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)

Polpharma Biologics International AG0 个研究点目标入组 222 人开始时间: 2026年10月1日最近更新: 2026年5月28日

适应症

试验速览

阶段: 1 期
状态: 尚未招募
发起方
入组人数: 222

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.

研究者

发起方

Polpharma Biologics International AG

申办方类型

Industry

责任方

Sponsor

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