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    Clinical Trial Results:
    The role of Interleukin-1B targeted therapy for patients suffering with allergic contact dermatitis: A randomized controlled trial with Anakinra vs. Placebo.

    Summary
    EudraCT number
    		 2021-004750-39
    Trial protocol
    		 DK  
    Global end of trial date
    27 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 May 2025
    First version publication date
    08 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LEOSIC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev Gentofte Hospital
    Sponsor organisation address
    Gentofte Hospitalsvej 15, Hellerup, Denmark,
    Public contact
    Kelvin Yeung, Herlev Gentofte Hospital. Department of Dermatology and Allergy, kelvin.yeung@sund.ku.dk
    Scientific contact
    Kelvin Yeung, Herlev Gentofte Hospital. Department of Dermatology and Allergy, kelvin.yeung@sund.ku.dk
    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
    13 Mar 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Oct 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess if there is a clinical difference in severity of ACD in participants treated with anakinra compared to placebo measured by different scoring systems for ACD.
    Protection of trial subjects
    Trial diary to register AE. Extra follow up visits. AE registration in the SOP for every visit.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2022
    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
    Denmark: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Potential participants were screened according to the trial protocol.

    Pre-assignment period milestones
    Number of subjects started
    		 20
    Number of subjects completed
    		 20

    Period 1
    Period 1 title
    First challenge
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 NaCl solution 9 mg/ml
    Arm type
    		 Placebo

    Investigational medicinal product name
    Natriumklorid "Fresenius Kabi" 9 mg/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 mL s.c. daily for 6 consecutive days

    Arm title
    		 Kineret
    Arm description
    		 Anakinra 100 mg/0,67 ml
    Arm type
    		 Experimental

    Investigational medicinal product name
    Kineret
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 mg daily s.c. for 6 consecutive days

    Number of subjects in period 1
    		Placebo Kineret
    Started
    8
    12
    Completed
    8
    12
    Period 2
    Period 2 title
    Second challenge
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Natriumklorid "Fresenius Kabi" 9 mg/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 mL s.c. daily for 6 consecutive days

    Arm title
    		 Kineret
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Kineret
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 mg daily s.c. for 6 consecutive days

    Number of subjects in period 2
    		placebo Kineret
    Started
    8
    12
    Completed
    8
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 NaCl solution 9 mg/ml

    Reporting group title
    Kineret
    Reporting group description
    		 Anakinra 100 mg/0,67 ml

    Reporting group values
    		 Placebo Kineret Total
    Number of subjects
    		 8 12 20
    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)
    		 8 12 20
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.6 ( 13.4 ) 39.8 ( 11.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 11 19
        Male
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 NaCl solution 9 mg/ml

    Reporting group title
    Kineret
    Reporting group description
    		 Anakinra 100 mg/0,67 ml
    Reporting group title
    placebo
    Reporting group description
    		 -

    Reporting group title
    Kineret
    Reporting group description
    		 -

    Primary: Participants achieving reduction in International Contact Dermatitis Research Group score

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    End point title
    		 Participants achieving reduction in International Contact Dermatitis Research Group score
    End point description
    Number of participants achieving a reduction in International Contact Dermatitis Research Group score during second challenge. Reactions can be scored as negative reaction (-), doubtful reaction (?+), weak positive reaction (+), strong positive reaction (++), extreme positive reaction (+++).
    End point type
    Primary
    End point timeframe
    International Contact Dermatitis Research Group scores during first challenge
    End point values
    		 Placebo Kineret
    Number of subjects analysed
    8
    12
    Units: Subjects
        Baseline: Doubtful reaction
    1
    1
        Baseline: Weak positive reaction
    4
    8
        Baseline: Strong positive reaction
    2
    3
        Baseline: Extreme positive reaction
    1
    0
    Statistical analysis title
    		 Fischer exact test with dunn bonferroni correction
    Statistical analysis description
    Since neither group had any participants with a reduction in ICDRG score, there is no evidence of a difference between the treatment and placebo groups. The p-value greater than 0.05 confirms that the two groups are statistically identical in this outcome. However, this result is also limited by the small sample size and the absence of any events, meaning no meaningful conclusion about treatment efficacy can be drawn from this test alone.
    Comparison groups
    Placebo v Kineret
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval

    Primary: Participants achieving reduction in International Contact Dermatitis Research Group score

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    End point title
    		 Participants achieving reduction in International Contact Dermatitis Research Group score
    End point description
    Number of participants achieving a reduction in International Contact Dermatitis Research Group score during second challenge. Reactions can be scored as negative reaction (-), doubtful reaction (?+), weak positive reaction (+), strong positive reaction (++), extreme positive reaction (+++).
    End point type
    Primary
    End point timeframe
    International Contact Dermatitis Research Group score during second challenge
    End point values
    		 placebo Kineret
    Number of subjects analysed
    8
    12
    Units: Subjects
        Second challenge: Doubtful reaction
    0
    0
        Second challenge: Weak positive reaction
    0
    0
        Second challenge: Strong positive reaction
    4
    5
        Second challenge: Extreme positive reaction
    4
    7
    Statistical analysis title
    		 Fischer exact test with dunn bonferroni correction
    Statistical analysis description
    Since neither group had any participants with a reduction in ICDRG score, there is no evidence of a difference between the treatment and placebo groups. The p-value greater than 0.05 confirms that the two groups are statistically identical in this outcome. However, this result is also limited by the small sample size and the absence of any events, meaning no meaningful conclusion about treatment efficacy can be drawn from this test alone.
    Comparison groups
    placebo v Kineret
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day 20 and until end of trial period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    2022
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 NaCl solution 9 mg/ml

    Reporting group title
    Kineret
    Reporting group description
    		 Anakinra 100 mg/0,67 ml

    Serious adverse events
    		 Placebo Kineret
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Kineret
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: None of the 20 participants experienced any AE to treatment or placebo. None was reported during the study period. This was expected since the study drug is well-known and well-tolerated and are used daily in the clinic for long periods of time to treat certain dermatological diseases. The most well-known AE are infections during long-term treatment. In our study the participants only received treatment for 6 consecutive days and none developed AE in this short study period.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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