NCT06281236

A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Sparrow Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polymyalgia Rheumatica

Interventions

Type	Name	Description
DRUG	Prednisolone	Prednisolone according to the participant's pre-trial dose, symptoms and inflammatory biomarkers.
DRUG	SPI-62	SPI-62 administered once daily.

Timeline

• Start date: 2022-02-22
• Primary completion: 2025-03-25
• Completion: 2025-04-25
• First posted: 2024-02-28
• Last updated: 2025-05-16

Locations

5 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study