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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - 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).


Treatment: Other: 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
Treatment: Other
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
Timepoint [1] 0 0
Baseline, Week 24
Primary outcome [2] 0 0
Change in FF-VEP Latency at Week 24: Per-protocol Population
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
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
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
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
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population
Timepoint [5] 0 0
Baseline, Week 24
Secondary outcome [6] 0 0
Change in LCLA at Week 24: Per-protocol Population
Timepoint [6] 0 0
Baseline, Week 24
Secondary outcome [7] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [7] 0 0
32 weeks
Secondary outcome [8] 0 0
Summary of BIIB033 Concentration
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
Sex
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
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
82
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01721161