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    Clinical Trial Results:
    Open label exploratory phase IIa trial to investigate the safety and efficacy of IFX-1 in treating patients with Pyoderma Gangrenosum (OPTIMA).

    Summary
    EudraCT number
    		 2020-003273-21
    Trial protocol
    		 PL  
    Global end of trial date
    03 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jul 2023
    First version publication date
    20 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IFX-1-P2.7
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03971643
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    InflaRx GmbH
    Sponsor organisation address
    Winzerlaer Strasse 2, Jena, Germany, 07745
    Public contact
    Prof. Niels C. Riedemann, M.D., Ph.D., InflaRx GmbH, +49 3641508180, niels.Riedemann@inflarx.de
    Scientific contact
    Prof. Niels C. Riedemann, M.D., Ph.D., InflaRx GmbH, +49 3641508180, niels.Riedemann@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
    30 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jan 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Explore the safety of Vilobelimab (development name: IFX-1) for the treatment of subjects with pyoderma gangrenosum (PG)
    Protection of trial subjects
    The study was conducted according to the ethical principles of the Declaration of Helsinki and in compliance with International Council for Harmonization (ICH) guideline on good clinical practice (GCP). All persons participating in the conduct of the study (e.g., Sponsor, Investigators) committed themselves to observe the Declaration of Helsinki and CIOMS guidelines, as well as all the requirements of 21 CFR, ICH guidelines, the IEC, European regulation 536/2014 for clinical studies, and all other applicable local regulations. 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
    16 May 2019
    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
    Canada: 5
    Country: Number of subjects enrolled
    United States: 7
    Country: Number of subjects enrolled
    Poland: 7
    Worldwide total number of subjects
    19
    EEA total number of subjects
    7
    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)
    12
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First Subject First Visit: 16-May-2019; Last Subject Last Visit: 03-Jan-2022; This study was conducted at 8 sites in 3 countries: Canada (1 site), the USA (5 sites) and in Poland (2 sites)

    Pre-assignment
    Screening details
    		 A total of 29 patients were screened (of whom one patient was re-screened, i.e. 30 Screenings took place), 19 patients were treated with vilobelimab. Reasons for screen failure included failure to meet inclusion/exclusion criteria (n=9, including the one patient that was successfully treated after re-screening) and adverse event (n=2).

    Period 1
    Period 1 title
    Treatment & observational visits (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 vilobelimab 800 mg (Q2W)
    Arm description
    		 Group 1 (N=6) received vilobelimab 800 mg every 2 weeks (Q2W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    vilobelimab
    Investigational medicinal product code
    IFX-1
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Proof of Concept with a total of 15 doses of vilobelimab. vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 1 (N=6) continued to receive vilobelimab 800 mg every 2 weeks (Q2W). With option to increase dose from Day 57 to 1600 mg every two week (Q2W).

    Arm title
    		 vilobelimab 1600 mg (Q2W)
    Arm description
    		 Group 2 (N=6) received vilobelimab 1600 mg every 2 weeks (Q2W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    vilobelimab
    Investigational medicinal product code
    IFX-1
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Proof of Concept with a total of 15 doses of vilobelimab. vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 2 (N=6) received vilobelimab 1600 mg every 2 weeks (Q2W). With option to increase dose from Day 57 to 2400 mg every two week (Q2W).

    Arm title
    		 vilobelimab 2400 mg (Q2W)
    Arm description
    		 Group 3 (N=7) received vilobelimab 2400 mg every 2 weeks (Q2W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    vilobelimab
    Investigational medicinal product code
    IFX-1
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Proof of Concept with a total of 15 doses of vilobelimab. vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 3 (N=7) received vilobelimab 2400 mg every 2 weeks (Q2W).

    Number of subjects in period 1
    		vilobelimab 800 mg (Q2W) vilobelimab 1600 mg (Q2W) vilobelimab 2400 mg (Q2W)
    Started
    6
    6
    7
    Completed until Day 99 (evaluable)
    6
    4
    7
    Completed
    1
    3
    6
    Not completed
    5
    3
    1
         Consent withdrawn by subject
    1
    1
    -
         Adverse event, non-fatal
    2
    1
    -
         Met exclusion criterion
    -
    -
    1
         Missed visits due to COVID-19
    1
    -
    -
         Progressive disease
    -
    1
    -
         Site closure
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    vilobelimab 800 mg (Q2W)
    Reporting group description
    		 Group 1 (N=6) received vilobelimab 800 mg every 2 weeks (Q2W).

    Reporting group title
    vilobelimab 1600 mg (Q2W)
    Reporting group description
    		 Group 2 (N=6) received vilobelimab 1600 mg every 2 weeks (Q2W).

    Reporting group title
    vilobelimab 2400 mg (Q2W)
    Reporting group description
    		 Group 3 (N=7) received vilobelimab 2400 mg every 2 weeks (Q2W).

    Reporting group values
    		 vilobelimab 800 mg (Q2W) vilobelimab 1600 mg (Q2W) vilobelimab 2400 mg (Q2W) Total
    Number of subjects
    		 6 6 7 19
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 3 3 6 12
        From 65-84 years
    		 3 3 1 7
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60 ± 11.4 61 ± 12.4 43 ± 15.0 -
    Gender categorical
    Units: Subjects
        Female
    		 4 3 3 10
        Male
    		 2 3 4 9

    End points

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    End points reporting groups
    Reporting group title
    vilobelimab 800 mg (Q2W)
    Reporting group description
    		 Group 1 (N=6) received vilobelimab 800 mg every 2 weeks (Q2W).

    Reporting group title
    vilobelimab 1600 mg (Q2W)
    Reporting group description
    		 Group 2 (N=6) received vilobelimab 1600 mg every 2 weeks (Q2W).

    Reporting group title
    vilobelimab 2400 mg (Q2W)
    Reporting group description
    		 Group 3 (N=7) received vilobelimab 2400 mg every 2 weeks (Q2W).

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least 1 dose of Investigational Medicinal Product (IMP).

    Primary: Occurrence, nature and intensity of treatment-emergent adverse events (TEAEs)

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    End point title
    		 Occurrence, nature and intensity of treatment-emergent adverse events (TEAEs) [1]
    End point description
    Number of patients with TEAEs
    End point type
    Primary
    End point timeframe
    First administration of vilobelimab 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: The primary objective of the study was to explore the safety by observing the occurrence, nature and intensity of the adverse events. No explicit statistical analysis was done. Adverse events is also reported in the 'Adverse events' section. No separate reporting on SOC/PT level is performed here.
    End point values
    		 vilobelimab 800 mg (Q2W) vilobelimab 1600 mg (Q2W) vilobelimab 2400 mg (Q2W)
    Number of subjects analysed
    6
    6
    7
    Units: Patient number
    6
    4
    5
    No statistical analyses for this end point

    Primary: Occurrence, nature and intensity of related TEAEs

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    End point title
    		 Occurrence, nature and intensity of related TEAEs [2]
    End point description
    Number of patients with related TEAEs
    End point type
    Primary
    End point timeframe
    First administration of vilobelimab until end of study
    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: The primary objective of the study was to explore the safety by observing the occurrence, nature and intensity of the adverse events. No explicit statistical analysis was done. Adverse events is also reported in the 'Adverse events' section. No separate reporting on SOC/PT level is performed here.
    End point values
    		 vilobelimab 800 mg (Q2W) vilobelimab 1600 mg (Q2W) vilobelimab 2400 mg (Q2W)
    Number of subjects analysed
    6
    6
    7
    Units: Patient number, occurrences
    0
    2
    2
    No statistical analyses for this end point

    Primary: Occurrence, nature and intensity of serious TEAEs

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    End point title
    		 Occurrence, nature and intensity of serious TEAEs [3]
    End point description
    Number of patients with serious TEAEs
    End point type
    Primary
    End point timeframe
    First administration of vilobelimab until end of study
    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: The primary objective of the study was to explore the safety by observing the occurrence, nature and intensity of the adverse events. No explicit statistical analysis was done. Adverse events is also reported in the 'Adverse events' section. No separate reporting on SOC/PT level is performed here.
    End point values
    		 vilobelimab 800 mg (Q2W) vilobelimab 1600 mg (Q2W) vilobelimab 2400 mg (Q2W)
    Number of subjects analysed
    6
    6
    7
    Units: Patient number
    1
    1
    2
    No statistical analyses for this end point

    Primary: Occurrence, nature and intensity of adverse events of special interest (AESIs) by investigator

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    End point title
    		 Occurrence, nature and intensity of adverse events of special interest (AESIs) by investigator [4]
    End point description
    Number of patients with AESIs by investigator
    End point type
    Primary
    End point timeframe
    First administration of vilobelimab until end of study
    Notes
    [4] - 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: The primary objective of the study was to explore the safety by observing the occurrence, nature and intensity of the adverse events. No explicit statistical analysis was done. Adverse events is also reported in the 'Adverse events' section. No separate reporting on SOC/PT level is performed here.
    End point values
    		 vilobelimab 800 mg (Q2W) vilobelimab 1600 mg (Q2W) vilobelimab 2400 mg (Q2W)
    Number of subjects analysed
    6
    6
    7
    Units: Patient number
    0
    1
    1
    No statistical analyses for this end point

    Primary: Occurrence, nature and intensity of adverse events of special interest (AESIs) by sponsor

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    End point title
    		 Occurrence, nature and intensity of adverse events of special interest (AESIs) by sponsor [5]
    End point description
    Number of patients with AESIs by sponsor
    End point type
    Primary
    End point timeframe
    First administration of vilobelimab until end of study
    Notes
    [5] - 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: The primary objective of the study was to explore the safety by observing the occurrence, nature and intensity of the adverse events. No explicit statistical analysis was done. Adverse events is also reported in the 'Adverse events' section. No separate reporting on SOC/PT level is performed here.
    End point values
    		 vilobelimab 800 mg (Q2W) vilobelimab 1600 mg (Q2W) vilobelimab 2400 mg (Q2W)
    Number of subjects analysed
    6
    6
    7
    Units: Patient number
    2
    1
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First administration of vilobelimab until end of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    vilobelimab 800 mg (Q2W)
    Reporting group description
    		 -

    Reporting group title
    vilobelimab 1600 mg (Q2W)
    Reporting group description
    		 -

    Reporting group title
    vilobelimab 2400 mg (Q2W)
    Reporting group description
    		 -

    Serious adverse events
    		 vilobelimab 800 mg (Q2W) vilobelimab 1600 mg (Q2W) vilobelimab 2400 mg (Q2W)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Pyoderma gangrenosum
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Endocarditis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Superinfection bacterial
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 vilobelimab 800 mg (Q2W) vilobelimab 1600 mg (Q2W) vilobelimab 2400 mg (Q2W)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    3 / 6 (50.00%)
    5 / 7 (71.43%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Traumatic haematoma
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    Burns second degree
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Contusion
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Head injury
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Skin laceration
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Superficial vein thrombosis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Glossitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Peptic ulcer
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    Pyoderma gangrenosum
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    0
    0
    2
    Actinic keratosis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Lichen planus
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Wound infection
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    3
    1
    0
    Wound infection pseudomonas
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    Abscess limb
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Cellulitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Gingivitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Impetigo
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Nov 2019
    Version 3.0 including Amendment 01 on vilobelimab dosing in dermatological diseases. The summary of changes is detailed in appendix 7 of the protocol (Appendix 16.1.1).
    14 May 2020
    Version 4.0 including Amendment 02 on trial enrollment and pain medication. The summary of changes is detailed in appendix 8 of the protocol (Appendix 16.1.1).

    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
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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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