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    Clinical Trial Results:
    Single-arm study to assess a potential effect of anti-IL-17 (Secukinumab) in the treatment of pyoderma gangrenosum

    Summary
    EudraCT number
    		 2015-000762-65
    Trial protocol
    		 DE  
    Global end of trial date
    19 Sep 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Oct 2020
    First version publication date
    02 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457ADE01T
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02733094
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Technische Universität München, Fakultät für Medizin
    Sponsor organisation address
    Ismaninger Str. 22, München, Germany, 81675
    Public contact
    Studienzentrum Dermatologie, Department of Dermatology and Allergy Technische Universität München , +49 894140 3579, kilian.eyerich@tum.de
    Scientific contact
    Studienzentrum Dermatologie, Department of Dermatology and Allergy Technische Universität München , +49 894140 3579, kilian.eyerich@tum.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
    02 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Sep 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate efficacy and tolerability of secukinumab in patients with pyoderma gangrenosum after 16 week treatment with 300 mg s.c. secukinumab.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance the ethical principles of Good Clinical Practice (GCP). Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. The study was regularly monitored by the Sponsor and all investigators connected to the study were GCP trained.
    Background therapy
    		 None applied
    Evidence for comparator
    		 n.a.
    Actual start date of recruitment
    30 May 2016
    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: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    7
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in Germany single-centre between 30.05.2016 (first Patient recruited) and 19.09.2019 (last patient completed).

    Pre-assignment
    Screening details
    		 Patients must have all screening evaluations performed prior to the first dose of study drug and must meet all inclusion and none of the exclusion criteria. The patients must be thoroughly informed about all aspects of the study, all evaluations as required per protocol and all regulatory requirements for informed consent.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This is a single-arm not blinded study.

    Arms
    Arm title
    		 CAIN trial
    Arm description
    		 Single arm study to assess a potential effect of anti IL 17 (Secukinumab) in the treatment of pyoderma gangrenosum.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cosentyx
    Investigational medicinal product code
    ATC L04AC10
    Other name
    Secukinumab
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg secukinumab per week 1-4 and subsequently each 4 weeks subcutaneuously over a study period of 16 weeks; follow up until week 40. 300 mg secukinumab per week 1-4 and subsequently each 2 weeks subcutaneuously over a study period of 32 weeks; follow up until week 40. (Amendment)

    Number of subjects in period 1
    		CAIN trial
    Started
    8
    Completed
    2
    Not completed
    6
         Consent withdrawn by subject
    3
         Adverse event, non-fatal
    2
         Deterioration of pre-existing health condition
    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
    		 8 8
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 7 7
        From 65-84 years
    		 1 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 45.3 (22 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 3 3
    Previous treatment for PG
    Number of patients receiving treatment for pyoderma gangrenosum prior to inclusion in the study
    Units: Subjects
        previous treatment
    		 8 8
        no previous treatment
    		 0 0
    Time between first diagnosis and study begin
    Duration (in months) between first diagnosis of pyoderma gangrenosum and study begin.
    Units: months
        arithmetic mean (standard deviation)
    		 32.3 ± 41.7 -
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients included in the study except one, who withdrew before receiving study medication.

    Subject analysis sets values
    		 ITT
    Number of subjects
    7
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    6
        From 65-84 years
    1
    Age continuous
    Units: years
        median (full range (min-max))
    39 (22 to 70)
    Gender categorical
    Units: Subjects
        Female
    4
        Male
    3
    Previous treatment for PG
    Number of patients receiving treatment for pyoderma gangrenosum prior to inclusion in the study
    Units: Subjects
        previous treatment
    7
        no previous treatment
    0
    Time between first diagnosis and study begin
    Duration (in months) between first diagnosis of pyoderma gangrenosum and study begin.
    Units: months
        arithmetic mean (standard deviation)
    33 ± 42

    End points

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    End points reporting groups
    Reporting group title
    CAIN trial
    Reporting group description
    		 Single arm study to assess a potential effect of anti IL 17 (Secukinumab) in the treatment of pyoderma gangrenosum.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients included in the study except one, who withdrew before receiving study medication.

    Primary: Change in PGA

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    End point title
    		 Change in PGA [1]
    End point description
    Change in PGA at week 16 as compared to baseline. Grade 0: Total resolution of ulcer(s) with no signs of active PG Grade 1: Almost completely healed uncer(s) with only minimal signs of active PG Grade 2: Evidence of ulcer healing which involves at least 50% of ulcer/ulcer margin Grade 3: Evidence of ulcer healing which involves less than 50% of ulcer/ulcer margin Grade 4: No evicence of ulcer healing
    End point type
    Primary
    End point timeframe
    16 weeks from baseline
    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: Only descriptive statistics were planned for this single arm study.
    End point values
    		 ITT
    Number of subjects analysed
    7
    Units: Patients
        Grade 0
    0
        Grade 1
    0
        Grade 2
    2
        Grade 3
    1
        Grade 4
    1
        Missing
    3
    No statistical analyses for this end point

    Primary: Change in PGA (LOCF)

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    End point title
    		 Change in PGA (LOCF) [2]
    End point description
    Sensitivity analysis of the primary endpoint using LOCF imputation for the three missing values at week 16.
    End point type
    Primary
    End point timeframe
    16 wochen from baseline
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics were planned for this single arm study.
    End point values
    		 ITT
    Number of subjects analysed
    7
    Units: Patients
        Grade 0
    0
        Grade 1
    0
        Grade 2
    4
        Grade 3
    1
        Grade 4
    2
    No statistical analyses for this end point

    Secondary: Change in surface area of PG at week 16

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    End point title
    		 Change in surface area of PG at week 16
    End point description
    Change in surface area of PG lesions at week 16 as compared to week 0.
    End point type
    Secondary
    End point timeframe
    At week 16
    End point values
    		 ITT
    Number of subjects analysed
    7
    Units: mm²
        arithmetic mean (standard deviation)
    -22.76 ± 1010.61
    No statistical analyses for this end point

    Secondary: Change in QoL

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    End point title
    		 Change in QoL
    End point description
    Change in patient's quality of life from week 0 to week 16.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 ITT
    Number of subjects analysed
    7
    Units: points
        arithmetic mean (standard deviation)
    -5.25 ± 7.25
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs and SAEs were documented in the timeframe from signed informed consent till the end of the follow-up period (week 40).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 The safety set consisted of all patients who entered the trial and was used for conducting all safety analyses.

    Serious adverse events
    		 Overall study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 8 (25.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pyoderma
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Overall study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 8 (75.00%)
    Nervous system disorders
    Dysaesthesia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Pyrexia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Gastrointestinal disorders
    Aphthous ulcer
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pain of skin
         subjects affected / exposed
    4 / 8 (50.00%)
         occurrences all number
    4
    Pruritus
    Additional description: Pruritus generalised
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Skin ulcer
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Infections and infestations
    Ulcer
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Acarodermatitis
         subjects affected / exposed
    3 / 8 (37.50%)
         occurrences all number
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 8 (37.50%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 May 2017
    After weekly administration of lnvestigational Medicinal Product (IMP) until week 4 (five injections), IMP tobe administered for 32 weeks every two weeks (14 injections) [instead of administration for 16 weeks every four weeks (3 injections)], secondary endpoints (and physician's global assessment (Grade 0 - 4) of the target lesion) should also be assessed at week 32; follow-up (FU).

    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.
    None reported
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    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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