- to assess safety and tolerability of ITF2357 <br>- to assess pharmacokinetic properties of ITF2357 <br>
- Secondary Outcome Measures
Name Time Method