A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

Inclusion Criteria:

• Diagnosis of PPMS or RMS according to the revised McDonald 2017 criteria (Thompsonet al. 2018)

• EDSS score, 0-6.5, inclusive, at screening

• Neurological stability for ≥30 days prior to both screening and baseline

• Disease duration from onset of MS symptoms of less than 15 years for patients withEDSS score <2.0 at screening

• For females participants, without reproductive potential may be enrolled ifpost-menopausal, unless receiving a hormonal therapy for menopause or if surgicallysterile

• For females of childbearing potential, agreement to remain abstinent or use adequatecontraceptive methods

Exclusion Criteria:

• Any known or suspected active infection at screening or baseline (except nailbedinfections), or any major episode of infection requiring hospitalization ortreatment with IV anti microbials within 8 weeks prior to and during screening ortreatment with oral anti microbials within 2 weeks prior to and during screening

• History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)

• History of cancer, including hematologic malignancy and solid tumors, within 10years of screening

• Immunocompromised state

• Receipt of a live-attenuated vaccine within 6 weeks prior to randomization Influenzavaccination is permitted if the inactivated vaccine formulation is administered

• Inability to complete an MRI or contraindication to gadolinium administration

• Contraindications to mandatory premedications for IRRs, including closed-angleglaucoma for antihistamines

• Known presence of other neurologic disorders

• Any concomitant disease that may require chronic treatment with systemiccorticosteroids or immunosuppressants during the course of the study

• Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal,hepatic, endocrine or gastrointestinal, or any other significant disease that maypreclude patient from participating in the study

• History of or currently active primary or secondary (non-drug-related)immunodeficiency

• Pregnant or breastfeeding, or intending to become pregnant during the study and 6 or 12 months

• Lack of peripheral venous access

• History of alcohol or other drug abuse within 12 months prior to screening

• Treatment with any investigational agent within 24 weeks prior to screening or 5half-lives of the investigational drug (whichever is longer), or treatment with anyexperimental procedure for MS (e.g., treatment for chronic cerebrospinal venousinsufficiency)

• Participants who have previously received anti-CD20s if the last treatment was lessthan 2 years before screening, and/or if B-cell count is below lower limit ofnormal, and/or the discontinuation of the treatment was due to safety reasons orlack of efficacy

• Previous treatment with cladribine, atacicept, and alemtuzumab

• Previous treatment with fingolimod, siponimod, ponesimod, or ozanimod within 6 weeksof baseline

• Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2weeks of baseline

• Previous treatment with natalizumab within 4.5 months of baseline

• Treatment with mitoxantrone within 2 years prior to baseline visit or evidence ofcardiotoxicity following mitoxantrone use or a cumulative lifetime dose of more than 60 mg/m2

• Previous treatment with any other immunomodulatory or immunosuppressive medicationnot already listed above without appropriate washout as described in the applicablelocal label.

• If the washout requirements are not described in the applicable local label, thenthe wash out period must be 5 times the half-life of the medication. The PD effectsof the previous medication must also be considered when determining the requiredtime for washout.

• Any previous treatment with bone marrow transplantation and hematopoietic stem celltransplantation

• Any previous history of transplantation or anti-rejection therapy

• Treatment with IV Ig or plasmapheresis within 12 weeks prior to randomization

• Systemic corticosteroid therapy within 4 weeks prior to screening

• Positive screening tests for active, latent, or inadequately treated hepatitis B

• Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab

• Any additional exclusionary criterion as per ocrelizumab (Ocrevus®) local label, ifmore stringent than the above