Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sandoz
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of RMS (relapsing remitting multiple sclerosis (MS) or active secondary progressive MS)
Evidence of recent disease activity as defined in study protocol
Expanded Disability Status scale score of 0 to 5.5 (inclusive) at screening
Neurological stability (no new signs or symptoms referable to Central Nervous System (CNS) within 30 days before both screening and first study treatment
You may not be if
Diagnosis of primary progressive MS
Disease duration of more than 10 years in participants with an Expanded Disability Status Scale (EDSS) ≤2.0 at screening
Inability to complete an MRI or contraindication to gadolinium administration
History of allergic or anaphylactic reactions to ocrelizumab or one of the premedications (methylprednisolone or equivalent corticosteroid, antihistamine, antipyretic)
Pregnant participants
Current or history of medical conditions as outlined in the study protocol
Prohibited medications (current and history) as outlined in the study protocol
Abnormal laboratory blood values as outlined in the study protocol
Clareo Health | Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis
