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    Clinical Trial Results:
    A Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Orally Administered DS107 in Adult Patients with Moderate to Severe Atopic Dermatitis

    Summary
    EudraCT number
    		 2019-000932-25
    Trial protocol
    		 LV   AT  
    Global end of trial date
    03 Sep 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Oct 2022
    First version publication date
    12 Mar 2022
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DS107G-05-AD3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03817190
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    DS Biopharma
    Sponsor organisation address
    Trintech Building, South County Business Park, Dublin 18, Ireland,
    Public contact
    Study Director, DS Biopharma, +353 1 2933590, dsbiopharma.regulatory@dsbiopharma.com
    Scientific contact
    Study Director, DS Biopharma, +353 1 2933590, dsbiopharma.regulatory@dsbiopharma.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
    29 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Efficacy Objective: o To compare the efficacy of orally administered DS107 versus placebo, in the treatment of adult patients with moderate to severe Atopic Dermatitis (AD). Safety Objective: o To assess the safety of orally administered DS107 versus placebo, in adult patients with moderate to severe AD.
    Protection of trial subjects
    The study was designed, conducted, and evaluated according to the study protocol and in compliance with the latest International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines on Good Clinical Practice (GCP) E6 and the ethical principles that have their origins in the World Medical Association Declaration of Helsinki, as well as with all national and local legal requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Sep 2019
    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
    Poland: 47
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Germany: 63
    Country: Number of subjects enrolled
    Latvia: 31
    Country: Number of subjects enrolled
    United States: 75
    Worldwide total number of subjects
    219
    EEA total number of subjects
    144
    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)
    205
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in 50 sites across 5 countries.

    Pre-assignment
    Screening details
    		 The observation period per patient was 20 weeks (treatment duration: 16 weeks, follow-up period: 4 weeks). Nine visits were scheduled: Screening, Baseline, Week 1 (phone call), Week 4, 8, 12, 16 (end of treatment), 18 (follow-up 1) and 20 (follow-up 2).

    Period 1
    Period 1 title
    Overall Study Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Patients randomised to placebo group received 4 placebo capsules administered orally once daily for 16 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 placebo capsules orally administered once daily for 16 weeks.

    Arm title
    		 DS107 2000mg
    Arm description
    		 Patients randomised to DS107 2000mg group received 4 DS107 capsules administered orally once daily for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DS107 Capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.

    Number of subjects in period 1
    		Placebo DS107 2000mg
    Started
    110
    109
    Completed
    50
    50
    Not completed
    60
    59
         Consent withdrawn by subject
    12
    8
         Physician decision
    5
    1
         Adverse Event
    10
    17
         Early Termination by Sponsor
    13
    20
         Other reason
    2
    1
         Lost to follow-up
    11
    7
         Lack of efficacy
    7
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomised to placebo group received 4 placebo capsules administered orally once daily for 16 weeks.

    Reporting group title
    DS107 2000mg
    Reporting group description
    		 Patients randomised to DS107 2000mg group received 4 DS107 capsules administered orally once daily for 16 weeks.

    Reporting group values
    		 Placebo DS107 2000mg Total
    Number of subjects
    		 110 109 219
    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)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 105 100 205
        From 65-84 years
    		 5 9 14
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.95 ( 14.90 ) 38.83 ( 15.45 ) -
    Gender categorical
    Units: Subjects
        Female
    		 60 55 115
        Male
    		 50 54 104
    Race
    Units: Subjects
        White
    		 90 87 177
        Black/African American
    		 17 18 35
        Asian
    		 2 2 4
        Other
    		 1 2 3
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 7 5 12
        Not Hispanic or Latino
    		 103 104 207

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomised to placebo group received 4 placebo capsules administered orally once daily for 16 weeks.

    Reporting group title
    DS107 2000mg
    Reporting group description
    		 Patients randomised to DS107 2000mg group received 4 DS107 capsules administered orally once daily for 16 weeks.

    Primary: Proportion of patients achieving a vIGA-ADTM score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from Baseline at Week 16.

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    End point title
    		 Proportion of patients achieving a vIGA-ADTM score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from Baseline at Week 16.
    End point description
    Proportion of patients achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis score of 0 or 1 and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from Baseline at Week 16 using GLMM.
    End point type
    Primary
    End point timeframe
    Up to 16 Weeks.
    End point values
    		 Placebo DS107 2000mg
    Number of subjects analysed
    86
    92
    Units: Number of Subjects
        Proportion of Patients
    15
    14
    Statistical analysis title
    		 DS107 2000mg V Placebo
    Comparison groups
    Placebo v DS107 2000mg
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.688
    Method
    		 GLMM
    Parameter type
    		 Proportion of Subjects
    Point estimate
    -0.2277
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.0415
         upper limit
    		 0.586

    Primary: Proportion of patients achieving EASI-75 (≥75% improvement from Baseline) in treated population compared to placebo population at Week 16.

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    End point title
    		 Proportion of patients achieving EASI-75 (≥75% improvement from Baseline) in treated population compared to placebo population at Week 16.
    End point description
    End point type
    Primary
    End point timeframe
    Up to 16 weeks.
    End point values
    		 Placebo DS107 2000mg
    Number of subjects analysed
    87
    93
    Units: Number of Subjects
        Proportion of Subjects
    30
    27
    Statistical analysis title
    		 DS107 2000mg V Placebo
    Comparison groups
    Placebo v DS107 2000mg
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4321
    Method
    		 GLMM
    Parameter type
    		 Proportion of Subjects
    Point estimate
    -0.276
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9185
         upper limit
    		 0.3665

    Secondary: Proportion of patients achieving a vIGA-ADTM score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from baseline to Week 4, 8, 12, 18 and 20

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    End point title
    		 Proportion of patients achieving a vIGA-ADTM score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from baseline to Week 4, 8, 12, 18 and 20
    End point description
    Proportion of patients achieving a vIGA-ADTM score of 0 or 1 and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from Baseline to Week 4, 8, 12, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.
    End point type
    Secondary
    End point timeframe
    Up to 20 Weeks.
    End point values
    		 Placebo DS107 2000mg
    Number of subjects analysed
    102
    99
    Units: Number of Subjects
        Week 4
    3
    2
        Week 8
    6
    6
        Week 12
    10
    7
        Week 18
    13
    7
        Week 20
    10
    13
        Week 16 to Week 18
    1
    1
        Week 16 to Week 20
    2
    1
    No statistical analyses for this end point

    Secondary: Proportion of patients achieving EASI-75 (≥75% improvement from Baseline) in treated population compared to placebo population at Weeks 4, 8, 12, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.

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    End point title
    		 Proportion of patients achieving EASI-75 (≥75% improvement from Baseline) in treated population compared to placebo population at Weeks 4, 8, 12, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.
    End point description
    Proportion of patients achieving EASI-75 in treated population compared to placebo population at Weeks 4, 8, 12, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.
    End point type
    Secondary
    End point timeframe
    Up to 20 Weeks.
    End point values
    		 Placebo DS107 2000mg
    Number of subjects analysed
    102
    99
    Units: Number of Subjects
        Week 4
    8
    8
        Week 8
    15
    7
        Week 12
    19
    10
        Week 18
    21
    20
        Week 20
    23
    22
    No statistical analyses for this end point

    Secondary: Change from Baseline in vIGA-ADTM score in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.

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    End point title
    		 Change from Baseline in vIGA-ADTM score in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.
    End point description
    Change from Baseline in vIGA-ADTM score in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.
    End point type
    Secondary
    End point timeframe
    Up to 20 Weeks.
    End point values
    		 Placebo DS107 2000mg
    Number of subjects analysed
    110
    109
    Units: vIGA-ADTM Score
    number (confidence interval 95%)
        Week 4
    0.7843 (0.4869 to 1.0816)
    -0.0454 (-0.4715 to 0.3807)
        Week 8
    0.3487 (0.03437 to 0.6630)
    0.2577 (-0.1929 to 0.7083)
        Week 12
    0.1224 (-0.2109 to 0.4558)
    0.3091 (-0.1687 to 0.7870)
        Week 16
    0.2813 (-0.01342 to 0.5761)
    0.1394 (-0.2781 to 0.5568)
        Week 18
    0.0862 (-0.2366 to 0.4089)
    0.1283 (-0.3349 to 0.5914)
        Week 18 V Last Visit
    0.0689 (-0.2153 to 0.3531)
    0.1024 (-0.3055 to 0.5102)
    No statistical analyses for this end point

    Secondary: Change from Baseline in EASI in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.

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    End point title
    		 Change from Baseline in EASI in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 20 Weeks.
    End point values
    		 Placebo DS107 2000mg
    Number of subjects analysed
    110
    109
    Units: EASI Score
    number (confidence interval 95%)
        Week 4
    31.4509 (17.6525 to 45.2493)
    3.5453 (-16.1397 to 23.2303)
        Week 8
    14.4747 (-0.08487 to 29.0342)
    8.8565 (-11.9180 to 29.6310)
        Week 12
    6.4487 (-8.9305 to 21.8279)
    10.4186 (-11.6294 to 32.4667)
        Week 16
    18.4269 (4.8107 to 32.0431)
    3.5470 (-15.6720 to 22.7661)
        Week 18
    4.1677 (-10.7908 to 19.1262)
    3.1252 (-18.2311 to 24.4815)
        Week 18 V Last Visit
    2.6189 (-53.4435 to 58.6812)
    10.1487 (-70.3673 to 90.6647)
    No statistical analyses for this end point

    Secondary: Proportion of patients achieving a decrease of at least 4 points in worst itch numeric rating scale (NRS) in treated population compared to placebo population from Baseline to Week 4, 8, 12, 16, 18 and 20.

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    End point title
    		 Proportion of patients achieving a decrease of at least 4 points in worst itch numeric rating scale (NRS) in treated population compared to placebo population from Baseline to Week 4, 8, 12, 16, 18 and 20.
    End point description
    Proportion of patients achieving a decrease of at least 4 points in worst itch numeric rating scale in treated population compared to placebo population from Baseline to Week 4, 8, 12, 16, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.
    End point type
    Secondary
    End point timeframe
    Up to 20 Weeks
    End point values
    		 Placebo DS107 2000mg
    Number of subjects analysed
    102
    99
    Units: Number of Patients
        Week 4
    6
    11
        Week 8
    12
    12
        Week 12
    10
    13
        Week 16
    13
    12
        Week 18
    12
    12
        Week 20
    11
    10
    No statistical analyses for this end point

    Secondary: Proportion of patients achieving a decrease of at least 3 points in worst itch NRS in treated population compared to placebo population from Baseline to Week 4, 8, 12, 16, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.

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    End point title
    		 Proportion of patients achieving a decrease of at least 3 points in worst itch NRS in treated population compared to placebo population from Baseline to Week 4, 8, 12, 16, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.
    End point description
    Proportion of patients achieving a decrease of at least 3 points in worst itch NRS in treated population compared to placebo population from Baseline to Week 4, 8, 12, 16, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.
    End point type
    Secondary
    End point timeframe
    Up to 20 weeks
    End point values
    		 Placebo DS107 2000mg
    Number of subjects analysed
    102
    99
    Units: Number of Patients
        Week 4
    12
    19
        Week 8
    18
    22
        Week 12
    21
    21
        Week 16
    20
    22
        Week 18
    17
    16
        Week 20
    16
    16
    No statistical analyses for this end point

    Secondary: Change from Baseline in worst itch NRS in treated population compared to placebo population to Week 4, 8, 12, 16, 18 and 20 and from Week 16 to Week 18 and 20.

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    End point title
    		 Change from Baseline in worst itch NRS in treated population compared to placebo population to Week 4, 8, 12, 16, 18 and 20 and from Week 16 to Week 18 and 20.
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 20 weeks.
    End point values
    		 Placebo DS107 2000mg
    Number of subjects analysed
    110
    109
    Units: NRS
    number (confidence interval 95%)
        Week 4
    1.9916 (1.1339 to 2.8493)
    -0.5094 (-1.7037 to 0.6848)
        Week 8
    1.2897 (0.4072 to 2.1723)
    -0.2826 (-1.5060 to 0.9408)
        Week 12
    0.8685 (-0.05200 to 1.7889)
    -0.2133 (-1.4913 to 1.0646)
        Week 16
    0.2244 (-0.7377 to 1.1865)
    0.0258 (-1.3063 to 1.3579)
        Week 18
    0.0905 (-0.9063 to 1.0873)
    0.1468 (-1.2412 to 1.5348)
        Week 18 V Last Visit
    0.0797 (-0.4720 to 0.6313)
    0.1101 (-0.6686 to 0.8889)
    No statistical analyses for this end point

    Secondary: Proportion of patients achieving EASI-50 (≥50% improvement from Baseline) in treated population compared to placebo population at Week 4, 8, 12, 16, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.

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    End point title
    		 Proportion of patients achieving EASI-50 (≥50% improvement from Baseline) in treated population compared to placebo population at Week 4, 8, 12, 16, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 20 weeks.
    End point values
    		 Placebo DS107 2000mg
    Number of subjects analysed
    102
    99
    Units: Number of Participants
        Week 4
    21
    15
        Week 8
    31
    26
        Week 12
    28
    23
        Week 16
    44
    45
        Week 18
    29
    35
        Week 20
    29
    33
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Body Surface Area (BSA) affected by AD in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.

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    End point title
    		 Change from Baseline in the Body Surface Area (BSA) affected by AD in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 20 Weeks.
    End point values
    		 Placebo DS107 2000mg
    Number of subjects analysed
    110
    109
    Units: BSA
    number (confidence interval 95%)
        Week 4
    10.5575 (5.0467 to 16.0682)
    -1.1911 (-9.0736 to 6.6913)
        Week 8
    7.0087 (1.1680 to 12.8495)
    -0.2839 (-8.6398 to 8.0720)
        Week 12
    4.8296 (-1.3215 to 10.9808)
    -1.4232 (-10.2908 to 7.4445)
        Week 16
    6.5413 (1.1144 to 11.9681)
    0.9244 (-6.7736 to 8.6224)
        Week 18
    1.4568 (-4.4994 to 7.4129)
    1.1470 (-7.3990 to 9.6929)
        Week 18 V Last Visit
    1.0590 (-2.7322 to 4.8502)
    0.7666 (-4.7036 to 6.2369)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the SCORing Atopic Dermatitis (SCORAD) score in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.

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    End point title
    		 Change from Baseline in the SCORing Atopic Dermatitis (SCORAD) score in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 20 Weeks.
    End point values
    		 Placebo DS107 2000mg
    Number of subjects analysed
    110
    109
    Units: SCORAD Score
    number (confidence interval 95%)
        Week 4
    15.7003 (8.8854 to 22.5153)
    -0.9182 (-10.6319 to 8.7955)
        Week 8
    12.6334 (5.4389 to 19.8279)
    -0.0799 (-10.3366 to 10.1769)
        Week 12
    4.0487 (-3.5504 to 11.6478)
    5.2956 (-5.5928 to 16.1840)
        Week 16
    7.3626 (0.6168 to 14.1084)
    1.8419 (-7.6580 to 11.3419)
        Week 18
    1.8556 (-5.5327 to 9.2439)
    4.3232 (-6.2245 to 14.8709)
        Week 18 V Last Visit
    2.5318 (-2.8807 to 7.9443)
    2.2924 (-5.4016 to 9.9865)
    No statistical analyses for this end point

    Secondary: Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).

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    End point title
    		 Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).
    End point description
    Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).
    End point type
    Secondary
    End point timeframe
    Up to 20 Weeks.
    End point values
    		 Placebo DS107 2000mg
    Number of subjects analysed
    110
    109
    Units: Number of AEs
        All AEs
    58
    62
        Serious AEs
    5
    5
        AEs with relationship to study medication
    23
    42
        AEs leading to death
    0
    0
        AEs that led to withdrawal
    12
    17
        AEs before first administration of DS107
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 20 Weeks.
    Adverse event reporting additional description
    An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational IMP(s). All Adverse Events (AEs) must be recorded in the CRF, defining relationship to IMP and severity.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    DS107 2000mg
    Reporting group description
    		 Patients randomised to DS107 2000mg group received 4 DS107 capsules administered orally once daily for 16 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomised to placebo group received 4 placebo capsules administered orally once daily for 16 weeks.

    Serious adverse events
    		 DS107 2000mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 109 (4.59%)
    5 / 110 (4.55%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (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
    Hypersensitivity
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    2 / 109 (1.83%)
    2 / 110 (1.82%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Coronavirus infection
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal skin infection
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 DS107 2000mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    57 / 109 (52.29%)
    53 / 110 (48.18%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    4
    Fatigue
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Feeling abnormal
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    General physical health deterioration
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Sluggishness
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    2
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 109 (0.00%)
    2 / 110 (1.82%)
         occurrences all number
    0
    3
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 109 (0.00%)
    3 / 110 (2.73%)
         occurrences all number
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 109 (0.92%)
    1 / 110 (0.91%)
         occurrences all number
    1
    1
    Cough
         subjects affected / exposed
    2 / 109 (1.83%)
    1 / 110 (0.91%)
         occurrences all number
    2
    1
    Rhinitis allergic
         subjects affected / exposed
    2 / 109 (1.83%)
    2 / 110 (1.82%)
         occurrences all number
    2
    2
    Throat tightness
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Emotional distress
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    2 / 109 (1.83%)
    1 / 110 (0.91%)
         occurrences all number
    2
    1
    Sleep disorder
         subjects affected / exposed
    1 / 109 (0.92%)
    2 / 110 (1.82%)
         occurrences all number
    1
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 109 (0.92%)
    1 / 110 (0.91%)
         occurrences all number
    1
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 109 (2.75%)
    1 / 110 (0.91%)
         occurrences all number
    3
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Blood pressure increased
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Blood triglycerides increased
         subjects affected / exposed
    1 / 109 (0.92%)
    3 / 110 (2.73%)
         occurrences all number
    1
    3
    White blood cell count increased
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Foot fracture
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Heat stroke
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Sunburn
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Tooth injury
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Cardiac disorders
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Dysgeusia
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    3 / 109 (2.75%)
    10 / 110 (9.09%)
         occurrences all number
    4
    20
    Hypoaesthesia
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 109 (0.92%)
    1 / 110 (0.91%)
         occurrences all number
    1
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 109 (0.92%)
    2 / 110 (1.82%)
         occurrences all number
    1
    5
    Eczema eyelids
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Eye pain
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Macular oedema
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    3
    0
    Abdominal distension
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    3 / 109 (2.75%)
    1 / 110 (0.91%)
         occurrences all number
    3
    1
    Abdominal pain upper
         subjects affected / exposed
    4 / 109 (3.67%)
    1 / 110 (0.91%)
         occurrences all number
    7
    1
    Constipation
         subjects affected / exposed
    1 / 109 (0.92%)
    1 / 110 (0.91%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    21 / 109 (19.27%)
    4 / 110 (3.64%)
         occurrences all number
    24
    5
    Dyspepsia
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Faeces soft
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Functional gastrointestinal disorder
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Haemorrhoids thrombosed
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Lip swelling
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    6 / 109 (5.50%)
    2 / 110 (1.82%)
         occurrences all number
    6
    2
    Toothache
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 109 (0.92%)
    1 / 110 (0.91%)
         occurrences all number
    1
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Alopecia areata
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Dermatitis atopic
         subjects affected / exposed
    13 / 109 (11.93%)
    26 / 110 (23.64%)
         occurrences all number
    15
    30
    Diffuse alopecia
         subjects affected / exposed
    0 / 109 (0.00%)
    2 / 110 (1.82%)
         occurrences all number
    0
    4
    Eczema
         subjects affected / exposed
    1 / 109 (0.92%)
    2 / 110 (1.82%)
         occurrences all number
    1
    2
    Erythrodermic atopic dermatitis
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Intertrigo
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    2 / 109 (1.83%)
    2 / 110 (1.82%)
         occurrences all number
    2
    2
    Skin exfoliation
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    5
    Skin ulcer
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Solar dermatitis
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Urinary tract inflammation
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Infections and infestations
    Breast abscess
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Folliculitis
         subjects affected / exposed
    1 / 109 (0.92%)
    1 / 110 (0.91%)
         occurrences all number
    2
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Herpes simplex
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Hordeolum
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Nasal herpes
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 109 (2.75%)
    3 / 110 (2.73%)
         occurrences all number
    4
    3
    Oral herpes
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Otitis media
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Pulpitis dental
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Pyoderma
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    1 / 109 (0.92%)
    1 / 110 (0.91%)
         occurrences all number
    1
    1
    Skin infection
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Superinfection bacterial
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    2 / 109 (1.83%)
    0 / 110 (0.00%)
         occurrences all number
    2
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Arthralgia
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Joint hyperextension
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Oct 2019
    Update to 24-hour contact number. Clarification of Inclusion Criteria. Clarification of Exclusion Criteria. Clarification of DGLA Plasma Concentration Sampling. Clarification of IMP administration and emollient use on day of visit. Clarification of AE and SAE reporting. Primary variables analysis updated. Open Label Safety Study Removed.
    18 Mar 2020
    Addition of Interim Analysis Section. Addition of COVID-19 Contingency section.

    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.
    The decision to terminate the study prematurely was based on the results from an interim analysis.
    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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