A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
423
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 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.
Time frame: From baseline to Day 253
Change From Baseline to Day 253 in N Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP)
To evaluate the effect of MEDI6570 on a surrogate biomarker of Heart Failure (HF) compared with placebo
Time frame: From baseline to Day 253
Change From Baseline to Day 253 in Left Ventricular Ejection Fraction (LVEF)
To evaluate the effect of MEDI6570 on left ventricular systolic function compared with placebo
Time frame: From baseline to Day 253
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 among participants with reduced ejection fraction (defined as \<50%) compared with placebo
Time frame: From baseline to Day 253
Change From Baseline to Day 253 in Global Longitudinal Strain (GLS)
To evaluate the effect of MEDI6570 on left ventricular systolic function compared with placebo
Time frame: From baseline to Day 253
Global Longitudinal Strain (GLS) Change From Baseline to Day 253 Among Subjects With Reduced Ejection Fraction (< 50%)
To evaluate the effect of MEDI6570 on left ventricular systolic function among participants with reduced ejection fraction (defined as \<50%) compared with placebo
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Research Site
Mobile, Alabama, United States
Research Site
Beverly Hills, California, United States
Research Site
Covina, California, United States
Research Site
Northridge, California, United States
Research Site
Northridge, California, United States
Research Site
Torrance, California, United States
Research Site
Ponte Vedra, Florida, United States
Research Site
Decatur, Georgia, United States
Research Site
Muncie, Indiana, United States
Research Site
Richmond, Indiana, United States
...and 74 more locations
Time frame: From baseline to Day 253
Change From Baseline to Day 253 in Global Non-calcified Plaque Volume (NCPV)
To evaluate the effect of MEDI6570 on other measures of non-calcified coronary atherosclerotic plaque compared with placebo
Time frame: From baseline to Day 253
Change From Baseline to Day 253 in Low Attenuation Plaque Volume (LAPV)
To evaluate the effect of MEDI6570 on other measures of non-calcified coronary atherosclerotic plaque compared with placebo
Time frame: From baseline to Day 253
Summary of ADA (Anti-drug Antibody) Responses During the Study
To evaluate the immunogenicity of MEDI6570
Time frame: From baseline to Day 325/405. Day 325/405: for participants who completed the study under clinical study protocol (CSP) Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.
Anti-drug Antibody Titre Summary by Visit
To evaluate the immunogenicity of MEDI6570
Time frame: From Baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.
Summary of Serum Concentrations (ug/mL) of MEDI6570
MEDI6570 concentrations as measured in serum during the intervention and follow-up periods
Time frame: From baseline to Day 325/Day 405
Number of Participants With Adverse Events in Any Category
To assess the safety and tolerability of MEDI6570 compared with placebo
Time frame: During study follow-up (from day 1 to day 325)
Number of Participants With Most Common Adverse Events (Frequency > 5%)
To assess the safety and tolerability of MEDI6570 compared with placebo
Time frame: During study follow-up (from day 1 to day 325)
Vital Signs (Change in Systolic and Diastolic Blood Pressure From Baseline) Over Time
To assess the safety and tolerability of MEDI6570 compared with placebo
Time frame: From baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.
Vital Signs (Change in Heart Rate From Baseline) Variables Over Time
To assess the safety and tolerability of MEDI6570 compared with placebo
Time frame: From baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.
Vital Signs (Change of Weight From Baseline to Day 325/405 )
To assess the safety and tolerability of MEDI6570 compared with placebo
Time frame: From baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively