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)

• Register: EUCTR
• Last refreshed on: 28 October 2013
• Main ID: EUCTR2011-002640-27-IT
• Date of registration: 09/02/2012
• Prospective Registration: No
• Primary sponsor: GIULIANI
• Public title: 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)
• Scientific title: 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) - I.G.O.N. 1 STUDY
• Date of first enrolment: 14/07/2011
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002640-27
• 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: yes Other specify the comparator: - same IMP used at different dosage Number of treatment arms in the trial: 4

Countries of recruitment

Germany, Italy

Contacts

• Name: PHARMA DIVISION
• Affiliation: GIULIANI S.P.A.

• Name: PHARMA DIVISION
• Affiliation: GIULIANI S.P.A.

Key inclusion & exclusion criteria

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.


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

Health Condition(s) or Problem(s) studied

ACTIVE CROHN'S DISEASE
MedDRA version: 14.1 Level: LLT Classification code 10021315 Term: Ileitis terminal System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: GED-0301
Product Code: NA
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg/g milligram(s)/gram
Concentration type: up to
Concentration number: 160-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 14 days and 28 days

Main Objective: a. Efficacy: the primary efficacy endpoint will be the percentage of patients in remission defined as CDAI < 150 at day 15 (after 14 days of study drug treatment) wich is maintained at Week 4. b. Evaluation of safety of GED-0301, 14-day oral administration.

Primary end point(s): a. Efficacy: the primary efficacy endpoint will be the percentage of patients in remission defined as CDAI < 150 at day 15 (after 14 days of study drug treatment) wich is maintained at Week 4. b. Evaluation of safety of GED-0301, 14-day oral administration.

Secondary Objective: %of pts in remission at week 2,4 and at week 12 - %of patients attaining 70-point clinical response (defined as a decrease from baseline in CDAI score of 70 points or more) at week 4 and at week 12. -%of patients attaining 100-point clinical response (defined as a decrease from baseline in CDAI score of 100 points or more) at week 4 and at week 12. - Time to Symptoms Disappearance (SD) : for each symptom, time to disappearance is defined as the interval of time in days between the date of symptom disappearance, evaluated on the basis of the data recorded in the patient’s diary, and the date of randomisation . - %of steroid-dependent patients achieving steroid therapy discontinuation at week 12 - Change in the endoscopic index of severity for Crohn’s Disease (SES-CD).This analysis will be done in the patients who accept to perform ileocolonoscopy before treatment and at week 4

Secondary Outcome(s)

Secondary end point(s): %of pts in remission at week 2,4 and at week 12 - %of patients attaining 70-point clinical response (defined as a decrease from baseline in CDAI score of 70 points or more) at week 4 and at week 12. -%of patients attaining 100-point clinical response (defined as a decrease from baseline in CDAI score of 100 points or more) at week 4 and at week 12. - Time to Symptoms Disappearance (SD) : for each symptom, time to disappearance is defined as the interval of time in days between the date of symptom disappearance, evaluated on the basis of the data recorded in the patient’s diary, and the date of randomisation . - %of steroid-dependent patients achieving steroid therapy discontinuation at week 12 - Change in the endoscopic index of severity for Crohn’s Disease (SES-CD).This analysis will be done in the patients who accept to perform ileocolonoscopy before treatment and at week 4

Timepoint(s) of evaluation of this end point: 14 days, week4 and week12

Secondary ID(s)

GED-301-01-11

Source(s) of Monetary Support

GIULIANI S.P.A.