A Study to Evaluate Safety and Efficacy of APO-2 at Three Different Doses in Patients With Diabetic Foot Ulcer

Diabetic Foot Ulcer (DFU) Clinical Trial

Official title: A Randomized, Placebo-controlled, Double-blind Study to Evaluate Safety and Dose Dependent Clinical Efficacy of APO-2 at Three Different Doses in Patients With Diabetic Foot Ulcer

Status Completed

Clinical Trial Summary

The MARSYAS II study which will be conducted in patients with diabetic foot ulcer (DFU) consists of a Lead-In Phase for safety assessment of multiple doses of the biologic investigational medicinal product (IMP) APO-2 and of a Main Phase (Phase II Study) to assess the efficacy and safety of the IMP. The phase II study will be a randomized study at multiple clinical centers and it will be double-blind meaning that neither the investigator nor the treated patient know if the IMP or a placebo is applied; the study will investigate the safety and clinical efficacy of multiple dose administrations at three dose levels of APO-2 (low dose, medium dose or high dose) compared with placebo.

Clinical Trial Description

APOSEC is a secretome released by cultured, stressed peripheral blood mononuclear cells (PBMC) in medium. Content analysis revealed that APOSEC harbors a myriad of proteins, exosomes, lipids, phospholipids, cholesterols as well as antimicrobial peptides. It was shown that the topical application of APOSEC mixed with a hydrogel, called APO-2, promotes/enhances wound healing. The MARSYAS II main study will be a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-ranging phase II study to investigate the safety and clinical efficacy of multiple dose administrations at three dose levels of APO-2 compared with placebo in patients with diabetic foot ulcer (DFU). The main study will be preceded by a safety lead-in period evaluating multiple dose safety (25 U/ml APO-2) in patients with DFU in a cohort of 12 patients randomized at a ratio of 3:1 between APO-2 and placebo at 2 to 4 study sites. The minimum duration of an individual patient in the safety lead-in period is 93 days (including screening), with a maximum of approximately 117 days. In the main study 120 eligible patients will be randomized at a ratio of 1:1:1:1 between APO-2 (three doses) and placebo. Patients will be stratified by wound size (at least 20% of patients will need to have wound size > 4 square cm), and randomly assigned to 1 of 4 treatment groups (low dose [12.5 U/ml], medium dose [25 U/ml], high dose [50 U/ml] or placebo). After randomization, patients will receive IMP three times per week during the 4-week active treatment period. 0.5 ml IMP will be applied per square cm wound surface area for each dose group. ;

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer (DFU)
• Foot Ulcer
• Ulcer

• NCT number: NCT04277598
• Study type: Interventional
• Source: Aposcience AG
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 9, 2020
• Completion date: December 6, 2023