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

October 29, 2025 updated by: GlaxoSmithKline

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: 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 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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
Pre-dose on Days 1, 15, and 71, and post-dose on Days 4, 74, and 85

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Up to 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, GSK Clinical Trials

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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