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

NCT07606521 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2026-05-26

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

US-Ocrevus

Intravenous(IV) infusion

BIOLOGICAL

PB018

Intravenous(IV) infusion

BIOLOGICAL

EU-Ocrevus

Intravenous(IV) infusion

Sponsors & Collaborators

  • Polpharma Biologics International AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-12-31
Completion
2028-04-30
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07606521 on ClinicalTrials.gov