Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
The primary goal of this clinical trial is to test the hypothesis that the drug canakinumab (anti-IL-1B monoclonal antibody) decreases vascular inflammation when used by people with a history of coronary artery disease, including those with and without clonal hematopoiesis driven by mutations in TET2.
Eligibility criteria
Qualifiers
18 years or older
Coronary artery disease, defined as prior heart attack, coronary stent procedure >180 days before baseline imaging, or advanced subclinical coronary atherosclerosis (coronary artery calcium score ≥300 Agatston units, CAD-RADS 3 or greater atherosclerosis on coronary CT angiography, or qualitatively severe coronary artery calcification identified on non-gated CT imaging)
Presence of either TET2 mutations or no myeloid driver mutations on prior sequencing
Disqualifiers
placement of a drug-eluting stent in a proximal coronary arterial segment <180 days before baseline imaging
prior coronary artery bypass grafting
pregnancy or breastfeeding
history of blood malignancy or current solid-tumor malignancy
Trial design
Treatments tested in this trial
- CANAKINUMAB (ILARIS®)
- Saline (NaCl 0,9 %) (placebo)
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Broad Institute of MIT and Harvard
Collaborator
Yale University
Collaborator
Source ClinicalTrials.gov