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    Clinical Trial Results:
    Safety of Abatacept in patients with interstitial lung disease and common variable immunodeficiency (CVID) and related disease

    Summary
    EudraCT number
    		 2015-002491-24
    Trial protocol
    		 DE  
    Global end of trial date
    26 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Feb 2020
    First version publication date
    23 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BMS-IM101-563
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 DRKS: DRKS00008783
    Sponsors
    Sponsor organisation name
    Medical Center - University of Freiburg
    Sponsor organisation address
    Hugstetter Str. 55, Freiburg, Germany, 79106
    Public contact
    Clinical Trials unit, Medical Center - University of Freiburg, +49 0761270-74040, sabine.schneider-fuchs@uniklinik-freiburg.de
    Scientific contact
    Clinical Trials unit, Medical Center - University of Freiburg, +49 0761270-74040, sabine.schneider-fuchs@uniklinik-freiburg.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
    26 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Sep 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety of Abatacept for interstitial lung disease in patients with CVID and related disorders
    Protection of trial subjects
    All AEs, no matter how intense, were followed up by the investigator in accordance with good clinical practice until resolved or judged no longer clinically relevant, or in case of a chronic condition, until it was fully characterized.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Between August 2016 and August 2017 10 patients were screened to take part in this study. All 10 patients were found eligible to take part and were enrolled in the trial.

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

    Arms
    Arm title
    		 Abatacept
    Arm description
    		 All patients were treated with a weekly dose of 125mg Abatacept s.c. for a period of 12 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abatacept
    Investigational medicinal product code
    Other name
    ORENCIA®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Abatacept solution for subcutaneous injection was supplied as a single-dose, ready-to-use, prefilled glass syringe with a passive needle safety guard. The prefilled syringe provided 125 mg of Abatacept in 1 ml. 125mg Abatacept was administered once weekly by subcutaneous injection.

    Number of subjects in period 1
    		Abatacept
    Started
    10
    Completed
    8
    Not completed
    2
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 10 10
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45 ( 13 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 5 5
    Subject analysis sets

    Subject analysis set title
    Per protocol population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The 'per protocol population' includes data from the 8 patients who completed the full 12-month treatment period (excludes 2 patients who terminated the trial prematurely).

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The saftey population includes all enrolled patients.

    Subject analysis sets values
    		 Per protocol population Safety population
    Number of subjects
    8
    10
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    8
    10
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42 ( 12 )
    45 ( 13 )
    Gender categorical
    Units: Subjects
        Female
    4
    5
        Male
    4
    5

    End points

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    End points reporting groups
    Reporting group title
    Abatacept
    Reporting group description
    		 All patients were treated with a weekly dose of 125mg Abatacept s.c. for a period of 12 months.

    Subject analysis set title
    Per protocol population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The 'per protocol population' includes data from the 8 patients who completed the full 12-month treatment period (excludes 2 patients who terminated the trial prematurely).

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The saftey population includes all enrolled patients.

    Primary: adverse events

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    End point title
    		 adverse events [1]
    End point description
    Number and type of severe infections under treatment. And number, type and severity of all other (serious) adverse events ((S)AE) in relation to study drug.
    End point type
    Primary
    End point timeframe
    From screening until end of follow-up.
    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: Due to the number of events and the design of the study, no statistical analyses of adverse events were performed.
    End point values
    		 Safety population
    Number of subjects analysed
    10
    Units: number
        SAEs
    6
        SAEs - related to treatment
    2
        total AEs
    50
        total AEs - related to treatment
    9
    No statistical analyses for this end point

    Secondary: Lung function - DLCOc/SB

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    End point title
    		 Lung function - DLCOc/SB
    End point description
    Primary efficacy endpoint was the change in lung function parameter DLCOc/SB [% predicted]. The mean fold-change of DLCOc/SB from baseline to final visit (month 12) is reported here.
    End point type
    Secondary
    End point timeframe
    12-month treatment period
    End point values
    		 Per protocol population
    Number of subjects analysed
    8
    Units: fold-change
        arithmetic mean (standard deviation)
    1.10 ( 0.12 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were documented from screening until end of follow-up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Abatacept
    Reporting group description
    		 All patients were treated with a weekly dose of 125mg Abatacept s.c. for a period of 12 months.

    Serious adverse events
    		 Abatacept
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 10 (40.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 10 (20.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 10 (20.00%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Abatacept
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 10 (100.00%)
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Interleukin-2 receptor increased
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 10 (20.00%)
         occurrences all number
    2
    Sciatica
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Impaired healing
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Eye disorders
    Photophobia
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 10 (20.00%)
         occurrences all number
    2
    Toothache
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Skin haemorrhage
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Infections and infestations
    Abscess jaw
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Diarrhoea infectious
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    2 / 10 (20.00%)
         occurrences all number
    2
    Oral herpes
         subjects affected / exposed
    2 / 10 (20.00%)
         occurrences all number
    2
    Rhinitis
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Salmonellosis
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 10 (60.00%)
         occurrences all number
    12
    Urinary tract infection
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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