Phase 2 Cardiomyopathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to understand the study and are willing to sign a consent form and follow the study rules
• People aged 18 to 80 years old
• Women who are postmenopausal (no periods for at least 12 months), have had a hysterectomy, both ovaries or fallopian tubes removed, or tubal ligation, or whose male partner has had a vasectomy — or, if none of these apply, women who are not pregnant or breastfeeding and agree to use an effective form of contraception from the start of the study until 5 months after receiving the study drug
• Men who have had a vasectomy, or who agree to use double barrier contraception (such as a condom plus diaphragm or spermicide) or condoms with hormonal contraception or an IUD with any female partner who could become pregnant, from the start of the study until 3 months after the last dose — and who agree not to donate sperm during this time
• People whose routine adult vaccinations are up to date, or who have received any recommended vaccines at least 2 weeks before joining the study
• People who have been diagnosed with cardiac sarcoidosis (a condition where inflammation affects the heart) according to recognised specialist guidelines
• People whose heart shows active inflammation in 3 or more areas on a specialised PET scan taken within 8 weeks before joining the study, even while already on standard treatment
• People who are willing to wear a heart rhythm monitoring device at specific points during the study

Who may not be able to join:

• People who are unable or unwilling to give informed consent
• People who weigh more than 380 pounds (172 kilograms)
• Women who are pregnant or breastfeeding, or women of childbearing age who are not willing to use an effective form of contraception throughout the study
• People who plan to start a type of medication called a TNF-alpha inhibitor during the study
• People with known claustrophobia or who have had significant difficulty completing a PET scan in the past
• People whose heart's left pumping chamber is significantly enlarged beyond a specific measurement on ultrasound (confirm with trial site)
• People who have another immune system disorder or condition that requires treatment with immune-suppressing or immune-modifying medications
• People who have received, or are scheduled to receive, a mechanical device to help support the heart
• People whose heart problems are explained by a structural heart condition present from birth, valve disease, or coronary artery disease
• People with a known allergy or sensitivity to the study drug rilonacept (also called KPL-914) or any of its ingredients
• People with a history of active tuberculosis (TB), untreated latent TB, signs or symptoms that could suggest active TB, recent close contact with someone who has active TB, or a positive TB blood test result at screening
• People who have recently had their immune-suppressing medication dose increased, or started a new immune-suppressing medication, within the month before their baseline PET scan up until the point of joining the study, or who have taken certain specific immune-suppressing medications too recently before the study start (specific timeframes vary by medication — confirm with trial site)
• People who have received another experimental drug or treatment within 30 days (or within 5 times that drug's half-life, whichever is longer) before the study drug
• People currently enrolled in another clinical trial (observational studies may be acceptable — confirm with trial site)
• People with uncontrolled high blood pressure (readings above 170/110 mmHg)
• People with uncontrolled thyroid disease based on blood test results outside a specified range
• People with uncontrolled diabetes based on fasting blood sugar above 180 mg/dL or a specific blood marker above 9%
• People with significantly reduced kidney function based on a blood test result
• People who have had major surgery within 8 weeks before screening, or who have major surgery planned within 6 months of receiving the study drug
• People who have had an organ transplant (except a corneal transplant performed more than 3 months before the study drug)
• People with serious, recurring, or ongoing infections, or who needed to be hospitalised or treated with intravenous antibiotics for an infection within the 12 weeks before screening — or who have a history of a severe opportunistic infection
• People considered at high risk of infection, including those with an immune deficiency condition, an infected joint replacement still in place, leg ulcers, a permanent urinary catheter, or persistent chest infections
• People with active chronic hepatitis B virus (HBV) infection based on specific blood test results
• People who have symptoms that could indicate a current COVID-19 infection, unless a recent negative PCR test has been confirmed
• People who have had cancer in the last 5 years before screening (except certain treated skin cancers or treated cervical in-situ carcinoma that are considered cured)
• People whose blood test results at screening fall outside acceptable ranges for red blood cells, white blood cells, platelets, or liver markers (confirm with trial site for specific values)
• People whose overall health situation, in the treating doctor's judgement, could interfere with the study results or their safety

Important: Always verify eligibility with the trial site directly before applying.