RecruitingPhase 3

Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis

United States, Bosnia and Herzegovina175 participantsStarted 2025-06-10

Plain-language 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

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Area under the concentration time curve

Timeframe: Week 1 - 3, week 3 - 25

Trial details

NCT IDNCT06847724

SponsorSandoz

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-14

Contact for this trial

Clinical Disclosure Representative

+49 8024 / 908 0 sandoz.disclosure@sandoz.com