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

Phase 1Not Yet RecruitingNCT07606521

Polpharma Biologics International AG222 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

222

Conditions

Multiple Sclerosis

Interventions

US-OcrevusBIOLOGICAL

Intravenous(IV) infusion

PB018BIOLOGICAL

Intravenous(IV) infusion

EU-OcrevusBIOLOGICAL

Intravenous(IV) infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Area under the concentration time curve

Demonstrate similar PK between Ocrevus and PB018

Time frame: Week 0 to Week 24

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.