Conditions: Acute Optic Neuritis
Keywords: Optic Neuritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 82
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants will receive BIIB033 once every 4 weeks for 20 weeks (a total of 6 doses). arm 2: Participants will receive Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).

Interventions: intervention 1: BIIB033 (anti-LINGO-1 mAb) intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses). intervention 2: via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)

Protocol document: