RecruitingPhase 3NCT06847724

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].

Sponsor

Sandoz

Enrollment

175 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

Relapsing Multiple Sclerosis

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

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new biosimilar version of ocrelizumab (called CYB704) to the original brand-name drug Ocrevus. Both are infusion treatments that reduce immune system attacks on the nervous system in people with relapsing multiple sclerosis (MS). A biosimilar is a near-identical copy of an approved biologic drug. **You may be eligible if...** - You have been diagnosed with relapsing-remitting MS or active secondary progressive MS - Your MS has shown recent activity (new symptoms or lesions) - Your disability score on the standard MS scale is between 0 and 5.5 - Your neurological condition is stable (no recent relapse in the weeks before screening) **You may NOT be eligible if...** - You have a primary progressive or stable secondary progressive form of MS - You have had a recent MS relapse or are neurologically unstable - You have other conditions that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCYB704

Intravenous Infusion

BIOLOGICALOcrevus-EU

Intravenous Infusion

BIOLOGICALOcrevus-US

Intravenous Infusion

Locations(41)

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 2

Lublin, 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

View Full Details on ClinicalTrials.gov

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NCT06847724

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