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New treatment option for Vascular Inflammation
Official title Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis
ClinicalTrials.gov ID: NCT06691217
What this study is testing
What is CANAKINUMAB (ILARIS®)?
CANAKINUMAB (ILARIS®) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for vascular inflammation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years or older
- Coronary artery disease, defined as prior heart attack, coronary stent procedure \>180 days before baseline imaging, or advanced subclinical coronary...
- Presence of either TET2 mutations or no myeloid driver mutations on prior sequencing
You likely can't join if
- 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...
See the full eligibility 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...
- Presence of either TET2 mutations or no myeloid driver mutations on prior sequencing
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.