Clinical trial NCT01721161: BIIB033 In Acute Optic Neuritis (AON)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Optic Neuritis
Keywords: Optic Neuritis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2012-11-04
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population
timeFrame: Baseline, Week 24
measure: Change in FF-VEP Latency at Week 24: Per-protocol Population
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population
timeFrame: Baseline, Week 24
measure: Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population
timeFrame: Baseline, Week 24
measure: Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population
timeFrame: Baseline, Week 24
measure: Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population
timeFrame: Baseline, Week 24
measure: Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population
timeFrame: Baseline, Week 24
measure: Change in LCLA at Week 24: Per-protocol Population
timeFrame: Baseline, Week 24
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 32 weeks
measure: Summary of BIIB033 Concentration
timeFrame: Up to 32 weeks
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Research Site
city: Sidney
country: Australia
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Ghent
country: Belgium
facility: Research Site
city: Limburg
country: Belgium
facility: Research Site
city: Halifax
country: Canada
facility: Research Site
city: Ottawa
country: Canada
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Prague
country: Czech Republic
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Bamberg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Dusseldorf
country: Germany
facility: Research Site
city: Tubingen
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Fidenza
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research site
city: Barcelona
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Palmar
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Klistorner A, Chai Y, Leocani L, Albrecht P, Aktas O, Butzkueven H, Ziemssen T, Ziemssen F, Frederiksen J, Xu L, Cadavid D; RENEW MF-VEP Investigators. Assessment of Opicinumab in Acute Optic Neuritis Using Multifocal Visual Evoked Potential. CNS Drugs. 2018 Dec;32(12):1159-1171. doi: 10.1007/s40263-018-0575-8.
citation: Petrillo J, Balcer L, Galetta S, Chai Y, Xu L, Cadavid D. Initial Impairment and Recovery of Vision-Related Functioning in Participants With Acute Optic Neuritis From the RENEW Trial of Opicinumab. J Neuroophthalmol. 2019 Jun;39(2):153-160. doi: 10.1097/WNO.0000000000000697.
citation: Cadavid D, Balcer L, Galetta S, Aktas O, Ziemssen T, Vanopdenbosch L, Frederiksen J, Skeen M, Jaffe GJ, Butzkueven H, Ziemssen F, Massacesi L, Chai Y, Xu L, Freeman S; RENEW Study Investigators. Safety and efficacy of opicinumab in acute optic neuritis (RENEW): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2017 Mar;16(3):189-199. doi: 10.1016/S1474-4422(16)30377-5. Epub 2017 Feb 15.