CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
- Registration Number
- NCT00038766
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief 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.
- Detailed Description
Crohn's disease (CD) is a chronic inflammatory disease involving the upper and lower gastrointestinal tract and characterized by abdominal pain, weight loss, gastrointestinal bleeding and formation of fistulas between loops of bowel and from the bowel to the skin or other organs. Current therapy for active Crohn's disease consists of symptomatic treatment, nutritional therapy, salicylates and immunosuppressants or surgical management.
Tumor necrosis factor a (TNF-a) plays a central role in the initiation and amplification of the granulomatous inflammatory reaction seen in CD (van Deventer, 1997). Increased TNF-a is present in gut mucosa as well as in stool of patients with active CD (Braegger et al, 1992). CNI-1493 is a synthetic guanylhydrazone compound that is an inhibitor of TNF-a synthesis. A monoclonal antibody to TNF, infliximab, is now approved for treatment of CD, but not all patients respond and many who do respond eventually become refractory to this treatment as well.
CNI-1493 is a synthetic compound which blocks the production of several inflammatory cytokines, including TNF. Because it blocks production of multiple inflammatory mediators, it may be more active than products targeted to a specific cytokine. In addition, as it is not a biologic, it should not cause hypersensitivity reactions or induce formation of antibodies.
The purpose of this trial is to determine if CNI-1493 is safe and effective in treating patients with moderate to severe Crohn's Disease in a placebo controlled setting.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Semapimod 60 mg semapimod Semapimod 60 mg IV x 5 days Semapimod IV 30 mg semapimod Semapimod IV 30 mg x 5 days Placebo placebo Placebo IV x 3 or 5 days
- Primary Outcome Measures
Name Time Method Change in CDAI Day 29
- Secondary Outcome Measures
Name Time Method Change in IBDQ Day 29
Trial Locations
- Locations (13)
University of Chicago
🇺🇸Chicago, Illinois, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Charlotte Gastroenterology and Hepatology, PLLC
🇺🇸Charlotte, North Carolina, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Institute of Healthcare Assessment
🇺🇸San Diego, California, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
🇺🇸Lancaster, Pennsylvania, United States
Oklahoma Foundation for Digestive Research
🇺🇸Oklahoma City, Oklahoma, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Long Island Clinical Research Associates
🇺🇸Great Neck, New York, United States