BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis

Lupus Nephritis Clinical Trial

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

Status Terminated

Clinical Trial Summary

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN).

Clinical Trial Description

This is an extension study for all participants who completed study 211LE201 (NCT01499355) through Week 52 and did not discontinue BIIB023 or placebo. Eligible participants from Study 211LE201 (NCT01499355) will be followed for up to 108 weeks.

Participants 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.

Participants who received placebo in 211LE201 (NCT01499355) are randomized to receive either BIIB023 low dose or high dose in addition to background therapy. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

• NCT number: NCT01930890
• Study type: Interventional
• Source: Biogen
• Status: Terminated
• Phase: Phase 2
• Start date: November 2013
• Completion date: January 2016