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），可以影响从口腔到肛门的胃肠道的任何部分。乳糜泻是一种病态且具有潜在毁灭性的疾病。细胞因子与它们的炎症以及调节活动可能在克罗恩病炎症的持续和可能的开始中发挥作用。虽然皮质类固醇对改善乳糜泻患者的症状非常有效，但停用类固醇具有挑战性，治疗结束后可能会出现早期复发。有一个未被满足的医学需求，以帮助受试者脱离类固醇治疗。几项研究表明，在大量乳糜泻患者中，使用SCH 52000是安全且耐受性良好的。此外，动物模型支持IL-10用于不太活跃的疾病。本研究的假设是SCH 52000 （rhll -10）是一种有效的治疗方法，可以使克罗恩病依赖类固醇的患者从皮质类固醇中断奶。1.具体目标主要目的评价类固醇依赖性克罗恩病患者皮下注射SCH 52000 （rhll -10）的安全性、耐受性和有效性。*疗效将被定义为受试者在第16周前摆脱类固醇的能力，并在28周治疗结束时保持临床缓解（CDAI <150），而无需额外的重大CD管理。将评估两种剂量的SCH 52000（4.0和8.0 mcg/kg）作为SC注射每天一次（QD），持续2周，然后每周三次（TIW），持续26周。2. 第二目标评估SCH 52000在第16周前使受试者戒断类固醇的能力。2. 评估治疗失败的时间。如果在治疗阶段发生以下任何情况，受试者将被视为治疗失败：*无法在第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来管理克罗恩病*由于不良事件而停药。*第28周，CDAI >150。3. 评估SCH 52000在治疗28周和随访第8周时对健康相关生活质量（HQL）的影响。4. 评估随访第8周的有效率。缓解将被定义为维持临床缓解（CDAI <150）的能力，而不需要额外的重大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.