Authorised Therapeutic exploratory (Phase II) Atherosclerotic Cardiovascular disease

FORTIFY – Focused Orticumab Research for Treating inflammation in Coronary Arteries

EU CTIS ID: 2025-520464-17-00

What this study is testing

To determine the clinical effect of orticumab treatment on inflammation in study participants with prior myocardial infarction who have elevated coronary inflammation based on pericoronary FAI measured during CCTA

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

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: • 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
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: a) Postmenopausal b) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. c)Females of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study drug, and agree to use a highly effective method of contraception from Baseline through 100 days after the last dose of study For male participants - Nonsterile male participants with sexual partners of childbearing potential must agree to use an adequate method of contraception such as condom, from Baseline through 100 days after last dose of the study drug.

You likely can't join if

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.
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): a) Systolic blood pressure < 90 mmHg or > 180 mmHg. b) Diastolic blood pressure > 100 mmHg. c) 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 d) Participants who are excluded based on elevated blood pressure may be rescreened following adequate treatment.
12. Participants with contraindications to CCTA
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 and inhaled steroid use is allowed).
14. COVID-19 vaccine within 90 days of screening CCTA.

See the full eligibility criteria

Who can join

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: • 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
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: a) Postmenopausal b) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. c)Females of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study drug, and agree to use a highly effective method of contraception from Baseline through 100 days after the last dose of study For male participants - Nonsterile male participants with sexual partners of childbearing potential must agree to use an adequate method of contraception such as condom, from Baseline through 100 days after last dose of the study drug.

What rules you out

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.
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): a) Systolic blood pressure < 90 mmHg or > 180 mmHg. b) Diastolic blood pressure > 100 mmHg. c) 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 d) Participants who are excluded based on elevated blood pressure may be rescreened following adequate treatment.
12. Participants with contraindications to CCTA
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 and inhaled 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.
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.
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.
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
9. History or presence of any of the following: a) Ongoing infection or febrile illness. b) Ongoing persistent or permanent atrial fibrillation or flutter. c) Cancer within 5 years before randomization, with the exception of non-melanoma skin cancer. d) Alcohol or substance abuse within 6 months before randomization, as judged by the investigator. e) 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. f) Active positive results on screening for serum hepatitis C core antibody. g) Clinically documented hepatitis B or HIV.

The study team makes the final eligibility decision.

Where it's taking place

United States
United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 2 diabetes Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.