NCT03409211已完成不适用
Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in % of Treg Cells in Blood
研究概览
简要总结
This is a proof-of-principle, placebo-controlled, open label study to assess the improvement in the Treg counts and PASI Scores with PEVCO given at 1000 mg four times daily in patients with PsO (subjects may or may not have PsA) , who have active disease and are not currently receiving other therapy (as defined by the inclusion/exclusion criteria) compared to healthy subjects.
The patients and healthy controls will receive placebo or PEVCO for a total of 9 weeks (3 weeks for placebo, followed by 6 weeks for PEVCO). No topical or systemic medications will be used during this period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have an active [psoriatric plaque >2cm
排除标准
- •History of sensitivity to study compound or any of their excipients
- •Previous intolerance to PEVCO or related compounds
- •Current (within 3 months of screening) treatment with DMARDs
- •Current (within 3 months of screening) treatment with biologic therapies (including but limited to anti-TNF,anti-IL-17, anti-IL-12/23)
- •Current antibiotic treatment (within 3 months of screening)
- •current consumption of probiotics (within 3 months of screening)
- •Severe hepatic impairment (eg, ac-sites and/or clinical signs of coagulopathy)
- •Renal failure (eGFR ,30 or require dialysis) by history
- •History of other autoimmune or inflammatory skin disease
- •Current immunodeficiency state (cancer, HIV, others)
- •Current immunodeficiency state (cancer, HIV, Other)
- •Concern for inability of the patient to comply with study procedure, and or follow up (alcohol or drug abuse)
结局指标
主要结局
Change in % of Treg Cells in Blood
时间窗: 6 Weeks
% change in the expansion of regulatory T cells; demonstrate an increase in %Treg at 6 weeks.
次要结局
- Increase in Medium Chain Fatty Acids (MCFA) content in the stool(12 Weeks)
- Improvement in skin disease severity PASI scores 50(12 Weeks)
- Improvement in skin disease severity PASI scores 75(12 Weeks)
- Improvement in skin disease severity PASI scores 90(12 Weeks)
- Improvement in the tender joint/swollen joint (TJ/SJ) counts at 6 weeks.(6 Weeks)
研究者
研究点 (1)
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