BIIB033 In Acute Optic Neuritis (AON)

Biogen82 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acute Optic Neuritis

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Key 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. Key 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.

Locations (32)

Research Site

Parkville, Australia

Outcomes

Primary Outcomes

Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population

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.

Time frame: Baseline, Week 24

Change in FF-VEP Latency at Week 24: Per-protocol Population

Time frame: Baseline, Week 24

Secondary Outcomes

Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population

Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye\*100. Adjusted for the baseline RNFL thickness.

Time frame: Baseline, Week 24

Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population

Time frame: Baseline, Week 24

Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population

Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.

Data from ClinicalTrials.gov

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Research Site

Sydney, Australia

Research Site

Bruges, Belgium

Research Site

Brussels, Belgium

Research Site

Ghent, Belgium

Research Site

Limbourg, Belgium

Research Site

Halifax, Canada

Research Site

Ottawa, Canada

Research Site

Olomouc, Czechia

Research Site

Prague, Czechia

...and 22 more locations

Time frame: Baseline, Week 24

Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population

Time frame: Baseline, Week 24

Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population

Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.

Time frame: Baseline, Week 24

Change in LCLA at Week 24: Per-protocol Population

Time frame: Baseline, Week 24

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.

Time frame: 32 weeks

Summary of BIIB033 Concentration

One pre-dose pharmacokinetic (PK) sample and 1 post-dose PK sample (approximately between 1 and 3 hours after the end of IV infusion) were collected for all participants on Day 1 and at Weeks 4 through 20 (every 4 weeks). Additionally, only 1 PK sample was collected at Week 24 and Week 32. (There was no dosing on Week 24 and Week 32, so only one blood sample for BIIB033 concentration was taken.) Samples collected at early termination visits were treated as predose samples for the next scheduled visit.

Time frame: Up to 32 weeks