Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)

Summary

The primary objective of Part 1 of this study is to evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks. The primary objective of Part 2 of this study is to evaluate the long-term safety profile of BIIB033 as an add-on therapy in participants with MS. The secondary objective of Part 1 is to evaluate the effects of BIIB033 versus placebo on additional measures of disability improvement. The secondary objective of Part 2 is to investigate long-term efficacy (disability improvement) and additional safety measures of BIIB033 as an add-on therapy in participants with MS.

Timeline

Start

2017-11-15

Primary completion

2021-02-12

Completion

2021-02-12

Publications

• Calabresi PA, Giovannoni G, Hartung HP, Naismith RT, Fox RJ, Sormani MP, Arnold DL, Kappos L, Valis M, Newsome SD, Belkin MI, Bartholome E, Riester K, Javor A, Lyons J, Bradley DP, Fisher E, Tagge I, Naylor ML, Belachew S, Deykin A, Franchimont N, Zhu B, Cheng W. Safety and efficacy of opicinumab in participants with relapsing multiple sclerosis (AFFINITY Part 1): A randomized, controlled, phase 2 trial. Mult Scler. 2026 Jan;32(1):107-120. doi: 10.1177/13524585251396433. Epub 2025 Dec 26.
• Elliott C, Rudko DA, Arnold DL, Fetco D, Elkady AM, Araujo D, Zhu B, Gafson A, Tian Z, Belachew S, Bradley DP, Fisher E. Lesion-level correspondence and longitudinal properties of paramagnetic rim and slowly expanding lesions in multiple sclerosis. Mult Scler. 2023 May;29(6):680-690. doi: 10.1177/13524585231162262. Epub 2023 Apr 10.
• Hanf KJM, Arndt JW, Liu Y, Gong BJ, Rushe M, Sopko R, Massol R, Smith B, Gao Y, Dalkilic-Liddle I, Lee X, Mojta S, Shao Z, Mi S, Pepinsky RB. Functional activity of anti-LINGO-1 antibody opicinumab requires target engagement at a secondary binding site. MAbs. 2020 Jan-Dec;12(1):1713648. doi: 10.1080/19420862.2020.1713648.

Drugs

Indications