BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
NCT ID: NCT01499355
Last Updated: 2017-01-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
276 participants
INTERVENTIONAL
2012-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and mycophenolate mofetil (MMF)
Placebo
mycophenolate mofetil
titrated to a target daily dose of 2 g (1 g twice daily)
oral corticosteroids
oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day
BIIB023 3 mg/kg
BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
BIIB023
mycophenolate mofetil
titrated to a target daily dose of 2 g (1 g twice daily)
oral corticosteroids
oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day
BIIB023 20 mg/kg
BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
BIIB023
mycophenolate mofetil
titrated to a target daily dose of 2 g (1 g twice daily)
oral corticosteroids
oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day
Interventions
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BIIB023
Placebo
mycophenolate mofetil
titrated to a target daily dose of 2 g (1 g twice daily)
oral corticosteroids
oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Torrance, California, United States
Research Site
Orlando, Florida, United States
Research Site
Boston, Massachusetts, United States
Research Site
Rochester, Minnesota, United States
Research Site
Lake Success, New York, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
Memphis, Tennessee, United States
Research Site
El Paso, Texas, United States
Research Site
Capital Federal, Ciudad Autonoma Buenos Aires, Argentina
Research Site
Córdoba, Córdoba Province, Argentina
Research Site
San Miguel de Tucumán, Tucumán Province, Argentina
Research Site
Ciudad Autonoma Buenos Aires, , Argentina
Research Site
La Plata, , Argentina
Research Site
San Juan, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
Melbourne, Victoria, Australia
Research Site
Leuven, , Belgium
Research Site
Liège, , Belgium
Research Site
Cuiabá, Mato Grosso, Brazil
Research Site
São Paulo, São Paulo, Brazil
Research Site
Barranquilla, , Colombia
Research Site
Bogotá, , Colombia
Research Site
Medellín, , Colombia
Research Site
Pessac, Gironde, France
Research Site
Lille, Nord, France
Research Site
Paris, , France
Research Site
Paris, , France
Research Site
Mainz, , Germany
Research Site
Hong Kong, , Hong Kong
Research Site
Shatin, , Hong Kong
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Pisa, , Italy
Research Site
Kuching, Sarawak, Malaysia
Research Site
Ipoh, , Malaysia
Research Site
Kuala Lumpur, , Malaysia
Research Site
Kuala Selangor, , Malaysia
Research Site
Pulau Pinang, , Malaysia
Research Site
Selangor Darul Ehsan, , Malaysia
Research Site
Saltillo, Coahuila, Mexico
Research Site
Cuauhtémoc, , Mexico
Research Site
León, , Mexico
Research Site
Mexico City, , Mexico
Research Site
San Luis Potosí City, , Mexico
Research Site
Lima, , Peru
Research Site
Manila, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Lodz, , Poland
Research Site
Wroclaw, , Poland
Research Site
Coimbra, , Portugal
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Busan, , South Korea
Research Site
Gyeonggi-do, , South Korea
Research Site
Sagunto, , Spain
Research Site
Bangkoknoi, Bangkok, Thailand
Research Site
Patumwan, Bangkok, Thailand
Countries
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Other Identifiers
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2011-002159-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
211LE201
Identifier Type: -
Identifier Source: org_study_id
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