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

Polpharma Biologics International AG

Status and phase: Begins enrollment in 1 month; Phase 1

Conditions: Multiple Sclerosis

Treatments: Biological: US-Ocrevus; Biological: EU-Ocrevus; Biological: PB018

Study type: Interventional

Funder types: Industry

Identifiers

NCT07606521

PB018-01-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 222 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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222 participants in 3 patient groups

PB018

Experimental group

Description:

PB018 (Ocrelizumab)

Treatment:

Biological: PB018

US-Ocrevus

Active Comparator group

Description:

US-licensed Ocrevus(Ocrelizumab)

Treatment:

Biological: US-Ocrevus

EU-Ocrevus

Active Comparator group

Description:

EU-approved Ocrevus(Ocrelizumab)

Treatment:

Biological: EU-Ocrevus