A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis

Официальное название

A Phase 1b Multicenter, Non-randomized, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Single Ascending Doses of a New Subcutaneous Formulation of Ocrelizumab in Patients With Multiple Sclerosis

Обзор

The main purpose of this study is to evaluate the safety and tolerability of the ocrelizumab subcutaneous (SC) test formulation in participants with multiple sclerosis (MS). The study consists of two treatment phases: a dose-escalation and dose-continuation phase. Participants will receive single ascending doses of ocrelizumab SC during an initial dose-escalation phase, with the option to continue treatment with the selected dose of ocrelizumab SC in the dose-continuation phase.

Вмешательства

• Препарат Ocrelizumab Co-formulated With rHuPH20
  Participants will receive ocrelizumab co-formulated with rHuPH20, as a SC injection, per the schedule specified in the treatment arm.

Первичные конечные точки

• Number of Participants With Adverse Events (AEs) [Срок оценки: Up to 168 weeks]

Вторичные конечные точки (3)

• Ocrelizumab Serum Concentration at Specified Timepoints Following Single SC Administration [Срок оценки: Up to 168 weeks]
• Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) to Ocrelizumab [Срок оценки: Up to 168 weeks]
• Number of Participants With Treatment-emergent ADAs to rHuPH20 [Срок оценки: Up to 168 weeks]

Критерии участия

Критерии включения

• Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018)
• Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening

Критерии исключения

• Participants who have previously received anti-cluster of differentiation 20 (CD20s) (including ocrelizumab) less than 2 years before screening
• Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening
• History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
• History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
• Immunocompromised state
• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
• Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study
• Lack of peripheral venous access
• Previous treatment with cladribine, atacicept, and alemtuzumab
• Previous treatment with fingolimod, siponimod, ponesimod, or ozanimod within 6 weeks of baseline
• Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
• Any previous history of transplantation or anti-rejection therapy
• Positive screening tests for active, latent, or inadequately treated hepatitis B
• Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Profound Research, LLC — Carlsbad
• Neurology Associates, PA — Maitland
• University of South Florida — Tampa
• Shepherd Center Inc. — Atlanta
• John Hopkins University School of Medicine — Baltimore
• Hope Neurology — Knoxville

Бразилия · 2 центра

• Instituto de Neurologia de Curitiba — Curitiba
• Centro de Pesquisas Clinicas — São Paulo

Мексика · 2 центра

• Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C. — Guadalajara
• Inovacion y Desarrollo en ciencias de la salud — Mexico City

Великобритания · 2 центра

• Nottingham University Hospitals NHS Trust — Nottingham
• Morriston Hospital — Swansea

Идентификаторы

NCT: NCT07667322 · WN45319 · 2024-513639-26-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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