This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in subjects with PMR. Up to 4 cohorts of 12 subjects could be recruited (12 to 48 subjects). Each subject 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 subjects 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 4, the dose of prednisolone co-administered with SPI-62 could be adjusted.
This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in subjects with PMR.