A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)
Study Details
Study Description
Brief Summary
This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in subjects with PMR.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Detailed Description
This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in subjects with PMR. Up to 4 cohorts of 12 subjects could be recruited (12 to 48 subjects). Each subject 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 subjects 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 4, the dose of prednisolone co-administered with SPI-62 could be adjusted.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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. |
Drug: SPI-62
11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor
Drug: SPI-62 matched placebo
Inactive tablets identical in appearance to SPI-62 tablets
Drug: Prednisolone 10mg
Standard of care prednisolone
|
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. |
Drug: SPI-62
11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor
Drug: SPI-62 matched placebo
Inactive tablets identical in appearance to SPI-62 tablets
Drug: Prednisolone 10mg
Standard of care prednisolone
Drug: Additional prednisolone
Over encapsulated prednisolone
Drug: Additional prednisolone matched placebo
Inactive capsules identical in appearance to over encapsulated prednisolone
|
Outcome Measures
Primary Outcome Measures
- Erythrocyte sedimentation rate [Baseline to Day 28]
- C-reactive protein [Baseline to Day 28]
- Plasma fibrinogen [Baseline to Day 28]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent
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Diagnosis of PMR according to EULAR/ACR classification criteria
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Absence of PMR relapse based on symptoms and acute phase markers
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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:
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Any contraindication for prednisolone administration.
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A diagnosis or any clinical features of giant cell arteritis.
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Any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than PMR.
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Use of medications for treatment of PMR within specified intervals prior to the Baseline Visit other than oral prednisolone.
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Use of other medications likely to interfere with trial assessments.
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History or diagnosis of endogenous hypercortisolism.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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 | ||
5 | Unikliniken Köln | Köln | Germany | ||
6 | Prof. Dr. med. Herbert Kellner | Munich | Germany |
Sponsors and Collaborators
- Sparrow Pharmaceuticals
Investigators
- Study Chair: David Katz, Sparrow Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SPI-62-CL-2003