Antibody To Il12 For Treatment of Crohn's Disease

本研究的目的是确定抗IL-12抗体治疗活动期克罗恩病的安全性和有效性。在这一年中，我们筛选了11名受试者，并招募了8名受试者参加这项方案。所有患者都顺利完成了治疗阶段，目前正在跟进中。两名受试者在最后一次服用研究药物12周后病情恶化，并被转移到标准治疗。这项研究使用了安慰剂对照的双盲设计，但80%的登记受试者获得了活性化合物。假设大多数受试者接受了活性化合物，我们观察到在服用研究药物后，疾病的临床症状显著改善，疾病的内窥镜外观改善，以及结肠粘膜炎性效应细胞凋亡的证据。这项研究仍在继续招募受试者，目前还没有中期数据分析。数据安全监测委员会最近对该协议的审查给出了继续进行研究而不进行修改的建议。

The purpose of this study is to determine the safety and efficacy of anti-IL-12 antibody therapy in active Crohn's disease. During this year we screened 11 and enrolled 8 subjects in this protocol. All successfully completed the treatment phase, and are now in follow-up. Two subjects had exacerbations of their disease 12 weeks after the last dose of study drug, and were transferred to standard therapy. This study uses a placebo-controlled, double-blind design, but 80% of enrolled subjects get the active compound. Assuming a majority of subjects received the active compound, we have observed significant improvement in clinical symptoms of disease, improvement of the endoscopic appearance of disease, and evidence of colonic mucosal inflammatory effector cell apoptosis following administration of the study drug. The study is continuing to enroll subjects, and no interim data analysis is available. A recent Data Safety Monitoring Board review of this protocol gave recommendations to proceed with the study without modifications.