NCT05917288CompletedPhase 1
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)
Source: ClinicalTrials.gov · Last updated 14 Nov 2025
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 14 Jun 2023
- Start date
- 7 Jul 2023
- Primary completion date
- 30 Oct 2024
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Lupus (SLE)
- NCT number
- NCT05917288
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 16
- From 7 Jul 2023 to the primary completion date, 30 Oct 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received a live or live-attenuated vaccine within 30 Days of Day 1.
Other illness
- 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.
- 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.
Lab values
- 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 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.
Other
- Have an estimated glomerular filtration rate as calculated by Schwartz Formula of less than 30 milliliter per minute (mL/min).
- 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.
Who the study is looking for
- 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:
- 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).
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| - Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| - Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| - Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.