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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGenentech, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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])

Trial design

Design model

Single group

Treatments tested in this trial

  • OCR SC

    Drug

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: OCR SCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, Week 24

Secondary outcomes

1

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

Time frame
At Week 24
2

Number of Participants With Adverse Events (AEs)

Time frame
Up to Week 48
3

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

Time frame
Baseline, Week 48
4

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

Time frame
At Week 48

Other outcomes

Sponsors and contacts

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