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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
175
Intravenous Infusion
Intravenous Infusion
Intravenous Infusion
Sandoz Investigational Site
Maitland, Florida, United States
RECRUITINGSandoz Investigational Site
Ormond Beach, Florida, United States
RECRUITINGSandoz Investigational Site
Banja Luka, Bosnia and Herzegovina
RECRUITINGSandoz Investigational Site
Bihać, Bosnia and Herzegovina
Area under the concentration time curve
Demonstrate similar PK between Ocrevus and CYB704
Time frame: Week 1 - 3, week 3 - 25
Area under the plasma concentration versus time curve (AUC)
Compare PK between Ocrevus and CYB704
Time frame: Week 1 - 25
Peak Plasma Concentration (Cmax)
Demonstrate similar PK between Ocrevus and CYB704
Time frame: Day 1 and Day 15
CD19+ B-cell count
Compare PD between Ocrevus and CYB704
Time frame: Up to 48 weeks
Number of new T1 GdE lesions on brain MRI scans
Compare efficacy between Ocrevus and CYB704
Time frame: Up to 48 weeks
Number of T1 GdE lesions
Compare efficacy between Ocrevus and CYB704
Time frame: Up to 48 weeks
Number of new/enlarging T2 lesions
Compare efficacy between Ocrevus and CYB704
Time frame: Up to 48 weeks
Number of combined unique active lesions
Compare efficacy between Ocrevus and CYB704
Time frame: Up to 48 weeks
Annualized Relapse Rate
Compare efficacy between Ocrevus and CYB704
Time frame: Up to 48 weeks
Treatment emergent Adverse Events and Serious Adverse Events
Compare safety between Ocrevus and CYB704
Time frame: Up to 48 weeks
Rate of patients with anti-drug antibodies
Compare immunogenicity between Ocrevus and CYB704
Time frame: Up to 48 weeks
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Sandoz Investigational Site 2
Sarajevo, Bosnia and Herzegovina
RECRUITINGSandoz Investigational Site
Sarajevo, Bosnia and Herzegovina
RECRUITINGSandoz Investigational Site
Pleven, Bulgaria
RECRUITINGSandoz Investigational Site 2
Plovdiv, Bulgaria
RECRUITINGSandoz Investigational Site
Plovdiv, Bulgaria
RECRUITINGSandoz Investigational Site 2
Sofia, Bulgaria
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