Health TrialsbyHealthPanel

Rilonacept in Subjects With Cardiac Sarcoidosis

ConditionCardiac Sarcoidosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to comprehend and willing to sign an ICF and to abide by the study restrictions and requirements

Age ≥ 18 years and ≤ 80 years

postmenopausal, defined as at least 12 months post cessation of menses (without an alternative medical cause), or

permanently sterile following documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation, or having a male partner with vasectomy as affirmed by the subject, or

Disqualifiers

Unable or unwilling to provide informed consent

Weight >380 pounds (172 kilograms)

Women who are pregnant or lactating or women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study

Planned to initiate TNF-α antagonist therapy over the course of the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rilonacept

    Drug

    320 mg subcutaneous (SC) loading dose delivered as two 2-mL, subcutaneous injections of 160 mg on the same day at different anatomical sites followed by once weekly 160 mg SC doses.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Rilonacept+Standard therapyExperimental treatment 1 intervention
Group B: Standard therapyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in number of segments with fluorodeoxyglucose F18 (FDG) uptake on cardiac fluorodeoxyglucose F18 - positron emission tomography (FDG-PET) scan

Fluorodeoxyglucose F18 uptake is evaluated across a 17 segment heart model. A higher number indicates higher myocardial inflammatory activity, while a lower number indicates lower inflammatory activity

Time frame
Baseline, Week 12, Week 24

Secondary outcomes

1

Change in maximum standardized uptake value (SUVMax) of the myocardium compared to baseline

Maximum standardized uptake is a ratio with the tracer uptake in region of interest / (injected activity / patient weight).

Time frame
Baseline, Week 12, Week 24
2

Summed perfusion rest score (SPRS) on fluorodeoxyglucose F18 - positron emission tomography (FDG-PET) scan

Summed perfusion rest score (SPRS) provides an overall assessment of myocardial perfusion. A higher score reflects worse perfusion, and a lower score reflects better perfusion.

Time frame
Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Johns Hopkins University

Collaborator

Source ClinicalTrials.gov
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