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

• Status: Not yet recruiting
• Trial end date: 2023-12-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sparrow Pharmaceuticals
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• 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

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 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.