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    Clinical Trial Results:
    A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations

    Summary
    EudraCT number
    		 2015-004359-32
    Trial protocol
    		 BG   PL  
    Global end of trial date
    18 Nov 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    08 Nov 2023
    First version publication date
    03 Dec 2020
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    • Correction of full data set
    To align with CT.gov results after resolving QA comments

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    230LE201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02847598
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biogen
    Sponsor organisation address
    225 Binney Street, Cambridge, United Kingdom,
    Public contact
    Biogen, Biogen Study Medical Director, clinicaltrials@biogen.com
    Scientific contact
    Biogen Study Medical Director, Biogen, clinicaltrials@biogen.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
    18 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part A: The primary objective of the study is to evaluate the efficacy of BIIB059 in reducing disease activity in systemic lupus erythematosus (SLE) subjects with active skin manifestations and joint involvement. Part B: The primary objective of the study is to evaluate the efficacy of BIIB059 in reducing disease activity in subjects with active cutaneous lupus erythematosus (CLE) (subacute cutaneous lupus erythematosus [SCLE] or chronic cutaneous lupus erythematosus [CCLE], including discoid lupus erythematosus [DLE]) with or without systemic manifestations.
    Protection of trial subjects
    Written informed consent was obtained from each subject or subject’s legally authorised representative (e.g., parent or legal guardian), as applicable, prior to evaluations performed for eligibility. Subjects or the subject’s legally authorised representative were given adequate time to review the information in the informed consent/assent and were allowed to ask, and have answered, questions concerning all portions of the conduct of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Oct 2016
    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
    Argentina: 19
    Country: Number of subjects enrolled
    Bulgaria: 21
    Country: Number of subjects enrolled
    Colombia: 15
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 3
    Country: Number of subjects enrolled
    Mexico: 23
    Country: Number of subjects enrolled
    Philippines: 47
    Country: Number of subjects enrolled
    Poland: 32
    Country: Number of subjects enrolled
    Serbia: 20
    Country: Number of subjects enrolled
    Taiwan: 9
    Country: Number of subjects enrolled
    Thailand: 16
    Country: Number of subjects enrolled
    United States: 56
    Worldwide total number of subjects
    264
    EEA total number of subjects
    53
    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)
    259
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects were enrolled at 129 investigative sites in Argentina, Bulgaria, Colombia, Israel, Korea, Mexico, Philippines, Poland, Serbia, Taiwan, Thailand, and the United States from October 20, 2016 to November 18, 2019.

    Pre-assignment
    Screening details
    		 A total of 264 subjects were enrolled in the study. The study had two periods, Part A (subjects with SLE with active skin manifestations and joint involvement) and Part B (subjects with active CLE, including DLE, with or without SLE).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A: Placebo
    Arm description
    		 Subjects with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo subcutaneously (SC) every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    BIIB059 matching placebo, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Arm title
    		 Part A: BIIB059 50 mg
    Arm description
    		 Subjects with SLE with active skin manifestations and joint involvement received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Litifilimab
    Investigational medicinal product code
    BIIB059
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Arm title
    		 Part A: BIIB059 150 mg
    Arm description
    		 Subjects with SLE with active skin manifestations and joint involvement received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Litifilimab
    Investigational medicinal product code
    BIIB059
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Arm title
    		 Part A: BIIB059 450 mg
    Arm description
    		 Subjects with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Litifilimab
    Investigational medicinal product code
    BIIB059
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Arm title
    		 Part B: Placebo
    Arm description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    BIIB059 matching placebo administered SC, every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Arm title
    		 Part B: BIIB059 50 mg
    Arm description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Litifilimab
    Investigational medicinal product code
    BIIB059
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Arm title
    		 Part B: BIIB059 150 mg
    Arm description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Litifilimab
    Investigational medicinal product code
    BIIB059
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Arm title
    		 Part B: BIIB059 450 mg
    Arm description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Litifilimab
    Investigational medicinal product code
    BIIB059
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Number of subjects in period 1
    		Part A: Placebo Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: BIIB059 450 mg Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Started
    56
    6
    6
    64
    33
    26
    25
    48
    Completed
    51
    6
    6
    60
    30
    23
    23
    44
    Not completed
    5
    0
    0
    4
    3
    3
    2
    4
         Adverse Event
    -
    -
    -
    -
    -
    -
    -
    1
         Death
    3
    -
    -
    -
    -
    -
    -
    -
         Lost to follow-up
    -
    -
    -
    -
    -
    1
    1
    -
         Consent withdrawn
    2
    -
    -
    4
    3
    2
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A: Placebo
    Reporting group description
    		 Subjects with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo subcutaneously (SC) every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Reporting group title
    Part A: BIIB059 50 mg
    Reporting group description
    		 Subjects with SLE with active skin manifestations and joint involvement received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Reporting group title
    Part A: BIIB059 150 mg
    Reporting group description
    		 Subjects with SLE with active skin manifestations and joint involvement received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Reporting group title
    Part A: BIIB059 450 mg
    Reporting group description
    		 Subjects with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Reporting group title
    Part B: Placebo
    Reporting group description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Reporting group title
    Part B: BIIB059 50 mg
    Reporting group description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Reporting group title
    Part B: BIIB059 150 mg
    Reporting group description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Reporting group title
    Part B: BIIB059 450 mg
    Reporting group description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Reporting group values
    		 Part A: Placebo Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: BIIB059 450 mg Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg Total
    Number of subjects
    		 56 6 6 64 33 26 25 48 132
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.4 ± 12.2 35.0 ± 14.4 40.8 ± 13.4 40.3 ± 11.4 43.4 ± 11.6 43.3 ± 15.3 43.6 ± 12.1 44.0 ± 12.6 -
    Sex: Female, Male
    Units: subjects
        Female
    		 49 6 5 63 30 20 20 36 229
        Male
    		 7 0 1 1 3 6 5 12 35
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 25 1 2 24 3 5 1 4 65
        Not Hispanic or Latino
    		 16 4 3 20 22 14 13 34 126
        Unknown or Not Reported
    		 15 1 1 20 8 7 11 10 73
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 8 0 0 5 0 0 0 0 13
        Asian
    		 13 4 2 12 14 7 6 17 75
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0 0 0
        Black or African American
    		 0 0 0 6 2 5 2 5 20
        White
    		 16 1 1 17 9 4 6 13 67
        Unknown or Not Reported
    		 15 1 1 20 8 7 11 10 73
        Other
    		 4 0 2 4 0 3 0 3 16

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Part A: Placebo
    Reporting group description
    		 Subjects with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo subcutaneously (SC) every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Reporting group title
    Part A: BIIB059 50 mg
    Reporting group description
    		 Subjects with SLE with active skin manifestations and joint involvement received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Reporting group title
    Part A: BIIB059 150 mg
    Reporting group description
    		 Subjects with SLE with active skin manifestations and joint involvement received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Reporting group title
    Part A: BIIB059 450 mg
    Reporting group description
    		 Subjects with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Reporting group title
    Part B: Placebo
    Reporting group description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Reporting group title
    Part B: BIIB059 50 mg
    Reporting group description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Reporting group title
    Part B: BIIB059 150 mg
    Reporting group description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Reporting group title
    Part B: BIIB059 450 mg
    Reporting group description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part A: Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 50 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 150 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 450 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part B: Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: BIIB059 50 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: BIIB059 150 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: BIIB059 450 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part A: Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 50 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 150 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 450 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 450 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 150 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 450 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 150 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 450 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 450 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 50 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 150 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 450 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 450 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part A: BIIB059 450 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.

    Subject analysis set title
    Part B: Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: BIIB059 50 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: BIIB059 150 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: BIIB059 450 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: BIIB059 50 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: BIIB059 150 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: BIIB059 450 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: BIIB059 50 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: BIIB059 450 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: BIIB059 50 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: BIIB059 150 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    Part B: BIIB059 450 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Subject analysis set title
    BIIB059
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Part A: Subjects with SLE with active skin manifestations and joint involvement received BIIB059 50 mg, 150 mg, 450 mg, and matching placebo SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20. Part B: Subjects with active CLE with or without systemic manifestations received BIIB059 50 mg, 150 mg, 450 mg, and matching placebo SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Primary: Part A: Change from Baseline in Active Joint Count (28-joint Assessment) to Week 24

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    End point title
    		 Part A: Change from Baseline in Active Joint Count (28-joint Assessment) to Week 24
    End point description
    An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week. Modified intent-to-treat (MITT) population included all randomised subjects in Part A who had received at least 1 dose of study treatment (whether or not the subjects adhered to the protocol). Here, '99999' signifies since only 1 subject was analysed, standard deviation (SD) was not evaluated.
    End point type
    Primary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Part A: Placebo Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: BIIB059 450 mg
    Number of subjects analysed
    41 [1]
    2 [2]
    1 [3]
    52 [4]
    Units: joints
        arithmetic mean (standard deviation)
    -12.7 ± 10.3
    -9.0 ± 5.7
    -13.0 ± 99999
    -14.5 ± 8.7
    Notes
    [1] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [2] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [3] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [4] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    Statistical analysis title
    		 Placebo vs BIIB059 450 mg
    Statistical analysis description
    A Mixed Effect Model Repeat Measurement (MMRM) model is performed, using treatment group, study visit, baseline corticosteroid usage level (<=10 mg, >10 mg), region, study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.
    Comparison groups
    Part A: Placebo v Part A: BIIB059 450 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.037
    Method
    		 MMRM
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.7
         upper limit
    		 -0.2

    Primary: Part B: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16

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    End point title
    		 Part B: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16
    End point description
    The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale(CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. MITT population included all randomised subjects in Part B who had received at least 1 dose of study treatment(whether or not the subjects adhered to the protocol).
    End point type
    Primary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    31 [5]
    23 [6]
    24 [7]
    42 [8]
    Units: percent change
        arithmetic mean (standard deviation)
    -15.03 ± 37.23
    -35.52 ± 33.35
    -47.11 ± 34.10
    -41.66 ± 37.33
    Notes
    [5] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [6] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [7] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [8] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    Statistical analysis title
    		 Placebo vs BIIB059 50 mg
    Statistical analysis description
    An MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (<=10 vs. >10) as fixed effect covariates.
    Comparison groups
    Part B: Placebo v Part B: BIIB059 50 mg
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.015
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -24.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -43.7
         upper limit
    		 -4.88
    Statistical analysis title
    		 Placebo vs BIIB059 150 mg
    Statistical analysis description
    An MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (<=10 vs. >10) as fixed effect covariates.
    Comparison groups
    Part B: Placebo v Part B: BIIB059 150 mg
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -33.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -52.71
         upper limit
    		 -14.12
    Statistical analysis title
    		 Placebo vs BIIB059 450 mg
    Statistical analysis description
    An MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (<=10 vs. >10) as fixed effect covariates.
    Comparison groups
    Part B: Placebo v Part B: BIIB059 450 mg
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -27.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.55
         upper limit
    		 -11.42

    Secondary: Part A: Percentage of Subjects with Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24

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    End point title
    		 Part A: Percentage of Subjects with Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24
    End point description
    CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Week 24. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. MITT population. "Number of subjects analyzed" signifies those with baseline CLASI-A >=8 following protocol amendment.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Part A: Placebo Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: BIIB059 450 mg
    Number of subjects analysed
    38
    6
    6
    39
    Units: percentage of subjects
        number (not applicable)
    42.11
    50.00
    16.67
    64.10
    No statistical analyses for this end point

    Secondary: Part B: Percentage of Subjects with Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16

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    End point title
    		 Part B: Percentage of Subjects with Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16
    End point description
    CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Weeks 12 and 16. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. MITT population. Here, "n" signifies number of subjects analysed at specific timepoint.
    End point type
    Secondary
    End point timeframe
    Week 12, Week 16
    End point values
    		 Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    33
    26
    25
    48
    Units: percentage of subjects
    number (not applicable)
        Week 12 (n= 33, 26, 25, 48)
    12.12
    38.46
    48.00
    37.50
        Week 16 (n= 32, 26, 25, 43)
    21.88
    38.46
    44.00
    46.51
    No statistical analyses for this end point

    Secondary: Part A: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24

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    End point title
    		 Part A: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24
    End point description
    The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. MITT population included all randomised subjects who had received at least 1 dose of study treatment (whether or not the subjects adhered to the protocol). Here, ‘n’ signifies number of subjects analysed at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 16 and 24
    End point values
    		 Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: BIIB059 450 mg Part A: Placebo
    Number of subjects analysed
    6 [9]
    6 [10]
    39 [11]
    38 [12]
    Units: percent change
    arithmetic mean (standard deviation)
        Change at Week 12 (n= 6, 6, 38, 37)
    -29.32 ± 14.66
    -8.39 ± 34.48
    -44.36 ± 39.69
    -36.63 ± 28.23
        Change at Week 16 (n= 6, 6, 38, 35)
    -41.76 ± 19.72
    -6.19 ± 21.31
    -50.20 ± 38.32
    -42.55 ± 32.46
        Change at Week 24 (n= 6, 6, 35, 35)
    -58.61 ± 35.16
    -17.92 ± 31.16
    -60.59 ± 37.36
    -45.40 ± 34.38
    Notes
    [9] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [10] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [11] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [12] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    Statistical analysis title
    		 Placebo vs BIIB059 450 mg
    Statistical analysis description
    Week 12: An MMRM model is performed, using treatment group study visit, baseline corticosteroid usage level (<=10 mg, >10 mg), region, study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.
    Comparison groups
    Part A: Placebo v Part A: BIIB059 450 mg
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.22
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -9.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.94
         upper limit
    		 6.08
    Statistical analysis title
    		 Placebo vs BIIB059 450 mg
    Statistical analysis description
    Week 16: An MMRM model is performed, using treatment group study visit, baseline corticosteroid usage level (<=10 mg, >10 mg), region, study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.
    Comparison groups
    Part A: Placebo v Part A: BIIB059 450 mg
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.293
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -8.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.82
         upper limit
    		 7.9
    Statistical analysis title
    		 Placebo vs BIIB059 450 mg
    Statistical analysis description
    Week 24: An MMRM model is performed, using treatment group study visit, baseline corticosteroid usage level (<=10 mg, >10 mg), region, study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.
    Comparison groups
    Part A: Placebo v Part A: BIIB059 450 mg
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.062
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -15.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.28
         upper limit
    		 0.79

    Secondary: Part B: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12

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    End point title
    		 Part B: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12
    End point description
    The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. MITT population included all randomised subjects in Part B who had received at least 1 dose of study treatment (whether or not the subjects adhered to the protocol).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    32 [13]
    23 [14]
    24 [15]
    44 [16]
    Units: percent change
        arithmetic mean (standard deviation)
    -10.73 ± 34.41
    -38.72 ± 32.99
    -47.82 ± 31.80
    -35.25 ± 35.77
    Notes
    [13] - "Number of Subjects Analysed" signifies number of subjects analysed in this endpoint.
    [14] - "Number of Subjects Analysed" signifies number of subjects analysed in this endpoint.
    [15] - "Number of Subjects Analysed" signifies number of subjects analysed in this endpoint.
    [16] - "Number of Subjects Analysed" signifies number of subjects analysed in this endpoint.
    Statistical analysis title
    		 Placebo vs BIIB059 50 mg
    Statistical analysis description
    An MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (<=10 vs. >10) as fixed effect covariates.
    Comparison groups
    Part B: Placebo v Part B: BIIB059 50 mg
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -30.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -48.75
         upper limit
    		 -11.97
    Statistical analysis title
    		 Placebo vs BIIB059 450 mg
    Statistical analysis description
    An MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (<=10 vs. >10) as fixed effect covariates.
    Comparison groups
    Part B: Placebo v Part B: BIIB059 450 mg
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -26.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -41.71
         upper limit
    		 -10.4
    Statistical analysis title
    		 Placebo vs BIIB059 150 mg
    Statistical analysis description
    An MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (<=10 vs. >10) as fixed effect covariates.
    Comparison groups
    Part B: Placebo v Part B: BIIB059 150 mg
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -37.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -55.46
         upper limit
    		 -18.87

    Secondary: Part A: Percentage of Subjects with a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24

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    End point title
    		 Part A: Percentage of Subjects with a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24
    End point description
    The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of subjects with a >=4-point reduction from baseline in CLASI-A score are reported here.MITT population included all randomised subjects who had received at least 1 dose of study treatment(whether or not the subjects adhered to the protocol).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Part A: Placebo Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: BIIB059 450 mg
    Number of subjects analysed
    38 [17]
    6 [18]
    6 [19]
    39 [20]
    Units: percentage of subjects
        number (not applicable)
    57.89
    83.66
    16.67
    71.79
    Notes
    [17] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [18] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [19] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [20] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    No statistical analyses for this end point

    Secondary: Part B: Percentage of Subjects with a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16

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    End point title
    		 Part B: Percentage of Subjects with a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16
    End point description
    The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of subjects with a >=4-point reduction from baseline in CLASI-A score are reported here. MITT population. Here, ‘n’ signifies number of subjects analysed at specific time point.
    End point type
    Secondary
    End point timeframe
    Week 12, Week 16
    End point values
    		 Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    33
    26
    25
    48
    Units: percentage of subjects
    number (not applicable)
        Week 12 (n= 33, 26, 25, 48)
    33.33
    50.00
    76.00
    47.92
        Week 16 (n= 32, 26, 25, 43)
    37.50
    46.15
    72.00
    55.81
    No statistical analyses for this end point

    Secondary: Part A: Percentage of Subjects with a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24

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    End point title
    		 Part A: Percentage of Subjects with a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24
    End point description
    The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of subjects with a >=7-point reduction from baseline in CLASI-A score are reported here.MITT population included all randomised subjects who had received at least 1 dose of study treatment(whether or not the subjects adhered to the protocol).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: BIIB059 450 mg Part A: Placebo
    Number of subjects analysed
    6 [21]
    6 [22]
    39 [23]
    38 [24]
    Units: percentage of subjects
        number (not applicable)
    66.67
    16.67
    56.41
    34.21
    Notes
    [21] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [22] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [23] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    [24] - "Number of subjects analyzed" signifies number of subject analysed in this endpoint.
    No statistical analyses for this end point

    Secondary: Part B: Percentage of Subjects with a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16

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    End point title
    		 Part B: Percentage of Subjects with a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16
    End point description
    The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of subjects with a >=7-point reduction from baseline in CLASI-A score are reported here. MITT population. Here, ‘n’ signifies number of subjects analysed at specific time point.
    End point type
    Secondary
    End point timeframe
    Week 12, Week 16
    End point values
    		 Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    33
    26
    25
    48
    Units: percentage of subjects
    number (not applicable)
        Week 12 (n= 33, 26, 25, 48)
    18.18
    38.46
    40.00
    33.33
        Week 16 (n= 32, 26, 25, 43)
    21.88
    30.77
    48.00
    41.86
    No statistical analyses for this end point

    Secondary: Part A: Percentage of Subjects Achieving a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) of >=4 at Week 24

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    End point title
    		 Part A: Percentage of Subjects Achieving a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) of >=4 at Week 24
    End point description
    An SRI-4 at Week 24 was a categorical response variable(Yes/No) incorporating the following criteria for achievement of responder status (all criteria must have been met to achieve responder status):A reduction from baseline of >=4 points in SLEDAI-2K,No new organ system affected, as defined by no new BILAG-2004 Grade A and no more than 1 new BILAG-2004 Grade B,No worsening from baseline in subject’s lupus disease activity, defined by a <1-point increase in the PGA(VAS) [on a scale of 0 to 10],No changes to protocol-specified medication rules,as follows(all criteria were required to be met):No initiation or increase of SLE standard of care therapy or other disallowed concomitant therapy;Concomitant corticosteroid dosage at Week 24 to be ≤10 mg/day;Concomitant corticosteroid dosage at Week 24 was no more than at Day 1;No increase in corticosteroid dose between Weeks 17 and 24.The percentage of subjects who had responded to each of the 4 criteria was reported. MITT population.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: Placebo Part A: BIIB059 450 mg
    Number of subjects analysed
    6
    6
    56
    64
    Units: percentage of subjects
        number (not applicable)
    33.33
    16.67
    28.57
    56.25
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24

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    End point title
    		 Part A: Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24 [25]
    End point description
    The SLEDAI-2K is a reliable, valid, simple, 1-page activity index that measures disease activity and records features of active lupus as present or not. It uses a weighted checklist to assign a numeric score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 28 days. Each symptom present is assigned between 1 and up to 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). MITT population included all randomised subjects in Part A who had received at least 1 dose of study treatment (whether or not the subjects adhered to the protocol).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analysed for Part A arm groups only.
    End point values
    		 Part A: Placebo Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: BIIB059 450 mg
    Number of subjects analysed
    50 [26]
    6 [27]
    3 [28]
    59 [29]
    Units: score on a scale
        arithmetic mean (standard deviation)
    -2.1 ± 3.3
    -3.0 ± 4.7
    -1.3 ± 2.4
    -4.4 ± 4.2
    Notes
    [26] - "Number of Subjects Analysed" signifies number of subjects analysed in this endpoint.
    [27] - "Number of Subjects Analysed" signifies number of subjects analysed in this endpoint.
    [28] - "Number of Subjects Analysed" signifies number of subjects analysed in this endpoint.
    [29] - "Number of Subjects Analysed" signifies number of subjects analysed in this endpoint.
    Statistical analysis title
    		 Placebo vs BIIB059 450 mg
    Statistical analysis description
    An MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (<=10 mg, >10 mg), region, study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.
    Comparison groups
    Part A: Placebo v Part A: BIIB059 450 mg
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 -0.5

    Secondary: Part A: Percentage of Subjects with No New Organ System Affected at Week 24

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    End point title
    		 Part A: Percentage of Subjects with No New Organ System Affected at Week 24
    End point description
    No new organ system affected, as defined by no new British Isles Lupus Activity Group (BILAG)-2004 A and no more than one new BILAG-2004 B. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity. MITT population included all randomised subjects in Part A who had received at least 1 dose of study treatment (whether or not the subjects adhered to the protocol).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: Placebo Part A: BIIB059 450 mg
    Number of subjects analysed
    6
    6
    56
    64
    Units: percentage of subjects
        number (not applicable)
    100.00
    50.00
    82.14
    85.94
    No statistical analyses for this end point

    Secondary: Part A: Change from baseline in Physician's Global Assessment (PGA) Visual Analog Scale (VAS) Score at Week 24

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    End point title
    		 Part A: Change from baseline in Physician's Global Assessment (PGA) Visual Analog Scale (VAS) Score at Week 24
    End point description
    The PGA is used to quantify disease activity and is measured using an anchored VAS. The PGA asks the Investigator to assess the subject’s current disease activity from a score of 0 (none) to 3 (severe), where higher score means severe SLE disease activity. MITT population included all randomised subjects in Part A who had received at least 1 dose of study treatment (whether or not the subjects adhered to the protocol).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: Placebo Part A: BIIB059 450 mg
    Number of subjects analysed
    6 [30]
    6 [31]
    49 [32]
    57 [33]
    Units: score on a scale
        arithmetic mean (standard deviation)
    -2.05 ± 1.18
    -0.12 ± 1.48
    -2.46 ± 2.13
    -2.45 ± 2.33
    Notes
    [30] - "Number of Subjects Analysed" signifies number of subjects analysed in this endpoint.
    [31] - "Number of Subjects Analysed" signifies number of subjects analysed in this endpoint.
    [32] - "Number of Subjects Analysed" signifies number of subjects analysed in this endpoint.
    [33] - "Number of Subjects Analysed" signifies number of subjects analysed in this endpoint.
    Statistical analysis title
    		 Placebo vs BIIB059 450 mg
    Statistical analysis description
    An MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (<=10 mg, >10 mg), region, study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.
    Comparison groups
    Part A: Placebo v Part A: BIIB059 450 mg
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.667
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.58

    Secondary: Part A: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Part A: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect. Safety population included all randomised subjects in Part A who had received at least one dose of randomised study treatment and was based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 36
    End point values
    		 Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: Placebo Part A: BIIB059 450 mg
    Number of subjects analysed
    6
    6
    56
    64
    Units: subjects
        AEs
    3
    6
    38
    36
        SAEs
    0
    1
    6
    3
    No statistical analyses for this end point

    Secondary: Part B: Number of Subjects with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Part B: Number of Subjects with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect. Safety population included all randomised subjects in Part B who had received at least one dose of randomised study treatment and was based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 28
    End point values
    		 Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    33
    26
    25
    48
    Units: subjects
        AEs
    22
    18
    15
    38
        SAEs
    3
    1
    3
    3
    No statistical analyses for this end point

    Secondary: Part A: Number of Subjects With Clinically Significant Laboratory Assessment Abnormalities

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    End point title
    		 Part A: Number of Subjects With Clinically Significant Laboratory Assessment Abnormalities
    End point description
    Safety population included all randomised subjects in Part A who had received at least one dose of randomised study treatment and was based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 36
    End point values
    		 Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: Placebo Part A: BIIB059 450 mg
    Number of subjects analysed
    6
    6
    56
    64
    Units: subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part B: Number of Subjects with Clinically Significant Laboratory Assessment Abnormalities

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    End point title
    		 Part B: Number of Subjects with Clinically Significant Laboratory Assessment Abnormalities
    End point description
    Safety population included all randomised subjects in Part B who had received at least one dose of randomised study treatment and was based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 28
    End point values
    		 Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    33
    26
    25
    48
    Units: subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part A: Number of Subjects With Clinically Significant Vital Sign Abnormalities

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    End point title
    		 Part A: Number of Subjects With Clinically Significant Vital Sign Abnormalities
    End point description
    Safety population included all randomised subjects in Part A who had received at least one dose of randomised study treatment and was based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 36
    End point values
    		 Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: Placebo Part A: BIIB059 450 mg
    Number of subjects analysed
    6
    6
    56
    64
    Units: subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part B: Number of Subjects with Clinically Significant Vital Sign Abnormalities

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    End point title
    		 Part B: Number of Subjects with Clinically Significant Vital Sign Abnormalities
    End point description
    Safety population included all randomised subjects in Part B who had received at least one dose of randomised study treatment and was based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 28
    End point values
    		 Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    33
    26
    25
    48
    Units: subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part A: Number of Subjects With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities

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    End point title
    		 Part A: Number of Subjects With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities
    End point description
    Safety population included all randomised subjects in Part A who had received at least one dose of randomised study treatment and was based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 36
    End point values
    		 Part A: BIIB059 50 mg Part A: Placebo Part A: BIIB059 150 mg Part A: BIIB059 450 mg
    Number of subjects analysed
    6
    56
    5
    64
    Units: subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part B: Number of Subjects with Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities

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    End point title
    		 Part B: Number of Subjects with Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities
    End point description
    Safety population included all randomised subjects in Part B who had received at least one dose of randomised study treatment and was based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 28
    End point values
    		 Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    33
    26
    25
    48
    Units: subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part A: Number of Subjects With Positive BIIB059 Antibodies

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    End point title
    		 Part A: Number of Subjects With Positive BIIB059 Antibodies
    End point description
    Safety population included all randomised subjects in Part A who had received at least one dose of randomised study treatment and was based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 24
    End point values
    		 Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: Placebo Part A: BIIB059 450 mg
    Number of subjects analysed
    6
    6
    56
    63
    Units: subjects
    0
    0
    1
    5
    No statistical analyses for this end point

    Secondary: Part B: Number of Subjects with Positive BIIB059 Antibodies

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    End point title
    		 Part B: Number of Subjects with Positive BIIB059 Antibodies
    End point description
    Safety population included all randomised subjects in Part B who had received at least one dose of randomised study treatment and was based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 16
    End point values
    		 Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg Part B: Placebo
    Number of subjects analysed
    26
    25
    48
    32
    Units: subjects
    5
    4
    5
    0
    No statistical analyses for this end point

    Secondary: Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels

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    End point title
    		 Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels
    End point description
    Safety population included all randomised subjects in Part A who had received at least one dose of randomised study treatment and was based on the actual treatment received. Here, ‘n’ signifies number of subjects analysed at specific time point and '99999' signifies no mean and SD were calculated due to 0 subjects in that particular arm at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 24
    End point values
    		 Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: Placebo Part A: BIIB059 450 mg
    Number of subjects analysed
    6
    6
    56
    64
    Units: grams per litre (g/L)
    arithmetic mean (standard deviation)
        Immunoglobulin A (IgA): Baseline (n= 6, 6, 56, 64)
    3.610 ± 0.730
    4.080 ± 1.537
    3.350 ± 1.862
    3.116 ± 1.682
        IgA: Change at Week 16 (n= 0, 0, 45, 54)
    99999 ± 99999
    99999 ± 99999
    0.033 ± 0.529
    -0.006 ± 0.305
        IgA: Change at Week 24 (n= 6, 6, 52, 59)
    -0.433 ± 1.188
    -0.057 ± 0.966
    -0.093 ± 0.704
    0.012 ± 0.505
        Immunoglobulin G (IgG): Baseline (n= 6, 6, 56, 64)
    15.723 ± 1.584
    17.620 ± 5.502
    14.423 ± 4.927
    14.792 ± 6.778
        IgG: Change at Week 16 (n= 0, 0, 45, 54)
    99999 ± 99999
    99999 ± 99999
    1.057 ± 2.832
    0.233 ± 2.478
        IgG: Change at Week 24 (n= 6, 6, 52, 59)
    -0.468 ± 1.333
    -0.790 ± 4.967
    0.874 ± 3.376
    0.758 ± 2.599
        Immunoglobulin M (IgM): Baseline (n= 6, 6, 56, 64)
    1.065 ± 0.507
    1.242 ± 0.718
    1.046 ± 0.657
    1.106 ± 0.953
        IgM: Change at Week 16 (n= 0, 0, 45, 54)
    99999 ± 99999
    99999 ± 99999
    0.004 ± 0.137
    -0.065 ± 0.294
        IgM: Change at Week 24 (n= 6, 6, 52, 59)
    -0.050 ± 0.113
    -0.150 ± 0.160
    -0.003 ± 0.191
    -0.072 ± 0.409
    No statistical analyses for this end point

    Secondary: Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels

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    End point title
    		 Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels
    End point description
    Safety population included all randomised subjects in Part B who had received at least one dose of randomised study treatment and was based on the actual treatment received. Here, ‘n’ signifies number of subjects analysed at specific time point and '99999' signifies no mean and SD were calculated due to 0 subjects in that particular arm at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 16
    End point values
    		 Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    33
    26
    25
    48
    Units: g/L
    arithmetic mean (standard deviation)
        IgA: Baseline (n= 33, 26, 25, 48)
    3.341 ± 1.113
    3.873 ± 1.663
    2.900 ± 1.705
    3.061 ± 1.413
        IgA: Change at Week 12 (n= 7, 0, 0, 14)
    -0.029 ± 0.249
    99999 ± 99999
    99999 ± 99999
    -0.304 ± 0.711
        IgA: Change at Week 16 (n= 25, 25, 25, 30)
    -0.045 ± 0.432
    -0.117 ± 0.356
    -0.016 ± 0.376
    -0.076 ± 0.254
        IgG: Baseline (n= 33, 26, 25, 48)
    13.480 ± 4.193
    14.087 ± 4.285
    13.700 ± 5.397
    14.874 ± 5.904
        IgG: Change at Week 12 (n= 7, 0, 0, 14)
    0.120 ± 0.662
    99999 ± 99999
    99999 ± 99999
    -1.961 ± 4.312
        IgG: Change at Week 16 (n= 25, 25, 25, 30)
    0.450 ± 3.366
    -0.776 ± 1.405
    -0.084 ± 3.975
    -0.064 ± 1.375
        IgM: Baseline (n= 33, 26, 25, 48
    0.978 ± 0.553
    0.880 ± 0.563
    1.095 ± 0.656
    0.993 ± 0.757
        IgM: Change at Week 12 (n= 7, 0, 0, 14)
    -0.009 ± 0.061
    99999 ± 99999
    99999 ± 99999
    -0.028 ± 0.096
        IgM: Change at Week 16 (n= 25, 25, 25, 30)
    -0.016 ± 0.125
    -0.072 ± 0.119
    -0.045 ± 0.217
    -0.035 ± 0.150
    No statistical analyses for this end point

    Secondary: Part A: Absolute Change From Baseline in Vaccine Titres - Streptococcus pneumoniae (S. pneumoniae) at Week 24

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    End point title
    		 Part A: Absolute Change From Baseline in Vaccine Titres - Streptococcus pneumoniae (S. pneumoniae) at Week 24
    End point description
    Vaccine-related immunoglobulin (Ig) titres for Pneumococcus (S. pneumoniae) were analysed, including 23 types of serotypes (sero). AB = Antibody. Safety population included all randomised subjects who had received at least one dose of randomised study treatment and was based on the actual treatment received. Here, ‘n’ signifies number of subjects analysed at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Part A: Placebo Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: BIIB059 450 mg
    Number of subjects analysed
    54
    6
    6
    63
    Units: milligrams per litre (mg/L)
    arithmetic mean (standard deviation)
        Sero 1 IgG AB: Baseline (n= 54, 6, 6, 63)
    2.017 ± 4.9787
    3.873 ± 3.8400
    2.705 ± 5.3558
    1.495 ± 3.3589
        Sero 1 IgG AB: Change at Week 24 (n= 51, 6, 6, 59)
    0.445 ± 1.9595
    0.055 ± 2.9840
    -0.565 ± 1.4395
    0.475 ± 3.5101
        Sero 2 IgG AB: Baseline (n= 54, 6, 6, 63)
    1.562 ± 2.4661
    5.715 ± 6.9239
    4.202 ± 4.8105
    1.626 ± 2.6861
        Sero 2 IgG AB: Change at Week 24 (n= 51, 6, 6, 59)
    0.014 ± 0.8316
    -1.648 ± 7.1790
    -1.975 ± 3.2500
    -0.011 ± 1.2676
        Sero 3 IgG AB: Baseline (n= 54, 6, 6, 63)
    1.2607 ± 1.77918
    2.1450 ± 2.39861
    1.2733 ± 0.96790
    1.6579 ± 3.35454
        Sero 3 IgG AB: Change at Week 24 (n= 51, 6, 6, 59)
    -0.0886 ± 0.75890
    -0.2017 ± 2.43817
    -0.2067 ± 1.39370
    0.8122 ± 3.62090
        Sero 4 IgG AB: Baseline (n= 54, 6, 6, 63)
    0.734 ± 1.2954
    2.602 ± 4.4908
    1.317 ± 1.5754
    0.429 ± 0.5696
        Sero 4 IgG AB: Change at Week 24 (n= 51, 6, 6, 59)
    -0.025 ± 0.5104
    -1.510 ± 4.9524
    -0.795 ± 1.6009
    0.060 ± 0.6525
        Sero 5 IgG AB: Baseline (n= 54, 6, 6, 63)
    4.921 ± 4.2218
    10.693 ± 17.4616
    13.507 ± 17.7231
    4.442 ± 3.9255
        Sero 5 IgG AB: Change at Week 24 (n= 51, 6, 6, 59)
    0.813 ± 3.9116
    -4.692 ± 19.3477
    -7.322 ± 16.4934
    0.329 ± 2.3390
        Sero 6B IgG AB: Baseline (n= 54, 6, 6, 63)
    3.348 ± 6.4940
    4.462 ± 4.1178
    4.458 ± 6.1968
    1.957 ± 2.7845
        Sero 6B IgG AB: Change at Week 24 (n=51, 6, 6, 59)
    -0.448 ± 2.4975
    -2.168 ± 5.1775
    -3.083 ± 5.3923
    0.070 ± 2.4772
        Sero 7F IgG AB: Baseline (n= 54, 6, 6, 63)
    6.4300 ± 10.99806
    8.5333 ± 7.97928
    7.0033 ± 8.53321
    3.0983 ± 6.90958
        Sero 7F IgG AB: Change at Week 24 (n=51, 6, 6, 59)
    -1.0336 ± 5.35192
    -1.3283 ± 7.23188
    -2.8917 ± 5.30027
    0.3053 ± 3.13517
        Sero 8 IgG AB: Baseline (n= 54, 6, 6, 63)
    3.1978 ± 7.08938
    3.1933 ± 3.01698
    2.6183 ± 3.21210
    1.5890 ± 4.46616
        Sero 8 IgG AB: Change at Week 24 (n= 51, 6, 6, 59)
    0.0925 ± 1.10700
    -1.3300 ± 3.85666
    -1.5483 ± 3.27227
    0.1281 ± 0.84548
        Sero 9N IgG AB: Baseline (n= 54, 6, 6, 63)
    1.781 ± 2.9291
    2.710 ± 3.7028
    2.810 ± 4.4518
    2.337 ± 4.6658
        Sero 9N IgG AB: Change at Week 24 (n=51, 6, 6, 59)
    0.217 ± 1.7957
    -1.327 ± 3.8703
    -0.907 ± 2.8144
    0.499 ± 4.0782
        Sero 9V IgG AB: Baseline (n= 54, 6, 6, 63)
    1.0274 ± 1.44706
    1.8300 ± 3.00647
    1.5900 ± 1.79117
    2.2696 ± 4.71508
        Sero 9V IgG AB: Change at Week 24 (n=51, 6, 6, 59)
    0.3963 ± 1.70256
    -0.0767 ± 0.64252
    -0.5750 ± 1.02039
    0.6701 ± 4.70300
        Sero 10A IgG AB: Baseline (n= 54, 6, 6, 63)
    6.443 ± 5.8006
    17.847 ± 32.7160
    14.040 ± 14.0133
    7.631 ± 8.2417
        Sero 10A IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    0.502 ± 7.1412
    -8.062 ± 36.3708
    0.100 ± 9.5476
    -0.384 ± 5.8464
        Sero 11A IgG AB: Baseline (n= 54, 6, 6, 63)
    1.768 ± 1.9872
    3.203 ± 3.6280
    4.095 ± 4.7768
    2.308 ± 3.0647
        Sero 11A IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    0.241 ± 1.1929
    -1.615 ± 4.5191
    -0.782 ± 5.3918
    -0.276 ± 1.6589
        Sero 12F IgG AB: Baseline (n= 54, 6, 6, 63)
    0.852 ± 2.5002
    2.355 ± 3.5388
    2.077 ± 2.0373
    0.262 ± 0.3381
        Sero 12F IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    0.060 ± 0.8496
    -1.648 ± 3.7849
    -1.220 ± 1.7397
    -0.072 ± 0.1772
        Sero 14 IgG AB: Baseline (n= 54, 6, 6, 63)
    7.910 ± 11.3177
    13.982 ± 16.1988
    8.167 ± 9.5488
    5.183 ± 6.5611
        Sero 14 IgG AB: Change at Week 24 (n=51, 6, 6, 59)
    -0.635 ± 6.6892
    -7.027 ± 19.5245
    -0.798 ± 7.1605
    0.597 ± 3.6401
        Sero 15B IgG AB: Baseline (n= 54, 6, 6, 63)
    3.926 ± 5.7931
    6.287 ± 7.4576
    4.332 ± 4.0216
    3.690 ± 5.3754
        Sero 15B IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    0.603 ± 5.1284
    -2.262 ± 9.1738
    -1.607 ± 4.1148
    -0.341 ± 2.2893
        Sero 17F IgG AB: Baseline (n= 54, 6, 6, 63)
    4.817 ± 5.7702
    11.422 ± 16.0156
    11.952 ± 10.2915
    4.277 ± 4.8458
        Sero 17F IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    0.427 ± 4.6695
    -6.123 ± 17.3744
    -5.898 ± 9.5001
    1.330 ± 4.8122
        Sero 18C IgG AB: Baseline (n= 54, 6, 6, 63)
    3.229 ± 4.8212
    3.475 ± 2.2460
    2.980 ± 1.8997
    2.485 ± 3.8363
        Sero 18C IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    -0.096 ± 2.8194
    -1.172 ± 2.2061
    -0.915 ± 1.0038
    0.054 ± 2.2468
        Sero 19A IgG AB: Baseline (n= 54, 6, 6, 63)
    15.2372 ± 11.46102
    35.2000 ± 58.79083
    50.3175 ± 56.06189
    14.9554 ± 11.40262
        Sero 19A IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    2.2418 ± 6.97357
    -18.0750 ± 61.75995
    -29.3558 ± 44.83082
    4.0988 ± 9.00464
        Sero 19F IgG AB: Baseline (n= 54, 6, 6, 63)
    4.203 ± 6.4231
    10.857 ± 14.6665
    8.353 ± 8.4621
    2.609 ± 3.1856
        Sero 19F IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    0.651 ± 3.5642
    -6.447 ± 16.0973
    -3.673 ± 8.5727
    1.136 ± 3.2837
        Sero 20 IgG AB: Baseline (n= 54, 6, 6, 63)
    5.4506 ± 6.82628
    26.7958 ± 45.54328
    21.8742 ± 22.32961
    4.0902 ± 4.01659
        Sero 20 IgG AB: Change at Week 24 (n=51, 6, 6, 59)
    0.0455 ± 4.96426
    -21.4475 ± 46.04992
    -13.0942 ± 16.16771
    1.2437 ± 2.42526
        Sero 22F IgG AB: Baseline (n= 54, 6, 6, 63)
    1.563 ± 2.0162
    5.743 ± 10.5586
    5.525 ± 6.4123
    1.138 ± 1.6187
        Sero 22F IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    0.244 ± 1.8324
    -4.000 ± 11.1710
    -3.657 ± 6.6997
    0.087 ± 0.9350
        Sero 23F IgG AB: Baseline (n= 54, 6, 6, 63)
    1.401 ± 2.0138
    1.897 ± 1.3080
    0.685 ± 0.3293
    1.797 ± 2.7461
        Sero 23F IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    0.078 ± 1.0468
    -0.150 ± 1.3425
    0.190 ± 0.4725
    0.125 ± 1.8192
        Sero 33F IgG AB: Baseline (n= 54, 6, 6, 63)
    2.610 ± 4.4802
    6.600 ± 12.2931
    5.630 ± 5.3371
    1.800 ± 2.2552
        Sero 33F IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    -0.392 ± 1.7998
    -5.042 ± 12.7997
    -3.740 ± 4.4122
    0.066 ± 1.1380
    No statistical analyses for this end point

    Secondary: Part B: Absolute Change From Baseline in Vaccine Titres - Streptococcus pneumoniae (S. pneumoniae) at Week 12

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    End point title
    		 Part B: Absolute Change From Baseline in Vaccine Titres - Streptococcus pneumoniae (S. pneumoniae) at Week 12
    End point description
    Vaccine-related immunoglobulin (Ig) titres for Pneumococcus (S. pneumoniae) were analysed, including 23 types of serotypes (sero). AB = Antibody. Safety population included all randomised subjects who had received at least one dose of randomised study treatment and was based on the actual treatment received. Here, ‘n’ signifies number of subjects analysed at specific time point, '9999' signifies since only 1 subject was analysed, SD was not evaluated and '99999' signifies no mean and SD were calculated due to 0 subjects in that particular arm at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    10
    1
    0 [34]
    21
    Units: mg/L
    arithmetic mean (standard deviation)
        Sero 1 IgG AB: Baseline (n= 10, 1, 0, 21)
    3.538 ± 6.0374
    0.210 ± 9999
    ±
    1.930 ± 2.6639
        Sero 1 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    4.193 ± 9.8131
    99999 ± 99999
    ±
    0.116 ± 0.4689
        Sero 2 IgG AB: Baseline (n= 10, 1, 0, 21)
    4.7775 ± 10.24616
    0.9900 ± 9999
    ±
    3.9669 ± 8.68701
        Sero 2 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    -0.4586 ± 0.72158
    99999 ± 99999
    ±
    -0.4734 ± 4.04649
        Sero 3 IgG AB: Baseline (n= 10, 1, 0, 21)
    3.881 ± 7.0122
    0.400 ± 9999
    ±
    1.133 ± 1.0457
        Sero 3 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    -1.886 ± 5.4670
    99999 ± 99999
    ±
    0.307 ± 0.7307
        Sero 4 IgG AB: Baseline (n= 10, 1, 0, 21)
    3.6185 ± 8.92846
    0.1000 ± 9999
    ±
    1.2376 ± 1.90643
        Sero 4 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    0.0571 ± 0.20934
    99999 ± 99999
    ±
    0.0450 ± 0.63581
        Sero 5 IgG AB: Baseline (n= 10, 1, 0, 21)
    7.2845 ± 10.00019
    3.3500 ± 9999
    ±
    5.0124 ± 5.83330
        Sero 5 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    4.4443 ± 7.54015
    99999 ± 99999
    ±
    3.4794 ± 5.30014
        Sero 6B IgG AB: Baseline (n= 10, 1, 0, 21)
    10.7965 ± 29.02953
    0.3600 ± 9999
    ±
    2.9210 ± 4.10508
        Sero 6B IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    0.2943 ± 0.63629
    99999 ± 99999
    ±
    0.2738 ± 1.49780
        Sero 7F IgG AB: Baseline (n= 10, 1, 0, 21)
    2.482 ± 3.0844
    0.660 ± 9999
    ±
    3.030 ± 2.6854
        Sero 7F IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    4.399 ± 10.6094
    99999 ± 99999
    ±
    0.796 ± 1.8650
        Sero 8 IgG AB: Baseline (n= 10, 1, 0, 21)
    3.6820 ± 3.59284
    0.2300 ± 9999
    ±
    2.6629 ± 3.61369
        Sero 8 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    1.5329 ± 4.51498
    99999 ± 99999
    ±
    0.5931 ± 1.32472
        Sero 9N IgG AB: Baseline (n= 10, 1, 0, 21)
    4.1090 ± 6.77642
    0.1300 ± 9999
    ±
    2.0848 ± 2.59536
        Sero 9N IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    3.3407 ± 8.56070
    99999 ± 99999
    ±
    0.5875 ± 1.62657
        Sero 9V IgG AB: Baseline (n= 10, 1, 0, 21)
    1.104 ± 1.2697
    0.070 ± 9999
    ±
    1.520 ± 2.4346
        Sero 9V IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    -0.001 ± 0.3491
    99999 ± 99999
    ±
    -0.181 ± 0.9893
        Sero 10A IgG AB: Baseline (n= 10, 1, 0, 21)
    6.760 ± 10.6571
    2.140 ± 9999
    ±
    6.600 ± 9.0014
        Sero 10A IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    1.833 ± 3.0611
    99999 ± 99999
    ±
    4.696 ± 13.8354
        Sero 11A IgG AB: Baseline (n= 10, 1, 0, 21)
    2.1860 ± 2.85529
    0.3500 ± 9999
    ±
    3.5831 ± 4.19998
        Sero 11A IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    0.6293 ± 3.04077
    99999 ± 99999
    ±
    0.6431 ± 1.74757
        Sero 12F IgG AB: Baseline (n= 10, 1, 0, 21)
    2.1680 ± 4.29056
    0.2700 ± 9999
    ±
    1.2424 ± 1.21257
        Sero 12F IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    1.1429 ± 2.54387
    99999 ± 99999
    ±
    0.3638 ± 0.72331
        Sero 14 IgG AB: Baseline (n= 10, 1, 0, 21)
    5.6435 ± 7.09870
    8.9000 ± 9999
    ±
    11.0210 ± 12.99039
        Sero 14 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    1.3686 ± 5.66545
    99999 ± 99999
    ±
    -1.0319 ± 3.43469
        Sero 15B IgG AB: Baseline (n= 10, 1, 0, 21)
    4.717 ± 9.7429
    1.430 ± 9999
    ±
    3.410 ± 3.5117
        Sero 15B IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    0.209 ± 0.2118
    99999 ± 99999
    ±
    0.624 ± 1.4874
        Sero 17F IgG AB: Baseline (n= 10, 1, 0, 21)
    16.0005 ± 15.82427
    17.4500 ± 9999
    ±
    6.8752 ± 9.02378
        Sero 17F IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    -2.0357 ± 4.29278
    99999 ± 99999
    ±
    1.4531 ± 1.4531
        Sero 18C IgG AB: Baseline (n= 10, 1, 0, 21)
    4.083 ± 6.6047
    0.140 ± 9999
    ±
    5.630 ± 7.8627
        Sero 18C IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    8.439 ± 21.2741
    99999 ± 99999
    ±
    0.077 ± 1.0131
        Sero 19A IgG AB: Baseline (n= 10, 1, 0, 21)
    24.5485 ± 44.24043
    13.7700 ± 9999
    ±
    16.5624 ± 15.27894
        Sero 19A IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    3.4457 ± 6.31401
    99999 ± 99999
    ±
    5.3575 ± 8.84223
        Sero 19F IgG AB: Baseline (n= 10, 1, 0, 21)
    4.1040 ± 5.50276
    2.0500 ± 9999
    ±
    3.3800 ± 3.26583
        Sero 19F IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    2.3893 ± 4.24918
    99999 ± 99999
    ±
    1.2275 ± 2.05550
        Sero 20 IgG AB: Baseline (n= 10, 1, 0, 21)
    11.5305 ± 18.12761
    0.7900 ± 9999
    ±
    8.2971 ± 8.28676
        Sero 20 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    -0.2271 ± 5.08362
    99999 ± 99999
    ±
    -1.6638 ± 6.48421
        Sero 22F IgG AB: Baseline (n= 10, 1, 0, 21)
    5.9930 ± 10.47744
    0.6700 ± 9999
    ±
    3.8002 ± 6.40547
        Sero 22F IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    -1.8500 ± 4.69494
    99999 ± 99999
    ±
    1.8431 ± 5.04651
        Sero 23F IgG AB: Baseline (n= 10, 1, 0, 21)
    1.6980 ± 2.81930
    0.5600 ± 9999
    ±
    1.9957 ± 2.72717
        Sero 23F IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    1.9964 ± 5.10312
    99999 ± 99999
    ±
    0.2775 ± 0.60481
        Sero 33F IgG AB: Baseline (n= 10, 1, 0, 21)
    5.500 ± 8.3404
    0.220 ± 9999
    ±
    4.245 ± 4.6106
        Sero 33F IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    -0.281 ± 0.4481
    99999 ± 99999
    ±
    0.203 ± 1.4614
    Notes
    [34] - 0 participants were available for analysis in this endpoint.
    No statistical analyses for this end point

    Secondary: Part A: Absolute Change From Baseline in Vaccine Titres - Clostridium tetani (C. tetani) and Diphtheria at Week 24

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    End point title
    		 Part A: Absolute Change From Baseline in Vaccine Titres - Clostridium tetani (C. tetani) and Diphtheria at Week 24
    End point description
    Vaccine-related immunoglobulin titres for tetanus and diphtheria were analysed. Safety population included all randomised subjects who had received at least one dose of randomised study treatment and was based on the actual treatment received. Here, ‘n’ signifies number of subjects analysed at specific time point. IU/mL = international units per millilitre.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Part A: Placebo Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: BIIB059 450 mg
    Number of subjects analysed
    54
    6
    6
    62
    Units: IU/mL
    arithmetic mean (standard deviation)
        C. tetani IgG Antibody: Baseline (n= 54, 6, 6, 62)
    2.46 ± 2.532
    1.73 ± 1.660
    2.52 ± 2.219
    3.30 ± 3.674
        C.tetani IgG Antibody:Change atWeek24(n=50,6,6,58)
    -0.07 ± 1.975
    0.07 ± 0.437
    1.07 ± 2.890
    -0.70 ± 2.398
        Diphtheria IgG Antibody: Baseline (n=54, 6, 6, 62)
    0.33 ± 0.511
    0.10 ± 0.089
    0.17 ± 0.163
    0.33 ± 0.444
        DiphtheriaIgGAntibody:Change atWeek24(n=50,6,6,58)
    -0.06 ± 0.266
    -0.03 ± 0.082
    0.07 ± 0.163
    -0.07 ± 0.340
    No statistical analyses for this end point

    Secondary: Part B: Absolute Change From Baseline in Vaccine Titres - Clostridium tetani (C. tetani) and Diphtheria at Week 12

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    End point title
    		 Part B: Absolute Change From Baseline in Vaccine Titres - Clostridium tetani (C. tetani) and Diphtheria at Week 12
    End point description
    Vaccine-related immunoglobulin (Ig) titres for tetanus and diphtheria were analysed. Safety population included all randomised subjects who had received at least one dose of randomised study treatment and was based on the actual treatment received. Here, ‘n’ signifies number of subjects analysed at specific time point, '9999' signifies since only 1 subject was analysed, SD was not evaluated and '99999' signifies no mean and SD were calculated due to 0 subjects in that particular arm at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    10
    1
    0 [35]
    21
    Units: IU/mL
    arithmetic mean (standard deviation)
        C. tetani IgG Antibody: Baseline (n= 10, 1, 0, 21)
    4.41 ± 3.469
    3.00 ± 9999
    ±
    5.04 ± 2.910
        C.tetani IgG Antibody:Change atWeek24(n=7,0,0,16)
    -0.61 ± 1.178
    99999 ± 99999
    ±
    1.20 ± 6.948
        Diphtheria IgG Antibody: Baseline (n=10, 1, 0, 21)
    0.46 ± 0.465
    0.10 ± 9999
    ±
    0.74 ± 1.027
        DiphtheriaIgGAntibody:Change atWeek24(n=7,0,0,16)
    -0.01 ± 0.146
    99999 ± 99999
    ±
    0.06 ± 0.875
    Notes
    [35] - 0 participants were available for analysis in this endpoint.
    No statistical analyses for this end point

    Secondary: Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels

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    End point title
    		 Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels
    End point description
    Safety population included all randomised subjects in Part A who had received at least one dose of randomised study treatment and was based on the actual treatment received. Here, ‘n’ signifies number of subjects analysed at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 24
    End point values
    		 Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: Placebo Part A: BIIB059 450 mg
    Number of subjects analysed
    6
    6
    56
    64
    Units: percent change
    arithmetic mean (standard deviation)
        IgA: Change at Week 16 (n= 0, 0, 45, 54)
    99999 ± 99999
    99999 ± 99999
    1.50 ± 11.91
    -0.53 ± 9.22
        IgA: Change at Week 24 (n= 6, 6, 52, 59)
    -15.55 ± 41.08
    -0.10 ± 18.22
    -1.51 ± 18.94
    -0.48 ± 12.94
        IgG: Change at Week 16 (n= 0, 0, 45, 54)
    99999 ± 99999
    99999 ± 99999
    7.30 ± 16.58
    2.63 ± 15.23
        IgG: Change at Week 24 (n= 6, 6, 52, 59)
    -2.53 ± 8.52
    -5.88 ± 23.39
    6.86 ± 19.20
    6.07 ± 16.44
        IgM: Change at Week 16 (n= 0, 0, 45, 54)
    99999 ± 99999
    99999 ± 99999
    0.96 ± 11.71
    -0.73 ± 40.24
        IgM: Change at Week 24 (n= 6, 6, 52, 59)
    -6.73 ± 12.57
    -14.99 ± 11.74
    1.86 ± 19.22
    0.87 ± 45.16
    No statistical analyses for this end point

    Secondary: Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels

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    End point title
    		 Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels
    End point description
    Safety population included all randomised subjects in Part B who had received at least one dose of randomised study treatment and was based on the actual treatment received. Here, ‘n’ signifies number of subjects analysed at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 16
    End point values
    		 Part B: BIIB059 150 mg Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    25
    33
    26
    48
    Units: percent change
    arithmetic mean (standard deviation)
        IgA: Change at Week 12 (n= 0, 7, 0, 14)
    99999 ± 99999
    -1.45 ± 7.14
    99999 ± 99999
    14.44 ± 14.44
        IgA: Change at Week 16 (n= 25, 25, 25, 30)
    0.19 ± 14.22
    12.92 ± 12.92
    -1.48 ± 10.13
    -2.98 ± 7.64
        IgG: Change at Week 12 (n= 0, 7, 0, 14)
    99999 ± 99999
    0.63 ± 5.76
    99999 ± 99999
    18.97 ± 18.97
        IgG: Change at Week 16 (n= 25, 25, 25, 30)
    1.05 ± 18.28
    2.48 ± 19.59
    -3.84 ± 11.14
    -0.39 ± 9.81
        IgM: Change at Week 12 (n= 0, 7, 0, 14)
    99999 ± 99999
    -1.25 ± 4.98
    99999 ± 99999
    18.25 ± 18.25
        IgM: Change at Week 16 (n= 25, 25, 25, 30)
    -1.25 ± 22.27
    -3.62 ± 10.84
    -7.60 ± 12.86
    -0.57 ± 11.85
    No statistical analyses for this end point

    Secondary: Part A: Percent Change From Baseline in Vaccine Titres at Week 24

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    End point title
    		 Part A: Percent Change From Baseline in Vaccine Titres at Week 24
    End point description
    Vaccine-related immunoglobulin (Ig) titres for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analysed. AB = Antibody. Safety population included all randomised subjects who had received at least one dose of randomised study treatment and was based on the actual treatment received. Here, ‘n’ signifies number of subjects analysed at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Part A: Placebo Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: BIIB059 450 mg
    Number of subjects analysed
    54
    6
    6
    63
    Units: percent change
    arithmetic mean (standard deviation)
        Sero 1 IgG AB: Change at Week 24 (n= 51, 6, 6, 59)
    53.629 ± 206.5979
    2.996 ± 56.3607
    -10.403 ± 40.9969
    159.298 ± 788.0577
        Sero 2 IgG AB: Change at Week 24 (n= 51, 6, 6, 59)
    -2.263 ± 52.3214
    17.857 ± 64.1746
    -26.089 ± 35.2991
    2.207 ± 57.5136
        Sero 3 IgG AB: Change at Week 24 (n= 51, 6, 6, 59)
    -10.854 ± 34.9399
    530.405 ± 1313.1947
    16.282 ± 89.2804
    51.000 ± 205.2211
        Sero 4 IgG AB: Change at Week 24 (n= 51, 6, 6, 59)
    -8.039 ± 43.2246
    -15.385 ± 70.4542
    -26.435 ± 50.4316
    26.481 ± 143.2057
        Sero 5 IgG AB: Change at Week 24 (n= 51, 6, 6, 59)
    13.293 ± 54.1115
    81.053 ± 156.0747
    2.937 ± 88.0683
    23.064 ± 57.0094
        Sero 6B IgG AB: Change at Week 24 (n=51, 6, 6, 59)
    -8.215 ± 36.4547
    -7.761 ± 68.3190
    -40.573 ± 28.7097
    34.204 ± 179.4443
        Sero 7F IgG AB: Change at Week 24 (n=51, 6, 6, 59)
    -7.560 ± 54.4647
    1.928 ± 90.5777
    -27.272 ± 30.2249
    19.827 ± 120.4336
        Sero 8 IgG AB: Change at Week 24 (n= 51, 6, 6, 59)
    13.540 ± 64.9487
    -14.917 ± 72.2397
    -19.919 ± 55.3947
    13.552 ± 54.9741
        Sero 9N IgG AB: Change at Week 24 (n=51, 6, 6, 59)
    13.302 ± 108.1678
    22.663 ± 111.5069
    2.985 ± 42.6740
    13.703 ± 137.0620
        Sero 9V IgG AB: Change at Week 24 (n=51, 6, 6, 59)
    32.983 ± 138.1448
    -3.399 ± 47.7558
    -13.591 ± 34.6936
    56.445 ± 189.5817
        Sero 10A IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    19.729 ± 111.4367
    101.031 ± 168.5588
    11.364 ± 51.7417
    24.321 ± 83.4616
        Sero 11A IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    51.134 ± 146.8640
    -16.656 ± 93.1140
    14.976 ± 131.8861
    18.956 ± 90.1198
        Sero 12F IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    -4.445 ± 72.6724
    -5.463 ± 105.9311
    -41.416 ± 37.8396
    -11.447 ± 58.0173
        Sero 14 IgG AB: Change at Week 24 (n=51, 6, 6, 59)
    -3.087 ± 55.1562
    -31.375 ± 69.5715
    2.213 ± 83.1715
    20.278 ± 136.8606
        Sero 15B IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    11.206 ± 116.7649
    17.353 ± 66.5358
    -5.380 ± 47.4598
    69.305 ± 570.5864
        Sero 17F IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    20.238 ± 90.3348
    1.009 ± 53.3534
    -29.346 ± 51.5854
    51.187 ± 152.3694
        Sero 18C IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    14.720 ± 64.9702
    -14.827 ± 57.5927
    -30.608 ± 35.7004
    43.454 ± 218.7604
        Sero 19A IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    21.433 ± 55.0044
    44.814 ± 73.1928
    -16.275 ± 73.1979
    32.146 ± 64.1971
        Sero 19F IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    54.691 ± 114.1882
    5.412 ± 83.2939
    -20.778 ± 54.8585
    101.397 ± 221.3435
        Sero 20 IgG AB: Change at Week 24 (n=51, 6, 6, 59)
    35.202 ± 90.9529
    -37.641 ± 33.1824
    -53.328 ± 21.6352
    75.407 ± 168.3388
        Sero 22F IgG AB:Change at Week 24 (n=51, 6, 6, 57)
    11.419 ± 127.0639
    23.828 ± 108.3336
    -27.150 ± 51.7944
    20.048 ± 139.8965
        Sero 23F IgG AB:Change at Week 24 (n=51, 6, 6, 59)
    0.215 ± 50.6348
    18.204 ± 57.8187
    35.862 ± 55.9954
    22.329 ± 156.8530
        Sero 33F IgG AB:Change at Week 24 (n=51, 6, 6, 58)
    2.245 ± 65.7260
    -3.348 ± 64.8128
    -47.069 ± 32.3779
    23.533 ± 102.5771
        C.tetani IgG Antibody:Change atWeek24(n=50,6,6,58)
    19.517 ± 194.1378
    39.032 ± 83.7958
    29.887 ± 80.9696
    -11.895 ± 48.3260
        DiphtheriaIgGAntibody:Change atWeek24(n=37,4,4,44)
    15.310 ± 141.4934
    -50.000 ± 70.7107
    77.083 ± 156.8461
    -8.842 ± 52.9312
    No statistical analyses for this end point

    Secondary: Part B: Percent Change From Baseline in Vaccine Titres at Week 12

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    End point title
    		 Part B: Percent Change From Baseline in Vaccine Titres at Week 12
    End point description
    Vaccine-related immunoglobulin (Ig) titres for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analysed. AB = Antibody. Safety population included all randomised subjects in Part B who had received at least one dose of randomised study treatment and was based on the actual treatment received. Here, ‘n’ signifies number of subjects analysed at specific time point, '9999' signifies since only 1 subject was analysed, SD was not evaluated and '99999' signifies no mean and SD were calculated due to 0 subjects in that particular arm at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    10
    1
    0 [36]
    21
    Units: percent change
    arithmetic mean (standard deviation)
        Sero 1 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    16.835 ± 59.1269
    99999 ± 99999
    ±
    4.257 ± 67.8533
        Sero 2 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    -20.725 ± 23.3306
    99999 ± 99999
    ±
    15.437 ± 65.9854
        Sero 3 IgG AB: Change at Week 12 (n= 7, 0, 0, 15)
    -3.370 ± 38.0473
    99999 ± 99999
    ±
    40.604 ± 72.3862
        Sero 4 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    6.349 ± 31.2778
    99999 ± 99999
    ±
    32.033 ± 125.5527
        Sero 5 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    39.578 ± 34.1628
    99999 ± 99999
    ±
    68.850 ± 127.9989
        Sero 6B IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    11.800 ± 36.9732
    99999 ± 99999
    ±
    43.759 ± 97.2095
        Sero 7F IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    67.784 ± 90.5075
    99999 ± 99999
    ±
    25.297 ± 48.3430
        Sero 8 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    28.981 ± 76.3568
    99999 ± 99999
    ±
    41.622 ± 84.8290
        Sero 9N IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    18.274 ± 61.3305
    99999 ± 99999
    ±
    19.616 ± 74.2945
        Sero 9V IgG AB: Change at Week 12 (n= 7, 0, 0, 15)
    -7.707 ± 27.1098
    99999 ± 99999
    ±
    -0.573 ± 35.9671
        Sero 10A IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    62.824 ± 94.6871
    99999 ± 99999
    ±
    60.437 ± 145.3385
        Sero 11A IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    12.392 ± 69.6069
    99999 ± 99999
    ±
    29.295 ± 118.2639
        Sero 12F IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    21.768 ± 44.1688
    99999 ± 99999
    ±
    62.768 ± 118.4103
        Sero 14 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    77.551 ± 191.9769
    99999 ± 99999
    ±
    18.059 ± 75.7757
        Sero 15B IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    14.160 ± 16.8040
    99999 ± 99999
    ±
    27.188 ± 56.4211
        Sero 17F IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    -14.128 ± 20.3094
    99999 ± 99999
    ±
    19.712 ± 69.9092
        Sero 18C IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    36.970 ± 99.7771
    99999 ± 99999
    ±
    8.882 ± 41.3781
        Sero 19A IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    15.179 ± 28.0371
    99999 ± 99999
    ±
    44.140 ± 113.5780
        Sero 19F IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    54.773 ± 49.4505
    99999 ± 99999
    ±
    46.995 ± 90.7514
        Sero 20 IgG AB: Change at Week 12 (n= 7, 0, 0, 16)
    1.131 ± 51.4091
    99999 ± 99999
    ±
    0.714 ± 49.6361
        Sero 22F IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    -14.748 ± 45.9399
    99999 ± 99999
    ±
    38.974 ± 83.4963
        Sero 23F IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    52.210 ± 75.6486
    99999 ± 99999
    ±
    16.859 ± 40.1773
        Sero 33F IgG AB:Change at Week 12 (n= 7, 0, 0, 16)
    0.600 ± 31.4400
    99999 ± 99999
    ±
    26.241 ± 66.5051
        C.tetani IgG Antibody:Change atWeek12(n=7,0,0,16)
    -6.387 ± 18.2069
    99999 ± 99999
    ±
    27.872 ± 128.3927
        DiphtheriaIgGAntibody:Change atWeek12(n=6,0,0,14)
    0.000 ± 34.0588
    99999 ± 99999
    ±
    28.845 ± 132.2208
    Notes
    [36] - 0 participants were available for analysis in this endpoint.
    No statistical analyses for this end point

    Secondary: Part A: Serum Concentration of BIIB059

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    End point title
    		 Part A: Serum Concentration of BIIB059 [37]
    End point description
    The PK population included the safety subjects who had at least 1 PK concentration measurement. The number analyzed is the number of subjects with data available for analysis at the specified time point. The number analyzed is the number of subjects with data available for analysis at the specified time point. Here '9999' signifies standard deviation was not estimable as only 1 subject was evaluated. Here '99999' signifies no mean and SD were calculated due to 0 subjects in that particular arm at specific time point.
    End point type
    Secondary
    End point timeframe
    Part A: pre-dose on Days 1, 29, 85 and 113 and post-dose on Days 1, 8, 29, 85, 169, 197 and 253
    Notes
    [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analysed for Part A BIIB059 arm groups.
    End point values
    		 Part A: BIIB059 50 mg Part A: BIIB059 150 mg Part A: BIIB059 450 mg
    Number of subjects analysed
    6
    6
    64
    Units: nanogram per milliliter (ng/mL)
    arithmetic mean (standard deviation)
        Day 1: Pre-dose (n= 6, 6, 64)
    0.0 ± 0.0
    0.0 ± 0.0
    0.0 ± 0.0
        Day 1: Post-dose (n= 6, 5, 51)
    0.7 ± 0.6
    2.1 ± 1.3
    1.9 ± 2.1
        Day 8 (n= 6, 6, 62)
    5.5 ± 2.0
    17.1 ± 4.1
    45.5 ± 16.5
        Day 29: Pre-dose (n= 6, 6, 61)
    7.0 ± 3.3
    23.7 ± 7.2
    53.6 ± 19.7
        Day 29: Post-dose (n= 6, 5, 60)
    7.9 ± 4.2
    25.9 ± 5.6
    52.5 ± 20.5
        Day 85: Pre-dose (n= 6, 6, 59)
    3.9 ± 1.6
    12.7 ± 3.7
    34.7 ± 19.1
        Day 85: Post-dose (n= 0, 0, 52)
    99999 ± 99999
    99999 ± 99999
    36.1 ± 20.8
        Day 113: Pre-dose (n= 6, 6, 59)
    3.4 ± 1.5
    11.3 ± 5.2
    34.6 ± 20.8
        Day 169 (n= 6, 4, 59)
    3.7 ± 1.5
    12.8 ± 4.8
    32.0 ± 18.6
        Day 197 (n= 4, 4, 56)
    0.9 ± 0.6
    4.1 ± 2.3
    12.6 ± 10.3
        Day 253 (n= 0, 1, 38)
    99999 ± 99999
    0.4 ± 9999
    2.8 ± 2.5
    No statistical analyses for this end point

    Secondary: Part B: Serum Concentration of BIIB059

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    End point title
    		 Part B: Serum Concentration of BIIB059 [38]
    End point description
    The PK population included the safety subjects who had at least 1 PK concentration measurement. Number analyzed is the number of subjects with data available for analysis at the specified time point.
    End point type
    Secondary
    End point timeframe
    Part B: pre-dose on Days 1, 29, 85 and post-dose on Days 1, 29, 85, 113, 141, 169 and 197
    Notes
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analysed for Part B BIIB059 arm groups.
    End point values
    		 Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Number of subjects analysed
    26
    25
    48
    Units: ng/mL
    arithmetic mean (standard deviation)
        Day 1: Pre-dose (n= 26, 25, 47)
    0.0 ± 0.1
    0.1 ± 0.2
    0.0 ± 0.1
        Day 1: Post-dose (n= 11, 17, 41)
    0.4 ± 0.3
    1.1 ± 1.1
    2.9 ± 3.7
        Day 8 (n= 26, 24, 27)
    6.8 ± 6.6
    13.3 ± 6.1
    47.8 ± 16.9
        Day 29: Pre-dose (n= 26, 24, 47)
    8.3 ± 7.1
    16.9 ± 9.1
    60.2 ± 23.3
        Day 29: Post-dose (n= 23, 24, 44)
    8.7 ± 6.6
    17.6 ± 10.2
    61.0 ± 24.2
        Day 85: Pre-dose (n= 22, 24, 29)
    3.8 ± 3.4
    11.0 ± 6.5
    42.0 ± 17.1
        Day 85: Post-dose (n= 21, 24, 29)
    4.1 ± 3.6
    11.6 ± 5.8
    42.0 ± 17.0
        Day 113 (n= 22, 25, 30)
    4.6 ± 5.9
    12.1 ± 6.5
    43.2 ± 14.3
        Day 141 (n= 14, 22, 44)
    2.5 ± 3.3
    4.6 ± 3.7
    19.3 ± 9.6
        Day 169 (n= 4, 12, 39)
    2.4 ± 2.0
    2.2 ± 1.1
    7.4 ± 5.0
        Day 197 (n= 2, 8, 35)
    0.8 ± 0.7
    1.1 ± 0.4
    3.4 ± 2.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Part A: up to Week 36, Part B: up to Week 28
    Adverse event reporting additional description
    Safety population included all the randomised subjects in Part A and B who had received at least one dose of randomised study treatment and was based on the actual treatment received. Data for safety was reported together for Parts A and B, by dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Part A: Placebo
    Reporting group description
    		 Subjects with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Reporting group title
    Part A: BIIB059 50 mg
    Reporting group description
    		 Subjects with SLE with active skin manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Reporting group title
    Part A: BIIB059 450 mg
    Reporting group description
    		 Subjects with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Reporting group title
    Part A: BIIB059 150 mg
    Reporting group description
    		 Subjects with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.

    Reporting group title
    Part B: Placebo
    Reporting group description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Reporting group title
    Part B: BIIB059 50 mg
    Reporting group description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Reporting group title
    Part B: BIIB059 150 mg
    Reporting group description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Reporting group title
    Part B: BIIB059 450 mg
    Reporting group description
    		 Subjects with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.

    Serious adverse events
    		 Part A: Placebo Part A: BIIB059 50 mg Part A: BIIB059 450 mg Part A: BIIB059 150 mg Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 56 (10.71%)
    0 / 6 (0.00%)
    3 / 64 (4.69%)
    1 / 6 (16.67%)
    3 / 33 (9.09%)
    1 / 26 (3.85%)
    3 / 25 (12.00%)
    3 / 48 (6.25%)
         number of deaths (all causes)
    3
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin angiosarcoma
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    1 / 64 (1.56%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    1 / 64 (1.56%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    1 / 64 (1.56%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    1 / 64 (1.56%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    1 / 64 (1.56%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal artery thrombosis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 26 (0.00%)
    2 / 25 (8.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parasitic gastroenteritis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic viral infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part A: Placebo Part A: BIIB059 50 mg Part A: BIIB059 450 mg Part A: BIIB059 150 mg Part B: Placebo Part B: BIIB059 50 mg Part B: BIIB059 150 mg Part B: BIIB059 450 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 56 (39.29%)
    3 / 6 (50.00%)
    22 / 64 (34.38%)
    6 / 6 (100.00%)
    19 / 33 (57.58%)
    16 / 26 (61.54%)
    10 / 25 (40.00%)
    28 / 48 (58.33%)
    Investigations
    Neutrophil count increased
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 6 (16.67%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    2 / 33 (6.06%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    4 / 64 (6.25%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    4
    0
    0
    0
    0
    0
    Repetitive strain injury
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
    3 / 48 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 56 (14.29%)
    1 / 6 (16.67%)
    1 / 64 (1.56%)
    1 / 6 (16.67%)
    3 / 33 (9.09%)
    6 / 26 (23.08%)
    0 / 25 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    9
    1
    1
    4
    4
    6
    0
    3
    Tension headache
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    1 / 64 (1.56%)
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 6 (0.00%)
    1 / 64 (1.56%)
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    1 / 64 (1.56%)
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    2 / 26 (7.69%)
    0 / 25 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    1
    0
    1
    1
    0
    2
    0
    2
    Injection site erythema
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    2 / 64 (3.13%)
    1 / 6 (16.67%)
    1 / 33 (3.03%)
    3 / 26 (11.54%)
    2 / 25 (8.00%)
    4 / 48 (8.33%)
         occurrences all number
    0
    0
    5
    2
    1
    5
    2
    6
    Injection site warmth
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Injection site pruritus
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
    3 / 48 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    4
    Injection site rash
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    3 / 48 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    3
    Pyrexia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    2 / 33 (6.06%)
    0 / 26 (0.00%)
    1 / 25 (4.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    0
    0
    0
    5
    0
    2
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Neutrophilia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 6 (16.67%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    2 / 33 (6.06%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 6 (16.67%)
    3 / 64 (4.69%)
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    3
    1
    3
    4
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 6 (16.67%)
    1 / 64 (1.56%)
    0 / 6 (0.00%)
    3 / 33 (9.09%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    1
    0
    3
    1
    0
    1
    Spigelian hernia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    2 / 26 (7.69%)
    1 / 25 (4.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    1
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 6 (16.67%)
    2 / 64 (3.13%)
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    1 / 26 (3.85%)
    3 / 25 (12.00%)
    1 / 48 (2.08%)
         occurrences all number
    2
    1
    2
    0
    1
    1
    3
    1
    Ecchymosis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Purpura
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 6 (16.67%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Cutaneous lupus erythematosus
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    4 / 33 (12.12%)
    1 / 26 (3.85%)
    1 / 25 (4.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    0
    0
    0
    4
    1
    1
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 6 (0.00%)
    2 / 64 (3.13%)
    1 / 6 (16.67%)
    2 / 33 (6.06%)
    1 / 26 (3.85%)
    2 / 25 (8.00%)
    3 / 48 (6.25%)
         occurrences all number
    2
    0
    2
    1
    2
    1
    2
    4
    Back pain
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    3 / 26 (11.54%)
    0 / 25 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    1 / 6 (16.67%)
    3 / 33 (9.09%)
    2 / 26 (7.69%)
    2 / 25 (8.00%)
    2 / 48 (4.17%)
         occurrences all number
    3
    0
    0
    2
    3
    2
    2
    2
    Myalgia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    2 / 33 (6.06%)
    1 / 26 (3.85%)
    1 / 25 (4.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    1
    2
    Infections and infestations
    Influenza
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 6 (0.00%)
    1 / 64 (1.56%)
    2 / 6 (33.33%)
    0 / 33 (0.00%)
    2 / 26 (7.69%)
    1 / 25 (4.00%)
    2 / 48 (4.17%)
         occurrences all number
    2
    0
    1
    2
    0
    2
    1
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 6 (16.67%)
    3 / 64 (4.69%)
    1 / 6 (16.67%)
    2 / 33 (6.06%)
    2 / 26 (7.69%)
    5 / 25 (20.00%)
    3 / 48 (6.25%)
         occurrences all number
    2
    4
    4
    1
    2
    2
    5
    3
    Sinusitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 26 (0.00%)
    2 / 25 (8.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    1
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 56 (10.71%)
    0 / 6 (0.00%)
    2 / 64 (3.13%)
    1 / 6 (16.67%)
    1 / 33 (3.03%)
    2 / 26 (7.69%)
    2 / 25 (8.00%)
    2 / 48 (4.17%)
         occurrences all number
    6
    0
    2
    1
    1
    2
    2
    2
    Urinary tract infection
         subjects affected / exposed
    4 / 56 (7.14%)
    0 / 6 (0.00%)
    4 / 64 (6.25%)
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    2 / 26 (7.69%)
    0 / 25 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    5
    0
    5
    1
    0
    2
    0
    1
    Cystitis
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 6 (16.67%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 6 (16.67%)
    0 / 64 (0.00%)
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 26 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 6 (0.00%)
    0 / 64 (0.00%)
    0 / 6 (0.00%)
    2 / 33 (6.06%)
    1 / 26 (3.85%)
    0 / 25 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 May 2017
    Part A was modified to evaluate the effects of a single dosing regimen of BIIB059 on the joint and skin manifestations of SLE. Joint symptoms are a common systemic component of SLE that have been shown to improve in the first 6 months of treatment, based on Phase 2 comparator data. With this change, Part A became a proof-of-concept study to evaluate whether BIIB059 works beyond the skin in SLE. Part B was modified to be a dose-ranging study of BIIB059 in CLE. The sample size for Part B was increased from 30 to 130 subjects to allow for a more thorough evaluation of the activity of BIIB059 in CLE observed in the Phase 1 study (2013-005361-39) and to identify an efficacious dose for CLE.
    11 Dec 2017
    Amended to inform the sites of the correct type of screening biopsy to be performed (i.e., punch biopsy, not shave biopsy). Note, Version 3 was retired due to errors in the text and was never distributed to the study sites.
    08 Feb 2018
    Errors was corrected that were inadvertently made in Table 1 (Schedule of Activities for Part A): • Erroneous footnotes (footnote 10 and footnote 12, Version 3 numbering) and corresponding footnote indicators were deleted from Table 1. The remaining footnotes were renumbered accordingly. • Footnote 13 (Version 3 numbering) was corrected to accurately reflect the instructions for Part A.
    15 Mar 2019
    To add an IA of efficacy and safety after the last subjects completed the double-blind treatment periods for Part A (at Week 24) and Part B (at Week 16).

    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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    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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