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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-000189-19-BE
• Date of registration: 03/08/2007
• Prospective Registration: Yes
• Primary sponsor: Italfarmaco S.p.A.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 16/08/2007
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000189-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium, Italy, Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:
- 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

Exclusion criteria:
- 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Moderate-to-severe active Crohn’s Disease
MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease

Intervention(s)

Product Code: ITF2357
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ITF2357
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

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)
- to evaluate the effect of ITF2357 on clinical disease activity, assessed using the Crohn’s Disease Activity Index (CDAI)
- to assess safety and tolerability of ITF2357
- to assess pharmacokinetic properties of ITF2357

Primary end point(s): Rate of complete mucosal healing at week 8

Main Objective: To determine the ability of ITF2357 to induce complete healing of mucosal ulcerations of ileum and/or colon, assessed by endoscopy

Secondary ID(s)

DSC/06/2357/23

2007-000189-19-NL