Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

Last updated: May 27, 2026
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

Multiple Sclerosis

Neurologic Disorders

Scar Tissue

Treatment

Ocrelizumab (US)

Ocrelizumab (EU)

ABP 692

Clinical Study ID

NCT06700343
20230309
2024-512914-16
  • Ages 18-99
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017 (Thompson etal, 2018).

  2. Expanded Disability Status Scale score at screening ≥ 0 and ≤ 5.5 inclusive.

  3. Evidence of recent MS activity as defined by the study protocol.

  4. Neurologically stable subject, with no relapse for ≤ 28 days before randomization.

Exclusion

Exclusion Criteria:

  1. Diagnosis of primary progressive or with secondary progressive MS (Thompson et al, 2018).

  2. Multiple sclerosis disease duration of ≥ 10 years in Participants with ExpandedDisability Status Scale (EDSS) score of ≤ 2.5 at screening.

  3. Any contraindications to study procedures or medications as outlined in the studyprotocol.

  4. Any prohibited medication as defined in the study protocol.

  5. Any significant concomitant disease that may require chronic treatment with systemiccorticosteroids and/or systemic immunosuppressants during the study.

  6. Current or history of any significant medical conditions as described in the studyprotocol.

  7. Any abnormal laboratory blood values as defined in the study protocol.

Study Design

Total Participants: 444
Treatment Group(s): 3
Primary Treatment: Ocrelizumab (US)
Phase: 3
Study Start date:
January 13, 2025
Estimated Completion Date:
December 17, 2027

Connect with a study center

  • Algemeen Ziekenhuis Delta

    Roeselare, West-Vlaanderen 8800
    Belgium

    Active - Recruiting

  • MS-Netwerk Limburg - Revalidatie & MS Centrum

    Overpelt, 3900
    Belgium

    Active - Recruiting

  • Diagnostic Consultative Center Convex Ltd

    Sofia, Sofiiska 1680
    Bulgaria

    Active - Recruiting

  • Diagnostic Consultative Center Convex Ltd

    Sofia 727011, Sofiiska 1680
    Bulgaria

    Active - Recruiting

  • UMHAT Dr.Georgi Stranski EAD

    Pleven, 5800
    Bulgaria

    Active - Recruiting

  • Medical Center Hera EOOD

    Sofia, 1510
    Bulgaria

    Active - Recruiting

  • UMHATEM N.I. Pirogov

    Sofia, 1606
    Bulgaria

    Active - Recruiting

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

    Sofia, 1431
    Bulgaria

    Active - Recruiting

  • UMHATEM N.I. Pirogov

    Sofia 727011, 1606
    Bulgaria

    Active - Recruiting

  • Foothills Medical Centre

    Calgary, Alberta T2N 2T9
    Canada

    Active - Recruiting

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Sestre milosrdnice University Hospital Center

    Zagreb, 10000
    Croatia

    Active - Recruiting

  • University Hospital Centre Zagreb

    Zagreb, 10000
    Croatia

    Active - Recruiting

  • Sestre milosrdnice University Hospital Center

    Zagreb 3186886, 10000
    Croatia

    Active - Recruiting

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91
    Czechia

    Active - Recruiting

  • Fakultni nemocnice u sv. Anny v Brne - ICRC

    Brno 3078610, 656 91
    Czechia

    Active - Recruiting

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 05
    Czechia

    Active - Recruiting

  • Privatni ordinace neurologie

    Hradec Králové, 50003
    Czechia

    Active - Recruiting

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové 3074967, 500 05
    Czechia

    Active - Recruiting

  • Regional Hospital Jihlava

    Jihlava, 58601
    Czechia

    Active - Recruiting

  • Nemocnice Teplice

    Teplice, 415 01
    Czechia

    Active - Recruiting

  • Aarhus Universitetshospital, Skejby

    Aarhus N, Central Jutland 8200
    Denmark

    Active - Recruiting

  • Sydvestjysk Sygehus

    Esbjerg, Region Syddanmark 6700
    Denmark

    Active - Recruiting

  • Dansk Multipel Sklerose Center

    Glostrup Municipality, 2600
    Denmark

    Active - Recruiting

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

    Nîmes, 30029
    France

    Active - Recruiting

  • Jo Ann Medical Center

    Tbilisi, 0159
    Georgia

    Active - Recruiting

  • Jo Ann University Hospital

    Tbilisi, 0159
    Georgia

    Active - Recruiting

  • LTD Pineo Medical Ecosystem

    Tbilisi, 0114
    Georgia

    Active - Recruiting

  • LTD Pineo Medical Ecosystem

    Tbilisi 611717, 0114
    Georgia

    Active - Recruiting

  • Zentrum fur klinische Forschung Dr.Scholl

    Bad Homburg, 61348
    Germany

    Active - Recruiting

  • Zentrum fur klinische Forschung Dr.Scholl

    Bad Homburg 2953436, 61350
    Germany

    Active - Recruiting

  • Studienzentrum Dr. Bischof GmbH

    Böblingen, 71034
    Germany

    Active - Recruiting

  • Studienzentrum fur Neurologie und Psychiatrie Boblingen

    Böblingen 2947444, 71034
    Germany

    Active - Recruiting

  • University Hospital Carl Gustav Carus

    Dresden, 01307
    Germany

    Active - Recruiting

  • Curiositas-ad-Sanum GmbH

    Ebersberg, 85560
    Germany

    Active - Recruiting

  • Curiositas-ad-sanum Beratungs-und Studien GmbH

    Ebersberg 2933945, 85560
    Germany

    Active - Recruiting

  • Universitaetsklinikum Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Klinische Forschung Hamburg GmbH

    Hamburg, 20253
    Germany

    Active - Recruiting

  • Multipel Studies Institut fuer klinische Studien GbR

    Hamburg, 22179
    Germany

    Active - Recruiting

  • Klinische Forschung Hamburg GmbH

    Hamburg 2911298, 20253
    Germany

    Active - Recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Universitaet Heidelberg

    Heidelberg 2907911, 69120
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Praxisgemeinschaft fuer Neurologie, Psychiatrie und Psychotherapie - Regensburg

    Regensburg, 93059
    Germany

    Completed

  • ZNS Siegen GmbH

    Siegen, 57076
    Germany

    Active - Recruiting

  • Neurologische Praxis Siegen

    Siegen 2832495, 57076
    Germany

    Active - Recruiting

  • Neuropraxis Munchen Sud - Unterhaching

    Unterhaching, 82008
    Germany

    Active - Recruiting

  • Bellaria-Maggiore Hospital-Azienda USL Bologna

    Bologna, 40139
    Italy

    Active - Recruiting

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

    Milan, 20144
    Italy

    Active - Recruiting

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

    Naples, 80138
    Italy

    Active - Recruiting

  • Ospedale Sant'Andrea Hospital

    Rome, 00189
    Italy

    Active - Recruiting

  • Hospital of Lithuanian University of Health Sciences Kaunas

    Kaunas, 50161
    Lithuania

    Active - Recruiting

  • Klaipedas University Hospital

    Klaipėda, LT-92288
    Lithuania

    Active - Recruiting

  • Vitamed Galaj i Cichomski sp.j.

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-079
    Poland

    Active - Recruiting

  • Vitamed Galaj i Cichomski sp.j.

    Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-079
    Poland

    Active - Recruiting

  • MA-LEK Clinical Sp. z o.o.

    Katowice, Silesian Voivodeship 40-571
    Poland

    Active - Recruiting

  • Neuro-Care

    Katowice, Silesian Voivodeship 40-749
    Poland

    Active - Recruiting

  • MA-LEK Clinical Sp. z o.o.

    Katowice 3096472, Silesian Voivodeship 3337497 40-571
    Poland

    Active - Recruiting

  • Neuro-Care

    Katowice 3096472, Silesian Voivodeship 3337497 40-749
    Poland

    Active - Recruiting

  • Neurocentrum Bydgoszcz

    Bydgoszcz, 85-796
    Poland

    Active - Recruiting

  • Neuro Medic Clinic

    Katowice, 40-686
    Poland

    Active - Recruiting

  • Resmedica Sp. z o.o.

    Kielce, 25-726
    Poland

    Active - Recruiting

  • Krakowska Akademia Neurologii

    Krakow, 31-505
    Poland

    Active - Recruiting

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324
    Poland

    Active - Recruiting

  • NZOZ Neuromed M. i M. Nastaj Sp.P

    Lublin, 20-064
    Poland

    Active - Recruiting

  • Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy

    Poznan, 61-853
    Poland

    Active - Recruiting

  • Centrum Medyczne Neuroprotect

    Warsaw, 01-684
    Poland

    Active - Recruiting

  • MTZ Clinical Research Powered by Pratia

    Warsaw, 02-172
    Poland

    Active - Recruiting

  • Centrum Medyczne Neuroprotect

    Warsaw 756135, 01-684
    Poland

    Active - Recruiting

  • ARENSIA Clinics

    Bucharest, 011658
    Romania

    Active - Recruiting

  • ARENSIA Exploratory Medicine at County Hospital Cluj-Napoca

    Cluj-Napoca, 400006
    Romania

    Active - Recruiting

  • Clinical Hospital Center Zvezdara

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • University Clinical Centre of Kragujevac

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • Clinic of Neurology, University Clinical Center Nis

    Niš, 18000
    Serbia

    Active - Recruiting

  • Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB)

    Bratislava, 82626
    Slovakia

    Active - Recruiting

  • Neurologicka ambulancia Empathy, s.r.o.

    Bratislava, 85101
    Slovakia

    Active - Recruiting

  • Neurologicka ambulancia Empathy, s.r.o.

    Bratislava 3060972, 85101
    Slovakia

    Active - Recruiting

  • Fakultna Nemocnica Trnava

    Trnava, 91775
    Slovakia

    Active - Recruiting

  • University Medical Centre Ljubljana-UKCL

    Ljubljana, 1110
    Slovenia

    Active - Recruiting

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, 28922
    Spain

    Active - Recruiting

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

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Vithas Nisa Sevilla

    Castilleja de la Cuesta, 41950
    Spain

    Active - Recruiting

  • Hospital de Denia Marina Salud

    Dénia, 03700
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon (HGUGM)

    Madrid, 28007
    Spain

    Active - Recruiting

  • Vithas Hospital Parque San Antonio

    Malag, 29016
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Santa Caterina

    Salt, 17190
    Spain

    Active - Recruiting

  • Universidad de Sevilla - Hospital Universitario Virgen Macarena

    Seville, 41009
    Spain

    Active - Recruiting

  • Hospital Universitario de Torrejon

    Torrejón de Ardoz, 28850
    Spain

    Active - Recruiting

  • Hospital Universitario Doctor Peset

    Valencia, 46017
    Spain

    Active - Recruiting

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

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hospital Universitario Doctor Peset

    Valencia 2509954, 46017
    Spain

    Active - Recruiting

  • Hospital Alvaro Cunqueiro

    Vigo, 36312
    Spain

    Active - Recruiting

  • MS Center Research Unit, Sahlgrenska University Hospital

    Gothenburg, 413 45
    Sweden

    Active - Recruiting

  • Academic Specialist Center

    Stockholm, SE113 65
    Sweden

    Completed

  • Universitaetsspital Bern - Inselspital

    Bern, 3010
    Switzerland

    Active - Recruiting

  • Ospedale Regionale di Lugano, Sede Civico

    Lugano, 6903
    Switzerland

    Active - Recruiting

  • Yeditepe University Kosuyolu Hospital

    Kadıköy, Istanbul 34718
    Turkey (Türkiye)

    Active - Recruiting

  • Uludag University Medical Faculty

    Bursa, 16059
    Turkey (Türkiye)

    Active - Recruiting

  • Ondokuz Mayis University Health Practice and Research Hospital

    Samsun, 55280
    Turkey (Türkiye)

    Active - Recruiting

  • Arencia Exploratory Medicine

    Kyiv, 01135
    Ukraine

    Active - Recruiting

  • University of South Alabama

    Mobile, Alabama 36617
    United States

    Active - Recruiting

  • Clinical Endpoints, LLC

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • Profound Research - Neurology Center of Southern California

    Carlsbad, California 92011
    United States

    Active - Recruiting

  • Mountain Neurological Research Center

    Basalt, Colorado 81621
    United States

    Active - Recruiting

  • Advanced Neurosciences Research, Llc

    Fort Collins, Colorado 80528
    United States

    Active - Recruiting

  • Hasbani Neurology

    New Haven, Connecticut 06511
    United States

    Active - Recruiting

  • Neurology Offices of South Florida

    Boca Raton, Florida 33428
    United States

    Active - Recruiting

  • Aqualane Clinical Research

    Naples, Florida 34105
    United States

    Active - Recruiting

  • Emerald Coast Neurology, Synergy Clinical Research

    Pensacola, Florida 32504
    United States

    Active - Recruiting

  • Emerald Coast Neurology/Synergy Clinical Research

    Pensacola, Florida 32504
    United States

    Active - Recruiting

  • Knight Neurology

    Rockledge, Florida 32955
    United States

    Active - Recruiting

  • Palm Beach Medical Group

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • Premiere Research Institute Palm Beach

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • Rush University Medical Center, Rush University Cancer Center

    Chicago, Illinois 60612-3841
    United States

    Completed

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Henry Ford Health

    Detroit, Michigan 48202
    United States

    Active - Recruiting

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

    Farmington, Michigan 48334-2979
    United States

    Active - Recruiting

  • JFK Medical Center

    Edison, New Jersey 08820
    United States

    Active - Recruiting

  • Hackensack Meridian Health

    Paramus, New Jersey 07652
    United States

    Active - Recruiting

  • University Of New Mexico School Of Medicine

    Albuquerque, New Mexico 87131
    United States

    Active - Recruiting

  • University of NM/Mind Imaging center

    Albuquerque, New Mexico 87131
    United States

    Active - Recruiting

  • Triad Neurological Associates

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Singlepoint Healthcare Opco, LLC

    Columbus, Ohio 43235
    United States

    Active - Recruiting

  • NDx Clinical Research, Inc

    Dayton, Ohio 45459
    United States

    Active - Recruiting

  • Neurology Diagnostics, Inc

    Dayton, Ohio 45459
    United States

    Active - Recruiting

  • The Boster Center for Multiple Sclerosis

    Columbus 4509177, Ohio 5165418 43235
    United States

    Active - Recruiting

  • Premier Neurology, PC

    Greenville, South Carolina 29650
    United States

    Active - Recruiting

  • Hope Neurology

    Knoxville, Tennessee 37922
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center (VUMC)

    Nashville, Tennessee 37215
    United States

    Active - Recruiting

  • Lone Star Neurology

    Frisco, Texas 75035
    United States

    Active - Recruiting

  • Froedtert & Medical College of Wisconsin - Clinical Cancer Center - Froedtert Hospital - Courage Cli

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Froedtert Hospital-Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Medical College of Wisconsin - Froedtert Health System

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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