BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis
The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in subjects with lupus nephritis (LN).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Dose-Blinded, 2-Dose Level, Parallel-Group, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Efficacy, and Immunogenicity of BIIB023 in Subjects With Lupus Nephritis|
- The number of subjects that experience adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to week 108 ] [ Designated as safety issue: Yes ]
- The number of subjects who discontinue study treatment or withdrawal from the study due to an adverse event (AE) [ Time Frame: Up to week 108 ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||November 2018|
|Estimated Primary Completion Date:||November 2018 (Final data collection date for primary outcome measure)|
Experimental: Group 1: BIIB023 low dose + Background Therapy
Subjects will receive BIIB023 low dose in addition to background therapy
Low Dose BIIB023 intravenous (IV) infusion
Experimental: Group 2: BIIB023 high dose+ Background Therapy
Subjects will receive BIIB023 high dose in addition to background therapy
High Dose BIIB023 intravenous (IV) infusion
This is an extension study for all subjects who completed study 211LE201 (NCT01499355) through Week 52 and did not discontinue BIIB023 or placebo. Eligible subjects from Study 211LE201 (NCT01499355) will be followed for up to 108 weeks, provided that BIIB023 continues to have a positive benefit/risk ratio in the overall study population.
Subjects who received BIIB023 low dose or high dose in 211LE201 (NCT01499355) will continue to receive the same dosing in 211LE202 in addition to background therapy.
Subjects who received placebo in 211LE201 (NCT01499355) are randomized to receive either BIIB023 low dose or high dose in addition to background therapy.