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    Clinical Trial Results:
    A randomized, placebo-controlled, double-blind study to scrutinize the efficacy of Secukinumab in patients with moderate to severe atopic dermatitis

    Summary
    EudraCT number
    		 2016-005181-57
    Trial protocol
    		 DE  
    Global end of trial date
    04 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Aug 2021
    First version publication date
    27 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GWT12395-2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03568136
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GWT-TUD GmbH
    Sponsor organisation address
    Freiberger Str. 33, Dresden, Germany, 01067
    Public contact
    Medical Consulting, GWT-TUD GmbH, +49 35125933172, carmen.weigt@gwtonline.de
    Scientific contact
    Medical Consulting, GWT-TUD GmbH, +49 35125933172, carmen.weigt@gwtonline.de
    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
    04 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    04 May 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate and demonstrate the efficacy of secukinumab in patients with atopic dermatitis based on the reduction of the eczema score EASI 50 at week 4 (visit 4).
    Protection of trial subjects
    The conduct of this study was in compliance with the Good Clinical Practice Guidelines and under the guiding principles detailed in the Declaration of Helsinki. The study was also be carried out in keeping with applicable local law(s) and regulation(s). In this study, no invasive investigations (e.g. biopsies) were planned. The skin condition was investigated at all study visits and blood samples were investigated which did, however, not implied a risk for the study patients. The risk to subjects in this trial was minimized by compliance with the eligibility criteria and close clinical monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Sep 2018
    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
    Germany: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    20
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Clinical conduct of the study was between 05 Sep 2018 (date of first informed consent) and 04 May 2020. 32 patients were screened at 5 study sites. 22 patients completed screening and were randomized to one of the two treatment groups, 16 in Arm A and 6 in Arm B. The study was prematurely ended by the sponsor because of poor recruitment.

    Pre-assignment
    Screening details
    		 During the screening period eligibility of the patients was confirmed. Eligible patients were randomized 2:1 to treatment Arm A or B at Day -7 (+2 to -15) during the randomization visit.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Patients were allocated in a ratio of 2:1 to Arm A or Arm B. All patients were randomized during the baseline visit using a central block randomization process based at the sponsor’s randomization office. The study site requesting randomization of a patient sent a randomization form containing site ID, patient screening number and confirmation of eligibility to the sponsor. In return, the site received the randomization form containing the randomization number (Patient ID) by fax or email.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Patients in treatment Arm A received 300 mg Secukinumab administered as 2 subcutaneous (SC) injections of 150 mg at baseline Day 1 (Visit 0) and Week 1 (Visit 1), Week 2 (Visit 2), Week 3 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 8), Week 12 (Visit 9) and injections with placebo (2 SC injections) at Week 5 (Visit 5), 6 (Visit 6), 7 (Visit 7) and 16 (Visit 10). Follow-up visits were performed at Week 20 (Visit 11) and 24 (Visit 12).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    Cosentyx®
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab (Cosentyx®) was used according to the local SmPC. The study dose was 300 mg of Secukinumab by SC injection with initial dosing at baseline (Day 1, Visit 0) and Week 1 (Visit 1), 2 (Visit 2) and 3 (Visit 3), followed by monthly maintenance dosing starting at Week 4. Each 300 mg dose was given as two SC injections of 150 mg.

    Arm title
    		 Arm B
    Arm description
    		 Patients in treatment Arm B received placebo until Week 3 (Visit 3) and then switched to Secukinumab as 2 SC injections of 150 mg at Week 4 (Visit 4) and Weeks 5, 6, 7, 8, 12 and 16 (Visits 5 to 10). Follow-up visits were performed at Week 20 (Visit 11) and 24 (Visit 12).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    Cosentyx®
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab (Cosentyx®) was used according to the local SmPC. The study dose was 300 mg of Secukinumab by SC injection with initial dosing at baseline (Day 1, Visit 0) and Week 1 (Visit 1), 2 (Visit 2) and 3 (Visit 3), followed by monthly maintenance dosing starting at Week 4. Each 300 mg dose was given as two SC injections of 150 mg.

    Number of subjects in period 1
    		Arm A Arm B
    Started
    16
    6
    Completed
    7
    2
    Not completed
    9
    4
         Consent withdrawn by subject
    8
    3
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 22 22
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.8 ± 18.3 -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 13 13

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Patients in treatment Arm A received 300 mg Secukinumab administered as 2 subcutaneous (SC) injections of 150 mg at baseline Day 1 (Visit 0) and Week 1 (Visit 1), Week 2 (Visit 2), Week 3 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 8), Week 12 (Visit 9) and injections with placebo (2 SC injections) at Week 5 (Visit 5), 6 (Visit 6), 7 (Visit 7) and 16 (Visit 10). Follow-up visits were performed at Week 20 (Visit 11) and 24 (Visit 12).

    Reporting group title
    Arm B
    Reporting group description
    		 Patients in treatment Arm B received placebo until Week 3 (Visit 3) and then switched to Secukinumab as 2 SC injections of 150 mg at Week 4 (Visit 4) and Weeks 5, 6, 7, 8, 12 and 16 (Visits 5 to 10). Follow-up visits were performed at Week 20 (Visit 11) and 24 (Visit 12).

    Primary: Reduction of EASI

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    End point title
    		 Reduction of EASI
    End point description
    The primary objective of this study was to investigate and demonstrate the efficacy of Secukinumab in patients with AD based on the reduction of the eczema score EASI 50 at week 4.
    End point type
    Primary
    End point timeframe
    at week 4 (Visit 4)
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    14
    5
    Units: Proportion of patients
        median (standard deviation)
    18.00 ± 20.33
    15.60 ± 16.68
    Statistical analysis title
    		 Comparison of treatment groups
    Statistical analysis description
    The hypothesis H0 : p1 = p2 was tested against the alternative hypothesis: H1: p1 ≠ p2, where p1 is the proportion of patients in the Secukinumab treated group with a reduction of EASI by at least 50% (EASI 50) at week 4 in comparison to baseline and p2 is the EASI 50 in the placebo arm. The hypothesis was tested by Fisher’s exact test (with Yates correction). The χ2-test originally planned in the study protocol could not be performed due to the reduced sample size.
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [1] - The hypothesis was tested by Fisher’s exact test (with Yates correction). The χ2-test originally planned in the study protocol could not be performed due to the reduced sample size.

    Secondary: Reduction of EASI at baseline and EoT

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    End point title
    		 Reduction of EASI at baseline and EoT
    End point description
    To compare the proportion of patients with a reduction of the eczema score EASI 50 at baseline and at end of treatment.
    End point type
    Secondary
    End point timeframe
    Day 1 (Visit 0), EoT (study Arm A, Visit 9; study Arm B, Visit 10)
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    16 [2]
    6 [3]
    Units: Proportion of patients
    median (standard deviation)
        Day 1
    22.80 ± 12.05
    24.65 ± 15.00
        EoT
    16.00 ± 17.46
    6.60 ± 3.25
    Notes
    [2] - Subjects analysed EoT: 7
    [3] - Subjects analysed EoT: 3
    No statistical analyses for this end point

    Secondary: Change in SCORAD by 50%

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    End point title
    		 Change in SCORAD by 50%
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 (Visit 0), week 4 (Visit 4) EoT (study Arm A, Visit 9; study Arm B Visit 10)
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    16
    6
    Units: Proportion of patients
    arithmetic mean (standard deviation)
        Day 1
    64.12 ± 12.45
    67.56 ± 14.58
        Week 4
    56.01 ± 23.65
    49.30 ± 20.42
        EoT
    50.93 ± 20.70
    31.37 ± 6.66
    No statistical analyses for this end point

    Secondary: IGA score of “clear" or "almost clear”

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    End point title
    		 IGA score of “clear" or "almost clear”
    End point description
    To compare the proportion of patients who achieve a score of "clear-0" or "almost clear-1" in the static IGA score at EoT as compared to baseline.
    End point type
    Secondary
    End point timeframe
    EoT (Study Arm A, Visit 9; Study Arm B, Visit 10)
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    16
    6
    Units: Proportion of patients
    number (not applicable)
        Yes
    0
    1
        No
    16
    5
    No statistical analyses for this end point

    Secondary: Increase in DLQI by 30%

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    End point title
    		 Increase in DLQI by 30%
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 (Visit 0), week 4 (Visit 4), EoT (study Arm A, Visit 9; study Arm B, Visit 10)
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    16
    6
    Units: Proportion of patients
    arithmetic mean (standard deviation)
        Day 1
    11.5 ± 7.9
    12.2 ± 4.7
        Week 4
    8.5 ± 6.3
    10.4 ± 5.0
        EoT
    7.7 ± 5.8
    5.7 ± 2.9
    No statistical analyses for this end point

    Secondary: Biomarker CCL17 and CCL22

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    End point title
    		 Biomarker CCL17 and CCL22
    End point description
    End point type
    Secondary
    End point timeframe
    at week 4 (Visit 4)
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    14
    4
    Units: Serum concentration
    median (standard deviation)
        CCL17
    139 ± 373
    168 ± 65
        CCL22
    1418 ± 3193
    2524 ± 2333
    No statistical analyses for this end point

    Secondary: Missing days at work

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    End point title
    		 Missing days at work
    End point description
    End point type
    Secondary
    End point timeframe
    at week 4 (Visit 4)
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    14
    3
    Units: Sum of missing days
        arithmetic mean (standard deviation)
    1.4 ± 3.1
    0.0 ± 0.0
    No statistical analyses for this end point

    Secondary: Consumption of topical corticosteroid drug

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    End point title
    		 Consumption of topical corticosteroid drug
    End point description
    End point type
    Secondary
    End point timeframe
    at week 4 (Visit 4)
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    16
    6
    Units: gram(s)
    arithmetic mean (standard deviation)
        With Imputation
    0.25 ± 36.87
    3.38 ± 34.90
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The observation phase for AEs started with signing the informed consent form and ended 28 days after the last intake of study drug, unless the investigator suspected a delayed adverse reaction to the study drug.
    Adverse event reporting additional description
    For this trial, only treatment-emergent AEs were documented. All AEs starting or worsening after first study drug administration up to 30 days after last study drug administration were considered as treatment-emergent.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Serious adverse events
    		 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 22 (81.82%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acanthoma
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Investigations
    Blood glucose increased
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Urine protein/creatinine ratio
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Urine analysis abnormal
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Diagnostic procedure
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Muscle strain
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    5
    Vomiting
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Flatulence
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Nasopharyngitis
         subjects affected / exposed
    13 / 22 (59.09%)
         occurrences all number
    23
    Eczema
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Dermatitis atopic
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    2
    Urticaria
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Acne
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Neurodermatitis
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Pain of skin
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    6
    Musculoskeletal pain
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Infections and infestations
    Gastrointestinal infection
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Otitis externa
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Abscess
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Diverticulitis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    3
    Tonsillitis
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Dec 2018
    Protocol Version 3.0, dated 16 Nov 2018 • Extension of exclusion criteria • Adjustment of time windows for screening and randomization • Documentation of adverse events between initial screening failure and re-screening not necessary • No fasting before blood collection necessary
    27 Aug 2019
    Protocol Version 4.0, dated 24 Jul 2019 • Implementation of telephone visits at V1 to V3 and V5 to V7 instead of visits at trial site • Implementation of patient diary at home on the days of telephone visits

    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.
    Study was prematurely terminated because of a delayed recruitment which did not suggest completion in a reasonable time frame. Due to the explorative character of the study inclusion of less subjects was deemed to have no impact on the study outcome.
    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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