RecruitingPhase 2NCT06691217

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


Sponsor

Massachusetts General Hospital

Enrollment

120 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • years or older
  • Prior heart attack or coronary stent procedure >180 days before baseline imaging
  • Presence of either TET2 CHIP or no CHIP variants on prior sequencing

Exclusion Criteria19

  • 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

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Interventions

DRUGCANAKINUMAB (ILARIS®)

Participants with and without TET2 CHIP will receive 150mg of canakinumab every 3 months for 4 doses as part of the randomized clinical trial part of this proposal.

DRUGSaline (NaCl 0,9 %) (placebo)

Participants with and without TET2 CHIP will receive placebo injection every 3 months for 4 doses as part of the randomized clinical trial part of this proposal.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06691217


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