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

NCT05917288 | Completed Phase 1 Results

• 1 other identifier: 217091
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 6

Brief Summary

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)

Conditions

Systemic Lupus Erythematosus

Keywords

Belimumab; Pediatric; Pharmacokinetics; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (1)

• Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) Through Week 12

  Up to Week 12

Study Arms (1)

Participants receiving belimumab + Standard of care (SOC)

EXPERIMENTAL

Participants will receive belimumab 200 milligrams SC injection according the Baseline body weight plus SOC.

Biological: Belimumab; Drug: Standard of care

Interventions

Belimumab BIOLOGICAL

Belimumab will be administered

Participants receiving belimumab + Standard of care (SOC)

Standard of care DRUG

Standard of care will be administered

Participants receiving belimumab + Standard of care (SOC)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• No contraceptive measures are required for male participants.
• 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).

You may not qualify if:

• 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:
• Stable Grade 3 hypoalbuminemia due to lupus nephritis and not related to liver disease or malnutrition.
• Any grade proteinuria
• 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.
• Stable Grade 3 neutropenia; or stable Grade 3 lymphopenia; or stable Grade 3 leukopenia, due to SLE.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Beijing, 100045, China

Location

GSK Investigational Site

Changsha, 410007, China

Location

GSK Investigational Site

Hangzhou, 310052, China

Location

GSK Investigational Site

Nanjing, 210011, China

Location

GSK Investigational Site

Shanghai, 361006, China

Location

GSK Investigational Site

Suzhou, 215007, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

belimumab; Standard of Care

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GSK Clinical Trials

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Click here to enter text.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: July 7, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: November 14, 2025
• Results First Posted: November 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

CN (6)