SUBCUTANEOUS RHUIL 10 IN SUBJECTS W/ STEROID DEPENDENT CROHNS DISEASE

克罗恩病(CD)是一种慢性炎症性肠病(IBD)，可影响从口腔到肛门的任何一段胃肠道。CD是一种病态的、具有潜在破坏性的疾病。细胞因子及其炎性和调节活性很可能在克罗恩病的持久存在以及可能的炎症启动中发挥作用。虽然糖皮质激素在改善CD患者的症状方面非常有效，但类固醇脱机是具有挑战性的，治疗结束后可能会出现早期复发。还有一种尚未得到满足的医学需求，即帮助受试者摆脱类固醇的治疗。几项研究表明，SCH 52000给药在CD受试者中的大量人群中是安全和耐受性良好的。此外，动物模型支持IL-10用于不太活跃的疾病。这项研究的假设是SCH 52000(rHulL-10)是一种有效的治疗方法，可用于类固醇依赖型克罗恩病患者的脱机治疗。具体目的1.初步目的评价皮下注射SCH 52000(rHulL-10)治疗类固醇依赖型克罗恩病的安全性、耐受性和有效性。*疗效将被定义为在第16周前使受试者摆脱类固醇的能力，并在28周的治疗结束时保持临床缓解(CDAI&lt；150)，而不需要额外的重大CD管理。两个剂量的SCH 52000(4微克/公斤和8微克/公斤)，每日一次(Qd)，作为SC注射，连续2周，然后每周三次(Tiw)，共26周，与安慰剂进行比较。2.次级目标1.评估SCH 52000在16周前撤除类固醇的能力。2.评估治疗失败的时间。如果在治疗阶段发生以下任何一种情况，受试者将被认为是治疗失败：*不能在第16周前停用类固醇。*需要将类固醇剂量增加到基线以上。*需要额外的重要治疗方法来管理克罗恩病*因不良事件而停止治疗(S)。*CDAI&GT；150，第28周。3.评估SCH 52000在治疗28周末和随访8周时对健康相关生活质量的影响。4.在8周随访时评估有效率。有效率将被定义为维持临床缓解(CDAI150)的能力，而不需要额外显著的CD管理。

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.