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

May 27, 2026 updated by: Sandoz

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].

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina
        • Sandoz Investigational Site
      • Bihać, Bosnia and Herzegovina
        • Sandoz Investigational Site
      • Sarajevo, Bosnia and Herzegovina
        • Sandoz Investigational Site
      • Sarajevo, Bosnia and Herzegovina
        • Sandoz Investigational Site 2
  • Bulgaria
      • Pleven, Bulgaria
        • Sandoz Investigational Site
      • Plovdiv, Bulgaria
        • Sandoz Investigational Site
      • Plovdiv, Bulgaria
        • Sandoz Investigational Site 2
      • Sofia, Bulgaria
        • Sandoz Investigational Site 2
      • Sofia, Bulgaria
        • Sandoz Investigational Site 3
      • Sofia, Bulgaria
        • Sandoz Investigational Site
      • Sofia, Bulgaria
        • Sandoz Investigational Site 4
      • Sofia, Bulgaria
        • Sandoz Investigational Site 5
  • Croatia
      • Varaždin, Croatia
        • Sandoz Investigational Site
      • Zagreb, Croatia
        • Sandoz Investigational Site
  • Georgia
      • Rustavi, Georgia
        • Sandoz Investigational Site
      • Tbilisi, Georgia
        • Sandoz Investigational Site
      • Tbilisi, 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
  • North Macedonia
      • Shtip, North Macedonia
        • Sandoz Investigational Site
      • Skopje, North Macedonia
        • Sandoz Investigational Site
  • Poland
      • Bydgoszcz, Poland
        • Sandoz Investigational Site
      • Katowice, Poland
        • Sandoz Investigational Site
      • Katowice, Poland
        • Sandoz Investigational Site 2
      • Lodz, Poland
        • Sandoz Investigational Site
      • Lublin, Poland
        • Sandoz Investigational Site
      • Lublin, Poland
        • Sandoz Investigational Site 2
      • Nowa Sól, Poland
        • Sandoz Investigational Site
      • Poznan, Poland
        • Sandoz Investigational Site
      • Poznan, Poland
        • Sandoz Investigational Site 2
      • Szczecin, Poland
        • Sandoz Investigational Site
      • Warsaw, Poland
        • Sandoz Investigational Site
      • Zabrze, Poland
        • Sandoz Investigational Site
  • Serbia
      • Belgrade, Serbia
        • Sandoz Investigational Site
      • Niš, Serbia
        • Sandoz Investigational Site
  • United States
    • Florida
      • Maitland, Florida, United States, 32751
        • Sandoz Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • Sandoz Investigational Site

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of RMS (relapsing remitting multiple sclerosis (MS) or 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CYB704
Drug: CYB704 (Ocrelizumab) Patients will be dosed 300 mg on day 1 and day 15. Subsequent dose of 600 mg will be administered 24 weeks after the initial dose.
Biological: CYB704
Intravenous Infusion
Other Names:
  • Ocrelizumab
Active Comparator: Ocrevus-US/Ocrevus-EU
Drug: Ocrevus-US/Ocrevus-EU Patients will be dosed 300 mg on day 1 and day 15 with Ocrevus-US. Subsequent dose of 600 mg Ocrevus-EU will be administered 24 weeks after the initial dose.
Biological: Ocrevus-EU
Intravenous Infusion
Other Names:
  • Ocrelizumab
Biological: Ocrevus-US
Intravenous Infusion
Other Names:
  • Ocrelizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the concentration time curve
Time Frame: Week 1 - 3, week 3 - 25
Demonstrate similar PK between Ocrevus and CYB704
Week 1 - 3, week 3 - 25

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration versus time curve (AUC)
Time Frame: Week 1 - 25
Compare PK between Ocrevus and CYB704
Week 1 - 25
Peak Plasma Concentration (Cmax)
Time Frame: Day 1 and Day 15
Demonstrate similar PK between Ocrevus and CYB704
Day 1 and Day 15
CD19+ B-cell count
Time Frame: Up to 48 weeks
Compare PD between Ocrevus and CYB704
Up to 48 weeks
Number of new T1 GdE lesions on brain MRI scans
Time Frame: Up to 48 weeks
Compare efficacy between Ocrevus and CYB704
Up to 48 weeks
Number of T1 GdE lesions
Time Frame: Up to 48 weeks
Compare efficacy between Ocrevus and CYB704
Up to 48 weeks
Number of new/enlarging T2 lesions
Time Frame: Up to 48 weeks
Compare efficacy between Ocrevus and CYB704
Up to 48 weeks
Number of combined unique active lesions
Time Frame: Up to 48 weeks
Compare efficacy between Ocrevus and CYB704
Up to 48 weeks
Annualized Relapse Rate
Time Frame: Up to 48 weeks
Compare efficacy between Ocrevus and CYB704
Up to 48 weeks
Treatment emergent Adverse Events and Serious Adverse Events
Time Frame: Up to 48 weeks
Compare safety between Ocrevus and CYB704
Up to 48 weeks
Rate of patients with anti-drug antibodies
Time Frame: Up to 48 weeks
Compare immunogenicity between Ocrevus and CYB704
Up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCYB704A12301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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