Vascular InflammationPhase 2TECTONICNCT06691217
Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis
A Phase 2 study testing CANAKINUMAB (ILARIS®) in people with Vascular Inflammation and ASCVD, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Inflammation, ASCVD, ASCVD Management
- What is being tested?
- CANAKINUMAB (ILARIS®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to 1 Apr 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Victoria R Viscosi, MS, 617-724-2996, vviscosi@mgh.harvard.edu
Jack H.A. Miller, BS, 617-643-7546, jmiller90@mgh.harvard.edu
About this study
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.
Read the detailed description
This is a prospective, randomized, double-blind, placebo-controlled study to test the effects of canakinumab, an inhibitor of interleukin-1B, on vascular inflammation in individuals with coronary artery disease. Half of the trial population will have mutations in TET2. Participants (total N=120) will be randomized 1:1 to receive canakinumab (n=60) versus placebo (n=60). Baseline assessment in all participants will include coronary CT angiography, and a subset of participants in each group (n=16 per group) will undergo SPECT imaging to assess macrophage-specific vascular inflammation. After randomization, participants will have injection/safety visits at Week 0, Week 12, Week 24, and Week 36. Repeat imaging assessments for vascular inflammation will occur during the Week 48 visit(s). Participants will undergo final study and safety assessments at Week 60. The primary endpoint is change in the fat attenuation index (FAI) as measured by coronary CT angiography between baseline and Week 48. Other key endpoints are change in macrophage-specific inflammation by SPECT between baseline and Week 48 and change in TET2 clonal variant allele fraction among participant with TET2 mutations.
- Conditions
- Vascular Inflammation, ASCVD, ASCVD Management
- Being tested
- CANAKINUMAB (ILARIS®), Saline (NaCl 0,9 %) (placebo)
- Keywords
- CHIP, TET2 CHIP, Clonal Hematopoiesis, Vascular Inflammation, ASCVD, ASCVD management, MDS, CMML, Myelodysplastic syndrome, Chronic Myelomonocytic Leukemia
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CANAKINUMAB (ILARIS®)Drug
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)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo: Control | Placebo comparator | 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. Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
| Treatment: Canakinumab | Experimental | 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. Receives: Drug: CANAKINUMAB (ILARIS®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference (canakinumab versus placebo) in the change in perivascular fat attenuation index (Hounsfield units) measured by coronary computed tomography angiography
Measured: 48 weeks
Secondary outcomes (1)
Between-group difference (canakinumab versus placebo) in the percent change in TET2 variant allele fraction (proportion of mutated alleles in peripheral blood cells) ascertained by targeted genomic sequencing
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start24 Mar 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular InflammationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective, randomized, double-blind clinical trial of individuals with established coronary heart disease.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Broad Institute of MIT and Harvard, Yale University
- Responsible party
- Principal investigator, Michael C. Honigberg, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691217
- Sponsor's protocol ID
- 2024P002825
- Acronym
- TECTONIC
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared outside of MGH. All samples and images being analyzed by outside vendors will be de-identified
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis
- ClinicalTrials.gov ID
- NCT06691217
- Acronym / sponsor ID
- TECTONIC / 2024P002825
- Conditions
- Vascular Inflammation, ASCVD, ASCVD Management
- Keywords
- CHIP, TET2 CHIP, Clonal Hematopoiesis, Vascular Inflammation, ASCVD, ASCVD management, MDS, CMML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Broad Institute of MIT and Harvard, Yale University
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, randomized, double-blind, placebo-controlled study to test the effects of canakinumab, an inhibitor of interleukin-1B, on vascular inflammation in individuals with coronary artery disease. Half of the trial population will have mutations in TET2. Participants (total N=120) will be randomized 1:1 to receive canakinumab (n=60) versus placebo (n=60). Baseline assessment in all participants will include coronary CT angiography, and a subset of participants in each group (n=16 per group) will undergo SPECT imaging to assess macrophage-specific vascular inflammation. After randomization, participants will have injection/safety visits at Week 0, Week 12, Week 24, and Week 36. Repeat imaging assessments for vascular inflammation will occur during the Week 48 visit(s). Participants will undergo final study and safety assessments at Week 60. The primary endpoint is change in the fat attenuation index (FAI) as measured by coronary CT angiography between baseline and Week 48. Other key endpoints are change in macrophage-specific inflammation by SPECT between baseline and Week 48 and change in TET2 clonal variant allele fraction among participant with TET2 mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective, randomized, double-blind clinical trial of individuals with established coronary heart disease.
| Arm | Type | Receives |
|---|---|---|
| Placebo: Control | Placebo comparator | Drug: 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. |
| Treatment: Canakinumab | Experimental | Drug: CANAKINUMAB (ILARIS®)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Treatment: Canakinumab |
| 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. | Drug | Placebo: Control |
Primary outcome
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
1 secondary outcome
Between-group difference (canakinumab versus placebo) in the percent change in TET2 variant allele fraction (proportion of mutated alleles in peripheral blood cells) ascertained by targeted genomic sequencing
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. IPD will not be shared outside of MGH. All samples and images being analyzed by outside vendors will be de-identified
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CANAKINUMAB (ILARIS®) in people with Vascular Inflammation and ASCVD, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael C Honigberg, MD MPP (617-726-1843, mhonigberg@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.