A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 10
- 主要终点
- Erythrocyte sedimentation rate
研究概览
简要总结
This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR.
详细描述
This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR. Up to 6 cohorts of 12 participants could be recruited (12 to 72 participants). Each participant who provides consent and meets all inclusion and exclusion criteria will participate in 3 periods: a screening period up to 28 days (Day -28 to Day-1), a 4-week treatment period (Day 1 to Day 28) and a follow up Period (Day 29 to Day 56). During the 4-week treatment period for the first cohort, all participants will receive prednisolone 10mg per day for 4-weeks plus SPI-62 for 2-weeks and matching placebo for 2-weeks. For cohorts 2 through 6, the dose of prednisolone co-administered with SPI-62 could be adjusted. For cohorts 5 and 6, the dose of SPI-62 could be adjusted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Drug and Placebo are masked and assigned via Interactive Response Technology (IRT)
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 EULAR/ACR classification criteria
- •Absence of PMR relapse based on symptoms and acute phase markers
- •Daily oral prednisolone 10mg dose that will have been stable for at least 1-week at the Baseline visit and is expected to remain stable during the treatment period
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 within specified intervals prior to the Baseline Visit other than oral prednisolone.
- •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
SPI-62
Active drug / placebo by mouth each morning for up to 4 weeks + standard of care 10mg prednisolone. Each participant will receive both placebo and active drug but will be blinded to the sequence of active drug and placebo.
干预措施: SPI-62 (Drug)
SPI-62
Active drug / placebo by mouth each morning for up to 4 weeks + standard of care 10mg prednisolone. Each participant will receive both placebo and active drug but will be blinded to the sequence of active drug and placebo.
干预措施: SPI-62 matched placebo (Drug)
SPI-62
Active drug / placebo by mouth each morning for up to 4 weeks + standard of care 10mg prednisolone. Each participant will receive both placebo and active drug but will be blinded to the sequence of active drug and placebo.
干预措施: Prednisolone 10mg (Drug)
SPI-62 + additional prednisolone
Active drug / placebo by mouth each morning for up to 4 weeks + standard of care 10mg prednisolone + additional prednisolone or placebo. Each participant will receive both placebo and active drug but will be blinded to the sequence of active drug and placebo.
干预措施: SPI-62 (Drug)
SPI-62 + additional prednisolone
Active drug / placebo by mouth each morning for up to 4 weeks + standard of care 10mg prednisolone + additional prednisolone or placebo. Each participant will receive both placebo and active drug but will be blinded to the sequence of active drug and placebo.
干预措施: SPI-62 matched placebo (Drug)
SPI-62 + additional prednisolone
Active drug / placebo by mouth each morning for up to 4 weeks + standard of care 10mg prednisolone + additional prednisolone or placebo. Each participant will receive both placebo and active drug but will be blinded to the sequence of active drug and placebo.
干预措施: Prednisolone 10mg (Drug)
SPI-62 + additional prednisolone
Active drug / placebo by mouth each morning for up to 4 weeks + standard of care 10mg prednisolone + additional prednisolone or placebo. Each participant will receive both placebo and active drug but will be blinded to the sequence of active drug and placebo.
干预措施: Additional prednisolone (Drug)
SPI-62 + additional prednisolone
Active drug / placebo by mouth each morning for up to 4 weeks + standard of care 10mg prednisolone + additional prednisolone or placebo. Each participant will receive both placebo and active drug but will be blinded to the sequence of active drug and placebo.
干预措施: Additional prednisolone matched placebo (Drug)
结局指标
主要结局
Erythrocyte sedimentation rate
时间窗: Baseline to Day 28
Plasma fibrinogen
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