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    Clinical Trial Results:
    A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)

    Summary
    EudraCT number
    		 2021-000665-32
    Trial protocol
    		 DE   ES   IT   PL   PT   NL   FR  
    Global end of trial date
    30 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Nov 2024
    First version publication date
    10 Nov 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    80202135SJS2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04968912
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.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
    30 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to evaluate the efficacy of nipocalimab versus placebo in subjects with primary Sjogren's syndrome (pSS).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Sep 2021
    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
    Germany: 30
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Japan: 7
    Country: Number of subjects enrolled
    Poland: 90
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Taiwan: 4
    Country: Number of subjects enrolled
    United States: 25
    Worldwide total number of subjects
    163
    EEA total number of subjects
    127
    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)
    147
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 163 subjects were enrolled, randomised (1:1:1 ratio) in this study and treated with either nipocalimab or placebo. Out of 163 subjects, 136 subjects completed the study.

    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
    		 Group 1: Placebo IV
    Arm description
    		 Subjects received placebo intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 22 along with standard of care treatments (SOC).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received placebo q2w from Week 0 through Week 22 along with SOC.

    Arm title
    		 Group 2: Nipocalimab 5 mg/kg IV
    Arm description
    		 Subjects received nipocalimab 5 milligrams per kilogram (mg/kg) IV infusion q2w from Week 0 through Week 22 along with SOC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nipocalimab
    Investigational medicinal product code
    Other name
    JNJ-80202135
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received nipocalimab 5 mg/kg q2w from Week 0 through Week 22 along with SOC.

    Arm title
    		 Group 3: Nipocalimab 15 mg/kg IV
    Arm description
    		 Subjects received nipocalimab 15 mg/kg IV infusion q2w from Week 0 through Week 22 along with SOC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nipocalimab
    Investigational medicinal product code
    Other name
    JNJ-80202135
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received nipocalimab 15 mg/kg q2w from Week 0 through Week 22 along with SOC.

    Number of subjects in period 1
    		Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Started
    56
    53
    54
    Completed
    46
    46
    44
    Not completed
    10
    7
    10
         Consent withdrawn by subject
    7
    4
    7
         Unspecified
    -
    1
    2
         No longer clinically benefited
    1
    1
    -
         Lost to follow-up
    2
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Placebo IV
    Reporting group description
    		 Subjects received placebo intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 22 along with standard of care treatments (SOC).

    Reporting group title
    Group 2: Nipocalimab 5 mg/kg IV
    Reporting group description
    		 Subjects received nipocalimab 5 milligrams per kilogram (mg/kg) IV infusion q2w from Week 0 through Week 22 along with SOC.

    Reporting group title
    Group 3: Nipocalimab 15 mg/kg IV
    Reporting group description
    		 Subjects received nipocalimab 15 mg/kg IV infusion q2w from Week 0 through Week 22 along with SOC.

    Reporting group values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV Total
    Number of subjects
    		 56 53 54 163
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 50 49 48 147
        From 65 to 84 years
    		 6 4 6 16
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.3 ( 12.6 ) 48.3 ( 11.83 ) 48.6 ( 12.07 ) -
    Title for Gender
    Units: subjects
        Female
    		 52 49 50 151
        Male
    		 4 4 4 12

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Placebo IV
    Reporting group description
    		 Subjects received placebo intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 22 along with standard of care treatments (SOC).

    Reporting group title
    Group 2: Nipocalimab 5 mg/kg IV
    Reporting group description
    		 Subjects received nipocalimab 5 milligrams per kilogram (mg/kg) IV infusion q2w from Week 0 through Week 22 along with SOC.

    Reporting group title
    Group 3: Nipocalimab 15 mg/kg IV
    Reporting group description
    		 Subjects received nipocalimab 15 mg/kg IV infusion q2w from Week 0 through Week 22 along with SOC.

    Primary: Change From Baseline in Clinical European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24

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    End point title
    		 Change From Baseline in Clinical European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24
    End point description
    In clinESSDAI, physician scores the systemic disease activity level on 11 organ-specific domains (constitutional, lymphadenopathy and lymphoma, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, and hematological), with each domain activity in 3 to 4 levels (no, low, moderate, high) according to their severity (0 = no disease activity; 3 or 4 = high disease activity). Each domain was assigned a weight between 1 and 7, and domain score was multiplied by domain weight. A higher score indicates worsening of the disease. Sum of the weighted domain scores is the overall score, which can range from 0 to 135. The full analysis set (FAS) included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    44
    42
    40
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -3.3 ( 4.72 )
    -3.8 ( 3.22 )
    -6.7 ( 4.50 )
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 53 and 54.
    Comparison groups
    Group 3: Nipocalimab 15 mg/kg IV v Group 1: Placebo IV
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.65
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.03
         upper limit
    		 -1.28
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 53.
    Comparison groups
    Group 2: Nipocalimab 5 mg/kg IV v Group 1: Placebo IV
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.681
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.34
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.71
         upper limit
    		 1.03

    Secondary: Percentage of Subjects With Improvement of Greater Than or Equal to (>=)4 Points From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Score (Minimal Clinically Important Improvement) at Week 24

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    End point title
    		 Percentage of Subjects With Improvement of Greater Than or Equal to (>=)4 Points From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Score (Minimal Clinically Important Improvement) at Week 24
    End point description
    ESSDAI was a validated tool used in clinical studies to measure systemic disease activity in subjects with primary Sjogren's syndrome. In ESSDAI, physician scores the systemic disease activity level on 12 organ-specific domains (constitutional, lymphadenopathy and lymphoma, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, and biological), with each domain activity in 3 to 4 levels (no, low, moderate, high) according to their severity (0 = no disease activity; 3 or 4 = high disease activity). Each domain was assigned a weight between 1 and 6, and domain score was multiplied by domain weight. Sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates worsening of disease. FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Percentage of subjects
        number (not applicable)
    28.6
    34.0
    46.3
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 54.
    Comparison groups
    Group 3: Nipocalimab 15 mg/kg IV v Group 1: Placebo IV
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.138
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportion
    Point estimate
    17.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 2.8
         upper limit
    		 32.7
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 53.
    Comparison groups
    Group 1: Placebo IV v Group 2: Nipocalimab 5 mg/kg IV
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.648
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportion
    Point estimate
    5.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -9.2
         upper limit
    		 20

    Secondary: Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 24

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    End point title
    		 Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 24
    End point description
    Change from baseline in ESSPRI score at Week 24 was reported. The ESSPRI was a patient-reported assessment of the severity of dryness, fatigue, and pain associated with primary sogrens syndrome. Subjects were asked to rate the severity of dryness, fatigue and pain over the past 2 weeks on a numeric rating scale (NRS), ranging from 0 “no symptom" to 10 “maximal imaginable" symptoms (dryness, fatigue, pain). Each domain was scored on scale of 0 to 10 (0 =no symptom at all and 10 = worst symptom imaginable). A total score was calculated as the mean of the 3 individual domain scores, where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10, where higher ESSPRI scores indicated more severe symptoms. The FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    44
    43
    41
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -1.8 ( 2.01 )
    -1.2 ( 1.90 )
    -2.3 ( 1.74 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Improvement of >=4 Points From Baseline in clinESSDAI Score (Minimal Clinically Important Improvement) at Week 24

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    End point title
    		 Percentage of Subjects With Improvement of >=4 Points From Baseline in clinESSDAI Score (Minimal Clinically Important Improvement) at Week 24
    End point description
    Percentage of subjects with improvement of >= 4 points from baseline in clinESSDAI score (minimal clinically important improvement) at Week 24 were reported. In clinESSDAI, physician scores the systemic disease activity level on 11 organ-specific domains (constitutional, lymphadenopathy and lymphoma, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, and hematological), with each domain activity in 3 to 4 levels (no, low, moderate, high) according to their severity (0 = no disease activity; 3 or 4 = high disease activity). A higher score indicates worsening of the disease. Each domain is assigned a weight between 1 and 7, and the domain score is multiplied by the domain weight. Sum of the weighted domain scores is the overall score, which can range from 0 to 135. FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Percentage of Subjects
        number (not applicable)
    33.9
    37.7
    51.9
    Statistical analysis title
    		 Statistical Analysis 6
    Statistical analysis description
    Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 54.
    Comparison groups
    Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.138
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportion
    Point estimate
    17.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 2.6
         upper limit
    		 33.2
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 53.
    Comparison groups
    Group 1: Placebo IV v Group 2: Nipocalimab 5 mg/kg IV
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.766
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportion
    Point estimate
    3.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -11.3
         upper limit
    		 18.9

    Secondary: Number of Subjects With Improvement of Greater Than or Equal to (>=)4 Points From Baseline in ESSDAI Score (Minimal Clinically Important Improvement) at Week 24

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    End point title
    		 Number of Subjects With Improvement of Greater Than or Equal to (>=)4 Points From Baseline in ESSDAI Score (Minimal Clinically Important Improvement) at Week 24
    End point description
    ESSDAI was a validated tool used in clinical studies to measure systemic disease activity in subjects with primary Sjogren's syndrome. In ESSDAI, physician scores the systemic disease activity level on 12 organ-specific domains (constitutional, lymphadenopathy and lymphoma, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, and biological), with each domain activity in 3 to 4 levels (no, low, moderate, high) according to their severity (0 = no disease activity; 3 or 4 = high disease activity). Each domain was assigned a weight between 1 and 6, and domain score was multiplied by domain weight. Sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates worsening of disease. FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Subjects
    16
    18
    25
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With ESSPRI Response Defined as a Decrease of one Point or a Decrease of >= 15 Percent (%) in the ESSPRI Score From Baseline (Minimal Clinically Important Improvement) at Week 24

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    End point title
    		 Percentage of Subjects With ESSPRI Response Defined as a Decrease of one Point or a Decrease of >= 15 Percent (%) in the ESSPRI Score From Baseline (Minimal Clinically Important Improvement) at Week 24
    End point description
    Percentage of subjects with ESSPRI response defined as a decrease of one point or a decrease of >= 15% from baseline (minimal clinically important improvement) at Week 24 was reported. The ESSPRI was a patient-reported assessment of the severity of dryness, fatigue, and pain associated with primary sjogren's syndrome. Subjects were asked to rate the severity of dryness, fatigue and pain over the past 2 weeks on a NRS, ranging from 0 “no symptom” to 10 “maximal imaginable" symptoms (dryness, fatigue, pain). Each domain was scored on scale of 0 to 10 (0 =no symptom at all and 10 = worst symptom imaginable). A total score was calculated as the mean of the 3 individual domain scores, where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10, where higher ESSPRI scores indicated more severe symptoms. The FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Percentage of Subjects
        number (not applicable)
    50.0
    39.6
    55.6
    Statistical analysis title
    		 Statistical Analysis 8
    Statistical analysis description
    Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 54.
    Comparison groups
    Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.788
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportion
    Point estimate
    5.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -10.1
         upper limit
    		 21.2
    Statistical analysis title
    		 Statistical Analysis 7
    Statistical analysis description
    Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 53.
    Comparison groups
    Group 1: Placebo IV v Group 2: Nipocalimab 5 mg/kg IV
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.28
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportion
    Point estimate
    -10.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -26
         upper limit
    		 5.2

    Secondary: Number of Subjects With Improvement of >=4 Points From Baseline in clinESSDAI Score (Minimal Clinically Important Improvement) at Week 24

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    End point title
    		 Number of Subjects With Improvement of >=4 Points From Baseline in clinESSDAI Score (Minimal Clinically Important Improvement) at Week 24
    End point description
    Number of subjects with improvement of >= 4 points from baseline in clinESSDAI score (minimal clinically important improvement) at Week 24 were reported. In clinESSDAI, physician scores the systemic disease activity level on 11 organ-specific domains (constitutional, lymphadenopathy and lymphoma, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, and hematological), with each domain activity in 3 to 4 levels (no, low, moderate, high) according to their severity (0 = no disease activity; 3 or 4 = high disease activity). A higher score indicates worsening of the disease. Each domain is assigned a weight between 1 and 7, and the domain score is multiplied by the domain weight. Sum of the weighted domain scores is the overall score, which can range from 0 to 135. FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Subjects
    19
    20
    28
    No statistical analyses for this end point

    Secondary: Number of Subjects With Disease Response According to the STAR Composite Score at Week 24

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    End point title
    		 Number of Subjects With Disease Response According to the STAR Composite Score at Week 24
    End point description
    Number of subjects with disease response according to the STAR composite score at Week 24 was reported. A STAR response is defined as a composite score of >=5 points in the 5 STAR domains, with weighting in parentheses: i) decrease of >=3 in clinESSDAI score (3), ii) decrease of >=1 point or >=15% from baseline in ESSPRI score (3), iii) abnormal Schirmer's test at baseline and an increase of >=5 millimetre (mm), or normal Schirmer's test at baseline and no change to abnormal, or abnormal ocular staining score at baseline and a decrease of >=2 points, or normal ocular staining score at baseline and no change to abnormal (1), iv) increase of >=25% in unstimulated whole saliva or any increase if score is 0 at baseline (1), v) decrease of >=25% in rheumatoid factor or decrease of >=10% in immunoglobulin G (IgG) (1). The FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Number
    22
    27
    34
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Disease Response According to the Sjögren's Tool for Assessing Response (STAR) Composite Score at Week 24

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    End point title
    		 Percentage of Subjects With Disease Response According to the Sjögren's Tool for Assessing Response (STAR) Composite Score at Week 24
    End point description
    Percentage of subjects with disease response according to the STAR composite score at Week 24 was reported. A STAR response is defined as a composite score of >=5 points in the 5 STAR domains, with weighting in parentheses: i) decrease of >=3 in clinESSDAI score (3), ii) decrease of >=1 point or >=15% from baseline in ESSPRI score (3), iii) abnormal Schirmer's test at baseline and an increase of >=5 millimetre (mm), or normal Schirmer's test at baseline and no change to abnormal, or abnormal ocular staining score at baseline and a decrease of >=2 points, or normal ocular staining score at baseline and no change to abnormal (1), iv) increase of >=25% in unstimulated whole saliva or any increase if score is 0 at baseline (1), v) decrease of >=25% in rheumatoid factor or decrease of >=10% in immunoglobulin G (IgG) (1). The FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Percentage of Subjects
        number (not applicable)
    39.3
    50.9
    63.0
    Statistical analysis title
    		 Statistical Analysis 10
    Statistical analysis description
    Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 54.
    Comparison groups
    Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportion
    Point estimate
    23.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 8.4
         upper limit
    		 38.9
    Statistical analysis title
    		 Statistical Analysis 9
    Statistical analysis description
    Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 53.
    Comparison groups
    Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.218
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportion
    Point estimate
    11.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.9
         upper limit
    		 27.2

    Secondary: Number of Subjects With ESSPRI Response Defined as a Decrease of one Point or a Decrease of >= 15 % in the ESSPRI Score From Baseline (Minimal Clinically Important Improvement) at Week 24

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    End point title
    		 Number of Subjects With ESSPRI Response Defined as a Decrease of one Point or a Decrease of >= 15 % in the ESSPRI Score From Baseline (Minimal Clinically Important Improvement) at Week 24
    End point description
    Number of subjects with ESSPRI response defined as a decrease of one point or a decrease of >= 15% from baseline (minimal clinically important improvement) at Week 24 was reported. The ESSPRI was a patient-reported assessment of the severity of dryness, fatigue, and pain associated with primary sjogren's syndrome. Subjects were asked to rate the severity of dryness, fatigue and pain over the past 2 weeks on a NRS, ranging from 0 “no symptom” to 10 “maximal imaginable" symptoms (dryness, fatigue, pain). Each domain was scored on scale of 0 to 10 (0 =no symptom at all and 10 = worst symptom imaginable). A total score was calculated as the mean of the 3 individual domain scores, where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10, where higher ESSPRI scores indicated more severe symptoms. The FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Subjects
    28
    21
    30
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an Improvement in Disease Activity Level (DAL) by >= 1 Level in at Least One clinESSDAI or ESSDAI Domain at Week 24

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    End point title
    		 Percentage of Subjects With an Improvement in Disease Activity Level (DAL) by >= 1 Level in at Least One clinESSDAI or ESSDAI Domain at Week 24
    End point description
    Percentage of subjects with improvement in DAL by >= 1 level in at least one clinESSDAI or ESSDAI domain at Week 24 was reported. In clinESSDAI, physician scores systemic disease activity level on 11 organ-specific domains (constitutional, lymphadenopathy and lymphoma, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, and hematological), with each domain activity in 3 to 4 levels (no, low, moderate, high) according to their severity (0 = no disease activity; 3 or 4 = high disease activity). A higher score indicates worsening of the disease. Each domain is assigned a weight between 1 and 7, and the domain score is multiplied by domain weight. Sum of the weighted domain scores is overall score, which can range from 0 to 135. FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Percentage of Subjects
        number (not applicable)
    33.9
    52.8
    53.7
    Statistical analysis title
    		 Statistical Analysis 12
    Statistical analysis description
    Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 54.
    Comparison groups
    Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.046
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportion
    Point estimate
    19.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 4.5
         upper limit
    		 35
    Statistical analysis title
    		 Statistical Analysis 11
    Statistical analysis description
    Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 53.
    Comparison groups
    Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.047
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportion
    Point estimate
    18.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 3.6
         upper limit
    		 34.2

    Secondary: Percentage of Subjects With Improvement From Baseline in >= 3 of 5 Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) Categories at Week 24

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    End point title
    		 Percentage of Subjects With Improvement From Baseline in >= 3 of 5 Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) Categories at Week 24
    End point description
    Percentage of subjects with Improvement from baseline in >= 3 of 5 CRESS categories at week 24 was reported. CRESS was a composite tool that incorporates measures of disease activity (clinESSDAI), symptoms (ESSPRI), glandular function and systemic inflammation to assess disease activity. A CRESS response was defined as a response in >=3 of the following 5 categories: i) clinESSDAI score <5 (low disease activity), ii) decrease of >=1 point or >=15% from baseline in ESSPRI score, iii) abnormal Schirmer's test at baseline (<=5 mm) and an increase of >=5 mm, or normal Schirmer's test at baseline and no change to abnormal, iv) increase of >=25% in unstimulated whole saliva or any increase if score is 0 at baseline, v) decrease of >=25% in rheumatoid factor or decrease of >=10% in IgG. The FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    at Week 24
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Percentage of Subjects
        number (not applicable)
    17.9
    43.4
    48.1
    Statistical analysis title
    		 Statistical Analysis 14
    Statistical analysis description
    Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 54.
    Comparison groups
    Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportion
    Point estimate
    30.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 16.3
         upper limit
    		 44.3
    Statistical analysis title
    		 Statistical Analysis 13
    Statistical analysis description
    Subjects analysed for both the treatments as per assigned treatment sequence in respective periods were 56 and 53.
    Comparison groups
    Group 1: Placebo IV v Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportion
    Point estimate
    25.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 11.5
         upper limit
    		 39.5

    Secondary: Number of Subjects With an Improvement in DAL by >= 1 Level in at Least One clinESSDAI or ESSDAI Domain at Week 24

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    End point title
    		 Number of Subjects With an Improvement in DAL by >= 1 Level in at Least One clinESSDAI or ESSDAI Domain at Week 24
    End point description
    Number of subjectS with improvement in DAL by >= 1 level in at least one clinESSDAI or ESSDAI domain at Week 24 was reported. In clinESSDAI, physician scores systemic disease activity level on 11 organ-specific domains (constitutional, lymphadenopathy and lymphoma, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, and hematological), with each domain activity in 3 to 4 levels (no, low, moderate, high) according to their severity (0 = no disease activity; 3 or 4 = high disease activity). A higher score indicates worsening of the disease. Each domain is assigned a weight between 1 and 7, and the domain score is multiplied by domain weight. Sum of the weighted domain scores is overall score, which can range from 0 to 135. FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Subjects
    19
    28
    29
    No statistical analyses for this end point

    Secondary: Number of Subjects With Improvement From Baseline in >= 3 of 5 CRESS Categories at Week 24

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    End point title
    		 Number of Subjects With Improvement From Baseline in >= 3 of 5 CRESS Categories at Week 24
    End point description
    Number of subjects with Improvement from baseline in >= 3 of 5 CRESS categories at week 24 was reported. CRESS was a composite tool that incorporates measures of disease activity (clinESSDAI), symptoms (ESSPRI), glandular function and systemic inflammation to assess disease activity. A CRESS response was defined as a response in >=3 of the following 5 categories: i) clinESSDAI score <5 (low disease activity), ii) decrease of >=1 point or >=15% from baseline in ESSPRI score, iii) abnormal Schirmer's test at baseline (<=5 mm) and an increase of >=5 mm, or normal Schirmer's test at baseline and no change to abnormal, iv) increase of >=25% in unstimulated whole saliva or any increase if score is 0 at baseline, v) decrease of >=25% in rheumatoid factor or decrease of >=10% in IgG. The FAS included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Subjects
    10
    23
    26
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events of Special Interests (AESIs)

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    End point title
    		 Number of Subjects With Adverse Events of Special Interests (AESIs)
    End point description
    Number of subjects with AESIs were reported. AEs was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. Treatment-emergent adverse events associated with the following situations are considered as AESIs: severe infections, severe hypoalbuminemia. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    Post first administration of study intervention (Week 0) up to 30 weeks
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Subjects
    1
    2
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as AEs with onset or worsening on or after date of first dose of study treatment. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    Post first administration of study intervention (Week 0) up to 30 weeks
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Subjects
    35
    42
    43
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Abnormalities in Vital Signs

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    End point title
    		 Number of Subjects With Clinically Significant Abnormalities in Vital Signs
    End point description
    Number of subject with clinically significant abnormalities in vital signs were reported. Vital sign parameters including temperature (less than [<]36 and greater than [>] 38), pulse rate (<=50 beats per minute [bpm] and with >=15 bpm decrease from baseline and >=120 bpm and with >=15 bpm increase from baseline), and blood pressure (systolic blood pressure [SBP]: <=90 millimeters of mercury [mmHg] and with >=20 mmHg decrease from baseline and diastolic blood pressure [DBP]: <=50 mmHg and with >=15 mmHg decrease from baseline and >=100 mmHg and with >=15 mmHg increase from baseline). The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. Only those categories in which at least 1 subject had data were reported.
    End point type
    Secondary
    End point timeframe
    post first administration of study intervention (Week 0) up to 30 weeks
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Subjects
        Pulse: =<50 bpm and with =>15 bpm
    0
    1
    0
        Pulse:>=120 bpm and with >=15 bpm
    0
    0
    0
        SBP: <=90 mmHg and with >=20 mmHg
    3
    1
    1
        SBP: >=160 mmHg and with >=20 mmHg
    0
    0
    2
        DBP: <=50 mmHg and with >=15 mmHg
    1
    1
    0
        DBP: >=100 mmHg and with >=15 mmHg
    0
    0
    1
        Temperature: <36
    5
    4
    6
        Temperature: > 38
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With TEAEs Leading to Treatment Discontinuation

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    End point title
    		 Number of Subjects With TEAEs Leading to Treatment Discontinuation
    End point description
    Number of subjects with TEAEs leading to treatment discontinuation were reported. AEs was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    Post first administration of study intervention (Week 0) up to 30 weeks
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Subjects
    2
    3
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-emergent Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Treatment-emergent Serious Adverse Events (SAEs)
    End point description
    Treatment-emergent SAEs were defined as SAEs with onset or worsening on or after date of first dose of study treatment. An AE is any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly or any situation deemed medically important by the investigator. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    End point type
    Secondary
    End point timeframe
    post first administration of study intervention (Week 0) up to 30 weeks
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Subjects
    3
    4
    4
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Abnormalities in Laboratory Parameters

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    End point title
    		 Number of Subjects With Clinically Significant Abnormalities in Laboratory Parameters
    End point description
    Laboratory parameters included hematology (platelet count [platelets: decrease >20% and value <100 (fraction 1)], red blood cell count, hemoglobin, hematocrit, white blood cell count with differential [lymphocytes: decrease >20% and value <0.08 ], [leukocytes: decrease >10% and value <2.5], [neutrophils: increase >30% and value >0.90], [eosinophils: increase >20% and value >0.10 ]), serum chemistry (phosphate [decrease >10% and value <0.6 ), lipid panel (high-density lipoprotein [HDL] and low-density lipoprotein [LDL], creatine kinase: increase >20% and value >960, cholesterol: value >=6.2), urinalysis, and blood coagulation. Safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. Here, W: denotes week, N: number of subjects evaluable, and n: number of subjects evaluable for each arm at specific time points. Only those categories in which at least 1 subject had data were reported.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, 16, 20, 24, and Week 30/final safety follow-up visit
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    55
    51
    50
    Units: Subjects
        W 2: Lymphocytes(n=55, 50, 50)
    1
    0
    0
        W 2: Platelets (n=54, 50, 50)
    1
    0
    0
        W4: Phosphate(n=54, 51, 49)
    0
    0
    1
        W 4: Cholesterol: Value >=6.2 (n=53, 51, 49)
    2
    1
    1
        W4: HDL Cholesterol- Value >=2.1 (n= 53, 49, 49 )
    1
    3
    7
        W4: LDL Cholesterol-Value >=4.1(n=53, 49, 49)
    0
    0
    1
        W4:Leukocytes (n=53, 51, 50)
    1
    0
    0
        W8: Cholesterol:Value >=6.2 (n=54, 48, 47)
    1
    2
    1
        W8: HDL Cholesterol:Value >=2.1(n=53, 48, 46)
    2
    4
    7
        W8:LDL Cholesterol: Value >=4.1(n=53, 48, 46)
    0
    2
    1
        W8: Neutrophils (n=53, 48, 47)
    0
    1
    0
        W8:Lymphocytes(n=53,48, 47)
    0
    2
    0
        W12:HDL Cholesterol:Value >=2.1 (n=50, 46, 46)
    1
    3
    6
        W12:HDL Cholesterol: Value <1.0 (n=50, 46, 46)
    0
    1
    0
        W12:Neutrophils (n=48, 44, 43)
    0
    0
    1
        W12:Lymphocytes (n=48,44,43)
    0
    1
    1
        W16: Leukocytes (n=48, 43,44)
    2
    0
    1
        W24:HDL Cholesterol:Value >=2.1 (n=49, 46, 48)
    2
    4
    6
        W24: LDL Cholesterol-Value >=4.1(n=49, 45, 48)
    0
    2
    0
        W24: Eosinophils (n=49, 47, 46)
    1
    0
    0
        W24: Creatine Kinase (n=50,48,49)
    0
    1
    0
        W24: Cholesterol (n=50, 46, 49)
    0
    1
    0
        W30: Leukocytes (n=45, 46,46)
    0
    1
    0
        W30: Eosinophils (n=45, 46, 46)
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Serum Nipocalimab Concentration Over Time

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    End point title
    		 Serum Nipocalimab Concentration Over Time [1]
    End point description
    Serum concentrations of nipocalimab over time in subjects receiving active study intervention will be reported. The pharmacokinetics (PK) analysis set was defined as all randomised subjects who had received at least 1 complete dose of nipocalimab and have at least 1 valid post-dose blood sample drawn for PK analysis. This endpoint was planned to be analysed for specified arms only. Here, N: number of subjects evaluable for this endpoint and n: number of subjects evaluable for each arm at specific time points.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 16, 20, 24, and Week 30/final safety follow-up pre dose and post dose
    Notes
    [1] - 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: The data was planned to be analysed for specified arms only.
    End point values
    		 Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    53
    54
    Units: micrograms per millilitre
    arithmetic mean (standard deviation)
        Week 0, predose (n= 53, 52)
    0.000 ( 0.0036 )
    0.001 ( 0.0079 )
        Week 0, postdose (n= 53, 54)
    108.132 ( 41.1048 )
    354.926 ( 129.2114 )
        Week 2, predose (n= 48, 50)
    0.001 ( 0.0066 )
    0.004 ( 0.0145 )
        Week 2, postdose (n= 47, 50)
    98.569 ( 48.0806 )
    340.360 ( 130.4009 )
        Week 4, predose (n= 44, 43)
    0.001 ( 0.0046 )
    0.001 ( 0.0067 )
        Week 8, predose (n= 34, 39)
    0.002 ( 0.0082 )
    0.001 ( 0.0031 )
        Week 8, postdose (n= 34, 38)
    109.944 ( 38.2894 )
    345.526 ( 130.7682 )
        Week 12, predose (n= 26, 32)
    0.020 ( 0.1018 )
    0.003 ( 0.0119 )
        Week 12, postdose (n= 26, 32)
    107.112 ( 35.8943 )
    331.531 ( 187.7316 )
        Week 16, predose (n= 22, 25)
    0.000 ( 0.0000 )
    0.004 ( 0.0069 )
        Week 24/final efficacy (n= 16, 19)
    0.001 ( 0.0026 )
    0.003 ( 0.0070 )
        Week 30/final safety follow-up visit (n= 16, 19)
    0.002 ( 0.0066 )
    0.000 ( 0.0000 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in C-reactive Protein (CRP)

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    End point title
    		 Change From Baseline in C-reactive Protein (CRP)
    End point description
    Change from baseline in biomarkers CRP were reported. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. Here, N: number of subjects evaluable for this endpoint and n: number of subjects evaluable for each arm at specific time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and Week 30/final safety follow-up visit
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Milligrams per litre
    arithmetic mean (standard deviation)
        Week 2 (n=55, 51, 51)
    1.513 ( 7.6158 )
    0.520 ( 6.8520 )
    0.939 ( 5.5131 )
        Week 4 (n=54, 50, 49)
    -0.243 ( 2.1402 )
    0.238 ( 7.1198 )
    0.302 ( 1.9397 )
        Week 6 (n=53, 47, 49)
    -0.279 ( 2.2463 )
    -0.285 ( 6.7629 )
    -0.090 ( 2.1916 )
        Week 8 (n=53, 49, 47)
    0.026 ( 3.3460 )
    0.361 ( 2.3499 )
    -0.121 ( 1.3529 )
        Week 10 (n=51, 45, 45)
    1.751 ( 1.8643 )
    2.242 ( 5.1090 )
    1.304 ( 1.3120 )
        Week 12 (n=50, 46, 46)
    0.918 ( 4.9796 )
    0.765 ( 3.2934 )
    0.139 ( 2.0962 )
        Week 16 (n=48, 44, 44)
    -0.154 ( 2.1477 )
    -0.927 ( 7.6604 )
    0.107 ( 1.5903 )
        Week 20 (n=46, 46, 43)
    0.735 ( 6.3374 )
    1.020 ( 5.4001 )
    0.267 ( 2.9934 )
        Week 24/ final efficacy visit (n=50, 48, 47)
    1.524 ( 9.4589 )
    1.515 ( 6.6511 )
    0.200 ( 1.9106 )
        Week 30/ final safety follow-up (n=46, 44, 46)
    0.789 ( 3.8812 )
    -0.716 ( 6.1862 )
    -0.176 ( 1.4461 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

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    End point title
    		 Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
    End point description
    Change from baseline in biomarkers ESR were reported. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. Here, N: number of subjects evaluable for this endpoint and n: number of subjects evaluable for each arm at specific time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Week 30/final safety follow-up visit
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: Millimetres per hour
    arithmetic mean (standard deviation)
        Week 2 (n= 54, 50, 49)
    -0.037 ( 14.8768 )
    0.100 ( 11.4682 )
    -6.816 ( 14.6283 )
        Week 4 (n= 53, 50, 49)
    -1.340 ( 13.7448 )
    -1.640 ( 12.3813 )
    -9.327 ( 16.4929 )
        Week 8 (n= 52, 46, 44)
    10.602 ( 54.9277 )
    -0.005 ( 114.9206 )
    -28.010 ( 35.4705 )
        Week 12 (n= 49, 44, 46)
    -1.163 ( 17.9691 )
    -7.932 ( 17.5544 )
    -11.217 ( 14.6271 )
        Week 16 (n= 47, 44, 40)
    -5.213 ( 16.6053 )
    -7.225 ( 14.7691 )
    -12.500 ( 15.5616 )
        Week 20 (n= 44, 44, 41)
    -9.523 ( 21.9741 )
    -5.273 ( 16.7726 )
    -12.390 ( 15.4659 )
        Week 24/ final efficacy visit (n=51, 46, 49)
    -6.118 ( 19.5332 )
    -5.261 ( 18.1322 )
    -9.653 ( 16.5951 )
        Week 30/ final safety follow-up (n= 46, 44, 45)
    -7.478 ( 20.4958 )
    -2.909 ( 17.3498 )
    -6.978 ( 19.1115 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Immunoglobulin [Ig]G, IgG1, IgG2, IgG3, IgG4

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    End point title
    		 Change From Baseline in Total Immunoglobulin [Ig]G, IgG1, IgG2, IgG3, IgG4
    End point description
    Change from baseline in total immunoglobulin [Ig]G, IgG1, IgG2, IgG3, IgG4 were reported. The pharmacodynamic (PD) analysis set was defined as subjects who had received at least 1 dose (partial or complete) of nipocalimab and have at least 1 valid post-dose blood sample drawn for PD analysis. Here, N: number of subjects evaluable for this endpoint and n: number of subjects evaluable for each arm at specific time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Week 30/final safety follow-up visit
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    55
    51
    51
    Units: Grams per litre
    arithmetic mean (standard deviation)
        IgG: Week 2 (n=55, 51, 51)
    -0.293 ( 2.5034 )
    -3.570 ( 1.5226 )
    -7.712 ( 3.2346 )
        IgG: Week 4 (n=53, 50, 50)
    -0.274 ( 2.6898 )
    -4.612 ( 1.7211 )
    -8.904 ( 3.3077 )
        IgG: Week 8 (n=52, 43, 45)
    -0.126 ( 2.6075 )
    -5.114 ( 1.7088 )
    -9.578 ( 4.1409 )
        IgG: Week 12 (n=45, 38, 38)
    -0.051 ( 2.6476 )
    -5.231 ( 1.8415 )
    -9.899 ( 4.3507 )
        IgG: Week 16 (n=41, 34, 34)
    -0.211 ( 2.9717 )
    -5.224 ( 2.0568 )
    -9.340 ( 4.3346 )
        IgG: Week 20 (n=39, 32, 32)
    -0.217 ( 2.6829 )
    -4.942 ( 2.2000 )
    -9.976 ( 5.2069 )
        IgG: Week 24/final efficacy (n=35, 31, 30)
    -0.171 ( 3.5555 )
    -4.360 ( 2.8371 )
    -9.467 ( 5.4390 )
        IgG: Week 30 /final safety (n=35, 30 30)
    -0.421 ( 4.0162 )
    -0.015 ( 2.3388 )
    -0.688 ( 4.9730 )
        IgG1: Week 2 (n=55, 51, 51)
    -0.422 ( 2.4279 )
    -2.590 ( 1.1672 )
    -5.720 ( 2.6621 )
        IgG1: Week 4 (n=52, 50, 50)
    -0.256 ( 2.8110 )
    -3.364 ( 1.8922 )
    -6.300 ( 2.7080 )
        IgG1: Week 8 (n=52, 44, 46)
    -0.316 ( 2.4727 )
    -3.444 ( 2.2316 )
    -6.728 ( 3.0146 )
        IgG1: Week 12 (n=44, 38, 38)
    -0.388 ( 2.6534 )
    -3.587 ( 2.7108 )
    -6.997 ( 2.8712 )
        IgG1: Week 16 (n=41, 34, 34)
    -0.155 ( 2.7970 )
    -3.391 ( 2.7162 )
    -6.678 ( 3.3193 )
        IgG1: Week 20 (n=39, 32, 32)
    -0.027 ( 2.9349 )
    -3.547 ( 4.3021 )
    -7.106 ( 3.1650 )
        IgG1: Week 24/final efficacy (n=35, 31, 30)
    -0.273 ( 3.4443 )
    -2.807 ( 3.8918 )
    -6.854 ( 3.3401 )
        IgG1: Week 30 /final safety (n=35, 29, 30)
    -0.567 ( 3.8984 )
    -0.203 ( 3.9916 )
    -0.642 ( 4.0439 )
        IgG2: Week 2 (n=55, 51, 51)
    0.011 ( 0.5523 )
    -0.478 ( 0.5438 )
    -1.208 ( 0.8527 )
        IgG2: Week 4 (n=52, 50, 50)
    0.058 ( 0.5328 )
    -0.657 ( 0.6511 )
    -1.471 ( 1.0384 )
        IgG2: Week 8 (n=52, 44, 46)
    -0.025 ( 0.5082 )
    -0.897 ( 0.6258 )
    -1.735 ( 1.0015 )
        IgG2: Week 12 (n=44, 38, 38)
    0.071 ( 0.4862 )
    -0.893 ( 0.6425 )
    -1.698 ( 1.0102 )
        IgG2: Week 16 (n=41, 34, 34)
    0.060 ( 0.5388 )
    -0.878 ( 0.7311 )
    -1.655 ( 1.0935 )
        IgG2: Week 20 (n=39, 32, 32)
    0.043 ( 0.5881 )
    -0.843 ( 0.7219 )
    -1.725 ( 1.0670 )
        IgG2: Week 24/final efficacy (n=35, 31, 30)
    0.013 ( 0.6359 )
    -0.786 ( 0.8167 )
    -1.720 ( 1.0577 )
        IgG2: Week 30 /final safety (n=35, 29, 30)
    0.151 ( 0.6005 )
    -0.242 ( 0.6325 )
    -0.600 ( 0.7790 )
        IgG3: Week 2 (n=55, 51, 51)
    -0.021 ( 0.1003 )
    -0.133 ( 0.1004 )
    -0.224 ( 0.1398 )
        IgG3: Week 4 (n=52, 50, 50)
    -0.010 ( 0.1030 )
    -0.148 ( 0.1113 )
    -0.217 ( 0.1539 )
        IgG3: Week 8 (n=52, 44, 46)
    -0.013 ( 0.0987 )
    -0.152 ( 0.1266 )
    -0.217 ( 0.1438 )
        IgG3: Week 12 (n=44, 38, 38)
    -0.002 ( 0.1175 )
    -0.146 ( 0.1316 )
    -0.231 ( 0.1396 )
        IgG3: Week 16 (n=41, 34, 34)
    -0.001 ( 0.1234 )
    -0.145 ( 0.1111 )
    -0.219 ( 0.1584 )
        IgG3: Week 20 (n=39, 32, 32)
    0.003 ( 0.1355 )
    -0.127 ( 0.1705 )
    -0.236 ( 0.1477 )
        IgG3: Week 24/final efficacy (n=35, 31, 30)
    -0.006 ( 0.1459 )
    -0.105 ( 0.1671 )
    -0.246 ( 0.1656 )
        IgG3: Week 30 /final safety (n=35, 29, 30)
    -0.004 ( 0.1334 )
    -0.012 ( 0.0964 )
    -0.015 ( 0.0979 )
        IgG4: Week 2 (n=55, 51, 51)
    -0.028 ( 0.1631 )
    -0.158 ( 0.4306 )
    -0.242 ( 0.2717 )
        IgG4: Week 4 (n=52, 50, 50)
    -0.001 ( 0.0606 )
    -0.175 ( 0.4426 )
    -0.292 ( 0.3429 )
        IgG4: Week 8 (n=52, 44, 46)
    -0.018 ( 0.1231 )
    -0.207 ( 0.4708 )
    -0.302 ( 0.3568 )
        IgG4: Week 12 (n=44, 38, 38)
    -0.003 ( 0.1137 )
    -0.226 ( 0.5036 )
    -0.317 ( 0.3557 )
        IgG4: Week 16 (n=41, 34, 34)
    -0.010 ( 0.1075 )
    -0.229 ( 0.5302 )
    -0.279 ( 0.2811 )
        IgG4: Week 20 (n=39, 32, 32)
    -0.010 ( 0.0923 )
    -0.227 ( 0.5416 )
    -0.307 ( 0.3435 )
        IgG4: Week 24/final efficacy (n=35, 31, 30)
    -0.004 ( 0.0803 )
    -0.207 ( 0.5828 )
    -0.308 ( 0.3133 )
        IgG4: Week 30 /final safety (n=35, 29, 30)
    -0.008 ( 0.1341 )
    -0.111 ( 0.5936 )
    -0.025 ( 0.1846 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Autoantibodies : Anti-Sjogren's Syndrome Related Antigen A (anti-Ro/SSA), Anti-Sjogren's Syndrome Related Antigen B (anti-La/SSB), and Anti-Ro52/TRIM21

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    End point title
    		 Change From Baseline in Autoantibodies : Anti-Sjogren's Syndrome Related Antigen A (anti-Ro/SSA), Anti-Sjogren's Syndrome Related Antigen B (anti-La/SSB), and Anti-Ro52/TRIM21
    End point description
    Change from baseline in autoantibodies included anti-Ro/SSA, anti-La/SSB, and anti-Ro52/tripartite motif-containing protein 21 (Anti-Ro52/TRIM21) were reported. The PD analysis set was defined as subjects who had received at least 1 dose (partial or complete) of nipocalimab and have at least 1 valid post-dose blood sample drawn for PD analysis. Here, N: number of subjects evaluable for this endpoint and n: number of subjects evaluable for each arm at specific time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Week 30/final safety follow-up visit
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: CU
    median (inter-quartile range (Q1-Q3))
        Anti-Ro60/SSA: Week 2 (n=51, 48, 49)
    -3.80 (-2480.00 to 893.30)
    -3327.70 (-10728.60 to -1492.30)
    -6838.30 (-20472.00 to -469.00)
        Anti-Ro60/SSA: Week 4 (n=50, 47, 48)
    90.80 (-87.90 to 3520.00)
    -5628.70 (-12174.20 to -2884.60)
    -8682.45 (-22604.00 to -882.15)
        Anti-Ro60/SSA: Week 8 (n=49, 40, 44)
    15.10 (-1480.00 to 1392.00)
    -6952.90 (-11828.00 to -2864.25)
    -11398.15 (-22522.35 to -925.20)
        Anti-Ro60/SSA: Week 16 (n=38, 33, 32)
    41.25 (-2340.20 to 3792.00)
    -5424.00 (-8576.00 to -3201.10)
    -8511.15 (-20066.55 to -1637.40)
        Anti-Ro60/SSA: Week 24/final (n=33, 29, 28)
    56.70 (-1787.10 to 2398.90)
    -5702.50 (-13240.00 to -804.00)
    -8384.40 (-18053.85 to -619.55)
        Anti-Ro60/SSA: Week 30 /final (n=32, 28, 27)
    -13.80 (-3208.15 to 2681.85)
    -73.60 (-2270.60 to 773.25)
    -39.90 (-2006.70 to 5976.00)
        Anti-Ro52/TRIM21: Week 2 (n=51, 49, 50)
    -0.50 (-181.60 to 26.00)
    -490.80 (-1877.50 to -107.40)
    -496.30 (-1988.40 to 0.00)
        Anti-Ro52/TRIM21: Week 4 (n=50, 48, 49)
    -0.45 (-170.20 to 24.40)
    -762.50 (-2876.90 to -277.25)
    -523.90 (-2412.50 to -24.70)
        Anti-Ro52/TRIM21: Week 8 (n=49, 41, 45)
    -1.30 (-880.30 to 7.00)
    -732.60 (-1943.40 to -272.80)
    -611.40 (-3042.30 to 0.00)
        Anti-Ro52/TRIM21: Week 16 (n=38, 34, 33)
    -0.05 (-430.60 to 253.80)
    -581.90 (-1741.30 to -249.10)
    -592.10 (-2494.10 to -21.90)
        Anti-Ro52/TRIM21: Week 24/final (n=33, 30, 29)
    0.60 (-36.90 to 1098.10)
    -525.95 (-1488.90 to -29.20)
    -493.20 (-1397.60 to 0.00)
        Anti-Ro52/TRIM21: Week 30 /final (n=32, 29, 28)
    0.00 (-1031.80 to 184.40)
    0.90 (-233.80 to 768.00)
    0.00 (-167.75 to 507.75)
        Anti-La/SSB: Week 2 (n= 54, 50, 50)
    0.00 (-3.70 to 6.00)
    -19.40 (-134.90 to -3.20)
    -25.30 (-346.10 to -2.60)
        Anti-La/SSB: Week 4 (n=53, 49, 49)
    0.00 (-3.80 to 10.20)
    -33.80 (-179.70 to -6.70)
    -38.90 (-369.90 to -6.00)
        Anti-La/SSB: Week 8 (n=52, 42, 45)
    -0.15 (-18.45 to 7.00)
    -27.25 (-122.40 to -5.40)
    -44.60 (-507.90 to -5.20)
        Anti-La/SSB: Week 16 (n=41, 35, 33)
    0.00 (-3.60 to 56.50)
    -28.10 (-323.30 to -1.30)
    -46.50 (-530.50 to -9.20)
        Anti-La/SSB: Week 24/final (n=36, 31, 29)
    1.10 (-5.35 to 53.10)
    -22.30 (-318.20 to 0.00)
    -40.80 (-2861.40 to -6.20)
        Anti-La/SSB: Week 30 /final (n=35, 30, 28)
    0.00 (-19.30 to 29.00)
    -1.40 (-29.60 to 6.80)
    -3.65 (-43.25 to 0.00)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Autoantibodies: Rheumatoid Factor (RF)

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    End point title
    		 Change From Baseline in Autoantibodies: Rheumatoid Factor (RF)
    End point description
    Change from baseline in autoantibodies included RF were reported. The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention. Here, N: number of subjects evaluable for this endpoint and n: number of subjects evaluable for each arm at specific time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Week 30/final safety follow-up visit
    End point values
    		 Group 1: Placebo IV Group 2: Nipocalimab 5 mg/kg IV Group 3: Nipocalimab 15 mg/kg IV
    Number of subjects analysed
    56
    53
    54
    Units: international unit per millilitre
    median (inter-quartile range (Q1-Q3))
        RF: Week 2 (n=55, 51, 51)
    -0.500 (-2.200 to 0.000)
    -1.700 (-4.500 to 0.000)
    -3.600 (-9.500 to 0.000)
        RF: Week 4 (n=54, 50, 47)
    -0.150 (-2.500 to 0.400)
    -3.300 (-6.600 to -0.600)
    -5.400 (-14.500 to -0.500)
        RF: Week 8 (n=53, 49, 45)
    -0.100 (-1.600 to 1.000)
    -3.200 (-6.000 to 0.000)
    -4.400 (-14.100 to 0.000)
        RF: Week 12 (n=49, 45, 46)
    0.000 (-1.500 to 3.400)
    -2.700 (-4.700 to 0.000)
    -5.650 (-16.800 to -0.500)
        RF: Week 16 (n=48, 44, 43)
    0.000 (-2.250 to 2.350)
    -3.450 (-6.900 to 0.000)
    -6.000 (-18.600 to -0.500)
        RF: Week 20 (n=46, 46, 43)
    0.000 (-3.000 to 2.500)
    -2.900 (-5.900 to 0.000)
    -6.900 (-18.600 to 0.000)
        RF: Week 24/final efficacy visit (n=50, 48, 47)
    0.000 (-1.700 to 1.400)
    -2.850 (-5.950 to 0.000)
    -4.400 (-16.000 to 0.000)
        RF: Week 30 /final safety(n=46, 44, 46)
    0.000 (-3.300 to 1.700)
    0.000 (-1.800 to 3.450)
    0.000 (-1.800 to 1.600)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline (Week 0) up to 30 Weeks
    Adverse event reporting additional description
    The safety analysis set included all randomised subjects who had received at least 1 dose (partial or complete) of any study intervention.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Group 1: Placebo IV
    Reporting group description
    		 Subjects received placebo intravenous (IV) infusion every 2 weeks (q2w) from Week 0 through Week 22 along with standard of care treatments (SOC)

    Reporting group title
    Group 3: Nipocalimab 15 mg/kg IV
    Reporting group description
    		 Subjects received nipocalimab 15 mg/kg IV infusion q2w from Week 0 through Week 22 along with SOC.

    Reporting group title
    Group 2: Nipocalimab 5 mg/kg IV
    Reporting group description
    		 Subjects received nipocalimab 5 milligrams per kilogram (mg/kg) IV infusion q2w from Week 0 through Week 22 along with SOC.

    Serious adverse events
    		 Group 1: Placebo IV Group 3: Nipocalimab 15 mg/kg IV Group 2: Nipocalimab 5 mg/kg IV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 56 (5.36%)
    4 / 54 (7.41%)
    4 / 53 (7.55%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Cardiac Failure Congestive
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Anembryonic Gestation
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic Reaction
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary Mass
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Sjogren's Syndrome
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute Sinusitis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Covid-19
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Genital Herpes Simplex
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1: Placebo IV Group 3: Nipocalimab 15 mg/kg IV Group 2: Nipocalimab 5 mg/kg IV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 56 (39.29%)
    32 / 54 (59.26%)
    35 / 53 (66.04%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 56 (14.29%)
    6 / 54 (11.11%)
    4 / 53 (7.55%)
         occurrences all number
    12
    7
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 56 (10.71%)
    6 / 54 (11.11%)
    3 / 53 (5.66%)
         occurrences all number
    9
    9
    4
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 54 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    3
    0
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 54 (1.85%)
    4 / 53 (7.55%)
         occurrences all number
    2
    1
    5
    Diarrhoea
         subjects affected / exposed
    2 / 56 (3.57%)
    8 / 54 (14.81%)
    3 / 53 (5.66%)
         occurrences all number
    2
    10
    3
    Nausea
         subjects affected / exposed
    2 / 56 (3.57%)
    6 / 54 (11.11%)
    0 / 53 (0.00%)
         occurrences all number
    4
    9
    0
    Vomiting
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 54 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 54 (1.85%)
    3 / 53 (5.66%)
         occurrences all number
    2
    1
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 54 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    0
    4
    Rash
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 54 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    0
    5
    1
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 54 (1.85%)
    3 / 53 (5.66%)
         occurrences all number
    2
    1
    3
    Infections and infestations
    Oral Herpes
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 54 (1.85%)
    3 / 53 (5.66%)
         occurrences all number
    0
    1
    3
    Nasopharyngitis
         subjects affected / exposed
    4 / 56 (7.14%)
    7 / 54 (12.96%)
    4 / 53 (7.55%)
         occurrences all number
    4
    9
    5
    Cystitis
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 54 (1.85%)
    3 / 53 (5.66%)
         occurrences all number
    3
    1
    5
    Covid-19
         subjects affected / exposed
    3 / 56 (5.36%)
    3 / 54 (5.56%)
    7 / 53 (13.21%)
         occurrences all number
    3
    4
    7
    Conjunctivitis
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 54 (1.85%)
    4 / 53 (7.55%)
         occurrences all number
    3
    1
    4
    Urinary Tract Infection
         subjects affected / exposed
    3 / 56 (5.36%)
    3 / 54 (5.56%)
    4 / 53 (7.55%)
         occurrences all number
    4
    3
    5
    Upper Respiratory Tract Infection
         subjects affected / exposed
    4 / 56 (7.14%)
    3 / 54 (5.56%)
    6 / 53 (11.32%)
         occurrences all number
    4
    3
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 May 2021
    The purpose of this amendment was to include additional safety criteria related to hypogammaglobulinemia, hyperlipidemia, and anaphylaxis; to update the use of oral contraceptives; and to clarify the use of NSAIDs prior to study visits involving joint counts or pain assessments.
    04 Feb 2022
    The purpose of this amendment was to amend eligibility criteria to include a broader population of Sjögren’s disease patients.
    20 Jul 2022
    The purpose of this amendment was to revise the inclusion criterion and secondary endpoint (Sjogren's Syndrome Responder Index response) that depends on erythrocyte sedimentation rate (ESR) as key laboratory supplies required for the ESR test that meet European Union Conformité Européene CE marking requirements for laboratory tests were no longer commercially available. In addition, a new secondary endpoint (Sjögren’s Tool for Assessing Response) was added.

    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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