Trials / Terminated
TerminatedNCT01499355
BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 276 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Participants who complete this study through Week 52 will be offered the option to enter an Extension study under a separate protocol 211LE202 (NCT0193089).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BIIB023 | |
| BIOLOGICAL | Placebo | |
| DRUG | mycophenolate mofetil | titrated to a target daily dose of 2 g (1 g twice daily) |
| DRUG | oral corticosteroids | oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2011-12-26
- Last updated
- 2017-01-18
- Results posted
- 2017-01-18
Locations
58 sites across 21 countries: United States, Argentina, Australia, Belgium, Brazil, Colombia, France, Germany, Hong Kong, Hungary, Italy, Malaysia, Mexico, Peru, Philippines, Poland, Portugal, Russia, South Korea, Spain, Thailand
Source: ClinicalTrials.gov record NCT01499355. Inclusion in this directory is not an endorsement.