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Comparing CYB704, a proposed ocrelizumab biosimilar, with Ocrevus for 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].

Phase 3 Interventional Sandoz · NCT06847724

This trial will test whether CYB704, a proposed biosimilar to Ocrevus, works the same and has similar side effects in people with relapsing multiple sclerosis.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment175 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorSandoz Industry-sponsored
Drugs / interventionsocrelizumab
Locations41 sites (Maitland, Florida and 40 other locations)
Trial IDNCT06847724 on ClinicalTrials.gov

What this trial studies

This Phase 3 randomized interventional trial compares the proposed biosimilar CYB704 to Ocrevus (US and EU formulations) using pharmacokinetic (PK), pharmacodynamic (PD), efficacy, and safety measures. Participants receive CYB704 or Ocrevus and attend at least 15 treatment visits with regular clinical checks and serial MRI scans. The study is designed to demonstrate PK similarity and to compare treatment effects and adverse events between the biosimilar and reference products. Eligibility focuses on adults with relapsing forms of MS who have recent disease activity and an EDSS score of 0–5.5.

Who should consider this trial

Good fit: Adults with relapsing-remitting MS or active secondary progressive MS who have recent disease activity, an EDSS score of 0–5.5, neurological stability, and ability to undergo MRI are ideal candidates.

Not a fit: People with primary progressive MS, pregnancy, known allergy to ocrelizumab or required premedications, inability to receive gadolinium MRI, or other excluded medical conditions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, CYB704 may provide a similarly effective treatment to Ocrevus and potentially increase treatment options and access for people with relapsing MS.

How similar studies have performed: While biosimilars to other monoclonal antibodies have been approved in different diseases, an ocrelizumab biosimilar like CYB704 is novel and requires Phase 3 data to confirm similar PK/PD, efficacy, and safety.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Maitland, Florida and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsing Multiple Sclerosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.