A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy

Официальное название

A Prospective, Multicenter, Single-arm Study of Ocrelizumab Administered Subcutaneously in Patients With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy

Обзор

The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differentiation 20 (aCD20) therapy approved for RMS (ofatumumab SC, ublituximab-xiiy intravenous \[IV\], ocrelizumab IV) or PPMS (ocrelizumab IV).

Вмешательства

• Препарат OCR SC
  Participants will receive OCR SC as per the schedule specified in the arm and the United States Prescribing Information (USPI).

Первичные конечные точки

• Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gadolinium-enhanced (Gd+) Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) at Week 24 [Срок оценки: Baseline, Week 24]

Вторичные конечные точки (10)

• Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 24 [Срок оценки: At Week 24]
• Number of Participants With Adverse Events (AEs) [Срок оценки: Up to Week 48]
• Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gd+ Lesions as Detected by Brain MRI at Week 48 [Срок оценки: Baseline, Week 48]
• Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 48 [Срок оценки: At Week 48]
• Change From Baseline in Cluster of Differentiation 19 (CD19+) B-cell Counts at Week 24 and Week 48 [Срок оценки: Baseline, Weeks 24 and 48]
• Treatment Satisfaction Score With Prior aCD20 Therapy, as Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-II) [Срок оценки: At Day 1 (Baseline)]
• Treatment Administration Satisfaction Score After Dose of OCR SC at Day 1 and Week 24, as Assessed Using Treatment Administration Satisfaction Questionnaire - Subcutaneous Injection (TASQ SC) [Срок оценки: At Day 1 (Baseline) and Week 24]
• Treatment Satisfaction Score With OCR SC at Week 24 and Week 48, as Assessed Using TSQM-II [Срок оценки: At Weeks 24 and 48]
• Change From Baseline in Multiple Sclerosis Impact Scale (MSIS-29) Scores at Week 24 and Week 48 [Срок оценки: Baseline, Weeks 24 and 48]
• Number of Participants who Switched From Approved aCD20 Therapy to OCR SC, Categorized by Reasons for Switching [Срок оценки: At Baseline]

Критерии участия

Критерии включения

• Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria
• Documented Expanded Disability Status Scale (EDSS) score of 0-6.5, inclusive, at screening (or within 6 months of screening)
• Participants discontinuing aCD20 therapy for reasons including, but not limited to, physician/participant preference, access to commercial drug (e.g., insurance coverage issues), or other logistical reasons (such as geographical relocation, travel, etc.) are eligible for this study
• Prior treatment with ofatumumab SC, ublituximab-xiiy IV, or ocrelizumab IV aCD20 therapy

Критерии исключения

• Participants who have demonstrated suboptimal response to aCD20 therapy
• Discontinuing aCD20 therapy because of any of the following treatment emergent adverse events (TEAEs): 1) Grade ≥3 severe infusion-related reaction (IRRs) or injection reactions (IRs); 2) Recurrent Grade ≥3 infections, or the need for ≥2 courses of antibiotics after starting aCD20 therapy, if the investigator believes infection is related to therapy
• Participants with contraindication to Gd+ and participants who for any reason cannot tolerate MRI procedure
• Known presence of active, recurrent, or chronic infection (e.g., human immunodeficiency virus \[HIV\], syphilis, human papillomavirus \[HPV\], tuberculosis \[TB\])
• History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
• Known presence of neurologic disorders that may interfere with the diagnosis of RMS or PPMS
• Any concomitant disease that may require treatment with systemic corticosteroids (e.g., mineralocorticoids and glucocorticoids) or immunosuppressants during the study
• Known allergy or hypersensitivity to ocrelizumab, rHuPH20, or excipients of the OCR SC formulation
• Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
• Treatment with any live-attenuated vaccine within 6 weeks prior to baseline
• Treatment with any experimental procedures for RMS or PPMS (e.g., treatment for chronic cerebrospinal venous insufficiency)
• Previous treatment with cladribine, atacicept, alemtuzumab or mitoxantrone
• Positive hepatitis B virus (HBV) and hepatitis C virus (HCV) antibody test at screening

Other protocol defined inclusion and exclusion criteria may apply.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 10 центров

• Alabama Neurology Associates — Birmingham
• Clinical Endpoints — Scottsdale
• Advanced Neurology of Colorado — Fort Collins
• Neurology Associates - Maitland — Orlando
• Multiple Sclerosis Center of Atlanta/Atlanta Neuroscience Institute — Atlanta
• Minneapolis Clinic of Neurology — Minneapolis
• Ohio State University, Multiple Sclerosis and Neuroimmunology Center — Columbus
• Neurology Clinic, P.C. — Cordova
• … и ещё 2 центра

Пуэрто-Рико · 1 центр

• Caribbean Center for Clinical Research — Guaynabo

Идентификаторы

NCT: NCT07609719 · ML46740

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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