BIIB033 In Acute Optic Neuritis (AON)

Biogen

Status and phase: Completed; Phase 2

Conditions: Acute Optic Neuritis

Treatments: Drug: Placebo; Biological: BIIB033 (anti-LINGO-1 mAb)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01721161

215ON201

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups, including a placebo group

BIIB033

Experimental group

Description:

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

Treatment:

Biological: BIIB033 (anti-LINGO-1 mAb)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo