A trial of prednisolone in combination with SPI-62 or placebo in participants with polymyalgia rheumatica (PMR)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517406-29-00

Acronym

SPI-62-CL-2003

Enrollment

Registered

2024-11-05

Start date

2022-07-26

Completion date

2025-04-25

Last updated

2025-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polymyalgia rheumatica (PMR)

Brief summary

Fibrinogen, erythrocyte sedimentation ratio, C-reactive protein

Detailed description

Oral glucose tolerance test glucose area under the concentration‑time curve, osteocalcin, urinary 11β-hydroxysteroid dehydrogenase type 1 ratio

Interventions

DRUGPrednisolon 5 mg JENAPHARM

DRUGSPI-62_DF2

DRUGCapsule

DRUGhard for oral use as placebo for prednisolone.

DRUGFilm-coated tablet for oral use as placebo for Clofutriben (SPI-62).

DRUGSPI-62_DF1

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Fibrinogen, erythrocyte sedimentation ratio, C-reactive protein	—

Secondary

Measure	Time frame
Oral glucose tolerance test glucose area under the concentration‑time curve, osteocalcin, urinary 11β-hydroxysteroid dehydrogenase type 1 ratio	—

Countries

Germany, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026