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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01721161




Registration number
NCT01721161
Ethics application status
Date submitted
25/10/2012
Date registered
4/11/2012
Date last updated
30/06/2016

Titles & IDs
Public title
BIIB033 In Acute Optic Neuritis (AON)
Scientific 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
Secondary ID [1] 0 0
215ON201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Optic Neuritis 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - BIIB033 (anti-LINGO-1 mAb)
Treatment: Drugs - Placebo

Experimental: BIIB033 - Participants will receive BIIB033 once every 4 weeks for 20 weeks (a total of 6 doses).

Placebo Comparator: Placebo - Participants will receive Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).


Other interventions: BIIB033 (anti-LINGO-1 mAb)
100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).

Treatment: Drugs: Placebo
via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population - 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.
Timepoint [1] 0 0
Baseline, Week 24
Primary outcome [2] 0 0
Change in FF-VEP Latency at Week 24: Per-protocol Population - 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.
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [1] 0 0
Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population - 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.
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population - 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.
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [3] 0 0
Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population - 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.
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population - 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.
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population - 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.
Timepoint [5] 0 0
Baseline, Week 24
Secondary outcome [6] 0 0
Change in LCLA at Week 24: Per-protocol Population - 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.
Timepoint [6] 0 0
Baseline, Week 24
Secondary outcome [7] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - 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.
Timepoint [7] 0 0
32 weeks
Secondary outcome [8] 0 0
Summary of BIIB033 Concentration - 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.
Timepoint [8] 0 0
Up to 32 weeks

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Parkville
Recruitment hospital [2] 0 0
Research Site - Sidney
Recruitment postcode(s) [1] 0 0
- Parkville
Recruitment postcode(s) [2] 0 0
- Sidney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brugge
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Ghent
Country [4] 0 0
Belgium
State/province [4] 0 0
Limburg
Country [5] 0 0
Canada
State/province [5] 0 0
Halifax
Country [6] 0 0
Canada
State/province [6] 0 0
Ottawa
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Olomouc
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Prague
Country [9] 0 0
Denmark
State/province [9] 0 0
Glostrup
Country [10] 0 0
Germany
State/province [10] 0 0
Bamberg
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Dresden
Country [13] 0 0
Germany
State/province [13] 0 0
Dusseldorf
Country [14] 0 0
Germany
State/province [14] 0 0
Tubingen
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Italy
State/province [16] 0 0
Fidenza
Country [17] 0 0
Italy
State/province [17] 0 0
Firenze
Country [18] 0 0
Italy
State/province [18] 0 0
Milano
Country [19] 0 0
Italy
State/province [19] 0 0
Roma
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
Cordoba
Country [22] 0 0
Spain
State/province [22] 0 0
Palmar
Country [23] 0 0
Spain
State/province [23] 0 0
Sevilla
Country [24] 0 0
Spain
State/province [24] 0 0
Valencia
Country [25] 0 0
Sweden
State/province [25] 0 0
Lund
Country [26] 0 0
Sweden
State/province [26] 0 0
Stockholm
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Birmingham
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Glasgow
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Leicester
Country [30] 0 0
United Kingdom
State/province [30] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01721161
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications