Phase 3 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 have given their written consent to participate before any study procedures begin (or whose legal representative has done so on their behalf, where permitted).
• People aged 18 or older at the time of giving consent.
• People who have recently received an FDA-approved immune checkpoint inhibitor (a type of cancer immunotherapy) within the past 6 months before their heart inflammation (myocarditis) was diagnosed, whether given alone or alongside other cancer treatments such as chemotherapy, radiation, or targeted therapy.
• People who have been diagnosed with myocarditis (inflammation of the heart muscle).
• People who are currently admitted to hospital at the time they are enrolled in the trial.
• People who are already receiving 1,000 mg per day of intravenous methylprednisolone (a strong steroid) for myocarditis, or whose doctors plan to start this treatment within 24 hours of the first study drug dose.
• People whose blood test shows a troponin level (a marker of heart muscle injury) at least 5 times higher than the normal upper limit used by their hospital, measured at some point in the 10 days before enrolment — even if that level has since come down after starting steroids.
• People whose recent blood test results (taken within 48 hours of enrolment) show: a total white blood cell count above 2,500/μl, a neutrophil count (a type of white blood cell) above 1,500/μl, and liver enzyme levels (ALT or AST) below 20 times the hospital's normal upper limit.
• Women who could potentially become pregnant must have a negative pregnancy test before enrolment, and both women and men of reproductive potential must be willing to use effective contraception from enrolment until at least 90 days after the last dose of the study drug.
• People who are willing and able to follow all study requirements and restrictions.

Who may not be able to join:

• People who have experienced any of the following serious heart events in the 30 days before enrolment: sudden cardiac arrest; cardiogenic shock (when the heart suddenly cannot pump enough blood); a serious slow heart rhythm problem requiring a temporary or permanent pacemaker; or a serious fast or irregular heart rhythm such as ventricular fibrillation or sustained ventricular tachycardia.
• People who have received abatacept or belatacept (certain immune-modifying medications) within the past 2 months.
• People who have used certain other non-steroid immune-suppressing medications in the past 2 months, including mycophenolate, JAK inhibitors (such as tofacitinib or baricitinib), tacrolimus, anti-thymocyte globulin, alemtuzumab, infliximab, or plasma exchange. (Note: intravenous immunoglobulin is permitted.)
• People who are currently enrolled in another clinical trial using systemic treatments for immune checkpoint inhibitor-related side effects.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study or within approximately 90 days of the last study drug dose.
• Men who are planning to father a child or donate sperm during the study or within approximately 30 days of the last study drug dose.
• People with certain active, chronic, or recurring viral infections that the trial doctor considers would make participation unsafe — including active hepatitis B, active hepatitis C, recurrent or widespread herpes zoster (shingles), widespread herpes simplex, or active COVID-19 infection.
• People with active tuberculosis (TB), a history of incompletely treated TB, TB affecting areas outside the lungs, or suspected or confirmed serious bacterial or fungal infections throughout the body.
• People who have received a live vaccine within the 4 weeks before the first study drug dose, or who are expected to need a live vaccine during the study or within at least 90 days after the last study drug dose.
• People with any other medical condition that, in the trial doctor's judgement, could affect the study results or would make participation unsafe.
• People who, in the trial doctor's opinion, are unlikely to be able to follow study procedures — for example, those with a history of missing scheduled appointments.

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