NCT00063830已完成2 期
ISIS 2302-CS27, Phase 2, Double-Blinded, Controlled Study of Four Dosing Regimens of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
This is a multi-center trial in the US and Europe to test the safety, efficacy and tolerability of alicaforsen (ISIS 2302), a new type of drug called an antisense drug, in patients with mild to moderate active Ulcerative Colitis (UC). Alicaforsen is designed to reduce the production of a specific protein, called ICAM-1, a substance that plays a significant role in the increase of inflammation and is likely to be involved in inflammatory bowel diseases such as ulcerative colitis. The ISIS 2302-CS27 study will compare four dosing regimens and determine the minimum effective dose of alicaforsen enema in UC patients over six weeks as compared to a placebo enema. (The probability of receiving active formulation is 4:1). The primary objective of this study is to evaluate the percentage reduction in DAI at Week 6.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet the following criteria at screening to be eligible for enrollment:
- •Age greater than or equal to 18 years
- •Diagnosis of left-sided ulcerative colitis of at least 6 months duration
- •Current left-sided flare, defined as activity in the colon 5-50 cm from the anal verge, extending at least 15 cm proximal to the anal verge and confirmed by endoscopic evaluation within 14 days of baseline visit.
- •Baseline DAI score of 4-10 including abnormal endoscopic score
- •On at least one or more of the following treatments for ulcerative colitis prior to baseline visit:
- •Stable background oral mesalamine therapy for greater than or equal to 30 days, and/or
- •Stable background mercaptopurine for greater than or equal to 60 days prior to baseline, and/or
- •Stable azathiprine therapy for greater than or equal to 60 days prior to baseline
- •Written informed consent prior to performing screening evaluations.
排除标准
- •Patients who meet any of the following criteria at screening are not eligible for enrollment:
- •Bowel stricture, toxic megacolon, colonic dysplasia, adenoma or carcinoma
- •Patients with pancolitis
- •Uncontrolled hematologic, renal, hepatic, metabolic, psychiatric, CNS, pulmonary or cardiovascular disease, or sufficient level of disease that could interfere with the patient's ability to comply with protocol participation
- •Enteric pathogens or presence of Clostridium difficile toxin in stool
- •History of colon resection
- •Major surgical procedure within one month of baseline visit
- •Steroid or mesalamine enema within 14 days of baseline visit
- •Systemic steroids (including ACTH) within 30 days of baseline visit
- •Tumor necrosis factor-alpha (TNF-α) inhibitor treatment within 90 days of baseline visit
- •Non-steroidal anti-inflammatory agents (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors, within 14 days of baseline visit
- •Methotrexate, cyclosporin or thalidomide within 90 days of baseline visit
- •Any active infection currently requiring treatment
- •Malignancy within 5 years except for squamous cell or basal cell cancers of the skin
- •Current infectious, ischemic, or immunological disease with gastrointestinal involvement
- •ISIS 2302 treatment within 12 months of baseline visit
- •Treatment with an investigational or off-label drug within 90 days of screening or currently in long-term follow up for another investigational treatment protocol
研究者
研究点 (1)
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