A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis

Официальное название

A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 1/3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis

Обзор

This is a double-blind, randomized, active-controlled, parallel group, Phase 1/3 study to compare efficacy, PK, PD and overall safety of CT-P53 with Ocrevus in patients with Relapsing-remitting Multiple Sclerosis.

Подробное описание

CT-P53, 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 efficacy, PK, PD and safety of CT-P53 and Ocrevus in patients with Relpasing-remitting Multiple Screlosis.

Вмешательства

• Биопрепарат CT-P53
  Intravenous(IV) infusion
• Биопрепарат US-Ocrevus
  Intravenous(IV) infusion
• Биопрепарат EU-Ocrevus
  Intravenous(IV) infusion

Первичные конечные точки

• Area under the concentration-time curve in PK group [Срок оценки: Up to Week 24]
• Total number of new GdE lesions on T1-weighted brain MRI in Main study group [Срок оценки: Up to Week 24]

Вторичные конечные точки (12)

• Absoulte CD19+ B-cell counts for PD assessments [Срок оценки: Up to Week 96]
• Area under the concentration-time curve in PK group [Срок оценки: Up to Week 16]
• Total body clearance in PK group [Срок оценки: Up to Week 2]
• Volume of distribution at steady state in PK group [Срок оценки: Up to Week 2]
• Safety: Immunogenecity [Срок оценки: Up to Week 96]
• Annualized Relapse Rate (ARR) [Срок оценки: Up to Week 96]
• Change in Expanded Disability Status Score (EDSS) [Срок оценки: Up to Week 96]
• Change in Multiple Sclerosis Functional Composite Score (MSFCS) [Срок оценки: Up to Week 96]
• Total Number of Lesions on Brain Magnetic Resonance Imaging [Срок оценки: Up to Week 96]
• Volume of Hypointense Lesions on T1-weighted Brain Magnetic Resonance Imaging [Срок оценки: Up to Week 96]
• Brain Volume on Brain Magnetic Resonance Imaging [Срок оценки: Up to Week 96]
• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: Up to Week 96]

Критерии участия

Критерии включения

• Patient diagnosed as multiple sclerosis (MS) in accordance with the revised McDonald criteria.
• Patient has evidence of recent MS activity as defined in the study protocol
• Patient has neurological stability for ≥30 days.
• Patient with 0 to 6.0 (both inclusive) on the EDSS score.

Критерии исключения

• Patient diagnosed with primary or secondary progressive MS.
• Patient diagnosed with MS for more than 15 years duration with an EDSS score ≤2.0 at Screening.
• 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 etcs 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 going to receive any of prohibited medications or treatments defined in the study protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Польша · 1 центр

• CT-P53 3.1 investigational site — Poznan

Идентификаторы

NCT: NCT05906992 · CT-P53 3.1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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