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New injection for kids with lupus shows promise in small study

NCT ID NCT05917288

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how a lupus medicine called belimumab works in Chinese children aged 5 to 17 who had already received the IV form for 48 weeks. The goal was to check the drug levels in the blood and see if switching to a shot under the skin is safe. Sixteen children took part, and the results help doctors understand the right dose for different body weights.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Jul 2023

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • GSK Investigational Site

    Beijing, 100045, China

  • GSK Investigational Site

    Changsha, 410007, China

  • GSK Investigational Site

    Hangzhou, 310052, China

  • GSK Investigational Site

    Nanjing, 210011, China

  • GSK Investigational Site

    Shanghai, 361006, China

  • GSK Investigational Site

    Suzhou, 215007, China

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