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    Clinical Trial Results:
    An Open Label, Multi-centre, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa

    Summary
    EudraCT number
    		 2014-005679-96
    Trial protocol
    		 AT   NL   GB   DE   PL   ES   LT   IT  
    Global end of trial date
    03 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Mar 2019
    First version publication date
    18 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SD-006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02670330
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Scioderm, Inc., An Amicus Therapeutics Company
    Sponsor organisation address
    1 Cedar Brook Drive, Cranbury, United States, NJ 08512
    Public contact
    Patient Advocacy, Amicus Therapeutics, Inc., Scioderm, Inc., clinicaltrials@amicusrx.com
    Scientific contact
    Patient Advocacy, Amicus Therapeutics, Inc., Scioderm, Inc., clinicaltrials@amicusrx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001590-PIP01-13
    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
    03 Sep 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate the long-term safety of SD-101-6.0 in subjects with simplex, recessive dystrophic and junctional non-Herlitz Epidermolysis Bullosa (EB).
    Protection of trial subjects
    This study was designed and monitored in accordance with sponsor procedures, which comply with the ethical principles of Good Clinical Practice, as required by the major regulatory authorities and in accordance with the Declaration of Helsinki and its updates.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jun 2015
    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
    Netherlands: 2
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    France: 15
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Lithuania: 3
    Country: Number of subjects enrolled
    Serbia: 16
    Country: Number of subjects enrolled
    United States: 57
    Country: Number of subjects enrolled
    Australia: 11
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Israel: 4
    Worldwide total number of subjects
    152
    EEA total number of subjects
    64
    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)
    8
    Children (2-11 years)
    77
    Adolescents (12-17 years)
    26
    Adults (18-64 years)
    40
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 152 subjects with EB were enrolled, between 9 June 2015 and 3 September 2018, in this open-label, multi-centre extension study. All enrolled subjects had previously completed Study SD-005 (EudraCT number: 2014-002288-14). The planned duration of the study, as per Protocol Version 3, was up to 48 months but it was terminated early by the sponsor.

    Pre-assignment
    Screening details
    		 Analysis groups were defined based on treatment in study SD-005. 77 subjects who received placebo in SD-005 were allocated to the 'Placebo to SD-101-6.0' group and 75 subjects who received SD-101-6.0 in SD-005 were allocated to the 'SD-101-6.0 to SD-101-6.0' group. All subjects received treatment with SD-101-6.0 upon enrolling in study SD-006.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo to SD-101-6.0
    Arm description
    		 Subjects who received placebo in Study SD-005 then went on to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SD-101-6.0
    Investigational medicinal product code
    Other name
    Allantoin 6% concentration, Zorblisa
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    SD-101 is a white, crystalline powder that is formulated within an odourless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxlylic acid, at a concentration of 6% and other excipients. Subjects (or their caregivers) applied the cream topically, once a day to the entire body.

    Arm title
    		 SD-101-6.0 to SD 101-6.0
    Arm description
    		 Subjects who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SD-101-6.0
    Investigational medicinal product code
    Other name
    Allantoin 6% concentration, Zorblisa
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    SD-101 is a white, crystalline powder that is formulated within an odourless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxlylic acid, at a concentration of 6% and other excipients. Subjects (or their caregivers) applied the cream topically, once a day to the entire body.

    Number of subjects in period 1
    		Placebo to SD-101-6.0 SD-101-6.0 to SD 101-6.0
    Started
    77
    75
    Completed as per Protocol Versions 1 & 2
    7
    5
    Completed
    0
    0
    Not completed
    77
    75
         Consent withdrawn by subject
    29
    34
         Adverse event, non-fatal
    3
    1
         Study terminated by sponsor
    43
    36
         Lost to follow-up
    2
    3
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo to SD-101-6.0
    Reporting group description
    		 Subjects who received placebo in Study SD-005 then went on to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.

    Reporting group title
    SD-101-6.0 to SD 101-6.0
    Reporting group description
    		 Subjects who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.

    Reporting group values
    		 Placebo to SD-101-6.0 SD-101-6.0 to SD 101-6.0 Total
    Number of subjects
    		 77 75 152
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 5 3 8
        Children (2-11 years)
    		 42 35 77
        Adolescents (12-17 years)
    		 10 16 26
        Adults (18-64 years)
    		 19 21 40
        From 65-84 years
    		 1 0 1
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.36 ± 13.599 14.18 ± 13.381 -
    Gender categorical
    Units: Subjects
        Female
    		 45 28 73
        Male
    		 32 47 79
    Race
    Units: Subjects
        White/Caucasian
    		 63 65 128
        Black or African-American
    		 3 4 7
        Asian
    		 7 3 10
        American Indian or Alaskan Native
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Other
    		 1 1 2
        Unknown
    		 3 2 5
    EB type
    Units: Subjects
        Simplex
    		 7 9 16
        Recessive dystrophic
    		 56 53 109
        Junctional non-Herlitz
    		 14 13 27

    End points

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    End points reporting groups
    Reporting group title
    Placebo to SD-101-6.0
    Reporting group description
    		 Subjects who received placebo in Study SD-005 then went on to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.

    Reporting group title
    SD-101-6.0 to SD 101-6.0
    Reporting group description
    		 Subjects who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.

    Primary: Number of Subjects with Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Subjects with Treatment Emergent Adverse Events (TEAEs) [1]
    End point description
    TEAEs were defined as adverse events that started or worsened on or after baseline visit.
    End point type
    Primary
    End point timeframe
    From baseline to 30 days after last application of study drug (up to a maximum of 37 months)
    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: In accordance with the statistical analysis plan no comparison between treatment groups was performed.
    End point values
    		 Placebo to SD-101-6.0 SD-101-6.0 to SD 101-6.0
    Number of subjects analysed
    77
    75
    Units: Subjects
        Any TEAE
    58
    51
        Any TEAE related to study drug
    17
    8
        Any fatal TEAE
    0
    0
        Any serious TEAE
    14
    11
        Any TEAE leading to discontinuation of study drug
    3
    2
    No statistical analyses for this end point

    Secondary: Change from Baseline in Body Surface Area Index (BSAI) of Lesional Skin

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    End point title
    		 Change from Baseline in Body Surface Area Index (BSAI) of Lesional Skin
    End point description
    Lesional skin was defined as areas that contained any of the following: blisters, erosions, ulcerations, scabbing, bullae, or eschars, as well as areas that were weeping, sloughing, oozing, crusted, or denuded. The percentage, ranging from 0% to 100%, of affected body surface area (BSA) was recorded for each defined body region (ie, head/neck, upper limbs, trunk [includes groin], and lower limbs), multiplied by the weighting factor, then summed for all body regions to calculate the BSAI. The BSA for lesional skin was to be assessed by the same study physician on each visit for a particular subject. The mean change from baseline in BSAI was assessed every 3 months. Only subjects with data available for analysis at each time point are presented.
    End point type
    Secondary
    End point timeframe
    From baseline to Month 30
    End point values
    		 Placebo to SD-101-6.0 SD-101-6.0 to SD 101-6.0
    Number of subjects analysed
    77
    75
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Month 1 (n=71, n=70)
    -0.54 ± 5.398
    -0.76 ± 4.185
        Month 3 (n=66, n=69)
    -1.21 ± 6.457
    -1.87 ± 5.999
        Month 6 (n=60, n=64)
    -1.35 ± 6.813
    -1.77 ± 6.015
        Month 9 (n=56, n=61)
    0.31 ± 10.117
    -2.48 ± 9.436
        Month 12 (n=50, n=52)
    0.44 ± 10.327
    -3.35 ± 9.566
        Month 15 (n=29, n=35)
    2.15 ± 12.546
    -1.90 ± 7.337
        Month 18 (n=26, n=25)
    -4.24 ± 8.207
    -2.46 ± 5.275
        Month 21 (n=16, n=18)
    -1.58 ± 10.442
    -3.06 ± 5.869
        Month 24 (n=7, n=11)
    -0.64 ± 5.981
    -1.63 ± 5.647
        Month 27 (n=6, n=6)
    -0.16 ± 6.514
    -1.87 ± 4.405
        Month 30 (n=5, n=3)
    3.37 ± 10.706
    -2.77 ± 5.465
    No statistical analyses for this end point

    Secondary: Change from Baseline in BSAI of Total Body Wound Burden

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    End point title
    		 Change from Baseline in BSAI of Total Body Wound Burden
    End point description
    A wound was defined as an open area on the skin (ie, epidermal covering disrupted). Total body wound burden was calculated using BSAI; the percentage, ranging from 0% to 100%, of affected BSA was recorded for each defined body region (ie, head/neck, upper limbs, trunk [includes groin], and lower limbs), multiplied by the weighting factor, then summed for all body regions. The BSAI for total body wound burden was to be assessed by the same study physician at each visit for a particular subject. The mean change from baseline in total body wound burden was assessed every 3 months. Only subjects with data available for analysis at each time point are presented.
    End point type
    Secondary
    End point timeframe
    From baseline to Month 30
    End point values
    		 Placebo to SD-101-6.0 SD-101-6.0 to SD 101-6.0
    Number of subjects analysed
    77
    75
    Units: Percentage of BSAI
    arithmetic mean (standard deviation)
        Month 1 (n=71, n=70)
    0.07 ± 4.044
    -1.75 ± 4.891
        Month 3 (n=66, n=69)
    -0.80 ± 3.001
    -1.52 ± 5.343
        Month 6 (n=60, n=64)
    -0.48 ± 3.595
    -1.54 ± 4.322
        Month 9 (n=56, n=61)
    -0.42 ± 3.586
    -1.82 ± 6.083
        Month 12 (n=50, n=52)
    -0.13 ± 3.211
    -1.38 ± 5.497
        Month 15 (n=29, n=35)
    0.26 ± 3.030
    -0.15 ± 4.511
        Month 18 (n=26, n=25)
    -1.31 ± 4.665
    -1.12 ± 3.053
        Month 21 (n=16, n=18)
    -0.28 ± 5.507
    -1.44 ± 3.150
        Month 24 (n=7, n=11)
    -0.01 ± 2.898
    -0.68 ± 3.890
        Month 27 (n=6, n=6)
    0.31 ± 3.615
    -0.43 ± 2.924
        Month 30 (n=5, n=3)
    1.69 ± 5.933
    -1.55 ± 2.883
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
    Adverse event reporting additional description
    The frequency threshold for reporting non-serious TEAEs is 2% in either treatment group.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo to SD-101-6.0
    Reporting group description
    		 Subjects who received placebo in Study SD-005 then went on to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.

    Reporting group title
    SD-101-6.0 to SD 101-6.0
    Reporting group description
    		 Subjects who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.

    Serious adverse events
    		 Placebo to SD-101-6.0 SD-101-6.0 to SD 101-6.0
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 77 (18.18%)
    11 / 75 (14.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 77 (1.30%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal papillary-mucinous carcinoma of pancreas
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Intermittent explosive disorder
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Body temperature increased
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Stoma site inflammation
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural fistula
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural vomiting
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma site extravasation
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital megaureter
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Pericarditis
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 77 (2.60%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Keratitis
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Oesophageal stenosis
         subjects affected / exposed
    2 / 77 (2.60%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 77 (1.30%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin disorder
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Staphylococcal skin infection
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    2 / 77 (2.60%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenterititis clostridial
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site infection
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin bacterial infection
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection bacterial
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 77 (1.30%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Feeding intolerance
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo to SD-101-6.0 SD-101-6.0 to SD 101-6.0
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    51 / 77 (66.23%)
    44 / 75 (58.67%)
    Injury, poisoning and procedural complications
    Corneal abrasion
         subjects affected / exposed
    2 / 77 (2.60%)
    2 / 75 (2.67%)
         occurrences all number
    5
    5
    Procedural pain
         subjects affected / exposed
    0 / 77 (0.00%)
    3 / 75 (4.00%)
         occurrences all number
    0
    5
    Wound
         subjects affected / exposed
    0 / 77 (0.00%)
    3 / 75 (4.00%)
         occurrences all number
    0
    3
    Wound complication
         subjects affected / exposed
    2 / 77 (2.60%)
    1 / 75 (1.33%)
         occurrences all number
    2
    1
    Congenital, familial and genetic disorders
    Epidermolysis bullosa
         subjects affected / exposed
    0 / 77 (0.00%)
    3 / 75 (4.00%)
         occurrences all number
    0
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 77 (6.49%)
    5 / 75 (6.67%)
         occurrences all number
    5
    10
    Lymphadenopathy
         subjects affected / exposed
    2 / 77 (2.60%)
    1 / 75 (1.33%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    10 / 77 (12.99%)
    5 / 75 (6.67%)
         occurrences all number
    15
    5
    Pain
         subjects affected / exposed
    2 / 77 (2.60%)
    2 / 75 (2.67%)
         occurrences all number
    2
    2
    Systemic inflammatory response syndrome
         subjects affected / exposed
    2 / 77 (2.60%)
    0 / 75 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    3 / 77 (3.90%)
    5 / 75 (6.67%)
         occurrences all number
    4
    8
    Oesophageal stenosis
         subjects affected / exposed
    4 / 77 (5.19%)
    3 / 75 (4.00%)
         occurrences all number
    9
    10
    Diarrhoea
         subjects affected / exposed
    3 / 77 (3.90%)
    2 / 75 (2.67%)
         occurrences all number
    4
    3
    Vomiting
         subjects affected / exposed
    3 / 77 (3.90%)
    2 / 75 (2.67%)
         occurrences all number
    6
    2
    Abdominal pain
         subjects affected / exposed
    3 / 77 (3.90%)
    1 / 75 (1.33%)
         occurrences all number
    4
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 77 (0.00%)
    3 / 75 (4.00%)
         occurrences all number
    0
    4
    Abdominal pain upper
         subjects affected / exposed
    2 / 77 (2.60%)
    0 / 75 (0.00%)
         occurrences all number
    2
    0
    Haematemesis
         subjects affected / exposed
    2 / 77 (2.60%)
    0 / 75 (0.00%)
         occurrences all number
    2
    0
    Oesophageal dilatation
         subjects affected / exposed
    0 / 77 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    3
    Toothache
         subjects affected / exposed
    0 / 77 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 77 (3.90%)
    4 / 75 (5.33%)
         occurrences all number
    5
    4
    Rhinorrhoea
         subjects affected / exposed
    1 / 77 (1.30%)
    2 / 75 (2.67%)
         occurrences all number
    1
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    6 / 77 (7.79%)
    3 / 75 (4.00%)
         occurrences all number
    7
    3
    Skin lesion
         subjects affected / exposed
    2 / 77 (2.60%)
    2 / 75 (2.67%)
         occurrences all number
    2
    2
    Excessive granulation tissue
         subjects affected / exposed
    1 / 77 (1.30%)
    2 / 75 (2.67%)
         occurrences all number
    1
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 77 (3.90%)
    1 / 75 (1.33%)
         occurrences all number
    3
    1
    Infections and infestations
    Skin infection
         subjects affected / exposed
    12 / 77 (15.58%)
    6 / 75 (8.00%)
         occurrences all number
    25
    8
    Nasopharyngitis
         subjects affected / exposed
    6 / 77 (7.79%)
    10 / 75 (13.33%)
         occurrences all number
    6
    13
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 77 (6.49%)
    4 / 75 (5.33%)
         occurrences all number
    6
    6
    Wound infection
         subjects affected / exposed
    6 / 77 (7.79%)
    3 / 75 (4.00%)
         occurrences all number
    8
    7
    Skin bacterial infection
         subjects affected / exposed
    4 / 77 (5.19%)
    4 / 75 (5.33%)
         occurrences all number
    10
    9
    Staphylococcal skin infection
         subjects affected / exposed
    4 / 77 (5.19%)
    4 / 75 (5.33%)
         occurrences all number
    7
    7
    Wound infection bacterial
         subjects affected / exposed
    5 / 77 (6.49%)
    2 / 75 (2.67%)
         occurrences all number
    5
    5
    Bronchitis
         subjects affected / exposed
    1 / 77 (1.30%)
    5 / 75 (6.67%)
         occurrences all number
    1
    6
    Pharyngitis streptococcal
         subjects affected / exposed
    4 / 77 (5.19%)
    2 / 75 (2.67%)
         occurrences all number
    5
    4
    Influenza
         subjects affected / exposed
    3 / 77 (3.90%)
    2 / 75 (2.67%)
         occurrences all number
    3
    2
    Sinusitis
         subjects affected / exposed
    1 / 77 (1.30%)
    4 / 75 (5.33%)
         occurrences all number
    1
    5
    Wound infection staphylococcal
         subjects affected / exposed
    3 / 77 (3.90%)
    2 / 75 (2.67%)
         occurrences all number
    3
    9
    Wound infection pseudomonas
         subjects affected / exposed
    2 / 77 (2.60%)
    2 / 75 (2.67%)
         occurrences all number
    2
    3
    Cellulitis
         subjects affected / exposed
    0 / 77 (0.00%)
    3 / 75 (4.00%)
         occurrences all number
    0
    5
    Eye infection
         subjects affected / exposed
    1 / 77 (1.30%)
    2 / 75 (2.67%)
         occurrences all number
    1
    2
    Gastroenteritis
         subjects affected / exposed
    3 / 77 (3.90%)
    0 / 75 (0.00%)
         occurrences all number
    4
    0
    Otitis media
         subjects affected / exposed
    0 / 77 (0.00%)
    3 / 75 (4.00%)
         occurrences all number
    0
    3
    Rhinitis
         subjects affected / exposed
    1 / 77 (1.30%)
    2 / 75 (2.67%)
         occurrences all number
    1
    2
    Urinary tract infection
         subjects affected / exposed
    1 / 77 (1.30%)
    2 / 75 (2.67%)
         occurrences all number
    1
    6
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 77 (2.60%)
    1 / 75 (1.33%)
         occurrences all number
    3
    1
    Cystitis
         subjects affected / exposed
    0 / 77 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    2
    Pyoderma
         subjects affected / exposed
    0 / 77 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    2
    Viral rash
         subjects affected / exposed
    2 / 77 (2.60%)
    0 / 75 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Dec 2015
    The main reason for Amendment 1 was to extend the duration of treatment with SD-101-6.0 from 360 days to 630 days (ie, 21 months).
    08 Nov 2016
    Major changes implemented with Amendment 2 included the following: • duration of treatment with SD-101-6.0 extended from 630 days to 1440 days (ie, 48 months). • enrolment estimate updated from approximately 130 patients to approximately 150 subjects to reflect the increase in enrolment in SD-005. • Adverse events (AE) follow-up period defined as 30 days after the last application of study drug treatment, with the exception of AEs that led to discontinuation of study drug, which were monitored until resolution or stabilisation.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Results are presented for all study visits assessed before the early termination of the study on 4 June 2018. The maximum study duration completed by at least 1 subject was 36 months.
    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.

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