This is a Phase IIa, multi-centre study conducted at 3 sites in Singapore (SGH and NUHS, KTPH). 70 patients with diabetes mellitus (DM) and peripheral arterial disease (PAD) will be randomised in a ratio 1:1 to receive normal saline control or MEDI6570 400mg by monthly subcutaneous injection for 9 months.
This is a mechanistic, randomised, double-blind, controlled Phase IIa trial that investigates whether 9 months of treatment with MEDI6570 affects lower limb microvascular perfusion and atheroma inflammation and progression. Patients with both DM and PAD will receive monthly subcutaneous injections of 400mg MEDI6570 (in an injection volume of 4.0ml), or injection/volume-matched normal saline control (4.0ml) subcutaneously, every 4 weeks for 32 weeks (9 doses in total). Com Approximately 70 participants will be randomly assigned to a study intervention, with an anticipated 35 participants being randomized to receive active study intervention, and 35 participants being randomized to receive normal saline control. The primary objective of the study is to determine whether monthly subcutaneous injections of MEDI6570 for 9 months reduces lower limb atheroma plaque inflammation and improves lower limb microvascular perfusion, when compared to normal saline control. The primary endpoint in REDUCE-PAD will be the between-group difference (intervention vs. normal saline control) in the change in PET and MRI scan parameters from baseline to 9 months. Efficacy, safety, PK, and immunogenicity of MEDI6570 will also be evaluated in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
Saline Control
Prof Derek J. Hausenloy
Singapore, Singapore, Singapore
Lower limb atheroma plaque inflammation
Lower limb atheroma plaque inflammation Changes from baseline to 9 months in lower limb atheroma plaque FDG uptake measured by PET/MRI scans.
Time frame: 9 months
Lower limb perfusion
Changes from baseline to 9 months in ankle brachial index (ABI) and toe brachial index (TBI)
Time frame: 9 months
Lower limb microvascular perfusion
Changes from baseline to 9 months in lower limb microvascular perfusion measured by MRI scans.
Time frame: 9 months
Lower limb atheroma plaque progression
Changes from baseline to 9 months in lower limb atheroma plaque volume measured by US arterial duplex and MRI scans
Time frame: 9 months
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