Rilonacept in Subjects With Cardiac Sarcoidosis

NCT06660732 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 23-013175
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiac Sarcoidosis

Keywords

Cardiac Sarcoidosis; Sarcoid Myocarditis; Myocarditis; Inflammation; PET scan; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in number of segments with fluorodeoxyglucose F18 (FDG) uptake on cardiac fluorodeoxyglucose F18 - positron emission tomography (FDG-PET) scan

  Fluorodeoxyglucose F18 uptake is evaluated across a 17 segment heart model. A higher number indicates higher myocardial inflammatory activity, while a lower number indicates lower inflammatory activity

  Baseline, Week 12, Week 24

Secondary Outcomes (2)

• Change in maximum standardized uptake value (SUVMax) of the myocardium compared to baseline

  Baseline, Week 12, Week 24

• Summed perfusion rest score (SPRS) on fluorodeoxyglucose F18 - positron emission tomography (FDG-PET) scan

  Week 24

Study Arms (2)

Rilonacept+Standard therapy

EXPERIMENTAL

Drug: Rilonacept

Standard therapy

NO INTERVENTION

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.

Also known as: KPL-914

Rilonacept+Standard therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to comprehend and willing to sign an ICF and to abide by the study restrictions and requirements
• Age ≥ 18 years and ≤ 80 years
• 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 (i.e., hormonal contraception, intrauterine device \[IUD\], or double barrier methods such as condom plus diaphragm or diaphragm plus spermicide or condom plus spermicide) from Screening Visit 1 until 5 months after study drug administration, if sexually active.
• Male subjects must have documented vasectomy or must use double barrier methods of contraception (such as condom plus diaphragm or diaphragm plus spermicide or condom plus spermicide) or use condoms plus hormonal contraceptives or condoms plus IUD with their female partners of childbearing potential from randomization to 3 months after the last dose of study drug administration. Male subjects must agree to refrain from donating sperm during this time period.
• Routine adult vaccinations should be up to date and/or offered at least 2 weeks prior to randomization according to regional and national guidelines based on medical history or presence of risk factors, in the opinion of the Investigator.
• Has a diagnosis of cardiac sarcoidosis by the Heart Rhythm Society (HRS) expert consensus statement on the diagnosis and management of arrhythmias associated with cardiac sarcoidosis, or the Japanese Circulation Society 2016 Guideline on diagnosis and treatment of cardiac sarcoidosis (Terasaki 2019)
• Three or more segments of active FDG uptake on PET scan within 8 weeks of randomization, despite standard therapy
• Willing to wear an ambulatory cardiac rhythm monitor at the specified timepoints

You may not qualify if:

• 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.
• Known claustrophobia, or difficulty completing prior PET scan procedure(s)
• Left ventricular end-systolic diameter (LVESD) \> 60 mm on echocardiogram
• Other systemic immune disorder(s) or other disorder(s) that require treatment with immunomodulators or immunosuppressants
• Has received, or is scheduled to receive after randomization, mechanical circulatory support
• Congenital, valvular, and/or coronary artery disease that could explain the severity of cardiac dysfunction
• Known hypersensitivity to rilonacept (KPL-914) or to any of its excipients
• Meets the following TB criteria:
• History of active TB prior to screening OR
• History of latent TB that was not adequately treated prior to screening OR
• Signs or symptoms suggestive of active TB (e.g., new cough of \>14 days in duration or a change in chronic cough, persistent fever, unintentional weight loss, or night sweats) upon review of medical history and/or physical examination at screening OR
• Recent close contact with a person with active TB OR

Sponsors & Collaborators

• Mayo Clinic: lead
• Johns Hopkins University: collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Myocarditis; Inflammation; Heart Failure

Interventions

rilonacept

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Rosenbaum

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lezlie Peterson, R.N.

CONTACT

507-255-2029; Johnson.Lezlie@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: March 5, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)