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

Not Applicable

• Conditions: -M32 Systemic lupus erythematosus; Systemic lupus erythematosus; M32

• Registration Number: PER-086-13
• Lead Sponsor: Biogen Idec Research Limited,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-18
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
2. Subjects who completed Week 52 of Study 211LE201 and did not discontinue BIIB023 or placebo study treatment.
3. Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 6 months after their last dose of study treatment.

Exclusion Criteria

1. Any significant change in medical history in subjects from Study 211LE201, including laboratory tests or current clinically significant condition that, in the opinion of the Investigator, would have excluded the subjects’ participation.
2. Subjects from Study 211LE201 who discontinued BIIB023 or placebo treatment prior to Week 52 of Study 211LE201.
3. Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.
4. Previous participation in Study 211LE202; subjects who were enrolled in Study 211LE202 and consequently withdrew for any reason are prohibited from re-entering the study.
5. Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s ability to comply with the protocol.
6. Subjects who were prescribed MMF >3 g/day during Study 211LE201 and/or subjects for whom the Investigator is planning to prescribe MMF >3 g/day during this study.
7. Subjects having received disallowed concomitant medication during Study 211LE201 including the items detailed in the protocol page N° 20
8. Subjects with the following laboratory test results at Week 48 of Study 211LE201including the items detailed in the protocol page N° 20 and 21.
9. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, makes the subject unsuitable for enrollment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified