EU Clinical Trial Information System (CTIS)

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Official Title

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A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction.

Efficacy and Safety of MEDI6570 in Patients with a History of Myocardial Infarction

This Phase IIB, proof-of-concept, dose-range finding clinical study is being conducted to evaluate the anti-inflammatory potential of MEDI6570 and its effect on surrogates for atherosclerotic and heart failure (HF) events in patients with a history of myocardial infarction (MI). The results of the Phase IIB study will inform future clinical development options and precision medicine strategy for future clinical studies.
Participants will be randomized in a 2:2:1:1 ratio after protocol Amend 2, 360 evaluable participants (111 evaluable participants in each of the 2 MEDI6570 groups, plus 27 evaluable participants in the legacy low dose MEDI6570 group, plus 111 participants in pooled placebo) will complete the study.

CTIS Number

EudraCT Number

NCT ID

Patient Level Data

Therapeutic Area

Research Site

A Phase IIB, Randomized, Double blinded, Placebo controlled, Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction and Persistent Inflammation

Change in non-calcified plaque volume in the most diseased coronary segment (NCPVMD), as measured by CTA imaging compared to placebo.

Ethnicity (NIH/OMB)

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Race/Ethnicity, Customized

Age Continuous

8 subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.

To evaluate the effect of MEDI6570 on non-calcified coronary atherosclerotic plaques compared with placebo. The primary endpoint of change in NCPVMD from baseline to Day 253 was assessed based on the CTA Analysis Populations.

Participants within the Intention To Treat (ITT) Population who had interpretable CTA scans at baseline and at Day 253.  Participants were analyzed according to their randomized treatment group.
Subjects initially randomized to the 250 mg group switched dose to 400 mg following clinical study protocol (CSP) amendment 1 and were analysed according to the 400 mg group.

Change from baseline to Day 253 in non-calcified plaque volume in the most diseased coronary segment (NCPVMD), as measured by Computed Tomography Angiography (CTA) imaging

To evaluate the effect of MEDI6570 on a surrogate
biomarker of Heart Failure (HF) compared with placebo

Randomized subjects who received any study treatment will be included
in the As-treated Population. Subjects will be analysed according to the actual treatment they received, regardless of their randomized treatment group. Subjects treated within 250 mg group that received at least one 400 mg dose during the study will be analysed according to the 400mg group.

Change from baseline to Day 253 in N Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP)

LVEF

To evaluate the effect of MEDI6570 on left ventricular
systolic function compared with placebo

Subjects within the ITT population who have interpretable
echocardiograms in the baseline and follow-up periods will be included
in the Echocardiogram Analysis Population.
Subjects will be analysed according to their randomized treatment group.
subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group

Change from baseline to Day 253 in Left Ventricular Ejection Fraction (LVEF)

To evaluate the effect of MEDI6570 on left ventricular
systolic function among participants with reduced
ejection fraction (defined as <50%) compared with
placebo

Subjects within the ITT population who have interpretable
echocardiograms in the baseline and follow-up periods will be included
in the Echocardiogram Analysis Population.
Subjects will be analysed according to their randomized treatment group.
Subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.

Left ventricular ejection fraction (LVEF) change from baseline to Day 253 among subjects with reduced ejection fraction (< 50%)

To evaluate the effect of MEDI6570 on left ventricular systolic function compared with placebo

Subjects within the ITT population who have interpretable echocardiograms in the baseline and follow-up periods will be included in the Echocardiogram Analysis Population. Subjects will be analysed according to their randomized treatment group. Subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.

Change from baseline to Day 253 in Global Longitudinal Strain (GLS)

Global longitudinal strain (GLS) change from baseline to Day 253 among subjects with reduced ejection fraction (< 50%)

To evaluate the effect of MEDI6570 on other measures
of non-calcified coronary atherosclerotic plaque
compared with placebo

Participants within the ITT Population who had interpretable b CTA scans at baseline and at Day 253 or at Day 122 were included. (Note that separate analyses were conducted for Day 253 and Day 122). Participants were analyzed according to their randomized treatment group.
Subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.

Change from baseline to Day 253 in Global non-calcified plaque volume (NCPV)

Participants within the ITT Population who had interpretable CTA scans at baseline and at Day 253. Participants were analyzed according to their randomized treatment group.
Subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.

Change from baseline to Day 253 in Low attenuation plaque volume (LAPV)

ADA (anti-drug antibody) prevalence (positive at baseline or post-baseline)

ADA (anti-drug antibody)  incidence (TEADA positive)

Treatment-induced ADA (anti-drug antibody) positive

Treatment-boosted ADA (anti-drug antibody) positive

ADA (anti-drug antibody) 
 persistently positive

To evaluate the immunogenicity of MEDI6570

Subjects included in the As-treated Population who
have ≥ 1 immunogenicity sample will be included in the
Immunogenicity Population.
Subjects will be analysed according to the actual treatment they received. Subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.

Summary of ADA (anti-drug antibody) Responses During the Study

Baseline

Day 29

Day 57

Day 113

Day 169

Day 253

Day 325/405

Anti-drug antibody Titre summary by visit

Day 10

Day 85

Day 122

Day 141

Day 197

Day 225

Day 325/Day
405

MEDI6570 concentrations as measured in serum
during the intervention and follow-up periods

All subjects who received ≥ 1 dose of MEDI6570 and have ≥ 1 one post dose evaluable MEDI6570 serum concentration will be included in the PK population. Subjects will be analysed according to the actual treatment they received. The pk data was analysed only for 50 mg, 150mg and 400mg groups.

Summary of serum concentrations (ug/mL) of MEDI6570

Any AEs

Any AEs with outcome of death

Any SAE (including events with outcome of death)

Any AE leading to treatment discontinuation

Any AE leading to withdrawal from study

To assess the safety and tolerability of MEDI6570
compared with placebo

Number of Participants with Adverse Events in Any Category

Participants with any AE

COVID-19

Hypertension

Non-cardiac chest pain

Dyspnoea

Hypotension

Angina pectoris

Pyrexia

Diarrhoea

Epistaxis

Influenza

Nausea

Pain in extremity

Number of Participants with Most Common Adverse Events (Frequency > 5%)

Systolic blood
pressure 

Day 10

Systolic blood
pressure 

Day 29

Systolic blood
pressure 

Day 57

Systolic blood
pressure 

Day 85

Systolic blood
pressure 

Day 113

Systolic blood
pressure 

Day 122

Systolic blood
pressure 

Day 141

Systolic blood
pressure 

Day 169

Systolic blood
pressure 

Day 197

Systolic blood
pressure 

Day 225

Systolic blood
pressure 

Day 253

Systolic blood
pressure 

Day 325/405

Diastolic blood
pressure 

Day 10

Diastolic blood
pressure 

Day 29

Diastolic blood
pressure 

Day 57

Diastolic blood
pressure 

Day 85

Diastolic blood
pressure 

Day 113

Diastolic blood
pressure 

Day 122

Diastolic blood
pressure 

Day 141

Diastolic blood
pressure 

Day 169

Diastolic blood
pressure 

Day 197

Diastolic blood
pressure 

Day 225

Diastolic blood
pressure 

Day 253

Diastolic blood
pressure 

Day 325/405

Vital signs (change in systolic and diastolic blood pressure from baseline) over time

Heart rate

Day 10

Heart rate


Day 29

Heart rate


Day 57

Heart rate

Day 85

Heart rate

Day 113

Heart rate


Day 122

Heart rate


Day 141

Heart rate


Day 169

Heart rate


Day 197

Heart rate


Day 225

Heart rate


Day 253

Heart rate


Day 325/405

Vital signs (change in Heart rate from baseline) variables over time

Weight (kg)

Day 325/405

Vital signs (change of Weight from baseline to Day 325/405 )

Overall Study

Global Clinical Lead

Change in LVEF as measured by echocardiography compared to placebo

Change in GLS as measured by echocardiography compared to placebo

Change in Global non-calcified plaque volume as measured by CTA imaging compared to placebo

Change in Low attenuation plaque volume as measured by CTA imaging compared to placebo

Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) compared to placebo

Adverse events (AEs) as evaluated by incidence of clinically important changes in vital signs, ECG, chemistry, or hematology values compared to placebo

Immunogenicity as measured by anti-drug antibodies (ADAs)

Non-compartmental analysis will be performed for MEDI6570 treated subjects

Change in LVEF as measured by echocardiography among participants with reduced ejection fraction compared to placebo

Change in GLS as measured by echocardiography among participants with reduced ejection fraction compared to placebo

An unexpected error has occurred.