Systemic Lupus ErythematosusPhase 2NCT04179032
Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)
A Phase 2 study testing Belimumab in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 11 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and pharmacodynamics (PD) of repeat doses of 200 milligrams per milliliter (mg/mL) belimumab administered via SC injection in pediatric participants 5 to 17 years of age with SLE on a background of standard of care therapy. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 11 sitesin 7 countries
- Study dates
- 28 Nov 2019to 30 Sep 2027
- Phase
- Phase 2
- 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
- Participant must be between 5 and 17 years of age inclusive, at the time of Day 1.
- Participants who meet the 1997 American College of Rheumatology (ACR) criteria for the classification of SLE;
- Have or have had in series 4 or more of the 11 ACR criteria for the classification of SLE.
- Have active SLE disease defined as a safety of estrogen in lupus erythematosus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score >=6 at screening.
- Have documented positive autoantibody test results within the study screening period, defined as an anti-nuclear antibody (ANA) titre >= 1:80 and/or a positive anti-dsDNA (>=30 international units per milliliter [IU/mL]) serum antibody test based on either the study's central laboratory results or the local laboratory results. Only unequivocally positive values as defined in the laboratory's reference range are acceptable; borderline values will not be accepted
- Are on a stable SLE treatment regimen, "Stable treatment at Baseline" consists of any of the following medications (alone or in combination) administered for a period of at least 30 days prior to Day 1;
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- Corticosteroids [prednisone or prednisone equivalent up to 0.5 milligram per kilogram per day (mg/kg/day)], for those participants on alternating day doses of steroids, use the average of 2 daily doses to calculate the average daily steroid dose.
- Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), calcineurin inhibitors (e.g. tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine or thalidomide.
- Anti-malarials (e.g. hydroxychloroquine, chloroquine, quinacrine).
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- New SLE therapy must not be added within 30 days of Day 1.
- Body weight >=15 kg.
- Male and/or female;
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- No contraceptive measures are required for male participants.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies, Is not a woman of childbearing potential (WOCBP) or Is a WOCBP and is using a contraceptive method that is highly effective, with a failure rate of <1%, during the belimumab treatment period and for at least 16 weeks, corresponding to the time needed to eliminate any study intervention(s) (e.g., 5 terminal half-lives), after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
- A WOCBP must have a negative highly sensitive pregnancy test (serum or as required by local regulations) within 35 days before the first dose of belimumab.
- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- 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).
Who cannot join
- Have an estimated glomerular filtration rate (eGFR) as calculated by Schwartz Formula of less than 30 milliliter/minute (mL/min).
- Have acute severe nephritis defined as significant renal disease (e.g., the presence of urinary sediments and other laboratory abnormalities) that, in the opinion of the study investigator, may lead to the participant requiring induction therapy during the first 12 weeks of the trial.
- Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoetic stem cell/marrow transplant.
- Have 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) 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.
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- Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months, or who in the investigator's opinion, pose a significant suicide risk.
- Have a history of a primary immunodeficiency.
- Have an immunoglobulin A (IgA) deficiency (IgA level <10 milligrams per deciliter [mg/dL]).
- Have acute or chronic infections requiring management, as follows;
- Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria).
- Use of parenteral [IV or Intramuscular (IM)] antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) for infection within 60 days of Day 1.
- Have a Grade 3 or greater laboratory abnormality based on the protocol defined adverse event and laboratory value severity grade 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 amininotransferase (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 ever received treatment with belimumab.
- Have received any of the following within 364 days of Day 1;
- Treatment with any B-cell targeted therapy [e.g., rituximab, other anti-CD20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], B lymphocyte stimulator (BLyS)-receptor fusion protein [BR3], transmembrane activator attached to the Fc portion of an immunoglobulin [TACI Fc]).
- Abatacept.
- Any 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 1 (topical or inhaled steroids are permitted).
- Have received any of the following within 90 days of Day 1;
- Anti-tumor necrosis factor (TNF) therapy (e.g., adalimumab, etanercept, infliximab).
- Interleukin-1 receptor antagonist (anakinra).
- Intravenous immunoglobulin (IVIG).
- Plasmapheresis.
- Have received any of the following within 30 days of Day 1;
- IV cyclophosphamide.
- A non-biologic investigational agent (30 day window or 5 half-lives, whichever is greater).
- Any new immunosuppressive/immunomodulatory agent.
- High dose prednisone or equivalent (>1.5 mg/kg/day) or any intramuscular or intravenous steroid injection.
- Have received a live or live-attenuated vaccine within 30 days of Day 1.
- 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 1.
- Have required renal replacement therapy (e.g. hemodialysis, peritoneal dialysis) within 90 days of Day 1 or are 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.
- Positive immunodeficiency virus (HIV) antibody 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 confirmed on an additional blood sample by ribonucleic acid (RNA) polymerase chain reaction (PCR) assay. Participants who are positive for Hepatitis C antibody and negative when the Hepatitis C RNA-PCR assay is performed on an additional sample will be eligible to participate. Participants who are positive for Hepatitis C antibody and have a positive result for the Hepatitis C virus (HCV) when the Hepatitis C RNA PCR assay is performed on the additional sample will not be eligible to participate. (Institution or country specific guidelines for blood sample volume limits must be followed in collection of the additional blood sample).
- Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to 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
- Children in Care: A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The determination of whether a child meets the definition of CiC should be made with the study centre staff in consultation with the responsible institutional review board (IRB)/Ethics Committee.
Trial locations and contacts
11 sites in 7 countries.
11 sites in 7 countries
Spain3 sites
GSK Investigational Site
Barcelona, 08950
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Valencia, 46026
Germany2 sites
GSK Investigational Site
Berlin, 13353
GSK Investigational Site
Saint Augustin, 53757
Japan2 sites
GSK Investigational Site
Kagoshima, 890-8520
GSK Investigational Site
Kanagawa, 216-8511
About this study
Official title: A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and pharmacodynamics (PD) of repeat doses of 200 milligrams per milliliter (mg/mL) belimumab administered via SC injection in pediatric participants 5 to 17 years of age with SLE on a background of standard of care therapy. This bridging PK study is part of an extrapolation strategy to support the use of SC belimumab in pediatric SLE participants, based on the completed adult SLE study with SC belimumab and the pediatric SLE study with intravenous (IV) belimumab. Part A is an open label 12-week treatment phase where participants will be enrolled and allocated to treatment cohorts based on their body weight at baseline. The dose and dosing regimens selected for SC administration in this pediatric population are intended to achieve a similar average exposure as observed with the weekly 200 mg SC dosing regimen in adult SLE patients. Part B is an optional 40-week open-label continuation phase, open to all participants who have completed Part A. Dosing of SC belimumab may continue at the same frequency in Part B or may require a change in frequency according to changes in participant body weight. The total duration of the study will be 68 weeks including a 12-Week open label treatment phase (Part A), an optional 40-week open-label continuation phase (Part B) and 16-week follow-up.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Belimumab
- Keywords
- Belimumab, Pediatric, Pharmacokinetics, Pharmacodynamics, Safety, Systemic lupus erythematosus
- 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.
BelimumabCombination product
Belimumab 200 mg/mL will be administered as SC injection in left or right thigh and the abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Belimumab 200 mg | Experimental | Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks. Receives: Combination Product: Belimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Belimumab Concentrations at Week 12
Blood samples were collected for measurement of serum concentrations of belimumab. Observed belimumab concentrations at Week 12 is presented.
Measured: At Week 12
Estimated Average Concentration (Cavg) of Belimumab at Steady State
Blood samples were collected for measurement of serum concentrations of belimumab at steady state. Average concentrations were analyzed and reported for all time-points from Week 1 through Week 60.
Measured: Pre dose on Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52, and Week 60
Estimated Maximum Concentration (Cmax) of Belimumab at Steady State
Blood samples were collected for measurement of serum concentrations of belimumab at steady state. Cmax was analyzed and reported for all time-points from Week 1 through Week 60.
Measured: Pre dose on Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52, and Week 60
Estimated Minimum Concentration (Cmin) of Belimumab at Steady State
Blood samples were collected for measurement of serum concentrations of belimumab at steady state. Cmin was analyzed and reported for all time-points from Week 1 through Week 60.
Measured: Pre dose on Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52, and Week 60
Secondary outcomes (10)
Number of Participants With Adverse Events (AEs)
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.
Measured: Up to Week 68
Number of Participants With Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death.
Measured: Up to Week 68
Number of Participants With Adverse Events of Special Interest (AESIs)
AESI included post-injection systemic reactions and hypersensitivity reactions, infections, malignancies, and depression/suicidality/self-injury. AESIs were followed until the event is resolved, stabilized, otherwise explained, or the participant is lost to follow-up.
Measured: Up to Week 68
Percent Change From Baseline in Complement C3 and Complement C4 at Week 12 and Week 52
Blood samples were collected from participants to assess complement C3 and complement C4 levels. Baseline status are defined as low complement [C3 less than (<) 90 milligrams per deciliter (mg/dL)] or normal/high (C3 >= 90 mg/dL) and low (C4 < 13 mg/dL) or normal/high (C4 >= 13 mg/dL) respectively. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100.
Measured: Baseline (Day 1), Week 12 and Week 52
Percent Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (dsDNA) Antibodies at Week 12 and Week 52
Blood samples were collected for anti-dsDNA- antibody biomarker analysis. Baseline status are defined as positive (Anti-dsDNA antibody >= 30 International Units Per Milliliter (IU/mL)) or negative (Anti-dsDNA antibody< 30 IU/mL). Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100.
Measured: Baseline (Day 1), Week 12 and Week 52
Percent Change From Baseline in CD19+ Total B Cells and CD20+ B Cells at Week 12 and Week 52
Blood samples were collected for biomarker analysis. B cell subsets included CD19+ total B cells and CD 20+ B cells. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100.
Measured: Baseline (Day 1), Week 12 and Week 52
Percent Change From Baseline in Naïve B Cells and Memory B Cells at Week 12 and Week 52
Blood samples were collected for biomarker analysis and included CD20+ CD27- Naïve B cells and CD20+ CD27+ memory B cell. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100.
Measured: Baseline (Day 1), Week 12 and Week 52
Percent Change From Baseline in in CD27bright CD38bright Plasma Blasts at Week 12 and Week 52
Blood samples were collected for CD27bright CD38bright Plasma blasts biomarker analysis. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100.
Measured: Baseline (Day 1), Week 12 and Week 52
Percent Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 12
Blood samples were collected for analysis of immunoglobulins: Immunoglobulin A (IgA), Immunoglobulin G (IgG), and Immunoglobulin M (IgM). Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 divided by the Baseline value X 100.
Measured: Baseline (Day 1) and Week 12
Percent Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 52
Blood samples were collected for analysis of immunoglobulins: Immunoglobulin A (IgA), Immunoglobulin A (IgG), and Immunoglobulin M (IgM). Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100.
Measured: Baseline (Day 1) and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start28 Nov 2019
- Primary completion16 Jan 2023
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohorts 1, 2, and 3 will be recruited in parallel design. In Part A participants will receive 200 mg/mL belimumab via SC injection once a week (QW) in Cohort 1, every 10 days (Q10d) in Cohort 2, and every 2 weeks (Q2W) in Cohort 3. In Part B, dosing frequency may change according to pre-defined criteria based on changes in body weight of the participant.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179032
- Sponsor's protocol ID
- 200908
- Other IDs
- 2023-509413-37-00, 2023
- Status last verified
- Jul 2026
- First submitted
- 25 Nov 2019
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Brunner HI, Anton J, Calvo-Penades I, Dimelow R, Horneff G, Kamphuis S, Marino R, van Maurik A, Minden K, Mori M, Ocran-Appiah J, Wilkinson C, Yamasaki Y, Assudani D; Pediatric Rheumatology Collaborative Study Group (PRCSG) and Paediatric Rheumatology International Trials Organisation (PRINTO) Network investigators. Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Belimumab in Pediatric Patients With Systemic Lupus Erythematosus: A Multicenter, Open-Label Trial. Arthritis Care Res (Hoboken). 2026 Jun;78(6):761-770. doi: 10.1002/acr.25700. Epub 2026 Feb 10.
PubMed 41261055
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT04179032
- Acronym / sponsor ID
- 200908
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Belimumab, Pediatric, Pharmacokinetics, Pharmacodynamics, Safety, Systemic lupus erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Posted 26 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and pharmacodynamics (PD) of repeat doses of 200 milligrams per milliliter (mg/mL) belimumab administered via SC injection in pediatric participants 5 to 17 years of age with SLE on a background of standard of care therapy. This bridging PK study is part of an extrapolation strategy to support the use of SC belimumab in pediatric SLE participants, based on the completed adult SLE study with SC belimumab and the pediatric SLE study with intravenous (IV) belimumab. Part A is an open label 12-week treatment phase where participants will be enrolled and allocated to treatment cohorts based on their body weight at baseline. The dose and dosing regimens selected for SC administration in this pediatric population are intended to achieve a similar average exposure as observed with the weekly 200 mg SC dosing regimen in adult SLE patients. Part B is an optional 40-week open-label continuation phase, open to all participants who have completed Part A. Dosing of SC belimumab may continue at the same frequency in Part B or may require a change in frequency according to changes in participant body weight. The total duration of the study will be 68 weeks including a 12-Week open label treatment phase (Part A), an optional 40-week open-label continuation phase (Part B) and 16-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohorts 1, 2, and 3 will be recruited in parallel design. In Part A participants will receive 200 mg/mL belimumab via SC injection once a week (QW) in Cohort 1, every 10 days (Q10d) in Cohort 2, and every 2 weeks (Q2W) in Cohort 3. In Part B, dosing frequency may change according to pre-defined criteria based on changes in body weight of the participant.
| Arm | Type | Receives |
|---|---|---|
| Belimumab 200 mg | Experimental | Combination Product: BelimumabParticipants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- Participant must be between 5 and 17 years of age inclusive, at the time of Day 1.
- Participants who meet the 1997 American College of Rheumatology (ACR) criteria for the classification of SLE;
- Have active SLE disease defined as a safety of estrogen in lupus erythematosus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score >=6 at screening.
- Have documented positive autoantibody test results within the study screening period, defined as an anti-nuclear antibody (ANA) titre >= 1:80 and/or a positive anti-dsDNA (>=30 international units per milliliter [IU/mL]) serum antibody test based on either the study's central laboratory results or the local laboratory results. Only unequivocally positive values as defined in the laboratory's reference range are acceptable; borderline values will not be accepted
- Are on a stable SLE treatment regimen, "Stable treatment at Baseline" consists of any of the following medications (alone or in combination) administered for a period of at least 30 days prior to Day 1;
Key exclusion criteria (46 listed)
- Have an estimated glomerular filtration rate (eGFR) as calculated by Schwartz Formula of less than 30 milliliter/minute (mL/min).
- Have acute severe nephritis defined as significant renal disease (e.g., the presence of urinary sediments and other laboratory abnormalities) that, in the opinion of the study investigator, may lead to the participant requiring induction therapy during the first 12 weeks of the trial.
- Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoetic stem cell/marrow transplant.
- Have 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) 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelimumabBelimumab 200 mg/mL will be administered as SC injection in left or right thigh and the abdomen. | Combination product | Belimumab 200 mg |
Primary outcome
Observed Belimumab Concentrations at Week 12
Time frame: At Week 12
Blood samples were collected for measurement of serum concentrations of belimumab. Observed belimumab concentrations at Week 12 is presented.
Estimated Average Concentration (Cavg) of Belimumab at Steady State
Time frame: Pre dose on Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52, and Week 60
Blood samples were collected for measurement of serum concentrations of belimumab at steady state. Average concentrations were analyzed and reported for all time-points from Week 1 through Week 60.
Estimated Maximum Concentration (Cmax) of Belimumab at Steady State
Time frame: Pre dose on Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52, and Week 60
Blood samples were collected for measurement of serum concentrations of belimumab at steady state. Cmax was analyzed and reported for all time-points from Week 1 through Week 60.
Estimated Minimum Concentration (Cmin) of Belimumab at Steady State
Time frame: Pre dose on Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52, and Week 60
Blood samples were collected for measurement of serum concentrations of belimumab at steady state. Cmin was analyzed and reported for all time-points from Week 1 through Week 60.
10 secondary outcomes
Number of Participants With Adverse Events (AEs)
Time frame: Up to Week 68
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to Week 68
Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Up to Week 68
Percent Change From Baseline in Complement C3 and Complement C4 at Week 12 and Week 52
Time frame: Baseline (Day 1), Week 12 and Week 52
Percent Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (dsDNA) Antibodies at Week 12 and Week 52
Time frame: Baseline (Day 1), Week 12 and Week 52
Percent Change From Baseline in CD19+ Total B Cells and CD20+ B Cells at Week 12 and Week 52
Time frame: Baseline (Day 1), Week 12 and Week 52
Percent Change From Baseline in Naïve B Cells and Memory B Cells at Week 12 and Week 52
Time frame: Baseline (Day 1), Week 12 and Week 52
Percent Change From Baseline in in CD27bright CD38bright Plasma Blasts at Week 12 and Week 52
Time frame: Baseline (Day 1), Week 12 and Week 52
Percent Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 12
Time frame: Baseline (Day 1) and Week 12
Percent Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 52
Time frame: Baseline (Day 1) and Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41261055Brunner HI, Anton J, Calvo-Penades I, Dimelow R, Horneff G, Kamphuis S, Marino R, van Maurik A, Minden K, Mori M, Ocran-Appiah J, Wilkinson C, Yamasaki Y, Assudani D; Pediatric Rheumatology Collaborative Study Group (PRCSG) and Paediatric Rheumatology International Trials Organisation (PRINTO) Network investigators. Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Belimumab in Pediatric Patients With Systemic Lupus Erythematosus: A Multicenter, Open-Label Trial. Arthritis Care Res (Hoboken). 2026 Jun;78(6):761-770. doi: 10.1002/acr.25700. Epub 2026 Feb 10.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
11 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belimumab in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 11 sites in 7 countries.
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 19 inclusion and 46 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, Germany, Japan, United States, Argentina and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Mar 2024). 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?
Observed Belimumab Concentrations at Week 12 (time frame: At Week 12). The study lists 4 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 NCT04179032, which also lists 1 linked publication.
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 19 Aug 2026.