A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)
Status: Completed
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie
Berlin
Internistische Praxisgemeinschaft Rheumatologie Nephrologie
Erlangen
Hamburger Rheuma Forschungszentrum II im MVZ für Rheumatologie und Autoimmunmedizin
Hamburg
Katholische Kliniken Rhein-Ruhr am Marien Hospital, Universitätsklinik der Ruhr-Universität
Herne
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz
Praxis Prof. Dr. med. Herbert Kellner
Munich
Poland
NovaReuma
Bialystok
The University of Gdańsk
Gdansk
MICS Centrum Medyczne Warszawa
Warsaw
Dolnośląski Szpital Specjalistyczny im. T. Marciniaka
Wroclaw
Time Frame
Start Date: 2022-07-22
Completion Date: 2025-04-25
Participants
Target number of participants: 66
Treatments
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Sparrow Pharmaceuticals