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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513639-26-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to evaluate the safety and tolerability of the ocrelizumab subcutaneous (SC) test formulation in participants with multiple sclerosis (MS). The study consists of two treatment phases: a dose-escalation and dose-continuation phase. Participants will receive single ascending doses of ocrelizumab SC during an initial dose-escalation phase, with the option to continue treatment with the selected dose of ocrelizumab SC in the dose-continuation phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab SC | Experimental | Participants will receive single ascending doses of ocrelizumab SC, co-formulated with recombinant human hyaluronidase (rHuPH20) on Day 1 of the 24 week dose-escalation phase. Participants who opt to continue treatment in the dose continuation phase will receive ocrelizumab SC at a dose determined in the dose escalation phase, every 24 weeks (Q24W) for 144 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab Co-formulated With rHuPH20 | Drug | Participants will receive ocrelizumab co-formulated with rHuPH20, as a SC injection, per the schedule specified in the treatment arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to 168 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ocrelizumab Serum Concentration at Specified Timepoints Following Single SC Administration | Up to 168 weeks | |
| Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) to Ocrelizumab | Up to 168 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: WN45319 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profound Research, LLC | Active, not recruiting | Carlsbad | California | 92011 | United States | |
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| Number of Participants With Treatment-emergent ADAs to rHuPH20 | Up to 168 weeks |
| Neurology Associates, PA |
| Active, not recruiting |
| Maitland |
| Florida |
| 32751 |
| United States |
| University of South Florida | Active, not recruiting | Tampa | Florida | 33612 | United States |
| Shepherd Center Inc. | Active, not recruiting | Atlanta | Georgia | 30309 | United States |
| John Hopkins University School of Medicine | Active, not recruiting | Baltimore | Maryland | 21287 | United States |
| Hope Neurology | Active, not recruiting | Knoxville | Tennessee | 37922 | United States |
| Instituto de Neurologia de Curitiba | Active, not recruiting | Curitiba | Paraná | 81210-310 | Brazil |
| Centro de Pesquisas Clinicas | Active, not recruiting | São Paulo | São Paulo | 01228-200 | Brazil |
| Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C. | Recruiting | Guadalajara | Jalisco | 44130 | Mexico |
| Inovacion y Desarrollo en ciencias de la salud | Active, not recruiting | Mexico City | Mexico CITY (federal District) | 14090 | Mexico |
| Nottingham University Hospitals NHS Trust | Active, not recruiting | Nottingham | NG7 2UH | United Kingdom |
| Morriston Hospital | Active, not recruiting | Swansea | SA6 6NL | United Kingdom |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C533411 | ocrelizumab |
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