OCARINA 3
What it found
No result yet.
What was tested
Treatment tested
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
Number of Participants With Adverse Events (AEs)
Up to 168 weeks
Safety
Other measures (3)
Ocrelizumab Serum Concentration at Specified Timepoints Following Single SC Administration
Up to 168 weeks
How the body handles the medicineNumber of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) to Ocrelizumab
Up to 168 weeks
Immune responseNumber of Participants With Treatment-emergent ADAs to rHuPH20
Up to 168 weeks
Who could take part
Relapsing and progressive · 18 to 65
Inclusion Criteria: * Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018) * Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening Exclusion Criteria: * Participants who have previously received anti-cluster of differentiation 20 (CD20s) (including ocrelizumab) less than 2 years before screening * Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening * History of confirmed or suspected progressive multifocal leukoencephalopathy (PML) * History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening * Immunocompromised state * Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study * Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study * Lack of peripheral venous access * Previous treatment with cladribine, atacicept, and alemtuzumab * Previous treatment with fingolimod, siponimod, ponesimod, or ozanimod within 6 weeks of baseline * Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation * Any previous history of transplantation or anti-rejection therapy * Positive screening tests for active, latent, or inadequately treated hepatitis B * Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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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History
Started
Dec 2024
Main results due
Feb 2028
Finished
Aug 2028
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