BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lupus Nephritis

Intervention / Treatment
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* Biological: BIIB023
* Drug: mycophenolate mofetil
* Drug: oral corticosteroids


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Subjects who completed Week 52 of Study 211LE201 (NCT01499355) and did not discontinue BIIB023 or placebo study treatment. 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. Key Exclusion Criteria: 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. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment under this protocol. Subjects from Study 211LE201 who discontinued BIIB023 or placebo treatment prior to Week 52 of Study 211LE201. Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding. 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. Other unspecified reasons that, in the opinion of the Investigator or Biogen, makes the subject unsuitable for enrollment. NOTE: Other Protocol-defined Inclusion/Exclusion Criteria May Apply.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIIB023 3 mg/kg<br>Participants will receive BIIB023 3 mg/kg IV every 4 weeks through Week 100 plus background therapy including oral steroids (prednisone or equivalent) and mycophenolate mofetil (MMF). | Biological: BIIB023<br> <br> Drug: mycophenolate mofetil<br>* titrated to a target daily dose of 2 g (1 g twice daily)<br>* Other names: MMF, Cellcept;Drug: oral corticosteroids<br>* oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day<br>|
| Experimental: BIIB023 20 mg/kg<br>Participants will receive BIIB023 20 mg/kg IV every 4 weeks through Week 100 plus background therapy including oral steroids (prednisone or equivalent) and MMF. | Biological: BIIB023<br> <br> Drug: mycophenolate mofetil<br>* titrated to a target daily dose of 2 g (1 g twice daily)<br>* Other names: MMF, Cellcept;Drug: oral corticosteroids<br>* oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. | Up to Week 108 | 
| Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE | AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. | Up to Week 108 |