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

NCT06281236 | Terminated Phase 1 FDA Drug

• 1 other identifier: SPI-62-CL-1002
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 5

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.

Conditions

Polymyalgia Rheumatica

Outcome Measures

Primary Outcomes (3)

• Erythrocyte sedimentation rate

  Baseline to Day 28

• C-reactive protein

  Baseline to Day 28

• Plasma fibrinogen

  Baseline to Day 28

Study Arms (1)

prednisolone + SPI-62

EXPERIMENTAL

Participants will receive prednisolone throughout the trial and SPI-62 on days 3-16.

Drug: Prednisolone; Drug: SPI-62

Interventions

Prednisolone DRUG

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

prednisolone + SPI-62

SPI-62 DRUG

SPI-62 administered once daily.

prednisolone + SPI-62

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sparrow Pharmaceuticals: lead

Study Sites (5)

Emovis Gmbh

Berlin, Germany

Location

Klinische Forschung Hannover Mitte GmbH/Pratia

Hanover, 30159, Germany

Location

Universitätsmedizin der Johannes Gutenburg Universität Mainz

Mainz, 55131, Germany

Location

Klinikum der Universität München

München, 80336, Germany

Location

Klinische Forschung Schwerin GmbH/Pratia

Schwerin, 19055, Germany

Location

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• David Katz

  Sparrow Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: February 22, 2022
• Primary Completion: March 25, 2025
• Study Completion: April 25, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)