Focused Orticumab Research for Treating Inflammation in Coronary Arteries

NCT06927739 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ORT-2024-02
• Study Type: interventional
• Target: 240
• Locations: 9 countries
• Sites: 41

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  Analysis of the mean FAI score around the coronary arteries will be performed from baseline and 6-month Coronary Computed Tomography Angiography (CCTA) procedures. FAI-score is a standardized measurement of coronary inflammation for each coronary artery (adjusted for age, sex as well as technical, biological, and anatomical characteristics) to allow individualized interpretation of the degree of coronary inflammation. FAI-Score is given at a scale of 0-100 with arbitrary unit. A higher FAI-score indicates an increase coronary inflammation.

  24 weeks

Secondary Outcomes (2)

• Change from baseline for coronary artery inflammation

  24 weeks

• Change from baseline for CaRi-Heart score for orticumab compared to placebo at 24 weeks of treatment

  24 weeks

Other Outcomes (5)

• Change in coronary artery plaque burden accessed by Coronary Computed Tomography Angiography (CCTA) at 24 weeks

  24 weeks

• Change in radiotranscriptomic biomarkers of coronary inflammation as assessed by Coronary Computed Tomography Angiography (CCTA)

  24 weeks

• Number and percent of participants with treatment-emergent adverse events (TEAEs), and any serious adverse events

  24 weeks

Study Arms (4)

Orticumab High Dose

ACTIVE COMPARATOR

Drug: Orticumab

Orticumab Low Dose

ACTIVE COMPARATOR

Drug: Orticumab

Placebo High Dose

PLACEBO COMPARATOR

Drug: Placebo

Placebo Low Dose

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Orticumab DRUG

Orticumab treatment for 24 weeks for post MI population

Also known as: MLDL1278a, BI204

Orticumab High Dose; Orticumab Low Dose

Placebo DRUG

Placebo for 24 weeks for the post MI population

Placebo High Dose; Placebo Low Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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).
• Participant must have an evaluable, pre-randomization CCTA with one of the following:
• 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
• 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
• Participant must have body mass index (BMI) ≤ 40 kg/m2.
• 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:
• 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.
• Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization.
• 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.

You may not qualify if:

• 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.
• 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.
• History of or planned coronary artery bypass grafting.
• Documented episode of post-MI pericarditis in the 3 months before enrollment.
• Presence of unstable or uncontrolled angina. Canadian CV society (CCS) angina class \> 2.
• Ongoing New York Heart Association Class IV HF.
• Poorly controlled type 1 or type 2 diabetes mellitus (hemoglobin A1c \>8.0%).
• Increased risk of bleeding:
• With history or presence of any bleeding disorder.
• 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).
• 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).
• History or presence of any of the following:
• Ongoing infection or febrile illness.
• Ongoing persistent or permanent atrial fibrillation or flutter.
• Cancer within 5 years before randomization, with the exception of non-melanoma skin cancer.

Sponsors & Collaborators

• Abcentra: lead

Study Sites (41)

Abcentra Investigational Site

Los Angeles, California, 90048, United States

NOT YET RECRUITING

Abcentra Investigational Site

Torrance, California, 90502, United States

RECRUITING

Abcentra Investigational Site

Boca Raton, Florida, 33434, United States

RECRUITING

Abcentra Investigational Site

Richmond, Indiana, 47374, United States

RECRUITING

Abcentra Investigational Site

Louisville, Kentucky, 40202, United States

NOT YET RECRUITING

Abcentra Investigational Site

Baltimore, Maryland, 21215, United States

RECRUITING

Abcentra Investigational Site

Midland, Michigan, 48670, United States

RECRUITING

Abcentra Investigational Site

Ostrava, Moravian-Silesian Region, 728 80, Czechia

RECRUITING

Abcentra Investigational Site

Pilsen, Plzeň Region, 323 00, Czechia

RECRUITING

Abcentra Investigational Site

Prague, Praha 2, 128 08, Czechia

RECRUITING

Abcentra Investigational Site

Prague, Praha 4, 140 21, Czechia

RECRUITING

Abcentra Investigational Site

Brno, South Moravian, 602 00, Czechia

RECRUITING

Abcentra Investigational Site

Pécs, Baranya, 7635, Hungary

RECRUITING

Abcentra Investigational Site

Budapest, Central Hungary, 1036, Hungary

RECRUITING

Abcentra Investigational Site

Budapest, Central Hungary, 1094, Hungary

RECRUITING

Abcentra Investigational Site

Budapest, Central Hungary, 1132, Hungary

RECRUITING

Abcentra Investigational Site

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

RECRUITING

Abcentra Investigational Site

Caserta, Campania, 81100, Italy

RECRUITING

Abcentra Investigational Site

Ferrara, Ferrara, 44124, Italy

RECRUITING

Abcentra Investigational Site

Brescia, Lombardy, 25123, Italy

RECRUITING

Abcentra Investigational Site

Milan, Lombardy, 20162, Italy

RECRUITING

Abcentra Investigational Site

Pavia, Lombardy, 27100, Italy

RECRUITING

Abcentra Investigational Site

Krakow, Lesser Poland Voivodeship, 30-082, Poland

RECRUITING

Abcentra Investigational Site

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

RECRUITING

Abcentra Investigational Site

Warsaw, Masovian Voivodeship, 03-505, Poland

RECRUITING

Abcentra Investigational Site

Baia Mare, Maramureş, 430031, Romania

RECRUITING

Abcentra Investigational Site

Târgu Mureş, Mureș County, 540124, Romania

RECRUITING

Abcentra Investigational Site

Timișoara, Timiș County, 300060, Romania

RECRUITING

Abcentra Investigational Site

Córdoba, Andalusia, 14004, Spain

RECRUITING

Abcentra Investigational Site

Madrid, Madrid, 28034, Spain

RECRUITING

Abcentra Investigational Site

Madrid, Madrid, 28046, Spain

RECRUITING

Abcentra Investigational Site

El Palmar, Murcia, 30120, Spain

RECRUITING

Abcentra Investigational Site

Seville, Sevilla, 41009, Spain

RECRUITING

Abcentra Investigational Site

Danderyd, Stockholm County, 182 88, Sweden

RECRUITING

Abcentra Investigational Site

Solna, Stockholm County, 171 76, Sweden

RECRUITING

Abcentra Investigational Site

Gothenburg, Västra Götaland County, 413 45, Sweden

RECRUITING

Abcentra Investigational Site

London, Greater London, EC1M 6BQ, United Kingdom

RECRUITING

Abcentra Investigational Site

Manchester, Greater Manchester, M23 9LT, United Kingdom

RECRUITING

Abcentra Investigational Site

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Abcentra Investigational Site

Bath, Somerset, BA1 3NG, United Kingdom

RECRUITING

Abcentra Investigational Site

Sheffield, South Yorkshire, S57AU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Inflammation; Heart Diseases; Myocardial Infarction

Interventions

MLDL1278A

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Necrosis

Central Study Contacts

Abcentra

CONTACT

424-369-4401; info@abcentra.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 15, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): February 8, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

CZ (5); SE (3); PL (3); ES (5); HU (5); IT (5); GB (5); RO (3); US (7)