RecruitingPhase 3NCT06700343

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety Between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects With Relapsing-remitting Multiple Sclerosis

Sponsor

Amgen

Enrollment

444 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

Relapsing-remitting Multiple Sclerosis (RRMS)

Summary

The main objectives of the study are to demonstrate pharmacokinetics (PK) similarity between ABP 692 and Ocrelizumab (US), and ABP 692 and Ocrelizumab (EU), and to demonstrate pharmacodynamics (PD) similarity between ABP 692 and Ocrelizumab reference product (RP) based on assessment of the suppression of new active brain lesions over 24 weeks as assessed by magnetic brain imaging (MRI).

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new biosimilar drug called ABP 692 to the already-approved multiple sclerosis drug Ocrelizumab (Ocrevus) to see if they work equally well and are equally safe in people with relapsing-remitting multiple sclerosis (MS). **You may be eligible if...** - You have been diagnosed with relapsing-remitting MS (a form of MS with flare-ups followed by recovery periods) - Your disability level is in the mild-to-moderate range - You have shown recent MS activity - You have been stable with no relapse in the past 28 days **You may NOT be eligible if...** - You have primary progressive or secondary progressive MS - You have had MS for 10 or more years with only minimal disability - You have significant other health conditions requiring long-term steroids or immune-suppressing medications - You have abnormal blood test results or other disqualifying medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOcrelizumab (US)

IV infusion

DRUGOcrelizumab (EU)

IV infusion

DRUGABP 692

IV infusion

Locations(107)

University of South Alabama

Mobile, Alabama, United States

Clinical Endpoints, LLC

Scottsdale, Arizona, United States

Profound Research - Neurology Center of Southern California

Carlsbad, California, United States

Mountain Neurological Research Center

Basalt, Colorado, United States

Advanced Neurosciences Research, Llc

Fort Collins, Colorado, United States

Hasbani Neurology

New Haven, Connecticut, United States

Neurology Offices of South Florida

Boca Raton, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

Knight Neurology

Rockledge, Florida, United States

Premiere Research Institute Palm Beach

West Palm Beach, Florida, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Henry Ford Health

Detroit, Michigan, United States

Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington Hills

Farmington, Michigan, United States

JFK Medical Center

Edison, New Jersey, United States

Hackensack Meridian Health

Paramus, New Jersey, United States

University of NM/Mind Imaging center

Albuquerque, New Mexico, United States

Triad Neurological Associates

Winston-Salem, North Carolina, United States

Singlepoint Healthcare Opco, LLC

Columbus, Ohio, United States

NDx Clinical Research, Inc

Dayton, Ohio, United States

Premier Neurology, PC

Greenville, South Carolina, United States

Hope Neurology

Knoxville, Tennessee, United States

Vanderbilt University Medical Center (VUMC)

Nashville, Tennessee, United States

Lone Star Neurology

Frisco, Texas, United States

Froedtert Hospital-Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Algemeen Ziekenhuis Delta

Roeselare, West-Vlaanderen, Belgium

MS-Netwerk Limburg - Revalidatie & MS Centrum

Overpelt, Belgium

Diagnostic Consultative Center Convex Ltd

Sofia, Sofiiska, Bulgaria

UMHAT Dr.Georgi Stranski EAD

Pleven, Bulgaria

University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski

Sofia, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

UMHATEM N.I. Pirogov

Sofia, Bulgaria

Foothills Medical Centre

Calgary, Alberta, Canada

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Sestre milosrdnice University Hospital Center

Zagreb, Croatia

University Hospital Centre Zagreb

Zagreb, Croatia

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

Fakultni Nemocnice Hradec Kralove

Hradec Králové, Czechia

Privatni ordinace neurologie

Hradec Králové, Czechia

Regional Hospital Jihlava

Jihlava, Czechia

Nemocnice Teplice

Teplice, Czechia

Aarhus Universitetshospital, Skejby

Aarhus N, Central Jutland, Denmark

Sydvestjysk Sygehus

Esbjerg, Region Syddanmark, Denmark

Dansk Multipel Sklerose Center

Glostrup Municipality, Denmark

Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau

Nîmes, France

LTD Pineo Medical Ecosystem

Tbilisi, Georgia

Jo Ann University Hospital

Tbilisi, Georgia

Zentrum fur klinische Forschung Dr.Scholl

Bad Homburg, Germany

Studienzentrum Dr. Bischof GmbH

Böblingen, Germany

University Hospital Carl Gustav Carus

Dresden, Germany

Curiositas-ad-Sanum GmbH

Ebersberg, Germany

Universitaetsklinikum Essen

Essen, Germany

Klinische Forschung Hamburg GmbH

Hamburg, Germany

Multipel Studies Institut fuer klinische Studien GbR

Hamburg, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Praxisgemeinschaft fuer Neurologie, Psychiatrie und Psychotherapie - Regensburg

Regensburg, Germany

ZNS Siegen GmbH

Siegen, Germany

Neuropraxis Munchen Sud - Unterhaching

Unterhaching, Germany

Bellaria-Maggiore Hospital-Azienda USL Bologna

Bologna, Italy

Casa di Cura Privata del Policlinico Igea S.p.A

Milan, Italy

Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia II - Centro Sclerosi Mul

Naples, Italy

Ospedale Sant'Andrea Hospital

Rome, Italy

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, Lithuania

Klaipedas University Hospital

Klaipėda, Lithuania

Vitamed Galaj i Cichomski sp.j.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

MA-LEK Clinical Sp. z o.o.

Katowice, Silesian Voivodeship, Poland

Neuro-Care

Katowice, Silesian Voivodeship, Poland

Neurocentrum Bydgoszcz

Bydgoszcz, Poland

Neuro Medic Clinic

Katowice, Poland

Resmedica Sp. z o.o.

Kielce, Poland

Krakowska Akademia Neurologii

Krakow, Poland

Centrum Neurologii Krzysztof Selmaj

Lodz, Poland

NZOZ Neuromed M. i M. Nastaj Sp.P

Lublin, Poland

Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy

Poznan, Poland

Centrum Medyczne Neuroprotect

Warsaw, Poland

MTZ Clinical Research Powered by Pratia

Warsaw, Poland

ARENSIA Clinics

Bucharest, Romania

ARENSIA Exploratory Medicine at County Hospital Cluj-Napoca

Cluj-Napoca, Romania

Clinical Hospital Center Zvezdara

Belgrade, Serbia

University Clinical Centre of Kragujevac

Kragujevac, Serbia

Clinic of Neurology, University Clinical Center Nis

Niš, Serbia

Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB)

Bratislava, Slovakia

Neurologicka ambulancia Empathy, s.r.o.

Bratislava, Slovakia

Fakultna Nemocnica Trnava

Trnava, Slovakia

University Medical Centre Ljubljana-UKCL

Ljubljana, Slovenia

Hospital Universitario Fundacion Alcorcon

Alcorcón, Spain

Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)

Barcelona, Spain

Hospital Vithas Nisa Sevilla

Castilleja de la Cuesta, Spain

Hospital de Denia Marina Salud

DÃ©nia, Spain

Hospital General Universitario Gregorio Maranon (HGUGM)

Madrid, Spain

Vithas Hospital Parque San Antonio

Malag, Spain

Hospital Regional Universitario de Malaga

Málaga, Spain

Hospital Santa Caterina

Salt, Spain

Universidad de Sevilla - Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitario de Torrejon

Torrejón de Ardoz, Spain

Hospital Universitario Doctor Peset

Valencia, Spain

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev

Valencia, Spain

Hospital Alvaro Cunqueiro

Vigo, Spain

MS Center Research Unit, Sahlgrenska University Hospital

Gothenburg, Sweden

Academic Specialist Center

Stockholm, Sweden

Universitaetsspital Bern - Inselspital

Bern, Switzerland

Ospedale Regionale di Lugano, Sede Civico

Lugano, Switzerland

Yeditepe University Kosuyolu Hospital

Kadıköy, Istanbul, Turkey (Türkiye)

Uludag University Medical Faculty

Bursa, Turkey (Türkiye)

Ondokuz Mayis University Health Practice and Research Hospital

Samsun, Turkey (Türkiye)

Arencia Exploratory Medicine

Kyiv, Ukraine

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