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NCT04544436

PHASE3

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

864

Start Date

2020-11-26

Completion Date

2028-08-31

Last Updated

2026-02-17

Healthy Volunteers

Conditions

Multiple Sclerosis

Interventions

DRUG

Ocrelizumab

The actual higher dose of ocrelizumab will be assigned to participants based on their body weight at baseline: 1200 mg (body weight \<75 kg) or 1800 mg (body weight ≥ 75 kg). The first dose of ocrelizumab will be administered as two 600 mg or 900 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 1200 mg or 1800 mg IV infusion Q24W. During the optional OLE phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total).

DRUG

Ocrelizumab

Ocrelizumab will be administered at a dose of 600 mg Q24W. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg IV infusion Q24W.

DRUG

Antihistamine

Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion.

DRUG

Methylprednisolone

Premedication with 100 mg of methylprednisolone (or equivalent) will be administered by IV infusion prior to each ocrelizumab infusion.

Inclusion Criteria: * Diagnosis of RMS * 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 * 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 magnetic resonance imaging (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 * Females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods * Female participants without reproductive potential may be enrolled e.g. if post-menopausal 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 infusion-related reaction (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- cluster of differentiation 20 (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 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

Locations (122)

North Central Neurology Associates

Cullman, Alabama, United States

Alabama Neurology Associates

Homewood, Alabama, United States

21st Century Neurology

Phoenix, Arizona, United States

Profound Research, LLC

Carlsbad, California, United States

Stanford University Medical Center

Stanford, California, United States

Advanced Neurology of Colorado, LLC

Fort Collins, Colorado, United States

Neurology Associates, PA

Maitland, Florida, United States

University of South Florida

Tampa, Florida, United States

American Health Network Institute, LLC

Avon, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

The NeuroMedical Clinic of Central Louisiana

Alexandria, Louisiana, United States

Maine Medical Center

Scarborough, Maine, United States

Dragonfly Research, LLC

Wellesley, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Cleveland Clinic Lou Ruvo

Las Vegas, Nevada, United States

Dent Neurological Institute

Amherst, New York, United States

UC Health Neurology

Dayton, Ohio, United States

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Abington Neurological Associates

Willow Grove, Pennsylvania, United States

Tri-State Mountain Neurology

Johnson City, Tennessee, United States

Hope Neurology

Knoxville, Tennessee, United States

Bhupesh Dihenia M.D. P.A.

Lubbock, Texas, United States

Lone Star Neurology of San Antonio

San Antonio, Texas, United States

Evergreen MS Center

Kirkland, Washington, United States

Centro de Especialidades Neurológicas y Rehabilitación - CENyR

Buenos Aires, Argentina

CEMIC

Buenos Aires, Argentina

Centro de Investigaciones Médicas Tucuman

San Miguel de Tucumán, Argentina

Austin Hospital

Heidelberg, Victoria, Australia

Hospital Erasme

Brussels, Belgium

Revalidatie en MS Centrum

Overpelt, Belgium

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil

IMV Pesquisa Neurológica

Porto Alegre, Rio Grande do Sul, Brazil

Clinica Neurologica

Joinville, Santa Catarina, Brazil

CPQuali Pesquisa Clinica Ltda

São Paulo, São Paulo, Brazil

Recherche Sepmus Inc.

Greenfield Park, Quebec, Canada

Centre de Recherche Saint-Louis

Lévis, Quebec, Canada

Rigshospitalet Glostrup

Glostrup Municipality, Denmark

Groupe Hospitalier Pellegrin

Bordeaux, France

CHU Hopital Gabriel Montpied

Clermont-Ferrand, France

CH St Vincent de Paul

Lille, France

Hôpital Charles Nicolle

Rouen, France

Charite - Universitätsmedizin Berlin

Berlin, Germany

St. Josef-Hospital, Klinik für Neurologie

Bochum, Germany

Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

Dresden, Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

Universität Leipzig

Leipzig, Germany

Universitätsklinikum Tübingen, Zentrum für Neurologie

Tübingen, Germany

Universitätsklinikum Ulm

Ulm, Germany

Deutsche Klinik für Diagnostik

Wiesbaden, Germany

401 Military Hospital of Athens

Athens, Greece

S-Medicon Egeszsegugyi Szolgaltato Kft.

Budapest, Hungary

UNO Medical Trials Kft.

Budapest, Hungary

Somogy Vármegyei Kaposi Mór Oktató Kórház

Kaposvár, Hungary

Universita? G. D'Annunzio

Chieti, Abruzzo, Italy

AOU Seconda Università degli Studi

Naples, Campania, Italy

AOU Seconda Università degli Studi

Naples, Campania, Italy

Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

Rome, Lazio, Italy

NCL Institute Neuroscience

Rome, Lazio, Italy

Policlinico Umberto I

Rome, Lazio, Italy

Fond. Istituto Neurologico C.Besta

Milan, Lombardy, Italy

IRCCS Istituto Neurologico Neuromed

Pozzilli, Molise, Italy

Hospital IV Alberto Sabogal Sologuren

Bellavista, Peru

Clinica Internacional

Lima, Peru

Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo

Lima, Peru

Hospital Maria Auxiliadora

Lima, Peru

Hospital Nacional Dos de Mayo

Lima, Peru

Clinica Sanchez Ferrer

Trujillo, Peru

Neurocentrum Bydgoszcz sp. z o.o

Bydgoszcz, Poland

COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika

Gdansk, Poland

MA-LEK Clinical Sp. Z o.o.

Katowice, Poland

SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM

Lodz, Poland

Centrum Neurologii Krzysztof Selmaj

Lodz, Poland

Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

Lublin, Poland

Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych

Plewiska, Poland

EMC Instytut Medyczny SA

Późna, Poland

Nmedis sp. z o.o.

Rzeszów, Poland

Osrodek Badan Klinicznych Euromedis

Szczecin, Poland

Centrum Medyczne NeuroProtect

Warsaw, Poland

Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

Warsaw, Poland

Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

Warsaw, Poland

Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy

Warsaw, Poland

Hospital de Braga

Braga, Portugal

Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz

Lisbon, Portugal

Hospital de Santa Maria

Lisbon, Portugal

FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

Krasnoyarsk, Krasnoyarsk Krai, Russia

Neiro Clinica LLC

Moscow, Moscow Oblast, Russia

Research Center of Neurology of RAMS

Moscow, Moscow Oblast, Russia

Federal center of brain research and neurotechnologies

Moskva, Moscow Oblast, Russia

City Clinical Hospital #24

Moskva, Moscow Oblast, Russia

National Center of Social Significant Disease

Saint Petersburg, Sankt-Peterburg, Russia

N.P. Bechtereva Institute of the Human Brain

Saint Petersburg, Sankt-Peterburg, Russia

City Hospital #40 of Kurortniy Administrative District

Saint Petersburg, Sankt-Peterburg, Russia

SHI Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, Sverdlovsk Oblast, Russia

Vertebronevrologiya LLC

Kazan', Tatarstan Republic, Russia

KSMU Interregional Clinical Diagnostic Centre

Kazan', Tatarstan Republic, Russia

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, Ulyanovsk Oblast, Russia

Saratov State Medical University of RosZdrav

Saratov, Russia

Nebbiolo Center for Clinical Trials

Tomsk, Russia

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, LA Coruna, Spain

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, Spain

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Puerta del Mar

Cadiz, Spain

Hospital Regional Universitario de Malaga ? Hospital General

Málaga, Spain

Universitätsspital Basel Medizin Neurologie

Basel, Switzerland

Inselspital Bern Medizin Neurologie

Bern, Switzerland

Ospedale Regionale di Lugano - Civico

Lugano, Switzerland

Kocaeli University Hospital

Kocaeli, Turkey (Türkiye)

5th Cherkasy City Center of Primary Health Care

Cherkasy, Ukraine

Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?

Chernihiv, Ukraine

Bukovinsky SMU RMI Chernivtsi RCH

Chernivtsi, Ukraine

SI USSRI of Medical and Social Problems of Disabilities of MOHU

Dnipro, Ukraine

Regional Clinical Hospital

Ivano-Frankivsk, Ukraine

Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

Kharkiv, Ukraine

St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU

Kharkiv, Ukraine

Medical Center of Private Execution First Private Clinic

Kyiv, Ukraine

Medical Center Dopomoga Plus

Kyiv, Ukraine

Lvivska oblasna tsentralna likarnia

Lviv, Ukraine

LCC "Medical center "Unimed"

Zaporizhzhia, Ukraine

Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

Zaporizhzhia, Ukraine

Derriford Hospital

Plymouth, United Kingdom

Clinical Research Directory

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (122)