ClinicalTrials.gg
RecruitingNCT07609719OSSIAUpdated Oct 30, 2026

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

A Phase 4 interventional study of OCR SC in Multiple Sclerosis, sponsored by Genentech, Inc.. Recruiting at 8 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Oct 30, 20265 sites addedGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Primary Progressive Multiple Sclerosis
  • Relapsing Multiple Sclerosis
03

In context

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Genentech, Inc. is the lead sponsor of 517 studies on the registry; 20 are open to participants now.

Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.

First submitted after Genentech, Inc. became part of Hoffmann-La Roche.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 to Gd+ and participants who for any reason cannot tolerate MRI procedure
  • Known presence of active, recurrent, or chronic infection (e.g., [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 (e.g., mineralocorticoids and glucocorticoids) or during the study
  • Known allergy or to ocrelizumab, rHuPH20, or of the OCR SC formulation
  • Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
  • Treatment with any 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 virus (HBV) and virus (HCV) antibody test at screening

Other protocol defined inclusion and exclusion criteria may apply.

Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    OCR SC

    Participants will receive OCR SC, 920 milligrams (mg) at Day 1 and at Week 24.

    Drug: OCR SC

Interventions

  • DrugOCR SC

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

    Also known as: Ocrevus Zunovo® USPI;, RO4964913

06

What researchers measure

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

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

    Time frame: Baseline, Weeks 24 and 48

  6. Treatment Satisfaction Score With Prior aCD20 Therapy, as Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-II)

    TSQM-II is an 11-item questionnaire with a 2- to 3-week recall period or since last use of medication. The questionnaire includes 4 domains: an effectiveness scale, a side effects scale, a convenience scale, and a global satisfaction scale. Each item is rated using Likert-type scales of 5 or 7 points and dichotomous (Yes/No) responses with higher scores corresponding to higher satisfaction in that domain.

    Time frame: At Day 1 (Baseline)

  7. 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)

    TASQ SC is a 13-item questionnaire to evaluate participants' experience on their most recent OCR SC administration. The questionnaire consists of items related to SC injections, each rated on a 3- or 5-point Likert scale with higher scores corresponding to higher satisfaction and/or a more positive experience.

    Time frame: At Day 1 (Baseline) and Week 24

  8. Treatment Satisfaction Score With OCR SC at Week 24 and Week 48, as Assessed Using TSQM-II

    TSQM-II is an 11-item questionnaire with a 2- to 3-week recall period or since last use of medication. The questionnaire includes 4 domains: an effectiveness scale, a side effects scale, a convenience scale, and a global satisfaction scale. Each item is rated using Likert-type scales of 5 or 7 points and dichotomous (Yes/No) with higher scores corresponding to higher satisfaction in that domain.

    Time frame: At Weeks 24 and 48

  9. Change From Baseline in Multiple Sclerosis Impact Scale (MSIS-29) Scores at Week 24 and Week 48

    MSIS-29 is a 29-item questionnaire to examine the impact of MS on physical and psychological functioning from a participant's perspective. Participants are asked to rate how much their functioning and well-being have been impacted over the past 14 days on a 4-point scale, from 1 = "Not at all" to 4 = "Extremely". The physical score is the sum of items 1-20, which is then transformed to a 0-100 scale. The psychological score is the sum of items 21-29, transformed to a 0-100 scale. Higher scores indicate a greater impact of MS.

    Time frame: Baseline, Weeks 24 and 48

  10. Number of Participants who Switched From Approved aCD20 Therapy to OCR SC, Categorized by Reasons for Switching

    Time frame: At Baseline

07

Study locations

8 of 8 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

09

Updates

2 registry updates since Sep 25, 2026
Sites
5 sites added
Show 5 added (5 United States)
  • Clinical Endpoints, LLC · Scottsdale, United States
  • Neurology Associates, PA · Maitland, United States
  • Alabama Neurology Associates · Birmingham, United States
  • Advanced Neurology of Colorado, LLC · Fort Collins, United States
  • Savannah Neurology Specialists,PC · Savannah, United States
across 2 updates, Sep 30, 2026 – Oct 30, 2026
Show all 2 updates
  1. Oct 30, 2026
    3 sites added
    Show 3 added (3 United States)
    • Alabama Neurology Associates · Birmingham, United States
    • Advanced Neurology of Colorado, LLC · Fort Collins, United States
    • Savannah Neurology Specialists,PC · Savannah, United States
    + 1 other change: verification date
  2. Sep 30, 2026
    2 sites added
    Show 2 added (2 United States)
    • Clinical Endpoints, LLC · Scottsdale, United States
    • Neurology Associates, PA · Maitland, United States

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07609719
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
May 27, 2026
Start date
Sep 2, 2026
Primary completion
Feb 28, 2029 (estimated)
Completion
Feb 28, 2029 (estimated)
Last update
Oct 30, 2026

Study contacts

Reference Study ID Number: ML46740 https://forpatients.roche.com/ No attachments to email below.
Contact
global-roche-genentech-trials@gene.com
888-662-6728 (U.S.)
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Ocrelizumab

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