Back to search results

Canakinumab for Vascular Inflammation in Coronary Artery Disease

This study is testing if a drug called canakinumab (ILARIS®) can reduce inflammation in blood vessels for people with coronary artery disease (blockages in the heart's arteries), including those with a specific genetic change called TET2 clonal hematopoiesis (CHIP). Canakinumab is a monoclonal antibody, which is a type of protein that can block specific inflammatory signals in the body. Participants will receive either canakinumab or a placebo (an inactive substance) every three months for a year. Researchers will measure changes in vascular inflammation using special CT scans. To join, you must be 18 or older and have coronary artery disease. The study aims to enroll 120 participants, but its current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study involving 120 participants. Half of the participants will have TET2 CHIP.
What's involved
You would have injection/safety visits at weeks 0, 12, 24, and 36, with repeat imaging at week 48. Final assessments occur at week 60.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 60 weeks, with the primary outcome measured at 48 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06691217

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Massachusetts General Hospital
~120 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:CANAKINUMAB (ILARIS®)Saline (NaCl 0,9 %) (placebo)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Between-group difference (canakinumab versus placebo) in the change in perivascular fat attenuation index (Hounsfield units) measured by coronary computed tomography angiography
Measured over 48 weeks

Conditions

Vascular Inflammation
ASCVD
ASCVD Management

Explore related trials

AtherosclerosisClonal HematopoiesisVesicular inflammation

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Michael C Honigberg, MD MPP
[email protected]
617-726-1843
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

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

Exclusion

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

What this trial measures

  • Between-group difference (canakinumab versus placebo) in the change in perivascular fat attenuation index (Hounsfield units) measured by coronary computed tomography angiography48 weeks