Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis
A Randomized, Double-blind, Parallel-group Study to Compare the Pharmacokinetics, Efficacy, Pharmacodynamics, Safety, and Immunogenicity of CYB704 (Proposed Ocrelizumab Biosimilar) and Ocrevus® in Participants With Relapsing Multiple Sclerosis (RMS) [STRIVE-MS].
Sandoz
175 participants
Jun 10, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if drug CYB704, a proposed biosimilar to Ocrevus, works to treat multiple sclerosis in the same way as the reference product Ocrevus(R). The main questions it aims to answer are: * Is CYB704 distributed in the body in the same way as the reference product (demonstration of pharmacokinetic (PK) similarity)? * Does have CYB704 the same treatment effect and side effects as the reference product? Researchers will compare CYB704 to a Ocrevus (Ocrevus-US and Ocrevus-EU). Participants will: * Take drug CYB704 or Ocrevus (Ocrevus-US and Ocrevus-EU) * Visit the clinic for at least 15 treatment visits, checkups and tests * Will undergo regular magnetic resonance imaging (MRI) examinations
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria8
- 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
Interventions
Intravenous Infusion
Intravenous Infusion
Intravenous Infusion
Locations(40)
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NCT06847724