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    Clinical Trial Results:
    A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE

    Summary
    EudraCT number
    		 2019-000780-24
    Trial protocol
    		 NL   ES   BE   FR   IT   PL  
    Global end of trial date
    02 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Aug 2023
    First version publication date
    16 Aug 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MOR202C103
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04145440
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hi-Bio
    Sponsor organisation address
    6000 Shoreline Court, Suite 304, South San Francisco, California, United States, 94080
    Public contact
    HI-Bio Clinical Program Lead, Hi-Bio, 1 408-548-7261, clinicaltrialdisclosure@hibio.com
    Scientific contact
    HI-Bio Clinical Program Lead, Hi-Bio, 1 408-548-7261, clinicaltrialdisclosure@hibio.com
    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 Aug 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of MOR202 treatment in participants with anti-PLA2R antibody positive membranous nephropathy (aMN)
    Protection of trial subjects
    This study was designed and conducted according to the ICH Harmonised Tripartite Guideline for Good Clinical Practices (GCP) and according to the Declaration of Helsinki that was in place during the time the study was conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jul 2019
    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
    Poland: 3
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 2
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    31
    EEA total number of subjects
    21
    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)
    24
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 65 participants were screened for this study. 31 participants were enrolled and received at least one dose of study drug.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1 (newly diagnosed or relapsed participants)
    Arm description
    		 Participants with newly diagnosed or relapsed membranous nephropathy
    Arm type
    		 Experimental

    Investigational medicinal product name
    MOR202
    Investigational medicinal product code
    Other name
    felzartamab
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

    Arm title
    		 Cohort 2 (refractory participants)
    Arm description
    		 Participants with membranous nephropathy refractory to immunosuppressive treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    MOR202
    Investigational medicinal product code
    Other name
    felzartamab
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

    Number of subjects in period 1
    		Cohort 1 (newly diagnosed or relapsed participants) Cohort 2 (refractory participants)
    Started
    18
    13
    Received at least one dose of study drug
    18
    13
    Completed
    13
    10
    Not completed
    5
    3
         Physician decision
    3
    -
         Use of prohibited therapy
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1 (newly diagnosed or relapsed participants)
    Reporting group description
    		 Participants with newly diagnosed or relapsed membranous nephropathy

    Reporting group title
    Cohort 2 (refractory participants)
    Reporting group description
    		 Participants with membranous nephropathy refractory to immunosuppressive treatment

    Reporting group values
    		 Cohort 1 (newly diagnosed or relapsed participants) Cohort 2 (refractory participants) Total
    Number of subjects
    		 18 13 31
    Age categorical
    The Full Analysis Set (FAS) included all participants who received at least one dose of study drug.
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 12 12 24
        From 65-84 years
    		 6 1 7
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.2 ± 11.34 55.0 ± 12.47 -
    Gender categorical
    Units: Subjects
        Female
    		 5 2 7
        Male
    		 13 11 24
    Race
    Units: Subjects
        White
    		 13 8 21
        Asian
    		 4 0 4
        Other
    		 0 4 4
        American Indian or Alaska Native
    		 1 0 1
        Black or African American
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1 (newly diagnosed or relapsed participants)
    Reporting group description
    		 Participants with newly diagnosed or relapsed membranous nephropathy

    Reporting group title
    Cohort 2 (refractory participants)
    Reporting group description
    		 Participants with membranous nephropathy refractory to immunosuppressive treatment

    Primary: Number of Participants with Adverse Events

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    End point title
    		 Number of Participants with Adverse Events [1]
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. The Safety Analysis Set included all participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to week 25
    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 summary statistics were planned for this endpoint.
    End point values
    		 Cohort 1 (newly diagnosed or relapsed participants) Cohort 2 (refractory participants)
    Number of subjects analysed
    18
    13
    Units: participants
    15
    12
    No statistical analyses for this end point

    Primary: Percentage of Participants with Adverse Events

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    End point title
    		 Percentage of Participants with Adverse Events [2]
    End point description
    An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. The Safety Analysis Set included all participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to week 25
    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: Only summary statistics were planned for this endpoint.
    End point values
    		 Cohort 1 (newly diagnosed or relapsed participants) Cohort 2 (refractory participants)
    Number of subjects analysed
    18
    13
    Units: percentage of participants
        number (not applicable)
    83.3
    92.3
    No statistical analyses for this end point

    Secondary: Best Immunological Response Rate (BIRR)

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    End point title
    		 Best Immunological Response Rate (BIRR)
    End point description
    The best immunological response rate (BIRR) was defined as the percentage of participants with a best immunological response of stringent immunological complete response (sICR), immunological complete response (ICR), or immunological partial response (IPR) prior to the start of prohibited treatment or progression, based on reduction of serum anti-PLA2R antibody titre. The FAS included all participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Cohort 1 (newly diagnosed or relapsed participants) Cohort 2 (refractory participants)
    Number of subjects analysed
    18
    13
    Units: percentage of participants
        number (confidence interval 95%)
    83.3 (58.6 to 96.4)
    61.5 (31.6 to 86.1)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Tested Positive for Anti-felzartamab Antibodies

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    End point title
    		 Percentage of Participants Tested Positive for Anti-felzartamab Antibodies
    End point description
    The IAS included all participants with at least one antidrug antibody (ADA) result available.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Cohort 1 (newly diagnosed or relapsed participants) Cohort 2 (refractory participants)
    Number of subjects analysed
    15
    13
    Units: percentage of participants
    number (not applicable)
        Baseline
    6.7
    7.7
        Post First Dose
    6.7
    0.0
    No statistical analyses for this end point

    Secondary: Antibody Titres of Participants Tested Positive for Anti-felzartamab Antibodies

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    End point title
    		 Antibody Titres of Participants Tested Positive for Anti-felzartamab Antibodies
    End point description
    The IAS included all participants with at least one ADA result available. Here, the number of subjects analyzed = the number of participants with positive ADA titers. 99999 = data not available (N/A).
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Cohort 1 (newly diagnosed or relapsed participants) Cohort 2 (refractory participants)
    Number of subjects analysed
    1
    1
    Units: anti-felzartamab antibody titres
    arithmetic mean (standard deviation)
        Baseline (n=1,1)
    13.10 ± 99999
    11.50 ± 99999
        Post First Dose (n=1,0)
    3.48 ± 99999
    99999 ± 99999
    No statistical analyses for this end point

    Secondary: Number of Participants Tested Positive for Anti-felzartamab Antibodies

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    End point title
    		 Number of Participants Tested Positive for Anti-felzartamab Antibodies
    End point description
    The Immunogenicity Analysis Set (IAS) included all participants with at least one antidrug antibody (ADA) result available.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Cohort 1 (newly diagnosed or relapsed participants) Cohort 2 (refractory participants)
    Number of subjects analysed
    15
    13
    Units: participants
        Baseline
    1
    1
        Post First Dose
    1
    0
    No statistical analyses for this end point

    Secondary: Felzartamab Serum Concentrations After Multiple Intravenous Administrations

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    End point title
    		 Felzartamab Serum Concentrations After Multiple Intravenous Administrations
    End point description
    The Pharmacokinetic Analysis Set (PKAS) included all participants with evaluable felzartamab serum concentration data. Here, "Subjects Analysed" is the number of participants evaluable for this outcome measure, and the row title shows the number of participants evaluated at each time point. 99999 = data not available (N/A).
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Cohort 1 (newly diagnosed or relapsed participants) Cohort 2 (refractory participants)
    Number of subjects analysed
    18 [3]
    13 [4]
    Units: nanogram(s)/millilitre (ng/mL)
    geometric mean (geometric coefficient of variation)
        Pre-dose Cycle 1 Day 1 (C1D1) (n=18,13)
    0.0 ± 0.0
    0.0 ± 0.0
        Post-dose C1D1 (n=18,13)
    323499.3 ± 98.3
    301417.5 ± 151.9
        Pre-dose C1D8 (n=17,11)
    89381.7 ± 97.9
    129924.9 ± 100.7
        Post-dose C1D8 (n=17,11)
    425669.4 ± 50.7
    429629.4 ± 91.7
        Pre-dose C1D15 (n=17,12)
    174658.7 ± 75.5
    189047.7 ± 80.9
        Post-dose C1D15 (n=16,12)
    456390.9 ± 70.6
    547940.5 ± 60.2
        Pre-dose C1D22 (n=17,11)
    185140.7 ± 78.0
    286607.9 ± 25.7
        Post-dose C1D22 (n=17,10)
    495612.5 ± 57.3
    656862.8 ± 29.7
        Pre-dose C2D1 (n=17,12)
    242903.4 ± 47.3
    148097.2 ± 193.7
        Post-dose C2D1 (n=16,11)
    474157.9 ± 108.0
    415814.9 ± 106.3
        Pre-dose C3D1 (n=17,12)
    34111.0 ± 164.7
    25879.8 ± 572.2
        Pre-dose C4D1 (n=13,11)
    19811.2 ± 218.1
    30655.9 ± 128.9
        Pre-dose C5D1 (n=14,9)
    27021.6 ± 152.0
    35176.1 ± 84.1
        Pre-dose C6D1 (n=14,8)
    28734.6 ± 116.9
    30383.0 ± 88.8
        End of Treatment (n=17,10)
    12367.0 ± 349.9
    33813.6 ± 61.9
        Follow-up visit (n=1,0)
    369.0 ± 99999
    99999 ± 99999
        End of Study (n=1,0)
    278.0 ± 99999
    99999 ± 99999
    Notes
    [3] - Geometric mean was not calculable when n=0. %CV was not calculable when n=0 or n=1.
    [4] - Geometric mean was not calculable when n=0. %CV was not calculable when n=0 or n=1.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with AEs During the Follow-up Period

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    End point title
    		 Percentage of Participants with AEs During the Follow-up Period
    End point description
    An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. The Safety Analysis Set included all participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Weeks 25 to 52
    End point values
    		 Cohort 1 (newly diagnosed or relapsed participants) Cohort 2 (refractory participants)
    Number of subjects analysed
    18
    13
    Units: Percentage of participants
        number (not applicable)
    44.4
    38.5
    No statistical analyses for this end point

    Secondary: Number of Participants with AEs During the Follow-up Period

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    End point title
    		 Number of Participants with AEs During the Follow-up Period
    End point description
    An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. The Safety Analysis Set included all participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Weeks 25 to 52
    End point values
    		 Cohort 1 (newly diagnosed or relapsed participants) Cohort 2 (refractory participants)
    Number of subjects analysed
    18
    13
    Units: participants
    8
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 52 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Cohort 1 Treatment Period
    Reporting group description
    		 Participants with newly diagnosed or relapsed membranous nephropathy

    Reporting group title
    Cohort 2 Post Treatment
    Reporting group description
    		 -

    Reporting group title
    Cohort 1 Post Treatment
    Reporting group description
    		 -

    Reporting group title
    Cohort 2 Treatment Period
    Reporting group description
    		 Participants with membranous nephropathy refractory to immunosuppressive treatment

    Serious adverse events
    		 Cohort 1 Treatment Period Cohort 2 Post Treatment Cohort 1 Post Treatment Cohort 2 Treatment Period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 13 (7.69%)
    1 / 18 (5.56%)
    3 / 13 (23.08%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Type I hypersensitivity
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1 Treatment Period Cohort 2 Post Treatment Cohort 1 Post Treatment Cohort 2 Treatment Period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 18 (83.33%)
    5 / 13 (38.46%)
    8 / 18 (44.44%)
    12 / 13 (92.31%)
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    Venous thrombosis limb
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    4 / 13 (30.77%)
         occurrences all number
    2
    1
    0
    7
    Chest pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    2 / 13 (15.38%)
         occurrences all number
    2
    0
    1
    4
    Fatigue
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    7
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    0
    2
    Asthenia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infusion site phlebitis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Malaise
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vaccination site pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Generalised oedema
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Immune system disorders
    Hypogammaglobulinaemia
         subjects affected / exposed
    7 / 18 (38.89%)
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    1 / 13 (7.69%)
         occurrences all number
    9
    0
    1
    1
    Drug hypersensitivity
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Immunisation reaction
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Reproductive system and breast disorders
    Pruritus genital
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    1
    0
    0
    2
    Cough
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    0
    0
    2
    Dysphonia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Confusional state
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Euphoric mood
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Lipase increased
         subjects affected / exposed
    3 / 18 (16.67%)
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
         occurrences all number
    5
    0
    1
    0
    Lymphocyte percentage decreased
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Blood immunoglobulin G decreased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haematocrit decreased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Monocyte count increased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Neutrophil count increased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    8 / 13 (61.54%)
         occurrences all number
    0
    0
    0
    8
    Animal bite
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye contusion
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Skin laceration
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 18 (16.67%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Carotid artery stenosis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Dysgeusia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Hyperaesthesia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lethargy
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Presyncope
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Decreased appetite
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    0
    0
    1
    Anaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 13 (7.69%)
    1 / 18 (5.56%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    1
    2
    Leukocytosis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lymphocytosis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lymphopenia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Increased tendency to bruise
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Eosinophilia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Vertigo positional
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Nausea
         subjects affected / exposed
    4 / 18 (22.22%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    13
    0
    0
    1
    Dry mouth
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Eructation
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    Dysphagia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    2
    Pancreatitis acute
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal impairment
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nephrotic syndrome
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 18 (16.67%)
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
         occurrences all number
    5
    0
    1
    0
    Back pain
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    4
    0
    0
    2
    Myalgia
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    0
    2
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Joint stiffness
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    4 / 13 (30.77%)
         occurrences all number
    0
    0
    1
    4
    COVID-19
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    2 / 18 (11.11%)
    2 / 13 (15.38%)
         occurrences all number
    2
    0
    2
    2
    Conjunctivitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal bacterial infection
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Hypoferritinaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Dehydration
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Iron deficiency
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gout
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 18 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Steroid diabetes
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 18 (5.56%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Oct 2019
    Updated inclusion/exclusion criteria; additional minor changes
    01 Jul 2020
    Inclusion and exclusion criteria were updated; planned total number of clinical trial sites and locations updated; other minor updates

    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.

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