An Efficacy and Safety Study With Integrated Pharmacokinetics (PK) and Pharmacodynamic (PD) Assessment to Compare the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis (RMS)

Description

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 a t least 15 treatment visits, checkups and tests * Will undergo regular magnetic resonance imaging (MRI) examinations

Conditions

Relapsing Multiple Sclerosis

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Study Overview

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Study Details

Study overview

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 a t least 15 treatment visits, checkups and tests * Will undergo regular magnetic resonance imaging (MRI) examinations

A Randomized, Double-blind, Parallel-group Study to Compare the Pharmacokinetics, Efficacy, Pharmacodynamics, Safety, and Immunogenicity of CYB704 (Proposed Ocrelizumab Biosimilar) and Ocrevus® (EU-authorized and US-licensed) in Participants With Relapsing Multiple Sclerosis (RMS)

An Efficacy and Safety Study With Integrated Pharmacokinetics (PK) and Pharmacodynamic (PD) Assessment to Compare the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis (RMS)

Condition
Relapsing Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Maitland

Sandoz Investigational Site, Maitland, Florida, United States, 32751

Ormond Beach

Sandoz Investigational Site, Ormond Beach, Florida, United States, 32174

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of RMS (relapsing remitting multiple sclerosis (MS) and active secondary progressive MS)
  • * Evidence of recent disease activity as defined in study protocol
  • * Expanded Disability Status scale score of 0 to 5.5 (inclusive) at screening
  • * Neurological stability (no new signs or symptoms referable to Central Nervous System (CNS) within 30 days before both screening and first study treatment
  • * Diagnosis of primary progressive MS
  • * Disease duration of more than 10 years in participants with an Expanded Disability Status Scale (EDSS) ≤2.0 at screening
  • * Inability to complete an MRI or contraindication to gadolinium administration
  • * History of allergic or anaphylactic reactions to ocrelizumab or one of the premedications (methylprednisolone or equivalent corticosteroid, antihistamine, antipyretic)
  • * Pregnant participants
  • * Current or history of medical conditions as outlined in the study protocol
  • * Prohibited medications (current and history) as outlined in the study protocol
  • * Abnormal laboratory blood values as outlined in the study protocol

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sandoz,

Study Record Dates

2029-10-14