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

May 13, 2025 updated by: Sparrow Pharmaceuticals
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • emovis GmbH
      • Hannover, Germany, 30159
        • Klinische Forschung Hannover Mitte GmbH/Pratia
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenburg Universität Mainz
      • München, Germany, 80336
        • Klinikum der Universität München
      • Schwerin, Germany, 19055
        • Klinische Forschung Schwerin GmbH/Pratia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: prednisolone + SPI-62
Participants will receive prednisolone throughout the trial and SPI-62 on days 3-16.
Drug: Prednisolone
Prednisolone according to the participant's pre-trial dose, symptoms and inflammatory biomarkers.
Drug: SPI-62
SPI-62 administered once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Erythrocyte sedimentation rate
Time Frame: Baseline to Day 28
Baseline to Day 28
C-reactive protein
Time Frame: Baseline to Day 28
Baseline to Day 28
Plasma fibrinogen
Time Frame: Baseline to Day 28
Baseline to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sparrow Pharmaceuticals

Investigators

  • Study Chair: David Katz, Sparrow Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2022

Primary Completion (Actual)

March 25, 2025

Study Completion (Actual)

April 25, 2025

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPI-62-CL-1002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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