Clinical trial NCT06847724: An Efficacy and Safety Study With Integrated Pharmacokinetics (PK) and Pharmacodynamic (PD) Assessment to Compare the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis (RMS)
Official title: A Randomized, Double-blind, Parallel-group Study to Compare the Pharmacokinetics, Efficacy, Pharmacodynamics, Safety, and Immunogenicity of CYB704 (Proposed Ocrelizumab Biosimilar) and Ocrevus® (EU-authorized and US-licensed) in Participants With Relapsing Multiple Sclerosis (RMS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 a t least 15 treatment visits, checkups and tests
* Will undergo regular magnetic resonance imaging (MRI) examinations


Eligibility criteria: Inclusion Criteria:

* Diagnosis of RMS (relapsing remitting multiple sclerosis (MS) and 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

Primary outcomes:
measure: Area under the concentration time curve in cohort 1
timeFrame: Week 1 - 3, week 3 - 25
measure: Total number of T1-weighted Gadolinium enhancing (GdE) lesions on brain MRI scans
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) in cohort 1
timeFrame: Week 1 - 25
measure: Peak Plasma Concentration (Cmax) in cohort 1
timeFrame: Day 1 and Day 15
measure: CD19+ B-cell count
timeFrame: Up to 48 weeks
measure: Total number of new/enlarging T2 lesions
timeFrame: Up to 48 weeks
measure: Total number of new T1 GdE lesions
timeFrame: Up to 48 weeks
measure: Annualized Relapse Rate
timeFrame: Up to 48 weeks
measure: Treatment emergent Adverse Events and Serious Adverse Events
timeFrame: Up to 48 weeks
measure: Rate of patients with anti-drug antibodies
timeFrame: Up to 48 weeks
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Sandoz Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Sandoz Investigational Site
state: Florida
Study officials:
References: