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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Biological: US-Ocrevus; Biological: EU-Ocrevus; Biological: PB018

Detailed Description

PB018, containing the active ingredient ocrelizumab, is a humanized monoclonal antibody that is being developed as a proposed biosimilar medicinal product to Ocrevus. The purpose of this study is to demonstrate similar PK, PD and safety of PB018 and Ocrevus in patients with Multiple Sclerosis.

• Study Type: Interventional
• Enrollment (Estimated): 222
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Male or female participants diagnosed with RMS and PPMS forms of MS in accordance with the revised McDonald criteria
• Evidence of recent disease activity as defined in study protocol
• Neurological stability for ≥ 30 days before both screening and first study treatment
• Baseline EDSS score between 0 to 6.0 (both inclusive) for RMS patients and between 3.0 and 6.5 (both inclusive) for PPMS patients.

Key Exclusion Criteria:

• Patient diagnosed with RMS for more than 10 years duration with an EDSS score ≤2.0 at Screening
• Patients diagnosed with PPMS < 10 years with an EDSS at screening ≤ 5.0 or < 15 years with an EDSS at screening > 5
• Patient unable to complete or has a contraindication to an MRI
• Patient with contraindications and/or severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or interventions defined in the study protocol.
• Patient who has currently or history of any of medical conditions described in the study protocol.
• Patients who have received or are going to receive any of prohibited medications or treatments defined in the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: US-Ocrevus; US-licensed Ocrevus(Ocrelizumab)	Biological: US-Ocrevus; Intravenous(IV) infusion
Active Comparator: EU-Ocrevus; EU-approved Ocrevus(Ocrelizumab)	Biological: EU-Ocrevus; Intravenous(IV) infusion
Experimental: PB018; PB018 (Ocrelizumab)	Biological: PB018; Intravenous(IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration time curve	Demonstrate similar PK between Ocrevus and PB018	Week 0 to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reach Maximum serum concentration (Cmax)		Week 0 and Week 2
Area under the concentration time curve in participants treated with PB018 versus US-licensed Ocrevus		Week 0 to Week 16
Area under the concentration time curve in participants treated with PB018 versus EU-approved Ocrevus		Week 0 to Week 16
Tmax (W0)		Week 0
Tmax (W2)		Week 2
T1/2		Week 0 to Week 24
Clearance		Week 0 to Week 24
Elimination rate constant		Week 0 to Week 24
Volume of Distribution (Vz)		Week 0 to Week 24
Ctrough		Week 0 to Week 24
Mean residence time (MRT)		Week 0 to Week 24
B-cell Depletion (CD19+ Cells)	Assessment of pharmacodynamic similarity between PB018 and reference ocrelizumab products based on the proportion of participants with CD19+ B-cell counts below predefined thresholds.	Week 0 to Week 24
MRI Lesion Activity	Assessment of similarity in MRI disease activity between PB018 and reference ocrelizumab products by evaluating new or enlarging brain lesions.	Week 0; Week 12; Week 24
Expanded Disability Status Scale (EDSS) score	Use of Disability Status Scale to measure for disability progression.	Screening to Week 24
Total number of participants with positive anti-drug antibodies (ADAs)		Week 0 to Week 24
Total number of participants with neutralizing antibodies (Nab)		Week 0 to Week 24
Number of participants with treatment-emergent adverse events (TEAE) as assessed by CTCAE v6.0		Week 0 to Week 24
Number of participants discontinued due to adverse events / serious adverse events as assessed by CTCAE v6.0		Week 0 to Week 24
Number of participants with treatment-emergent adverse events of special interest (TEAESI) as assessed by CTCAE v6.0		Week 0 to Week 24

Collaborators and Investigators

• Sponsor: Polpharma Biologics International AG

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: PB018-01-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes