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A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis


Brief Summary:

This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate
efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV)
infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose
of ocrelizumab.


Inclusion Criteria:

– Diagnosis of relapsing multiple sclerosis (RMS).

– At least two documented clinical attacks within the last 2 years prior to screening,
or one clinical attack in the year prior to screening. No relapse 30 days prior to
screening and at baseline.

– Participants must be neurologically stable for at least 30 days prior to randomization
and baseline.

– Expanded disability status scale (EDSS), at screening and baseline, from 0 to 5.5

– Documented MRI of brain with abnormalities consistent with MS prior to screening.

– Participants requiring symptomatic treatment for MS and/or physiotherapy must be
treated at a stable dose. No initiation of symptomatic treatment for MS or
physiotherapy within 4 weeks of randomization.

– For females of childbearing potential, agreement to remain abstinent or use adequate
contraceptive methods.

– For female participants, without reproductive potential may be enrolled if
post-menopausal, unless receiving a hormonal therapy for her menopause or if
surgically sterile

Exclusion Criteria:

– History of primary progressive MS at 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 IV antimicrobials within 8 weeks or treatment with oral antimicrobials within 2
weeks, prior to and during screening.

– History of confirmed or suspected progressive multifocal leukoencephalopathy.

– History of cancer, including hematologic malignancy and solid tumors, within 10 years
of screening.

– Immunocompromised state.

– Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.

– Inability to complete an MRI or contraindication to gadolinium administration.

– Contraindications to mandatory pre-medications for IRRs.

– 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 that may preclude participant from participating in
the study.

– History of or currently active primary or secondary, non-drug-related,

– Pregnant or breastfeeding or intending to become pregnant.

– Lack of peripheral venous access.

– History of alcohol or other drug abuse within 12 months prior to screening.

– Treatment with any investigational agent or treatment with any experimental procedure
for MS.

– Previous use of anti-CD20s if in the last 2 years before screening, or if B-cell count
is not normal, or if treatment was stopped due to safety reasons or lack of efficacy.

– Previous use of mitoxantrone, cladribine, atacicept, and alemtuzumab.

– Previous treatment with any other immunomodulatory or immunosuppressive medication not
already listed above without appropriate washout as described in the applicable local

– If the washout requirements are not described in the applicable local label, then the
wash out period must be five times the half-life of the medication.

– Any previous treatment with bone marrow transplantation and hematopoietic stem cell

– Any previous history of transplantation or anti-rejection therapy.

– Treatment with intravenous (IV) immunoglobulin (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 of ocrelizumab.

– Any additional exclusionary criterion as per ocrelizumab local label, if more
stringent than the above.


  • North County Neurology Associates, Carlsbad, California, United States, 92011
  • University of California Davis Medical Center, Sacramento, California, United States, 95817
  • University of California San Francisco, San Francisco, California, United States, 94117
  • Stanford University Medical Center; Stanford Neuroscience Health Center, Stanford, California, United States, 94305
  • Collaborative Neuroscience Network Inc., Torrance, California, United States, 90502
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