Running, not recruitingPhase 3Relapsing and progressiveNCT068477242024-512319-40-00

What it found

Still running

No result yet.

What was tested

Treatment tested

Compared with

What it measured

Main measures

  • Area under the concentration time curve

    Week 1 - 3, week 3 - 25

    How the body handles the medicine

Other measures (10)

  • Area under the plasma concentration versus time curve (AUC)

    Week 1 - 25

    How the body handles the medicine
  • Peak Plasma Concentration (Cmax)

    Day 1 and Day 15

    How the body handles the medicine
  • CD19+ B-cell count

    Up to 48 weeks

    Immune response
  • Number of new T1 GdE lesions on brain MRI scans

    Up to 48 weeks

    MRI lesions
  • Number of T1 GdE lesions

    Up to 48 weeks

    MRI lesions
  • Number of new/enlarging T2 lesions

    Up to 48 weeks

    MRI lesions
  • Number of combined unique active lesions

    Up to 48 weeks

    MRI lesions
  • Annualized Relapse Rate

    Up to 48 weeks

    Relapses
  • Treatment emergent Adverse Events and Serious Adverse Events

    Up to 48 weeks

    Safety
  • Rate of patients with anti-drug antibodies

    Up to 48 weeks

    Immune response

Who could take part

Relapsing and progressive · 18 to 55

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Loading reviews and guidelines…

Related trials

History

    1. Started

      Jun 2025

    2. Main results due

      Nov 2026

    3. Finished

      May 2027

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error