Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex

Summary

The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex. Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.

Timeline

Start

2013-08

Primary completion

2015-12

Completion

2016-03

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs BIIB033, 3 mg/kg vs BIIB033, 10 mg/kg vs BIIB033, 30 mg/kg vs BIIB033, 100 mg/kg; p = 0.8931; Trend test NCT01864148 ↗

paper Our findings did not show a significant dose-linear improvement in disability compared with placebo in patients with relapsing multiple sclerosis. PMID 31285147 ↗

Publications

• Cadavid D, Mellion M, Hupperts R, Edwards KR, Calabresi PA, Drulovic J, Giovannoni G, Hartung HP, Arnold DL, Fisher E, Rudick R, Mi S, Chai Y, Li J, Zhang Y, Cheng W, Xu L, Zhu B, Green SM, Chang I, Deykin A, Sheikh SI; SYNERGY study investigators. Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2019 Sep;18(9):845-856. doi: 10.1016/S1474-4422(19)30137-1. Epub 2019 Jul 5.
• Wilhelm H, Schabet M. The Diagnosis and Treatment of Optic Neuritis. Dtsch Arztebl Int. 2015 Sep 11;112(37):616-25; quiz 626. doi: 10.3238/arztebl.2015.0616.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	opicinumab	Protein / enzyme biologic	3 mg/kg	Intravenous
Subject	opicinumab	Protein / enzyme biologic	10 mg/kg	Intravenous
Subject	opicinumab	Protein / enzyme biologic	30 mg/kg	Intravenous
Subject	opicinumab	Protein / enzyme biologic	100 mg/kg	Intravenous
Background	Interferon beta-1a	Protein / enzyme biologic	—	Intramuscular

Indications