Tests canakinumab for vascular inflammation in people with coronary artery disease

Trial details

Who runs it

Massachusetts General Hospital

Trial code

NCT06691217

Record updated

15 October 2026

Original description

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 TET2 mutations.Read full original descriptionShow less

Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis

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 TET2 mutations.

Inclusion: 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; TET2-mutant myelodysplastic syndrome (MDS) or dysplastic-type chronic myelomonocytic leukemia (CMML) participants only must meet all of the following criteria:; Very low, low, or moderate-low risk for disease progression according to IPSS-M (score ≤0); Peripheral blood blasts <2% and bone marrow blasts <5%; WBC <13 ×10⁹/L; ANC ≥1.0 ×10⁹/L; Hemoglobin ≥10 g/dL; Platelet count ≥50 ×10⁹/L; No clinically significant transfusion requirement attributable to MDS/CMML, defined as receipt of <2 units of RBCs and no platelet transfusions during the 8 weeks preceding screening (excluding transfusions for acute bleeding, surgery, or another transient intercurrent condition); In the judgment of the treating oncologist, clinically stable disease for which disease-modifying therapy is not anticipated to be required within the subsequent 24 months.

Exclusion: placement of a drug-eluting stent in a proximal coronary arterial segment <180 days before baseline imaging; prior coronary artery bypass grafting; current treatment with prescription, systemic (oral, IV [intravenous], or IM [intramuscular]) steroids or anti-inflammatory/immune suppressant medical therapies (including colchicine but excluding topical therapies, UV therapy, ASA-derivative therapies, or NSAIDS) for autoimmune/inflammatory diseases, post-transplant care, asthma, or pain; use of oral steroids or prescription oral anti-inflammatory/immune suppressant medication for >7 days within the past 1 month; use of IV or IM steroids or IV or IM anti-inflammatory/immune suppressant medication within the past 3 months; use of phosphodiesterase type 5 inhibitor AND refusal to abstain from use of these medications within the 5 days prior to scheduled CCTA scan; significant radiation exposure (40msV) received within the past 12 months; concurrent enrollment in another research study judged by the investigators to interfere with the current study; live vaccinations within 3 months prior to randomization visit or live vaccinations planned during the trial; history of blood malignancy or current solid-tumor malignancy; history of organ or stem cell transplantation; known allergy to dextran's and/or DTPA and/or radiometals and/or severe allergy to iodinated contrast media; history or evidence of tuberculosis (TB) (active or latent) infection or risk factor for TB; active bacterial, fungal or viral infection at the time of enrollment or history of recurrent infections; estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73 m2; known active or recurrent hepatic disease (including cirrhosis or ALT/AST levels >3 times the upper limit oof or total bilirubin >2 times the upper limits of normal); pregnancy or breastfeeding; contraindications to nitroglycerin known narrow angle glaucoma, or known severe aortic stenosis; suspected or proven immunocompromised state.

ClinicalTrials.gov NCT06691217