A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR)
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.
- EligibilityCriteria: Inclusion Criteria:  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  Exclusion Criteria:  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 - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult