RecruitingPhase 4Relapsing and progressiveNCT07609719

What it found

Still running

No result yet.

What was tested

Treatment tested

  • OCR SC

What it measured

Main measures

  • 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

    Baseline, Week 24

    MRI lesions

Other measures (10)

  • Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 24

    At Week 24

    MRI lesions
  • Number of Participants With Adverse Events (AEs)

    Up to Week 48

    Safety
  • Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gd+ Lesions as Detected by Brain MRI at Week 48

    Baseline, Week 48

    MRI lesions
  • Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 48

    At Week 48

    MRI lesions
  • Change From Baseline in Cluster of Differentiation 19 (CD19+) B-cell Counts at Week 24 and Week 48

    Baseline, Weeks 24 and 48

    Immune response
  • Treatment Satisfaction Score With Prior aCD20 Therapy, as Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-II)

    At Day 1 (Baseline)

    Quality of life (reported by participants)Immune responseSafety
  • 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)

    At Day 1 (Baseline) and Week 24

    Quality of life (reported by participants)
  • Treatment Satisfaction Score With OCR SC at Week 24 and Week 48, as Assessed Using TSQM-II

    At Weeks 24 and 48

    Quality of life (reported by participants)Safety
  • Change From Baseline in Multiple Sclerosis Impact Scale (MSIS-29) Scores at Week 24 and Week 48

    Baseline, Weeks 24 and 48

    Quality of life (reported by participants)
  • Number of Participants who Switched From Approved aCD20 Therapy to OCR SC, Categorized by Reasons for Switching

    At Baseline

    Immune response

Who could take part

Relapsing and progressive · 18 to 65

Inclusion Criteria: * 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 Exclusion Criteria: * 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 in the 12 months prior to screening, 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.

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

Contact details on the registry

About this trial

In the sponsor's words

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).

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History

    1. Started

      Sept 2026

    2. Main results due

      Feb 2029

    3. Finished

      Feb 2029

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