Ocrevus (ocrelizumab)

P3, N=250, Recruiting, University Hospital, Montpellier | Not yet recruiting --> Recruiting | Trial completion date: Sep 2030 --> Jun 2031 | Initiation date: Sep 2025 --> Jun 2026 | Trial primary completion date: Sep 2030 --> Jun 2031

P4, N=60, Active, not recruiting, Georgia State University | Trial completion date: Apr 2026 --> Sep 2026

P4, N=296, Active, not recruiting, Amsterdam UMC, location VUmc | Recruiting --> Active, not recruiting | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Apr 2024 --> Feb 2027

P3, N=152, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting | N=444 --> 152

We summarize pivotal translational inflection points, from rituximab extension beyond lymphoma to approvals of ocrelizumab, ofatumumab, ublituximab, and inebilizumab in neuroimmunology. We further review plasma cell-directed and T-cell-engaging strategies for deep immune resets in refractory disease, while clarifying implications for trial design, long-term safety, and implementation. Finally, we introduce a model-informed roadmap integrating population PK/PD, exposure-response, and quantitative systems pharmacology to optimize indication selection, patient enrichment, and dose/regimen design-supporting confident extrapolation rather than empiricism.

P=N/A, N=1178, Active, not recruiting, Biogen | Recruiting --> Active, not recruiting

P1, N=222, Not yet recruiting, Polpharma Biologics International AG

P1, N=180, Active, not recruiting, R-Pharm

P2, N=360, Recruiting, Hoffmann-La Roche

P4, N=50, Recruiting, Johns Hopkins University | Not yet recruiting --> Recruiting

P=N/A, N=2604, Completed, Novartis Pharmaceuticals

P3, N=360, Recruiting, Novartis Pharmaceuticals | N=215 --> 360