Running, not recruitingPhase 1Relapsing and progressiveNCT076673222024-513639-26-00

What it found

Still running

No result yet.

What was tested

Treatment tested

What it measured

Main measures

  • Number of Participants With Adverse Events (AEs)

    Up to 168 weeks

    Safety

Other measures (3)

  • Ocrelizumab Serum Concentration at Specified Timepoints Following Single SC Administration

    Up to 168 weeks

    How the body handles the medicine
  • Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) to Ocrelizumab

    Up to 168 weeks

    Immune response
  • Number of Participants With Treatment-emergent ADAs to rHuPH20

    Up to 168 weeks

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 Exclusion Criteria: * 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

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

About this trial

In the sponsor's words

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.

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History

    1. Started

      Dec 2024

    2. Main results due

      Feb 2028

    3. Finished

      Aug 2028

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