Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An adaptive open label, multiple ascending dose study of the safety, tolerability and bio-effect of Aurase for wound debridement in patients with venous leg ulcers and diabetic foot ulcers (CLEANVLU/DFU)

    Summary
    EudraCT number
    		 2020-001392-32
    Trial protocol
    		 HU  
    Global end of trial date
    06 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Mar 2024
    First version publication date
    13 Mar 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SC-VLU-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04956900
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    SolasCure Ltd
    Sponsor organisation address
    Wellington House, East Road, Cambridge, United Kingdom, CB1 1BH
    Public contact
    David Fairlamb, SolasCure Limited, 44 1274519914, dfairlamb@solascure.com
    Scientific contact
    David Fairlamb, SolasCure Limited, 44 1274519914, dfairlamb@solascure.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Feb 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of multiple ascending doses of Aurase Wound Gel when administered cutaneously (topically) to participants with Venous Leg Ulcers (VLU)
    Protection of trial subjects
    Study will be conducted in accordance with the requirements of International Council for Harmonisation Good Clinical Practice (ICH GCP), the Declaration of Helsinki (revised version of 2013), Good Manufacturing Practice (GMP), and the current national regulations and guidelines. The protocol will be approved by both the local ethics committee(s) (IEC) / institutional review board(s) (IRB) and regulatory authority(ices). Safety was evaluated based on adverse events (AEs), clinical laboratory tests, tolerability assessments, ECGs, concomitant medication review as well as a number of entry assessments (e.g. vital signs, medical history, physical examination) For each study cohort a sentinel patient was enrolled and safety data through at least day 8 was reviewed in a safety review meeting (sponsor and enrolling investigator attended). A safety review meeting was also conducted at the end of each cohort to determine whether it was safe to dose escalate in the next cohort.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Oct 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Hungary: 27
    Country: Number of subjects enrolled
    United States: 15
    Worldwide total number of subjects
    43
    EEA total number of subjects
    27
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    16
    From 65 to 84 years
    25
    85 years and over
    2

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 43 participants were enrolled onto the study and received treatment however 1 participant number has been excluded from demographic summary data as they were re-screened with a different reference ulcer

    Pre-assignment
    Screening details
    		 Participants with at least one defined VLU suitable for treatment that was no smaller than 2 cm2 but no larger than 50cm2 and was confirmed as venous in origin by clinical assessments, by Ankle Brachial Pressure Index (ABPI) ≥ 0.8 and/or toe systolic BP pressure > 70mm Hg and with presence of devitalized tissue suitable for debridement

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1; Aurase wound gel x0 dose concentration
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aurase Wound Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Aurase wound gel x0 dose concentration administered cutaneously (topically) to the reference Venous Leg Ulcer (VLU) 3 times per week for up to 4 weeks. The actual volume of gel to be administered in the clinical trial will be dependent on the surface area of the VLU measured.

    Arm title
    		 Cohort 2; Aurase wound gel x1 dose concentration
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aurase Wound Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Aurase wound gel x1 dose concentration administered cutaneously (topically) to the reference Venous Leg Ulcer (VLU) 3 times per week for up to 4 weeks. The actual volume of gel to be administered in the clinical trial will be dependent on the surface area of the VLU measured.

    Arm title
    		 Cohort 3; Aurase wound gel x1.8 dose concentration
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aurase Wound Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Aurase wound gel x1.8 dose concentration administered cutaneously (topically) to the reference Venous Leg Ulcer (VLU) 3 times per week for up to 4 weeks. The actual volume of gel to be administered in the clinical trial will be dependent on the surface area of the VLU measured.

    Arm title
    		 Cohort 4; Aurase wound gel x5 dose concentration
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aurase Wound Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Aurase wound gel x5 dose concentration administered cutaneously (topically) to the reference Venous Leg Ulcer (VLU) 3 times per week for up to 4 weeks. The actual volume of gel to be administered in the clinical trial will be dependent on the surface area of the VLU measured.

    Arm title
    		 Cohort 5; Aurase wound gel x9 dose concentration
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aurase Wound Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Aurase wound gel x9 dose concentration administered cutaneously (topically) to the reference Venous Leg Ulcer (VLU) 3 times per week for up to 4 weeks. The actual volume of gel to be administered in the clinical trial will be dependent on the surface area of the VLU measured.

    Number of subjects in period 1
    		Cohort 1; Aurase wound gel x0 dose concentration Cohort 2; Aurase wound gel x1 dose concentration Cohort 3; Aurase wound gel x1.8 dose concentration Cohort 4; Aurase wound gel x5 dose concentration Cohort 5; Aurase wound gel x9 dose concentration
    Started
    5
    9
    10
    9
    10
    Completed
    5
    7
    10
    7
    10
    Not completed
    0
    2
    0
    2
    0
         Adverse event, serious fatal
    -
    -
    -
    1
    -
         Adverse event, non-fatal
    -
    -
    -
    1
    -
         Protocol deviation
    -
    2
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 43 43
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 68.6 ± 14.8 -
    Gender categorical
    Units: Subjects
        Female
    		 18 18
        Male
    		 25 25
    Subject analysis sets

    Subject analysis set title
    Demographics set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    1 participant number has been excluded from demographic summary data as they were re-screened with a different reference ulcer

    Subject analysis set title
    Intent to treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent to treat population consists of participants who are enrolled, receive at least one dose of study treatment, and have at least one assessment of safety and/ or tolerability.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population consists of all participants who take at least one administration of study treatment

    Subject analysis sets values
    		 Demographics set Intent to treat population Safety population
    Number of subjects
    43
    43
    43
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    68.6 ± 14.75
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    18
        Male
    24

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Cohort 1; Aurase wound gel x0 dose concentration
    Reporting group description
    		 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.

    Reporting group title
    Cohort 2; Aurase wound gel x1 dose concentration
    Reporting group description
    		 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.

    Reporting group title
    Cohort 3; Aurase wound gel x1.8 dose concentration
    Reporting group description
    		 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.

    Reporting group title
    Cohort 4; Aurase wound gel x5 dose concentration
    Reporting group description
    		 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.

    Reporting group title
    Cohort 5; Aurase wound gel x9 dose concentration
    Reporting group description
    		 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.

    Subject analysis set title
    Demographics set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    1 participant number has been excluded from demographic summary data as they were re-screened with a different reference ulcer

    Subject analysis set title
    Intent to treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent to treat population consists of participants who are enrolled, receive at least one dose of study treatment, and have at least one assessment of safety and/ or tolerability.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population consists of all participants who take at least one administration of study treatment

    Primary: Change in Study Wound Pain Burden From Baseline Measured by Numerical Rating Scale (NRS) at Day 29 (End of Study)

    		 Close Top of page
    End point title
    		 Change in Study Wound Pain Burden From Baseline Measured by Numerical Rating Scale (NRS) at Day 29 (End of Study) [1]
    End point description
    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. Baseline is defined as the last non-missing value (including scheduled and unscheduled assessments) prior to the participant receiving the first study treatment
    End point type
    Primary
    End point timeframe
    Pre-dose at day 1 (baseline) through to day 29 (end of study)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics only were used in the first-in-human clinical study
    End point values
    		 Cohort 1; Aurase wound gel x0 dose concentration Cohort 2; Aurase wound gel x1 dose concentration Cohort 3; Aurase wound gel x1.8 dose concentration Cohort 4; Aurase wound gel x5 dose concentration Cohort 5; Aurase wound gel x9 dose concentration Intent to treat population
    Number of subjects analysed
    5
    9
    10
    9
    10
    43
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    2.40 ± 1.52
    3.11 ± 1.05
    3.40 ± 1.51
    3.11 ± 2.71
    2.90 ± 1.52
    3.05 ± 1.70
        Day 29
    1.00 ± 1.71
    2.22 ± 1.56
    2.50 ± 2.51
    2.13 ± 2.75
    2.20 ± 1.62
    2.12 ± 1.99
    No statistical analyses for this end point

    Primary: Change in Study Wound Itch Burden From Baseline Measured by Numerical Rating Scale (NRS) at Day 29 (End of Study)

    		 Close Top of page
    End point title
    		 Change in Study Wound Itch Burden From Baseline Measured by Numerical Rating Scale (NRS) at Day 29 (End of Study) [2]
    End point description
    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. Baseline is defined as the last non-missing value (including scheduled and unscheduled assessments) prior to the participant receiving the first study treatment
    End point type
    Primary
    End point timeframe
    Pre-dose at day 1 (baseline) through to day 29 (end of study)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics only were used in the first-in-human clinical study
    End point values
    		 Cohort 1; Aurase wound gel x0 dose concentration Cohort 2; Aurase wound gel x1 dose concentration Cohort 3; Aurase wound gel x1.8 dose concentration Cohort 4; Aurase wound gel x5 dose concentration Cohort 5; Aurase wound gel x9 dose concentration Intent to treat population
    Number of subjects analysed
    5
    9
    10
    9
    10
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    1.20 ± 0.84
    2.11 ± 1.05
    1.60 ± 2.40
    2.00 ± 2.40
    2.00 ± 2.21
    1.84 ± 1.70
        Day 29
    1.00 ± 1.23
    1.67 ± 1.50
    1.30 ± 1.25
    1.50 ± 2.45
    1.30 ± 1.34
    1.38 ± 1.55
    No statistical analyses for this end point

    Secondary: Change in Surface Area of Wound Compared to Baseline

    		 Close Top of page
    End point title
    		 Change in Surface Area of Wound Compared to Baseline
    End point description
    Determination of surface area made by clinical assessor upon assessment of wound at each study visit.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)
    End point values
    		 Cohort 1; Aurase wound gel x0 dose concentration Cohort 2; Aurase wound gel x1 dose concentration Cohort 3; Aurase wound gel x1.8 dose concentration Cohort 4; Aurase wound gel x5 dose concentration Cohort 5; Aurase wound gel x9 dose concentration
    Number of subjects analysed
    5
    9
    10
    9
    10
    Units: cm2
    arithmetic mean (standard deviation)
        Baseline
    27.9 ± 20.1
    12.1 ± 11.2
    10.4 ± 8.2
    8.7 ± 7.1
    16.8 ± 13.7
        Day 5
    25.4 ± 18.9
    12.7 ± 11.8
    9.9 ± 9.2
    8.1 ± 9.1
    14.2 ± 11.7
        Day 12
    21.8 ± 18.7
    11.9 ± 11.8
    10.0 ± 9.8
    7.6 ± 9.4
    13.0 ± 11.2
        Day 19
    20.9 ± 18.5
    9.4 ± 11.3
    10.6 ± 11.3
    6.9 ± 8.0
    13.3 ± 9.1
        Day29
    21.8 ± 24.4
    8.8 ± 10.8
    10.1 ± 11.9
    6.2 ± 7.3
    10.5 ± 8.8
    No statistical analyses for this end point

    Secondary: Number of Patients Achieving Different Levels of Debridement at 4 Weeks

    		 Close Top of page
    End point title
    		 Number of Patients Achieving Different Levels of Debridement at 4 Weeks
    End point description
    Determination of debridement made by clinical assessor upon assessment of wound at each study visit. The extent of debridement is the inverse of the percentage of non-viable tissue present in the wound, where 0% debridement equates to the same percentage of non-viable tissue at baseline and 100% debridement equates to 100% removal of the non-viable tissue
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Cohort 1; Aurase wound gel x0 dose concentration Cohort 2; Aurase wound gel x1 dose concentration Cohort 3; Aurase wound gel x1.8 dose concentration Cohort 4; Aurase wound gel x5 dose concentration Cohort 5; Aurase wound gel x9 dose concentration
    Number of subjects analysed
    5
    9
    10
    9
    10
    Units: patients
        100% Debridement
    0
    0
    1
    2
    2
        >90% Debridement
    2
    0
    2
    3
    3
        >80% Debridement
    3
    1
    5
    3
    3
        >70% Debridement
    3
    2
    6
    5
    6
    No statistical analyses for this end point

    Secondary: Change in Surface Area of Devitalised Tissue (Slough) Compared to Baseline

    		 Close Top of page
    End point title
    		 Change in Surface Area of Devitalised Tissue (Slough) Compared to Baseline
    End point description
    Determination of devitalised tissue made by clinical assessor upon assessment of wound at each study visit.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)
    End point values
    		 Cohort 1; Aurase wound gel x0 dose concentration Cohort 2; Aurase wound gel x1 dose concentration Cohort 3; Aurase wound gel x1.8 dose concentration Cohort 4; Aurase wound gel x5 dose concentration Cohort 5; Aurase wound gel x9 dose concentration
    Number of subjects analysed
    5
    9
    10
    9
    10
    Units: cm2
    arithmetic mean (standard deviation)
        Baseline
    7.2 ± 6.0
    7.4 ± 6.4
    7.2 ± 6.0
    6.2 ± 6.7
    10.2 ± 10.2
        Day 5
    4.1 ± 4.1
    7.2 ± 7.2
    5.4 ± 4.5
    5.8 ± 8.5
    7.3 ± 8.2
        Day 12
    4.6 ± 5.5
    7.9 ± 8.0
    5.3 ± 6.8
    5.0 ± 8.6
    5.9 ± 5.3
        Day 19
    3.8 ± 5.1
    7.6 ± 9.7
    5.7 ± 8.8
    4.3 ± 7.0
    6.2 ± 5.1
        Day 29
    2.3 ± 2.6
    5.6 ± 7.1
    4.6 ± 8.6
    4.0 ± 6.6
    3.6 ± 3.9
    No statistical analyses for this end point

    Secondary: Change in Surface Area of Granulation Tissue From Baseline

    		 Close Top of page
    End point title
    		 Change in Surface Area of Granulation Tissue From Baseline
    End point description
    Determination of granulation tissue made by clinical assessor upon assessment of wound at each study visit.
    End point type
    Secondary
    End point timeframe
    Day 1 (baseline) , day 5, day 12, day 19, day 29 (end of study)
    End point values
    		 Cohort 1; Aurase wound gel x0 dose concentration Cohort 2; Aurase wound gel x1 dose concentration Cohort 3; Aurase wound gel x1.8 dose concentration Cohort 4; Aurase wound gel x5 dose concentration Cohort 5; Aurase wound gel x9 dose concentration
    Number of subjects analysed
    5
    9
    10
    9
    10
    Units: Percent
    arithmetic mean (standard deviation)
        Baseline
    75.0 ± 9.8
    33.8 ± 24.6
    33.7 ± 26.9
    25.6 ± 32.0
    36.2 ± 34.2
        Day 5
    84.9 ± 10.5
    42.1 ± 24.5
    47.6 ± 28.8
    46.0 ± 35.2
    59.3 ± 32.0
        Day 12
    76.4 ± 34.6
    32.8 ± 34.2
    49.0 ± 31.3
    55.2 ± 40.1
    63.1 ± 43.8
        Day 19
    76.4 ± 34.6
    32.8 ± 32.2
    65.1 ± 33.9
    57.0 ± 35.7
    61.2 ± 31.0
        Day 29
    77.4 ± 39.4
    39.1 ± 37.2
    74.4 ± 29.3
    62.1 ± 36.8
    69.6 ± 34.2
    No statistical analyses for this end point

    Secondary: Systemic Absorption of Aurase Enzyme Assessed Through Pharmacokinetic Profiling of Blood Samples

    		 Close Top of page
    End point title
    		 Systemic Absorption of Aurase Enzyme Assessed Through Pharmacokinetic Profiling of Blood Samples
    End point description
    The Analysis of Aurase enzyme in Human Plasma measured by Liquid chromatography-mass spectrometry (LCMS). Values of Below the limit of quantification (BLQ) (<50 ng/mL) will be substituted by zeros
    End point type
    Secondary
    End point timeframe
    Visit 14 (end of study/early termination)
    End point values
    		 Cohort 1; Aurase wound gel x0 dose concentration Cohort 2; Aurase wound gel x1 dose concentration Cohort 3; Aurase wound gel x1.8 dose concentration Cohort 4; Aurase wound gel x5 dose concentration Cohort 5; Aurase wound gel x9 dose concentration
    Number of subjects analysed
    5
    9
    10
    9
    10
    Units: ng/mL
    arithmetic mean (standard deviation)
        Overall
    0 ± 0
    0 ± 0
    0 ± 0
    0 ± 0
    0 ± 0
    No statistical analyses for this end point

    Secondary: Assessment of the Presence of Antibodies to Aurase in Plasma (Anti-Drug Antibody [ADA] Activity) Through Applicable Laboratory Analysis of Blood Samples

    		 Close Top of page
    End point title
    		 Assessment of the Presence of Antibodies to Aurase in Plasma (Anti-Drug Antibody [ADA] Activity) Through Applicable Laboratory Analysis of Blood Samples
    End point description
    Assay for antibodies to Aurase performed using Meso Scale Discovery electrochemiluminescence (MSD ECL). Negative results have been substituted with zeros.
    End point type
    Secondary
    End point timeframe
    Visit 14 (end of study/early termination)
    End point values
    		 Cohort 1; Aurase wound gel x0 dose concentration Cohort 2; Aurase wound gel x1 dose concentration Cohort 3; Aurase wound gel x1.8 dose concentration Cohort 4; Aurase wound gel x5 dose concentration Cohort 5; Aurase wound gel x9 dose concentration
    Number of subjects analysed
    5
    9
    10
    9
    10
    Units: ng/mL
    arithmetic mean (standard deviation)
        Overall
    0 ± 0
    0 ± 0
    0 ± 0
    0 ± 0
    0 ± 0
    No statistical analyses for this end point

    Secondary: Change in Systemic Clotting Factor (Fibrinogen) in Plasma From Baseline [Time Frame: Visit 2 (Baseline) and Visit 14 (end of study/early termination)]

    		 Close Top of page
    End point title
    		 Change in Systemic Clotting Factor (Fibrinogen) in Plasma From Baseline [Time Frame: Visit 2 (Baseline) and Visit 14 (end of study/early termination)]
    End point description
    Fibrinogen plasma concentrations determined through laboratory analysis of blood samples
    End point type
    Secondary
    End point timeframe
    Visit 2 (Baseline) and Visit 14 (end of study/early termination)
    End point values
    		 Cohort 1; Aurase wound gel x0 dose concentration Cohort 2; Aurase wound gel x1 dose concentration Cohort 3; Aurase wound gel x1.8 dose concentration Cohort 4; Aurase wound gel x5 dose concentration Cohort 5; Aurase wound gel x9 dose concentration
    Number of subjects analysed
    5
    9
    10
    9
    10
    Units: g/L
    arithmetic mean (standard deviation)
        Baseline
    3.84 ± 0.98
    3.57 ± 0.95
    3.59 ± 1.01
    3.17 ± 1.16
    3.53 ± 0.97
        Visit 14
    4.10 ± 0.74
    3.49 ± 0.71
    3.13 ± 0.94
    3.53 ± 1.40
    3.34 ± 0.89
    No statistical analyses for this end point

    Secondary: Change in Systemic Clotting Factor (Activated Partial Thromboplastin Clotting Time [APTT]) in Plasma From Baseline

    		 Close Top of page
    End point title
    		 Change in Systemic Clotting Factor (Activated Partial Thromboplastin Clotting Time [APTT]) in Plasma From Baseline
    End point description
    APTT determined through laboratory analysis of blood samples
    End point type
    Secondary
    End point timeframe
    Visit 2 (baseline) and Visit 14 (end of study/early termination)
    End point values
    		 Cohort 1; Aurase wound gel x0 dose concentration Cohort 2; Aurase wound gel x1 dose concentration Cohort 3; Aurase wound gel x1.8 dose concentration Cohort 4; Aurase wound gel x5 dose concentration Cohort 5; Aurase wound gel x9 dose concentration
    Number of subjects analysed
    5
    9
    10
    9
    10
    Units: seconds
    arithmetic mean (standard deviation)
        Baseline
    26.92 ± 3.53
    27.90 ± 1.27
    28.74 ± 2.46
    28.60 ± 1.84
    29.51 ± 4.48
        Visit 14
    26.93 ± 2.93
    27.86 ± 3.06
    29.04 ± 1.63
    26.99 ± 2.71
    29.70 ± 4.69
    No statistical analyses for this end point

    Secondary: Change in Systemic Clotting Factor (Prothrombin Time [PT]) From Baseline

    		 Close Top of page
    End point title
    		 Change in Systemic Clotting Factor (Prothrombin Time [PT]) From Baseline
    End point description
    PT determined through laboratory analysis of blood samples
    End point type
    Secondary
    End point timeframe
    Visit 2 (baseline) and Visit 14 (end of study/early termination)
    End point values
    		 Cohort 1; Aurase wound gel x0 dose concentration Cohort 2; Aurase wound gel x1 dose concentration Cohort 3; Aurase wound gel x1.8 dose concentration Cohort 4; Aurase wound gel x5 dose concentration Cohort 5; Aurase wound gel x9 dose concentration
    Number of subjects analysed
    5
    9
    10
    9
    10
    Units: seconds
    arithmetic mean (standard deviation)
        Baseline
    10.78 ± 0.82
    10.69 ± 0.26
    10.86 ± 0.51
    11.70 ± 1.43
    11.51 ± 1.19
        Visit 14
    10.70 ± 0.58
    10.63 ± 0.42
    11.13 ± 0.60
    11.24 ± 0.50
    11.25 ± 0.77
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From time of participants informed consent to completion of study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Cohort 1; Aurase wound gel x0 dose concentration
    Reporting group description
    		 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.

    Reporting group title
    Cohort 2; Aurase wound gel x1 dose concentration
    Reporting group description
    		 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.

    Reporting group title
    Cohort 3; Aurase wound gel x1.8 dose concentration
    Reporting group description
    		 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.

    Reporting group title
    Cohort 4; Aurase wound gel x5 dose concentration
    Reporting group description
    		 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.

    Reporting group title
    Cohort 5; Aurase wound gel x9 dose concentration
    Reporting group description
    		 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.

    Serious adverse events
    		 Cohort 1; Aurase wound gel x0 dose concentration Cohort 2; Aurase wound gel x1 dose concentration Cohort 3; Aurase wound gel x1.8 dose concentration Cohort 4; Aurase wound gel x5 dose concentration Cohort 5; Aurase wound gel x9 dose concentration
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    2 / 9 (22.22%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    1
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Debility
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septicaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cohort 1; Aurase wound gel x0 dose concentration Cohort 2; Aurase wound gel x1 dose concentration Cohort 3; Aurase wound gel x1.8 dose concentration Cohort 4; Aurase wound gel x5 dose concentration Cohort 5; Aurase wound gel x9 dose concentration
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 5 (40.00%)
    2 / 9 (22.22%)
    6 / 10 (60.00%)
    6 / 9 (66.67%)
    5 / 10 (50.00%)
    Injury, poisoning and procedural complications
    Inflammation of wound
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    3 / 10 (30.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    3
    1
    0
    Wound complication
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    1
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    1
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Tissue irritation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Gastric ulcer
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dysponea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    5 / 10 (50.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    5
    1
    1
    Skin irritation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin maceration
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Erysipelas
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Infected skin ulcer
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Sepsis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Wound infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Nov 2020
    Protocol V1 to V2 - update of exclusion criteria, clarification on safety definitions/sections
    02 Jun 2021
    Protocol V2 to V3 - Inclusion of COVID-19 risk assessment, reduction in cohort 1 patient number, modification/clarification of endpoints, correction to discrepancies, pre-clinical information added, update to trial schedule
    15 Oct 2021
    protocol V3 to v4 - update to exploratory endpoints, addressing comments from FDA, safety review required attendees updated, off-site visit information updated
    20 Apr 2022
    Protocol V4 to V5 - modification to make study more adaptive, addition of cohorts (6&7)
    20 Oct 2022
    Protocol V5 to V6 - modification to conduct of previously added cohorts, visit window and screening period updated

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    02 Jan 2023
    Cohorts 6 & 7 not completed, trial end declared (in line with original plan)
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Apr 28 12:58:14 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA