Actively Recruiting
Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis
Led by Massachusetts General Hospital · Updated on 2026-05-13
120
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of canakinumab, an anti-IL-1B monoclonal antibody, on vascular inflammation in people with a history of coronary artery disease. This study includes individuals with and without clonal hematopoiesis driven by TET2 gene mutations. The trial is a phase 2, randomized, double-blind, placebo-controlled study involving 120 participants to test if canakinumab reduces vascular inflammation compared to placebo. Participants will be randomly assigned to receive either canakinumab 150 mg or a placebo injection every three months for four doses. Baseline assessments include coronary CT angiography, with a subset undergoing SPECT imaging to evaluate macrophage-specific vascular inflammation. Follow-up visits for injections and safety occur at weeks 0, 12, 24, and 36. Repeat imaging to assess changes in vascular inflammation happens at week 48, and final safety assessments are completed at week 60. Throughout the study, participants will have multiple visits for injections, safety checks, and imaging tests including coronary CT angiography and SPECT scans. Researchers will measure changes in perivascular fat attenuation index by CT angiography and macrophage inflammation by SPECT imaging. They will also monitor changes in TET2 clonal variant allele fractions in those with TET2 clonal hematopoiesis. The study duration for each participant is about 60 weeks, with ongoing safety monitoring during this period.
CONDITIONS
Brief Title
Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Prior heart attack or coronary stent procedure more than 180 days before baseline imaging
- Presence of either TET2 clonal hematopoiesis or no CHIP variants on prior sequencing
You will not qualify if you...
- Placement of a drug-eluting stent in a proximal coronary artery less than 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 systemic steroids or immune suppressant medications (oral, IV, or IM) for autoimmune or inflammatory diseases, post-transplant care, asthma, or pain
- Use of oral steroids or prescription anti-inflammatory medication for more than 7 days within the past month
- Use of IV or IM steroids or anti-inflammatory medication within the past 3 months
- Known allergy to dextran, DTPA, radiometals, or severe allergy to iodinated contrast media
- Estimated glomerular filtration rate below 45 ml/min/1.73 m2
- Contraindications to nitroglycerin, known narrow angle glaucoma, or severe aortic stenosis
- Use of phosphodiesterase type 5 inhibitors and refusal to abstain within 5 days before coronary CT angiography
- Significant radiation exposure (40 mSv) within the past 12 months
- Concurrent enrollment in another interfering research study
- Known active or recurrent liver disease or elevated liver enzymes
- History or evidence of tuberculosis infection or risk factors
- Active bacterial, fungal, or viral infection at enrollment or history of recurrent infections
- Suspected or proven immunocompromised state
- Live vaccinations within 3 months before randomization or planned during the trial
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 weeks
Participants receive injections of canakinumab or placebo every 3 months for 4 doses to study the effects on vascular inflammation.
4 injection and safety visits at Week 0, Week 12, Week 24, and Week 36
Duration - 24 weeks
Participants undergo repeat imaging assessments and final safety evaluations to measure changes in vascular inflammation and other study outcomes.
Visits at Week 48 and Week 60 for imaging and final assessments
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
M
Michael C Honigberg, MD MPP
M
Mabel Toribio, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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