Phase-2, Multi-centre, Prospective, Randomized, Standard-of-care Plus Placebo-controlled, Patient and Central Evaluator Blinded, Parallel Arm, Clinical Study to Evaluate Safety, Tolerability and Efficacy of the AUP1602-C as Treatment for Non-healing Neuro-ischemic DFU

Aurealis Oy10 sites in 3 countries64 target enrollmentJuly 21, 2023

ConditionsDiabetic Foot Ulcer

InterventionsAUP1602-C Placebo

Overview

Phase: Phase 2
Intervention: AUP1602-C
Conditions: Diabetic Foot Ulcer
Sponsor: Aurealis Oy
Enrollment: 64
Locations: 10
Primary Endpoint: Incidence of local and systematic adverse events (AEs)
Status: Completed
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 2 study performed in diabetic foot ulcer (DFU) patients with chronic non-healing, neuro-ischemic wounds to investigate the safety, tolerability and efficacy of AUP1602-C.

Detailed Description

This is a phase 2 multi-centre, parallel arm, patient and central evaluator-blinded, randomized, SoC plus placebo-controlled study of the RP2D of AUP1602-C performed in DFU patients with non-healing wounds. The RP2D of AUP1602-C derived from phase 1 study is 2.5 x 10E8 CFU/cm2 ulcer area and is used in this study.

Registry

clinicaltrials.gov

Start Date

July 21, 2023

End Date

November 28, 2025

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Aurealis Oy

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients aged 18 and above
•Patients with DM of type 1 or 2 having a glycosylated haemoglobin (HbA1c) of ≤ 11.0% OR 97.0 mmol/mol OR 14.9 mmol/l at randomization undergoing therapy for glycaemic control using available diabetes drugs including insulin
•Patients with at least one DFU that fulfils all the following criteria:
•Non-healing target ulcer defined as ≤ 20.0% reduction in area in response to SoC during the 2-weeks run-in period,
•Duration: ≥ 4 weeks and ≤ 12 months at screening visit 1,
•Located either in the plantar or on the dorsum of foot, or at or below the ankle,
•Ulcer is accessible for administration of IMP and can be completely covered by the primary and secondary dressings,
•Full-thickness, not involving bone or joints (i.e., University of Texas classification Grade 1A, 1C, 2A, 2C)(5),
•No clinical signs of active wound infection defined by IDSA/IWGDF criteria(6) or clinical evidence osteomyelitis at randomization (V1),
•Area of the target ulcer between 1.0-10.0 cm2 after debridement at randomization (V1)

Exclusion Criteria

•Participating in another clinical study or treatment with another investigational product and/or medical device in the 30 days prior to inclusion in the study or within the 5 half-lives of the investigational product, whichever is longer.
•Current or previous (within 30 days prior to start of run-in period) treatment of target ulcer with a treatment that could interfere with wound healing/IMP such as biological agents, growth factors, skin equivalents/substitutes (e.g., Regranex®, Apligraf®, or Dermagraft®), keratinocytes, platelet-rich-plasma, collagen products, blood products, placental products, oxygen therapy, topical steroids.
•Current or previous (within 1 week prior to first IMP (AUP1602-C or placebo) dosing) treatment with active wound care agents (e.g., local/topical antibiotics OR antibacterials such as silver, iodine, chlorhexidine) OR systemic antibiotics for any indication.
•Current or previous (within 2 weeks prior to first IMP (AUP1602-C or placebo) dosing) use of corticosteroids and immunosuppressants. Treatment with immunosuppressive agents with known therapeutic effects longer than 2 weeks may be considered as exclusion and should be consulted with Medical Monitor/Sponsor.
•Known hypersensitivity to any of the components of AUP1602-C or placebo
•Ulcer of University of Texas Grade ≥ 3, with deep abscess, sinus track, necrosis or gangrene that cannot be removed by debridement.
•Target ulcers with excessive exudation requiring more than one dressing change within 24-hrs.
•Target ulcers with clinically significant periwound skin maceration.
•Target ulcer with known or suspected active infection, which requires antimicrobials. Any antibiotic therapy must be completed or discontinued within 1 week prior to first IMP (AUP1602-C or placebo) dosing.
•Target ulcers requiring urgent vascular surgical interventions.

Arms & Interventions

AUP1602-C

AUP1602-C is administered topically during the treatment period.

Intervention: AUP1602-C

Placebo

Placebo is administered topically during the treatment period.

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of local and systematic adverse events (AEs)

Time Frame: 6 weeks

Incidence of local and systematic adverse events (AEs) for repeatedly administered AUP1602-C and of the placebo control arm.

Incidence of Wound Closure

Time Frame: 20 weeks

Proportion of patients with a target ulcer achieving complete wound closure

Secondary Outcomes

Changes in Quality of Life according to DLQI(20 weeks)
To evaluate the effect of the RP2D and selected treatment schedules long-term healing in DFU patients(20 weeks)
To evaluate the effect of the RP2D and selected treatment schedules ulcer recurrence in DFU patients(20 weeks)
Changes in Quality of Life according to EQ-5D-5L(20 weeks)
Changes in pain assessment according to VAS(20 weeks)
Incidence of target ulcer related hospital visits(20 weeks)
To evaluate the effect size of the efficacy parameters for AUP1602-C and placebo control arm in DFU patients(20 weeks)
To evaluate the effect of the RP2D and selected treatment schedules on the percentage of wound area reduction in DFU patients(20 weeks)