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

NCT ID: NCT06281236

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-22
• Study Completion Date: 2025-04-25

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

prednisolone + SPI-62

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

Group Type: EXPERIMENTAL

Prednisolone

Intervention Type: DRUG

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

SPI-62

Intervention Type: DRUG

SPI-62 administered once daily.

Interventions

Prednisolone

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

Intervention Type: DRUG

SPI-62

SPI-62 administered once daily.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sparrow Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Katz

Role: STUDY_CHAIR

Sparrow Pharmaceuticals

Locations

Emovis Gmbh

Berlin, , Germany

Klinische Forschung Hannover Mitte GmbH/Pratia

Hanover, , Germany

Universitätsmedizin der Johannes Gutenburg Universität Mainz

Mainz, , Germany

Klinikum der Universität München

München, , Germany

Klinische Forschung Schwerin GmbH/Pratia

Schwerin, , Germany

Countries

Germany

Other Identifiers

SPI-62-CL-1002

Identifier Type: -

Identifier Source: org_study_id