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
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
Treatments tested in this trial
- Rilonacept
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mayo Clinic
Lead sponsor
Johns Hopkins University
Collaborator
Source ClinicalTrials.gov