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

Condition(s) studied

Investigational drug(s) / intervention(s)

CYB704: Intravenous Infusion

Ocrevus-EU: Intravenous Infusion

Ocrevus-US: Intravenous Infusion

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

Eligibility

Primary outcome measure(s)

• Area under the concentration time curve — Week 1 - 3, week 3 - 25
  Demonstrate similar PK between Ocrevus and CYB704

Trial sites (41)

+ 1 more sites — see the full list on the official registry below.