NCT02733094已完成1 期
Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum
Technical University of Munich1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change of the Physician's global assessment
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of anti-Interleukin-(IL)17 therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration until week 16) for the treatment of pyoderma gangrenosum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Pyoderma gangrenosum
- •Biopsy-proven, non-healing ulcer with primarily neutrophil infiltration, regardless of size and location
- •Characterization of target lesion (size, PGA, duration)
- •18-75 years of age
- •Body weight ≥ 40 kg and ≤ 160 kg
- •Signed informed consent
排除标准
- •Permanent severe diseases, especially those affecting the immune system
- •Pregnancy or breast feeding
- •History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
- •Myocardial infarction or cardiac arrhythmia which requires drug therapy
- •Evidence of severe renal dysfunction or significant hepatic disease
- •History of irritable bowel disease
- •History of lymphoproliferative disorders
- •Evidence for active infection including but not limited to active tuberculosis, HIV or hepatitis B/C that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
- •History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
研究组 & 干预措施
Open-label
Experimental
300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 2 weeks until week 32.
干预措施: Secukinumab (Drug)
结局指标
主要结局
Change of the Physician's global assessment
时间窗: Week 16
The primary response parameter change of the physician global assessment (PGA) 5-point scale at week 16 as compared to week 0.
次要结局
- Assessment of patient's quality of life(Week 2, 4, 8, 16, 28, 40)
- Measurement of serum C reactive protein (mg/dl)(Week 2, 4, 8, 16, 28, 40)
- Change in surface area of lesions of pyoderma gangrenosum (two-dimensional surface in mm²)(Week 2,3,8,16,28,40)
- Measurement of leukocyte counts (x10.e3/µl)(Week 2, 4, 8, 16, 28, 40)
- Measurement of blood sedimentation rate (mm/h)(Week 2, 4, 8, 16, 28, 40)
- Immunohistochemical analysis of IL-17+ immune cells(Week 16)
研究者
研究点 (1)
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