NCT00820365

SC12267 (4SC-101) for Treatment of Patients With Inflammatory Bowel Disease

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: 4SC AG · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Disease (IBD)

Interventions

Type	Name	Description
DRUG	SC12267 (4SC-101)	Peroral administration of SC12267 (4SC-101) in patients with Inflammatory Bowel Disease over 12 weeks.

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-10-01
• Completion: 2011-03-01
• First posted: 2009-01-12
• Last updated: 2011-05-18

Locations

16 sites across 3 countries: Bulgaria, Germany, Romania