A phase 3 clinical trial is evaluating the efficacy and safety of abatacept for treating myocarditis associated with immune checkpoint inhibitors, according to a study record from ClinicalTrials.gov. The study aims to determine if abatacept can reduce major adverse cardiac events in patients hospitalized due to this condition.
The trial, identified as the ATRIUM study, is a randomized, double-blind, placebo-controlled investigation. It focuses on participants who develop myocarditis after receiving FDA-approved immune checkpoint inhibitors, which are used to treat various cancers. While the standard treatment for ICI-related myocarditis involves corticosteroids, data from international cohorts indicates that the rate of major adverse cardiac events remains high, ranging from 25% to 50% despite corticosteroid administration. In contrast, the rate of such events in myocarditis unrelated to ICI is less than 5%.
Abatacept is a selective co-stimulation modulator that works by binding to CD80 and CD86 to inhibit T cell activation. Researchers are testing whether administering abatacept alongside corticosteroids can reduce the risk of major adverse cardiac events, which include cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure.
The study is currently recruiting participants at multiple locations, including the University of Utah in Salt Lake City. The trial is estimated to reach primary completion in April 2029 and study completion in October 2029.
