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New hope for kids with lupus: drug trial shows promise

NCT ID NCT01649765

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the drug belimumab in children aged 5 to 17 with active lupus. Participants received either belimumab or a placebo alongside their usual treatments. The goal was to see if belimumab could safely reduce lupus disease activity over 52 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
belimumab (a drug that targets a protein involved in lupus)
What this could lead to
If successful, this could provide a new treatment option to help control lupus in children, reducing disease flares and improving quality of life.
What could go wrong
This is a Phase 2 trial with only 93 participants, so results are preliminary. The drug may not work better than placebo, and side effects like infections are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

93 people

The number who actually took part.

Started

Sep 2012

Finished

Sep 2025

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: * 5 years to 17 years of age at enrollment * Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria. * Have active SLE disease (SELENA SLEDAI score ≥ 6). * Have positive anti-nuclear antibody (ANA) test results. * Are on a stable SLE treatment regimen at a fixed dose for a period of at least 30 days prior to Day 0. * Females of childbearing age are willing to use appropriate contraception * Subject age appropriate assent and parent or legal guardian informed consent to participate Exclusion Criteria: * Pregnant or nursing. * Have received treatment with belimumab (BENLYSTA®) at any time. (BENLYSTA® is a registered trademark of the GSK group of companies.) * Treatment with any B cell targeted therapy (for example, rituximab) or an investigational biological agent in the past year. * Have received anti-TNF therapy; Interleukin-1 receptor antagonist; IVIG; or plasmapheresis within 90 days of Day 0. * Have received high dose prednisone or equivalent (\>1.5mg/kg/day) within 60 days of baseline. * Have received intravenous (IV) cyclophosphamide within 60 days of Day 0. * Have received any new immunosuppressive/immunomodulatory agent, anti-malarial agent within 60 days of baseline. * Have severe lupus kidney disease. * Have active central nervous system (CNS) lupus. * Have had a major organ transplant. * Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE. * Have a planned surgical procedure. * History of malignant neoplasm within the last 5 years. * Have required management of acute or chronic infections in the past 60 days. * Have current drug or alcohol abuse or dependence. * Have a historically positive test, or test positive at screening for HIV, Hepatitis B, or Hepatitis C. * Have an IgA deficiency. * Have severe laboratory abnormalities. * Have had anaphylactic reaction to X-ray contrast agents or biologic agents. * Suicidal behavior or ideation. * Children in Care(CiC): a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

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

Systemic lupus erythematosus

Contacts and locations

Locations

  • GSK Investigational Site

    Phoenix, Arizona, 85016, United States

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20010, United States

  • GSK Investigational Site

    Augusta, Georgia, 30912, United States

  • GSK Investigational Site

    St Louis, Missouri, 63104, United States

  • GSK Investigational Site

    New York, New York, 10032, United States

  • GSK Investigational Site

    The Bronx, New York, 10467, United States

  • GSK Investigational Site

    Cincinnati, Ohio, 45229, United States

  • GSK Investigational Site

    Buenos Aires, C1270AAN, Argentina

  • GSK Investigational Site

    Rosario, 2000, Argentina

  • GSK Investigational Site

    Santa Fe, 5400, Argentina

  • GSK Investigational Site

    Calgary, Alberta, T3B 6A8, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 1X8, Canada

  • GSK Investigational Site

    Aichi, 474-8710, Japan

  • GSK Investigational Site

    Kagoshima, 890-8520, Japan

  • GSK Investigational Site

    Miyagi, 989-3126, Japan

  • GSK Investigational Site

    Tokyo, 113-8519, Japan

  • GSK Investigational Site

    San Luis Potosí City, 78240, Mexico

  • GSK Investigational Site

    Lima, Lima 27, Peru

  • GSK Investigational Site

    Lima, Lima 5, Peru

  • GSK Investigational Site

    Surco, Lima 33, Peru

  • GSK Investigational Site

    Lodz, 91-738, Poland

  • GSK Investigational Site

    Warsaw, 02-637, Poland

  • GSK Investigational Site

    Moscow, 119435, Russia

  • GSK Investigational Site

    Saint Petersburg, 194100, Russia

  • GSK Investigational Site

    Tolyatti, 445846, Russia

  • GSK Investigational Site

    Espluges de Llobregat, 08950, Spain

  • GSK Investigational Site

    Madrid, 28034, Spain

  • GSK Investigational Site

    Valencia, 46026, Spain

  • GSK Investigational Site

    Bristol, BS2 8BJ, United Kingdom

  • GSK Investigational Site

    Liverpool, L12 2AP, United Kingdom

  • GSK Investigational Site

    London, NW1 2PG, United Kingdom

  • GSK Investigational Site

    London, WC1N 3JH, United Kingdom

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