Multiple Sclerosis Clinical Trial
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
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.
Participants will be treated for a minimum of 120 weeks in the double-blind phase. Upon positive primary results after the double-blind phase, an optional higher dose extension treatment (OLE phase) is planned for eligible participants. The OLE will be carried out for approximately 96 weeks. Participants will be followed for safety for 48 weeks thereafter. Participants whose B-cell levels still did not replete to their baseline level or the low level of normal (LLN), whichever is lower, will move into the B-cell monitoring (BCM) phase following the safety follow-up phase. The study will end when all participants who were not treated with an alternative B-cell depleting therapy have repleted their B-cells to the baseline value or the lower limit of normal.
Diagnosis of relapsing multiple sclerosis (RMS) (i.e., RRMS or aSPMS where participants still experience relapses) in accordance with the revised McDonald Criteria 2017
At least two documented clinical relapses within the last 2 years prior to screening, or one clinical relapse 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) score, at screening and baseline, from 0 to 5.5 inclusive.
Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds
Average 9HPT score over four trials at screening and over four trials at baseline respectively, up to 250 (inclusive) seconds
Documented MRI of brain with abnormalities consistent with MS at 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
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.
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 that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
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, immunodeficiency.
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 within 24 weeks prior to screening or treatment with any experimental procedure for MS.
Previous use of anti-CD20s (including ocrelizumab), unless the last infusion was more than 2 years before screening, B-cell count is normal, and the stop of the treatment was not motivated by safety reasons or lack of efficacy.
Previous treatment with fingolimod, siponimod, or ozanimod within 6 weeks of baseline
Previous treatment with natalizumab within 4.5 months of baseline
Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline
Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and daclizumab
Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label. 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 transplantation.
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 (including excipients) of ocrelizumab.
Any additional exclusionary criterion as per ocrelizumab local label, if more stringent than the above.
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There are 124 Locations for this study
Cullman Alabama, 35058, United States
Homewood Alabama, 35209, United States
Phoenix Arizona, 85004, United States
Carlsbad California, 92011, United States
Stanford California, 94305, United States
Torrance California, 90502, United States
Basalt Colorado, 81621, United States
Fort Collins Colorado, 80528, United States
Maitland Florida, 32751, United States
Tampa Florida, 33612, United States
Avon Indiana, 46123, United States
Kansas City Kansas, 66160, United States
Alexandria Louisiana, 71301, United States
Scarborough Maine, 04074, United States
Wellesley Massachusetts, 02481, United States
Detroit Michigan, 48202, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89106, United States
Amherst New York, 14226, United States
Dayton Ohio, 45417, United States
Oklahoma City Oklahoma, 73104, United States
Abington Pennsylvania, 19001, United States
Johnson City Tennessee, 37604, United States
Knoxville Tennessee, 37922, United States
Lubbock Texas, 79410, United States
San Antonio Texas, 78258, United States
Kirkland Washington, 98034, United States
Buenos Aires , C1424, Argentina
Buenos Aires , C1431, Argentina
San Miguel , T4000, Argentina
Heidelberg Victoria, 3084, Australia
Bruxelles , 1070, Belgium
Overpelt , 3900, Belgium
Curitiba PR, 81210, Brazil
Porto Alegre RS, 90110, Brazil
Joinville SC, 89202, Brazil
Sao Paulo SP, 01228, Brazil
Greenfield Park Quebec, J4V 2, Canada
Quebec , G1W 4, Canada
Glostrup , 2600, Denmark
Bordeaux , 33076, France
Clermont Ferrand , 63003, France
Lille , 59000, France
Rouen , 76031, France
Berlin , 12203, Germany
Bochum , 44791, Germany
Dresden , 01307, Germany
Kiel , 24105, Germany
Leipzig , 04103, Germany
Leipzig , 04275, Germany
Tübingen , 72076, Germany
Ulm , 89081, Germany
Wiesbaden , 65191, Germany
Athens , 115 2, Greece
Thessaloniki , 546 3, Greece
Budapest , 1138, Hungary
Budapest , 1152, Hungary
Kaposvar , 7400, Hungary
Chieti Abruzzo, 66100, Italy
Napoli Campania, 80131, Italy
Napoli Campania, 80138, Italy
Roma Lazio, 00133, Italy
Roma Lazio, 00178, Italy
Roma Lazio, 00185, Italy
Milano Lombardia, 20133, Italy
Pozzilli Molise, 86077, Italy
Bellavista , Calla, Peru
Lima , 15001, Peru
Lima , 15003, Peru
Lima , Lima , Peru
Lima , Lima , Peru
Trujillo , 13009, Peru
Bydgoszcz , 85-79, Poland
Gdansk , 80-80, Poland
Katowice , 40-59, Poland
Lodz , 90-15, Poland
Lodz , 90-32, Poland
Lublin , 20-01, Poland
Plewiska , 62-06, Poland
Pozna? , 60-30, Poland
Rzeszów , 35-23, Poland
Szczecin , 70-11, Poland
Warszawa , 01-68, Poland
Warszawa , 02-09, Poland
Warszawa , 02-95, Poland
Warszawa , 04-14, Poland
Braga , 4710-, Portugal
Lisboa , 1349-, Portugal
Lisboa , 1649-, Portugal
Krasnoyarsk Krasnojarsk, 66003, Russian Federation
Sankt-peterburg Leningrad, 19711, Russian Federation
Moscow Moskovskaja Oblast, 11718, Russian Federation
Moscow Moskovskaja Oblast, 12536, Russian Federation
Moskva Moskovskaja Oblast, 11799, Russian Federation
Moskva Moskovskaja Oblast, 12701, Russian Federation
Sankt-petersburg Sankt Petersburg, 19737, Russian Federation
St. Petersburg Sankt Petersburg, 19770, Russian Federation
Ekaterinburg Sverdlovsk, 62010, Russian Federation
Kazan Tatarstan, 42004, Russian Federation
Kazan Tatarstan, 42010, Russian Federation
Ulyanovsk Uljanovsk, 43206, Russian Federation
Saratov , 41001, Russian Federation
Tomsk , 63400, Russian Federation
Coruña LA Coruña, 15006, Spain
Pozuelo de Alarcon Madrid, 28223, Spain
Vigo Pontevedra, , Spain
Barcelona , 08035, Spain
Cadiz , 11009, Spain
Malaga , 29010, Spain
Basel , 4031, Switzerland
Bern , 3010, Switzerland
Lugano , 6903, Switzerland
Kocaeli , 41380, Turkey
Kyiv Chernihiv Governorate, 02123, Ukraine
Zaporizhzhia Katerynoslav Governorate, 69600, Ukraine
Zaporizhzhye Katerynoslav Governorate, 69063, Ukraine
Kharkiv Kharkiv Governorate, 61058, Ukraine
Kyiv KIEV Governorate, 03037, Ukraine
Lviv KIEV Governorate, 79010, Ukraine
Dnipropetrovsk Tavria Okruha, 49100, Ukraine
Cherkasy , 18009, Ukraine
Chernihiv , 14029, Ukraine
Chernivtsi , 58013, Ukraine
Ivano-Frankivsk , 76008, Ukraine
Kharkov , 61068, Ukraine
Plymouth , PL6 8, United Kingdom
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