Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02880852
• Collaborator: (none)
• Enrollment: 20
• Locations: 2
• Arm: 1
• Actual Duration (Months): 7.5
• Patients Per Site: 10
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

In China, Belimumab (GSK1550188) will be developed for a dosing regimen of once-monthly intravenous (IV) infusion for the treatment of SLE. This open-label, single dose study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of belimumab in Chinese SLE subjects. A total of approximately 20 subjects will be enrolled to receive IV infusion of 10 milligrams per kilogram (mg/kg) GSK1550188 on Day 0 for the treatment of SLE. Subjects will be followed for 84 days after the administration of drug.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: Belimumab	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1550188 in Chinese Subjects With Systemic Lupus Erythematosus (SLE)
• Actual Study Start Date: Jan 23, 2017
• Actual Primary Completion Date: Sep 8, 2017
• Actual Study Completion Date: Sep 8, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Belimumab 10 mg/kg In this open label study, a single dose of 10 mg/kg Belimumab will be administered intravenously in Chinese subjects with systemic lupus erythematosus.	Drug: Belimumab; Belimumab will be provided as white uniform lyophilized cake in vials with unit dose strength of 400 mg/vial plus excipients (citric acid/sodium citrate/sucrose/polysorbate) for reconstitution in 4.8 milliliter sterile water for injection (SWFI). Belimumab will be administered as 10 mg/kg intravenous infusion for over 1 hour on Day 0.

Outcome Measures

Primary Outcome Measures

1. Maximum Observed Concentration (Cmax) of Belimumab [Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose]

   Blood samples were collected at the indicated timepoints to calculate Cmax of belimumab.

2. Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0 to t]) and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0 to Inf]) of Belimumab [Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose]

   Blood samples were collected at the indicated timepoints to calculate AUC (0 to t) and AUC (0 to inf) of belimumab.

3. Terminal Phase Half-life (t1/2) of Belimumab [Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose]

   Blood samples were collected at the indicated time points to calculate t1/2 of belimumab.

4. Terminal Phase Rate Constant (Lambda z) of Belimumab [Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose]

   Blood samples were collected at the indicated time points to calculate lambda z of belimumab.

5. Systemic Clearance (CL) of Belimumab [Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose]

   Blood samples were collected at the indicated time points to calculate CL of belimumab.

6. Volume of Distribution (Vz) of Belimumab [Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose]

   Blood samples were collected at the indicated time points to calculate Vz of belimumab.

7. Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [Up to Day 84]

   AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant, or associated with liver injury and impaired liver function.

Secondary Outcome Measures

1. Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [Baseline (pre-dose on Day 0) to Day 84]

   Vital signs included SBP and DBP. SBP and DBP were measured with the participant in the sitting position. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.

2. Change From Baseline to Day 84 in Vital Sign- Pulse Rate [Baseline (pre-dose on Day 0) to Day 84]

   Vital signs included pulse rate. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.

3. Change From Baseline to Day 84 in Vital Sign- Temperature [Baseline (pre-dose on Day 0) to Day 84]

   Vital signs included temperature. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.

4. Number of Participants With Abnormal-clinically Significant 12-lead Electrocardiogram (ECG) Findings [Up to Day 84]

   ECG parameters included heart rate, PR interval, QRS interval, QT interval and corrected QT (QTc) interval. Number of participants with abnormal-clinically significant 12-lead ECG findings are presented.

5. Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase [Baseline (pre-dose on Day 0) to Day 84]

   Clinical chemistry parameters included ALT, ALP, AST, GGT and lactate dehydrogenase. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.

6. Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein [Baseline (pre-dose on Day 0) to Day 84]

   Clinical chemistry parameters included albumin and protein. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.

7. Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate [Baseline (pre-dose on Day 0) to Day 84]

   Clinical chemistry parameters included bilirubin, creatinine, direct bilirubin, indirect bilirubin and urate. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.

8. Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose [Baseline (pre-dose on Day 0) to Day 84]

   Clinical chemistry parameters included calcium, calcium corrected, carbon dioxide, chloride, magnesium, phosphate, potassium, sodium, urea and glucose. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.

9. Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets [Baseline (pre-dose on Day 0) to Day 84]

   Hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.

10. Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes [Baseline (pre-dose on Day 0) to Day 84]

    Hematology parameter included erythrocytes. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.

11. Change From Baseline to Day 84 in Hematology Parameter- Hematocrit [Baseline (pre-dose on Day 0) to Day 84]

    Hematology parameter included hematocrit. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.

12. Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin [Baseline (pre-dose on Day 0) to Day 84]

    Hematology parameter included hemoglobin. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.

13. Number of Participants With Positive Urinalysis Dipstick Results [Day 0 (24 hours), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84]

    Urinalysis was done by the dipstick method to detect the presence of protein, glucose, ketones and occult blood in urine. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood, urine protein and urine ketones can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample; results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per Liter (g/L), 2+ or 1/2 g/L, 3+ or 1 g/L and 4+ indicating proportional concentrations in the urine sample. *a indicates two participants did not take the urinalysis test at Day 14 on scheduled date but took an unscheduled sample at the next visit (Day 21) and *b indicates one participant did not take the urinalysis test at Day 28 on scheduled date but took an unscheduled sample at the next visit (Day 42). Only those participants with positive results have been presented.

14. Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment [Baseline (pre-dose on Day 0) to Day 84]

    Immunoglobulin B cell subsets included CD19 and CD 20+. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by [(Post-Baseline Visit Value minus Baseline) / Baseline]. Pharmacodynamic population comprised of participants who received the study medication and for whom pharmacodynamic data was available.

15. Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment [Baseline (pre-dose on Day 0) to Day 84]

    Immunoglobulin B cell subset included CD20+/27+ memory and CD20+/27-naïve. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by [(Post-Baseline Visit Value minus Baseline) / Baseline].

16. Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment [Baseline (pre-dose on Day 0) to Day 84]

    Immunoglobulin B cell subset inlcuded Norm CD19+/27Br/38Br SLE subset, Norm CD20+/138+plasmacytoid, Norm CD20+/69+activated and Norm CD20-/CD138+plasma cell. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by [(Post-Baseline Visit Value minus Baseline) / Baseline].

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects who give consent to this study participation and sign informed consent form.

• Subjects at least 18 years of age inclusive at screening visit.

• SLE Classification: Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria, with 4 or more of the 11 ACR criteria present, serially or simultaneously during any interval or observation.

• SLE Treatment: Be on either no SLE medication or a stable SLE treatment regimen of any medication (alone or in combination) for a period of at least 2 months prior to Day 0; corticosteroids (prednisone or prednisone equivalent, up to 40 mg/day); immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), mizoribine, calcineurin inhibitors (example [e.g.], tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine, or thalidomide; anti-malarials (e.g., hydroxychloroquine, chloroquine, quinacrine) and non-steroidal anti-inflammatory drugs (NSAIDs).

• The subjects with positive test for anti-nuclear antibody (ANA) or anti-double stranded deoxyribonucleic acid (DNA) serum antibody.

• Males and females: A female subject is eligible to enter the study if she is: not pregnant or nursing; of non-childbearing potential (i.e., women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to one of the following: complete abstinence from penile-vaginal intercourse, when this is the female's preferred and usual lifestyle, from 2 weeks prior to administration of the 1st dose of investigational product (IP) until study complete; or consistent and correct use of one of the following acceptable methods of birth control for 1 month prior to the start of the IP and for 16 weeks after the last dose of IP: any intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1 percent (%) per year; oral contraceptives; double barrier method with vaginal spermicidal agent: condom and an occlusive cap (cervical cap/vault or diaphragm) with a vaginal spermicidal agent (foam/gel/film/cream/suppository); implants of etonogestrel or levonorgestrel; estrogenic vaginal ring; injectable progesterone; percutaneous contraceptive patch; male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subject.

• Based on single or averaged corrected QT (QTc) interval values of triplicate ECGs obtained over a brief recording period: [QTc corrected by Bazett's (QTcB) or QTc corrected by Fridericia's (QTcF) formula] <450 milliseconds (msec); or QTcB or QTcF <480 msec in subjects with bundle branch block.

Exclusion Criteria:

• B-cell Therapy: Have received treatment with any B cell targeted therapy (e.g., rituximab, other anti-CD20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], Transmembrane activator and calcium-modulator and cytophilin ligand interactor [TACI] Fc, or belimumab) at any time.

• The subject has received a biologic investigational or non-investigational agent within 12 months prior to Day 0.

• Received IV immunoglobulin (Ig), plasmapheresis, hemodialysis, intravenous cyclophosphamide, or high dose prednisone and its equivalents (>60 mg/day) within 6 months prior to Day 0.

• The subject has received a non-biologic investigational agent within 2 months prior to Day 0.

• The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational agent.

• The subject has severe lupus kidney disease (defined by proteinuria >6 grams [g]/24 hours) within 6 months prior to the Screening visit.

• History of renal transplant.

• Active central nervous system (CNS) lupus [including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), motor neuropathy, vasculitis] requiring medical intervention within 6 months prior to Screening visit.

• Infections: Have required management of acute or chronic infections, as follows: currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria); hospitalization for treatment of infection within 2 months prior to Day 0; use of parenteral (IV or intramuscular [IM]) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 2 months prior to Day 0.

• The subject has hypogammaglobulinemia or immunoglobulin A (IgA) deficiency (IgA level <10 mg/deciliter [dL]).

• Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.

• Uncontrolled other diseases: History or clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.

• Have a planned surgical procedure, or a history of any other medical disease, or laboratory abnormalities, or conditions which would make the subject (in the opinion of the Investigator) unsuitable for the study.

• The subject has an abnormality on 12-lead ECG at screening which is clinically significant in the opinion of the investigator.

• Have evidence of current drug or alcohol abuse or dependence.

• AST and ALT >=2x upper limit of normal (ULN); ALP and bilirubin >1.5xULN (isolated bilirubin >1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

• Have a historically positive human immunodeficiency virus (HIV) test or test positive at screening for HIV.

• History of or positive test at screening visit for any of Hepatitis B surface antigen (HBsAg), anti- Hepatitis B core antibody (HBcAb) or anti-hepatitis C virus antibodies (HCVAb). If only anti-HBcAb result is positive, hepatitis B virus (HBV)-(DNA) test will be performed. If HBV-DNA results in negative, the patient is eligible.

• Laboratory Abnormalities: Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed:

• Stable Grade 3 prothrombin time (PT) secondary to warfarin treatment.

• Stable Grade 3/4 proteinuria (=<6 g/24 hour equivalent by spot urine protein to creatinine ratio allowed).

• Stable Grade 3 hypoalbuminemia due to lupus nephritis, and not related to liver disease or malnutrition.

• Stable Grade 3 neutropenia or stable Grade 3 white blood cell count.

• Subjects who 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Shanghai		China
2	GSK Investigational Site	Suzhou		China	215004

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Mar 15, 2017
• Statistical Analysis Plan - May 2, 2017

More Information

Publications

• Zhang J, Wan W, Miao L, Wu J, Dong J, Shen Y, Xiong C, Li C, Xue Y, Cao G, Ma P. Pharmacokinetics, Pharmacodynamics and Safety of Belimumab in Chinese Patients with Systemic Lupus Erythematosus: A Phase I, Open-Label Study. Rheumatol Ther. 2020 Mar;7(1):191-200. doi: 10.1007/s40744-020-00193-9. Epub 2020 Jan 17.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02880852
• Other Study ID Numbers: 200909
• First Posted: Aug 26, 2016
• Last Update Posted: Mar 27, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GlaxoSmithKline: Systemic Lupus Erythematosus; Belimumab; Pharmacodynamics; safety tolerability; Pharmacokinetics; Chinese subjects
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic; Belimumab

Study Results

Participant Flow

Recruitment Details	A total of 20 participants with Systemic Lupus Erythematosus (SLE) were enrolled. The study was conducted at 2 centers in China from 23-Jan-2017 to 08-Sep-2017.
Pre-assignment Detail	A total of 25 participants were screened, of which 5 participants were screen failures. The reason for screen failures were: did not meet inclusion/exclusion criteria (4 participants) and investigator discretion (1 participant).

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 milligrams (mg) per kilogram (kg) as intravenous infusion for over an hour on Day 0.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Overall Participants	20
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	37.4 (14.07)
Sex: Female, Male (Count of Participants)
Female	16 80%
Male	4 20%
Race/Ethnicity, Customized (Count of Participants)
Asian - East Asian Heritage	20 100%

Outcome Measures

1. Primary Outcome

Title	Maximum Observed Concentration (Cmax) of Belimumab
Description	Blood samples were collected at the indicated timepoints to calculate Cmax of belimumab.
Time Frame	Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) Parameter Population, which comprised of all those participants who received a dose of belimumab and for whom PK parameters could be calculated.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Geometric Mean (Geometric Coefficient of Variation) [Micrograms per milliliter]	221.3532 (12.8405)

2. Primary Outcome

Title	Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0 to t]) and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0 to Inf]) of Belimumab
Description	Blood samples were collected at the indicated timepoints to calculate AUC (0 to t) and AUC (0 to inf) of belimumab.
Time Frame	Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
AUC(0 to t)	2395.3030 (23.2924)
AUC(0 to inf)	2461.8013 (24.7125)

3. Primary Outcome

Title	Terminal Phase Half-life (t1/2) of Belimumab
Description	Blood samples were collected at the indicated time points to calculate t1/2 of belimumab.
Time Frame	Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Geometric Mean (Geometric Coefficient of Variation) [Days]	14.6283 (35.4339)

4. Primary Outcome

Title	Terminal Phase Rate Constant (Lambda z) of Belimumab
Description	Blood samples were collected at the indicated time points to calculate lambda z of belimumab.
Time Frame	Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Geometric Mean (Geometric Coefficient of Variation) [1/day]	0.0474 (35.4339)

5. Primary Outcome

Title	Systemic Clearance (CL) of Belimumab
Description	Blood samples were collected at the indicated time points to calculate CL of belimumab.
Time Frame	Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Geometric Mean (Geometric Coefficient of Variation) [(Milliliters/day)/kilogram]	4.0621 (24.7125)

6. Primary Outcome

Title	Volume of Distribution (Vz) of Belimumab
Description	Blood samples were collected at the indicated time points to calculate Vz of belimumab.
Time Frame	Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Geometric Mean (Geometric Coefficient of Variation) [Milliliters/kilogram]	85.7265 (21.6704)

7. Primary Outcome

Title	Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Description	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant, or associated with liver injury and impaired liver function.
Time Frame	Up to Day 84

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
AE	12 60%
SAE	1 5%

8. Secondary Outcome

Title	Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Description	Vital signs included SBP and DBP. SBP and DBP were measured with the participant in the sitting position. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline (pre-dose on Day 0) to Day 84

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
DBP: Day 0 (5 minutes post-dose)	-0.5 (6.35)
DBP: Day 0 (1 hour post-dose)	-1.5 (12.51)
DBP: Day 0 (6 hours post-dose)	-2.1 (8.57)
DBP: Day 0 (24 hours post-dose)	-0.1 (7.95)
DBP: Day 1	2.2 (8.37)
DBP: Day 7	1.1 (7.91)
DBP: Day 14	0.5 (8.65)
DBP: Day 21	0.1 (6.91)
DBP: Day 28	0.2 (8.86)
DBP: Day 42	-3.2 (7.99)
DBP: Day 56	-0.8 (8.85)
DBP: Day 84	-0.6 (11.06)
SBP: Day 0 (5 minutes post-dose)	0.8 (9.92)
SBP: Day 0 (1 hour post-dose)	-2.5 (11.44)
SBP: Day 0 (6 hours post-dose)	-4.5 (12.15)
SBP: Day 0 (24 hours post-dose)	-3.7 (11.76)
SBP: Day 1	-2.4 (10.92)
SBP: Day 7	0.7 (10.65)
SBP: Day 14	-1.0 (12.09)
SBP: Day 21	-4.4 (12.05)
SBP: Day 28	-1.5 (14.01)
SBP: Day 42	-7.4 (9.26)
SBP: Day 56	-4.0 (11.14)
SBP: Day 84	-7.4 (14.91)

9. Secondary Outcome

Title	Change From Baseline to Day 84 in Vital Sign- Pulse Rate
Description	Vital signs included pulse rate. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline (pre-dose on Day 0) to Day 84

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Day 0 (5 minutes post-dose)	-1.2 (11.13)
Day 0 (1 hour post-dose)	-1.6 (8.43)
Day 0 (6 hours post-dose)	2.6 (12.14)
Day 0 (24 hours post-dose)	2.3 (11.08)
Day 1	5.7 (11.09)
Day 7	4.7 (11.82)
Day 14	6.9 (10.55)
Day 21	5.0 (8.90)
Day 28	7.6 (10.02)
Day 42	8.3 (12.06)
Day 56	4.1 (10.80)
Day 84	3.2 (14.21)

10. Secondary Outcome

Title	Change From Baseline to Day 84 in Vital Sign- Temperature
Description	Vital signs included temperature. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline (pre-dose on Day 0) to Day 84

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Day 0 (5 minutes post-dose)	0.21 (0.485)
Day 0 (1 hour post-dose)	0.17 (0.473)
Day 0 (6 hours post-dose)	0.20 (0.552)
Day 0 (24 hours post-dose)	0.40 (0.617)
Day 1	0.24 (0.486)
Day 7	0.40 (0.793)
Day 14	0.40 (0.504)
Day 21	0.41 (0.454)
Day 28	0.37 (0.457)
Day 42	0.53 (0.595)
Day 56	0.52 (0.473)
Day 84	0.38 (0.434)

11. Secondary Outcome

Title	Number of Participants With Abnormal-clinically Significant 12-lead Electrocardiogram (ECG) Findings
Description	ECG parameters included heart rate, PR interval, QRS interval, QT interval and corrected QT (QTc) interval. Number of participants with abnormal-clinically significant 12-lead ECG findings are presented.
Time Frame	Up to Day 84

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Count of Participants [Participants]	0 0%

12. Secondary Outcome

Title	Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
Description	Clinical chemistry parameters included ALT, ALP, AST, GGT and lactate dehydrogenase. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline (pre-dose on Day 0) to Day 84

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
ALT: Day 0 (24 hours)	-1.6 (3.46)
ALT: Day 14	-1.3 (11.93)
ALT: Day 28	-3.2 (12.34)
ALT: Day 56	-5.0 (12.18)
ALT: Day 84	-5.5 (11.84)
ALP: Day 0 (24 hours)	-3.9 (3.56)
ALP: Day 14	-5.6 (10.72)
ALP: Day 28	-3.4 (8.80)
ALP: Day 56	-7.2 (9.26)
ALP: Day 84	-7.3 (11.80)
AST: Day 0 (24 hours)	-1.9 (2.48)
AST: Day 14	-1.8 (8.58)
AST: Day 28	-2.6 (8.46)
AST: Day 56	-2.8 (6.15)
AST: Day 84	-3.6 (6.86)
GGT: Day 0 (24 hours)	-1.5 (2.33)
GGT: Day 14	-0.5 (7.34)
GGT: Day 28	0.5 (7.22)
GGT: Day 56	-4.1 (6.08)
GGT: Day 84	-3.3 (8.44)
Lactate dehydrogenase: Day 0 (24 hours)	-8.1 (10.56)
Lactate dehydrogenase: Day 14	-3.2 (18.88)
Lactate dehydrogenase: Day 28	-1.4 (22.30)
Lactate dehydrogenase: Day 56	1.3 (24.30)
Lactate dehydrogenase: Day 84	1.5 (20.68)

13. Secondary Outcome

Title	Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein
Description	Clinical chemistry parameters included albumin and protein. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline (pre-dose on Day 0) to Day 84

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Albumin: Day 0 (24 hours)	-1.4 (1.88)
Albumin: Day 14	-1.1 (3.08)
Albumin: Day 28	-0.6 (2.68)
Albumin: Day 56	-0.5 (3.14)
Albumin: Day 84	-0.6 (3.10)
Protein: Day 0 (24 hours)	-3.8 (2.67)
Protein: Day 14	-3.2 (5.12)
Protein: Day 28	-3.3 (4.47)
Protein: Day 56	-3.8 (5.41)
Protein: Day 84	-3.8 (4.23)

14. Secondary Outcome

Title	Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Description	Clinical chemistry parameters included bilirubin, creatinine, direct bilirubin, indirect bilirubin and urate. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline (pre-dose on Day 0) to Day 84

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Bilirubin: Day 0 (24 hours)	-2.8 (3.07)
Bilirubin: Day 14	-2.4 (4.48)
Bilirubin: Day 28	-3.4 (4.55)
Bilirubin: Day 56	-3.2 (5.17)
Bilirubin: Day 84	-2.1 (4.83)
Creatinine: Day 0 (24 hours)	-0.18 (4.479)
Creatinine: Day 14	-0.80 (5.502)
Creatinine: Day 28	-0.43 (6.698)
Creatinine: Day 56	-0.25 (5.962)
Creatinine: Day 84	-0.18 (6.062)
Direct bilirubin: Day 0 (24 hours)	-0.4 (1.05)
Direct bilirubin: Day 14	0.1 (1.37)
Direct bilirubin: Day 28	-0.6 (1.14)
Direct bilirubin: Day 56	-0.6 (1.47)
Direct bilirubin: Day 84	-0.2 (1.28)
Indirect bilirubin: Day 0 (24 hours)	-2.4 (2.87)
Indirect bilirubin: Day 14	-2.5 (4.10)
Indirect bilirubin: Day 28	-2.8 (4.12)
Indirect bilirubin: Day 56	-2.6 (4.26)
Indirect bilirubin: Day 84	-1.9 (4.79)
Urate: Day 0 (24 hours)	-14.5 (21.88)
Urate: Day 14	-10.5 (34.41)
Urate: Day 28	-13.5 (47.49)
Urate: Day 56	-2.5 (49.93)
Urate: Day 84	-7.5 (50.67)

15. Secondary Outcome

Title	Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Description	Clinical chemistry parameters included calcium, calcium corrected, carbon dioxide, chloride, magnesium, phosphate, potassium, sodium, urea and glucose. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline (pre-dose on Day 0) to Day 84

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Calcium: Day 0 (24 hours)	-0.040 (0.0599)
Calcium: Day 14	-0.020 (0.1049)
Calcium: Day 28	0.004 (0.0848)
Calcium: Day 56	-0.020 (0.1054)
Calcium: Day 84	-0.027 (0.0909)
Calcium Corrected: Day 0 (24 hours)	-0.010 (0.0466)
Calcium Corrected: Day 14	0.003 (0.0663)
Calcium Corrected: Day 28	0.017 (0.0578)
Calcium Corrected: Day 56	-0.007 (0.0694)
Calcium Corrected: Day 84	-0.016 (0.0501)
Carbon dioxide: Day 0 (24 hours)	-0.3 (1.86)
Carbon dioxide: Day 14	-0.2 (2.32)
Carbon dioxide: Day 28	0.1 (2.09)
Carbon dioxide: Day 56	-0.1 (2.33)
Carbon dioxide: Day 84	-0.2 (1.64)
Chloride: Day 0 (24 hours)	1.3 (2.12)
Chloride: Day 14	0.3 (2.05)
Chloride: Day 28	0.4 (1.53)
Chloride: Day 56	1.3 (1.63)
Chloride: Day 84	1.2 (1.74)
Magnesium: Day 0 (24 hours)	-0.044 (0.0564)
Magnesium: Day 14	-0.046 (0.0623)
Magnesium: Day 28	-0.049 (0.0709)
Magnesium: Day 56	-0.029 (0.0750)
Magnesium: Day 84	-0.034 (0.0751)
Phosphate: Day 0 (24 hours)	-0.085 (0.1299)
Phosphate: Day 14	-0.132 (0.2104)
Phosphate: Day 28	-0.135 (0.2201)
Phosphate: Day 56	-0.140 (0.2037)
Phosphate: Day 84	-0.152 (0.1509)
Potassium: Day 0 (24 hours)	-0.10 (0.333)
Potassium: Day 14	-0.04 (0.355)
Potassium: Day 28	-0.11 (0.335)
Potassium: Day 56	-0.13 (0.370)
Potassium: Day 84	-0.29 (0.356)
Sodium: Day 0 (24 hours)	0.1 (2.24)
Sodium: Day 14	0.3 (1.59)
Sodium: Day 28	0.1 (1.28)
Sodium: Day 56	0.8 (1.68)
Sodium: Day 84	0.8 (1.67)
Urea: Day 0 (24 hours)	0.20 (0.733)
Urea: Day 14	0.38 (1.122)
Urea: Day 28	0.10 (1.382)
Urea: Day 56	-0.13 (0.793)
Urea: Day 84	-0.20 (1.152)
Glucose: Day 0 (24 hours)	0.98 (3.248)
Glucose: Day 14	1.66 (2.094)
Glucose: Day 28	0.33 (2.230)
Glucose: Day 56	0.19 (2.093)
Glucose: Day 84	0.57 (2.749)

16. Secondary Outcome

Title	Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Description	Hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline (pre-dose on Day 0) to Day 84

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Basophils: Day 0 (24 hours)	-0.006 (0.0110)
Basophils: Day 14	-0.011 (0.0176)
Basophils: Day 28	-0.013 (0.0186)
Basophils: Day 56	-0.008 (0.0162)
Basophils: Day 84	-0.005 (0.0115)
Eosinophils: Day 0 (24 hours)	-0.019 (0.0506)
Eosinophils: Day 14	-0.024 (0.0564)
Eosinophils: Day 28	-0.006 (0.0535)
Eosinophils: Day 56	-0.022 (0.0595)
Eosinophils: Day 84	-0.028 (0.0670)
Leukocytes: Day 0 (24 hours)	0.29 (0.899)
Leukocytes: Day 14	0.09 (1.403)
Leukocytes: Day 28	1.00 (1.589)
Leukocytes: Day 56	0.54 (1.337)
Leukocytes: Day 84	-0.04 (1.754)
Lymphocytes: Day 0 (24 hours)	-0.068 (0.5214)
Lymphocytes: Day 14	-0.180 (0.6718)
Lymphocytes: Day 28	-0.364 (0.6746)
Lymphocytes: Day 56	-0.287 (0.5812)
Lymphocytes: Day 84	-0.257 (0.5697)
Monocytes: Day 0 (24 hours)	0.005 (0.1300)
Monocytes: Day 14	-0.025 (0.1575)
Monocytes: Day 28	-0.077 (0.2568)
Monocytes: Day 56	-0.076 (0.1574)
Monocytes: Day 84	-0.059 (0.1878)
Neutrophils: Day 0 (24 hours)	0.389 (0.9085)
Neutrophils: Day 14	0.332 (1.8713)
Neutrophils: Day 28	1.464 (1.9750)
Neutrophils: Day 56	0.932 (1.3943)
Neutrophils: Day 84	0.305 (1.7297)
Platelets: Day 0 (24 hours)	-6.3 (12.68)
Platelets: Day 14	2.1 (26.11)
Platelets: Day 28	10.0 (30.14)
Platelets: Day 56	1.0 (20.84)
Platelets: Day 84	-4.1 (29.04)

17. Secondary Outcome

Title	Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes
Description	Hematology parameter included erythrocytes. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline (pre-dose on Day 0) to Day 84

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Day 0 (24 hours)	-0.12 (0.158)
Day 14	-0.19 (0.246)
Day 28	-0.13 (0.205)
Day 56	-0.16 (0.239)
Day 84	-0.18 (0.282)

18. Secondary Outcome

Title	Change From Baseline to Day 84 in Hematology Parameter- Hematocrit
Description	Hematology parameter included hematocrit. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline (pre-dose on Day 0) to Day 84

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Day 0 (24 hours)	-0.0112 (0.0170)
Day 14	-0.0176 (0.0272)
Day 28	0.0006 (0.0310)
Day 56	-0.0060 (0.0226)
Day 84	-0.0126 (0.0313)

19. Secondary Outcome

Title	Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin
Description	Hematology parameter included hemoglobin. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Time Frame	Baseline (pre-dose on Day 0) to Day 84

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Day 0 (24 hours)	-3.7 (4.83)
Day 14	-5.0 (7.14)
Day 28	-4.0 (5.55)
Day 56	-5.0 (8.04)
Day 84	-5.7 (10.11)

20. Secondary Outcome

Title	Number of Participants With Positive Urinalysis Dipstick Results
Description	Urinalysis was done by the dipstick method to detect the presence of protein, glucose, ketones and occult blood in urine. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood, urine protein and urine ketones can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample; results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per Liter (g/L), 2+ or 1/2 g/L, 3+ or 1 g/L and 4+ indicating proportional concentrations in the urine sample. *a indicates two participants did not take the urinalysis test at Day 14 on scheduled date but took an unscheduled sample at the next visit (Day 21) and *b indicates one participant did not take the urinalysis test at Day 28 on scheduled date but took an unscheduled sample at the next visit (Day 42). Only those participants with positive results have been presented.
Time Frame	Day 0 (24 hours), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Glucose: Day 14, 1+ or 1/4 g/L	1 5%
Glucose: Day 14, 2+ or 1/2 g/L	1 5%
Glucose: Day 14, Trace	1 5%
Glucose: Day 28, 1+ or 1/4 g/L	1 5%
Glucose: Day 56, 1+ or 1/4 g/L	1 5%
Occult Blood: Day 0 (24 hours), Trace	5 25%
Occult Blood: Day 0 (24 hours), 1+	1 5%
Occult Blood: Day 0 (24 hours), 3+	1 5%
Occult Blood: Day 14, Trace	4 20%
Occult Blood: Day 14, 1+	2 10%
Occult Blood: Day 14, 2+	1 5%
Occult Blood: Day 21*a, Trace	1 5%
Occult Blood: Day 28, Trace	6 30%
Occult Blood: Day 28, 2+	2 10%
Occult Blood: Day 56, Trace	5 25%
Occult Blood: Day 56, 1+	2 10%
Occult Blood: Day 56, 2+	2 10%
Occult Blood: Day 84, Trace	1 5%
Occult Blood: Day 84, 1+	3 15%
Occult Blood: Day 84, 2+	1 5%
Protein: Day 0 (24 hours), 2+	1 5%
Protein: Day 14, Trace	3 15%
Protein: Day 14, 1+	1 5%
Protein: Day 28, 2+	1 5%
Protein: Day 42*b, Trace	1 5%
Protein: Day 56, Trace	2 10%
Protein: Day 84, Trace	3 15%
Protein: Day 84, 2+	1 5%

21. Secondary Outcome

Title	Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment
Description	Immunoglobulin B cell subsets included CD19 and CD 20+. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by [(Post-Baseline Visit Value minus Baseline) / Baseline]. Pharmacodynamic population comprised of participants who received the study medication and for whom pharmacodynamic data was available.
Time Frame	Baseline (pre-dose on Day 0) to Day 84

Outcome Measure Data

Analysis Population Description

Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
CD19: Day 14, n=20	26.6444 (78.2275)
CD19: Day 28, n=20	-4.1141 (49.0574)
CD19: Day 42, n=19	-12.6852 (46.6312)
CD19: Day 56, n=20	-20.4908 (44.2536)
CD19: Day 84, n=20	-27.0912 (49.5965)
CD20+: Day 14, n=20	35.3407 (100.7209)
CD20+: Day 28, n=20	0.3444 (54.1435)
CD20+: Day 42, n=19	-8.6327 (52.1804)
CD20+: Day 56, n=20	-20.6313 (42.8535)
CD20+: Day 84, n=20	-23.7421 (62.8031)

22. Secondary Outcome

Title	Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment
Description	Immunoglobulin B cell subset included CD20+/27+ memory and CD20+/27-naïve. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by [(Post-Baseline Visit Value minus Baseline) / Baseline].
Time Frame	Baseline (pre-dose on Day 0) to Day 84

Outcome Measure Data

Analysis Population Description

Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
CD20+/27+ memory: Day 14, n=20	186.4701 (199.5187)
CD20+/27+ memory: Day 28, n=20	118.1433 (135.2351)
CD20+/27+ memory: Day 42, n=19	91.2965 (125.1803)
CD20+/27+ memory: Day 56, n=20	135.8139 (167.0084)
CD20+/27+ memory: Day 84, n=20	70.6332 (108.1058)
CD20+/27-naïve: Day 14, n=20	4.0530 (61.8752)
CD20+/27-naïve: Day 28, n=20	-15.9190 (48.8363)
CD20+/27-naïve: Day 42, n=19	-17.0090 (61.5514)
CD20+/27-naïve: Day 56, n=20	-40.2078 (37.1774)
CD20+/27-naïve: Day 84, n=20	-42.6608 (43.8690)

23. Secondary Outcome

Title	Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Description	Immunoglobulin B cell subset inlcuded Norm CD19+/27Br/38Br SLE subset, Norm CD20+/138+plasmacytoid, Norm CD20+/69+activated and Norm CD20-/CD138+plasma cell. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by [(Post-Baseline Visit Value minus Baseline) / Baseline].
Time Frame	Baseline (pre-dose on Day 0) to Day 84

Outcome Measure Data

Analysis Population Description

Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
Measure Participants	20
Norm CD19+/27Br/38Br SLE subset: Day 14, n=20	5.3271 (85.7472)
Norm CD19+/27Br/38Br SLE subset: Day 28, n=20	-4.4623 (91.3321)
Norm CD19+/27Br/38Br SLE subset: Day 42, n=19	17.2492 (132.2146)
Norm CD19+/27Br/38Br SLE subset: Day 56, n=20	48.1481 (148.1877)
Norm CD19+/27Br/38Br SLE subset: Day 84, n=20	24.9838 (118.1567)
Norm CD20+/138+plasmacytoid: Day 14, n=19	200.6464 (702.0072)
Norm CD20+/138+plasmacytoid: Day 28, n=19	255.8559 (1010.9303)
Norm CD20+/138+plasmacytoid: Day 42, n=18	2.7891 (145.0411)
Norm CD20+/138+plasmacytoid: Day 56, n=19	20.1061 (220.7714)
Norm CD20+/138+plasmacytoid: Day 84, n=19	-44.0743 (65.0501)
Norm CD20+/69+activated: Day 14, n=19	-0.9711 (196.9956)
Norm CD20+/69+activated: Day 28, n=19	106.5032 (379.9580)
Norm CD20+/69+activated: Day 42, n=18	9.8018 (138.7995)
Norm CD20+/69+activated: Day 56, n=19	15.6984 (132.7055)
Norm CD20+/69+activated: Day 84, n=19	-18.3523 (120.1047)
Norm CD20-/CD138+plasma cells: Day 14, n=20	24.3489 (151.0876)
Norm CD20-/CD138+plasma cells: Day 28, n=20	21.4906 (180.2169)
Norm CD20-/CD138+plasma cells: Day 42, n=19	-6.6055 (129.1377)
Norm CD20-/CD138+plasma cells: Day 56, n=20	3.0692 (175.5913)
Norm CD20-/CD138+plasma cells: Day 84, n=20	-51.0462 (38.0848)

Adverse Events

Time Frame	Up to Day 84
Adverse Event Reporting Description	Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
All Cause Mortality
	Belimumab 10 mg/kg
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Belimumab 10 mg/kg
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
Blood and lymphatic system disorders
Neutropenia	1/20 (5%)
Infections and infestations
Upper respiratory tract infection	1/20 (5%)
Other (Not Including Serious) Adverse Events
	Belimumab 10 mg/kg
	Affected / at Risk (%)	# Events
Total	11/20 (55%)
Blood and lymphatic system disorders
Anaemia	1/20 (5%)
Infections and infestations
Upper respiratory tract infection	4/20 (20%)
Gingivitis	1/20 (5%)
Pharyngitis	1/20 (5%)
Metabolism and nutrition disorders
Hyperglycaemia	2/20 (10%)
Hypokalaemia	1/20 (5%)
Musculoskeletal and connective tissue disorders
Bone infarction	1/20 (5%)
Osteoarthritis	1/20 (5%)
Reproductive system and breast disorders
Balanoposthitis	1/20 (5%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	1/20 (5%)
Productive cough	1/20 (5%)
Skin and subcutaneous tissue disorders
Ecchymosis	1/20 (5%)
Vascular disorders
Hypertension	1/20 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring 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.