A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)
- Conditions
- Polymyalgia Rheumatica
- Interventions
- Drug: SPI-62 matched placebo
- Registration Number
- NCT05436652
- Lead Sponsor
- Sparrow Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SPI-62 Prednisolone 10mg 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. SPI-62 + additional prednisolone Additional prednisolone matched placebo 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. SPI-62 SPI-62 matched placebo 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. SPI-62 + additional prednisolone SPI-62 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. SPI-62 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. SPI-62 + additional prednisolone SPI-62 matched placebo 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. SPI-62 + additional prednisolone Prednisolone 10mg 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. SPI-62 + additional prednisolone 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.
- Primary Outcome Measures
Name Time Method Erythrocyte sedimentation rate Baseline to Day 28 C-reactive protein Baseline to Day 28 Plasma fibrinogen Baseline to Day 28
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
NovaReuma
🇵🇱Białystok, Poland
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
Universitätsmedizin der Johannes Gutenberg Universität Mainz
🇩🇪Mainz, Germany
Praxis Prof. Dr. med. Herbert Kellner
🇩🇪Munich, Germany
The University of Gdańsk
🇵🇱Gdansk, Poland
MICS Centrum Medyczne Warszawa
🇵🇱Warszawa, Poland
Dolnośląski Szpital Specjalistyczny im. T. Marciniaka
🇵🇱Wrocław, Poland