Clinical Trial Results:
A Multi-Centre, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subcutaneously Administered Belimumab Plus Standard Therapy in Chinese Paediatric Participants with Systemic Lupus Erythematosus (SLE)
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Summary
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EudraCT number |
2025-000142-26 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
30 Oct 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Nov 2025
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First version publication date |
14 Nov 2025
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
217091
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05917288 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GlaxoSmithKline
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Sponsor organisation address |
980 Great West Road, Brentford,Middlesex, United Kingdom, TW8 9GS
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Public contact |
GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
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Scientific contact |
GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Nov 2024
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Oct 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To characterize belimumab exposure following belimumab 200 mg SC in Chinese paediatric systemic lupus erythematosus (SLE) participants who have previously been treated with IV belimumab.
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Protection of trial subjects |
NA
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
07 Jul 2023
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
China: 16
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Worldwide total number of subjects |
16
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
4
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Adolescents (12-17 years) |
12
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 16 participants were enrolled in this study. | ||||||
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Pre-assignment
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Screening details |
Participants who had completed 48 weeks of intravenous (IV) belimumab treatment in study 213560 (NCT04908865) were enrolled in this study. | ||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Belimumab 200 mg/mL | ||||||
Arm description |
Participants with systemic lupus erythematosus (SLE), who had completed 48 weeks of IV belimumab treatment in study 213560 (NCT04908865), received belimumab 200 milligrams per milliliter (mg/mL) as a subcutaneous (SC) injection over 12 weeks along with standard of care (SOC) therapy. The dosing frequency of belimumab was based on the body weight of the participants. Participants weighing greater than or equal to (>=) 50 kilograms (kg) received belimumab every week, participants weighing between 30 kg and less than (<) 50 kg received belimumab every 10 days, and participants weighing between 15 kg and < 30 kg received belimumab every 2 weeks. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Belimumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
200 mg/mL SC injection according to the baseline body weight plus SOC
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Baseline characteristics reporting groups
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Reporting group title |
Belimumab 200 mg/mL
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Reporting group description |
Participants with systemic lupus erythematosus (SLE), who had completed 48 weeks of IV belimumab treatment in study 213560 (NCT04908865), received belimumab 200 milligrams per milliliter (mg/mL) as a subcutaneous (SC) injection over 12 weeks along with standard of care (SOC) therapy. The dosing frequency of belimumab was based on the body weight of the participants. Participants weighing greater than or equal to (>=) 50 kilograms (kg) received belimumab every week, participants weighing between 30 kg and less than (<) 50 kg received belimumab every 10 days, and participants weighing between 15 kg and < 30 kg received belimumab every 2 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Belimumab 200 mg/mL Every Week
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Participants with SLE, who had completed 48 weeks of IV belimumab treatment in study 213560 (NCT04908865) and weighed >= 50 kg, received belimumab 200 mg/mL as an SC injection every week over 12 weeks along with SOC therapy.
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Subject analysis set title |
Belimumab 200 mg/mL Every 10 Days
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Participants with SLE, who had completed 48 weeks of IV belimumab treatment in study 213560 (NCT04908865) and weighed between 30 kg and < 50 kg, received belimumab 200 mg/mL as an SC injection every 10 days over 12 weeks along with SOC therapy.
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Subject analysis set title |
Belimumab 200 mg/mL Every 2 Weeks
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Participants with SLE, who had completed 48 weeks of IV belimumab treatment in study 213560 (NCT04908865) and weighed between 15 kg and < 30 kg, received belimumab 200 mg/mL as an SC injection every 2 weeks over 12 weeks along with SOC therapy.
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End points reporting groups
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Reporting group title |
Belimumab 200 mg/mL
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Reporting group description |
Participants with systemic lupus erythematosus (SLE), who had completed 48 weeks of IV belimumab treatment in study 213560 (NCT04908865), received belimumab 200 milligrams per milliliter (mg/mL) as a subcutaneous (SC) injection over 12 weeks along with standard of care (SOC) therapy. The dosing frequency of belimumab was based on the body weight of the participants. Participants weighing greater than or equal to (>=) 50 kilograms (kg) received belimumab every week, participants weighing between 30 kg and less than (<) 50 kg received belimumab every 10 days, and participants weighing between 15 kg and < 30 kg received belimumab every 2 weeks. | ||
Subject analysis set title |
Belimumab 200 mg/mL Every Week
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Participants with SLE, who had completed 48 weeks of IV belimumab treatment in study 213560 (NCT04908865) and weighed >= 50 kg, received belimumab 200 mg/mL as an SC injection every week over 12 weeks along with SOC therapy.
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Subject analysis set title |
Belimumab 200 mg/mL Every 10 Days
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Participants with SLE, who had completed 48 weeks of IV belimumab treatment in study 213560 (NCT04908865) and weighed between 30 kg and < 50 kg, received belimumab 200 mg/mL as an SC injection every 10 days over 12 weeks along with SOC therapy.
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Subject analysis set title |
Belimumab 200 mg/mL Every 2 Weeks
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Participants with SLE, who had completed 48 weeks of IV belimumab treatment in study 213560 (NCT04908865) and weighed between 15 kg and < 30 kg, received belimumab 200 mg/mL as an SC injection every 2 weeks over 12 weeks along with SOC therapy.
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End point title |
Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Between 30 kg and Less Than (<) 50 kg [1] | ||||||||
End point description |
Blood samples were collected at indicated time points for PK analysis of belimumab. AUCss,0-tau of belimumab for participants weighing between 30 kg and < 50 kg has been reported. PK Analysis Set 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.
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End point type |
Primary
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End point timeframe |
Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
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| 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. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Greater than or Equal to (>=) 50 kilograms (kg) [2] | ||||||||
End point description |
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of belimumab. AUCss,0-tau of belimumab for participants weighing >= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. PK Analysis Set 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.
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End point type |
Primary
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End point timeframe |
Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
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| 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. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg [3] | ||||||||
End point description |
Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing between 30 kg and < 50 kg has been reported. PK Analysis Set 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.
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End point type |
Primary
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End point timeframe |
Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
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| 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. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing >= 50 kg [4] | ||||||||
End point description |
Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing >= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. PK Analysis Set 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.
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End point type |
Primary
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End point timeframe |
Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
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| 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. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg [5] | ||||||||
End point description |
Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing between 15 kg and < 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. PK Analysis Set 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. '99999' indicates that geometric coefficient of variation could not be calculated as only 1 participant was analyzed.
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End point type |
Primary
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End point timeframe |
Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was descriptive; hence no statistical analysis to report. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing >= 50 kg [6] | ||||||||
End point description |
Blood samples were collected at indicated time points for PK analysis of belimumab. Cavg,ss of belimumab for participants weighing >= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. PK Analysis Set 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.
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End point type |
Primary
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End point timeframe |
Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was descriptive; hence no statistical analysis to report. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Area Under the Curve at Steady-state to the End of the Dosing Period (AUCss,0-tau) of Belimumab for Participants Weighing Between 15 kg and < 30 kg [7] | ||||||||
End point description |
Blood samples were collected at indicated time points for PK analysis of belimumab. AUCss,0-tau of belimumab for participants weighing between 15 kg and < 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. PK Analysis Set 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. '99999' indicates that geometric coefficient of variation could not be calculated as only 1 participant was analyzed.
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End point type |
Primary
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End point timeframe |
Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was descriptive; hence no statistical analysis to report. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg [8] | ||||||||
End point description |
Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing 15 kg and < 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. PK Analysis Set 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. '99999' indicates that geometric coefficient of variation could not be calculated as only 1 participant was analyzed.
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End point type |
Primary
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End point timeframe |
Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was descriptive; hence no statistical analysis to report. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Maximum Serum Concentration during the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg [9] | ||||||||
End point description |
Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing between 30 kg and < 50 kg has been reported. PK Analysis Set 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.
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End point type |
Primary
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End point timeframe |
Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
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| Notes [9] - 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. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg [10] | ||||||||
End point description |
Blood samples were collected at indicated time points for PK analysis of belimumab. Cmin,ss of belimumab for participants weighing 30 kg and < 50 kg has been reported. PK Analysis Set 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.
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End point type |
Primary
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End point timeframe |
Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
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| Notes [10] - 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. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Maximum Serum Concentration during the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing >= 50 kg [11] | ||||||||
End point description |
Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing >= 50 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. PK Analysis Set 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.
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End point type |
Primary
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End point timeframe |
Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
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| Notes [11] - 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. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Maximum Serum Concentration during the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg [12] | ||||||||
End point description |
Blood samples were collected at indicated time points for PK analysis of belimumab. Cmax,ss of belimumab for participants weighing between 15 kg and < 30 kg has been reported. As the first dose of belimumab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, i.e., Day 85. PK Analysis Set 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. '99999' indicates that geometric coefficient of variation could not be calculated as only 1 participant was analyzed.
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End point type |
Primary
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End point timeframe |
Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
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| Notes [12] - 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. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Participants with Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) Through Week 12 | ||||||||||||
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. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per medical and scientific judgement of the Investigator. AESIs defined in the protocol included post-injection systemic reactions and hypersensitivity reactions, infections of special interest, malignancies, and depression, suicidality, or self-injury. Intent-to-Treat (ITT) Analysis Set included all participants assigned treatment who received at least one dose of study treatment.
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End point type |
Secondary
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End point timeframe |
Up to Week 12
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
All-cause mortality, SAEs, and non-SAEs were collected up to 28 weeks (treatment: up to 12 weeks and follow-up: up to 16 weeks)
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Adverse event reporting additional description |
All-cause mortality, SAEs, and non-SAEs were analyzed for ITT Analysis Set that included all participants assigned treatment who received at least one dose of study treatment.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
27.1
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Reporting groups
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Reporting group title |
Belimumab 200 mg/mL
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Reporting group description |
Participants with SLE, who had completed 48 weeks of IV belimumab treatment in study 213560 (NCT04908865), received belimumab 200 mg/mL as an SC injection over 12 weeks along with SOC therapy. The dosing frequency of belimumab was based on the body weight of the participants. Participants weighing >= 50 kg received belimumab every week, participants weighing between 30 kg and < 50 kg received belimumab every 10 days, and participants weighing between 15 kg and < 30 kg received belimumab every 2 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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03 Jan 2023 |
Protocol Amendment 01 |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
