Inflammatory Bowel Disease (IBD) Clinical Trial
Official title:
Exploratory, Open-label Study to Demonstrate Efficacy, Safety and Tolerability of SC12267 (35 mg) in Patients With Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
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.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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