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

Sparrow Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Polymyalgia Rheumatica

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05436652

SPI-62-CL-2003

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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66 participants in 2 patient groups

SPI-62

Experimental group

Description:

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.

Treatment:

Drug: SPI-62 matched placebo

Drug: SPI-62

Drug: Prednisolone 10mg

SPI-62 + additional prednisolone

Experimental group

Description:

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.

Treatment:

Drug: SPI-62 matched placebo

Drug: SPI-62

Drug: Additional prednisolone

Drug: Additional prednisolone matched placebo

Drug: Prednisolone 10mg