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

NCT07606521 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: PB018-01-01
• Study Type: interventional
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief 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

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Area under the concentration time curve

  Demonstrate similar PK between Ocrevus and PB018

  Week 0 to Week 24

Secondary Outcomes (19)

• 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

Study Arms (3)

PB018

EXPERIMENTAL

PB018 (Ocrelizumab)

Biological: PB018

US-Ocrevus

ACTIVE COMPARATOR

US-licensed Ocrevus(Ocrelizumab)

Biological: US-Ocrevus

EU-Ocrevus

ACTIVE COMPARATOR

EU-approved Ocrevus(Ocrelizumab)

Biological: EU-Ocrevus

Interventions

US-Ocrevus BIOLOGICAL

Intravenous(IV) infusion

US-Ocrevus

PB018 BIOLOGICAL

Intravenous(IV) infusion

PB018

EU-Ocrevus BIOLOGICAL

Intravenous(IV) infusion

EU-Ocrevus

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Polpharma Biologics International AG: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share