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    Clinical Trial Results:
    An open label Phase II trial to evaluate the safety of IFX-1 in patients with moderate to severe Hidradenitis suppurativa

    Summary
    EudraCT number
    		 2016-002988-33
    Trial protocol
    		 GR  
    Global end of trial date
    04 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Nov 2021
    First version publication date
    19 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IFX-1-P2.3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    InflaRx GmbH
    Sponsor organisation address
    Winzerlaer Strasse 2, Jena, Germany, 07745
    Public contact
    InflaRx GmbH, InflaRx GmbH, +49 3641 508 180, info@inflarx.de
    Scientific contact
    InflaRx GmbH, InflaRx GmbH, +49 3641 508 180, info@inflarx.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
    25 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jul 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Explore the safety and tolerability of IFX-1 administered over 8 weeks in patients with moderate to severe hidradenitis suppurativa (HS)
    Protection of trial subjects
    The study was conducted in accordance with the Good Clinical Practice (GCP) as required by the International Conference on Harmonization (ICH) E6 Guideline for GCP, 1996, in agreement with the standard operating procedures for clinical investigation and documentation. Complience with these requirements also constitutes conformity with the ethical principles of the Declaration of Helsinki (revised version, Fortaleza 2013) and any local regulations were followed appropriately. Only subjects that met all inclusion criteria and no exclusion criteria were to enter the study. All patients were free to discontinue their participation in the study at any time.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Dec 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
    Greece: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study included male or female patients of 18 years or older, who suffered from HS lesions in at least 2 distinct anatomic areas one of which was Hurley Stage II or III, diagnosed for at least 1 year, with an AN count ≥ 3 and failure of previous antimicrobial and biological treatment.

    Pre-assignment
    Screening details
    		 Between 13-Dec-2016 and 20-Feb-2017, 12 patients were screened in one site in Greece. All 12 patients were screened for eligibility before participating in the active treatment phase of the study. Subjects were not to be entered to trial treatment if any of the eligibility criteria were violated. All of the 12 patients were randomized and treated.

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

    Arms
    Arm title
    		 Overall
    Arm description
    		 All patients received 9 infusions of IFX-1 800 mg at the study center on Day 1 (day of first treatment) and on Days 4, 8, 15, 22, 29, 36, 43, and 50 after first treatment administration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IFX-1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Drug product was supplied in 10 mL glass vials at a concentration of 10 mg/mL and was administered by intravenous infusion. The drug was diluted to a volume of 250 mL with sodium chloride and administered over 60 min.

    Number of subjects in period 1
    		Overall
    Started
    12
    Completed
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All patients received 9 infusions of IFX-1 800 mg at the study center on Day 1 (day of first treatment) and on Days 4, 8, 15, 22, 29, 36, 43, and 50 after first treatment administration.

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 12 12
    Age categorical
    Age at screening. Full Analysis Set (FAS): All subjects who received study medication.
    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)
    		 11 11
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Age at screening, FAS
    Units: years
        arithmetic mean (standard deviation)
    		 48.3 ± 14.7 -
    Gender categorical
    FAS
    Units: Subjects
        Female
    		 4 4
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 All patients received 9 infusions of IFX-1 800 mg at the study center on Day 1 (day of first treatment) and on Days 4, 8, 15, 22, 29, 36, 43, and 50 after first treatment administration.

    Primary: Treatment emergent adverse events

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    End point title
    		 Treatment emergent adverse events [1]
    End point description
    Treatment emergent adverse events (TEAEs) are adverse events which started with the administration of IFX-1 or later. The safety analysis was performed on the FAS which was the same as the Safety Set in this study.
    End point type
    Primary
    End point timeframe
    From first treatment administration on Day 1 until end of study
    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 analyses were defined and performed.
    End point values
    		 Overall
    Number of subjects analysed
    12 [2]
    Units: Number of subjects
        TEAEs from Day 1 until Day 50
    5
        TEAEs from Day 1 until Day 134
    6
        Serious TEAEs
    4
        Related TEAEs
    0
        Related serious TEAEs
    0
        Not related TEAEs (max. relationship)
    5
        Unlikely related TEAEs (max. relationship)
    1
    Notes
    [2] - FAS
    No statistical analyses for this end point

    Primary: Anti-drug antibodies

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    End point title
    		 Anti-drug antibodies [3]
    End point description
    The number of subjects with any detection of anti-drug antibodies (ADA) at the pre-dosing visit (i.e., Visit 1) and at any post-dosing visit (i.e., Visit 9, Visit 10, Visit 11, and Visit 12) was summarized. FAS
    End point type
    Primary
    End point timeframe
    The subjects were examined forADA at Visit 1/Day 1, Visit 9/Day 50, Visit 10/Day 78, Visit 11/Day 106 and Visit 12/Day 134.
    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: Only descriptive analyses were defined and performed.
    End point values
    		 Overall
    Number of subjects analysed
    12 [4]
    Units: number of subjects
        Positive at pre-dosing visit
    0
        Not detectable at pre-dosing visit
    12
        Positive at any post-dosing visit
    1
        Not detectable at any post-dosing visit
    11
    Notes
    [4] - FAS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first administration of IFX-1 until end of study (8 weeks treatment period and 12 weeks follow-up period).
    Adverse event reporting additional description
    Reporting of TEAEs. The safety analysis was performed on the FAS which was the same as the Safety set in this study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 All patients received 9 infusions of IFX-1 800 mg at the study center on Day 1 (day of first treatment) and on Days 4, 8, 15, 22, 29, 36, 43, and 50 after first treatment administration.

    Serious adverse events
    		 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 12 (33.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Soft tissue infection
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 12 (25.00%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Infections and infestations
    Furuncle
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1

    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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