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
Outcome
Missed primary endpoint
Stopped: “The top-line results from the Part 1 did not meet the pre-specified primary endpoint nor the key secondary endpoints. The decision to discontinue study 215MS202 Part 2 was not based on safety concerns.”
paper Adjusted mean difference (95% confidence interval (CI)) on ODRS was 0.15 (-0.05 to 0.35; p = 0.148) over 72 weeks, favoring opicinumab versus placebo. PMID 41454463 ↗
paper CONCLUSION: Although the AFFINITY study did not show significant difference in mean ODRS between opicinumab and placebo groups PMID 41454463 ↗
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | opicinumab | Protein / enzyme biologic | 750 mg | Intravenous |