Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06847724 | Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis | PHASE3 | ACTIVE NOT_RECRUITING | 183 | — | — | Jun 10, 2025 | May 1, 2027 | May 29, 2026 | 41 | United States, Bosnia and Herzegovina +6 |
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...