Relapsing Multiple Sclerosis
Conditions
Brief summary
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
Interventions
BIOLOGICALCYB704
Intravenous Infusion
BIOLOGICALOcrevus-EU
Intravenous Infusion
BIOLOGICALOcrevus-US
Intravenous Infusion
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration time curve | Week 1 - 3, week 3 - 25 | Demonstrate similar PK between Ocrevus and CYB704 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | Week 1 - 25 | Compare PK between Ocrevus and CYB704 |
| Peak Plasma Concentration (Cmax) | Day 1 and Day 15 | Demonstrate similar PK between Ocrevus and CYB704 |
| CD19+ B-cell count | Up to 48 weeks | Compare PD between Ocrevus and CYB704 |
| Number of new T1 GdE lesions on brain MRI scans | Up to 48 weeks | Compare efficacy between Ocrevus and CYB704 |
| Number of T1 GdE lesions | Up to 48 weeks | Compare efficacy between Ocrevus and CYB704 |
| Number of new/enlarging T2 lesions | Up to 48 weeks | Compare efficacy between Ocrevus and CYB704 |
| Number of combined unique active lesions | Up to 48 weeks | Compare efficacy between Ocrevus and CYB704 |
| Annualized Relapse Rate | Up to 48 weeks | Compare efficacy between Ocrevus and CYB704 |
| Treatment emergent Adverse Events and Serious Adverse Events | Up to 48 weeks | Compare safety between Ocrevus and CYB704 |
| Rate of patients with anti-drug antibodies | Up to 48 weeks | Compare immunogenicity between Ocrevus and CYB704 |
Countries
Bosnia and Herzegovina, Bulgaria, Croatia, Georgia, North Macedonia, Poland, Serbia, United States
Outcome results
None listed