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

May 6, 2025 updated by: Sparrow Pharmaceuticals
This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie
      • Erlangen, Germany
        • Internistische Praxisgemeinschaft Rheumatologie Nephrologie
      • Hamburg, Germany
        • Hamburger Rheuma Forschungszentrum II im MVZ für Rheumatologie und Autoimmunmedizin
      • Herne, Germany
        • Katholische Kliniken Rhein-Ruhr am Marien Hospital, Universitätsklinik der Ruhr-Universität
      • Mainz, Germany
        • Universitätsmedizin der Johannes Gutenberg Universität Mainz
      • Munich, Germany
        • Praxis Prof. Dr. med. Herbert Kellner
  • Poland
      • Białystok, Poland
        • NovaReuma
      • Gdansk, Poland
        • The University of Gdańsk
      • Warszawa, Poland
        • MICS Centrum Medyczne Warszawa
      • Wrocław, Poland
        • Dolnośląski Szpital Specjalistyczny im. T. Marciniaka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPI-62
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
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
Experimental: SPI-62 + additional prednisolone
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Erythrocyte sedimentation rate
Time Frame: Baseline to Day 28
Baseline to Day 28
C-reactive protein
Time Frame: Baseline to Day 28
Baseline to Day 28
Plasma fibrinogen
Time Frame: Baseline to Day 28
Baseline to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sparrow Pharmaceuticals

Investigators

  • Study Chair: David Katz, Sparrow Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2022

Primary Completion (Actual)

April 25, 2025

Study Completion (Actual)

April 25, 2025

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

June 23, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPI-62-CL-2003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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