Rilonacept / Cardiac Sarcoidosis · Phase 2 Trial

Rilonacept in Subjects With Cardiac Sarcoidosis

ClinicalTrials.gov · August 20, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered Phase 2 trial of rilonacept in cardiac sarcoidosis that is currently recruiting. No results have been posted to the registry. The study aims to evaluate effect on myocardial inflammation using FDG-PET imaging over 24 weeks, but efficacy and safety data are not yet available.

What was studied

Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Cardiac Sarcoidosis; age from 18 Years; to 80 Years. Intervention: Rilonacept+Standard therapy. Compared with: Standard therapy — No Intervention. n = 60. 2 sites: United States.

Key findings

Safety

This is a registry record with no results posted; no efficacy, safety, or outcome data are available.

Who this may help

Clinicians should note this trial is active but not yet informative. Results are needed before any practice recommendations can be made. Monitor ClinicalTrials.gov for outcome publication.

Plain-language summary

Phase 2 interventional trial currently recruiting with no results posted; early-stage evidence in a rare disease with surrogate inflammatory endpoint.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change in number of segments with fluorodeoxyglucose F18 (FDG) uptake on cardiac fluorodeoxyglucose F18 - positron emission tomography (FDG-PET) scan (assessed at Baseline, Week 12, Week 24)

DesignPhase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationCardiac Sarcoidosis; age from 18 Years; to 80 Years

Sample size60

InterventionRilonacept+Standard therapy

ComparatorStandard therapy — No Intervention

Setting2 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment60

Study phasePhase 2

Primary outcome measureChange in number of segments with FDG uptake on cardiac FDG-PET scan

Primary assessment timepointsBaseline, Week 12, Week 24

Clinical bottom line

Clinicians should note this trial is active but not yet informative. Results are needed before any practice recommendations can be made. Monitor ClinicalTrials.gov for outcome publication.

Caveats

This is a registry record with no results posted; no efficacy, safety, or outcome data are available.
Primary endpoint is a surrogate (myocardial inflammation on imaging); hard clinical endpoints are not specified.
Blinding status, allocation concealment, comparator details, and study conduct are not described in this registry summary.
Recruitment status is active; study completion and results dissemination timeline unknown.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 randomized interventional design, but results not yet available.

Directness

moderate

Primary endpoint is FDG-PET inflammation, a surrogate; clinical outcomes not specified.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or conduct.

Sample adequacy

limited

Estimated 60 participants total; small for Phase 2 in rare disease.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06660732). This is a study registration, not published results. Lead sponsor: Mayo Clinic. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Cardiac Sarcoidosis. Interventions: DRUG: Rilonacept. Primary outcome measures: Change in number of segments with fluorodeoxyglucose F18 (FDG) uptake on cardiac fluorodeoxyglucose F18 - positron emission tomography (FDG-PET) scan , Baseline, Week 12, Week 24. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

RilonaceptCardiac SarcoidosisNCT06660732Mayo Clinic