A RandomizEd PhAse II TrIal of Rilonacept in Subjects With Cardiac Sarcoidosis (REPAIR-CS)
Mayo Clinic
Summary
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
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Able to comprehend and willing to sign an ICF and to abide by the study restrictions and requirements 2. Age ≥ 18 years and ≤ 80 years 3. Female subjects must be: * 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 * nonpregnant, nonlactating, and having agreed to use an effective method of contraception…
Interventions
- DrugRilonacept
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.
Locations (2)
- Johns Hopkins UniversityBaltimore, Maryland
- Mayo Clinic in RochesterRochester, Minnesota