MS patients may soon get a simpler shot option
NCT ID NCT07609719
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 8 times
Summary
This study looks at whether people with multiple sclerosis can safely switch from their current anti-CD20 therapy to a new under-the-skin version of ocrelizumab. About 100 participants will be followed for up to 48 weeks to see if brain lesions stay stable and if they are satisfied with the treatment. The goal is to offer a more convenient option for managing the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ocrelizumab combined with recombinant human hyaluronidase (rHuPH20) given as a shot under the skin
- What this could lead to
- If it works, this could offer a more convenient way to control multiple sclerosis with fewer clinic visits.
- What could go wrong
- This is a small, early-phase study with no placebo group, so results may not apply broadly. Switching therapies could also cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Atlanta Neuroscience Institute
RECRUITINGAtlanta, Georgia, 30327, United States
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Caribbean Center for Clinical Research
RECRUITINGGuaynabo, 00968, Puerto Rico
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Neurology Clinic PC
RECRUITINGCordova, Tennessee, 38108, United States
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