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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Prednisolone according to the participant's pre-trial dose, symptoms and inflammatory biomarkers.
SPI-62 administered once daily.
Emovis Gmbh
Berlin, Germany
Klinische Forschung Hannover Mitte GmbH/Pratia
Hanover, Germany
Universitätsmedizin der Johannes Gutenburg Universität Mainz
Mainz, Germany
Klinikum der Universität München
München, Germany
Erythrocyte sedimentation rate
Time frame: Baseline to Day 28
C-reactive protein
Time frame: Baseline to Day 28
Plasma fibrinogen
Time frame: Baseline to Day 28
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Klinische Forschung Schwerin GmbH/Pratia
Schwerin, Germany