Open-Label Study to Assess the Safety and Efficacy of Apremilast in Patients With Chronic Plaque Psoriasis Who Have Failed One Course of Biologic Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Safety/efficacy of apremilast in CPP pts that have failed 1 course of biologic therapy
研究概览
简要总结
This is a Phase II, open label, investigator-initiated study to be done at Duke University Medical Center to treat adult patients (ages 18-80) with chronic plaque psoriasis who have failed Biologic Therapy with Apremilast 30 mg BID for 24 weeks. At the time of enrollment, the patient must have received biologic therapy without achieving a response of "almost clear" or "clear" according to PGA or has not responded with a 75% reduction of PASI score. Once deemed eligible, subjects will return for a baseline visit and receive Apremilast therapy and instructions. Subjects will be treated at weeks 0,4,8,12,16,20 and 24; subjects will be evaluated 28 days after last dose of Apremilast for safety and efficacy.
详细描述
Data Analysis Data will be analyzed and reported after all subjects have completed follow-up phase of study. All subsequent data collected will be analyzed and reported in a follow-up clinical report.
Data & Safety Monitoring Dr. Murray will be following all laboratory values and adverse events during this trial. In addition, Celgene will provide a study monitor to, at regular intervals, review all data. All data will be reported to Celgene.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18-80 yrs diagnosed with moderate-to-severe chronic plaque psoriasis with a PGA of 3 or greater and require systemic therapy
- •Must have received a biologic therapy for CPP and did not achieve a PGA of 'almost clear' or 'clear'
- •Must meet lab criteria per Pg 20-21 of protocol
- •All subjects must follow contraceptive measures as described in protocol, Pg 21.
排除标准
- •Abnormal Chest x-ray
- •Significant abnormality of ECG
- •Positive HIV Ab, Hepatitis B & C
- •Subjects with erythrodermic, pustular or guttate psoriasis are ineligible
- •Serious local infection or systemic infection, or tuberculosis within 3 mos of first dose of apremilast
研究组 & 干预措施
apremilast for all subjects
干预措施: apremilast (Drug)
结局指标
主要结局
Safety/efficacy of apremilast in CPP pts that have failed 1 course of biologic therapy
时间窗: 6 mos. treatment and 1 month F/U post treatment
次要结局
- Mechanistic studies performed to assess efficacy of apremilast to inhibit inflammatory responses in non-involved, mildly traumatized skin.(Treatment course of 6 months)