SC12267 (4SC-101) for Treatment of Patients With Inflammatory Bowel Disease
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
This is an exploratory, open-label, uncontrolled, multi-center, 1-arm study conducted at 16
sites in Bulgaria, Germany and Romania.
A total of ca. 30 - 35 patients will receive SC12267 (4SC-101) tablets, 35 mg once daily for
12 weeks. First of all the patients will undergo a screening period of 1 week and a follow-up
visit will be performed 4 weeks after study drug discontinuation or earlier in case of
relapse during follow up. Total study duration will be up to 36 (+2) weeks.
There will be 8 study visits: one screening visit, 6 visits during the treatment period and
one follow-up visit. In addition, four telephone visits will be performed at Week 6, Week 10,
Week 20 (+1) and Week 36 (+2).
The duration of the entire study (first patient in till last patient out) is expected to be
about 13 months.