Trials / Recruiting
RecruitingNCT06927739
Focused Orticumab Research for Treating Inflammation in Coronary Arteries
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Orticumab in Participants With Prior Myocardial Infarction Who Have Elevated Coronary Inflammation Based on FAI Score Assessed by CCTA
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- Sponsor
- Abcentra · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Detailed description
Participants will have the opportunity to participate in a Day 14 sub study. Participants who enroll in this optional sub study will have safety assessment (AE monitoring) and a blood sample obtained for serum orticumab concentration measurement, ADA titer, clinical safety labs and cardiometabolic and inflammation biomarkers.
Conditions
- Acute Coronary Syndromes
- Coronary Arterial Disease (CAD)
- Inflammation
- Heart Disease
- Myocardial Infarct
- Atherosclerotic Coronary Vascular Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Orticumab | Orticumab treatment for 24 weeks for post MI population |
| DRUG | Placebo | Placebo for 24 weeks for the post MI population |
Timeline
- Start date
- 2025-08-11
- Primary completion
- 2027-02-08
- Completion
- 2027-06-01
- First posted
- 2025-04-15
- Last updated
- 2026-01-27
Locations
41 sites across 9 countries: United States, Czechia, Hungary, Italy, Poland, Romania, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06927739. Inclusion in this directory is not an endorsement.