A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy

Allergan Limited0 个研究点目标入组 29 人开始时间: 2018年5月10日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•-Diagnosis of ileal, ileo-colonic, or colonic CD for > 3 months prior to screening
•- Men or women age 18 - 80 years at the time of screening
•- Moderate to severely active CD, as defined by CDAI AND endoscopic demonstration of inflammation
•- Stable dose of medications for Crohn’s disease therapy
•- Prior treatment failure or intolerance with at least one anti-TNFa agent
•-Effective contraception from screening, and for 26 weeks after the last dose of investigational product
•-No known history of active tuberculosis (TB) & negative assessment for TB/latent TB
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 308
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 34

•-Severe underlying immunosuppression
•- Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation
•- Significant infections at screening; Infected abscess, positive for Clostridium difficile, recent infectious hospitalization,
•-Recent treatment with approved or investigational biologic therapy for Crohn’s disease
•- Recent or planned live attenuated vaccine
•- History of cancer, except for basal cell carcinoma or CIS of the cervix with apparent cure = 12 months before screening
•- Pregnancy/breast feeding
•- Drug abuse

发起方