Acute Optic Neuritis MedDRA version: 17.0 Level: PT Classification code 10030942 Term: Optic neuritis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: BIIB033
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Not applicable
Current Sponsor code: BIIB033
Other descriptive name: Human anti-LINGO-1 monoclonal antibody
Concen
Sponsors
Biogen Idec Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. 2. Males and females with a confirmed diagnosis (by a physician with expertise in diagnosis and treatment of diseases of the optic nerve) of a first episode of unilateral AON with an onset within 28 days prior to study dosing at Day 1/Baseline. The diagnostic criteria of AON should include at least 2 of the following: reduced visual acuity, afferent pupillary defect, color vision loss, visual field abnormality, and/or pain on eye movement. Onset of ocular pain alone cannot be used to determine the onset of AON. Subjects are allowed to enroll regardless of if there are demyelinating lesions on brain MRI. 3. Aged 18 to 55 years old, inclusive, at the time of informed consent. 4. Must have received treatment of AON with 1 gram IV methylprednisolone for a minimum of 3 days and a maximum of 5 days prior to randomization. 5. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior episode(s) of optic neuritis or any other previous clinical CNS demyelinating events characteristic of MS as determined by a physician with expertise in the diagnosis and treatment of MS. 2. Subjects with an established diagnosis of MS are excluded except if newly diagnosed based on the current episode of AON and positive brain MRI results consistent with the 2010 revisions to the McDonald’s criteria. [Polman 2011]. 3. Severe refractive errors defined as myopia or hypermetropia of ±6 diopters sphere or worse in either eye. 4. Loss of vision not due to AON. 5. Previous history of, or current severe disc edema or hemorrhage. 6. Abnormal FF-VEP in the fellow eye at Screening as determined by the central reader. 7. Concomitant ophthalmologic disorders (e.g., diabetic retinopathy, macular degeneration, macular exudate, macular edema, glaucoma, severe astigmatism, ocular trauma, neuromyelitis optica, ischemic optic neuropathy, congenital nystagmus) or other ophthalmologic conditions that could interfere with the proposed protocol as determined by a physician with expertise in the diagnosis and treatment of ophthalmologic disorders. 8. History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, oncologic, renal, severe allergic or anaphylactic reactions, or other major disease, as determined by the Investigator. 9. Females who have a positive pregnancy test result, or who are pregnant, breastfeeding, or planning to conceive during the study. 10. History of positive test result for human immunodeficiency virus (HIV). 11. History of hepatitis C virus antibody (HCV Ab) or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]). 12. History or evidence of drug or alcohol abuse (as defined by the Investigator) within 2 years prior to Screening. 13. Current enrollment in any other study treatment or disease study within 3 months prior to Day 1/Baseline. 14. Participation in previous studies with BIIB033. 15. Inability to comply with study requirements. 16. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective of this study in this study population is to assess the safety, tolerability, and PK of BIIB033.;Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: Week 24;Main Objective: The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with their first episode of unilateral AON. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoint: -Change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by spectral-domain optical coherence tomography (SD-OCT). -Change in thicknesses of the retinal ganglion cell layer/inner plexiform retinal layer (RGCL/IPL) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. -Change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low-contrast Sloan letter charts. Safety Endpoints: The following safety parameters will be used to address the safety and tolerability portion of the secondary objective: -Adverse events (AEs) and serious adverse events (SAEs) -Clinical laboratory results and vital sign measurements -Physical examination findings -Brain MRI results -12-lead electrocardiogram (ECG) readings -AON signs and symptoms PK Endpoint: The PK portion of the secondary objective will be addressed by a population PK assessment;Timepoint(s) of evaluation of this end point: Efficacy endpoints: Week 24 Safety/PK endpoints: Throughout the course of the study | — |
Countries
Australia, Belgium, Canada, Czech Republic, Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Contacts
Public Contact215ON201 Clinical Trial Team
Biogen Idec Research Limited
Outcome results
None listed