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    Clinical Trial Results:
    A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated dose, Multicentre Phase IIa Proof-of-Concept Study with BT063 in Subjects with Systemic Lupus Erythematosus (BT063 in SLE)

    Summary
    EudraCT number
    		 2014-005526-35
    Trial protocol
    		 PL  
    Global end of trial date
    25 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    990
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02554019
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biotest AG
    Sponsor organisation address
    Landsteinerstr. 5, Dreieich, Germany, 63303
    Public contact
    Director Operations & Systems, Corporate Clinical Research & Development, Biotest AG, 49 61038010, peter.roettgen@biotest.com
    Scientific contact
    Director Operations & Systems, Corporate Clinical Research & Development, Biotest AG, 49 61038010, peter.roettgen@biotest.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
    25 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study has 2 parts. The primary objective of Part I of this study is to evaluate the safety and tolerability of 3 months of treatment with 50 mg BT063 versus placebo in subjects with SLE. The primary objective of Part II of this study is to evaluate the safety and tolerability of either 25 mg, 50, mg or 100 mg BT063 versus placebo in subjects with SLE. The dose level for Part II will be determined based on an interim analysis conducted after the last subject of Part I has completed the treatment.
    Protection of trial subjects
    After the end of the first 2-hour infusion of IMP (D0 [baseline]), the subject must stay at the investigational site for at least an additional 2 hours to enable monitoring for a type I hypersensitivity reaction. At all subsequent visits the subject should be observed for at least half an hour after the infusion of IMP. Adverse Events of Special Interest Adverse Events of special interest (AESI; serious or nonserious) are events that are of scientific and medical concern specific to the Sponsor’s product for which close monitoring and rapid communication by the investigator to the Sponsor is appropriate. For this study, the following AEs of special interest will be recorded: • Aphthous mouth ulcers (new, recurrent or aggravation of pre-existing lesions) • Any other GI ulcers or significant GI symptoms (e.g., pain, blood in stool, dyspepsia or similar)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Sep 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belarus: 9
    Country: Number of subjects enrolled
    Georgia: 6
    Country: Number of subjects enrolled
    Serbia: 7
    Country: Number of subjects enrolled
    Poland: 14
    Worldwide total number of subjects
    36
    EEA total number of subjects
    14
    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)
    33
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: 01 Sep 2015 to 05 Apr 2017. A total of 12 study sites enrolled subjects into the study in 4 countries: Georgia, Poland, Belarus, and Serbia.

    Pre-assignment
    Screening details
    		 Adult subjects had SLE as defined by ACR criteria such that ≥ 4 of the 11 criteria were met for ≥ 3 months before screening, moderate to severe SLE disease activity at screening and baseline demonstrated by SLEDAI-2K total score ≥ 6, including skin and joint involvement (CLASI ≥ 5 or at least 5 of 66/68 joints with pain and signs of inflammation)

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Subjects, investigators, and study personnel will remain blinded with regard to the randomized treatment assignment until after database lock. An interactive web response system (IWRS) will be implemented and used for randomization and IMP re supply.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BT063 Placebo
    Arm description
    		 End formulation buffer without BT063 drug product
    Arm type
    		 Placebo

    Investigational medicinal product name
    BT063 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The IMP was available in single-use vials containing 1.0 mL placebo. During Part I of the study, 1.0 mL IMP was diluted in 20 mL of a physiological sodium chloride solution (0.9% NaCl solution). During Part II 2.0 mL IMP was used. The diluted IMP was infused completely via a perfusor pump at an infusion rate of 10 mL/h.

    Arm title
    		 BT063 50mg
    Arm description
    		 BT063 provided as a sterile solution containing the IL-10 binding monoclonal antibody (mAb)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BT063 50 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    BT063 50mg: The IMP was available in single-use vials containing 1.0 mL BT063 (50mg/ml). During Part I of the study, 1.0 mL IMP was diluted in 20 mL of a physiological sodium chloride solution (0.9% NaCl solution). The diluted IMP was infused completely via a perfusor pump at an infusion rate of 10 mL/h.

    Arm title
    		 BT063 100mg
    Arm description
    		 BT063 will be provided as a sterile solution containing the IL-10 binding monoclonal antibody (mAb)
    Arm type
    		 Experimental

    Investigational medicinal product name
    BT063 100mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    BT063 100mg: The IMP was available in single-use vials containing 1.0 mL BT063 (50mg/ml). During Part II of the study, 2.0 mL IMP was diluted in 20 mL of a physiological sodium chloride solution (0.9% NaCl solution). The diluted IMP was infused completely via a perfusor pump at an infusion rate of 10 mL/h.

    Number of subjects in period 1
    		BT063 Placebo BT063 50mg BT063 100mg
    Started
    12
    12
    12
    Completed
    10
    10
    12
    Not completed
    2
    2
    0
         Consent withdrawn by subject
    2
    1
    -
         Adverse event, non-fatal
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BT063 Placebo
    Reporting group description
    		 End formulation buffer without BT063 drug product

    Reporting group title
    BT063 50mg
    Reporting group description
    		 BT063 provided as a sterile solution containing the IL-10 binding monoclonal antibody (mAb)

    Reporting group title
    BT063 100mg
    Reporting group description
    		 BT063 will be provided as a sterile solution containing the IL-10 binding monoclonal antibody (mAb)

    Reporting group values
    		 BT063 Placebo BT063 50mg BT063 100mg Total
    Number of subjects
    		 12 12 12 36
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    age of 18-75 years (inclusive)
    Units: years
        median (full range (min-max))
    		 43.5 (30 to 68) 35.5 (21 to 61) 53.0 (38 to 59) -
    Gender categorical
    Male or Female
    Units: Subjects
        Female
    		 12 10 11 33
        Male
    		 0 2 1 3
    Have a family history of lupus
    subject number and proportion, who had a family history of lupus, were collected
    Units: Subjects
        Yes
    		 1 0 0 1
        No
    		 10 11 11 32
        Unknown
    		 1 1 1 3
    Race
    Units: Subjects
        white
    		 12 12 12 36
    Subject analysis sets

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The safety set comprises all subjects who have received the study medication at least once.

    Subject analysis set title
    Intention-to-treat set:
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intention-to treat (ITT) set consists of all subjects who have received any study medication and have at least 1 post-baseline efficacy measurement.

    Subject analysis sets values
    		 Safety Set Intention-to-treat set:
    Number of subjects
    36
    36
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    age of 18-75 years (inclusive)
    Units: years
        median (full range (min-max))
    44.5 (21 to 68)
    44.5 (21 to 68)
    Gender categorical
    Male or Female
    Units: Subjects
        Female
    33
    33
        Male
    3
    3
    Have a family history of lupus
    subject number and proportion, who had a family history of lupus, were collected
    Units: Subjects
        Yes
    1
    1
        No
    32
    32
        Unknown
    3
    3
    Race
    Units: Subjects
        white
    36
    36

    End points

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    End points reporting groups
    Reporting group title
    BT063 Placebo
    Reporting group description
    		 End formulation buffer without BT063 drug product

    Reporting group title
    BT063 50mg
    Reporting group description
    		 BT063 provided as a sterile solution containing the IL-10 binding monoclonal antibody (mAb)

    Reporting group title
    BT063 100mg
    Reporting group description
    		 BT063 will be provided as a sterile solution containing the IL-10 binding monoclonal antibody (mAb)

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The safety set comprises all subjects who have received the study medication at least once.

    Subject analysis set title
    Intention-to-treat set:
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intention-to treat (ITT) set consists of all subjects who have received any study medication and have at least 1 post-baseline efficacy measurement.

    Primary: Incidence of AEs

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    End point title
    		 Incidence of AEs [1]
    End point description
    Incidence of AEs (including SAEs and AEs leading to discontinuation) from baseline (week 0) to week 14
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to week 14
    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: Explorative descriptive statistics were used for all variables. No statistical tests were performed.
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg Safety Set
    Number of subjects analysed
    12
    12
    12
    36
    Units: events
    14
    12
    32
    58
    No statistical analyses for this end point

    Primary: Changes in safety parameters

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    End point title
    		 Changes in safety parameters [2]
    End point description
    Changes from baseline in the following safety parameters were assessed: • Physical examinations • Vital signs • ECGs • Safety laboratory parameters (full blood count including white differential count, clinical chemistry, thyroid hormones, urinalysis, and faecal occult blood test) • Development of anti-drug antibodies against BT063 (anti-BT063) • Immunological status of potential viral and bacterial infections (HBV, HCV, HIV, tetanus, diphtheria tuberculosis) • EBV / CMV Serology • Premature withdrawals
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to week 14
    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: Explorative descriptive statistics were used for all variables. No statistical tests were performed.
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg Safety Set
    Number of subjects analysed
    12
    12
    12
    36
    Units: subject with any safety relevant change
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Subject with TEAEs

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    End point title
    		 Subject with TEAEs [3]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to week 14
    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: Explorative descriptive statistics were used for all variables. No statistical tests were performed.
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg Safety Set
    Number of subjects analysed
    12
    12
    12
    36
    Units: subjects
    8
    5
    8
    21
    No statistical analyses for this end point

    Primary: Subjects with TEAEs leading to early termination

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    End point title
    		 Subjects with TEAEs leading to early termination [4]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to week 14
    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: Explorative descriptive statistics were used for all variables. No statistical tests were performed.
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg Safety Set
    Number of subjects analysed
    12
    12
    12
    36
    Units: subjects
    0
    1
    0
    1
    No statistical analyses for this end point

    Primary: Subjects with treatment-emergent SAEs

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    End point title
    		 Subjects with treatment-emergent SAEs [5]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to week 14
    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: Explorative descriptive statistics were used for all variables. No statistical tests were performed.
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg Safety Set
    Number of subjects analysed
    12
    12
    12
    36
    Units: subjects
    0
    1
    1
    2
    No statistical analyses for this end point

    Primary: Subjects with drug-related TEAEs

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    End point title
    		 Subjects with drug-related TEAEs [6]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to week 14
    Notes
    [6] - 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: Explorative descriptive statistics were used for all variables. No statistical tests were performed.
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg Safety Set
    Number of subjects analysed
    12
    12
    12
    36
    Units: subjects
    0
    1
    2
    3
    No statistical analyses for this end point

    Primary: Subjects with severe TEAEs

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    End point title
    		 Subjects with severe TEAEs [7]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to week 28
    Notes
    [7] - 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: Explorative descriptive statistics were used for all variables. No statistical tests were performed.
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg Safety Set
    Number of subjects analysed
    12
    12
    12
    36
    Units: subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Subjects with TEAEs leading to death

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    End point title
    		 Subjects with TEAEs leading to death [8]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to week 14
    Notes
    [8] - 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: Explorative descriptive statistics were used for all variables. No statistical tests were performed.
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg Safety Set
    Number of subjects analysed
    12
    12
    12
    36
    Units: subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Subjects with 50% Improvement of Swollen/Tender Joints or in CLASI at Week 28

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    End point title
    		 Subjects with 50% Improvement of Swollen/Tender Joints or in CLASI at Week 28
    End point description
    subjects who had at least 50% improvement of swollen/tender joints or 50% improvement in CLASI score at week 28 for the ITT set
    End point type
    Secondary
    End point timeframe
    from baseline (week 0) to week 28
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    10
    11
    12
    Units: subjects
    6
    8
    7
    No statistical analyses for this end point

    Secondary: Subjects with 50% Improvement of Swollen/Tender Joints or in CLASI at Week 14

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    End point title
    		 Subjects with 50% Improvement of Swollen/Tender Joints or in CLASI at Week 14
    End point description
    Subjects who had at least 50% improvement of swollen/tender joints or 50% improvement in CLASI score at week 14 for the ITT set
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to End of Treatment Visit (week 14)
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    12
    12
    12
    Units: subjects
    6
    7
    7
    No statistical analyses for this end point

    Secondary: Subjects with 50% Improvement in Swollen Joints at week 14

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    End point title
    		 Subjects with 50% Improvement in Swollen Joints at week 14
    End point description
    Subjects with 50% improvement in swollen joints at week 14 for ITT set
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to End of Treatment Visit (week 14)
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    11
    12
    12
    Units: subjects
    8
    8
    5
    No statistical analyses for this end point

    Secondary: Subjects with 50% Improvement in Swollen Joints at week 28

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    End point title
    		 Subjects with 50% Improvement in Swollen Joints at week 28
    End point description
    subjects with 50% improvement in swollen joints from baseline to week 28 in swollen joints for ITT set
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 28
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    10
    11
    12
    Units: subjects
    7
    7
    4
    No statistical analyses for this end point

    Secondary: Subjects with 50% improvement in tender joints at week 14

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    End point title
    		 Subjects with 50% improvement in tender joints at week 14
    End point description
    Subjects with 50% improvement in tender joints from baseline to week 14 in tender joints for ITT set
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to End of Treatment Visit (week 14)
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    11
    12
    12
    Units: subjects
    6
    5
    7
    No statistical analyses for this end point

    Secondary: Subjects with 50% improvement in tender joints at week 28

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    End point title
    		 Subjects with 50% improvement in tender joints at week 28
    End point description
    subjects with 50% improvement in tender joints from baseline to week 28 in tender joints for ITT set
    End point type
    Secondary
    End point timeframe
    from baseline (week 0) to week 28
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    10
    11
    12
    Units: subjects
    6
    7
    6
    No statistical analyses for this end point

    Secondary: Subjects with 50% Improvement in CLASI Score at week 14

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    End point title
    		 Subjects with 50% Improvement in CLASI Score at week 14
    End point description
    Subjects who had at least 50% improvement in CLASI at week 14 for ITT set
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to End of Treatment Visit (week 14)
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    11
    12
    12
    Units: subjects
    3
    6
    5
    No statistical analyses for this end point

    Secondary: Subjects with 50% Improvement in CLASI Score at week 28

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    End point title
    		 Subjects with 50% Improvement in CLASI Score at week 28
    End point description
    Subjects who had at least 50% improvement in CLASI at week 28 for ITT set
    End point type
    Secondary
    End point timeframe
    from baseline (week 0) to week 28
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    10
    11
    12
    Units: subjects
    3
    7
    4
    No statistical analyses for this end point

    Secondary: SLEDAI-2K Responders at week 14

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    End point title
    		 SLEDAI-2K Responders at week 14
    End point description
    SLEDAI-2K Response was defined as subjects with more than a 3-point reduction from baseline in SLEDAI-2K score. SLEDAI-2K Responders at week 14 for ITT set
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to End of Treatment Visit (week 14)
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    11
    12
    12
    Units: subjects
    4
    5
    4
    No statistical analyses for this end point

    Secondary: SLEDAI-2K Responders at week 28

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    End point title
    		 SLEDAI-2K Responders at week 28
    End point description
    SLEDAI-2K Response was defined as subjects with more than a 3-point reduction from baseline in SLEDAI-2K score. SLEDAI-2K Responders at week 28 for ITT set
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 28
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    10
    11
    12
    Units: subjects
    3
    5
    7
    No statistical analyses for this end point

    Secondary: BILAG Response and Partial Response at week 14

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    End point title
    		 BILAG Response and Partial Response at week 14
    End point description
    BILAG=British Isles Lupus Assessment Group Response was defined as loss of “A” or “B” scores in all systems without the development of any new “A” or “B” scores. Partial response was defined as a loss of “A” scores but with “B” scores persisting or developing while in treatment. Subjects with BILAG Response or Partial Response at week 14 for ITT set
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to End of Treatment Visit (week 14)
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    11
    12
    12
    Units: subjects
        Response
    2
    4
    2
        Partial Response
    6
    3
    8
        No Response
    3
    5
    2
    No statistical analyses for this end point

    Secondary: BILAG Response and Partial Response at week 28

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    End point title
    		 BILAG Response and Partial Response at week 28
    End point description
    BILAG=British Isles Lupus Assessment Group Response was defined as loss of “A” or “B” scores in all systems without the development of any new “A” or “B” scores. Partial response was defined as a loss of “A” scores but with “B” scores persisting or developing while in treatment. Subjects with BILAG Response or Partial Response at week 28 for ITT set
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 28
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    10
    11
    12
    Units: subjects
        Response
    2
    3
    2
        Partial Response
    6
    5
    8
        No Response
    2
    3
    2
    No statistical analyses for this end point

    Secondary: Percent Change in ECLAM from Baseline to week 14

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    End point title
    		 Percent Change in ECLAM from Baseline to week 14
    End point description
    Mean percent change from baseline in ECLAM scores at week 14
    End point type
    Secondary
    End point timeframe
    From Baseline (week 0) to End of Treatment (week 14)
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    11
    12
    12
    Units: percent changed score point
        arithmetic mean (standard deviation)
    -25.4 ( 32.47 )
    -15.5 ( 42.48 )
    -9.0 ( 48.05 )
    No statistical analyses for this end point

    Secondary: Percent Change in ECLAM from Baseline to week 28

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    End point title
    		 Percent Change in ECLAM from Baseline to week 28
    End point description
    Mean percent change from baseline in ECLAM scores at week 28
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 28
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    10
    11
    12
    Units: percent changed score point
        arithmetic mean (standard deviation)
    -1.5 ( 46.46 )
    -42.1 ( 41.25 )
    -15.9 ( 48.24 )
    No statistical analyses for this end point

    Secondary: Classified Disease Activity in Physician’s Global Assessment at week 14

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    End point title
    		 Classified Disease Activity in Physician’s Global Assessment at week 14
    End point description
    The proportion of subjects with no or mild or moderate or severe disease activity at week 14. The Physician’s Global Assessment of disease activity is based on a 100 mm visual analogue scale (VAS) with the following range and increments: Score Definition 0 No disease activity 1 Mild disease activity 2 Moderate disease activity 3 Severe disease activity
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to End of Treatment Visit (week 14)
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    12
    12
    12
    Units: Subjects
        No disease activity
    2
    3
    1
        Mild disease activity
    5
    3
    5
        Moderate disease activity
    4
    6
    6
        Severe disease activity
    0
    0
    0
        Missing
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Classified Disease Activity in Physician’s Global Assessment at Weeks 28

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    End point title
    		 Classified Disease Activity in Physician’s Global Assessment at Weeks 28
    End point description
    The proportion of subjects with no or mild or moderate or severe disease activity at week 28. The Physician’s Global Assessment of disease activity is based on a 100 mm visual analogue scale (VAS) with the following range and increments: Score Definition 0 No disease activity 1 Mild disease activity 2 Moderate disease activity 3 Severe disease activity
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 28
    End point values
    		 BT063 Placebo BT063 50mg BT063 100mg
    Number of subjects analysed
    12
    12
    12
    Units: Subjects
        No disease activity
    1
    3
    0
        Mild disease activity
    6
    5
    8
        Moderate disease activity
    3
    3
    3
        Severe disease activity
    0
    0
    1
        Missing
    2
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline (week 0) to week 28
    Adverse event reporting additional description
    An AE can be any unfavourable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE, that occurs from the first dose of study drug until week 28, is defined as a TEAE.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    BT063 Placebo
    Reporting group description
    		 End formulation buffer without BT063 drug product

    Reporting group title
    BT063 50mg
    Reporting group description
    		 BT063 provided as a sterile solution containing the IL-10 binding monoclonal antibody (mAb)

    Reporting group title
    BT063 100mg
    Reporting group description
    		 BT063 will be provided as a sterile solution containing the IL-10 binding monoclonal antibody (mAb)

    Serious adverse events
    		 BT063 Placebo BT063 50mg BT063 100mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Overdose
    Additional description: Post-treatment event; Baseline Date: 01-Mar-2017; Date of Last Administration: 24-May-2017; AE Onset/Resolution Date: 17-Aug-2017/ 30-Aug-2017 Severity: moderate Relationship: not related to study drug Outcome: resolved
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Synovitis
    Additional description: Post-treatment event; Baseline Date: 24-Feb-2016; Date of Last Administration: 18-May-2016; AE Onset/Resolution Date: 12-Jun-2016/20-Jun-2016 Severity: mild Relationship: not related to study drug Outcome: resolved
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopneumonia
    Additional description: Post-treatment event; Baseline Date: 01-Mar-2017; Date of Last Administration: 24-May-2017; AE Onset/Resolution Date: 27-Jul-2017/ 30-Aug-2017 Severity: moderate Relationship: not related to study drug Outcome: resolved
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         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
    		 BT063 Placebo BT063 50mg BT063 100mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 12 (66.67%)
    4 / 12 (33.33%)
    7 / 12 (58.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    2
    0
    1
    Venous occlusion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    2
    Fatigue
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    1
    Tenderness
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Pleurisy
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract inflammat
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Complement factor decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Bradycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Leukopenia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Anal fissure
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Aphthous stomatitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Nausea
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Periostitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Spinal pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    Demodicidosis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Erysipelas
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (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? 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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