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Keep this study
Lead
Polpharma Biologics International AG
PB018, containing the active ingredient ocrelizumab, is a humanized monoclonal antibody that is being developed as a proposed biosimilar medicinal product to Ocrevus. The purpose of this study is to demonstrate similar PK, PD and safety of PB018 and Ocrevus in patients with Multiple Sclerosis.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
Patient diagnosed with RMS for more than 10 years duration with an EDSS score ≤2.0 at Screening
Patients diagnosed with PPMS \< 10 years with an EDSS at screening ≤ 5.0 or \< 15 years with an EDSS at screening \> 5
Patient unable to complete or has a contraindication to an MRI
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.
Patients who have received or are going to receive any of prohibited medications or treatments defined in the study protocol.
Clareo Health | A Biosimilar Trial to Investigate PK, PD, Safety With PB018 Versus US-licensed Ocrevus and EU-approved Ocrevus
