Trials / Completed
CompletedNCT01721161
BIIB033 In Acute Optic Neuritis (AON)
A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With First Episode of Acute Optic Neuritis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with their first episode of unilateral acute optic neuritis (AON). The secondary objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033 in this study population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BIIB033 (anti-LINGO-1 mAb) | 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses). |
| DRUG | Placebo | via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses) |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2014-10-01
- Completion
- 2014-10-01
- First posted
- 2012-11-05
- Last updated
- 2016-06-30
- Results posted
- 2016-06-30
Locations
32 sites across 11 countries: Australia, Belgium, Canada, Czechia, Denmark, Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01721161. Inclusion in this directory is not an endorsement.