eligibility_summary
Eligible: MS per revised McDonald criteria, recent MS activity, neurologically stable ≥30 days, EDSS 0–6.0. Exclude: primary/secondary progressive MS, MS >15 years with EDSS ≤2.0, inability/contraindication to MRI, hypersensitivity to corticosteroids (e.g., methylprednisolone) or study-drug excipients, protocol-defined medical conditions, use or planned use of protocol-prohibited medications/treatments.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Double-blind, randomized, active-controlled Phase 1/3 trial in RRMS comparing CT-P53 (Celltrion’s proposed ocrelizumab biosimilar) with US- and EU-licensed Ocrevus. Interventions: intravenous ocrelizumab (biologic, humanized IgG1 monoclonal antibody). Mechanism of action: binds CD20 on pre‑B to mature B lymphocytes, depleting them primarily via antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, and inducing apoptosis, plasma cells (CD20–) are spared. Targeted cells/pathways: CD20+ B cells that propagate MS inflammation, downregulation of antigen presentation, costimulation, and proinflammatory cytokines, thereby modulating T-cell–mediated CNS autoimmunity. Outcomes: efficacy, PK/PD, safety.