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
Overview
- Phase
- Phase 2
- Intervention
- BIIB033 (anti-LINGO-1 mAb)
- Conditions
- Acute Optic Neuritis
- Sponsor
- Biogen
- Enrollment
- 82
- Locations
- 2
- Primary Endpoint
- Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability to provide written consent and any authorization required by law.
- •Confirmed diagnosis of AON
- •All male or female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment.
Exclusion Criteria
- •Prior episode(s) of optic neuritis or loss of vision not due to AON.
- •Subjects with an established diagnosis of multiple sclerosis are excluded except if newly diagnosed based on the current episode of AON and positive brain magnetic resonance imaging results consistent with the 2010 revisions to the McDonald's criteria.
- •Previous history of a clinically significant disease.
- •Females who have a positive pregnancy test result, or who are pregnant, breastfeeding, or planning to conceive during the study.
- •History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus.
- •History or evidence of drug or alcohol abuse within 2 years prior to Screening.
- •Current enrollment in any other study treatment or disease study within 3 months prior to Day 1/Baseline.
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Arms & Interventions
BIIB033
Participants will receive BIIB033 once every 4 weeks for 20 weeks (a total of 6 doses).
Intervention: BIIB033 (anti-LINGO-1 mAb)
Placebo
Participants will receive Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population
Time Frame: Baseline, Week 24
Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.
Change in FF-VEP Latency at Week 24: Per-protocol Population
Time Frame: Baseline, Week 24
Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.
Secondary Outcomes
- Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population(Baseline, Week 24)
- Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population(Baseline, Week 24)
- Change in LCLA at Week 24: Per-protocol Population(Baseline, Week 24)
- Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population(Baseline, Week 24)
- Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population(Baseline, Week 24)
- Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population(Baseline, Week 24)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(32 weeks)
- Summary of BIIB033 Concentration(Up to 32 weeks)