At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 60 target
Drug / intervention
Rilonaceptdrug
Likely dose
Rilonacept 320 mgfrom record
Key inclusion· 6
- ✓Age between 18 and 80 years
- ✓Diagnosis of cardiac sarcoidosis per HRS expert consensus or JCS 2016 guidelines
- ✓Three or more segments of active FDG uptake on PET scan within 8 weeks of randomization despite standard therapy
- ✓Willing to wear ambulatory cardiac rhythm monitor at specified timepoints
Key exclusion· 34
- ✕Weight >380 pounds (172 kilograms)
- ✕Pregnant or lactating women or women of childbearing age refusing highly effective contraception
- ✕Planned TNF-α antagonist therapy over the course of the study
- ✕Known claustrophobia or difficulty completing prior PET scan procedures
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A RandomizEd PhAse II TrIal of Rilonacept in Subjects With Cardiac Sarcoidosis (REPAIR-CS)
In Brief
A Phase 2 clinical trial evaluating Rilonacept for Cardiac Sarcoidosis. Currently recruiting, targeting 60 participants across 2 sites.
Signals
Enrolling ahead of pace
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Sarcoidosis
CountriesUnited States
CollaboratorsJohns Hopkins University
Timeline
Phase 2Recruiting
202520262027
First PostedOct 2024
Enrollment StartMar 2025
TodayJul 2026
Primary CompletionNov 2026
Study CompletionMar 2027
First PostedOct 28, 2024
Enrollment StartMar 5, 2025
Primary CompletionNov 1, 2026
Study CompletionMar 1, 2027
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 1.7 years agoPrimary completion in 4 months
Interventions
Rilonaceptdrug
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.