Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2012-12-31
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis
NCT00404612
A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis
NCT00404885
Rituximab in the Treatment of Scleritis and Non-Infectious Orbital Inflammation
NCT00415506
A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis
NCT00404742
Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
NCT00615693
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BIIB033
Participants will receive BIIB033 once every 4 weeks for 20 weeks (a total of 6 doses).
BIIB033 (anti-LINGO-1 mAb)
100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
Placebo
Participants will receive Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
Placebo
via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BIIB033 (anti-LINGO-1 mAb)
100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
Placebo
via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biogen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Parkville, , Australia
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
Research Site
Glostrup Municipality, , Denmark
Research Site
Bamberg, , Germany
Research Site
Berlin, , Germany
Research Site
Dresden, , Germany
Research Site
Düsseldorf, , Germany
Research Site
Tübingen, , Germany
Research Site
Budapest, , Hungary
Research Site
Fidenza, , Italy
Research Site
Florence, , Italy
Research Site
Milan, , Italy
Research site
Roma, , Italy
Research Site
Barcelona, , Spain
Research Site
Córdoba, , Spain
Research Site
Palmar, , Spain
Research Site
Seville, , Spain
Research Site
Valencia, , Spain
Research Site
Lund, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Birmingham, , United Kingdom
Research Site
Glasgow, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
215ON201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.