BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis
NCT ID: NCT01930890
Last Updated: 2017-01-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
87 participants
INTERVENTIONAL
2013-11-30
2016-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BIIB023 3 mg/kg
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).
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
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.
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
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
* 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
* 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.
19 Years
76 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
Lake Success, New York, United States
Research Site
Columbus, Ohio, United States
Research Site
Memphis, Tennessee, United States
Research Site
El Paso, Texas, United States
Research Site
Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Research Site
San Juan, San Juan Province, Argentina
Research Site
San Miguel de Tucumán, Tucumán Province, Argentina
Research Site
Melbourne, Victoria, Australia
Research Site
Leuven, , Belgium
Research Site
Liège, , Belgium
Research Site
Cuiabá, Mato Grosso, Brazil
Research Site
Barranquilla, , Colombia
Research Site
Bogotá, , Colombia
Research Site
Medellín, , Colombia
Research Site
Pessac, Gironde, France
Research Site
Paris, Paris Cedex 13, France
Research Site
Shatin, , Hong Kong
Research Site
Debrecen, , Hungary
Research Site
Pisa, Pisa, Italy
Research Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Research Site
Kuching, Sarawak, Malaysia
Research Site
Kuala Selangor, , Malaysia
Research Site
Kuala Selangor, , Malaysia
Research Site
Cuauhtémoc, Mexico City, Mexico
Research Site
Lima, , Peru
Research Site
Manila, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Lodz, , Poland
Research Site
Moscow, , Russia
Research Site
Suwon, Gyeonggi-do, South Korea
Research Site
Sagunto, Valencia, Spain
Research Site
Bangkoknoi, Bangkok, Thailand
Research Site
Pathumwan, Bangkok, Thailand
Countries
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Other Identifiers
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2013-000594-69
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
211LE202
Identifier Type: -
Identifier Source: org_study_id
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