MedTrace Logo

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

NCT06847724 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2026-04-27

No results posted yet for this study

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

Interventions

BIOLOGICAL

CYB704

Intravenous Infusion

BIOLOGICAL

Ocrevus-EU

Intravenous Infusion

BIOLOGICAL

Ocrevus-US

Intravenous Infusion

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-10
Primary Completion
2026-10-14
Completion
2029-10-14
FDA Drug
Yes

Countries

  • United States
  • Bosnia and Herzegovina
  • Bulgaria
  • Croatia
  • Georgia
  • North Macedonia
  • Poland
  • Serbia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06847724 on ClinicalTrials.gov