A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn’s disease (Ileo-Colitis)

• Conditions: ACTIVE CROHN'S DISEASE; MedDRA version: 14.1Level: LLTClassification code 10021315Term: Ileitis terminalSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-002640-27-IT
• Lead Sponsor: GIULIANI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-09
• Last Update Posted: 28 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Written informed consent, personally signed and dated by the patient prior any study-related procedures is carried out. 2. Male and female outpatients aging 18-75 years old. 3. Female patients not of childbearing potential (women in menopause defined as surgically sterile or one year postmenopausal); female patients of childbearing potential upon negative pregnancy testing at screening and using effective method of birth control during the study. 4. Patients with Crohn’s disease in the active phase at screening visit (the activity is defined using the Crohn’s disease Activity Index (CDAI) according to the European guidelines). 5. Crohn’s disease limited to terminal ileum and/or right colon,.that has been documented by instrumental information on localization and extension according to inclusion criteria 9. . 6. Patients with a CDAI score of >220 and =400 for at least one week prior to enrollment. 7. No treatment with biologics (e.g.:infliximab, adalimumab, or natalizumab), in the 90 days prior the enrolment. 8. Patients with steroid resistance or steroid dependence, defined according to the ECCO consensus document 9. Absence of Strictures with pre-stenotic dilatation documented by ultrasonography or Rx or NMR, performed within 1 year prior to the enrollment 10. Ability to understand and comply with study procedures and restrictions.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Pregnant or breast-feeding women. 2. Patients with Ulcerative Colitis. 3. Patients with Crohn’s disease involving the stomach and/or the proximal small intestine, or patients with lesions confined to the transverse or left colon as assessed by standard clinical criteria. 4. Patients treated with biologics(e.g.:infliximab, adalimumab, or natalizumab), in the 90 days prior the enrolment. 5. Patients in treatment with a standard dose of immunomodulators (e.g.: azathioprine, mercaptopurine, methotrexate) maintained stably for less than 6 months (patients treated with a stable dose for at least 6 months are eligible).The standard doses, according to ECCO consensus document, are 2-2.5 mg/kg/day for azathioprine and 1-1.5 mg/kg/day for mercaptopurine. 6. Oral and/or systemic antibiotic treatment within 3 weeks before screening 7. Presence of local complications (e.g. abscesses, strictures and fistulae), dysplasia and malignancies. 8. A history of colon surgery performed within the past 12 months prior to first dose or an ileal resection more than 70 cm in the past. 9. Strictures with pre-stenotic dilatation. 10. Presence of stoma or ileo-recto-anastomosis. 11. Screening laboratory values within the following parameters: ? APTT > 1.5 ULN ? plateletcount =100,000 /mm3 ? serum creatinine >1.5 ULN ? total bilirubin >1.5 ULN (excluding Gilbert Syndrome) ? AST and ALT >1.5 ULN. 12. QTc interval >450 msec for males and >470 msec for females. 13. Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, including infections, malignancy, medical disorder that may require treatment (e.g. renal or hepatic impairment) or that make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures. 14. History of alcohol or other drug abuse within the last year. 15. Patients potentially presenting poor reliability (e.g. bad mental conditions). 16. Known hypersensitivity to oligonucleotides or any ingredient in the study products. 17. Patients who used another investigational agent or who took part in a clinical trial within the last 6 months prior first dose.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified