Focused Orticumab Research for Treating Inflammation in Coronary Arteries

Part of paid clinical trials in Los Angeles, California.

Sponsor
Abcentra
Study ID
NCT06927739
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Coronary Syndromes
  • Atherosclerotic Coronary Vascular Disease
  • Coronary Arterial Disease (CAD)
  • Heart Disease
  • Inflammation
  • Myocardial Infarct

Eligibility Criteria

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

Interventions

  • Orticumab — DRUG
    Orticumab treatment for 24 weeks for post MI population
  • Placebo — DRUG
    Placebo for 24 weeks for the post MI population

Study Details

The goal of this clinical trial is to determine the clinical effect of orticumab treatment on inflammation in study participants with prior myocardial infarction who have elevated coronary inflammation based on CCTA. The main question it aims to answer is: Clinical effects of orticumab treatment on inflammation of the coronary artery parameters measured with CCTA Researchers will compare the effects with placebo group after 6 months of treatment Participants will Keep the planned study visit appointments Provide complete information about medical and medical history Speak to the study doctor before changing any of non-study treatments, including starting new medications, receiving any vaccinations, or setting out to join any other clinical studies

Key Dates

Start date
Aug 11, 2025
Status verified
Oct 2025
Primary completion
Feb 8, 2027
Completion
Jun 1, 2027

Study Design

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

Arms

  • Active Comparator: Orticumab High Dose
  • Active Comparator: Orticumab Low Dose
  • Placebo Comparator: Placebo High Dose
  • Placebo Comparator: Placebo Low Dose

Primary Outcome Measure

Percent change from baseline of the mean Fat Attenuation Index (FAI) score for the 3 coronary arteries (RCA, LAD and LCX) for orticumab compared to placebo at 24 weeks [ Time Frame: 24 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Abcentra Investigational SiteLos AngelesCalifornia90048-
Abcentra Investigational SiteTorranceCalifornia90502-
Abcentra Investigational SiteBoca RatonFlorida33434-
Abcentra Investigational SiteRichmondIndiana47374-
Abcentra Investigational SiteLouisvilleKentucky40202-
Abcentra Investigational SiteBaltimoreMaryland21215-
Abcentra Investigational SiteMidlandMichigan48670-

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Abcentra Investigational Site· Los Angeles, CAAbcentra Investigational Site· Torrance, CAAbcentra Investigational Site· Boca Raton, FLAbcentra Investigational Site· Richmond, INAbcentra Investigational Site· Louisville, KYAbcentra Investigational Site· Baltimore, MD

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