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New treatment option for Cardiac Sarcoidosis
Official title Rilonacept in Subjects With Cardiac Sarcoidosis
ClinicalTrials.gov ID: NCT06660732
What this study is testing
What is Rilonacept?
Rilonacept is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for cardiac sarcoidosis.
Also referred to as KPL-914.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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 people 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...
You likely can't join 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...
- 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
See the full eligibility criteria
Who can 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 people 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...
- Male people 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...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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 \ 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. people with a...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.