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Systemic Lupus ErythematosusPhase 4NCT04908865

Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)

A Phase 4 study testing Belimumab and Standard therapy in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be conducted to evaluate the safety, efficacy and pharmacokinetics of belimumab administered in combination with background standard therapy in pediatric participants with active SLE. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Belimumab and Standard therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
9 sitesChina
Study dates
21 Oct 2021to 13 Aug 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Participants have or have had in series, 4 or more of the American College of Rheumatology (ACR) 11 criteria for the classification of SLE.
  • Participant's age is 5 to 17 years at the time of informed consent.
  • Have active SLE disease defined as a SELENA SLEDAI score >= 8 at screening (SELENA SLEDAI scoring).
  • Have unequivocally positive autoantibody test results defined as an anti-nuclear antibody (ANA) titer >=1:80 and/or a positive anti-Double stranded deoxyribonucleic acid (dsDNA) serum antibody test.
  • Are on a stable SLE therapy at Baseline. The stable treatment at Baseline consists of corticosteroids, anti-malarials, immunosuppressive/immunomodulatory agents and Non-steroidal anti-inflammatory drugs (NSAIDs), alone or in combination, at a fixed dose for a period of at least 30 days prior to Day 0.
  • No gender restriction. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • The investigator, or a person designated by the investigator, will obtain written informed assent from each study participant or the participant's legally acceptable representative, parent(s), or legal guardian and the participant's assent, when applicable, before any study-specific activity is performed. The investigator will retain the original copy of each participant's signed assent document.

Who cannot join

  • Have an estimated glomerular filtration rate (eGFR) as calculated by Schwartz Formula of less than 30 mL/minutes.
  • Have acute severe nephritis defined as a significant worsening of renal disease (for example [e.g.], the presence of urinary sediments and other lab abnormalities) that, in the opinion of the study investigator, may lead to the participant requiring induction therapy with intravenous (IV) cyclophosphamide, Mycophenolate mofetil (MMF) or high dose corticosteroids during the first 6 months of the study.
  • Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
  • Have clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.
  • Have a planned surgical procedure or a history of any other medical disease (e.g., cardiopulmonary), laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the investigator, makes the participant unsuitable for the study.
  • Have a history of malignant neoplasm within the last 5 years.
Show all 44Show fewer
  • Have a history of a primary immunodeficiency.
  • Have an Immunoglobulin A (IgA) deficiency (IgA level less than [<]10 mg/deciliters [milligrams/dL]).
  • Have acute or chronic infections requiring management.
  • Have recent infections that, in the opinions of the investigator, makes the participant unsuitable for the study or could put the participant at undue risk.
  • Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0.
  • Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed:
  • Stable Grade 3 prothrombin time (PT) secondary to warfarin treatment.
  • Stable Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy.
  • 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 aminotransferase (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
  • Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
  • Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months or who in the investigator's judgment, poses a significant suicide risk.
  • Have received treatment with belimumab at any time.
  • Have received any of the following within 364 days of Day 0:
  • Treatment with any B-cell targeted
  • Abatacept
  • A biologic investigational agent
  • Have required 3 or more courses of systemic corticosteroids for concomitant conditions (e.g., asthma, atopic dermatitis) within 90 days of Day 0.
  • Have received any of the following within 90 days of Day 0:
  • Anti-Tumour Necrosis Factor (TNF) or anti-interleukin (IL)-6 therapy (e.g., adalimumab, etanercept, infliximab, tocilizumab certolizumab, golimumab)
  • Interleukin-1 receptor antagonist (anakinra)
  • Intravenous immunoglobulin (IVIG)
  • Plasmapheresis
  • Have received any of the following within 30 days of Day 0:
  • IV cyclophosphamide
  • A non-biologic investigational agent (30 days window OR 5 half-lives, whichever is longer)
  • Any new immunosuppressive/immunomodulatory agent, anti-malarial, NSAID
  • High dose prednisone or equivalent (>1.5 mg/kilogram/day) or any intramuscular or intravenous steroid injection.
  • Have received a live or live-attenuated vaccine within 30 days of Day 0.
  • Have active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis) requiring therapeutic intervention within 60 days of Day 0.
  • Have required renal replacement therapy (e.g., hemodialysis, peritoneal dialysis) within 90 days of Day 0 or be currently on renal replacement therapy.
  • Participation in an interventional clinical study either concurrently or within 6 months of screening. Participation in an observational study may be permitted.
  • Have a historically positive test or test positive at screening for Human immunodeficiency virus (HIV) antibody.
  • Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posteroanterior) and a positive (not indeterminate) QuantiFERON-TB Gold Plus test.
  • Hepatitis B: Serologic evidence of Hepatitis B (HB) infection defined as Hepatitis B surface antigen positive (HBsAg+) or Hepatitis B core antibody positive (HBcAb+).
  • Hepatitis C: Positive test for Hepatitis C antibody at screening.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • GSK Investigational Site

    Beijing, 100045

  • GSK Investigational Site

    Changchun, 130021

  • GSK Investigational Site

    Changsha, 410007

  • GSK Investigational Site

    Chongqing, 400014

  • GSK Investigational Site

    Hangzhou, 310052

  • GSK Investigational Site

    Nanjing, 210011

  • GSK Investigational Site

    Shanghai, 361006

  • GSK Investigational Site

    Suzhou, 215007

  • GSK Investigational Site

    Xi'an, 710054

Other trials in China

About this study

Official title: A Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients With Active Systemic Lupus Erythematosus (SLE)

This study will be conducted to evaluate the safety, efficacy and pharmacokinetics of belimumab administered in combination with background standard therapy in pediatric participants with active SLE.

Being tested
Belimumab, Standard therapy
Keywords
Pediatric, Belimumab, Pharmacokinetics, Active Systemic Lupus Erythematosus, Safety, Efficacy
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BelimumabDrug

    Belimumab will be administered.

  • Standard therapyDrug

    Standard therapy will be continued.

Study groups in NCT04908865
Study groupRoleWhat they receive
Pediatric participants receiving belimumabExperimentalNot described
Receives: Drug: Belimumab; Drug: Standard therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events of Special Interest (AESIs) Through Week 52

    An adverse event (AE) is defined as 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. AESIs included malignancies, post-infusion systemic or hypersensitivity reactions, infections (including serious infections of special interest), and depression, suicide, or self-injury. Infections of special interest included opportunistic infections (OI), herpes zoster (HZ), tuberculosis (TB), and sepsis. Number of participants with AESIs as identified by custom Medical Dictionary for Regulatory Activities (MedDRA) query has been reported.

    Measured: Up to Week 52

  2. Number of Participants With Greater Than Equal to (>=) 4 Points Reduction From Baseline to Week 52 in Safety of Estrogen in Lupus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Score

    The SELENA-SLEDAI score is a cumulative and weighted index for assessing SLE disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with a decrease of 4 points or more in the score at Week 52 compared to their Baseline score is presented.

    Measured: Baseline (Day 0) and Week 52

Secondary outcomes (15)

  1. Number of Participants With AEs and Serious Adverse Events (SAEs) Through Week 52

    An AE is defined as 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 or incapacity, is a birth defect or congenital anomaly, or other situations as per the medical or scientific judgment of the investigator. Number of participants with AEs and SAEs has been reported.

    Measured: Up to Week 52

  2. Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit

    The SELENA-SLEDAI score is a cumulative and weighted index for assessing SLE disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage of participants with a decrease of 4 points or more in the score at each visit compared to their Baseline score is presented.

    Measured: Baseline (Day 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  3. Change From Baseline to Week 52 in Physician Global Assessment (PGA)

    The PGA is used to assess the participant's current disease activity by investigator. It is collected on a 10 centimeter (cm) visual analogue scale. The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 0) and Week 52

  4. Change From Baseline to Week 52 in Parent Global Assessment (ParentGA)

    The ParentGA is used to assess the participant's overall well-being at the moment rated on a 21-numbered circle visual analog scale by the parent. The score ranges from 0 (very well) to 10 (very poorly). Higher score indicates worse effect of the illness on the child. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 0) and Week 52

  5. Change From Baseline in Average Daily Prednisone Equivalent Dose at Week 52

    The average daily prednisone equivalent dose accounted for all steroids taken IV, intramuscularly (IM), subcutaneously (SC), intradermally, and orally for both SLE and non-SLE reasons. All steroid dosages were converted to a prednisone equivalent in mg at each visit. The daily prednisone equivalent dose for a steroid was calculated as follows: collected dose of the steroid in mg multiplied by (*) conversion factor * frequency factor. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. At Baseline, the average daily prednisone equivalent dose was the sum of all prednisone doses over 7 consecutive days up to but not including Day 0, divided by 7. The average daily prednisone dose at Week 52 visit was the sum of all prednisone doses over 7 consecutive days up to and including the Week 52 visit, divided by 7. Average daily prednisone equivalent dose was expressed in milligrams per day.

    Measured: Baseline (Day 0) and Week 52

  6. Time to First Flare Over 52 Weeks

    The SLE flare index (SFI) is used to categorize SLE flares as mild/moderate or severe. A mild/moderate SFI flare involves: a SELENA-SLEDAI score increase of 3 to 12 points (higher score means greater disease activity); SLE symptom development; prednisone dose increase (but not above 0.5 milligrams per kilogram per day [mg/kg/day]); non-steroidal anti-inflammatory drugs (NSAIDs)/hydroxychloroquine addition; or PGA score increase by 1 or more, but not to more than 2.5 (higher score means greater disease activity). A severe SFI flare involves: SELENA-SLEDAI score increase over 12 points; onset or worsening of severe SLE symptoms; prednisone dose increase above 0.5 mg/kg/day; introduction of potent immunosuppressants; hospitalization; or PGA score reaching 2.5 or higher. Time to first SLE flare (mild/moderate or severe) was the number of days from treatment start date until the participant met an event. Time to first flare was defined as event date minus treatment start date plus 1.

    Measured: Up to Week 52

  7. Time to First Severe Flare Over 52 Weeks

    The SFI is used to categorize SLE flares as mild/moderate or severe. A severe SFI flare involves SELENA-SLEDAI score increase over 12 points (higher score means greater disease activity), onset or worsening of severe SLE symptoms, prednisone dose increase above 0.5 mg/kg/day, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher (higher score means higher disease activity). Time to first severe SLE flare was the number of days from treatment start date until the participant met an event. Time to first severe flare was defined as event date minus treatment start date plus 1.

    Measured: Up to Week 52

  8. Median Belimumab Concentration Levels at Day 0, 7, and 14 Days Post First Dose, and Pre-infusion and Post-infusion at Day 84

    Blood samples were collected at indicated time points for measurement of plasma concentrations of belimumab.

    Measured: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84

  9. Apparent Total Clearance of Belimumab

    Blood samples were collected at indicated time points for PK analysis of belimumab.

    Measured: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84

  10. Volume of Distribution of Belimumab

    Blood samples were collected at indicated time points for PK analysis of belimumab.

    Measured: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84

  11. Terminal Half-life (t1/2) of Belimumab

    Blood samples were collected at indicated time points for PK analysis of belimumab.

    Measured: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84

  12. Maximum Plasma Concentration (Cmax) of Belimumab at Steady State

    Blood samples were collected at indicated time points for PK analysis of belimumab.

    Measured: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84

  13. Minimum Plasma Concentration Reached Prior to Administration of Next Dose (Cmin) of Belimumab at Steady State

    Blood samples were collected at indicated time points for PK analysis of belimumab.

    Measured: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84

  14. Average Plasma Concentration (Cavg) of Belimumab at Steady State

    Blood samples were collected at indicated time points for PK analysis of belimumab.

    Measured: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84

  15. Area Under the Concentration Curve (AUC) of Belimumab at Steady State

    Blood samples were collected at indicated time points for PK analysis of belimumab.

    Measured: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2021
  2. Study start21 Oct 2021
  3. Primary completion23 May 2024
  4. Study completion13 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04908865
Sponsor's protocol ID
213560
Status last verified
May 2026
First submitted
26 May 2021
Last updated
11 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Belimumab and Standard therapy in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events of Special Interest (AESIs) Through Week 52 (time frame: Up to Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04908865.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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