Crohn's Disease (CD) is a chronic inflammatroy bowel disease (IBD) that can affect any segment of the GI tract from mouth to anus. CD is a morbid and potentially devastating disease. Cytokines with their inflammatory, as well as regulatory, activities are likely to play a role in the perpetuation and, possibly, the initiation of inflammation in Crohn's Disease. Although cortiocosteroids are highly effective in improving symptoms in CD subjects, steroid-weaning is challenging and early relapses may occur after the end of treatment. There is an unmet medical need for a therapy to assist in weaning subjects off steroids. Several studies have shown that SCH 52000 administration is safe and well tolerated in a large population of CD subjects. Furthermore, animal models support IL-10 being used in less active disease. The hypothesis of this study is that SCH 52000 (rHulL-10) is a useful therapy for weaning steroid-dependent patients with Crohn's disease from the corticosteroids.
SPECIFIC AIMS 1. Primary Aim To evaluate the safety, tolerance and efficacy of subcutaneous SCH 52000 (rHulL-10) in steroid-dependent Crohn's Disease subjects. * Efficacy will be defined as the ability to wean subjects off steroids by Week 16 and to maintain clinical remission (CDAI <150) at the end of 28 weeks of treatment without the need for additional significant CD management. Two doses of SCH 52000 (4.0 and 8.0 mcg/kg) administered once daily (QD) as a SC injection for 2 weeks followed by three times a week (TIW) for 26 weeks vs. placebo will be evaluated. 2. Secondary Aims 1. To evaluate the ability of SCH 52000 to wean subjects off steroids by Week 16. 2. To evaluate the time to treatment failure. The subject will be considered a treatment failure if any of the following occurs during the treatment phase: * The inability to wean steroids by Week 16. * The need to increase the steroid dose above Baseline. * The need for additional significant therapy for the management of Crohn's Disease * Discontinuation due to adverse event(s). * CDAI >150 at Week 28. 3. To evaluate the effect of SCH 52000 on the Health-Related Quality of Life (HQL) at end of 28 weeks of treatment and at Follow-Up Week 8. 4. To evaluate the response rate at Follow-Up Week 8. Response will be defined as the ability to maintain clinical remission (CDAI <150) without the need for additional significant CD management.
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