Skip to main content
OpenTrials
Completed

NCT Number: NCT01721161

BIIB033 In Acute Optic Neuritis (AON)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Optic Neuritis Cranial Nerve Diseases Eye Diseases Nervous System Diseases Optic Nerve Diseases Optic Neuritis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Parkville, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIIB033 (anti-LINGO-1 mAb)

Biological

100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).

Other names: anti-LINGO-1 monoclonal antibody (mAb), Opicinumab

Placebo

Drug

via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)

Primary outcomes

  1. 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.

  2. 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

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

    Time frame: Baseline, Week 24

    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.

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

    Time frame: Baseline, Week 24

    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.

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

    Time frame: Baseline, Week 24

    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.

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

    Time frame: Baseline, Week 24

    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.

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

    Time frame: Baseline, Week 24

    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.

  6. Change in LCLA at Week 24: Per-protocol Population

    Time frame: Baseline, Week 24

    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.

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

    Time frame: 32 weeks

    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.

  8. Summary of BIIB033 Concentration

    Time frame: Up to 32 weeks

    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.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 5, 2012
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.