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

A Multi-Centre, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subcutaneously Administered Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Systemic Lupus Erythematosus (SLE)

This study will evaluate the pharmacokinetic characteristics and safety of belimumab subcutaneous (SC) in Chinese pediatric participants with SLE who have completed 48 weeks belimumab Intravenous (IV) treatment in 213560 study (NCT04908865)

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Biological: Belimumab; Drug: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100045
    • GSK Investigational Site
  • Changsha, China, 410007
    • GSK Investigational Site
  • Hangzhou, China, 310052
    • GSK Investigational Site
  • Nanjing, China, 210011
    • GSK Investigational Site
  • Shanghai, China, 361006
    • GSK Investigational Site
  • Suzhou, China, 215007
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants between 5 and 17 years of age inclusive, at the time of informed consent
• Chinese pediatric participants with SLE, who have completed 48 weeks treatment in study 213560 and who, in the opinion of the investigator, may benefit from treatment with GSK1550188.
• Body weight greater than equal to >=15 kilograms (kg), at the time of signing the informed consent.

• Male and/or female:

  1. No contraceptive measures are required for male participants.
  2. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:

  i) Is a woman of non-childbearing potential OR ii) Is a woman of childbearing potential and using a contraceptive method that is highly effective, with a failure rate of <1%

• Participant signs and dates a written age-appropriate assent form (in accordance with applicable regulations) and the parent or legal guardian (or emancipated minor) that has the ability to understand the requirements of the study, provides written informed consent (including consent for the use and disclosure of research-related health information) that the participant will comply with the study protocol procedures (including required study visits).

Exclusion Criteria:

• Participants who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an Adverse events (AE) in 213560 study that could, in the opinion of the principal investigator, put the participant at undue risk.
• Have developed any other medical diseases (e.g., cardiopulmonary), laboratory abnormalities, or conditions that, in the opinion of the principal investigator, makes the participant unsuitable for the study.
• Have an estimated glomerular filtration rate as calculated by Schwartz Formula of less than 30 milliliter per minute (mL/min).
• Have an Immunoglobulin A (IgA) deficiency (IgA level <10 milli gram per deciliter [mg/dL]).

• Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed:

  1. Stable Grade 3 hypoalbuminemia due to lupus nephritis and not related to liver disease or malnutrition.
  2. Any grade proteinuria
  3. Stable Grade 3 gamma glutamyl transferase (GGT) elevation due to lupus hepatitis and not related to alcoholic liver disease, uncontrolled diabetes or viral hepatitis. If present, any abnormalities in the alanine transaminase (ALT) and/or aspartate aminotransferase (AST) must be <= Grade 2.
  4. Stable Grade 3 neutropenia; or stable Grade 3 lymphopenia; or stable Grade 3 leukopenia, due to SLE.
• Developing a positive test for Human immunodeficiency virus (HIV) antibody after inclusion into 213560, per investigator's discretion according to clinical need.
• Developing hepatitis B: Serologic evidence of Hepatitis B (HB) infection defined as Hepatitis B surface antigen positive (HBsAg+) OR Hepatitis B core antibody positive (HBcAb+) after inclusion into 213560, per investigator's discretion according to clinical need.
• Developing a positive test for Hepatitis C antibody after inclusion into 213560, per investigator's discretion according to clinical need.
• Have received a live or live-attenuated vaccine within 30 Days of Day 1.
• Are unable or unlikely, in the opinion of the investigator, to administer belimumab by SC injection and have no reliable source to administer the injection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants receiving belimumab + Standard of care (SOC); Participants will receive belimumab 200 milligrams SC injection according the Baseline body weight plus SOC.	Biological: Belimumab; Belimumab will be administered; Drug: Standard of care; Standard of care will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
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	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.	Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
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	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.	Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing >= 50 kg	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.	Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg	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.	Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
Average Serum Concentration at Steady State (Cavg,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg	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.	Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing >= 50 kg	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.	Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg	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.	Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
Minimum Serum Concentration at Steady State (Cmin,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg	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.	Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85
Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing >= 50 kg	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.	Pre-dose on Days 1, 8, and 78, and post-dose on Days 4, 81, and 85
Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 30 kg and < 50 kg	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.	Pre-dose on Days 1, 11, and 71, and post-dose on Days 4, 74, and 81
Maximum Serum Concentration During the Dosing Interval at Steady State (Cmax,ss) of Belimumab for Participants Weighing Between 15 kg and < 30 kg	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.	Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) Through Week 12	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.	Up to Week 12

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GSK Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric; Pharmacokinetics; Systemic Lupus Erythematosus; Belimumab
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care; belimumab
• Other Study ID Numbers: 217091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No