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

NCT06847724 · Sandoz
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Official title
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].
About this study
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 criteria
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
Study design
Enrollment target: 175 participants
Allocation: randomized
Masking: quadruple
Age groups: adult
Timeline
Starts: 2025-06-10
Estimated completion: 2029-10-14
Last updated: 2026-03-05
Interventions
Biological: CYB704Biological: Ocrevus-EUBiological: Ocrevus-US
Primary outcomes
  • Area under the concentration time curve (Week 1 - 3, week 3 - 25)
Sponsor
Sandoz · industry
Contacts & investigators
ContactClinical Disclosure Representative · contact · sandoz.disclosure@sandoz.com · +49 8024 / 908 0
All locations (40)
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Maitland, Florida, United States
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Ormond Beach, Florida, United States
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Banja Luka, Bosnia and Herzegovina
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Bihać, Bosnia and Herzegovina
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Sarajevo, Bosnia and Herzegovina
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Sarajevo, Bosnia and Herzegovina
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Varaždin, Croatia
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Zagreb, Croatia
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Rustavi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Shtip, North Macedonia
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Skopje, North Macedonia
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Bydgoszcz, Poland
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Katowice, Poland
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Katowice, Poland
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Lodz, Poland
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Lublin, Poland
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Nowa Sól, Poland
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Poznan, Poland
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Poznan, Poland
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Szczecin, Poland
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Warsaw, Poland
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Zabrze, Poland
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Belgrade, Serbia
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Niš, Serbia
Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis · TrialPath