NCT06847724

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].

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	CYB704	Intravenous Infusion
BIOLOGICAL	Ocrevus-EU	Intravenous Infusion
BIOLOGICAL	Ocrevus-US	Intravenous Infusion

Timeline

• Start date: 2025-06-10
• Primary completion: 2026-10-14
• Completion: 2029-10-14
• First posted: 2025-02-26
• Last updated: 2026-03-05

Locations

40 sites across 8 countries: United States, Bosnia and Herzegovina, Bulgaria, Croatia, Georgia, North Macedonia, Poland, Serbia

Regulatory

• FDA-regulated drug study