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NOT YET RECRUITING
NCT07606521
PHASE1

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

Sponsor: Polpharma Biologics International AG

View on ClinicalTrials.gov

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.

Official title: A Randomized, Parallel-Group Double-Blind, Biosimilar Trial to Compare Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of PB018 Versus Ocrevus® in Participants With Multiple Sclerosis (MS)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

222

Start Date

2026-10

Completion Date

2028-04

Last Updated

2026-05-28

Healthy Volunteers

No

Interventions

BIOLOGICAL

US-Ocrevus

Intravenous(IV) infusion

BIOLOGICAL

PB018

Intravenous(IV) infusion

BIOLOGICAL

EU-Ocrevus

Intravenous(IV) infusion