SAFETY AND EFFICACY OF ISIS 2302 IN STEROID DEPENDENT CROHN'S DISEASE

点击翻译按钮获取中文摘要

This is a six month, three arm, double-masked, randomized, placebo- controlled, repeated fixed dose within patient, intravenous trial of ISIS 2302 in 300 evaluable subjects with steroid-dependent Crohn's disease. ISIS 2302 is a 20 base phosphorothioate oligodeoxynucleotide designed to specifically hybridize to a sequence in the 3' untranslated region of the human Intercellular Adhesion Molecule-1 (ICAM-1). ICAM-1 is an adhesion molecule of fundamental importance to the inflammatory process. ISIS 2302 is a ICAM-1 inhibitor. Effective inhibition of such a molecule would be expected to have potent anti-inflammatory potential without the concomitant side effects of corticosteroid use. Patients will be tapered off their steroids and then put on one of three treatment arms: high or low dose ISIS 2302, or placebo. This will be administered three times a week for 4 weeks in months one and three. Efficacy will be assessed by change in 1) Crohn's Disease Activity Index (CDAI); and 2) the Inflammatory Bowel Disease Questionnaire (IBDQ). The primary endpoint will be the proportion of patients in complete remission at the end of Week 14. Subjects will be evaluated during the two 28 day treatment courses, the interim phase, and for the following 3 months in order to observe the kinetics and duration of response.