Active Systemic Lupus Erythematosus (SLE)
Conditions
Interventions
Trade Name: Benlysta
Product Name: Belimumab Powder for solution for infusion [120 mg/vial]
Product Code: NA
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Belimu
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type of Participant and Disease Characteristics 1.Participants have or have had in series, 4 or more of the American College of Rheumatology (ACR) 11 criteria for the classification of SLE (Section 10.7: Appendix 7). 2.Participant’s age is 5 to 17 years at the time of informed consent. 3.Have active SLE disease defined as a SELENA SLEDAI score = 8 at screening (SELENA SLEDAI scoring see Section 10.8: Appendix 8). 4.Have unequivocally positive autoantibody test results defined as an ANA titre = 1:80 and/or a positive anti-dsDNA serum antibody test. 5.Are on a stable SLE therapy at Baseline. Are the trial subjects under 18? yes Number of subjects for this age range: 67 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: 1. Have an estimated glomerular filtration rate (eGFR) as calculated by Schwartz Formula of less than 30 mL/min. 2. Have acute severe nephritis defined as a significant worsening of renal disease 3. Have clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE 4. Have a history of a primary immunodeficiency. 5. Have an IgA deficiency (IgA level <10 mg/dL). 6. Have acute or chronic infections requiring management, 7. Have recent infections that, in the opinions of the investigator, makes the participant unsuitable for the study or could put the participant at undue risk. 8. Have evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months or who in the investigator's judgment, poses a significant suicide risk. Prior/Concomitant Therapy 9. Have received treatment with belimumab at any time. 10. Have active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis) requiring therapeutic intervention within 60 days of Day 0. 11. Have required renal replacement therapy (e.g. haemodialysis, peritoneal dialysis) within 90 days of Day 0 or be currently on renal replacement therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of belimumab IV in Chinese pediatric participants with SLE.;Secondary Objective: - To evaluate safety and tolerability of belimumab IV in Chinese pediatric participants with SLE. - To evaluate the efficacy of belimumab IV in Chinese pediatric participants with SLE. - To evaluate the PK of belimumab (10 mg/kg) IV in Chinese pediatric participants with SLE.;Primary end point(s): Safety Incidence of adverse events of special interest (AESIs) through 52 weeks: •All infections of special interest, including serious infections of special interest and opportunistic infections •Infusion-related systemic reactions and anaphylactic reactions •Depression, suicidality •Malignancies Efficacy Incidence of patients with =4-point reduction from Baseline to Week 52 in SELENA SLEDAI ;Timepoint(s) of evaluation of this end point: 52 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence of AEs through 52 Weeks Incidence of SAEs through 52 weeks Incidence of patients with ?4-point reduction from Baseline in SELENA SLEDAI by visit Change from Baseline to Week 52 in Physician Global Assessment (PGA) Change from Baseline to Week 52 in Parent Global Assessment (ParentGA) Change from Baseline in daily prednisone equivalent dose at Week 52 Time to first flare/ first severe flare over 52 weeks Median belimumab concentration levels at Day 0, 7 and 14 days post first dose, and pre-infusion and post-infusion at Day 84 The PK will be evaluated with respect to clearance, volume of distribution and half-life, and individual steady state exposures Cmin, Cavg, Cmax and AUC ;Timepoint(s) of evaluation of this end point: week 52/ Median belimumab concentration levels at Day 0, 7 and 14 days post first dose, and pre-infusion and post-infusion at Day 84 | — |
Countries
China
Contacts
Public ContactHafsa Khan
GlaxoSmithKline Research & Development Limited
Outcome results
None listed