The Immunological and Blood Effects of STA-5326 Mesylate on Patients With Crohn's Disease

This study will test whether a new experimental drug called STA-5326 mesylate will decrease inflammatory chemicals called cytokines in patients with Crohn's disease. The drug has prevented gut inflammation in mice and rats and has improved symptoms in humans with active Crohn's disease. Patients with Crohn's Disease between 18 and 75 years of age and who have active disease symptoms may be eligible for this study. Candidates are screened with a review of their medical records, a medical history and physical examination, electrocardiogram, blood and urine tests, chest x-ray and tuberculin skin test. They fill out diary cards for 7 days (measuring their symptoms on the Crohn's Disease Activity Index, or CDAI) and complete a 32-item Inflammatory Bowel Disease Questionnaire (IBDQ) that surveys how their disease affects their live and activities. Participants have a colonoscopy (an examination of the colon using a lighted tube) before starting the study medication. Colon tissue samples are biopsied during the procedure. Following the colonoscopy, patients are randomly assigned to receive either STA-5326 mesylate or placebo (sugar or dummy pill). They take four tablets a day and are seen in the clinic once a week (days 1, 8, 15, 22 and 29) for the following tests and procedures: * Physical examination - Days 1, 8, 15, 22, 29 * Blood tests - Days 1, 8, 15, 22, 29 * Pharmacodynamic study (blood collected before the first dose of medicine and again after 1, 2, 4, 6 and 8 hours to measure levels of the drug in the blood) - Day 1 * CDAI and IBDQ - Days 1, 15, 29 * Review of medications and symptoms - Days 1, 8, 15, 22, 29 * EKG - Days 8, 29 * Pregnancy test for women of child-bearing potential - Days 15, 29 * Urine test - Day 29 After patients complete the above treatment and tests, they undergo a second colonoscopy within 48 hours of their last dose of study medication and may be offered another 1-week supply of medication. Those for whom additional treatment is deemed po