Recruiting
Phase 2

Canakinumab

Sponsor:

Massachusetts General Hospital

Code:

NCT06691217

Conditions

Vascular Inflammation

ASCVD

ASCVD Management

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CANAKINUMAB (ILARIS®)

Saline (NaCl 0,9 %) (placebo)

Study Details

Brief 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 TET2 mutations.

Conditions

Vascular Inflammation

ASCVD

ASCVD Management

Study ID

NCT06691217

Start date

Mar 24, 2026

Status verified date

Oct, 2026

Completion date

Apr 1, 2030

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo: Control

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

experimental: Treatment: Canakinumab

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

Interventions

CANAKINUMAB (ILARIS®)

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

Saline (NaCl 0,9 %) (placebo)

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

Primary outcome measure

  • Between-group difference (canakinumab versus placebo) in the change in perivascular fat attenuation index (Hounsfield units) measured by coronary computed tomography angiography [ Time Frame: 48 weeks ]

Central Contacts and Locations

Central contacts

Michael C Honigberg, MD MPP

617-726-1843mhonigberg@mgh.harvard.edu

Mabel Toribio, MD

(617)-724-2826mptoribio@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Victoria R Viscosi, MS

617-724-2996vviscosi@mgh.harvard.edu

Jack H.A. Miller, BS

617-643-7546jmiller90@mgh.harvard.edu

Principal Investigator:

Michael C Honigberg, MD, MPP

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

  • CHIP
  • TET2 CHIP
  • Clonal Hematopoiesis
  • Vascular Inflammation
  • ASCVD
  • ASCVD management
  • MDS
  • CMML
  • Myelodysplastic syndrome
  • Chronic Myelomonocytic Leukemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.