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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06691217
Phase
PHASE2
Status
Recruiting
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Conditions

  • ASCVD
  • ASCVD Management
  • Vascular Inflammation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CANAKINUMAB (ILARIS®) — DRUG
    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.
  • Saline (NaCl 0,9 %) (placebo) — DRUG
    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.

Study Details

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 Dates

Start date
Mar 24, 2026
Status verified
May 2026
Primary completion
Jan 1, 2029
Completion
Apr 1, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo: Control
    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.
  • Experimental: Treatment: Canakinumab
    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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Victoria R Viscosi, MS
[email protected]
617-724-2996
Jack H.A. Miller, BS
[email protected]
617-643-7546
Michael C Honigberg, MD, MPP (PRINCIPAL_INVESTIGATOR)

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Massachusetts General Hospital· Boston, MA

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