Clinical trial NCT06281236: A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR)
Official title: A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Polymyalgia Rheumatica
Lead sponsor: Sparrow Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Erythrocyte sedimentation rate
timeFrame: Baseline to Day 28
measure: C-reactive protein
timeFrame: Baseline to Day 28
measure: Plasma fibrinogen
timeFrame: Baseline to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Emovis Gmbh
city: Hannover
country: Germany
facility: Klinische Forschung Hannover Mitte GmbH/Pratia
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenburg Universität Mainz
city: München
country: Germany
facility: Klinikum der Universität München
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH/Pratia
Study officials:
affiliation: Sparrow Pharmaceuticals
name: David Katz
role: STUDY_CHAIR
References: