Clinical Trial Enzyme Application Targeting Venous Leg Ulcers

NCT04956900 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: SC-VLU-0012020-001392-32
• Study Type: interventional
• Target: 43
• Locations: 3 countries
• Sites: 8

Brief Summary

This is an adaptive open-label, first-in-human (Phase IIa) study designed to assess the safety (and efficacy) of Aurase Wound Gel, an enzymatic debridement product, intended for topical application to sloughy venous leg ulcers (VLU)

Conditions

Venous Leg Ulcer; Leg Injuries and Disorders

Keywords

Wounds; Chronic Leg Ulcer; Leg Ulcer; Venous Leg Ulcer

Outcome Measures

Primary Outcomes (5)

• Incidence of treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From the time of signing informed consent up to the last visit (Day 29)

• Change in study wound pain burden from baseline measured by Numerical Rating Scale (NRS)

  Subject will be asked to describe the level of wound pain on a scale of 0-10: 0 being no pain, 10 being worst imaginable pain

  Pre-dosing and post-dose at day 1 (baseline) through to day 29 (end of study)

• Change in study wound itch burden from baseline measured by Numerical Rating Scale (NRS)

  Subject will be asked to describe the level of wound itch on a scale of 0-10: 0 being no itch, 10 being worst imaginable itch

  Pre-dose at day 1 (baseline) through to day 29 (end of study)

• Grading of clinical signs of wound inflammation

  5-point ordinal grading scale (1 \[none\] to 5 \[severe\] ) of wound erythema, oedema made by clinical assessor by Visual Assessment (VA)

  Pre-dosing and Post-dose at day 1 (baseline) through to day 29 (end of study)

• Grading of clinical signs of wound infection

  5-point ordinal grading scale (1 \[none\] to 5 \[severe\] ) of wound exudate and induration or grading of presence/absence of wound bleeding and infection made by clinical assessor by Visual Assessment (VA)

  Day 1 (baseline) through to day 29 (end of study)

Secondary Outcomes (7)

• Change in surface area of wound compared to baseline

  Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)

• Change in surface area of devitalised tissue (slough, eschar) compared to baseline

  Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)

• Change in surface area of granulation tissue from baseline

  Day 1 (baseline) , day 5, day 12, day 19, day 29 (end of study)

• Number of patients achieving 100% debridement

  Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)

• Systemic absorption of Aurase enzyme assessed through pharmacokinetic profiling of blood samples

  Pre-dose and Post dose at day 1 (baseline) and day 29 (end of study) or early termination visit (if applicable)

Study Arms (5)

Aurase wound gel X0

EXPERIMENTAL

Cohort 1: Aurase wound gel x0 dose concentration

Drug: Aurase Wound gel

Aurase wound gel X1

EXPERIMENTAL

Cohort 2: Aurase wound gel x1 dose concentration

Drug: Aurase Wound gel

Aurase wound gel X1.8

EXPERIMENTAL

Cohort 3: Aurase wound gel X1.8 dose concentration

Drug: Aurase Wound gel

Aurase wound gel X5

EXPERIMENTAL

Cohort 4: Aurase wound gel X5 dose concentration

Drug: Aurase Wound gel

Aurase wound gel X9

EXPERIMENTAL

Cohort 5: Aurase wound gel X9 dose concentration

Drug: Aurase Wound gel

Interventions

Aurase Wound gel DRUG

Aurase Wound Gel is reconstituted from Aurase Component A (a hydrogel) and Aurase Component B (stabilised solutions of Aurase enzyme). By diluting different strengths of Aurase Component B with Component A, specific concentrations of Aurase Wound Gels with differing Aurase contents are yielded.

Aurase wound gel X0; Aurase wound gel X1; Aurase wound gel X1.8; Aurase wound gel X5; Aurase wound gel X9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 18 years and older at screening
• Patients with at least one defined Venous Leg Ulcer (VLU) suitable for treatment that is no smaller than 2cm2 but no larger than 50cm2
• Presence of devitalised tissue within the reference ulcer suitable for debridement therapy
• Confirmed, clinically diagnosed VLU (30 days or more) which has been present for less than 2 years
• Willing and able to attend and comply with study visits and study related activities

You may not qualify if:

• Diabetic Foot Ulcer
• A clinical history of a bleeding disorder including haemophilia, purpura, or thrombocytopenia
• Current or history of use of anti-thrombotic therapy less than 7 days prior to screening.
• Stage 4 or 5 chronic kidney disease, defined as estimated glomerular filtration rate (eGFR) less than or equal to 30 mL/min
• Reference ulcer has active infection or florid oedema at screening
• Oral or intravenous antibiotics for any indication within 72 hours of screening
• Reference ulcer has exposed tendons, ligaments, muscle, or bone
• Active osteomyelitis, cellulitis or gangrene in either leg
• Patients with amputation above a trans metatarsal amputation (TMA) in the target leg
• Planned vascular surgery, angioplasty, or thrombolysis procedures within the study period, or 4 weeks before screening

Sponsors & Collaborators

• SolasCure Limited: lead

Study Sites (8)

Center for Clinical Research

San Francisco, California, 94117, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Doctors Research Network

Miami, Florida, 33143, United States

Location

University of Miami

Miami, Florida, 33146, United States

Location

FASMA

Salem, Virginia, 24153, United States

Location

Óbudai Egészségügyi Centrum Kft.

Budapest, 1036, Hungary

Location

Uno Medical Trials

Budapest, Hungary

Location

Hull Royal Infirmary

Hull, HU32JZ, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer; Leg Injuries; Disease; Wounds and Injuries; Leg Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohort study design with each cohort having an ascending dose of Aurase wound gel. At the time of initiation, 5 sequential cohorts are planned.

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 9, 2021
• Study Start: August 9, 2021
• Primary Completion: February 6, 2023
• Study Completion: February 6, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); HU (2); GB (1)