NCT01622348已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, 4-week Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 13
- 主要终点
- Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment
研究概览
简要总结
The purpose of this study is to evaluate different dose levels of IMO-3100 compared to placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.
详细描述
To evaluate the safety, tolerability and treatment effect of different dose levels of IMO-3100 compared to placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Is age 18 to 70 years, inclusive;
- •Completes the informed consent procedure (see Section 15.3), including signing and dating the informed consent form;
- •Has moderate to severe plaque psoriasis meeting the criteria specified above;
- •Female subjects must have a negative pregnancy test at screening and on Day 1 prior to start of treatment;
- •Female subjects of childbearing potential (see Section 8.4.1) and male subjects who have partners of childbearing potential must agree to use effective birth control (contraception; see Section 8.4.1) from Screening through the treatment period and for four (4) weeks after the last injection of study drug.
排除标准
- •Has known hypersensitivity to any oligodeoxynucleotide;
- •Is nursing;
- •Has body weight < 50 kg;
- •Has BMI > 34.9 kg/m2;
- •Regularly consumes > 3 drinks of alcoholic beverages (beer, wine, or distilled spirits) per day;
- •Has a positive test for antibody to human immunodeficiency virus (HIV-1 or -2) or hepatitis C virus;
- •Has a positive test for hepatitis B surface antigen (HBsAg);
- •Has at screening safety laboratory tests meeting one or more of the following criteria:
- •hemoglobin < 10.5 g/dL
- •white blood cell count < 4,000 cells/mm3
- •absolute neutrophil count (ANC) < 1500/mm3
- •platelet count < 100,000/mm3
- •alanine transaminase (ALT; SGPT) > 1.5x ULN
- •aspartate transaminase (AST; SGOT) > 1.5x ULN
- •serum total bilirubin > 1.4x ULN
- •serum creatinine > 1.3x ULN;
- •Has a history of allogeneic organ transplant (including bone marrow or stem cells);
- •Has, within the past 10 years, had evidence of or required treatment for cancer (except treated basal or squamous cell carcinoma of the skin or cured cervical carcinoma-in-situ);
- •Has had within the past three months or is expected to have during the study period any of the following treatments:
- •surgery requiring general anesthesia
- •hematopoietic stimulating agents (e.g., erythropoietin, G-CSF, GM-CSF)
- •another investigational drug;
- •Has other significant medical disease (chronic or active within the past 6 months), including, but not limited to: cardiac disease (e.g., unstable angina, myocardial infarction, congestive heart failure, ventricular arrhythmia); uncontrolled seizure disorder; liver disease; chronic infection (e.g., tuberculosis); uncontrolled diabetes;
- •Has any other condition that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial.
研究组 & 干预措施
Placebo
Placebo Comparator
Saline for Injection
干预措施: Saline for Injection (Drug)
IMO-3100 at 0.16 mg/kg
Active Comparator
IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection
干预措施: IMO-3100 at 0.16 mg/kg (Drug)
IMO-3100 at 0.32 mg/kg
Active Comparator
IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection
干预措施: IMO-3100 at 0.32 mg/kg (Drug)
结局指标
主要结局
Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment
时间窗: 8 weeks
The change from pre-treatment baseline to End-of-Treatment (EOT) in the epidermal thickness of the index lesion
次要结局
未报告次要终点
研究者
研究点 (13)
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