drugset / Trial / NCT07606521

A Biosimilar Trial to Investigate PK, PD, Safety With PB018 Versus US-licensed Ocrevus and EU-approved Ocrevus

NCT07606521

Phase 1 Not yet recruiting 222 enrolled Polpharma Biologics International AG
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, parallel group, double-blind, active-controlled, clinical pharmacology study to compare Pharmacokinetics, Pharmacodynamics and safety of PB018 versus Ocrevus in patients with Multiple Sclerosis.

Timeline

Start
2026-10
Primary completion
2027-12
Completion
2028-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ocrelizumab Monoclonal antibody Intravenous

Indications