NCT05436652

A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Sparrow Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR.

Detailed description

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.

Conditions

• Polymyalgia Rheumatica

Interventions

Type	Name	Description
DRUG	SPI-62	11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor
DRUG	SPI-62 matched placebo	Inactive tablets identical in appearance to SPI-62 tablets
DRUG	Prednisolone 10mg	Standard of care prednisolone
DRUG	Additional prednisolone	Over encapsulated prednisolone
DRUG	Additional prednisolone matched placebo	Inactive capsules identical in appearance to over encapsulated prednisolone

Timeline

• Start date: 2022-07-22
• Primary completion: 2025-04-25
• Completion: 2025-04-25
• First posted: 2022-06-29
• Last updated: 2025-05-11

Locations

10 sites across 2 countries: Germany, Poland

Regulatory

• FDA-regulated drug study