Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, multicenter Phase II study to determine efficacy and safety of IFX-1 in subjects with moderate to severe hidradenitis suppurativa

    Summary
    EudraCT number
    		 2017-004501-40
    Trial protocol
    		 NL   DE   GR   BG   DK   PL  
    Global end of trial date
    14 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Dec 2020
    First version publication date
    09 Dec 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IFX-1-P2.4
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03487276
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    InflaRx GmbH
    Sponsor organisation address
    Winzerlaer Str. 2, Jena, Germany, 07745
    Public contact
    InflaRx GmbH, InflaRx GmbH, +49 3641508 180, info@inflarx.de
    Scientific contact
    InflaRx GmbH, InflaRx GmbH, +49 3641508 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
    16 Apr 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate a dose-response signal of IFX-1 in subjects with moderate to severe hidradenitis suppurativa according to the Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16.
    Protection of trial subjects
    The study was conducted in accordance with Good Clinical Practice (GCP). All persons participating in the conduct of the study (Sponsor, Investigators, and other personnel) committed themselves to observe the Declaration of Helsinki (Version Fortaleza 2013) as well as all pertinent national laws and the ICH guidelines for GCP issued in June 1996 and CPMP/ICH/135/95 from September 1997. 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
    01 Feb 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Poland: 38
    Country: Number of subjects enrolled
    Bulgaria: 9
    Country: Number of subjects enrolled
    Denmark: 5
    Country: Number of subjects enrolled
    France: 19
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Greece: 47
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    United States: 33
    Worldwide total number of subjects
    177
    EEA total number of subjects
    136
    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)
    174
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study included patients of 18 years or older with moderate to severe HS. The study was conducted at 38 study sites in 9 countries (Bulgaria 3, Canada 2, Denmark 2, France 6, Germany 4, Greece 3, the Netherlands 1, Poland 5, USA 12). 177 subjects were enrolled between and treated out of 225 subjects screened between 28-Feb-2018 and 02-Nov-2018.

    Pre-assignment
    Screening details
    		 225 patients were screened for eligibility before participating in the active treatment phase of the study. Subjects were not to be entered to the trial treatment if any of the eligibility criteria were violated. Of the 225 patients, 179 patients were randomized and of these, 177 were treated.

    Period 1
    Period 1 title
    Main Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The identity of the treatments was concealed by the use of IMP that was identical in packaging, labeling, administration schedule, appearance, taste, and odor.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo (Cohort 1)
    Arm description
    		 Subjects in this cohort received intravenous infusions of Placebo every other week starting at Week 0.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo is provided in 10 mL vials containing sodium chloride, sodium phosphate, and Polysorbate 80. The placebo vials and content have the same appearance as the IFX-1 vials and additives. Placebo was administered via an intravenous (iv) line over a period of 30 to 60 minutes.

    Arm title
    		 IFX-1 400 mg Q4W (Cohort 2)
    Arm description
    		 Subjects in this cohort received alternating intravenous infusions of IFX-1 400mg every 4 weeks starting at Week 0, and Placebo starting at Week 2, following a fractionated loading dosing during the first treatment interval.
    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
    IFX-1 is provided in 10 mL vials containing 100 mg IFX-1 and will be infused over a period of 30 to 60 minutes (min) via an intravenous (iv) line.

    Arm title
    		 IFX-1 800 mg Q4W (Cohort 3)
    Arm description
    		 Subjects in this cohort received alternating intravenous infusions of IFX-1 800mg every 4 weeks starting at Week 0, and Placebo starting at Week 2, following a fractionated loading dosing during the first treatment interval.
    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
    IFX-1 is provided in 10 mL vials containing 100 mg IFX-1 and will be infused over a period of 30 to 60 minutes (min) via an intravenous (iv) line.

    Arm title
    		 IFX-1 800 mg Q2W (Cohort 4)
    Arm description
    		 Subjects in this cohort received intravenous infusions of IFX-1 800mg every other week starting at Week 0, following a fractionated loading dosing during the first treatment interval.
    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
    IFX-1 is provided in 10 mL vials containing 100 mg IFX-1 and will be infused over a period of 30 to 60 minutes (min) via an intravenous (iv) line.

    Arm title
    		 IFX-1 1200 mg Q2W (Cohort 5)
    Arm description
    		 Subjects in this cohort received intravenous infusions of IFX-1 1200mg every other week starting at Week 0, following a fractionated loading dosing during the first treatment interval.
    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
    IFX-1 is provided in 10 mL vials containing 100 mg IFX-1 and will be infused over a period of 30 to 60 minutes (min) via an intravenous (iv) line.

    Number of subjects in period 1
    		Placebo (Cohort 1) IFX-1 400 mg Q4W (Cohort 2) IFX-1 800 mg Q4W (Cohort 3) IFX-1 800 mg Q2W (Cohort 4) IFX-1 1200 mg Q2W (Cohort 5)
    Started
    36
    34
    35
    36
    36
    Completed
    34
    30
    32
    30
    31
    Not completed
    2
    4
    3
    6
    5
         Consent withdrawn by subject
    1
    -
    1
    1
    -
         Adverse event, non-fatal
    -
    2
    1
    2
    1
         Other
    -
    -
    -
    1
    1
         Non-compliance with study drug
    -
    -
    -
    -
    1
         Lost to follow-up
    1
    2
    -
    1
    -
         Progressive disease
    -
    -
    -
    1
    -
         Lack of efficacy
    -
    -
    1
    -
    2
    Period 2
    Period 2 title
    Extension Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IFX-1 800mg Q4W (HiSCR responders)
    Arm description
    		 Subjects from all main period cohorts who were HiSCR responders at Week 16 received IFX-1 at a dose of 800mg every 4 weeks, starting at Week 20 through Week 40.
    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
    IFX-1 is provided in 10 mL vials containing 100 mg IFX-1 and will be infused over a period of 30 to 60 minutes (min) via an intravenous (iv) line.

    Arm title
    		 IFX-1 800mg Q2W (HiSCR nonresponders)
    Arm description
    		 Subjects from all main period cohorts who were HiSCR non-responders at Week 16 received IMP during an Induction Phase, followed by IFX-1 at a dose of 800 mg every two Weeks up to Week 40. IMP administration during the induction phase depended on the main period cohort of the subject.
    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
    IFX-1 is provided in 10 mL vials containing 100 mg IFX-1 and will be infused over a period of 30 to 60 minutes (min) via an intravenous (iv) line.

    Number of subjects in period 2 [1]
    		IFX-1 800mg Q4W (HiSCR responders) IFX-1 800mg Q2W (HiSCR nonresponders)
    Started
    72
    84
    Completed
    67
    54
    Not completed
    5
    30
         Consent withdrawn by subject
    -
    12
         Adverse event, non-fatal
    1
    -
         Protocol-specified withdrawal criterion met
    -
    1
         Other
    -
    2
         Disease relapse
    1
    1
         Progressive disease
    1
    3
         Lack of efficacy
    2
    11
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One patient completed the main period but was not treated in the extension period, thus this patient is not counted as having started the extension period

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo (Cohort 1)
    Reporting group description
    		 Subjects in this cohort received intravenous infusions of Placebo every other week starting at Week 0.

    Reporting group title
    IFX-1 400 mg Q4W (Cohort 2)
    Reporting group description
    		 Subjects in this cohort received alternating intravenous infusions of IFX-1 400mg every 4 weeks starting at Week 0, and Placebo starting at Week 2, following a fractionated loading dosing during the first treatment interval.

    Reporting group title
    IFX-1 800 mg Q4W (Cohort 3)
    Reporting group description
    		 Subjects in this cohort received alternating intravenous infusions of IFX-1 800mg every 4 weeks starting at Week 0, and Placebo starting at Week 2, following a fractionated loading dosing during the first treatment interval.

    Reporting group title
    IFX-1 800 mg Q2W (Cohort 4)
    Reporting group description
    		 Subjects in this cohort received intravenous infusions of IFX-1 800mg every other week starting at Week 0, following a fractionated loading dosing during the first treatment interval.

    Reporting group title
    IFX-1 1200 mg Q2W (Cohort 5)
    Reporting group description
    		 Subjects in this cohort received intravenous infusions of IFX-1 1200mg every other week starting at Week 0, following a fractionated loading dosing during the first treatment interval.

    Reporting group values
    		 Placebo (Cohort 1) IFX-1 400 mg Q4W (Cohort 2) IFX-1 800 mg Q4W (Cohort 3) IFX-1 800 mg Q2W (Cohort 4) IFX-1 1200 mg Q2W (Cohort 5) Total
    Number of subjects
    		 36 34 35 36 36 177
    Age categorical
    Analysis of baseline characteristics is based on the Safety Analysis Set (SAS): all subjects who received at least 1 infusion of IMP. Subjects will be analyzed according to the treatment they actually received.
    Units: Subjects
        Adults (18-64 years)
    		 35 33 35 36 35 174
        From 65-84 years
    		 1 1 0 0 1 3
    Age continuous
    Analysis of baseline characteristics is based on the Safety Analysis Set (SAS): all subjects who received at least 1 infusion of IMP. Subjects will be analyzed according to the treatment they actually received.
    Units: years
        arithmetic mean (standard deviation)
    		 35.4 ± 11.25 39.6 ± 10.03 37.3 ± 12.52 38.3 ± 11.05 35.8 ± 12.33 -
    Gender categorical
    Analysis of baseline characteristics is based on the Safety Analysis Set (SAS): all subjects who received at least 1 infusion of IMP. Subjects will be analyzed according to the treatment they actually received.
    Units: Subjects
        Female
    		 21 16 18 20 23 98
        Male
    		 15 18 17 16 13 79

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo (Cohort 1)
    Reporting group description
    		 Subjects in this cohort received intravenous infusions of Placebo every other week starting at Week 0.

    Reporting group title
    IFX-1 400 mg Q4W (Cohort 2)
    Reporting group description
    		 Subjects in this cohort received alternating intravenous infusions of IFX-1 400mg every 4 weeks starting at Week 0, and Placebo starting at Week 2, following a fractionated loading dosing during the first treatment interval.

    Reporting group title
    IFX-1 800 mg Q4W (Cohort 3)
    Reporting group description
    		 Subjects in this cohort received alternating intravenous infusions of IFX-1 800mg every 4 weeks starting at Week 0, and Placebo starting at Week 2, following a fractionated loading dosing during the first treatment interval.

    Reporting group title
    IFX-1 800 mg Q2W (Cohort 4)
    Reporting group description
    		 Subjects in this cohort received intravenous infusions of IFX-1 800mg every other week starting at Week 0, following a fractionated loading dosing during the first treatment interval.

    Reporting group title
    IFX-1 1200 mg Q2W (Cohort 5)
    Reporting group description
    		 Subjects in this cohort received intravenous infusions of IFX-1 1200mg every other week starting at Week 0, following a fractionated loading dosing during the first treatment interval.
    Reporting group title
    IFX-1 800mg Q4W (HiSCR responders)
    Reporting group description
    		 Subjects from all main period cohorts who were HiSCR responders at Week 16 received IFX-1 at a dose of 800mg every 4 weeks, starting at Week 20 through Week 40.

    Reporting group title
    IFX-1 800mg Q2W (HiSCR nonresponders)
    Reporting group description
    		 Subjects from all main period cohorts who were HiSCR non-responders at Week 16 received IMP during an Induction Phase, followed by IFX-1 at a dose of 800 mg every two Weeks up to Week 40. IMP administration during the induction phase depended on the main period cohort of the subject.

    Primary: Percentage of subjects with a response on the basis of the HiSCR.

    		 Close Top of page
    End point title
    		 Percentage of subjects with a response on the basis of the HiSCR.
    End point description
    Analysis of the primary efficacy endpoint is based on the Full analysis set (FAS): the FAS consists of all subjects who received at least 1 infusion of IMP. The analysis will be based on the cohort the subjects were randomized to (intention-to-treat principle).
    End point type
    Primary
    End point timeframe
    Response on the basis of the HiSCR is determined at Week 16 before IMP administration.
    End point values
    		 Placebo (Cohort 1) IFX-1 400 mg Q4W (Cohort 2) IFX-1 800 mg Q4W (Cohort 3) IFX-1 800 mg Q2W (Cohort 4) IFX-1 1200 mg Q2W (Cohort 5)
    Number of subjects analysed
    34
    30
    33
    31
    33
    Units: Subjects
        Responder
    16
    12
    17
    12
    15
        Non-responder
    18
    18
    16
    19
    18
    Statistical analysis title
    		 Dose-response analysis by MCP-Mod
    Statistical analysis description
    Primary analysis of primary efficacy endpoint: Dose-response analysis by MCP-Mod for HiSCR at Week 16. Analysis of the primary efficacy endpoint is based on the Full analysis set (FAS): the FAS consists of all subjects who received at least 1 infusion of IMP. The analysis will be based on the cohort the subjects were randomized to (intention-to-treat principle).
    Comparison groups
    Placebo (Cohort 1) v IFX-1 400 mg Q4W (Cohort 2) v IFX-1 800 mg Q4W (Cohort 3) v IFX-1 800 mg Q2W (Cohort 4) v IFX-1 1200 mg Q2W (Cohort 5)
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.5955 [2]
    Method
    		 MCP-Mod (Logistic model)
    Confidence interval
    Notes
    [1] - Dose-response analysis by MCP-Mod.
    [2] - P-value based on MCP-Mod with Emax model: 0.6519

    Post-hoc: IHS4 percentage change from baseline

    		 Close Top of page
    End point title
    		 IHS4 percentage change from baseline
    End point description
    IHS4 count (total number of inflammatory nodules + 2 x total number of abscesses + 4 x total number of draining fistulas) percentage change from baseline at Week 16. Analysis is based on the Full analysis set (FAS): the FAS will consist of all subjects who will receive at least 1 infusion of IMP. The analysis will be based on the cohort the subjects are randomized to (intention-to-treat principle).
    End point type
    Post-hoc
    End point timeframe
    Week 16
    End point values
    		 Placebo (Cohort 1) IFX-1 400 mg Q4W (Cohort 2) IFX-1 800 mg Q4W (Cohort 3) IFX-1 800 mg Q2W (Cohort 4) IFX-1 1200 mg Q2W (Cohort 5)
    Number of subjects analysed
    34
    30
    32
    30
    32
    Units: percent
        arithmetic mean (standard deviation)
    -21.40 ± 63.327
    -25.14 ± 70.589
    -42.57 ± 49.216
    -40.19 ± 36.356
    -51.27 ± 47.066
    No statistical analyses for this end point

    Post-hoc: IHS4 percentage change from baseline ANCOVA

    		 Close Top of page
    End point title
    		 IHS4 percentage change from baseline ANCOVA
    End point description
    ANCOVA results of IHS4 count (total number of inflammatory nodules + 2 x total number of abscesses + 4 x total number of draining fistulas) percentage change from baseline at Week 16. Analysis is based on the Full analysis set (FAS): the FAS will consist of all subjects who will receive at least 1 infusion of IMP. The analysis will be based on the cohort the subjects are randomized to (intention-to-treat principle).
    End point type
    Post-hoc
    End point timeframe
    Week 16
    End point values
    		 Placebo (Cohort 1) IFX-1 400 mg Q4W (Cohort 2) IFX-1 800 mg Q4W (Cohort 3) IFX-1 800 mg Q2W (Cohort 4) IFX-1 1200 mg Q2W (Cohort 5)
    Number of subjects analysed
    34
    30
    32
    30
    32
    Units: percent
        least squares mean (confidence interval 95%)
    -19.82 (-38.39 to -1.24)
    -24.61 (-44.34 to -4.88)
    -41.08 (-60.18 to -21.98)
    -38.40 (-58.19 to -18.60)
    -51.45 (-70.49 to -32.42)
    Statistical analysis title
    		 ANCOVA of IHS4 relative change at Week 16
    Statistical analysis description
    Ancova results of IHS4 relative change from baseline at Week 16. P-values of the contrast for each treatment cohort versus Placebo are reported. Analysis is based on the Full analysis set (FAS): the FAS consists of all subjects who received at least 1 infusion of IMP. The analysis will be based on the cohort the subjects were randomized to (intention-to-treat principle).
    Comparison groups
    Placebo (Cohort 1) v IFX-1 400 mg Q4W (Cohort 2) v IFX-1 800 mg Q4W (Cohort 3) v IFX-1 800 mg Q2W (Cohort 4) v IFX-1 1200 mg Q2W (Cohort 5)
    Number of subjects included in analysis
    158
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.0202 [3]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [3] - P-value for the contrast 1200 mg IFX-1 Q2W versus Placebo. P-values for the other treatment cohorts versus Placebo are: 800 mg IFX-1 Q2W versus Placebo: 0.1754 800 mg IFX-1 Q4W versus Placebo: 0.1159 400 mg IFX-1 Q4W versus Placebo: 0.7276

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events are reported seperately for the main period (start of study treatment until Week 16, Cohort 1.X) and the extension period (Week 16 until Week 44, Cohort 2.X).
    Adverse event reporting additional description
    Adverse events analysis is based on the Safety analysis set (SAS): the SAS consists of all subjects who received at least 1 infusion of IMP. Subjects will be analyzed according to the treatment they actually received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Cohort 1.1 Placebo (Main Period Data)
    Reporting group description
    		 -

    Reporting group title
    Cohort 1.2 IFX-1 400 mg Q4W (Main Period Data)
    Reporting group description
    		 -

    Reporting group title
    Cohort 1.3 IFX-1 800 mg Q4W (Main Period Data)
    Reporting group description
    		 -

    Reporting group title
    Cohort 1.4 IFX-1 800 mg Q2W (Main Period Data)
    Reporting group description
    		 -

    Reporting group title
    Cohort 1.5 IFX-1 1200 mg Q2W (Main Period Data)
    Reporting group description
    		 -

    Reporting group title
    Cohort 2.1 IFX-1 800 mg Q4W (Extension Period Data)
    Reporting group description
    		 -

    Reporting group title
    Cohort 2.2 IFX-1 800 mg Q2W (Extension Period Data)
    Reporting group description
    		 -

    Serious adverse events
    		 Cohort 1.1 Placebo (Main Period Data) Cohort 1.2 IFX-1 400 mg Q4W (Main Period Data) Cohort 1.3 IFX-1 800 mg Q4W (Main Period Data) Cohort 1.4 IFX-1 800 mg Q2W (Main Period Data) Cohort 1.5 IFX-1 1200 mg Q2W (Main Period Data) Cohort 2.1 IFX-1 800 mg Q4W (Extension Period Data) Cohort 2.2 IFX-1 800 mg Q2W (Extension Period Data)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
    2 / 36 (5.56%)
    3 / 36 (8.33%)
    2 / 72 (2.78%)
    3 / 84 (3.57%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Femoral neck fracture
    Additional description: Femoral neck fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 72 (1.39%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
    Additional description: Sciatica
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 72 (1.39%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
    Additional description: Bile duct stone
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 72 (1.39%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    Additional description: Asthma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 72 (1.39%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
    Additional description: Chronic obstructive pulmonary disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 72 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
    Additional description: Dyspnoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hidradenitis
    Additional description: Hidradenitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    0 / 72 (0.00%)
    2 / 84 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bursitis
    Additional description: Bursitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess bacterial
    Additional description: Abscess bacterial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis infective
    Additional description: Cholangitis infective
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 72 (1.39%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
    Additional description: Influenza
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    Additional description: Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 72 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
    Additional description: Sepsis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1.1 Placebo (Main Period Data) Cohort 1.2 IFX-1 400 mg Q4W (Main Period Data) Cohort 1.3 IFX-1 800 mg Q4W (Main Period Data) Cohort 1.4 IFX-1 800 mg Q2W (Main Period Data) Cohort 1.5 IFX-1 1200 mg Q2W (Main Period Data) Cohort 2.1 IFX-1 800 mg Q4W (Extension Period Data) Cohort 2.2 IFX-1 800 mg Q2W (Extension Period Data)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 36 (58.33%)
    20 / 34 (58.82%)
    16 / 35 (45.71%)
    18 / 36 (50.00%)
    17 / 36 (47.22%)
    25 / 72 (34.72%)
    31 / 84 (36.90%)
    Investigations
    International normalised ratio increased
    Additional description: International normalised ratio increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    2 / 36 (5.56%)
    1 / 72 (1.39%)
    3 / 84 (3.57%)
         occurrences all number
    2
    0
    0
    0
    2
    1
    3
    Injury, poisoning and procedural complications
    Foot fracture
    Additional description: Foot fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    Vascular disorders
    Hypertension
    Additional description: Hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    2 / 36 (5.56%)
    1 / 36 (2.78%)
    2 / 72 (2.78%)
    1 / 84 (1.19%)
         occurrences all number
    0
    0
    0
    2
    1
    2
    1
    Nervous system disorders
    Headache
    Additional description: Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 36 (16.67%)
    4 / 34 (11.76%)
    0 / 35 (0.00%)
    4 / 36 (11.11%)
    5 / 36 (13.89%)
    4 / 72 (5.56%)
    6 / 84 (7.14%)
         occurrences all number
    10
    12
    0
    12
    12
    9
    7
    Presyncope
    Additional description: Presyncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    2 / 35 (5.71%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 72 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    0
    Syncope
    Additional description: Syncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    2 / 36 (5.56%)
    1 / 36 (2.78%)
    1 / 72 (1.39%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    5
    1
    1
    0
    General disorders and administration site conditions
    Fatigue
    Additional description: Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 34 (0.00%)
    3 / 35 (8.57%)
    2 / 36 (5.56%)
    3 / 36 (8.33%)
    0 / 72 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    2
    0
    3
    3
    5
    0
    1
    Pain
    Additional description: Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    2 / 36 (5.56%)
    0 / 72 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    0
    Pyrexia
    Additional description: Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 36 (2.78%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    2 / 36 (5.56%)
    2 / 72 (2.78%)
    0 / 84 (0.00%)
         occurrences all number
    1
    2
    0
    0
    2
    3
    0
    Gastrointestinal disorders
    Diarrhoea
    Additional description: Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    4 / 34 (11.76%)
    2 / 35 (5.71%)
    3 / 36 (8.33%)
    1 / 36 (2.78%)
    2 / 72 (2.78%)
    2 / 84 (2.38%)
         occurrences all number
    0
    5
    2
    3
    1
    2
    2
    Dyspepsia
    Additional description: Dyspepsia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    1
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 36 (5.56%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 72 (1.39%)
    1 / 84 (1.19%)
         occurrences all number
    2
    1
    0
    0
    0
    1
    1
    Nausea
    Additional description: Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 36 (5.56%)
    2 / 34 (5.88%)
    1 / 35 (2.86%)
    1 / 36 (2.78%)
    2 / 36 (5.56%)
    0 / 72 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    4
    2
    1
    1
    2
    0
    2
    Vomiting
    Additional description: Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 72 (1.39%)
    0 / 84 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Hidradenitis
    Additional description: Hidradenitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 36 (13.89%)
    4 / 34 (11.76%)
    2 / 35 (5.71%)
    6 / 36 (16.67%)
    5 / 36 (13.89%)
    8 / 72 (11.11%)
    10 / 84 (11.90%)
         occurrences all number
    5
    8
    4
    8
    8
    9
    12
    Pain of skin
    Additional description: Pain of skin
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    3 / 34 (8.82%)
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 72 (1.39%)
    1 / 84 (1.19%)
         occurrences all number
    0
    4
    3
    0
    0
    2
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    2 / 36 (5.56%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    1
    Back pain
    Additional description: Back pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 36 (2.78%)
    1 / 34 (2.94%)
    0 / 35 (0.00%)
    2 / 36 (5.56%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    0
    2
    0
    0
    1
    Pain in extremity
    Additional description: Pain in extremity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 36 (2.78%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 72 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    2
    2
    0
    0
    1
    0
    0
    Infections and infestations
    Abscess
    Additional description: Abscess
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    1 / 34 (2.94%)
    2 / 35 (5.71%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    0
    Bronchitis
    Additional description: Bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 36 (5.56%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    0
    Cellulitis
    Additional description: Cellulitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    2 / 36 (5.56%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Gastroenteritis
    Additional description: Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    2 / 36 (5.56%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    1
    0
    0
    3
    0
    0
    1
    Influenza
    Additional description: Influenza
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    3 / 36 (8.33%)
    2 / 72 (2.78%)
    2 / 84 (2.38%)
         occurrences all number
    3
    0
    0
    0
    3
    2
    2
    Nasopharyngitis
    Additional description: Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 36 (16.67%)
    4 / 34 (11.76%)
    6 / 35 (17.14%)
    4 / 36 (11.11%)
    3 / 36 (8.33%)
    4 / 72 (5.56%)
    8 / 84 (9.52%)
         occurrences all number
    6
    5
    8
    5
    3
    5
    8
    Pharyngitis
    Additional description: Pharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 36 (5.56%)
    1 / 34 (2.94%)
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    2 / 72 (2.78%)
    2 / 84 (2.38%)
         occurrences all number
    2
    1
    1
    0
    1
    2
    2
    Sinusitis
    Additional description: Sinusitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 34 (0.00%)
    2 / 35 (5.71%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    1 / 72 (1.39%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    2
    1
    1
    2
    0
    Viral upper respiratory tract infection
    Additional description: Viral upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 36 (0.00%)
    2 / 34 (5.88%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Vulvovaginal candidiasis
    Additional description: Vulvovaginal candidiasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 36 (5.56%)
    0 / 34 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    0 / 72 (0.00%)
    3 / 84 (3.57%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    4

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Nov 2018
    Global Protocol Amendment 1.1 leading to protocol version 2.0, dated 16-Nov-2018. There were 33 changes to the original protocol (Version 1.0 dated: 30-Nov-2017).

    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
    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.

    European Medicines Agency © 1995-Thu May 02 05:28:04 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA