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Completed

NCT Number: NCT05917288

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

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)

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Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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).

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:
  • 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.
  • 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.

Treatment and study plan

Belimumab

Biological

Belimumab will be administered

Standard of care

Drug

Standard of care will be administered

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2023
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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