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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Focused Orticumab Research for Treating Inflammation in Coronary Arteries (NCT06927739) is a Phase 2 interventional studying Acute Coronary Syndromes and Coronary Arterial Disease (CAD), sponsored by Abcentra. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Acute Coronary Syndromes and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 240 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Acute Coronary Syndromes subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participant must provide willing to sign a consent form before any study specific activities are performed, must be able and willing to meet all requirements for randomization and must adhere to the schedules of activities. 2. Participant must be \>180 days after presumed type-1 myocardial infarction (i.e., due to plaque rupture or erosion, either STEMI or NSTEMI) without subsequent unstable or severe angina (Canadian Cardiovascular Society Class 3 or 4) at the time of enrollment. Participants who have undergone PCI are allowed. 3. Participant must be on a stable cardiovascular treatment regimen consistent with local treatment guidelines for post-AMI patients (such as maximally tolerated statin and/or PCSK9 inhibitor medication for LDL reduction, antiplatelet medication, and hypertension treatment). 4. Participant must have an evaluable, pre-randomization CCTA with one of the following: 1. A quantifiable Fat Attenuation Index (FAI) Score greater than or equal to the 50th centile (per reference standard) for their age group in at least two coronary arteries or 2. A quantifiable Fat Attenuation Index (FAI) Score greater than or equal to the 75th centile (per reference standard) for their age group in at least one coronary artery 5. Participant must have body mass index (BMI) ≤ 40 kg/m2. 6. Adult male and female participants ≥18 years of age at the Screening Visit: For female participants, the participant must not be pregnant or lactating and must be one of the following: 1. Postmenopausal, defined as amenorrhea for ≥ 12 months following cessation of all exogenous hormonal treatments; follicle stimulating hormone levels may be obtained at the investigator's discretion to confirm the participant is postmenopausal. 2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomization and must adhere to the schedules of activities. 2. Participant must be \>180 days after presumed type-1 myocardial infarction (i.e., due to plaque rupture or erosion, either STEMI or NSTEMI) without subsequent unstable or severe angina (Canadian Cardiovascular Society Class 3 or 4) at the time of enrollment. Participants who have undergone PCI are allowed. 3. Participant must be on a stable cardiovascular treatment regimen consistent with local treatment guidelines for post-AMI patients (such as maximally tolerated statin and/or PCSK9 inhibitor medication for LDL reduction, antiplatelet medication, and hypertension treatment). 4. Participant must have an evaluable, pre-randomization CCTA with one of the following: 1. A quantifiable Fat Attenuation Index (FAI) Score greater than or equal to the 50th centile (per reference standard) for their age group in at least two coronary arteries or 2. A quantifiable Fat Attenuation Index (FAI) Score greater than or equal to the 75th centile (per reference standard) for their age group in at least one coronary artery 5. Participant must have body mass index (BMI) ≤ 40 kg/m2. 6. Adult male and female participants ≥18 years of age at the Screening Visit: For female participants, the participant must not be pregnant or lactating and must be one of the following: 1. Postmenopausal, defined as amenorrhea for ≥ 12 months following cessation of all exogenous hormonal treatments; follicle stimulating hormone levels may be obtained at the investigator's discretion to confirm the participant is postmenopausal. 2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization. 3. Females of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study drug. In the case of positive urine pregnancy testing, a negative serum sample for pregnancy testing, to confirm that the participant is not pregnant, must be obtained prior to start of study. They must also agree to use an adequate method of contraception from Baseline through the End of the study or for 30 days after the last dose of study drug (whichever is longer), which include the following: sexual abstinence (if preferred and usual lifestyle of the participant), condom with spermicidal gel, diaphragm with spermicidal gel, coil (intrauterine device), surgical sterilization, vasectomy, oral contraceptive pill, depo progesterone injections, progesterone implant (i.e., Implanon®), NuvaRing®, Ortho Evra®. For male participants - Nonsterile male participants with sexual partners of childbearing potential must agree to use an adequate method of contraception, including sexual abstinence (if preferred and usual lifestyle of the participant), from Baseline through the End of the study. Exclusion Criteria: 1. History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study. 2. Percutaneous coronary intervention or invasive diagnostic coronary angiogram planned after screening. Eligible participants who have an invasive diagnostic coronary angiogram performed in the absence of undergoing a new PCI may continue screening after the diagnostic angiogram has been performed or may be rescreened. 3. History of or planned coronary artery bypass grafting. 4. Documented episode of post-MI pericarditis in the 3 months before enrollment. 5. Presence of unstable or uncontrolled angina. Canadian CV society (CCS) angina class \> 2. 6. Ongoing New York Heart Association Class IV HF. 7. Poorly controlled type 1 or type 2 diabetes mellitus (hemoglobin A1c \>8.0%). 8. Increased risk of bleeding: 1. With history or presence of any bleeding disorder. 2. Signs of ongoing bleeding at screening (e.g., identified macroscopic bleeding, low hemoglobin presumed to be caused by bleeding) or high risk for major bleeding in accordance with the Investigator's assessment (participants taking clinically indicated antiplatelet and antithrombotic agents are acceptable). 3. Known severe liver disease (e.g., \>5´ upper limit of normal elevations in ALT and/or AST and other evidence of grade 3 or higher criteria applies such as from the CTCAE 5.0 guidelines). 9. History or presence of any of the following: 1. Ongoing infection or febrile illness. 2. Ongoing persistent or permanent atrial fibrillation or flutter. 3. Cancer within 5 years before randomization, with the exception of non-melanoma skin cancer. 4. Alcohol or substance abuse within 6 months before randomization, as judged by the investigator. 5. Known history of hypersensitivity reactions to other biologics, to human IgG preparations, or to any component of orticumab, or ongoing severe allergy as judged by the investigator. 6. Active positive results on screening for serum hepatitis C core antibody. 7. Clinically documented hepatitis B or HIV. 10. Any clinically important abnormalities in clinical chemistry, hematology, coagulation parameters, as judged by the investigator. 11. Blood pressure values at screening (taken as the average of triplicate measurements): 1. Systolic blood pressure \< 90 mmHg or \> 180 mmHg. 2. Diastolic blood pressure \> 100 mmHg. 3. One triplicate retest (repeat of all 3) will be allowed during the same visit, at which point if the retest result is no longer exclusionary, the participant may be randomized 4. Participants who are excluded based on elevated blood pressure may be rescreened following adequate treatment. 12. Participants with any of the following contraindications to CCTA. 1. eGFR \< 40 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration equation, or end stage renal disease treated with kidney transplant or renal replacement therapy. 2. Allergy to iodinated contrast. 3. History of contrast-induced nephropathy. 4. Contraindication to nitroglycerin. 5. Rapid heart rate that is uncontrolled by medical therapy. 6. Inability to hold breath for at least 6 seconds. 13. Use of any of the following in the 180 days before randomization: IL-17 inhibitor, TNF inhibitor, IL-6 inhibitor, IL-1β inhibitor, methotrexate, cyclosporine, apremilast, colchicine, systemic steroids (topical steroid use is allowed). 14. COVID-19 vaccine within 90 days of screening CCTA. 15. Participants with a confirmed positive COVID-19 test within 90 days of screening CCTA. 16. Receipt of any investigational device or therapy within 6 months or 5 half-lives before screening (whichever is longer). 17. Planned participation in an additional investigational study of an intervention or biologic before the end of the follow-up period. Participation in observational studies or studies without investigational drugs or devices is allowed. 18. Participants who have previously been exposed to orticumab. 19. Participants who are legally institutionalized. 20. An employee or close relative of an employee of the sponsor, the CRO, or the study site, regardless of the employee or close relative's role.

Treatments Being Tested

DRUG

Orticumab

Orticumab treatment for 24 weeks for post MI population

DRUG

Placebo

Placebo for 24 weeks for the post MI population

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Abcentra Investigational Site
Los Angeles, California, United States
Abcentra Investigational Site
Torrance, California, United States
Abcentra Investigational Site
Boca Raton, Florida, United States
Abcentra Investigational Site
Richmond, Indiana, United States
Abcentra Investigational Site
Louisville, Kentucky, United States
Abcentra Investigational Site
Baltimore, Maryland, United States
Abcentra Investigational Site
Midland, Michigan, United States
Abcentra Investigational Site
Ostrava, Moravian-Silesian Region, Czechia
Abcentra Investigational Site
Pilsen, Plzeň Region, Czechia
Abcentra Investigational Site
Prague, Praha 2, Czechia
Abcentra Investigational Site
Prague, Praha 4, Czechia
Abcentra Investigational Site
Brno, South Moravian, Czechia
Abcentra Investigational Site
Pécs, Baranya, Hungary
Abcentra Investigational Site
Budapest, Central Hungary, Hungary
Abcentra Investigational Site
Budapest, Central Hungary, Hungary
Abcentra Investigational Site
Budapest, Central Hungary, Hungary
Abcentra Investigational Site
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Abcentra Investigational Site
Caserta, Campania, Italy
Abcentra Investigational Site
Ferrara, Ferrara, Italy
Abcentra Investigational Site
Brescia, Lombardy, Italy

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06927739), the sponsor (Abcentra), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06927739 clinical trial studying?

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 docto… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06927739?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06927739?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06927739. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06927739. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.