Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000368-88 | EudraCT Number | ||
| 2024-512730-15-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Human Genome Sciences Inc., a GSK Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus
This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus (SELENA SLEDAI score ≥ 6). The study will consist of three phases: a 52-week randomized, placebo-controlled, double-blind phase; a long term open label continuation phase; and a long term safety follow up phase. The long term open label continuation and safety follow up periods will continue for at least 5 years and possibly up to 10 years from a subject's initial treatment with belimumab. Enrolment will be staggered by age cohorts to allow safety and PK interim analyses. Subjects will be randomized to belimumab 10mg/kg or placebo IV monthly dosing while continuing to receive background standard therapy throughout the study. An independent data monitoring committee (IDMC) will monitor the study as it progresses.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Placebo | Placebo Comparator | Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care. |
|
| Part A: Belimumab 10 mg/kg | Experimental | Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care. |
|
| Part B: Open-Label Belimumab | Experimental | Participants who entered Part B after completing 48 weeks of belimumab or placebo on a background of standard of care and the Week 52 assessments in Part A, received 10 mg/kg belimumab intravenously monthly up to 10 years from the first administration of belimumab. |
|
| Part C: Safety Follow-up Phase | No Intervention | Participants who entered Part C after discontinuing study intervention in Part A or Part B were included in this arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab 10 mg/kg | Drug | Belimumab was administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SLE Responder Index (SRI) Response at Week 52 | SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=12 vs. >=13). Percentage of participants with SRI response at Week 52 of Part A were reported. Intent-to-Treat Population comprised of all participants who were randomized and treated with at least one dose of study agent in Part A. One participant had missing data at Baseline and therefore, could not be included in the analysis. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Meeting Pediatric Rheumatology International Trials Organization (PRINTO)/ American College of Rheumatology (ACR) Juvenile SLE Response Evaluation Criteria for Improvement in Juvenile SLE at Week 52 Using Definition 1 and 2 | Percentage of participants meeting PRINTO/ACR Juvenile SLE Response Evaluation criteria for improvement in juvenile SLE using two different PRINTO/ACR Juvenile SLE Response Evaluation definitions of improvement that is Definition 1: At least 50% improvement in any 2 of 5 endpoints below and no more than 1 of the remaining worsening by more than 30% and Definition 2: At least 30% improvement in 3 of 5 endpoints below and no more than 1 of the remaining worsening more than 30%. Endpoints were: 1. Percent change in Parent's Global Assessment (ParentGA) at Week 52, 2. Percent change in PGA at Week 52, 3. Percent change in SELENA SLEDAI score at Week 52, 4. Percent change in Pediatric Quality of Life Inventory (PedsQL) physical functioning domain at Week 52, 5. Percent change in 24 hour proteinuria at Week 52 (gram/24hour equivalent by spot urine protein to creatinine ratio). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85016 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32699034 | Background | Brunner HI, Abud-Mendoza C, Viola DO, Calvo Penades I, Levy D, Anton J, Calderon JE, Chasnyk VG, Ferrandiz MA, Keltsev V, Paz Gastanaga ME, Shishov M, Boteanu AL, Henrickson M, Bass D, Clark K, Hammer A, Ji BN, Nino A, Roth DA, Struemper H, Wang ML, Martini A, Lovell D, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial. Ann Rheum Dis. 2020 Oct;79(10):1340-1348. doi: 10.1136/annrheumdis-2020-217101. Epub 2020 Jul 22. | |
| 34531304 |
Not provided
Not provided
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
A total of 93 participants were enrolled in the study. Data for Part A of the study was disclosed in 2018. This submission includes adverse event data for Parts B and C. Per protocol, long-term follow-up in Parts B and C could conclude earlier than planned once pre-defined criteria were met. 9 participants from Part B were in the study when these criteria were met.
The study consisted of three parts (Parts A, B, and C). Part A was a parallel-group study where participants could receive either belimumab or placebo. Participants who completed 48 weeks of treatment and Week 52 assessments in Part A could continue to the open label extension phase (Part B) to receive belimumab. Participants who discontinued study intervention in Part A or Part B could enter the long-term safety follow-up phase (Part C).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Placebo | Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care. |
| FG001 | Part A: Belimumab 10 mg/kg | Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2020 | Mar 26, 2026 |
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Placebo was administered |
|
|
| Week 52 |
| Percent Change From Baseline in ParentGA at Week 52 | ParentGA assesses the participant's overall well-being at the moment rated on a 21-numbered circle visual analog scale (VAS; 0 - very well, 10 - very poorly). Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. Last Observation Carried Forward (LOCF) was used. Eight participants had a score of zero at Baseline and therefore, could not be included in the analysis. | Baseline (Day 0) and Week 52 |
| Percent Change From Baseline in PGA at Week 52 | The PGA is a 10 centimeter (cm) visual analogue scale (VAS), anchored at 0 (none) and 3 (severe), designed for the physician to indicate the participant's overall disease activity at a particular visit as part of the validated SELENA SLEDAI index. Primary investigator or a subinvestigator scored the PGA for the participant, and same person evaluated the participant each time. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. LOCF was used. | Baseline (Day 0) and Week 52 |
| Percent Change From Baseline in SELENA SLEDAI at Week 52 | The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. One participant had missing data at Baseline and therefore, could not be included in the analysis. | Baseline (Day 0) and Week 52 |
| Percent Change From Baseline in PedsQL Physical Functioning Domain Score at Week 52 | The PedsQL is a generic quality of life scale validated for the pediatric population which consists of 23 items, encompassing 4 health domains: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). From the raw scores of the 23 items, a total summary score and individual domain scores can be calculated. The total and domain scores are each transformed on a 0 to 100 score with higher scores indicating higher quality of life. For Physical Functioning Domain scale, score was from 0 to 100 where, 0 indicates lower quality of life and 100 indicates greater quality of life. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline Value X 100. LOCF was used. | Baseline (Day 0) and Week 52 |
| Percent Change From Baseline in Proteinuria at Week 52 | Percent change from Baseline in proteinuria was calculated. The percent change from baseline to Week 52 in 24 hour proteinuria was analyzed using summary statistics and 95% confidence intervals, without any adjustment for covariates. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline Value X 100. LOCF was used. | Baseline (Day 0) and Week 52 |
| Percentage of Participants With a Sustained SRI Response | Sustained SRI response was defined as having a response on the primary efficacy endpoint at Weeks 44, 48, and 52. Data for percentage of participants with a sustained SRI response was presented. Drop Outs and Treatment Failures were considered Non-Responders. Only those participants with data available at specific time point were analyzed. | Up to 52 weeks |
| Percentage of Participants With a Sustained ParentGA Response | Sustained ParentGA response was defined as having >0.7 improvement at Weeks 44, 48, and 52 compared at Baseline. Data for percentage of participants with a sustained ParentGA response was presented. Thirteen participants had a score of <=0.7 at Baseline and therefore, could not be included in the analysis. | Up to 52 weeks |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported. | Up to 60 weeks |
| Maximum Concentration at Steady State (Cmax, ss) and Minimum Concentration at Steady State (Cmin, ss) | The pharmacokinetic (PK) population comprised all participants included in the As- Treated population for whom at least one post belimumab treatment PK sample was obtained and analyzed. The PK model was fitted to the observed serum concentration-time data. The maximum (Cmax) and minimum (Cmin) concentrations reported in this table are model derived values at ss, assuming a 10 mg/kg dose administered once every 28 days. | 28-days dosing interval at steady state |
| Area Under Curve of Belimumab at Steady State (AUC, ss) | The PK model was fitted to the observed serum concentration-time data. The AUC values reported in this table are model derived values at ss, assuming a 10 mg/kg dose administered once every 28 days. | 28-days dosing interval at steady state |
| 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 |
| Background |
| Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747. |
| 34628605 | Background | Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9. |
| 38775637 | Derived | Arends EJ, Zlei M, Tipton CM, Cotic J, Osmani Z, de Bie FJ, Kamerling SWA, van Maurik A, Dimelow R, Gregan YI, Fox NL, Rabelink TJ, Roth DA, Sanz I, van Dongen JJM, van Kooten C, Teng YKO. Disruption of memory B-cell trafficking by belimumab in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2024 Sep 1;63(9):2387-2398. doi: 10.1093/rheumatology/keae286. |
| 33687069 | Derived | Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2. |
| FG002 | Part B: Open-Label Belimumab | Participants who entered Part B after completing 48 weeks of belimumab or placebo on a background of standard of care and the Week 52 assessments in Part A, received 10 mg/kg belimumab intravenously monthly up to 10 years from the first administration of belimumab. |
| FG003 | Part C: Safety Follow-up Phase | Participants who entered Part C after discontinuing study intervention in Part A or Part B were included in this arm. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part B |
|
|
| Part C |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Placebo | Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care. |
| BG001 | Part A: Belimumab 10 mg/kg | Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With SLE Responder Index (SRI) Response at Week 52 | SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=12 vs. >=13). Percentage of participants with SRI response at Week 52 of Part A were reported. Intent-to-Treat Population comprised of all participants who were randomized and treated with at least one dose of study agent in Part A. One participant had missing data at Baseline and therefore, could not be included in the analysis. | Intent-to-Treat Population | Posted | Number | Percentage of participants | Week 52 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Meeting Pediatric Rheumatology International Trials Organization (PRINTO)/ American College of Rheumatology (ACR) Juvenile SLE Response Evaluation Criteria for Improvement in Juvenile SLE at Week 52 Using Definition 1 and 2 | Percentage of participants meeting PRINTO/ACR Juvenile SLE Response Evaluation criteria for improvement in juvenile SLE using two different PRINTO/ACR Juvenile SLE Response Evaluation definitions of improvement that is Definition 1: At least 50% improvement in any 2 of 5 endpoints below and no more than 1 of the remaining worsening by more than 30% and Definition 2: At least 30% improvement in 3 of 5 endpoints below and no more than 1 of the remaining worsening more than 30%. Endpoints were: 1. Percent change in Parent's Global Assessment (ParentGA) at Week 52, 2. Percent change in PGA at Week 52, 3. Percent change in SELENA SLEDAI score at Week 52, 4. Percent change in Pediatric Quality of Life Inventory (PedsQL) physical functioning domain at Week 52, 5. Percent change in 24 hour proteinuria at Week 52 (gram/24hour equivalent by spot urine protein to creatinine ratio). | Intent-to-Treat Population | Posted | Number | Percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in ParentGA at Week 52 | ParentGA assesses the participant's overall well-being at the moment rated on a 21-numbered circle visual analog scale (VAS; 0 - very well, 10 - very poorly). Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. Last Observation Carried Forward (LOCF) was used. Eight participants had a score of zero at Baseline and therefore, could not be included in the analysis. | Intent-to-Treat Population | Posted | Median | Full Range | Percent change | Baseline (Day 0) and Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in PGA at Week 52 | The PGA is a 10 centimeter (cm) visual analogue scale (VAS), anchored at 0 (none) and 3 (severe), designed for the physician to indicate the participant's overall disease activity at a particular visit as part of the validated SELENA SLEDAI index. Primary investigator or a subinvestigator scored the PGA for the participant, and same person evaluated the participant each time. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. LOCF was used. | Intent-to-Treat Population | Posted | Mean | Standard Deviation | Percent change | Baseline (Day 0) and Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in SELENA SLEDAI at Week 52 | The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. One participant had missing data at Baseline and therefore, could not be included in the analysis. | Intent-to-Treat Population | Posted | Mean | Standard Deviation | Percent change | Baseline (Day 0) and Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in PedsQL Physical Functioning Domain Score at Week 52 | The PedsQL is a generic quality of life scale validated for the pediatric population which consists of 23 items, encompassing 4 health domains: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). From the raw scores of the 23 items, a total summary score and individual domain scores can be calculated. The total and domain scores are each transformed on a 0 to 100 score with higher scores indicating higher quality of life. For Physical Functioning Domain scale, score was from 0 to 100 where, 0 indicates lower quality of life and 100 indicates greater quality of life. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline Value X 100. LOCF was used. | Intent-to-Treat Population | Posted | Median | Full Range | Percent change | Baseline (Day 0) and Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Proteinuria at Week 52 | Percent change from Baseline in proteinuria was calculated. The percent change from baseline to Week 52 in 24 hour proteinuria was analyzed using summary statistics and 95% confidence intervals, without any adjustment for covariates. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline Value X 100. LOCF was used. | Intent-to-Treat Population | Posted | Median | Full Range | Percent change | Baseline (Day 0) and Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Sustained SRI Response | Sustained SRI response was defined as having a response on the primary efficacy endpoint at Weeks 44, 48, and 52. Data for percentage of participants with a sustained SRI response was presented. Drop Outs and Treatment Failures were considered Non-Responders. Only those participants with data available at specific time point were analyzed. | Intent-to-Treat Population | Posted | Number | Percentage of participants | Up to 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Sustained ParentGA Response | Sustained ParentGA response was defined as having >0.7 improvement at Weeks 44, 48, and 52 compared at Baseline. Data for percentage of participants with a sustained ParentGA response was presented. Thirteen participants had a score of <=0.7 at Baseline and therefore, could not be included in the analysis. | Intent-to-Treat Population | Posted | Number | Percentage of participants | Up to 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported. | Intent-to-Treat Population | Posted | Count of Participants | Participants | Up to 60 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration at Steady State (Cmax, ss) and Minimum Concentration at Steady State (Cmin, ss) | The pharmacokinetic (PK) population comprised all participants included in the As- Treated population for whom at least one post belimumab treatment PK sample was obtained and analyzed. The PK model was fitted to the observed serum concentration-time data. The maximum (Cmax) and minimum (Cmin) concentrations reported in this table are model derived values at ss, assuming a 10 mg/kg dose administered once every 28 days. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | 28-days dosing interval at steady state |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under Curve of Belimumab at Steady State (AUC, ss) | The PK model was fitted to the observed serum concentration-time data. The AUC values reported in this table are model derived values at ss, assuming a 10 mg/kg dose administered once every 28 days. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Days*micrograms per milliliter | 28-days dosing interval at steady state |
|
|
Part A: From start of study intervention (Day 0) up to Week 60. Part B: From first dose of belimumab (Part A Day 0 for participants randomized to belimumab in Part A; Part A Week 52 for participants randomized to placebo in Part A) up to approximately 10.3 years. Part C: From Part C Day 1 (exit visit from Part A or B, or 28 days after last belimumab infusion in Part B) up to 12 weeks for non-SAEs and up to 10 years for SAEs.
Part A: Intent-to-Treat Population. Part B: Safety Population for Part B included all participants who completed Part A and received a dose of open-label belimumab at Week 52. Part C: Safety Population for Part C included all participants who received belimumab and completed an Exit Visit in either Part A or B and hence entered Part C of the trial. SAEs and non-SAEs were coded to Medical Dictionary for Regulatory Activity (MedDRA) version 20.1 for Part A and version 28.0 for Part B and Part C.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: Placebo | Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care. | 1 | 40 | 14 | 40 | 27 | 40 |
| EG001 | Part A: Belimumab 10 mg/kg | Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care. | 0 | 53 | 9 | 53 | 36 | 53 |
| EG002 | Part B: Open-Label Belimumab | Participants who entered Part B after completing 48 weeks of belimumab or placebo on a background of standard of care and the Week 52 assessments in Part A, received 10 mg/kg belimumab intravenously monthly up to 10 years from the first administration of belimumab. | 1 | 75 | 30 | 75 | 71 | 75 |
| EG003 | Part C: Safety Follow-up Phase | Participants who entered Part C after discontinuing study intervention in Part A or Part B were included in this arm. | 2 | 38 | 13 | 38 | 3 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Pleuropericarditis | Cardiac disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Retinal vasculitis | Eye disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Vasculitis gastrointestinal | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Ovarian abscess | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Puerperal infection | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Vulval abscess | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Blood immunoglobulin G decreased | Investigations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Lupus myositis | Musculoskeletal and connective tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| SLE arthritis | Musculoskeletal and connective tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Idiopathic intracranial hypertension | Nervous system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Lupus nephritis | Renal and urinary disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Breast enlargement | Reproductive system and breast disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Blood immunoglobulin G decreased | Investigations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Vascular headache | Nervous system disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Lupus nephritis | Renal and urinary disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v20.1; v28.0 | Systematic Assessment |
|
This submission adds adverse event data for Parts B and C. The previously posted Part A results are otherwise unchanged, except for a minor cosmetic change. The Statistical Analysis Plan for Part A has not been amended since the 2018 (Part A results) submission. Protocol Amendment 8, included with this submission, has not been amended for Part A of the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 30, 2025 | Mar 26, 2026 | SAP_003.pdf |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C511911 | belimumab |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Adverse Event |
|
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Long-term follow-up concluded early per pre-defined protocol criteria |
|
| Physician Decision |
|
| Lost to Follow-up |
|
| Adverse Event |
|
| Male |
|
| Asian |
|
| African American/African Heritage |
|
| American Indian or Alaskan Native |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| Participants |
|
|
|
|