Clinical trial NCT04956900: Clinical Trial Enzyme Application Targeting Venous Leg Ulcers
Official title: An Open Label, Multiple Ascending Dose Study of the Safety, Tolerability and Bio-effect of Aurase for Wound Debridement in Patients With Venous Leg Ulcers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Leg Ulcer
Leg Injuries and Disorders
Keywords: Wounds
Chronic Leg Ulcer
Leg Ulcer
Venous Leg Ulcer
Lead sponsor: SolasCure Limited
Sponsor class: INDUSTRY
First posted: 2021-07-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cohort study design with each cohort having an ascending dose of Aurase wound gel. At the time of initiation, 5 sequential cohorts are planned.
Primary purpose: TREATMENT

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)

Detailed description: The study has been designed as a dose escalation study, and will serially explore increasing concentrations of the Aurase enzyme in a relevant patient population. Five cohorts (of 10 patients each, except cohort 1 with 5 patients), will receive standard of care supplemented with increasing concentrations of Aurase and will be assessed for clinical tolerability at the wound site, systemic safety and efficacy (extent of wound debridement) over a period of 4 weeks. Patients will receive a total of 12 doses of Aurase Wound Gel. At the end of the study, patients will revert to standard of care only.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From the time of signing informed consent up to the last visit (Day 29)
measure: Change in study wound pain burden from baseline measured by Numerical Rating Scale (NRS)
timeFrame: Pre-dosing and post-dose at day 1 (baseline) through to day 29 (end of study)
measure: Change in study wound itch burden from baseline measured by Numerical Rating Scale (NRS)
timeFrame: Pre-dose at day 1 (baseline) through to day 29 (end of study)
measure: Grading of clinical signs of wound inflammation
timeFrame: Pre-dosing and Post-dose at day 1 (baseline) through to day 29 (end of study)
measure: Grading of clinical signs of wound infection
timeFrame: Day 1 (baseline) through to day 29 (end of study)
Secondary outcomes:
measure: Change in surface area of wound compared to baseline
timeFrame: Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)
measure: Change in surface area of devitalised tissue (slough, eschar) compared to baseline
timeFrame: Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)
measure: Change in surface area of granulation tissue from baseline
timeFrame: Day 1 (baseline) , day 5, day 12, day 19, day 29 (end of study)
measure: Number of patients achieving 100% debridement
timeFrame: Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)
measure: Systemic absorption of Aurase enzyme assessed through pharmacokinetic profiling of blood samples
timeFrame: Pre-dose and Post dose at day 1 (baseline) and day 29 (end of study) or early termination visit (if applicable)
measure: Assessment of the presence of antibodies to Aurase in plasma (Anti-Drug Antibody [ADA] activity) through applicable laboratory analysis of blood samples
timeFrame: Day 1 (Baseline) and day 29 (end of study) or early termination visit (if applicable)
measure: Assessment of systemic clotting factors in plasma
timeFrame: Day 0 (Screening), day 1 (Baseline), day 8 and day 29 (end of study) or early termination visit (if applicable)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Center for Clinical Research
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami
country: United States
facility: Doctors Research Network
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Salem
country: United States
facility: FASMA
state: Virginia
city: Budapest
country: Hungary
facility: Óbudai Egészségügyi Centrum Kft.
city: Budapest
country: Hungary
facility: Uno Medical Trials
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
Study officials:
References: