STA-5326 is an experimental drug that has been shown to block the release of interleukin-12 from peripheral blood mononuclear cells. Given this activity on the immune system, STA-5326 mesylate is a potential treatment for various autoimmune diseases, such as Crohn's disease, that are mediated by the inappropriate expression of Th1 cytokines. This study is evaluating the use of STA-5326 mesylate in patients with moderate to severe, active Crohn's disease. Study visits include a screening visit, 9 treatment period visits over 6 months and a follow-up visit that will occur 30 days following the end of treatment. Study drug treatment will continue for up to 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
282
Gastroenterology Associates
Little Rock, Arkansas, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Community Clinical Trials
Orange, California, United States
Medical Associates Research Group
San Diego, California, United States
Southern Clinical Research Consultants
Hollywood, Florida, United States
Proportion of patients achieving clinical remission and clinical response at Day 29
Proportion of patients achieving: a clinical remission at Days 29 and 43
a clinical response from Baseline to Day 29 and from Baseline to Day 43
a reduction in endoscopic scores from Baseline to Day 29
an increase in the Inflammatory Bowel Disease Questionnaire (IBDQ) score from Baseline to Days 29 and 43
a clinical remission or clinical response at Days 29 and 43 in the subset of patients with elevated C-reactive protein
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Borland Groover Clinic
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Miami Research Associates
Miami, Florida, United States
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Shafran Gastroenterology Center
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Atlanta Gastroenterology
Atlanta, Georgia, United States
...and 25 more locations