Status:
COMPLETED
A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)
Lead Sponsor:
Sparrow Pharmaceuticals
Conditions:
Polymyalgia Rheumatica
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (1...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05436652
Start Date
July 22 2022
End Date
April 25 2025
Last Update
May 11 2025
Active Locations (10)
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1
Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie
Berlin, Germany
2
Internistische Praxisgemeinschaft Rheumatologie Nephrologie
Erlangen, Germany
3
Hamburger Rheuma Forschungszentrum II im MVZ für Rheumatologie und Autoimmunmedizin
Hamburg, Germany
4
Katholische Kliniken Rhein-Ruhr am Marien Hospital, Universitätsklinik der Ruhr-Universität
Herne, Germany