A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 5
- 主要终点
- Plasma fibrinogen
研究概览
简要总结
This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited.
详细描述
This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited.
Patients diagnosed with PMR whose PMR symptoms do not vary in intensity or frequency to the degree that a clinically indicated increase in prednisolone prescription might be anticipated will be included in the trial.
Participants will continue to receive prednisolone and will receive SPI-62 from Days 3-16
Inflammatory biomarkers, symptom measures, biomarkers of prednisolone toxicity, PK of prednisolone and SPI-62, and biomarkers of SPI-62 pharmacological activity will be measured on Days 2, 3, and 16. ABPM will be monitored on days 1 and 15.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Diagnosis of PMR according to European League Against Rheumatism and American College of Rheumatology classification criteria confirmed by a rheumatologist
- •Absence of PMR relapse based on symptoms and acute phase markers
- •Daily oral prednisolone 10, 12.5, 15, 17.5, or 20 mg dose that will have been stable for at least 7 days prior to Day 1
排除标准
- •Any contraindication for prednisolone administration
- •A diagnosis or any clinical features of giant cell arteritis
- •Any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than PMR
- •Use of medications for treatment of PMR other than oral prednisolone within specified intervals prior to Day 1 and during the treatment period
- •Use of other medications likely to interfere with trial assessments
- •History or diagnosis of endogenous hypercortisolism
- •Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the trial or the evaluation of its results
研究组 & 干预措施
prednisolone + SPI-62
Participants will receive prednisolone throughout the trial and SPI-62 on days 3-16.
干预措施: Prednisolone (Drug)
prednisolone + SPI-62
Participants will receive prednisolone throughout the trial and SPI-62 on days 3-16.
干预措施: SPI-62 (Drug)
结局指标
主要结局
Plasma fibrinogen
时间窗: Baseline to Day 28
Erythrocyte sedimentation rate
时间窗: Baseline to Day 28
C-reactive protein
时间窗: Baseline to Day 28
次要结局
未报告次要终点