215ON201 BIIB033 In Acute Optic Neuritis (AON)

Acute Optic Neuritis Clinical Trial

— RENEW  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721161
• Other study ID #: 215ON201
• Status: Completed
• Phase: Phase 2
• First received: October 25, 2012
• Last updated: August 21, 2015
• Start date: December 2012
• Est. completion date: October 2014

Study information

• Verified date: August 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsSpain: Spanish Agency for Medicines and Health ProductsAustralia: Department of Health and Ageing Therapeutic Goods AdministrationItaly: The Italian Medicines AgencyCzech Republic: State Institute for Drug ControlSweden: Medical Products AgencyHungary: National Institute of PharmacyCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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 in this study population is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• Ability to provide written consent and any authorization required by law.

• Confirmed diagnosis of Acute Optic Neuritis (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 MRI 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Optic Neuritis
• Neuritis
• Optic Neuritis

Intervention

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

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

Locations

Country	Name	City	State
Australia	Research Site	Melbourne
Belgium	Research Site	Ath
Belgium	Research Site	Brugge
Belgium	Research Site	Brussels
Belgium	Research Site	Ghent
Belgium	Research Site	Limberg
Canada	Research Site	Calgary
Canada	Research Site	Halifax
Canada	Research Site	Montreal
Canada	Research Site	Ottawa
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Prague
Denmark	Research Site	Glostrup
Germany	Research Site	Bamberg
Germany	Research Site	Berlin
Germany	Research Site	Dresden
Germany	Research Site	Dusseldorf
Germany	Research	Hannover
Germany	Research Site	Tubingen
Hong Kong	Research Site	Shatin
Hungary	Research Site	Budapest
Hungary	Research Site	Szeged
Italy	Research Site	Fidenza
Italy	Research Site	Firenze
Italy	Research Site	Milano
Italy	Research site	Roma
Spain	Research Site	Barcelona
Spain	Research Site	Cordoba
Spain	Research Site	Malaga
Spain	Research Site	Palmar
Spain	Research Site	Sevilla
Spain	Research Site	Valencia
Sweden	Research Site	Lund
Sweden	Research Site	Stockholm
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  Czech Republic,  Denmark,  Germany,  Hong Kong,  Hungary,  Italy,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		24 weeks	No
Secondary	Change in thickness of the retinal nerve fiber layer (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).		24 weeks	No
Secondary	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.		24 weeks	No
Secondary	Change in low-contrast letter acuity (LCLA) at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts.		24 weeks	No
Secondary	Number of participants with Adverse events (AEs) and serious adverse events (SAEs)		32 weeks	Yes
Secondary	PK Parameters will be estimated based on Population based PK modeling.	One pre-dose PK sample and 1 post-dose PK sample (approximately between 1 and 3 hours after the end of IV infusion) will be collected for ALL participants on Day 1 and at Weeks 4 through 20 (every 4 weeks). Additionally, only 1 PK sample will be collected at Week 24 and Week 32.	Up to 32 weeks	No