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Not yet recruiting NCT07606521

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

Phase I Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: US-Ocrevus, PB018, EU-Ocrevus.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

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.

Interventions

  • Biological US-Ocrevus
    Intravenous(IV) infusion
  • Biological PB018
    Intravenous(IV) infusion
  • Biological EU-Ocrevus
    Intravenous(IV) infusion

Primary outcome measures

  • Area under the concentration time curve [Time frame: Week 0 to Week 24]
Secondary outcome measures (12)
  • Time to reach Maximum serum concentration (Cmax) [Time frame: Week 0 and Week 2]
  • Area under the concentration time curve in participants treated with PB018 versus US-licensed Ocrevus [Time frame: Week 0 to Week 16]
  • Area under the concentration time curve in participants treated with PB018 versus EU-approved Ocrevus [Time frame: Week 0 to Week 16]
  • Tmax (W0) [Time frame: Week 0]
  • Tmax (W2) [Time frame: Week 2]
  • T1/2 [Time frame: Week 0 to Week 24]
  • Clearance [Time frame: Week 0 to Week 24]
  • Elimination rate constant [Time frame: Week 0 to Week 24]
  • Volume of Distribution (Vz) [Time frame: Week 0 to Week 24]
  • Ctrough [Time frame: Week 0 to Week 24]
  • Mean residence time (MRT) [Time frame: Week 0 to Week 24]
  • B-cell Depletion (CD19+ Cells) [Time frame: Week 0 to Week 24]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07606521 · PB018-01-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗