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

NCT ID: NCT05917288

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-07
• Study Completion Date: 2024-10-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants receiving belimumab + Standard of care (SOC)

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

Group Type: EXPERIMENTAL

Belimumab

Intervention Type: BIOLOGICAL

Belimumab will be administered

Standard of care

Intervention Type: DRUG

Standard of care will be administered

Interventions

Belimumab

Belimumab will be administered

Intervention Type: BIOLOGICAL

Standard of care

Standard of care will be administered

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GSK Clinical Trials

Locations

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Changsha, , China

GSK Investigational Site

Hangzhou, , China

GSK Investigational Site

Nanjing, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Suzhou, , China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

217091

Identifier Type: -

Identifier Source: org_study_id