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

Polymyalgia Rheumatica Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06281236
• Other study ID #: SPI-62-CL-1002
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 1, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Sparrow Pharmaceuticals
• Contact: David Katz
• Phone: +1 (617) 465-0328
• Email: david[@]sparrowpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Drug:
• Prednisolone
Prednisolone according to the participant's pre-trial dose, symptoms and inflammatory biomarkers.
• SPI-62
SPI-62 administered once daily.

Locations

Country	Name	City	State
Germany	Emovis Gmbh	Berlin
Germany	Klinische Forschung Hannover Mitte GmbH/Pratia	Hannover
Germany	Klinische Forschung Schwerin GmbH/Pratia	Schwerin

Sponsors (1)

Lead Sponsor	Collaborator
Sparrow Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythrocyte sedimentation rate		Baseline to Day 28
Primary	C-reactive protein		Baseline to Day 28
Primary	Plasma fibrinogen		Baseline to Day 28