Clinical trial NCT05436652: A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)
Official title: A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polymyalgia Rheumatica
Keywords: polymyalgia rheumatica
PMR
Steroids
Prednisolone
glucocorticoid
glucocorticoids
Lead sponsor: Sparrow Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-06-29
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Erythrocyte sedimentation rate
timeFrame: Baseline to Day 28
measure: C-reactive protein
timeFrame: Baseline to Day 28
measure: Plasma fibrinogen
timeFrame: Baseline to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie
city: Erlangen
country: Germany
facility: Internistische Praxisgemeinschaft Rheumatologie Nephrologie
city: Hamburg
country: Germany
facility: Hamburger Rheuma Forschungszentrum II im MVZ für Rheumatologie und Autoimmunmedizin
city: Herne
country: Germany
facility: Katholische Kliniken Rhein-Ruhr am Marien Hospital, Universitätsklinik der Ruhr-Universität
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz
city: Munich
country: Germany
facility: Praxis Prof. Dr. med. Herbert Kellner
city: Białystok
country: Poland
facility: NovaReuma
city: Gdansk
country: Poland
facility: The University of Gdańsk
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
city: Wrocław
country: Poland
facility: Dolnośląski Szpital Specjalistyczny im. T. Marciniaka
Study officials:
affiliation: Sparrow Pharmaceuticals
name: David Katz
role: STUDY_CHAIR
References: