CCYB704A12301
What it found
No result yet.
What was tested
Treatment tested
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
Compared with
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
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 medicinePeak Plasma Concentration (Cmax)
Day 1 and Day 15
How the body handles the medicineCD19+ B-cell count
Up to 48 weeks
Immune responseNumber of new T1 GdE lesions on brain MRI scans
Up to 48 weeks
MRI lesionsNumber of T1 GdE lesions
Up to 48 weeks
MRI lesionsNumber of new/enlarging T2 lesions
Up to 48 weeks
MRI lesionsNumber of combined unique active lesions
Up to 48 weeks
MRI lesionsAnnualized Relapse Rate
Up to 48 weeks
RelapsesTreatment emergent Adverse Events and Serious Adverse Events
Up to 48 weeks
SafetyRate 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
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History
Started
Jun 2025
Main results due
Nov 2026
Finished
May 2027
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