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

Sparrow Pharmaceuticals66 enrolled

Overview

This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Polymyalgia Rheumatica

Interventions

SPI-62DRUG

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

SPI-62 matched placeboDRUG

Inactive tablets identical in appearance to SPI-62 tablets

Prednisolone 10mgDRUG

Standard of care prednisolone

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

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

Outcomes

Primary Outcomes

Erythrocyte sedimentation rate

Time frame: Baseline to Day 28

C-reactive protein

Time frame: Baseline to Day 28

Plasma fibrinogen

Time frame: Baseline to Day 28

Data from ClinicalTrials.gov

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