NCT01930890

BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 19 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 will be followed for up to 108 weeks. Participants who received BIIB023 low dose or high dose in 211LE201 will continue to receive the same dosing in this study (211LE202; NCT01930890) in addition to background therapy. Participants who received placebo in 211LE201 are randomized to receive either BIIB023 low dose or high dose in addition to background therapy.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
BIOLOGICAL	BIIB023
DRUG	mycophenolate mofetil	titrated to a target daily dose of 2 g (1 g twice daily)
DRUG	oral corticosteroids	oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2013-08-29
• Last updated: 2017-01-18
• Results posted: 2017-01-18

Locations

33 sites across 19 countries: United States, Argentina, Australia, Belgium, Brazil, Colombia, France, Hong Kong, Hungary, Italy, Malaysia, Mexico, Peru, Philippines, Poland, Russia, South Korea, Spain, Thailand