NCT00740103

Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease

Long-term Study of Semapimod (CNI-1493) for Treatment of Moderate to Severe Crohn's Disease With Reference to Study CNI-1493-CD-04, 1 or 3 Days' Treatment vs. Placebo

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease in Crohn's Disease Activity Index (CDAI).

Detailed description

CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease in Crohn's Disease Activity Index (CDAI). In addition, the safety of repeated courses was measured by recording adverse events over time.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Semapimod	60 mg IV x 3 days q 6 - 8 weeks

Timeline

• Start date: 2002-12-01
• Primary completion: 2004-07-01
• Completion: 2004-09-01
• First posted: 2008-08-22
• Last updated: 2025-03-28

Locations

26 sites across 5 countries: United States, Belgium, Germany, Israel, Netherlands