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

NCT ID: NCT05436652

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-22
• Study Completion Date: 2025-04-25

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.

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.

Conditions

Polymyalgia Rheumatica

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

SPI-62

Intervention Type: DRUG

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

SPI-62 matched placebo

Intervention Type: DRUG

Inactive tablets identical in appearance to SPI-62 tablets

Prednisolone 10mg

Intervention Type: DRUG

Standard of care prednisolone

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.

Group Type: EXPERIMENTAL

SPI-62

Intervention Type: DRUG

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

SPI-62 matched placebo

Intervention Type: DRUG

Inactive tablets identical in appearance to SPI-62 tablets

Prednisolone 10mg

Intervention Type: DRUG

Standard of care prednisolone

Additional prednisolone

Intervention Type: DRUG

Over encapsulated prednisolone

Additional prednisolone matched placebo

Intervention Type: DRUG

Inactive capsules identical in appearance to over encapsulated prednisolone

Interventions

SPI-62

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

Intervention Type: DRUG

SPI-62 matched placebo

Inactive tablets identical in appearance to SPI-62 tablets

Intervention Type: DRUG

Prednisolone 10mg

Standard of care prednisolone

Intervention Type: DRUG

Additional prednisolone

Over encapsulated prednisolone

Intervention Type: DRUG

Additional prednisolone matched placebo

Inactive capsules identical in appearance to over encapsulated prednisolone

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sparrow Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Katz

Role: STUDY_CHAIR

Sparrow Pharmaceuticals

Locations

Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie

Berlin, , Germany

Internistische Praxisgemeinschaft Rheumatologie Nephrologie

Erlangen, , Germany

Hamburger Rheuma Forschungszentrum II im MVZ für Rheumatologie und Autoimmunmedizin

Hamburg, , Germany

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

Herne, , Germany

Universitätsmedizin der Johannes Gutenberg Universität Mainz

Mainz, , Germany

Praxis Prof. Dr. med. Herbert Kellner

Munich, , Germany

NovaReuma

Bialystok, , Poland

The University of Gdańsk

Gdansk, , Poland

MICS Centrum Medyczne Warszawa

Warsaw, , Poland

Dolnośląski Szpital Specjalistyczny im. T. Marciniaka

Wroclaw, , Poland

Countries

Germany; Poland

Other Identifiers

SPI-62-CL-2003

Identifier Type: -

Identifier Source: org_study_id