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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Vascular Inflammation, ASCVD, ASCVD Management

In brief

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.

Key facts

Study ID

NCT06691217

Run by

Massachusetts General Hospital

People needed

120

Starts

2026-03-24

Expected to finish

2030-04-01

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• history of organ or stem cell transplantation
• 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
• known allergy to dextran's and/or DTPA and/or radiometals and/or severe allergy to iodinated contrast media
• estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73 m2
• contraindications to nitroglycerin known narrow angle glaucoma, or known severe aortic stenosis
• 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
• 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)
• 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
• suspected or proven immunocompromised state
• live vaccinations within 3 months prior to randomization visit or live vaccinations planned during the trial

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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