Polymyalgia Rheumatica
Conditions
Brief summary
This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited.
Detailed description
This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited. Patients diagnosed with PMR whose PMR symptoms do not vary in intensity or frequency to the degree that a clinically indicated increase in prednisolone prescription might be anticipated will be included in the trial. Participants will continue to receive prednisolone and will receive SPI-62 from Days 3-16 Inflammatory biomarkers, symptom measures, biomarkers of prednisolone toxicity, PK of prednisolone and SPI-62, and biomarkers of SPI-62 pharmacological activity will be measured on Days 2, 3, and 16. ABPM will be monitored on days 1 and 15.
Interventions
DRUGPrednisolone
Prednisolone according to the participant's pre-trial dose, symptoms and inflammatory biomarkers.
DRUGSPI-62
SPI-62 administered once daily.
Sponsors
Sparrow Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Diagnosis of PMR according to European League Against Rheumatism and American College of Rheumatology classification criteria confirmed by a rheumatologist * Absence of PMR relapse based on symptoms and acute phase markers * Daily oral prednisolone 10, 12.5, 15, 17.5, or 20 mg dose that will have been stable for at least 7 days prior to Day 1
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 other than oral prednisolone within specified intervals prior to Day 1 and during the treatment period * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erythrocyte sedimentation rate | Baseline to Day 28 |
| C-reactive protein | Baseline to Day 28 |
| Plasma fibrinogen | Baseline to Day 28 |
Countries
Germany
Outcome results
None listed