BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: BIIB023; Placebo; mycophenolate mofetil; oral corticosteroids
Intervention description: titrated to a target daily dose of 2 g (1 g twice daily); oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to assess the efficacy of BIIB023 as an add-on
      treatment to background therapy compared with placebo in combination with background therapy
      in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary
      objectives of this study are to assess the safety and tolerability of BIIB023 compared with
      placebo in this study population.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Documented diagnosis of systemic lupus erythematosus (SLE) according to current
             American College of Rheumatology (ACR) criteria. At least 4 ACR criteria must be
             documented, 1 of which must be a positive antinuclear antibody (ANA), anti Sm, or anti
             dsDNA antibody.

          -  Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS)
             2003 Class III or IV lupus nephritis with either active or active/chronic disease,
             confirmed by biopsy within 3 months prior to Screening. Participants are permitted to
             have co existing Class V lupus nephritis. If a renal biopsy has not been performed
             within 3 months of the Screening Visit, one can be performed during the Screening
             Period after all other eligibility criteria have been confirmed. The local
             histological diagnosis must be confirmed by the central study pathologist.

          -  Must have proteinuria at Screening (from a 24 hour urine sample collection) defined as
             urinary protein:creatinine ratio (uPCR) >1.0 mg/mg.

        Key Exclusion Criteria:

          -  Retinitis, poorly-controlled seizure disorder, acute confusional state, myelitis,
             stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and
             resulting from SLE at Screening

          -  Estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m^2 (calculated using
             the abbreviated Modification of Diet in Renal Disease equation) or the presence of
             oliguria or end-stage renal disease requiring dialysis or transplantation

          -  Subjects requiring dialysis within 12 months prior to Screening

          -  History of renal transplant

          -  Treatment with any biologic B-cell-depleting therapy (e.g., anti-CD20 [rituximab],
             anti-CD22 [epratuzumab], anti-BLyS/B-cell activating factor [e.g., briobacept,
             belimumab] therapy), or TACI-Ig within 12 months prior to Run-in Day 1.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.