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CANAKINUMAB

Phase 2

Vascular Inflammation | Small molecule | Other |Harvard Bioscience, Inc.|Last Updated: Apr 14, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06691217Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal HematopoiesisPHASE2 RECRUITING 120Apr 1, 2026Apr 1, 2030Apr 14, 20261 United States
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Study Endpoints
Primary Endpoints
Between-group difference (canakinumab versus placebo) in the change in perivascular fat attenuation index (Hounsfield units) measured by coronary computed tomography angiography
48 weeks
Secondary Endpoints
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
48 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo: ControlPLACEBO_COMPARATORParticipants 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.
Treatment: CanakinumabEXPERIMENTALParticipants 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.
Interventions
NameTypeDescription
CANAKINUMAB (ILARIS®)DRUGParticipants 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)DRUGParticipants 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.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 18 years or older * Prior heart attack or coronary stent procedure \>180 days before baseline imaging * Presence of either TET2 CHIP or no CHIP variants on prior sequencing Exclusion Criteria: * placement of a drug-eluting stent in a proximal coronary arterial segment \<180 ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06691217studyFirstPostDate: changed