Adults 5 to 17, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events of Special Interest (AESIs) Through Week 52Primary· Up to 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 Dic
All malignancies
Group
Value
95% CI
Belimumab
0
Post-infusion systemic reactions (PISR)
Group
Value
95% CI
Belimumab
0
All infections of special interest (OI, HZ, TB, sepsis)
Group
Value
95% CI
Belimumab
2
Depression (including mood disorders and anxiety)/suicide/self-injury
Group
Value
95% CI
Belimumab
0
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) ScorePrimary· Baseline (Day 0) and Week 52
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 diseas
Group
Value
95% CI
Belimumab
44
Number of Participants With AEs and Serious Adverse Events (SAEs) Through Week 52Secondary· Up to 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 partic
AEs
Group
Value
95% CI
Belimumab
56
SAEs
Group
Value
95% CI
Belimumab
19
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each VisitSecondary· Baseline (Day 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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 diseas
Week 4
Group
Value
95% CI
Belimumab
39.8
Week 8
Group
Value
95% CI
Belimumab
51.8
Week 12
Group
Value
95% CI
Belimumab
68.9
Week 16
Group
Value
95% CI
Belimumab
69.0
Week 20
Group
Value
95% CI
Belimumab
65.4
Week 24
Group
Value
95% CI
Belimumab
68.1
Week 28
Group
Value
95% CI
Belimumab
65.7
Week 32
Group
Value
95% CI
Belimumab
67.7
Change From Baseline to Week 52 in Physician Global Assessment (PGA)Secondary· Baseline (Day 0) and Week 52
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.
Group
Value
95% CI
Belimumab
-0.931
± 0.6046
Change From Baseline to Week 52 in Parent Global Assessment (ParentGA)Secondary· Baseline (Day 0) and Week 52
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.
Group
Value
95% CI
Belimumab
-2.71
± 2.713
Change From Baseline in Average Daily Prednisone Equivalent Dose at Week 52Secondary· Baseline (Day 0) and 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 prednis
Group
Value
95% CI
Belimumab
-6.020
± 9.2970
Time to First Flare Over 52 WeeksSecondary· Up to Week 52
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
Group
Value
95% CI
Belimumab
141.0
58.0 – 333.0
Time to First Severe Flare Over 52 WeeksSecondary· Up to Week 52
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 treatm
Group
Value
95% CI
Belimumab
NA
289.0 – NA
Median Belimumab Concentration Levels at Day 0, 7, and 14 Days Post First Dose, and Pre-infusion and Post-infusion at Day 84Secondary· Days 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.
Day 0
Group
Value
95% CI
Belimumab
197.1173
141.9326 – 257.3748
Day 7
Group
Value
95% CI
Belimumab
71.3616
35.9532 – 100.5913
Day 14
Group
Value
95% CI
Belimumab
37.8585
14.5944 – 74.1679
Day 84, pre-infusion
Group
Value
95% CI
Belimumab
28.2415
2.3467 – 89.0718
Day 84, post-infusion
Group
Value
95% CI
Belimumab
238.5688
139.1862 – 357.0316
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality, SAEs, and non-serious adverse events (non-SAEs) were collected from the start of the study intervention (Day 0) up to the post-treatment follow-up visit at Week 64.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Belimumab
Serious: 20/67 (30%)
Deaths: 0/67
Serious adverse events (23 terms)
Reaction
System
Belimumab
Rash
Skin and subcutaneous tissue disorders
—
Bronchitis
Infections and infestations
—
Systemic lupus erythematosus
Musculoskeletal and connective tissue disorders
—
Headache
Nervous system disorders
—
Pyrexia
General disorders
—
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
—
COVID-19
Infections and infestations
—
Gastroenteritis
Infections and infestations
—
H1N1 influenza
Infections and infestations
—
Pneumonia
Infections and infestations
—
Upper respiratory tract infection
Infections and infestations
—
Urinary tract infection
Infections and infestations
—
Cerebral infarction
Nervous system disorders
—
Alopecia
Skin and subcutaneous tissue disorders
—
Gastrointestinal haemorrhage
Gastrointestinal disorders
—
Pulmonary arterial hypertension
Respiratory, thoracic and mediastinal disorders
—
Thrombocytopenia
Blood and lymphatic system disorders
—
Myocarditis
Cardiac disorders
—
Eyelid oedema
Eye disorders
—
Hepatic function abnormal
Hepatobiliary disorders
—
Hypogammaglobulinaemia
Immune system disorders
—
Neuromyelitis optica spectrum disorder
Nervous system disorders
—
Pancreatitis necrotising
Gastrointestinal disorders
—
Other adverse events (124 terms — click to expand)
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06716606 — A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Ass
· Phase 3
· recruiting
NCT06572384 — A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tiss
· Phase 3
· recruiting
NCT06576271 — A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Jap
· Phase 1
· recruiting
NCT04893161 — A Model About the Response of Belimumab in SLE
· Phase 4
· unknown
NCT06410833 — Belimumab After Rituximab in Resistant Primary Juvenile SS
· Phase 4
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 23 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04908865.