Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease
NCT00740103 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 119
Last updated 2025-03-28
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).
Conditions
Interventions
- DRUG
-
Semapimod
60 mg IV x 3 days q 6 - 8 weeks
Sponsors & Collaborators
-
Ferring Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Daan Hommes, MD · Academic Medical Center, Netherlands
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-12-31
- Primary Completion
- 2004-07-31
- Completion
- 2004-09-30
Countries
- United States
- Belgium
- Germany
- Israel
- Netherlands
Study Locations
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