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

NCT05436652 | Completed Phase 2 FDA Drug

• 1 other identifier: SPI-62-CL-2003
• Study Type: interventional
• Target: 66
• Locations: 2 countries
• Sites: 10

Brief 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

Keywords

polymyalgia rheumatica; PMR; Steroids; Prednisolone; glucocorticoid; glucocorticoids

Outcome Measures

Primary Outcomes (3)

• Erythrocyte sedimentation rate

  Baseline to Day 28

• C-reactive protein

  Baseline to Day 28

• Plasma fibrinogen

  Baseline to Day 28

Study Arms (2)

SPI-62

EXPERIMENTAL

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; Drug: SPI-62 matched placebo; Drug: Prednisolone 10mg

SPI-62 + additional prednisolone

EXPERIMENTAL

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; Drug: SPI-62 matched placebo; Drug: Prednisolone 10mg; Drug: Additional prednisolone; Drug: Additional prednisolone matched placebo

Interventions

SPI-62 DRUG

11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor

SPI-62; SPI-62 + additional prednisolone

SPI-62 matched placebo DRUG

Inactive tablets identical in appearance to SPI-62 tablets

SPI-62; SPI-62 + additional prednisolone

Prednisolone 10mg DRUG

Standard of care prednisolone

SPI-62; SPI-62 + additional prednisolone

Additional prednisolone DRUG

Over encapsulated prednisolone

SPI-62 + additional prednisolone

Additional prednisolone matched placebo DRUG

Inactive capsules identical in appearance to over encapsulated prednisolone

SPI-62 + additional prednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sparrow Pharmaceuticals: lead

Study Sites (10)

Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie

Berlin, Germany

Location

Internistische Praxisgemeinschaft Rheumatologie Nephrologie

Erlangen, Germany

Location

Hamburger Rheuma Forschungszentrum II im MVZ für Rheumatologie und Autoimmunmedizin

Hamburg, Germany

Location

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

Herne, Germany

Location

Universitätsmedizin der Johannes Gutenberg Universität Mainz

Mainz, Germany

Location

Praxis Prof. Dr. med. Herbert Kellner

Munich, Germany

Location

NovaReuma

Bialystok, Poland

Location

The University of Gdańsk

Gdansk, Poland

Location

MICS Centrum Medyczne Warszawa

Warsaw, Poland

Location

Dolnośląski Szpital Specjalistyczny im. T. Marciniaka

Wroclaw, Poland

Location

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• David Katz

  Sparrow Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Drug and Placebo are masked and assigned via Interactive Response Technology (IRT)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: July 22, 2022
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6); PL (4)