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New drug aims to cool inflammation in heart arteries after attack

NCT ID NCT06927739

Disease control Sponsor: Abcentra Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a drug called orticumab in 240 people who had a heart attack and still have high inflammation in their heart arteries. Participants receive either orticumab or a placebo for 24 weeks. The main goal is to see if orticumab lowers inflammation measured by a special CT scan. The trial is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
orticumab
What this could lead to
If it works, this could lead to a new treatment that reduces dangerous inflammation in heart arteries after a heart attack, potentially lowering the risk of future heart problems.
What could go wrong
This is an early phase 2 trial with only 240 participants, so results may not apply to everyone. The drug may not reduce inflammation better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome coronary artery disorder coronary atherosclerosis heart disorder Inflammation inflammatory disease myocardial infarction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute coronary syndromes Atherosclerotic coronary vascular disease Coronary arterial disease (CAD) Heart disease Inflammation Myocardial infarct

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    41 sites in 9 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Abcentra Investigational Site

    NOT_YET_RECRUITING

    Los Angeles, California, 90048, United States

  • Abcentra Investigational Site

    RECRUITING

    Torrance, California, 90502, United States

  • Abcentra Investigational Site

    RECRUITING

    Boca Raton, Florida, 33434, United States

  • Abcentra Investigational Site

    RECRUITING

    Richmond, Indiana, 47374, United States

  • Abcentra Investigational Site

    NOT_YET_RECRUITING

    Louisville, Kentucky, 40202, United States

  • Abcentra Investigational Site

    RECRUITING

    Baltimore, Maryland, 21215, United States

  • Abcentra Investigational Site

    RECRUITING

    Midland, Michigan, 48670, United States

  • Abcentra Investigational Site

    RECRUITING

    Ostrava, Moravian-Silesian Region, 728 80, Czechia

  • Abcentra Investigational Site

    RECRUITING

    Pilsen, Plzeň Region, 323 00, Czechia

  • Abcentra Investigational Site

    RECRUITING

    Prague, Praha 2, 128 08, Czechia

  • Abcentra Investigational Site

    RECRUITING

    Prague, Praha 4, 140 21, Czechia

  • Abcentra Investigational Site

    RECRUITING

    Brno, South Moravian, 602 00, Czechia

  • Abcentra Investigational Site

    RECRUITING

    Pécs, Baranya, 7635, Hungary

  • Abcentra Investigational Site

    RECRUITING

    Budapest, Central Hungary, 1036, Hungary

  • Abcentra Investigational Site

    RECRUITING

    Budapest, Central Hungary, 1094, Hungary

  • Abcentra Investigational Site

    RECRUITING

    Budapest, Central Hungary, 1132, Hungary

  • Abcentra Investigational Site

    RECRUITING

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

  • Abcentra Investigational Site

    RECRUITING

    Caserta, Campania, 81100, Italy

  • Abcentra Investigational Site

    RECRUITING

    Ferrara, Ferrara, 44124, Italy

  • Abcentra Investigational Site

    RECRUITING

    Brescia, Lombardy, 25123, Italy

  • Abcentra Investigational Site

    RECRUITING

    Milan, Lombardy, 20162, Italy

  • Abcentra Investigational Site

    RECRUITING

    Pavia, Lombardy, 27100, Italy

  • Abcentra Investigational Site

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-082, Poland

  • Abcentra Investigational Site

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

  • Abcentra Investigational Site

    RECRUITING

    Warsaw, Masovian Voivodeship, 03-505, Poland

  • Abcentra Investigational Site

    RECRUITING

    Baia Mare, Maramureş, 430031, Romania

  • Abcentra Investigational Site

    RECRUITING

    Târgu Mureş, Mureș County, 540124, Romania

  • Abcentra Investigational Site

    RECRUITING

    Timișoara, Timiș County, 300060, Romania

  • Abcentra Investigational Site

    RECRUITING

    Córdoba, Andalusia, 14004, Spain

  • Abcentra Investigational Site

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • Abcentra Investigational Site

    RECRUITING

    Madrid, Madrid, 28046, Spain

  • Abcentra Investigational Site

    RECRUITING

    El Palmar, Murcia, 30120, Spain

  • Abcentra Investigational Site

    RECRUITING

    Seville, Sevilla, 41009, Spain

  • Abcentra Investigational Site

    RECRUITING

    Danderyd, Stockholm County, 182 88, Sweden

  • Abcentra Investigational Site

    RECRUITING

    Solna, Stockholm County, 171 76, Sweden

  • Abcentra Investigational Site

    RECRUITING

    Gothenburg, Västra Götaland County, 413 45, Sweden

  • Abcentra Investigational Site

    RECRUITING

    London, Greater London, EC1M 6BQ, United Kingdom

  • Abcentra Investigational Site

    RECRUITING

    Manchester, Greater Manchester, M23 9LT, United Kingdom

  • Abcentra Investigational Site

    RECRUITING

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Abcentra Investigational Site

    RECRUITING

    Bath, Somerset, BA1 3NG, United Kingdom

  • Abcentra Investigational Site

    RECRUITING

    Sheffield, South Yorkshire, S57AU, United Kingdom

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