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    Clinical Trial Results:
    A dermal inflammatory challenge study to evaluate complement activation in healthy volunteers

    Summary
    EudraCT number
    		 2020-005595-35
    Trial protocol
    		 NL  
    Global end of trial date
    23 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Oct 2022
    First version publication date
    19 Oct 2022
    Other versions
    Summary report(s)
    		 M2. CHDR2036_Synopsis CSR_09Mar2022

    Trial information

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    Trial identification
    Sponsor protocol code
    CHDR2036
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Toetsingonline: NL76227.056.20
    Sponsors
    Sponsor organisation name
    Centre for Human Drug Research
    Sponsor organisation address
    Zernikedreef 8, Leiden, Netherlands, 2333 CL
    Public contact
    M. Moerland, Centre for Human Drug Research, +31 715246400, clintrails@chdr.nl
    Scientific contact
    M. Moerland, Centre for Human Drug Research, +31 715246400, clintrails@chdr.nl
    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 Jun 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate complement activation in skin after topical imiquimod challenge • To evaluate complement activation in skin after local UV-B challenge
    Protection of trial subjects
    Aldara / imiquimod Possible skin reactions should be monitored carefully during treatment. Since psoriasis exacerbations due to imiquimod treatment have been described, psoriasis patients as well as patients with other autoimmune diseases and skin diseases are excluded to participate in this study to minimize potential risk(s). CHDR has run multiple topical imiquimod challenge studies over the last 3 years, without any safety concerns. Imiquimod exposure in this study will be within the normal therapeutic range, at a limited duration. UV-B UV irradiation from sunlight is associated with an increased incidence of skin cancer. UV irradiation contains a spectrum of wavelengths with UV-B being one of the risk factors for skin cancer. The UV-B wavelength range used in this study is the narrow band (NB) range 310-315nm, which is also used for phototherapy of skin conditions such as psoriasis. In general, UV-B phototherapy is a very safe treatment modality [Lee, 2005]. Participants with pre-existing risk factor for skin cancer will be excluded. As risk mitigation, participants with Fitzpatrick skin type IV, V or VI will be excluded. Dose of UV irradiation will be at 2 x MED. The potential occurrence of hyperpigmentation will be carefully monitored. Before study participation, study participants will be thoroughly informed of the potential risk of PIH at the UV irradiation sites. Skin punch biopsies Since complement deposition can only be assessed histologically, skin biopsies are indispensable in this study. Biopsies will be taken in a minimally invasive manner. Since the diameter is only 3 mm no stitching is necessary. Study participants will have no health benefit.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    19 Feb 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 19-FEB-2021 to 18-MAR-2021, the Netherlands

    Pre-assignment
    Screening details
    		 Enrolled in this study were healthy male participants with Fitzpatrick skin type I-III

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part 1: Imiquimod
    Arm description
    		 Two-part inflammatory challenge study in HV. Part 1: Imiquimod challenged group
    Arm type
    		 Experimental

    Investigational medicinal product name
    Imiquimod/Aldara
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    A dosage of 5 mg imiquimod (100 mg Aldara®) per treatment site was applied, for 3 days

    Arm title
    		 Part 2: UV-B
    Arm description
    		 Two-part inflammatory challenge study in HV. Part 2: UV-B challenged group
    Arm type
    		 Experimental without IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Part 1: Imiquimod Part 2: UV-B
    Started
    5
    6
    Completed
    5
    5
    Not completed
    0
    1
         Physician decision
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 11 11
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 11 11
    Gender categorical
    Units: Subjects
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    Part 1: Imiquimod
    Reporting group description
    		 Two-part inflammatory challenge study in HV. Part 1: Imiquimod challenged group

    Reporting group title
    Part 2: UV-B
    Reporting group description
    		 Two-part inflammatory challenge study in HV. Part 2: UV-B challenged group

    Primary: Complement factors in skin biopsies following imiquimod challenge

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    End point title
    		 Complement factors in skin biopsies following imiquimod challenge [1] [2]
    End point description
    In naïve, unchallenged skin, trace or mild C3d staining was observed in the dermis, with no significant C3c deposition. No significant induction of C3c was seen at any time point after imiquimod challenge.
    End point type
    Primary
    End point timeframe
    Biopsies taken at baseline, 24h, 48hr, 72hr and 120hr post-dose.
    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: See attachment.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: See attachment.
    End point values
    		 Part 1: Imiquimod
    Number of subjects analysed
    5
    Units: Intensity of staining signal
        number (not applicable)
    5
    No statistical analyses for this end point

    Primary: Complement factors in skin biopsies following UV-B challenge

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    End point title
    		 Complement factors in skin biopsies following UV-B challenge [3] [4]
    End point description
    In naïve, unchallenged skin, trace or mild C3d staining was observed in the dermis, with no significant C3c deposition. No significant induction of C3c was seen at any time point after UV-B challenge.
    End point type
    Primary
    End point timeframe
    Biopsies taken at baseline, 6h, 24h, 48hr and 72hr post-UV-B challenge.
    Notes
    [3] - 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: See attachment.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: See attachment.
    End point values
    		 Part 2: UV-B
    Number of subjects analysed
    6
    Units: IHC-staining
        number (not applicable)
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Study day 1-8
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Part 1: Imiquimod
    Reporting group description
    		 Two-part inflammatory challenge study in HV. Part 1: Imiquimod challenged group

    Reporting group title
    Part 2: UV-B
    Reporting group description
    		 Two-part inflammatory challenge study in HV. Part 2: UV-B challenged group

    Serious adverse events
    		 Part 1: Imiquimod Part 2: UV-B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (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: 5%
    Non-serious adverse events
    		 Part 1: Imiquimod Part 2: UV-B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    1 / 6 (16.67%)
    Injury, poisoning and procedural complications
    Application site pruritus
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    Skin and subcutaneous tissue disorders
    Skin lesion inflammation
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0

    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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