Actively Recruiting
Rilonacept in Subjects With Cardiac Sarcoidosis
Led by Mayo Clinic · Updated on 2025-08-15
60
Participants Needed
2
Research Sites
103 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
J
Johns Hopkins University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rilonacept in Subjects With Cardiac Sarcoidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent and follow study rules
- Age between 18 and 80 years
- Female participants must be postmenopausal, permanently sterile, or use effective contraception if sexually active
- Male participants must have a vasectomy or use effective contraception with female partners of childbearing potential and agree not to donate sperm during the study
- Routine adult vaccinations up to date or offered before randomization as per guidelines
- Diagnosis of cardiac sarcoidosis by expert consensus or guidelines
- At least three segments showing active FDG uptake on PET scan within 8 weeks before randomization despite standard therapy
- Willing to wear an ambulatory cardiac rhythm monitor at specified times
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Weight over 380 pounds (172 kilograms)
- Women who are pregnant, lactating, or of childbearing age refusing effective contraception
- Planned use of TNF-alpha antagonist therapy during the study
- Claustrophobia or difficulty completing PET scans
- Left ventricular end-systolic diameter greater than 60 mm on echocardiogram
- Other systemic immune disorders requiring immunosuppressive treatment
- Receiving or scheduled for mechanical circulatory support
- Heart conditions such as congenital, valvular, or coronary artery disease explaining cardiac dysfunction
- Known allergy to rilonacept or its ingredients
- History or signs of active or latent tuberculosis not adequately treated
- Recent or increased immunosuppressive or immunomodulatory therapy as specified
- Use of investigational products within 30 days before study drug
- Participation in other clinical studies except observational ones
- Uncontrolled high blood pressure
- Uncontrolled thyroid disease
- Uncontrolled diabetes
- Severe kidney impairment (eGFR less than 30 mL/min)
- Major surgery within 8 weeks before or planned within 6 months after first dose
- Organ transplant recipients except certain corneal transplants
- Severe or recurrent infections or conditions increasing infection risk
- Chronic active hepatitis B infection
- Symptoms suggestive of COVID-19 without negative test
- Recent history of cancer except certain skin and cervical cancers
- Laboratory abnormalities including low blood counts or elevated liver enzymes
- Any condition that may interfere with study evaluation or safety per investigator judgment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
L
Lezlie Peterson, R.N.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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