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

NCT06281236 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-05-16

No results posted yet for this study

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.

Conditions

  • Polymyalgia Rheumatica

Interventions

DRUG

Prednisolone

Prednisolone according to the participant's pre-trial dose, symptoms and inflammatory biomarkers.

DRUG

SPI-62

SPI-62 administered once daily.

Sponsors & Collaborators

  • Sparrow Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • David Katz · Sparrow Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2025-03-25
Completion
2025-04-25
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06281236 on ClinicalTrials.gov