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

NCT05436652 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-05-11

No results posted yet for this study

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.

Conditions

  • Polymyalgia Rheumatica

Interventions

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

Sponsors & Collaborators

  • Sparrow Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • David Katz · Sparrow Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2025-04-25
Completion
2025-04-25
FDA Drug
Yes

Countries

  • Germany
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05436652 on ClinicalTrials.gov