A Phase 2 interventional study of SPI-62 and SPI-62 matched placebo in Polymyalgia Rheumatica, sponsored by Sparrow Pharmaceuticals. Completed at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Sparrow Pharmaceuticals · Phase 2, Interventional, and Treatment
This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR.
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.
Exclusion Criteria:
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.
Drug: SPI-62 · Drug: SPI-62 matched placebo · Drug: Prednisolone 10mg
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.
Drug: SPI-62 · Drug: SPI-62 matched placebo · Drug: Prednisolone 10mg · Drug: Additional prednisolone · Drug: Additional prednisolone matched placebo
11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor
Inactive tablets identical in appearance to SPI-62 tablets
Standard of care prednisolone
Over encapsulated prednisolone
Inactive capsules identical in appearance to over encapsulated prednisolone
Erythrocyte sedimentation rate
Time frame: Baseline to Day 28
C-reactive protein
Time frame: Baseline to Day 28
Plasma fibrinogen
Time frame: Baseline to Day 28
Plan to share: No
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Sparrow Pharmaceuticals