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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
Sponsor: Sandoz
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
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].
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
175
Start Date
2025-06-10
Completion Date
2029-10-14
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
CYB704
Intravenous Infusion
Ocrevus-EU
Intravenous Infusion
Ocrevus-US
Intravenous Infusion
Locations (40)
Sandoz Investigational Site
Maitland, Florida, United States
Sandoz Investigational Site
Ormond Beach, Florida, United States
Sandoz Investigational Site
Banja Luka, Bosnia and Herzegovina
Sandoz Investigational Site
Bihać, Bosnia and Herzegovina
Sandoz Investigational Site 2
Sarajevo, Bosnia and Herzegovina
Sandoz Investigational Site
Sarajevo, Bosnia and Herzegovina
Sandoz Investigational Site
Pleven, Bulgaria
Sandoz Investigational Site 2
Plovdiv, Bulgaria
Sandoz Investigational Site
Plovdiv, Bulgaria
Sandoz Investigational Site 2
Sofia, Bulgaria
Sandoz Investigational Site 3
Sofia, Bulgaria
Sandoz Investigational Site 4
Sofia, Bulgaria
Sandoz Investigational Site 5
Sofia, Bulgaria
Sandoz Investigational Site
Sofia, Bulgaria
Sandoz Investigational Site
Varaždin, Croatia
Sandoz Investigational Site
Zagreb, Croatia
Sandoz Investigational Site
Rustavi, Georgia
Sandoz Investigational Site 2
Tbilisi, Georgia
Sandoz Investigational Site 3
Tbilisi, Georgia
Sandoz Investigational Site 4
Tbilisi, Georgia
Sandoz Investigational Site 5
Tbilisi, Georgia
Sandoz Investigational Site 6
Tbilisi, Georgia
Sandoz Investigational Site 7
Tbilisi, Georgia
Sandoz Investigational Site 8
Tbilisi, Georgia
Sandoz Investigational Site
Tbilisi, Georgia
Sandoz Investigational Site
Shtip, North Macedonia
Sandoz Investigational Site
Skopje, North Macedonia
Sandoz Investigational Site
Bydgoszcz, Poland
Sandoz Investigational Site 2
Katowice, Poland
Sandoz Investigational Site
Katowice, Poland
Sandoz Investigational Site
Lodz, Poland
Sandoz Investigational Site
Lublin, Poland
Sandoz Investigational Site
Nowa Sól, Poland
Sandoz Investigational Site 2
Poznan, Poland
Sandoz Investigational Site
Poznan, Poland
Sandoz Investigational Site
Szczecin, Poland
Sandoz Investigational Site
Warsaw, Poland
Sandoz Investigational Site
Zabrze, Poland
Sandoz Investigational Site
Belgrade, Serbia
Sandoz Investigational Site
Niš, Serbia