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BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis

NCT01930890 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2017-01-18

Study results available
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Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Colombia
  • France
  • Hong Kong
  • Hungary
  • Italy
  • Malaysia
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Russia
  • South Korea
  • Spain
  • Thailand

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01930890 on ClinicalTrials.gov