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

Polymyalgia Rheumatica Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05436652
• Other study ID #: SPI-62-CL-2003
• Status: Recruiting
• Phase: Phase 2
• Start date: July 22, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2024
• Source: Sparrow Pharmaceuticals
• Contact: David Katz
• Phone: +1-617-465-0328
• Email: david[@]sparrowpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Drug:
• SPI-62
11ß hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor
• SPI-62 matched placebo
Inactive tablets identical in appearance to SPI-62 tablets
• Prednisolone 10mg
Standard of care prednisolone
• Additional prednisolone
Over encapsulated prednisolone
• Additional prednisolone matched placebo
Inactive capsules identical in appearance to over encapsulated prednisolone

Locations

Country	Name	City	State
Germany	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	Unikliniken Köln	Köln
Germany	Prof. Dr. med. Herbert Kellner	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Sparrow Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythrocyte sedimentation rate		Baseline to Day 28
Primary	C-reactive protein		Baseline to Day 28
Primary	Plasma fibrinogen		Baseline to Day 28