Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE)

    Summary
    EudraCT number
    		 2018-004645-16
    Trial protocol
    		 DE   NL   ES  
    Global end of trial date

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Mar 2024
    First version publication date
    01 Feb 2024
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    200908
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04179032
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford,Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000313-PIP20-20
    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?
    Yes
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    16 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2023
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To characterize the PK profile of belimumab 200 mg SC in pediatric SLE participants.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Nov 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety, Scientific research
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 4
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Japan: 2
    Country: Number of subjects enrolled
    Mexico: 3
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    25
    EEA total number of subjects
    12
    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)
    3
    Adolescents (12-17 years)
    22
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The primary study included Part A which is an open label 12-week treatment phase and Part B an optional 40-week open-label continuation phase, open to all participants who have completed Part A. An optional access extension phase is ongoing and additional data will be provided after study completion date is achieved.

    Pre-assignment
    Screening details
    		 A total of 28 participants were screened and 25 were enrolled to the study.

    Period 1
    Period 1 title
    Part A (Up to Week 12)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Belimumab 200 mg
    Arm description
    		 Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Cohort 1 (≥50 kg): 200 mg weekly

    Investigational medicinal product name
    Belimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Cohort 3 (<30 kg): 200 mg every 2 weeks

    Investigational medicinal product name
    Belimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Cohort 2 (≥ 30 kg - <50 kg): 200 mg every 10 days

    Number of subjects in period 1
    		Belimumab 200 mg
    Started
    25
    Completed
    25
    Period 2
    Period 2 title
    Part B (Up to Week 52)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Belimumab 200 mg
    Arm description
    		 Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Cohort 1 (≥50 kg): 200 mg weekly

    Investigational medicinal product name
    Belimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Cohort 3 (<30 kg): 200 mg every 2 weeks

    Investigational medicinal product name
    Belimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Cohort 2 (≥ 30 kg - <50 kg): 200 mg every 10 days

    Number of subjects in period 2
    		Belimumab 200 mg
    Started
    25
    Completed
    23
    Not completed
    2
         Adverse event, non-fatal
    1
         INVESTIGATOR DISCRETION
    1
    Period 3
    Period 3 title
    Access Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Belimumab 200 mg
    Arm description
    		 Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Cohort 1 (≥50 kg): 200 mg weekly

    Investigational medicinal product name
    Belimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Cohort 3 (<30 kg): 200 mg every 2 weeks

    Investigational medicinal product name
    Belimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Cohort 2 (≥ 30 kg - <50 kg): 200 mg every 10 days

    Number of subjects in period 3 [1]
    		Belimumab 200 mg
    Started
    11
    Completed
    0
    Not completed
    11
         Ongoing
    11
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: A total of 28 participants were screened and 25 were enrolled to the study. The primary study included Part A which is an open label 12-week treatment phase and Part B an optional 40-week open-label continuation phase, open to all participants who have completed Part A. An optional access extension phase is ongoing.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Belimumab 200 mg
    Reporting group description
    		 Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.

    Reporting group values
    		 Belimumab 200 mg Total
    Number of subjects
    		 25 25
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 3 3
        Adolescents (12-17 years)
    		 22 22
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Sex: Female, Male
    Units: Participants
        Female
    		 21 21
        Male
    		 4 4
    Race/Ethnicity, Customized
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
    		 3 3
        ASIAN
    		 4 4
        BLACK OR AFRICAN AMERICAN
    		 1 1
        WHITE
    		 16 16
        MIXED RACE
    		 1 1
    Age, Continuous
    Units: YEARS
        arithmetic mean (standard deviation)
    		 14.0 ( 2.09 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Belimumab 200 mg
    Reporting group description
    		 Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
    Reporting group title
    Belimumab 200 mg
    Reporting group description
    		 Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
    Reporting group title
    Belimumab 200 mg
    Reporting group description
    		 Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.

    Subject analysis set title
    Belimumab 200 mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.

    Primary: Observed belimumab concentrations at Week 12

    		 Close Top of page
    End point title
    		 Observed belimumab concentrations at Week 12 [1]
    End point description
    Blood samples were collected for analysis of belimumab concentration. The analysis was performed on the pharmacokinetic (PK) Set that included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
    End point type
    Primary
    End point timeframe
    At Week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belimumab 200 mg
    Number of subjects analysed
    25
    Units: microgram per milliliter (ug/ml)
        geometric mean (confidence interval 95%)
    106.42 (87.80 to 128.99)
    No statistical analyses for this end point

    Primary: Estimated average concentration (Cavg) of belimumab at steady state

    		 Close Top of page
    End point title
    		 Estimated average concentration (Cavg) of belimumab at steady state [2]
    End point description
    Blood samples were collected for measurement of serum concentrations of belimumab at steady state. Average concentrations were analyzed and reported for all time-points from Week 1 through Week 60. The analysis was performed on the PK Set that included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
    End point type
    Primary
    End point timeframe
    Pre dose on Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52, and Week 60
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belimumab 200 mg
    Number of subjects analysed
    25
    Units: ug/ml
        geometric mean (geometric coefficient of variation)
    124 ( 37.3 )
    No statistical analyses for this end point

    Primary: Estimated maximum concentration (Cmax) of belimumab at steady state

    		 Close Top of page
    End point title
    		 Estimated maximum concentration (Cmax) of belimumab at steady state [3]
    End point description
    Blood samples were collected for measurement of serum concentrations of belimumab at steady state. Cmax was analyzed and reported for all time-points from Week 1 through Week 60The analysis was performed on the PK Set that included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
    End point type
    Primary
    End point timeframe
    Pre dose on Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52, and Week 60
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belimumab 200 mg
    Number of subjects analysed
    25
    Units: ug/ml
        geometric mean (geometric coefficient of variation)
    131 ( 34.9 )
    No statistical analyses for this end point

    Primary: Estimated minimum concentration (Cmin) of belimumab at steady state

    		 Close Top of page
    End point title
    		 Estimated minimum concentration (Cmin) of belimumab at steady state [4]
    End point description
    Blood samples were collected for measurement of serum concentrations of belimumab at steady state. Cmin was analyzed and reported for all time-points from Week 1 through Week 60 The analysis was performed on the PK Set that included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
    End point type
    Primary
    End point timeframe
    Pre dose on Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52, and Week 60
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belimumab 200 mg
    Number of subjects analysed
    25
    Units: ug/ml
        geometric mean (geometric coefficient of variation)
    112 ( 41.7 )
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events (AEs)

    		 Close Top of page
    End point title
    		 Number of participants with adverse events (AEs)
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The safety analysis was performed on the Intent-To-Treat (ITT) set that included all participants assigned treatment who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to Week 68
    End point values
    		 Belimumab 200 mg
    Number of subjects analysed
    25
    Units: Participants
    22
    No statistical analyses for this end point

    Secondary: Number of participants with serious adverse events (SAEs)

    		 Close Top of page
    End point title
    		 Number of participants with serious adverse events (SAEs)
    End point description
    A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. The safety analysis was performed on the Intent-To-Treat (ITT) set that included all participants assigned treatment who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to Week 68
    End point values
    		 Belimumab 200 mg
    Number of subjects analysed
    25
    Units: Participants
    1
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events of special interest (AESIs)

    		 Close Top of page
    End point title
    		 Number of participants with adverse events of special interest (AESIs)
    End point description
    AESI included post-injection systemic reactions and hypersensitivity reactions, infections, malignancies, and depression/suicidality/self-injury. AESIs were followed until the event is resolved, stabilized, otherwise explained, or the participant is lost to follow-up. The safety analysis was performed on the Intent-To-Treat (ITT) set that included all participants assigned treatment who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to Week 68
    End point values
    		 Belimumab 200 mg
    Number of subjects analysed
    25
    Units: Participants
        Malignancies
    0
        Post-Injection Systemic Reactions
    3
        Infections
    0
        Depression/Suicide/Self-injury
    0
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in anti-double stranded deoxyribonucleic acid (dsDNA) Antibodies at Week 12 and Week 52

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in anti-double stranded deoxyribonucleic acid (dsDNA) Antibodies at Week 12 and Week 52
    End point description
    Blood samples were collected for anti-dsDNA- antibody biomarker analysis. Baseline status are defined as positive (Anti-dsDNA antibody >= 30 International Units Per Milliliter (IU/mL)) or negative (Anti-dsDNA antibody< 30 IU/mL). Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100. The analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment. Participants who had positive anti-dsDNA antibody levels at baseline were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 12 and Week 52
    End point values
    		 Belimumab 200 mg
    Number of subjects analysed
    15
    Units: Percent change
    median (full range (min-max))
        Week 12
    -17.74 (-68.0 to 40.0)
        Week 52
    -58.88 (-85.3 to -2.4)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Complement C3 and Complement C4 at Week 12 and Week 52

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Complement C3 and Complement C4 at Week 12 and Week 52
    End point description
    Blood samples were collected from participants to assess complement C3 and complement C4 levels. Baseline status are defined as low complement [C3 less than (<) 90 milligrams per deciliter (mg/dL)] or normal/high (C3 >= 90 mg/dL) and low (C4 < 13 mg/dL) or normal/high (C4 >= 13 mg/dL) respectively. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100. The analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment. Participants who had low baseline C3 and C4 levels were included in the respective analysis. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 12 and Week 52
    End point values
    		 Belimumab 200 mg
    Number of subjects analysed
    15
    Units: Percent change
    median (full range (min-max))
        Complement C3 (Week 12)
    8.26 (2.0 to 24.8)
        Complement C3 (Week 52)
    23.46 (-7.6 to 61.6)
        Complement C4 (Week 12)
    31.03 (-3.5 to 67.3)
        Complement C4 (Week 52)
    67.52 (21.8 to 443.2)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in CD19+ Total B cells and CD20+ B Cells at Week 12 and Week 52

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in CD19+ Total B cells and CD20+ B Cells at Week 12 and Week 52
    End point description
    Blood samples were collected for biomarker analysis. B cell subsets included CD19+ total B cells and CD 20+ B cells. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100. The analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 12 and Week 52
    End point values
    		 Belimumab 200 mg
    Number of subjects analysed
    15
    Units: Percent change
    median (full range (min-max))
        CD19+ Total B cells (Week 12)
    -42.97 (-74.4 to 68.8)
        CD19+ Total B cells (Week 52)
    -61.32 (-89.4 to 95.5)
        CD20+ B cells (Week 12)
    -41.85 (-75.8 to 92.1)
        CD20+ B cells (Week 52)
    -61.65 (-89.9 to 92.3)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Naïve B Cells and Memory B Cells at Week 12 and Week 52

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Naïve B Cells and Memory B Cells at Week 12 and Week 52
    End point description
    Blood samples were collected for biomarker analysis and included CD20+ CD27- Naïve B cells and CD20+ CD27+ memory B cells. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100. The analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 12 and Week 52
    End point values
    		 Belimumab 200 mg
    Number of subjects analysed
    15
    Units: Percent change
    median (full range (min-max))
        Naïve B Cells (Week 12)
    -53.19 (-81.5 to 21.0)
        Naïve B Cells (Week 52)
    -72.13 (-94.5 to 20.3)
        Memory B Cells (Week 12)
    69.06 (-36.7 to 531.8)
        Memory B Cells (Week 52)
    27.10 (-63.2 to 402.9)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 12

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 12
    End point description
    Blood samples were collected for analysis of immunoglobulins: Immunoglobulin A (IgA), Immunoglobulin G (IgG), and Immunoglobulin M (IgM). Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 divided by the Baseline value X 100. The analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 12
    End point values
    		 Belimumab 200 mg
    Number of subjects analysed
    25
    Units: Percent change
    median (full range (min-max))
        Immunoglobulin A (IgA)
    -3.13 (-35.2 to 8.0)
        Immunoglobulin G (IgG)
    -3.40 (-30.7 to 12.7)
        Immunoglobulin M (IgM)
    -10.41 (-49.2 to 4.3)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in in CD27bright CD38bright Plasma blasts at Week 12 and Week 52

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in in CD27bright CD38bright Plasma blasts at Week 12 and Week 52
    End point description
    Blood samples were collected for CD27bright CD38bright Plasma blasts biomarker analysis. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100. The analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 12 and Week 52
    End point values
    		 Belimumab 200 mg
    Number of subjects analysed
    15
    Units: Percent change
    median (full range (min-max))
        Week 12
    9.40 (-81.8 to 428.1)
        Week 52
    -70.07 (-88.9 to 193.1)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 52

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 52
    End point description
    Blood samples were collected for analysis of immunoglobulins: Immunoglobulin A (IgA), Immunoglobulin A (IgG), and Immunoglobulin M (IgM). Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. The analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 52
    End point values
    		 Belimumab 200 mg
    Number of subjects analysed
    21
    Units: Percent change
    median (full range (min-max))
        Immunoglobulin A (IgA)
    -13.06 (-37.5 to 41.0)
        Immunoglobulin G (IgG)
    -12.29 (-34.0 to 10.6)
        Immunoglobulin M (IgM)
    -30.79 (-56.7 to -8.9)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A plus 40 weeks Part B extension phase] and follow-up: 16 weeks)
    Adverse event reporting additional description
    The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Belimumab 200 mg
    Reporting group description
    		 Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.

    Serious adverse events
    		 Belimumab 200 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 25 (4.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Infections and infestations
    COVID-19
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Belimumab 200 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 25 (76.00%)
    Investigations
    Neutrophil count decreased
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Urine protein/creatinine ratio increased
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    White blood cell count decreased
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Leukopenia
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences all number
    4
    Anaemia
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    3
    Neutropenia
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences all number
    5
    Lymphopenia
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    General disorders and administration site conditions
    Injection site pain
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences all number
    9
    Injection site erythema
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Erythema
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Infections and infestations
    Upper respiratory tract infection
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Viral infection
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    COVID-19
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    8 / 25 (32.00%)
         occurrences all number
    8
    Nasopharyngitis
    alternative dictionary used: v25.1 25.1
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Apr 2019
    Original protocol (00)
    24 Jul 2019
    Amendment 1
    24 Apr 2020
    Amendment 2
    14 Jul 2021
    Amendment 3
    14 Dec 2022
    Amendment 4

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 04 14:14:13 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA