CompletedPhase 1Relapsing and progressiveNCT03972306

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Ocrelizumab

    B-lymphocyte antigen CD20 binding agent

  • Hyaluronidase (human recombinant)

    Hyaluronic acid hydrolytic enzyme

What it measured

Main measures

  • Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab following subcutaneous (SC) administration

    At predefined intervals from baseline through end of study (approximately 5 years)

    How the body handles the medicine
  • Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab following single IV (intravenous Infusion)administration

    At predefined intervals from baseline through end of study (approximately 5 years)

    How the body handles the medicine
  • Percentage of participants with adverse events

    Baseline to end of study (approximately 5 years)

    Safety
  • Percentage of participants with change from baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters

    Baseline to end of study (approximately 5 years)

  • Incidence of local pain at site of injection assessed using Visual Analog Scale (VAS

    Baseline to end of study (approximately 5 years)

    Pain
  • Incidence of local-injection reaction (ISR) assessed using Local Injection-Site Symptom Assessment (LISSA)

    Baseline to end of study (approximately 5 years)

    Safety

Other measures (2)

  • Percentage of Participants with Anti-Drug Antibodies (ADAs) to ocrelizumab

    Baseline to end of study (approximately 5 years)

    Immune response
  • Percentage of Participants with Anti-Drug Antibodies (ADAs) to rHuPH20

    Baseline to end of study (approximately 5 years)

    Immune response

Who could take part

Relapsing and progressive · 18 to 65

Inclusion Criteria: * 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 * Absence of relapses for 30 days prior to the screening visit * For the dose escalation phase for participants pretreated with ocrelizumab (Group A): treatment with IV ocrelizumab for at least 1 year prior to screening (i.e., at least two 600-mg doses of ocrelizumab separated by 24 weeks) * For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab. * For female perticipants without reproductive potential: Women may be enrolled if post-menopausal unless the participant is receiving a hormonal therapy for her menopause or if surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy). Exclusion Criteria: * MS disease duration of more than 15 years for participants with an Expanded Disability Status Scale (EDSS) score \<2.0 at screening. * Known presence of other neurologic disorders that may mimic MS, including, but not limited to, the following: * History of ischemic cerebrovascular disorders (e.g., stroke, transient ischemic attack) or ischemia of the spinal cord * History or known presence of Central Nervous System (CNS) or spinal cord tumor (e.g., meningioma,glioma) * History or known presence of potential metabolic causes of myelopathy (e.g., untreated vitamin B12 deficiency) * History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, human T-lymphotropic virus 1, herpes zoster and myelopathy. * History of genetically inherited progressive CNS degenerative disorder (e.g., hereditary paraparesis and mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke syndrome) * Neuromyelitis optica * History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sjögren syndrome, Behçet disease, sarcoidosis). * History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This study will evaluate the pharmacokinetics, safety and tolerability, and immunogenicity of ocrelizumab administered subcutaneously to participants with multiple sclerosis (MS).

Papers

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Linked trials

  • Extended by

    OleroMAX

    Phase 3 · Recruiting

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Aug 2019

    2. Main results due

      Jun 2025

    3. Finished

      Jun 2025

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