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

Phase 1

Terminated

• Conditions: Polymyalgia Rheumatica
• Interventions: Drug: Prednisolone; Drug: SPI-62

• Registration Number: NCT06281236
• Lead Sponsor: Sparrow Pharmaceuticals

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.

Study Timeline

• Study Start: 2022-02-22
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Primary Completion: 2025-03-25
• Study Completion: 2025-04-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prednisolone + SPI-62	SPI-62	Participants will receive prednisolone throughout the trial and SPI-62 on days 3-16.
prednisolone + SPI-62	Prednisolone	Participants will receive prednisolone throughout the trial and SPI-62 on days 3-16.

Primary Outcome Measures

Name	Time	Method
Plasma fibrinogen	Baseline to Day 28
Erythrocyte sedimentation rate	Baseline to Day 28
C-reactive protein	Baseline to Day 28

Trial Locations

Locations (5)

Klinische Forschung Hannover Mitte GmbH/Pratia; 🇩🇪 Hannover, Germany

Emovis Gmbh; 🇩🇪 Berlin, Germany

Klinikum der Universität München; 🇩🇪 München, Germany

Universitätsmedizin der Johannes Gutenburg Universität Mainz; 🇩🇪 Mainz, Germany

Klinische Forschung Schwerin GmbH/Pratia; 🇩🇪 Schwerin, Germany