Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

NCT ID: NCT06700343

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-13

Study Completion Date

2027-12-17

Brief Summary

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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).

Detailed Description

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Conditions

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Relapsing-remitting Multiple Sclerosis (RRMS)

Keywords

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Neuroscience Neurology Neuroimmunology Immunosuppressants Ocrelizumab ABP 692

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ABP 692

Participants affected by relapsing-remitting multiple sclerosis (RRMS) will receive an initial dose of 300 mg ABP 692 intravenous (IV) infusion on Day 1, followed by a second dose of 300 mg ABP 692 IV infusion on Day 15. A subsequent dose of 600 mg ABP 692 IV infusion will be administered 24 weeks after the initial dose.

Group Type EXPERIMENTAL

ABP 692

Intervention Type DRUG

IV infusion

Ocrelizumab (US)/ABP 692

Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (US) IV infusion on Day 1, followed by a second dose of 300 mg Ocrelizumab (US) IV infusion on Day 15. At Week 24, the treatment will switch to a 600 mg Ocrelizumab (US) IV infusion of ABP 692.

Group Type EXPERIMENTAL

Ocrelizumab (US)

Intervention Type DRUG

IV infusion

ABP 692

Intervention Type DRUG

IV infusion

Ocrelizumab (EU)

Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (EU) IV infusion on Day 1, followed by a 300 mg Ocrelizumab (EU) IV infusion on Day 15. At Week 24, participants will receive a dose of 600 mg Ocrelizumab (EU) IV infusion.

Group Type EXPERIMENTAL

Ocrelizumab (EU)

Intervention Type DRUG

IV infusion

Interventions

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Ocrelizumab (US)

IV infusion

Intervention Type DRUG

Ocrelizumab (EU)

IV infusion

Intervention Type DRUG

ABP 692

IV infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017 (Thompson et al, 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 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 Expanded Disability Status Scale (EDSS) score of ≤ 2.5 at screening.
3. Any contraindications to study procedures or medications as outlined in the study protocol.
4. Any prohibited medication as defined in the study protocol.
5. Any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study.
6. Current or history of any significant medical conditions as described in the study protocol.
7. Any abnormal laboratory blood values as defined in the study protocol.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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University of South Alabama

Mobile, Alabama, United States

Site Status RECRUITING

Clinical Endpoints, LLC

Scottsdale, Arizona, United States

Site Status RECRUITING

Profound Research - Neurology Center of Southern California

Carlsbad, California, United States

Site Status RECRUITING

Mountain Neurological Research Center

Basalt, Colorado, United States

Site Status RECRUITING

Advanced Neurosciences Research, Llc

Fort Collins, Colorado, United States

Site Status RECRUITING

Hasbani Neurology

New Haven, Connecticut, United States

Site Status RECRUITING

Neurology Offices of South Florida

Boca Raton, Florida, United States

Site Status RECRUITING

Aqualane Clinical Research

Naples, Florida, United States

Site Status RECRUITING

Knight Neurology

Rockledge, Florida, United States

Site Status RECRUITING

Premiere Research Institute Palm Beach

West Palm Beach, Florida, United States

Site Status RECRUITING

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Site Status RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

Henry Ford Health

Detroit, Michigan, United States

Site Status RECRUITING

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

Farmington, Michigan, United States

Site Status RECRUITING

Hackensack Meridian Health

Paramus, New Jersey, United States

Site Status RECRUITING

University of NM/Mind Imaging center

Albuquerque, New Mexico, United States

Site Status RECRUITING

Triad Neurological Associates

Winston-Salem, North Carolina, United States

Site Status RECRUITING

The Boster Center for Multiple Sclerosis

Columbus, Ohio, United States

Site Status RECRUITING

Neurology Diagnostics, Inc.

Dayton, Ohio, United States

Site Status RECRUITING

Premier Neurology, PC

Greenville, South Carolina, United States

Site Status RECRUITING

Hope Neurology

Knoxville, Tennessee, United States

Site Status RECRUITING

Vanderbilt University Medical Center (VUMC)

Nashville, Tennessee, United States

Site Status RECRUITING

Lone Star Neurology

Frisco, Texas, United States

Site Status RECRUITING

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

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Algemeen Ziekenhuis Delta

Roeselare, West-Vlaanderen, Belgium

Site Status RECRUITING

MS-Netwerk Limburg - Revalidatie & MS Centrum

Overpelt, , Belgium

Site Status RECRUITING

Diagnostic Consultative Center Convex Ltd

Sofia, Sofiiska, Bulgaria

Site Status RECRUITING

UMHAT Dr.Georgi Stranski EAD

Pleven, , Bulgaria

Site Status RECRUITING

Medical Center Hera EOOD

Sofia, , Bulgaria

Site Status RECRUITING

UMHATEM N.I. Pirogov

Sofia, , Bulgaria

Site Status RECRUITING

Foothills Medical Centre

Calgary, Alberta, Canada

Site Status RECRUITING

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status RECRUITING

Sestre milosrdnice University Hospital Center

Zagreb, , Croatia

Site Status RECRUITING

University Hospital Centre Zagreb

Zagreb, , Croatia

Site Status RECRUITING

Fakultni Nemocnice Hradec Kralove

Hradec Králové, , Czechia

Site Status RECRUITING

Privatni ordinace neurologie

Hradec Králové, , Czechia

Site Status RECRUITING

Regional Hospital Jihlava

Jihlava, , Czechia

Site Status RECRUITING

Aarhus Universitetshospital, Skejby

Aarhus N, Central Jutland, Denmark

Site Status RECRUITING

LTD Pineo Medical Ecosystem

Tbilisi, , Georgia

Site Status RECRUITING

Jo Ann University Hospital

Tbilisi, , Georgia

Site Status RECRUITING

Zentrum fur klinische Forschung Dr.Scholl

Bad Homburg, , Germany

Site Status RECRUITING

Studienzentrum fur Neurologie und Psychiatrie Boblingen

Böblingen, , Germany

Site Status RECRUITING

University Hospital Carl Gustav Carus

Dresden, , Germany

Site Status RECRUITING

Klinische Forschung Hamburg GmbH

Hamburg, , Germany

Site Status RECRUITING

Praxisgemeinschaft fuer Neurologie, Psychiatrie und Psychotherapie - Regensburg

Regensburg, , Germany

Site Status RECRUITING

Neuropraxis Munchen Sud - Unterhaching

Unterhaching, , Germany

Site Status RECRUITING

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

Milan, , Italy

Site Status RECRUITING

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

Naples, , Italy

Site Status RECRUITING

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, , Lithuania

Site Status RECRUITING

Klaipedas University Hospital

Klaipėda, , Lithuania

Site Status RECRUITING

Vitamed Galaj i Cichomski sp.j.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status RECRUITING

MA-LEK Clinical Sp. z o.o.

Katowice, Silesian Voivodeship, Poland

Site Status RECRUITING

Neuro-Care

Katowice, Silesian Voivodeship, Poland

Site Status RECRUITING

Neurocentrum Bydgoszcz

Bydgoszcz, , Poland

Site Status RECRUITING

Neuro Medic Clinic

Katowice, , Poland

Site Status RECRUITING

Resmedica Sp. z o.o.

Kielce, , Poland

Site Status RECRUITING

Krakowska Akademia Neurologii

Krakow, , Poland

Site Status RECRUITING

Centrum Neurologii Krzysztof Selmaj

Lodz, , Poland

Site Status RECRUITING

NZOZ Neuromed M. i M. Nastaj Sp.P

Lublin, , Poland

Site Status RECRUITING

Centrum Medyczne Neuroprotect

Warsaw, , Poland

Site Status RECRUITING

MTZ Clinical Research Powered by Pratia

Warsaw, , Poland

Site Status RECRUITING

Clinical Hospital Center Zvezdara

Belgrade, , Serbia

Site Status RECRUITING

University Clinical Centre of Kragujevac

Kragujevac, , Serbia

Site Status RECRUITING

Clinic of Neurology, University Clinical Center Nis

Niš, , Serbia

Site Status RECRUITING

Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB)

Bratislava, , Slovakia

Site Status RECRUITING

Neurologicka ambulancia Empathy, s.r.o.

Bratislava, , Slovakia

Site Status RECRUITING

Hospital Universitario Fundacion Alcorcon

Alcorcón, , Spain

Site Status RECRUITING

Hospital Vithas Nisa Sevilla

Castilleja de la Cuesta, , Spain

Site Status RECRUITING

Hospital de Denia Marina Salud

Dénia, , Spain

Site Status RECRUITING

Vithas Hospital Parque San Antonio

Malag, , Spain

Site Status RECRUITING

Hospital Regional Universitario de Malaga

Málaga, , Spain

Site Status RECRUITING

Universidad de Sevilla - Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status RECRUITING

Hospital Universitario Doctor Peset

Valencia, , Spain

Site Status RECRUITING

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

Valencia, , Spain

Site Status RECRUITING

Hospital Alvaro Cunqueiro

Vigo, , Spain

Site Status RECRUITING

MS Center Research Unit, Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Academic Specialist Center

Stockholm, , Sweden

Site Status TERMINATED

Universitaetsspital Bern - Inselspital

Bern, , Switzerland

Site Status RECRUITING

Ospedale Regionale di Lugano, Sede Civico

Lugano, , Switzerland

Site Status RECRUITING

Yeditepe University Kosuyolu Hospital

Kadıköy, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Uludag University Medical Faculty

Bursa, , Turkey (Türkiye)

Site Status RECRUITING

Ondokuz Mayis University Health Practice and Research Hospital

Samsun, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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United States Belgium Bulgaria Canada Croatia Czechia Denmark Georgia Germany Italy Lithuania Poland Serbia Slovakia Spain Sweden Switzerland Turkey (Türkiye)

Central Contacts

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Amgen Call Center

Role: CONTACT

Phone: 866-572-6436

Email: [email protected]

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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2024-512914-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20230309

Identifier Type: -

Identifier Source: org_study_id