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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:
Researchers will compare CYB704 to a Ocrevus (Ocrevus-US and Ocrevus-EU). Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYB704 | Biological | Intravenous Infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve | Demonstrate similar PK between Ocrevus and CYB704 | Week 1 - 3, week 3 - 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | Compare PK between Ocrevus and CYB704 | Week 1 - 25 |
| Peak Plasma Concentration (Cmax) | Demonstrate similar PK between Ocrevus and CYB704 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandoz Investigational Site | Maitland | Florida | 32751 | United States | ||
| Sandoz Investigational Site |
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| Ocrevus-EU | Biological | Intravenous Infusion |
|
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| Ocrevus-US | Biological | Intravenous Infusion |
|
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| Day 1 and Day 15 |
| CD19+ B-cell count | Compare PD between Ocrevus and CYB704 | Up to 48 weeks |
| Number of new T1 GdE lesions on brain MRI scans | Compare efficacy between Ocrevus and CYB704 | Up to 48 weeks |
| Number of T1 GdE lesions | Compare efficacy between Ocrevus and CYB704 | Up to 48 weeks |
| Number of new/enlarging T2 lesions | Compare efficacy between Ocrevus and CYB704 | Up to 48 weeks |
| Number of combined unique active lesions | Compare efficacy between Ocrevus and CYB704 | Up to 48 weeks |
| Annualized Relapse Rate | Compare efficacy between Ocrevus and CYB704 | Up to 48 weeks |
| Treatment emergent Adverse Events and Serious Adverse Events | Compare safety between Ocrevus and CYB704 | Up to 48 weeks |
| Rate of patients with anti-drug antibodies | Compare immunogenicity between Ocrevus and CYB704 | Up to 48 weeks |
| Ormond Beach |
| Florida |
| 32174 |
| United States |
| Sandoz Investigational Site | Banja Luka | Bosnia and Herzegovina |
| Sandoz Investigational Site | Bihać | Bosnia and Herzegovina |
| Sandoz Investigational Site 2 | Sarajevo | 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 2 | Sofia | Bulgaria |
| Sandoz Investigational Site 3 | Sofia | Bulgaria |
| Sandoz Investigational Site 4 | Sofia | Bulgaria |
| Sandoz Investigational Site 5 | Sofia | 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 3 | Tbilisi | Georgia |
| Sandoz Investigational Site 4 | Tbilisi | Georgia |
| Sandoz Investigational Site 5 | Tbilisi | Georgia |
| Sandoz Investigational Site 6 | Tbilisi | Georgia |
| Sandoz Investigational Site 7 | Tbilisi | Georgia |
| Sandoz Investigational Site 8 | Tbilisi | Georgia |
| Sandoz Investigational Site | Tbilisi | Georgia |
| Sandoz Investigational Site | Shtip | North Macedonia |
| Sandoz Investigational Site | Skopje | North Macedonia |
| Sandoz Investigational Site | Bydgoszcz | Poland |
| Sandoz Investigational Site 2 | Katowice | Poland |
| Sandoz Investigational Site | Katowice | Poland |
| Sandoz Investigational Site | Lodz | Poland |
| Sandoz Investigational Site 2 | Lublin | Poland |
| Sandoz Investigational Site | Lublin | 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 | Warsaw | Poland |
| Sandoz Investigational Site | Zabrze | Poland |
| Sandoz Investigational Site | Belgrade | Serbia |
| Sandoz Investigational Site | Niš | Serbia |
| ID | Term |
|---|---|
| C533411 | ocrelizumab |
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