Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CYB704 · 1 trial · 1 indication
Demonstrate similar PK between Ocrevus and CYB704
| Arm | Type | Description |
|---|---|---|
| CYB704 | EXPERIMENTAL | 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. |
| Ocrevus-US/Ocrevus-EU | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| CYB704 | BIOLOGICAL | Intravenous Infusion |
| Ocrevus-EU | BIOLOGICAL | Intravenous Infusion |
| Ocrevus-US | BIOLOGICAL | Intravenous Infusion |
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 s...
CYB704 is an investigational monoclonal antibody being studied for the treatment of relapsing multiple sclerosis. It is currently in Phase 3 clinical development as a proposed biosimilar to Ocrevus. The drug is being evaluated for its efficacy, pharmacokinetics, pharmacodynamics, and safety in patients with this condition.
CYB704 is a monoclonal antibody designed as a proposed biosimilar to Ocrevus. As a biosimilar, it targets the same molecular target as Ocrevus, which is the CD20 antigen on B-cells. By binding to CD20, it is intended to deplete B-cells, a mechanism relevant to the treatment of relapsing multiple sclerosis.
CYB704 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting a Phase 3 clinical trial to assess the proposed biosimilar in participants with relapsing multiple sclerosis.
CYB704 is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 3 trial is actively not recruiting participants and is designed to compare CYB704 with Ocrevus in patients with relapsing multiple sclerosis.
CYB704 is being studied in one Phase 3 clinical trial with the identifier NCT06847724. This randomized, double-blind, active-controlled study is assessing the comparative pharmacokinetics, pharmacodynamics, efficacy, and safety of CYB704 versus Ocrevus in 183 participants with relapsing multiple sclerosis across multiple countries.
CYB704 is not the same as Ocrevus, but it is being developed as a proposed biosimilar to Ocrevus. A biosimilar is a biological product that is highly similar to an already approved reference product, with no clinically meaningful differences in safety or efficacy. CYB704 is currently being compared to Ocrevus in a Phase 3 trial.