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NCT Number: NCT06847724

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Relapsing Multiple Sclerosis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sandoz Investigational Site, Banja Luka, Bosnia and Herzegovina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CYB704

Biological

Intravenous Infusion

Other names: Ocrelizumab

Ocrevus-EU

Biological

Intravenous Infusion

Other names: Ocrelizumab

Ocrevus-US

Biological

Intravenous Infusion

Other names: Ocrelizumab

Primary outcomes

  1. Area under the concentration time curve

    Time frame: Week 1 - 3, week 3 - 25

    Demonstrate similar PK between Ocrevus and CYB704

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC)

    Time frame: Week 1 - 25

    Compare PK between Ocrevus and CYB704

  2. Peak Plasma Concentration (Cmax)

    Time frame: Day 1 and Day 15

    Demonstrate similar PK between Ocrevus and CYB704

  3. CD19+ B-cell count

    Time frame: Up to 48 weeks

    Compare PD between Ocrevus and CYB704

  4. Number of new T1 GdE lesions on brain MRI scans

    Time frame: Up to 48 weeks

    Compare efficacy between Ocrevus and CYB704

  5. Number of T1 GdE lesions

    Time frame: Up to 48 weeks

    Compare efficacy between Ocrevus and CYB704

  6. Number of new/enlarging T2 lesions

    Time frame: Up to 48 weeks

    Compare efficacy between Ocrevus and CYB704

  7. Number of combined unique active lesions

    Time frame: Up to 48 weeks

    Compare efficacy between Ocrevus and CYB704

  8. Annualized Relapse Rate

    Time frame: Up to 48 weeks

    Compare efficacy between Ocrevus and CYB704

  9. Treatment emergent Adverse Events and Serious Adverse Events

    Time frame: Up to 48 weeks

    Compare safety between Ocrevus and CYB704

  10. Rate of patients with anti-drug antibodies

    Time frame: Up to 48 weeks

    Compare immunogenicity between Ocrevus and CYB704

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

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].

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 26, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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