Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

NCT06700343 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 202303092024-512914-16
• Study Type: interventional
• Target: 444
• Locations: 20 countries
• Sites: 101

Brief 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).

Conditions

Relapsing-remitting Multiple Sclerosis (RRMS)

Keywords

Neuroscience; Neurology; Neuroimmunology; Immunosuppressants; Ocrelizumab; ABP 692

Outcome Measures

Primary Outcomes (3)

• Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day 15 (AUC0-d15) Following Infusion 1 of the Initial Dose of Investigational Product (IP)

  Day 1 to Day 15

• AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of the Entire Initial Dose of IP

  Day 1 to Day 15

• Total Number of New Gadolinium Enhanced (GdE) T1-weighted Lesions per Brain MRI

  Up to Week 24

Secondary Outcomes (27)

• Maximum Concentration (Cmax) Following Infusion 1 of the Initial Dose of IP at Day 1 (Cmax, d1)

  Day 1

• Cmax Following Infusion 2 of the Initial Dose of IP at Day 15 (Cmax, d15)

  Day 15

• AUC of the Initial Dose From Time 0 to Week 16 (AUC0-wk16) of IP

  Up to Week 16

• AUC of Infusion 2 of IP From Day 15 to Week 16 (AUCd15-wk16)

  Day 15 to Week 16

• Time at Which Cmax, d1 (Tmax, d1) of IP is Observed

  Day 1

Study Arms (3)

ABP 692

EXPERIMENTAL

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.

Drug: ABP 692

Ocrelizumab (US)/ABP 692

EXPERIMENTAL

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.

Drug: Ocrelizumab (US); Drug: ABP 692

Ocrelizumab (EU)

EXPERIMENTAL

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.

Drug: Ocrelizumab (EU)

Interventions

Ocrelizumab (EU) DRUG

IV infusion

Ocrelizumab (EU)

ABP 692 DRUG

IV infusion

ABP 692; Ocrelizumab (US)/ABP 692

Ocrelizumab (US) DRUG

IV infusion

Ocrelizumab (US)/ABP 692

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017 (Thompson et al, 2018).
• Expanded Disability Status Scale score at screening ≥ 0 and ≤ 5.5 inclusive.
• Evidence of recent MS activity as defined by the study protocol.
• Neurologically stable subject, with no relapse for ≤ 28 days before randomization.

You may not qualify if:

• Diagnosis of primary progressive or with secondary progressive MS (Thompson et al, 2018).
• Multiple sclerosis disease duration of ≥ 10 years in Participants with Expanded Disability Status Scale (EDSS) score of ≤ 2.5 at screening.
• Any contraindications to study procedures or medications as outlined in the study protocol.
• Any prohibited medication as defined in the study protocol.
• Any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study.
• Current or history of any significant medical conditions as described in the study protocol.
• Any abnormal laboratory blood values as defined in the study protocol.

Sponsors & Collaborators

• Amgen: lead

Study Sites (107)

University of South Alabama

Mobile, Alabama, 36617, United States

RECRUITING

Clinical Endpoints, LLC

Scottsdale, Arizona, 85258, United States

RECRUITING

Profound Research - Neurology Center of Southern California

Carlsbad, California, 92011, United States

RECRUITING

Mountain Neurological Research Center

Basalt, Colorado, 81621, United States

RECRUITING

Advanced Neurosciences Research, Llc

Fort Collins, Colorado, 80528, United States

RECRUITING

Hasbani Neurology

New Haven, Connecticut, 06511, United States

RECRUITING

Neurology Offices of South Florida

Boca Raton, Florida, 33428, United States

RECRUITING

Aqualane Clinical Research

Naples, Florida, 34105, United States

RECRUITING

Knight Neurology

Rockledge, Florida, 32955, United States

RECRUITING

Premiere Research Institute Palm Beach

West Palm Beach, Florida, 33407, United States

RECRUITING

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

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

Farmington, Michigan, 48334-2979, United States

RECRUITING

JFK Medical Center

Edison, New Jersey, 08820, United States

RECRUITING

Hackensack Meridian Health

Paramus, New Jersey, 07652, United States

RECRUITING

University of NM/Mind Imaging center

Albuquerque, New Mexico, 87131, United States

RECRUITING

Triad Neurological Associates

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Singlepoint Healthcare Opco, LLC

Columbus, Ohio, 43235, United States

RECRUITING

NDx Clinical Research, Inc

Dayton, Ohio, 45459, United States

RECRUITING

Premier Neurology, PC

Greenville, South Carolina, 29650, United States

RECRUITING

Hope Neurology

Knoxville, Tennessee, 37922, United States

RECRUITING

Vanderbilt University Medical Center (VUMC)

Nashville, Tennessee, 37215, United States

RECRUITING

Lone Star Neurology

Frisco, Texas, 75035, United States

RECRUITING

Froedtert Hospital-Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Algemeen Ziekenhuis Delta

Roeselare, West-Vlaanderen, 8800, Belgium

RECRUITING

MS-Netwerk Limburg - Revalidatie & MS Centrum

Overpelt, 3900, Belgium

RECRUITING

Diagnostic Consultative Center Convex Ltd

Sofia, Sofiiska, 1680, Bulgaria

RECRUITING

UMHAT Dr.Georgi Stranski EAD

Pleven, 5800, Bulgaria

RECRUITING

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

Sofia, 1431, Bulgaria

RECRUITING

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

RECRUITING

UMHATEM N.I. Pirogov

Sofia, 1606, Bulgaria

RECRUITING

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

The Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Sestre milosrdnice University Hospital Center

Zagreb, 10000, Croatia

RECRUITING

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

RECRUITING

Fakultni nemocnice u sv. Anny v Brne

Brno, 656 91, Czechia

RECRUITING

Fakultni Nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

RECRUITING

Privatni ordinace neurologie

Hradec Králové, 50003, Czechia

RECRUITING

Regional Hospital Jihlava

Jihlava, 58601, Czechia

RECRUITING

Nemocnice Teplice

Teplice, 415 01, Czechia

RECRUITING

Aarhus Universitetshospital, Skejby

Aarhus N, Central Jutland, 8200, Denmark

RECRUITING

Sydvestjysk Sygehus

Esbjerg, Region Syddanmark, 6700, Denmark

RECRUITING

Dansk Multipel Sklerose Center

Glostrup Municipality, 2600, Denmark

RECRUITING

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

Nîmes, 30029, France

RECRUITING

LTD Pineo Medical Ecosystem

Tbilisi, 0114, Georgia

RECRUITING

Jo Ann University Hospital

Tbilisi, 0159, Georgia

RECRUITING

Zentrum fur klinische Forschung Dr.Scholl

Bad Homburg, 61348, Germany

RECRUITING

Studienzentrum Dr. Bischof GmbH

Böblingen, 71034, Germany

RECRUITING

University Hospital Carl Gustav Carus

Dresden, 01307, Germany

RECRUITING

Curiositas-ad-Sanum GmbH

Ebersberg, 85560, Germany

RECRUITING

Universitaetsklinikum Essen

Essen, 45147, Germany

RECRUITING

Klinische Forschung Hamburg GmbH

Hamburg, 20253, Germany

RECRUITING

Multipel Studies Institut fuer klinische Studien GbR

Hamburg, 22179, Germany

RECRUITING

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

RECRUITING

Praxisgemeinschaft fuer Neurologie, Psychiatrie und Psychotherapie - Regensburg

Regensburg, 93059, Germany

COMPLETED

ZNS Siegen GmbH

Siegen, 57076, Germany

RECRUITING

Neuropraxis Munchen Sud - Unterhaching

Unterhaching, 82008, Germany

RECRUITING

Bellaria-Maggiore Hospital-Azienda USL Bologna

Bologna, 40139, Italy

RECRUITING

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

Milan, 20144, Italy

RECRUITING

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

Naples, 80138, Italy

RECRUITING

Ospedale Sant'Andrea Hospital

Rome, 00189, Italy

RECRUITING

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, 50161, Lithuania

RECRUITING

Klaipedas University Hospital

Klaipėda, LT-92288, Lithuania

RECRUITING

Vitamed Galaj i Cichomski sp.j.

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

RECRUITING

MA-LEK Clinical Sp. z o.o.

Katowice, Silesian Voivodeship, 40-571, Poland

RECRUITING

Neuro-Care

Katowice, Silesian Voivodeship, 40-749, Poland

RECRUITING

Neurocentrum Bydgoszcz

Bydgoszcz, 85-796, Poland

RECRUITING

Neuro Medic Clinic

Katowice, 40-686, Poland

RECRUITING

Resmedica Sp. z o.o.

Kielce, 25-726, Poland

RECRUITING

Krakowska Akademia Neurologii

Krakow, 31-505, Poland

RECRUITING

Centrum Neurologii Krzysztof Selmaj

Lodz, 90-324, Poland

RECRUITING

NZOZ Neuromed M. i M. Nastaj Sp.P

Lublin, 20-064, Poland

RECRUITING

Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy

Poznan, 61-853, Poland

RECRUITING

Centrum Medyczne Neuroprotect

Warsaw, 01-684, Poland

RECRUITING

MTZ Clinical Research Powered by Pratia

Warsaw, 02-172, Poland

RECRUITING

ARENSIA Clinics

Bucharest, 011658, Romania

RECRUITING

ARENSIA Exploratory Medicine at County Hospital Cluj-Napoca

Cluj-Napoca, 400006, Romania

RECRUITING

Clinical Hospital Center Zvezdara

Belgrade, 11000, Serbia

RECRUITING

University Clinical Centre of Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

Clinic of Neurology, University Clinical Center Nis

Niš, 18000, Serbia

RECRUITING

Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB)

Bratislava, 82626, Slovakia

RECRUITING

Neurologicka ambulancia Empathy, s.r.o.

Bratislava, 85101, Slovakia

RECRUITING

Fakultna Nemocnica Trnava

Trnava, 91775, Slovakia

RECRUITING

University Medical Centre Ljubljana-UKCL

Ljubljana, 1110, Slovenia

RECRUITING

Hospital Universitario Fundacion Alcorcon

Alcorcón, 28922, Spain

RECRUITING

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

Barcelona, 08036, Spain

RECRUITING

Hospital Vithas Nisa Sevilla

Castilleja de la Cuesta, 41950, Spain

RECRUITING

Hospital de Denia Marina Salud

Dénia, 03700, Spain

RECRUITING

Hospital General Universitario Gregorio Maranon (HGUGM)

Madrid, 28007, Spain

RECRUITING

Vithas Hospital Parque San Antonio

Malag, 29016, Spain

RECRUITING

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

RECRUITING

Hospital Santa Caterina

Salt, 17190, Spain

RECRUITING

Universidad de Sevilla - Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital Universitario de Torrejon

Torrejón de Ardoz, 28850, Spain

RECRUITING

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

RECRUITING

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

Valencia, 46026, Spain

RECRUITING

Hospital Alvaro Cunqueiro

Vigo, 36312, Spain

RECRUITING

MS Center Research Unit, Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

RECRUITING

Academic Specialist Center

Stockholm, SE113 65, Sweden

COMPLETED

Universitaetsspital Bern - Inselspital

Bern, 3010, Switzerland

RECRUITING

Ospedale Regionale di Lugano, Sede Civico

Lugano, 6903, Switzerland

RECRUITING

Yeditepe University Kosuyolu Hospital

Kadıköy, Istanbul, 34718, Turkey (Türkiye)

RECRUITING

Uludag University Medical Faculty

Bursa, 16059, Turkey (Türkiye)

RECRUITING

Ondokuz Mayis University Health Practice and Research Hospital

Samsun, 55280, Turkey (Türkiye)

RECRUITING

Arencia Exploratory Medicine

Kyiv, 01135, Ukraine

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 22, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): December 17, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

TU (3); DK (3); DE (12); PL (12); SE (2); CR (2); IT (4); CZ (5); UA (1); LI (2); BE (2); CA (2); GE (2); CH (2); US (25); SL (1); ES (13); FR (1); RO (2); BU (5)