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

Last updated: May 6, 2025
Sponsor: Sparrow Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Collagen Vascular Diseases

Polymyalgia Rheumatica (Pmr)

Connective Tissue Diseases

Treatment

Prednisolone 10mg

SPI-62 matched placebo

Additional prednisolone

Clinical Study ID

NCT05436652
SPI-62-CL-2003
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 atthe Baseline visit and is expected to remain stable during the treatment period

Exclusion

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 theBaseline 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 clinicaltrial participation expected to interfere with the conduct of the trial or theevaluation of its results.

Study Design

Total Participants: 66
Treatment Group(s): 5
Primary Treatment: Prednisolone 10mg
Phase: 2
Study Start date:
July 22, 2022
Estimated Completion Date:
April 25, 2025

Study 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.

Connect with a study center

  • Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie

    Berlin,
    Germany

    Site Not Available

  • Internistische Praxisgemeinschaft Rheumatologie . Nephrologie

    Erlangen,
    Germany

    Completed

  • Internistische Praxisgemeinschaft Rheumatologie Nephrologie

    Erlangen,
    Germany

    Site Not Available

  • Hamburger Rheuma Forschungszentrum II im MVZ für Rheumatologie und Autoimmunmedizin

    Hamburg,
    Germany

    Site Not Available

  • Katholische Kliniken Rhein-Ruhr am Marien Hospital, Universitätsklinik der Ruhr-Universität

    Herne,
    Germany

    Site Not Available

  • Unikliniken Köln

    Köln,
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes Gutenberg Universität Mainz

    Mainz,
    Germany

    Site Not Available

  • Praxis Prof. Dr. med. Herbert Kellner

    Munich,
    Germany

    Site Not Available

  • Prof. Dr. med. Herbert Kellner

    Munich,
    Germany

    Active - Recruiting

  • NovaReuma

    Białystok,
    Poland

    Site Not Available

  • The University of Gdańsk

    Gdansk,
    Poland

    Site Not Available

  • MICS Centrum Medyczne Warszawa

    Warszawa,
    Poland

    Site Not Available

  • Dolnośląski Szpital Specjalistyczny im. T. Marciniaka

    Wrocław,
    Poland

    Site Not Available

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