Description Module

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Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module

Ignite Creation Date: 2025-12-25 @ 4:41 AM
Ignite Modification Date: 2025-12-25 @ 4:41 AM
NCT ID: NCT05912218
Brief Summary: 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.
Detailed Description: 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: NCT05912218
Study Brief:
Protocol Section: NCT05912218