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Cardiac SarcoidosisPhase 2NCT06660732

Rilonacept in Subjects With Cardiac Sarcoidosis

A Phase 2 study testing Rilonacept in people with Cardiac Sarcoidosis, run by Mayo Clinic at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cardiac Sarcoidosis
What is being tested?
Rilonacept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
5 Mar 2025to Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Cardiac Inclusion Criteria:
  • 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

Who cannot join

  • 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
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  • 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
  • Positive or indeterminate Interferon Gamma Release Assay (IGRA) test results or results from another positive TB test at screening based on acceptable local clinical practice
  • Use of the following immunosuppressive or immunomodulatory therapies (see also Section 5.6 "Prior and Concomitant Therapy") within the timeframe prior to randomization as defined below for each drug class or category:
  • INCREASE in dose of existing immunosuppression/immunomodulation drug or INITIATION of new immunosuppression/immunomodulation drug in the one month prior to or ON or AFTER the date of the eligibility/baseline FDG-PET scan until the date of randomization.
  • Anakinra within 1 week prior to first dose of study drug; canakinumab within 8 weeks prior to the first dose of study drug; abatacept within 8 weeks prior to first dose of study drug;
  • TNF inhibitors within 2-8 weeks of or 5 half-lives (etanercept within 2 weeks; infliximab, certolizumab, golimumab, or adalimumab within 8 weeks) prior to first dose of study drug, whichever is longer.
  • Rituximab within 6 months prior to the first dose of study drug unless levels of CD20+ B cells have been assessed and have returned to normal.
  • Cyclosporine A (CsA) within 4 weeks prior to the first dose of study drug.
  • Received any investigational product within 30 days or 5 half-lives (if the half-life is known) of an investigational product (whichever is longer) prior to first dose of study drug
  • Concurrent enrollment in another clinical study, with the exception of observational studies
  • Uncontrolled hypertension (systolic blood pressure >170 mmHg and diastolic blood pressure >110 mmHg
  • Uncontrolled thyroid disease (serum TSH < 0.1 mU/L or > 10 mU/L)
  • Uncontrolled diabetes mellitus (serum glucose > 180 mg/dL fasting or HbA1c >9%)
  • Estimated glomerular filtration rate (eGFR) <30mL/min
  • Major surgery within 8 weeks prior to screening or planned major surgery within 6 months after first dose of study drug.
  • Transplanted organs (except corneal transplant performed more than 3 months prior to first dose of study drug).
  • Severe active, recurrent, or chronic infection (per PI discretion), or any episode of infection requiring hospitalization or treatment with a course of IV antibiotics within 12 weeks before screening. Subjects with a history of severe opportunistic infection (per PI discretion) are also excluded from the study.
  • High risk of infection (e.g., history of hereditary or acquired immune deficiency disorder), a history of an infected joint prosthesis at any time with that prosthesis still in situ, leg ulcers, indwelling urinary catheter, or persistent or recurrent chest infections.
  • Chronic active HBV infection, defined as:
  • HBV surface antigen positive
  • HBV anti-core antibody positive but anti-surface antibody negative
  • Presence of symptoms indicative of COVID-19 infection (per PI discretion), unless a PCR test for COVID-19 has been reported as negative within the previous 7 days or is acquired prior to randomization.
  • History of cancer within the last 5 years from screening, except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured.
  • Has screening laboratory test results meeting any of the following criteria:
  • Hemoglobin level < 8.0 g/dL
  • WBC count < 3.0 × 103/µL
  • Neutrophil count <1.5 × 103/µL
  • Platelet count < 100 × 103/µL
  • Total bilirubin level >1.5 × ULN unless the test results are consistent with those for Gilbert's syndrome
  • AST or ALT values > 2 × ULN
  • Any condition that, in the opinion of the investigator, could interfere with evaluation of the investigational product or interpretation of subject safety or confound the results of the study

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lezlie Peterson, R.N. contact

507-255-2029

Johnson.Lezlie@mayo.edu

United States2 sites, 2 recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21205

    Nisha Gilotra, M.D.

    Nisha Gilotra, M.D.

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Andrew N Rosenbaum

    Recruiting

Other trials in United States

About this study

Official title: A RandomizEd PhAse II TrIal of Rilonacept in Subjects With Cardiac Sarcoidosis (REPAIR-CS)

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.

Being tested
Rilonacept
Keywords
Cardiac Sarcoidosis, Sarcoid Myocarditis, Myocarditis, Inflammation, PET scan, Heart Failure
Medical subject headings
Myocarditis, Inflammation, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RilonaceptDrug

    Also called KPL-914

    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 groups in NCT06660732
Study groupRoleWhat they receive
Rilonacept+Standard therapyExperimentalNot described
Receives: Drug: Rilonacept
Standard therapyNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, Week 12, Week 24

Secondary outcomes (2)

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

    Maximum standardized uptake is a ratio with the tracer uptake in region of interest / (injected activity / patient weight).

    Measured: Baseline, Week 12, Week 24

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

    Summed perfusion rest score (SPRS) provides an overall assessment of myocardial perfusion. A higher score reflects worse perfusion, and a lower score reflects better perfusion.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2024
  2. Study start5 Mar 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06660732
Sponsor's protocol ID
23-013175
Status last verified
Aug 2026
First submitted
25 Oct 2024
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rilonacept in people with Cardiac Sarcoidosis, run by Mayo Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lezlie Peterson, R.N. (507-255-2029, Johnson.Lezlie@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06660732.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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