CN42097

Treatment tested

• Ocrelizumab

  B-lymphocyte antigen CD20 binding agent

Compared with

• Ocrelizumab

  B-lymphocyte antigen CD20 binding agent

Other measures (12)

Inclusion: - Diagnosis of primary progressive MS (PPMS) or relapsing forms of MS (RMS) according to the revised McDonald 2017 criteria - Age 18-65 years, inclusive, at time of signing Informed Consent Form - Expanded disability status scale (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 with EDSS score <2.0 at screening - Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 6 months or 12 months (as applicable by the ocrelizumab IV [Ocrevus] local label) after the final dose of ocrelizumab Exclusion: - Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks prior to and during screening or treatment 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 10 years of screening - Immunocompromised state - Receipt of a live attenuated vaccine within 6 weeks prior to randomization - Inability to complete an MRI or contraindication to gadolinium administration

To demonstrate pharmacokinetics (PK) non-inferiority of the SC formulation of ocrelizumab in patients with MS