A Phase 2a, Open-label Study of Visilizumab in Patients With Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Clinical response, defined as a 100-point or more decrease in Crohn's Disease Activity Index, without an accompanying increase in dose of concomitant medications, additional medications, or Crohn's Disease-related surgery.
研究概览
简要总结
The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat moderate to severe inflammatory, nonstricturing, nonpenetrating Crohn's disease. The research is being conducted at up to 5 clinical research sites in the US and Europe and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site up to 17 months. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.
Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances) that is directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing so, it may prevent them from causing inflammation. Visilizumab has also been observed to have a suppressive effect on the body's immune system (system in the body that reacts to foreign or occasionally one's own proteins).
详细描述
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years old
- •Diagnosis of moderate-to-severe inflammatory, nonstricturing, nonpenetrating Crohn's disease, defined as Crohn's Disease Activity Index greater than or equal to 250, C-reactive protein greater than or equal to upper limit of normal, and endoscopic evidence of moderate-to-severe active inflammatory disease
- •Test negative for Clostridium difficile within 3 weeks
- •Signed informed consent, including permission to use protected health information
排除标准
- •History of lymphoproliferative disorder or prior malignancy within 5 years or current malignancy
- •Pregnant or nursing
- •HIV, Hepatitis B or Hepatitis C infection
- •Presence of obstructive symptoms, confirmed by endoscopy
- •Serious infections within 12 months
- •Active infections that require antibiotic therapy
- •Started or changed dose of sulfasalazine, 5-aminosalicylic acid; or antibiotics, probiotics, or topical therapies for Crohn's within 2 weeks
- •Serious infections that required IV antibiotic therapy or hospitalization within 8 weeks
- •Increase dose of corticosteroid medication within 2 weeks
- •Received a live vaccine within 6 weeks
- •Received any monoclonal antibodies or investigational agents within 3 months
- •Received cyclosporine or tacrolimus (FK506) within 4 weeks
- •Dose change or discontinuation from 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks
- •Significant organ dysfunction
- •Likely to require surgery in the next 6 months
- •History of lymphoproliferative disorder
- •History of tuberculosis or mycobacteria infection or positive chest x-ray
- •History of thrombophlebitis or pulmonary embolus
- •History of immune deficiency or autoimmune disorders other than Crohn's
- •History of subtherapeutic blood levels of anticonvulsive medications within 1 week
结局指标
主要结局
Clinical response, defined as a 100-point or more decrease in Crohn's Disease Activity Index, without an accompanying increase in dose of concomitant medications, additional medications, or Crohn's Disease-related surgery.
次要结局
- Frequency of clinical remission, duration of effect, endoscopic evidence of mucosal healing, change in C-reactive protein levels, pharmacokinetics, and immunogenicity.