Multiple SclerosisPhase 4OSSIANCT07609719
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
A Phase 4 study testing OCR SC in people with Multiple Sclerosis, run by Genentech, Inc. at 8 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- OCR SC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 2 Sep 2026to 28 Feb 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: ML46740 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
8 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
Atlanta Neuroscience Institute
Atlanta, Georgia, 30327
- Recruiting
Alabama Neurology Associates
Birmingham, Alabama, 35209
- Recruiting
Neurology Clinic PC
Cordova, Tennessee, 38108
- Recruiting
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, 80528
- Recruiting
Neurology Associates, PA
Maitland, Florida, 32751
- Recruiting
Savannah Neurology Specialists,PC
Savannah, Georgia, 31406
- Recruiting
Clinical Endpoints, LLC
Scottsdale, Arizona, 85258
Puerto Rico1 site, 1 recruiting
- Recruiting
Caribbean Center for Clinical Research
Guaynabo, 00968
About this study
Official title: A Prospective, Multicenter, Single-arm Study of Ocrelizumab Administered Subcutaneously in Patients With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
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).
- Conditions
- Multiple Sclerosis
- Being tested
- OCR SC
- Keywords
- Primary Progressive Multiple Sclerosis, Relapsing Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCR SCDrug
Also called Ocrevus Zunovo® USPI;, RO4964913
Participants will receive OCR SC as per the schedule specified in the arm and the United States Prescribing Information (USPI).
| Study group | Role | What they receive |
|---|---|---|
| OCR SC | Experimental | Participants will receive OCR SC, 920 milligrams (mg) at Day 1 and at Week 24. Receives: Drug: OCR SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Week 24
Secondary outcomes (10)
Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 24
Measured: At Week 24
Number of Participants With Adverse Events (AEs)
Measured: Up to Week 48
Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gd+ Lesions as Detected by Brain MRI at Week 48
Measured: Baseline, Week 48
Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 48
Measured: At Week 48
Change From Baseline in Cluster of Differentiation 19 (CD19+) B-cell Counts at Week 24 and Week 48
Measured: Baseline, Weeks 24 and 48
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.
Measured: At Day 1 (Baseline)
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.
Measured: At Day 1 (Baseline) and Week 24
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.
Measured: At Weeks 24 and 48
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.
Measured: Baseline, Weeks 24 and 48
Number of Participants who Switched From Approved aCD20 Therapy to OCR SC, Categorized by Reasons for Switching
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start2 Sep 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609719
- Sponsor's protocol ID
- ML46740
- Acronym
- OSSIA
- Status last verified
- Oct 2026
- First submitted
- 20 May 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm Study of Ocrelizumab Administered Subcutaneously in Patients With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
- ClinicalTrials.gov ID
- NCT07609719
- Acronym / sponsor ID
- OSSIA / ML46740
- Conditions
- Multiple Sclerosis
- Keywords
- Primary Progressive Multiple Sclerosis, Relapsing Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCR SC | Experimental | Drug: OCR SCParticipants will receive OCR SC, 920 milligrams (mg) at Day 1 and at Week 24. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCR SCAlso: Ocrevus Zunovo® USPI;, RO4964913Participants will receive OCR SC as per the schedule specified in the arm and the United States Prescribing Information (USPI). | Drug | OCR SC |
Primary outcome
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
10 secondary outcomes
Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 24
Time frame: At Week 24
Number of Participants With Adverse Events (AEs)
Time frame: Up to Week 48
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
Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 48
Time frame: At Week 48
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
Treatment Satisfaction Score With Prior aCD20 Therapy, as Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-II)
Time frame: At Day 1 (Baseline)
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)
Time frame: At Day 1 (Baseline) and Week 24
Treatment Satisfaction Score With OCR SC at Week 24 and Week 48, as Assessed Using TSQM-II
Time frame: At Weeks 24 and 48
Change From Baseline in Multiple Sclerosis Impact Scale (MSIS-29) Scores at Week 24 and Week 48
Time frame: Baseline, Weeks 24 and 48
Number of Participants who Switched From Approved aCD20 Therapy to OCR SC, Categorized by Reasons for Switching
Time frame: At Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: ML46740 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OCR SC in people with Multiple Sclerosis, run by Genentech, Inc. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: ML46740 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S.), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.