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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
CompletedPhase 2Optic neuritisNCT017211612011-006291-39

What it found

Missed its main goal

The main measure did not show a significant benefit.

MeasureEstimate95% CIp
Change in FF-VEP Latency at Week 24: Per-protocol PopulationDifference -7.55-15.12–0.010.0504
Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) PopulationDifference -3.48-10.61–3.650.3337

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Opicinumab

    Leucine-rich repeat and immunoglobulin-like domain-containing nogo receptor-interacting protein 1 inhibitor

Placebo or sham

  • Placebo

Results by group

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

Baseline, Week 24

GroupValueIntervalNumber analysed
Placebo20.83 msec2.53 (Standard Error)41
BIIB03317.34 msec2.53 (Standard Error)41

Placebo

20.83

BIIB033

17.34

p = 0.3337; Difference -3.48 (95% CI -10.61–3.65)

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

Baseline, Week 24

GroupValueIntervalNumber analysed
Placebo22.24 msec2.61 (Standard Error)36
BIIB03314.69 msec2.72 (Standard Error)33

Placebo

22.24

BIIB033

14.69

p = 0.0504; Difference -7.55 (95% CI -15.12–0.01)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo412 (4.9%)
BIIB033 100 mg/kg415 (12.2%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

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

    Baseline, Week 24

    Myelin repair

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

    Baseline, Week 24

    Myelin repair

  • Primary Efficacy Endpoint: Change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by full-field visual evoked potential (FF-VEP).

    Myelin repair

Other measures (9)

  • 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

    Retina scans (OCT)

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

    Baseline, Week 24

    Retina scans (OCT)

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

    Baseline, Week 24

    Retina scans (OCT)

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

    Baseline, Week 24

    Retina scans (OCT)

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

    Baseline, Week 24

    Vision

  • Change in LCLA at Week 24: Per-protocol Population

    Baseline, Week 24

    Vision

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

    32 weeks

    Safety

  • Summary of BIIB033 Concentration

    Up to 32 weeks

    How the body handles the medicine

  • Secondary Efficacy Endpoint:

Who could take part

Optic neuritis · 18 to 55

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

Linked trials

  • Extended by

    RENEWED

    Phase 2 · Completed

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Dec 2012

    2. Main results due

      Oct 2014

    3. Finished

      Oct 2014

    4. Results posted

      Jun 2016

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