60 Participants Needed

Rilonacept for Cardiac Sarcoidosis

Recruiting at 1 trial location
LP
Overseen ByLezlie Peterson, R.N.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to evaluate the effect of rilonacept, added to standard therapy and compared with standard therapy alone, on improvement in myocardial inflammation in subjects with cardiac sarcoidosis after 24 weeks of therapy.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does mention that you cannot start new immunosuppressive drugs or increase the dose of existing ones close to the trial's start. It's best to discuss your specific medications with the trial team.

How does the drug Rilonacept differ from other treatments for cardiac sarcoidosis?

Rilonacept is unique because it targets interleukin-1 (IL-1), a protein involved in inflammation, which is different from other treatments like corticosteroids or TNFα antagonists that suppress the immune system more broadly. This specific targeting may offer a novel approach for managing inflammation in cardiac sarcoidosis.12345

Research Team

AR

Andrew Rosenbaum

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults aged 18-80 with cardiac sarcoidosis, evidenced by active FDG uptake in the heart. Participants must understand and agree to study requirements, have completed vaccinations, and use effective contraception if applicable. Exclusions include pregnancy, weight over 380 pounds, other severe health conditions or treatments that could affect results.

Inclusion Criteria

Able to comprehend and willing to sign an ICF and to abide by the study restrictions and requirements
I am either postmenopausal, permanently sterile, or using effective birth control.
My PET scan shows active cancer in three or more areas recently.
See 5 more

Exclusion Criteria

Received or scheduled to receive mechanical circulatory support after randomization
My weight is over 380 pounds.
Unable or unwilling to provide informed consent
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rilonacept added to standard therapy or standard therapy alone for 24 weeks

24 weeks
Visits at Baseline, Week 12, and Week 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Rilonacept
Trial OverviewThe study tests rilonacept's effectiveness on myocardial inflammation when added to standard therapy versus standard therapy alone in cardiac sarcoidosis patients over a period of 24 weeks. Participants will be monitored using an ambulatory cardiac rhythm monitor at certain times.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Rilonacept+Standard therapyExperimental Treatment1 Intervention
Group II: Standard therapyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Johns Hopkins University

Collaborator

Trials
2,366
Recruited
15,160,000+

Findings from Research

Rituximab, an anti-CD20 monoclonal antibody, has shown promise in treating refractory sarcoidosis, particularly in cases involving the lungs, eyes, lymph nodes, and skin, as evidenced by three case reports.
While steroids are the standard first-line treatment for sarcoidosis, the use of Rituximab may offer an alternative for patients who do not respond to conventional therapies, highlighting its potential role in managing this challenging condition.
Rituximab in refractory sarcoidosis: a single centre experience.Cinetto, F., Compagno, N., Scarpa, R., et al.[2020]
In a retrospective study of 4 patients with cardiac sarcoidosis (CS), TNFα antagonists (infliximab or adalimumab) were effective in treating refractory cases, showing promise for earlier intervention in treatment protocols.
All patients tolerated TNFα antagonists well, with no serious adverse events reported, and three patients were able to discontinue corticosteroid therapy without experiencing relapses or major cardiac issues during a follow-up period averaging 54.75 months.
Case Report: TNFα Antagonists Are an Effective Therapy in Cardiac Sarcoidosis.Stievenart, J., Le Guenno, G., Ruivard, M., et al.[2021]
In a study of 50 patients with cardiac sarcoidosis, treatment with tumor necrosis factor inhibitors (TNFi), particularly adalimumab, significantly reduced cardiac inflammation as measured by 18F-FDG PET/CT scans, showing better efficacy than traditional corticosteroid therapies.
TNFi was found to be safe and effective even in patients with severely reduced left ventricular ejection fraction (LVEF), with many patients achieving inactive or remitting disease status after treatment.
Assessment of treatment response in cardiac sarcoidosis based on myocardial 18F-FDG uptake.Frischknecht, L., Schaab, J., Schmauch, E., et al.[2023]

References

Rituximab in refractory sarcoidosis: a single centre experience. [2020]
Case Report: TNFα Antagonists Are an Effective Therapy in Cardiac Sarcoidosis. [2021]
Assessment of treatment response in cardiac sarcoidosis based on myocardial 18F-FDG uptake. [2023]
Controversies in the Treatment of Cardiac Sarcoidosis. [2022]
[Cardiac sarcoidosis: Diagnosis and therapeutic challenges]. [2017]