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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001392-32 | EudraCT Number |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aurase wound gel X0 | Experimental | Cohort 1: Aurase wound gel x0 dose concentration |
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| Aurase wound gel X1 | Experimental | Cohort 2: Aurase wound gel x1 dose concentration |
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| Aurase wound gel X1.8 | Experimental | Cohort 3: Aurase wound gel X1.8 dose concentration |
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| Aurase wound gel X5 | Experimental | Cohort 4: Aurase wound gel X5 dose concentration |
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| Aurase wound gel X9 | Experimental | Cohort 5: Aurase wound gel X9 dose concentration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Research | San Francisco | California | 94117 | United States | ||
| Mayo Clinic Jacksonville |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2026 |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D007869 | Leg Injuries |
| D004194 | Disease |
| D014947 | Wounds and Injuries |
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012883 | Skin Ulcer |
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Cohort study design with each cohort having an ascending dose of Aurase wound gel. At the time of initiation, 5 sequential cohorts are planned.
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| 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 | Determination of 100% debridement made by clinical assessor upon assessment of wound at each study visit | 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) |
| Assessment of the presence of antibodies to Aurase in plasma (Anti-Drug Antibody [ADA] activity) through applicable laboratory analysis of blood samples | Day 1 (Baseline) and day 29 (end of study) or early termination visit (if applicable) |
| Assessment of systemic clotting factors in plasma | Activated partial thromboplastin time (APTT)/ prothrombin time (PT)/Fibrinogen plasma concentrations determined through laboratory analysis of blood samples | Day 0 (Screening), day 1 (Baseline), day 8 and day 29 (end of study) or early termination visit (if applicable) |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Doctors Research Network | Miami | Florida | 33143 | United States |
| University of Miami | Miami | Florida | 33146 | United States |
| FASMA | Salem | Virginia | 24153 | United States |
| Óbudai Egészségügyi Centrum Kft. | Budapest | 1036 | Hungary |
| Uno Medical Trials | Budapest | Hungary |
| Hull Royal Infirmary | Hull | HU32JZ | United Kingdom |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |