Trial Outcomes & Findings for A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus (NCT NCT05917288)

Last Updated: 2025-11-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81

Results posted on

2025-11-14

Participant Flow

A total of 16 participants were enrolled in this study.

Participants who had completed 48 weeks of intravenous (IV) belimumab treatment in study 213560 (NCT04908865) were enrolled in this study.

Participant milestones

Participant milestones
Measure	Belimumab 200 mg/mL 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.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belimumab 200 mg/mL n=16 Participants 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.
Age, Continuous	12.9 YEARS STANDARD_DEVIATION 2.55 • n=10 Participants
Sex: Female, Male Female	11 Participants n=10 Participants
Sex: Female, Male Male	5 Participants n=10 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	16 Participants n=10 Participants

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg/mL Every Week n=10 Participants 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.
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)	633.26 Days*micrograms per milliliter Geometric Coefficient of Variation 27.50

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg/mL Every Week n=5 Participants 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.
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	807.57 Days*micrograms per milliliter Geometric Coefficient of Variation 17.44

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg/mL Every Week n=1 Participants 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.
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	1365.23 Days*micrograms per milliliter Geometric Coefficient of Variation NA 'NA' indicates that geometric coefficient of variation could not be calculated as only 1 participant was analyzed.

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg/mL Every Week n=10 Participants 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.
Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing >= 50 kg	90.47 Micrograms per milliliter Geometric Coefficient of Variation 27.50

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg/mL Every Week n=5 Participants 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.
Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg	80.76 Micrograms per milliliter Geometric Coefficient of Variation 17.44

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg/mL Every Week n=1 Participants 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.
Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg	97.52 Micrograms per milliliter Geometric Coefficient of Variation NA 'NA' indicates that geometric coefficient of variation could not be calculated as only 1 participant was analyzed.

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg/mL Every Week n=10 Participants 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.
Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing >= 50 kg	82.63 Micrograms per milliliter Geometric Coefficient of Variation 28.69

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg/mL Every Week n=5 Participants 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.
Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg	70.71 Micrograms per milliliter Geometric Coefficient of Variation 20.14

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg/mL Every Week n=1 Participants 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.
Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg	80.95 Micrograms per milliliter Geometric Coefficient of Variation NA 'NA' indicates that geometric coefficient of variation could not be calculated as only 1 participant was analyzed.

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg/mL Every Week n=10 Participants 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.
Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing >= 50 kg	93.36 Micrograms per milliliter Geometric Coefficient of Variation 25.80

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg/mL Every Week n=5 Participants 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.
Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg	87.15 Micrograms per milliliter Geometric Coefficient of Variation 15.91

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg/mL Every Week n=1 Participants 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.
Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg	109.59 Micrograms per milliliter Geometric Coefficient of Variation NA 'NA' indicates that geometric coefficient of variation could not be calculated as only 1 participant was analyzed.

SECONDARY outcome

Timeframe: Up to Week 12

Population: Intent-to-Treat (ITT) Analysis Set included all participants assigned treatment who received at least one dose of study treatment.

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. Number of participants with AEs, SAEs, and AESIs has been reported.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg/mL Every Week n=16 Participants 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.
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) Through Week 12 AEs	13 Participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) Through Week 12 SAEs	0 Participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) Through Week 12 AESIs	0 Participants

Adverse Events

Belimumab 200 mg/mL

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Belimumab 200 mg/mL n=16 participants at risk 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.
Infections and infestations Upper respiratory tract infection	56.2% 9/16 • Number of events 17 • 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) 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.
Infections and infestations Bronchitis	18.8% 3/16 • Number of events 3 • 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) 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.
Infections and infestations Bacterial infection	6.2% 1/16 • Number of events 1 • 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) 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.
Infections and infestations Conjunctivitis	6.2% 1/16 • Number of events 1 • 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) 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.
Infections and infestations Mycoplasma infection	6.2% 1/16 • Number of events 1 • 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) 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.
Infections and infestations Tinea versicolour	6.2% 1/16 • Number of events 1 • 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) 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.
Infections and infestations Tonsillitis	6.2% 1/16 • Number of events 1 • 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) 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.
Infections and infestations Viral infection	6.2% 1/16 • Number of events 1 • 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) 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.
Gastrointestinal disorders Diarrhoea	6.2% 1/16 • Number of events 1 • 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) 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.
Gastrointestinal disorders Lip swelling	6.2% 1/16 • Number of events 1 • 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) 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.
Gastrointestinal disorders Noninfective gingivitis	6.2% 1/16 • Number of events 1 • 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) 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.
Hepatobiliary disorders Hepatic function abnormal	12.5% 2/16 • Number of events 3 • 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) 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.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 • Number of events 1 • 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) 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.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	6.2% 1/16 • Number of events 1 • 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) 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.
Skin and subcutaneous tissue disorders Acne	6.2% 1/16 • Number of events 1 • 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) 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.
Skin and subcutaneous tissue disorders Rash	6.2% 1/16 • Number of events 1 • 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) 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.
Investigations White blood cell count decreased	6.2% 1/16 • Number of events 2 • 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) 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.
Metabolism and nutrition disorders Weight fluctuation	6.2% 1/16 • Number of events 1 • 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) 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.
Musculoskeletal and connective tissue disorders Growth retardation	6.2% 1/16 • Number of events 1 • 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) 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.

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
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