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BIIB033 In Acute Optic Neuritis (AON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01721161
Recruitment Status : Completed
First Posted : November 4, 2012
Results First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE October 25, 2012
First Posted Date  ICMJE November 4, 2012
Results First Submitted Date  ICMJE May 24, 2016
Results First Posted Date  ICMJE June 30, 2016
Last Update Posted Date June 30, 2016
Study Start Date  ICMJE December 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2012)
Change of latency of conduction velocity at 24 weeks from the baseline of unaffected fellow eye as measured by the Visual Evoked Potential p100 in milliseconds [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2012)
Change of thickness of the retinal nerve fiber layer at Week 24 from the baseline of unaffected fellow eye as measured by spectral-domain optical coherence tomography in microns. [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BIIB033 In Acute Optic Neuritis (AON)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Optic Neuritis
Intervention  ICMJE
  • Biological: BIIB033 (anti-LINGO-1 mAb)
    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
  • Drug: Placebo
    via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Study Arms  ICMJE
  • Experimental: BIIB033
    Participants will receive BIIB033 once every 4 weeks for 20 weeks (a total of 6 doses).
    Intervention: Biological: BIIB033 (anti-LINGO-1 mAb)
  • Placebo Comparator: Placebo
    Participants will receive Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2014)
82
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2012)
80
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czech Republic,   Denmark,   Germany,   Hungary,   Italy,   Spain,   Sweden,   United Kingdom
Removed Location Countries Hong Kong
 
Administrative Information
NCT Number  ICMJE NCT01721161
Other Study ID Numbers  ICMJE 215ON201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP