NCT00808262已完成1 期
A Phase I/II, Open-label, Escalating Dose, "Optimal Two-stage", Study of TNFα-Kinoid (TNF- K) Immunization in Crohn's Disease Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Neovacs
- 入组人数
- 21
- 试验地点
- 7
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
Evaluation of the safety and the immune response induced by active immunization through a TNFa kinoid in patients with Crohn's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have Active Crohn's Disease, as defined by a Crohn's Disease Activity Index (CDAI) score of >220 but ≤400, with active Crohn's disease of ileum and/or colon (Other areas may be involved if ileum and/or colon are also involved)based upon either endoscopic, histologic and/or radiographic evidence
- •Patients with active disease despite treatment with 5-ASAs or sulfasalazine, corticosteroids (prednisone, budesonide, other), AZA or 6-MP or cyclosporine or MTX or Tacrolimus, ; OR intolerant of 5-ASAs or sulfasalazine; or intolerant of antibiotics; or intolerant of corticosteroids (prednisone, budesonide, other); or intolerant of AZA or 6-MP or cyclosporine or MTX or Tacrolimus
- •Patients might have previously responded to any prior anti-TNF agents and then lost response OR might be intolerant of any prior anti-TNF agents
- •Positive skin reaction to challenge with Candida antigens
- •Written informed consent
排除标准
- •Prior history of tuberculosis or positive chest X ray or positive purified protein derivative skin test or positive interferon gamma TB assay
- •Signs or symptoms of clinically significant stricture of bowel.
- •Total parenteral nutrition or elemental diet required for treatment of disease or support of short bowel syndrome
- •Presence of an enteric stoma
- •Imminent or urgent surgery required for infection, abscess, bleeding or any other cause relating to their Crohn's Disease or other condition
- •History of malignancy. However, subjects with basal call carcinomas or less than 3 squamous cell carcinomas are allowed
- •History of asthma or serious allergic condition (including history of seafood allergy)
- •Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of study drug
- •History of opportunistic infection excluding oral candidiasis on steroids
- •Enteric infection as evidenced by positive stool C&S, O&P and C. difficile obtained during screening
- •Any significant or decompensated cardiac, neurologic, liver, pulmonary or renal disease
- •History of lymphoproliferative disorders
- •Clinically significant abnormal hematology values, as determined by the investigator, for hematocrit, hemoglobin, white blood cell count or platelets
- •Clinically significant abnormal blood chemistry values as determined by the investigator
- •Current significant drug or alcohol abuse as determined by the investigator
- •Positive for hepatitis C antibody or positive for hepatitis B surface antigen (HbsAg) or HIV infection
- •Surgery within the previous 3 months (other than minor cosmetic surgery or minor dental procedures)
- •Participation in a clinical study (including previous participation in this study) within the previous 4 months
- •Had a primary non-response to any prior anti-TNF agents as defined by the investigator OR received any prior anti-TNF agents within the past 8 weeks prior to study entry
- •Pregnancy and lactation
结局指标
主要结局
Incidence and severity of adverse events
时间窗: Whole study period
次要结局
- Antibody response(Day 38)
研究者
研究点 (7)
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