Long-Term Assessment of Remyelinating Therapy (RENEWED)

Biogen

Status and phase: Completed; Phase 2

Conditions: Acute Optic Neuritis

Treatments: Drug: BIIB033 100mg/Kg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02657915

215ON203

2015-003618-26 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study is to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. The secondary objective is to assess clinical progression and severity of central nervous system (CNS) demyelinating disease in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. Intervention was administered in the previous study. The participants, investigator and outcome assessors remain blinded in this follow-up study.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Must have participated in Study NCT01721161 and received at least 1 dose of BIIB033 or placebo, as per protocol, within 2 years (+ 4 months) from Day 1 of this study (2 years from Week 32 or projected Week 32 visit, if the subject did not complete all visits in Study NCT01721161).

Key Exclusion Criteria:

• Not previously enrolled in Study NCT01721161
• Subjects with recent kidney function, such as serum creatinine above upper limit of normal range, will not be allowed to receive administration of Gd but will otherwise be allowed to participate in the study, including magnetic resonance imaging (MRI) assessments not requiring the use of Gd.
• Female subjects must have had a recent pregnancy test and must not be breastfeeding prior to MRI assessments with Gd.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

This was a follow-up study, investigational product was administered in the previous study. Participants in the placebo arm have received at least 1 dose of placebo.

Treatment:

Drug: Placebo

BIIB033 100mg/Kg

Experimental group

Description:

This was a follow-up study, investigational product was administered in the previous study. Participants in the BIIB033 arm have received at least 1 dose of 100 mg/kg BIIB033.

Treatment:

Drug: BIIB033 100mg/Kg