Phase 1 Study of Belimumab in Subjects With Systemic Lupu... | NCT00657007 | Trialant

Phase 1 Study of Belimumab in Subjects With Systemic Lupu... | NCT00657007 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	IV infusion over 2 hours	Biological: Placebo
Belimumab 1 mg/kg	Experimental	1 mg/kg IV infused over 2 hours	Biological: belimumab
Belimumab 4 mg/kg	Experimental	4 mg/kg IV infused over 2 hours	Biological: belimumab
Beimumab 10 mg/kg	Experimental	10 mg/kg IV infused over 2 hours	Biological: belimumab
Belimumab 20 mg/kg	Experimental	20 mg/kg IV infused over 2 hours	Biological: belimumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
belimumab	Biological	1 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 1). 1 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 5).

Outcomes Module

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the effect of belimumab on clinical disease activity, total serum IgG (and IgM, IgA, IgE) and concentrations of peripheral mature B lymphocytes and plasmacytoid cells, and markers of SLE disease activity, including autoantibodies.		Days 0-105

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34741731	Derived	Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.
34628605	Derived