NCT01294774已完成2 期
A Multi-center, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy and Tolerability of KRP203 in Patients With Active Subacute Cutaneous Lupus Erythematosus
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
- 10
- 试验地点
- 1
- 主要终点
- Efficacy of KRP203 in reduction of severity of symptoms, as measured using the activity score of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
研究概览
简要总结
This study will assess the safety and efficacy of KRP203 in clinically active subacute cutaneous lupus erythematosus patients, who have demonstrated inadequate response to standard treatment, such as antimalarials.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients,18 to 65 years of age inclusive, who have been defined as having SCLE based on the typical clinical picture and the characteristic histopathological features as described by Sontheimer et al. at least three months before study entry (screening)
排除标准
- •Patients with preexisting nephritis, central nervous or pulmonary involvement or any major internal organ damage, either related or unrelated to lupus, which are deemed by the Investigator to be clinically significant. Patients having signs or symptoms of other autoimmune diseases such as systemic lupus erythematosus or Sjogren's syndrome are allowed to enter the study at the Investigator's discretion.
- •Patients who have been treated with:
- •immunoglobulins and/or monoclonal antibodies within 6 months prior to randomization.
- •rituximab, cyclophosphamide, or other immunosuppressive treatments with effects potentially lasting over 6 months, within 12 months prior to randomization.
- •a medium or high dose (≥ 1 mg prednisone or equivalent per body weight kg) corticosteroid therapy in the last 8 weeks prior to randomization.
- •antimalarial agents (hydroxychloroquine, chloroquine or quinacrine) in the last 6 weeks prior to randomization.
- •biologic therapies, such as etanercept, within the last 4 weeks prior to randomization.
- •any other immunosuppressive or immunomodulatory therapy such as methotrexate, azathioprine, cyclosporin A or mycophenolate, thalidomide, retinoids or dapsone in the last 4 weeks prior to randomization.
- •total lymphoid irradiation or bone marrow transplantation.
- •Pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
KRP203 - 1.2 mg
Experimental
干预措施: KRP203 - 1.2mg (Drug)
Placebo to KRP203 - 1.2 mg
Placebo Comparator
干预措施: Placebo to KRP203 - 1.2 mg (Drug)
结局指标
主要结局
Efficacy of KRP203 in reduction of severity of symptoms, as measured using the activity score of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
时间窗: 12 weeks
次要结局
- Safety and tolerability of oral KRP203 in patients with subacute cutaneous lupus erythematosus(12 weeks)
- Steady-state blood concentrations of KRP203 and KRP203-Phosphate (KRP203-P) in SCLE patients(12 weeks)
- Changes in the activity of SCLE using visual analogue scales for global skin health as assessed by the physician and the patient(12 weeks)
- Measure the systemic features of SCLE using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)(12 weeks)
研究者
研究点 (1)
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