NL-OMON46166已完成2 期
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 - LUX
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Diagnosis of ileal, ileo-colonic, or colonic CD for > 3 months prior to
- •- 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-TNF* 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
排除标准
- •-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
研究者
相似试验
进行中（未招募）
1 期
A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyMedDRA version: 18.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersCrohn's DiseaseEUCTR2015-000609-38-BEMedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UK342
进行中（未招募）
1 期
A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersCrohn's DiseaseEUCTR2015-000609-38-GBAllergan Limited29
进行中（未招募）
1 期
A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersCrohn's DiseaseEUCTR2015-000609-38-BGAllergan Limited342
进行中（未招募）
1 期
A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyCrohn's DiseaseEUCTR2015-000609-38-ESMedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UK342
进行中（未招募）
1 期
A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyMedDRA version: 18.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersCrohn's DiseaseEUCTR2015-000609-38-CZMedImmune Limited342