Rilonacept in Subjects With Cardiac Sarcoidosis

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Mayo Clinic
Study ID
NCT06660732
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cardiac Sarcoidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 5, 2025
Status verified
Aug 2025
Primary completion
Nov 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rilonacept+Standard therapy
  • No Intervention: Standard therapy

Primary Outcome Measure

Change in number of segments with fluorodeoxyglucose F18 (FDG) uptake on cardiac fluorodeoxyglucose F18 - positron emission tomography (FDG-PET) scan [ Time Frame: Baseline, Week 12, Week 24 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21205
Nisha Gilotra, M.D.
Nisha Gilotra, M.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Andrew N Rosenbaum (PRINCIPAL_INVESTIGATOR)

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