Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis
NCT ID: NCT06847724
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
175 participants
INTERVENTIONAL
2025-06-10
2029-10-14
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CYB704
Drug: CYB704 (Ocrelizumab) Patients will be dosed 300 mg on day 1 and day 15. Subsequent dose of 600 mg will be administered 24 weeks after the initial dose.
CYB704
Intravenous Infusion
Ocrevus-US/Ocrevus-EU
Drug: Ocrevus-US/Ocrevus-EU Patients will be dosed 300 mg on day 1 and day 15 with Ocrevus-US. Subsequent dose of 600 mg Ocrevus-EU will be administered 24 weeks after the initial dose.
Ocrevus-EU
Intravenous Infusion
Ocrevus-US
Intravenous Infusion
Interventions
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CYB704
Intravenous Infusion
Ocrevus-EU
Intravenous Infusion
Ocrevus-US
Intravenous Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Sandoz
INDUSTRY
Responsible Party
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Locations
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Sandoz Investigational Site
Maitland, Florida, United States
Sandoz Investigational Site
Ormond Beach, Florida, United States
Sandoz Investigational Site
Banja Luka, , Bosnia and Herzegovina
Sandoz Investigational Site
Bihać, , Bosnia and Herzegovina
Sandoz Investigational Site
Sarajevo, , Bosnia and Herzegovina
Sandoz Investigational Site
Pleven, , Bulgaria
Sandoz Investigational Site 2
Plovdiv, , Bulgaria
Sandoz Investigational Site
Plovdiv, , Bulgaria
Sandoz Investigational Site
Sofia, , Bulgaria
Sandoz Investigational Site
Varaždin, , Croatia
Sandoz Investigational Site
Zagreb, , Croatia
Sandoz Investigational Site
Rustavi, , Georgia
Sandoz Investigational Site 2
Tbilisi, , Georgia
Sandoz Investigational Site
Tbilisi, , Georgia
Sandoz Investigational Site
Shtip, , North Macedonia
Sandoz Investigational Site
Skopje, , North Macedonia
Sandoz Investigational Site 2
Bydgoszcz, , Poland
Sandoz Investigational Site
Bydgoszcz, , Poland
Sandoz Investigational Site
Katowice, , Poland
Sandoz Investigational Site
Lodz, , Poland
Sandoz Investigational Site
Nowa Sól, , Poland
Sandoz Investigational Site 2
Poznan, , Poland
Sandoz Investigational Site
Poznan, , Poland
Sandoz Investigational Site
Szczecin, , Poland
Sandoz Investigational Site 2
Warsaw, , Poland
Sandoz Investigational Site
Warsaw, , Poland
Sandoz Investigational Site
Zabrze, , Poland
Sandoz Investigational Site
Belgrade, , Serbia
Sandoz Investigational Site
Niš, , Serbia
Countries
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Central Contacts
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Other Identifiers
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CCYB704A12301
Identifier Type: -
Identifier Source: org_study_id
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