Phase 2 N=82 Randomized Double-blind Treatment

BIIB033 In Acute Optic Neuritis (AON)

Acute Optic Neuritis

Bottom Line

View on ClinicalTrials.gov: NCT01721161 ↗

Enrolled (actual)

Serious AEs

8.5%

Results posted

Jun 2016

Primary outcome: Primary: Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population — 20.83; 17.34 msec — p=0.3337

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: BIIB033 (anti-LINGO-1 mAb) (Biological); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Biogen
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population	20.83; 17.34	0.3337
PRIMARY Change in FF-VEP Latency at Week 24: Per-protocol Population	22.24; 14.69	0.0504
SECONDARY Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population	-11.77; -15.66	0.1868
SECONDARY Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population	-12.22; -16.98	0.1488
SECONDARY Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population	-9.90; -11.05	0.4975
SECONDARY Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population	-10.17; -11.93	0.3505
SECONDARY Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population	8.1; 6.5; 11.9; 11.0	0.5371
SECONDARY Change in LCLA at Week 24: Per-protocol Population	7.2; 6.0; 11.6; 10.8	0.6645
SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	34; 34; 22; 21; 2; 3	—
SECONDARY Summary of BIIB033 Concentration	0.00; 2030.00; 375.00; 2350.00; 537.00; 2585.00	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01721161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.