At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 82 enrolled
Drug / intervention
BIIB033 (anti-LINGO-1 mAb) +1 morebiological
Likely dose
BIIB033 (anti-LINGO-1 mAb) 100 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating BIIB033 (anti-LINGO-1 mAb) and Placebo for Acute Optic Neuritis. Completed, enrolled 82 participants across 32 sites in 11 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Optic Neuritis
CountriesAustralia, Belgium, Canada, Czechia, Denmark, Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartDec 2012
Primary CompletionOct 2014
TodayJul 2026
First PostedNov 5, 2012
Enrollment StartDec 1, 2012
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.7 years ago
Interventions
BIIB033 (anti-LINGO-1 mAb)biological
100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
Placebodrug
via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)