CNI-1493 for Treatment of Moderate to Severe Crohn's Disease

• Status: Terminated
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether CNI-1493 is safe and effective in the treatment of moderate to severe Crohn's Disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Semapimod

Criteria

Inclusion Criteria

• Baseline Crohn's Disease Activity Index (CDAI) 250-400, inclusive

• Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy

• Patients receiving medications for CD must be on stable doses entering the study

• Any CD medication which has been discontinued must have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which must have been discontinued at least 8 weeks prior to screening

Exclusion Criteria

• Patients with any ostomy or extensive bowel resection

• Current evidence of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery

• Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin

• Treatment with any other experimental therapeutics within the last 4 weeks before enrollment