SLE systemic lupus erythematosus
Conditions
Interventions
The total maximum duration of study participation for each participant is 73
weeks (screening:5 weeks, treatment: up to 52 weeks [12 weeks Part A plus 40
weeks extension phase] and follow-up: 16 wee
Sponsors
GlaxoSmithKline
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: For parts A and B of the study 1. Participants between 5 and 17 years of age inclusive, at the time of Day 1. 2. SLE according to the ACR criteria (at least 4/11 criteria). (Appendix 9 of the protocol) 3. Screening SLEDAI-2K score >=6 (total score). (Appendix 10 of the protocol.) 4. Have unequivocally documented positive autoantibody test results. See protocol page 48 for details. 5. Stable SLE treatment regimen consisting of any of the following medications (alone or in combination) for a period of at least 30 days prior to Day 1: corticosteroids, immunosuppressants, anti-malarials, NSAIDs. See protocol page 48-49 for details. 6. Body weight >=15 kg. 7. Male and/or female participants. Female participant of childbearing potential who agrees to follow the contraceptive guidance in appendix 4 of the protocol during the treatment period and for at least 16 weeks after the last dose of belimumab. 8. Participant signs and dates a written age appropriate assent form/ informed consent form and the parent(s) or legal guardian provides written informed consent for minors between 5 and 16 year old. Optional Access Extension 1. Male or female participants who complete Week 52 visit of the 200908 study. 2. Age
Exclusion criteria
Exclusion criteria: For parts A + B of the study 1. eGFR of less than 30 mL/min 2. Acute severe nephritis defined as significant renal disease. See protocol page 50 for details. 3. History of a major organ transplant or hematopoetic stem cell/marrow transplant. 4. Clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE. See protocol page 50 for details. 5. Planned surgical procedure or a history of any other medical disease , laboratory abnormality, or condition that, in the opinion of the investigator, makes the participant unsuitable for the study. 6. History of malignant neoplasm within the last 5 years. 7. 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. 8. History of a primary immunodeficiency. 9. IgA deficiency (IgA level 1.5 mg/kg/day) or any i.m.or i.v. steroid injection. 18. Have received a live or live-attenuated vaccine within 30 days of Day 1. 19. Have active CNS lupus requiring therapeutic intervention within 60 days of Day 1. 20. Have required renal replacement therapy within 90 days of Day 1 or are currently on renal replacement therapy. 21. Participation in an interventional clinical study either concurrently or within 6 months of screening. Participation in an observational study may be permitted. 22/23/24. Positive HIV, hepatitis B or C test. See protocol p 45 for details 25. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 1. 26. Are unable or unlikely, in the opinion of the investigator, to administer belimumab by SC injection and have no reliable source to administer the injection. 27. Children in Care. See protocol page 53 for details. - Pregnancy/breastfeeding Optional Access Extension 1. Female participant has positive urine pregnancy test at Week 52 visit. 2. Female participant wishes to become pregnant at or within 4 months of Week 52 visit. 3. Participant has experienced any change in his/her medical history that, per the investigator*s judgement, continued administration of belimumab therapy wou
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Observed belimumab concentrations at Week 12. • Steady-state PK parameters: Cavg (AUC), Cmax, Cmin (based on population PK estimates). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Incidence of adverse events, serious adverse events and adverse events of special interest through Week 52. • Change from baseline in biomarkers (C3/C4, anti-dsDNA, B cell subsets, and immunoglobulins) at Weeks 12 and 52. • Percent of subjects with a >= 4 point reduction from baseline in SELENA SLEDAI at Weeks 12 and 52. | — |
Countries
Netherlands
Outcome results
None listed