A Biosimilar Trial to Investigate PK, PD, Safety With PB018 Versus US-licensed Ocrevus and EU-approved Ocrevus

Korábbi kezelés

• Patients who have received or are going to receive any of prohibited medications or treatments defined in the study protocol.

Más betegség

• Patient with contraindications and/or severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or interventions defined in the study protocol.
• Patient who has currently or history of any of medical conditions described in the study protocol.

Életkor

• Patients diagnosed with PPMS < 10 years with an EDSS at screening ≤ 5.0 or < 15 years with an EDSS at screening > 5

Egyéb

• Patient diagnosed with RMS for more than 10 years duration with an EDSS score ≤2.0 at Screening
• Patient unable to complete or has a contraindication to an MRI

• Male or female participants diagnosed with RMS and PPMS forms of MS in accordance with the revised McDonald criteria
• Evidence of recent disease activity as defined in study protocol
• Neurological stability for ≥ 30 days before both screening and first study treatment
• Baseline EDSS score between 0 to 6.0 (both inclusive) for RMS patients and between 3.0 and 6.5 (both inclusive) for PPMS patients.