A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis (Ocarina II)

  • STATUS
    Recruiting
  • End date
    Feb 22, 2025
  • participants needed
    232
  • sponsor
    Hoffmann-La Roche
Updated on 14 September 2022
corticosteroids
methylprednisolone
disease or disorder
ocrelizumab

Summary

This study will evaluate the pharmacokinetics, pharmacodynamics, safety, immunogenicity, and radiological and clinical effects of subcutaneous (SC) administration of ocrelizumab compared with the intravenous (IV) infusion of ocrelizumab in patients with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS).

Details
Condition Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis
Treatment Ocrelizumab IV, Ocrelizumab SC, Methylprednisolone IV, Diphenhydramine IV, Dexamethasone given orally, Desloratadine given orally
Clinical Study IdentifierNCT05232825
SponsorHoffmann-La Roche
Last Modified on14 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of PPMS or RMS according to the revised McDonald 2017 criteria (Thompson et al. 2018)
EDSS score, 0-6.5, inclusive, at screening
Neurological stability for ≥30 days prior to both screening and baseline
Disease duration from onset of MS symptoms of less than 15 years for patients with EDSS score <2.0 at screening
For females participants, without reproductive potential may be enrolled if post-menopausal, unless receiving a hormonal therapy for menopause or if surgically sterile
For females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods

Exclusion Criteria

Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV anti microbials within 8 weeks prior to and during screening or treatment with oral anti microbials 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
Receipt of a live-attenuated vaccine within 6 weeks prior to randomization Influenza vaccination is permitted if the inactivated vaccine formulation is administered
Inability to complete an MRI or contraindication to gadolinium administration
Contraindications to mandatory premedications for IRRs, including closed-angle glaucoma for antihistamines
Known presence of other neurologic disorders
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, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude patient from participating in the study
History of or currently active primary or secondary (non-drug-related) immunodeficiency
Pregnant or breastfeeding, or intending to become pregnant during the study and 6 or 12 months
Lack of peripheral venous access
History of alcohol or other drug abuse within 12 months prior to screening
Treatment with any investigational agent within 24 weeks prior to screening or 5 half-lives of the investigational drug (whichever is longer), or treatment with any experimental procedure for MS (e.g., treatment for chronic cerebrospinal venous insufficiency)
Participants who have previously received anti-CD20s if the last treatment was less than 2 years before screening, and/or if B-cell count is below lower limit of normal, and/or the discontinuation of the treatment was due to safety reasons or lack of efficacy
Previous treatment with cladribine, atacicept, and alemtuzumab
Treatment with mitoxantrone within 2 years prior to baseline visit or evidence of cardiotoxicity following mitoxantrone use or a cumulative lifetime dose of more than 60 mg/m2
Previous treatment with fingolimod, siponimod, ponesimod, or ozanimod within 6 weeks of baseline
Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label
Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline
Previous treatment with natalizumab within 4.5 months of baseline
If the washout requirements are not described in the applicable local label, then the wash out period must be 5 times the half-life of the medication. The PD effects of the previous medication must also be considered when determining the required time for washout
Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
Any previous history of transplantation or anti-rejection therapy
Treatment with IV Ig or plasmapheresis within 12 weeks prior to randomization
Systemic corticosteroid therapy within 4 weeks prior to screening
Positive screening tests for active, latent, or inadequately treated hepatitis B
Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
Any additional exclusionary criterion as per ocrelizumab (Ocrevus®) local label, if more stringent than the above
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