NCT01434576撤回1 期
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacodynamics and Safety of HGS1025, a Human Monoclonal Anti-CCR5 Antibody, in Subjects With Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Pharmacodynamics (serum & tissue biological markers; CCR5 receptor occupancy)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacodynamics, safety, and pharmacokinetics of HGS1025 in patients with moderate to severe ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults at least 18 years of age
- •Active, moderate to severe ulcerative colitis (UC) confirmed by endoscopy
- •Currently on 1 or more of the following UC treatment medications: 5-aminosalicylates (5-ASA), corticosteroids, azathioprine, 6-mercaptopurine (6MP), and/or other immunosuppressive or immunomodulatory agents including cyclosporine, tacrolimus, methotrexate, and mycophenolic acid
- •Not pregnant or nursing
- •Females of non-childbearing potential or females of childbearing potential must be willing to practice abstinence from intercourse from 2 weeks prior to first dose of study agent and for 8 weeks after the last dose of study agent or use effective contraception for 1 month prior to the 1st dose of study agent and through 8 weeks after the last dose of study agent
- •Males must agree to use effective contraception throughout the study and for 8 weeks after the last dose of study agent
- •Have the ability to provide informed consent and comply with study procedures
排除标准
- •Received any of the following within 60 days of the first dose of study agent: Anti-TNFα therapy; integrin receptor antagonist; intravenous immunoglobulin; high dose prednisone or prednisone equivalent (greater than 60 mg/day); any investigational agent including immunosuppressive/immunomodulatory or non-biologic agents
- •Have had a change in corticosteroid, 5-ASA, or other immunosuppressive/immunomodulatory agents within 30 days of Day 0
- •History of liver disease
- •History of a major organ transplant
- •History of prior large bowel resection
- •Current unstable or uncontrolled acute or chronic diseases not due to UC
- •History of malignant neoplasm within the last 5 years, except for some types of adequately treated cancers of the skin or carcinoma in situ of the uterine cervix
- •Current or recent drug or alcohol abuse or dependence
- •History of a positive test for HIV or test positive for Hepatitis B (HBsAg) or Hepatitis C
- •Have a history of severe drug allergies
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
HGS1025 2 mg/kg
Experimental
干预措施: HGS1025 (Biological)
HGS1025 10 mg/kg
Experimental
干预措施: HGS1025 (Biological)
结局指标
主要结局
Pharmacodynamics (serum & tissue biological markers; CCR5 receptor occupancy)
时间窗: 8 weeks
Change in CCR5 properties; change in inflammatory markers in blood and colon.
Clinical Response
时间窗: 8 weeks
Decrease in Mayo Score and rectal bleeding.
次要结局
- Type, frequency, and severity of adverse events(Through 8 weeks after the last dose of study agent)
- Clinical response(4 weeks)
- Clinical remission(4 weeks & 8 weeks)
- Mucosal healing(4 weeks & 8 weeks)
研究者
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