Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

NCT06700343 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 202303092024-512914-16
• Study Type: interventional
• Target: 152
• Locations: 20 countries
• Sites: 105

Brief Summary

The Main objectives of the study are to demonstrate pharmacokinetic (PK) similarity between ABP 692 and ocrelizumab (US), as well as between ABP 692 and ocrelizumab (EU).

Conditions

Relapsing-remitting Multiple Sclerosis (RRMS)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day15 (AUC0-d15) Following Infusion 1 ofthe Initial Dose of InvestigationalProduct (IP)

  Day 1 to Day 15

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

  Day 1 to Week 16

Secondary Outcomes (24)

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

  Day 1 to Day 15

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

  Day 15 to Week 16

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

  Day 1 to Week 16

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

  Day 15- Week 16

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

  Day 1 to Day 15

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

ACTIVE COMPARATOR

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 IV infusion of ABP 692.

Drug: Ocrelizumab (US); Drug: ABP 692

Ocrelizumab (EU)

ACTIVE COMPARATOR

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 (109)

University of South Alabama

Mobile, Alabama, 36617, United States

Location

Clinical Endpoints, LLC

Scottsdale, Arizona, 85258, United States

Location

Profound Research - Neurology Center of Southern California

Carlsbad, California, 92011, United States

Location

Mountain Neurological Research Center

Basalt, Colorado, 81621, United States

Location

Advanced Neurosciences Research, Llc

Fort Collins, Colorado, 80528, United States

Location

Hasbani Neurology

New Haven, Connecticut, 06511, United States

Location

Neurology Offices of South Florida

Boca Raton, Florida, 33428, United States

Location

Aqualane Clinical Research

Naples, Florida, 34105, United States

Location

Emerald Coast Neurology/Synergy Clinical Research

Pensacola, Florida, 32504, United States

Location

Knight Neurology

Rockledge, Florida, 32955, United States

Location

Premiere Research Institute Palm Beach

West Palm Beach, Florida, 33407, United States

Location

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

Location

Rush University Medical Center, Rush University Cancer Center

Chicago, Illinois, 60612-3841, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

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

Farmington, Michigan, 48334-2979, United States

Location

JFK Medical Center

Edison, New Jersey, 08820, United States

Location

Hackensack Meridian Health

Paramus, New Jersey, 07652, United States

Location

University of NM/Mind Imaging center

Albuquerque, New Mexico, 87131, United States

Location

Triad Neurological Associates

Winston-Salem, North Carolina, 27103, United States

Location

Singlepoint Healthcare Opco, LLC

Columbus, Ohio, 43235, United States

Location

NDx Clinical Research, Inc

Dayton, Ohio, 45459, United States

Location

Premier Neurology, PC

Greenville, South Carolina, 29650, United States

Location

Hope Neurology

Knoxville, Tennessee, 37922, United States

Location

Vanderbilt University Medical Center (VUMC)

Nashville, Tennessee, 37215, United States

Location

Lone Star Neurology

Frisco, Texas, 75035, United States

Location

Froedtert Hospital-Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Algemeen Ziekenhuis Delta

Roeselare, West-Vlaanderen, 8800, Belgium

Location

MS-Netwerk Limburg - Revalidatie & MS Centrum

Overpelt, 3900, Belgium

Location

Diagnostic Consultative Center Convex Ltd

Sofia, Sofiiska, 1680, Bulgaria

Location

UMHAT Dr.Georgi Stranski EAD

Pleven, 5800, Bulgaria

Location

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

Sofia, 1431, Bulgaria

Location

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

Location

UMHATEM N.I. Pirogov

Sofia, 1606, Bulgaria

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

The Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Sestre milosrdnice University Hospital Center

Zagreb, 10000, Croatia

Location

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Fakultni nemocnice u sv. Anny v Brne

Brno, 656 91, Czechia

Location

Fakultni Nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Privatni ordinace neurologie

Hradec Králové, 50003, Czechia

Location

Regional Hospital Jihlava

Jihlava, 58601, Czechia

Location

Nemocnice Teplice

Teplice, 415 01, Czechia

Location

Aarhus Universitetshospital, Skejby

Aarhus N, Central Jutland, 8200, Denmark

Location

Sydvestjysk Sygehus

Esbjerg, Region Syddanmark, 6700, Denmark

Location

Dansk Multipel Sklerose Center

Glostrup Municipality, 2600, Denmark

Location

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

Nîmes, 30029, France

Location

LTD Pineo Medical Ecosystem

Tbilisi, 0114, Georgia

Location

Jo Ann University Hospital

Tbilisi, 0159, Georgia

Location

Zentrum fur klinische Forschung Dr.Scholl

Bad Homburg, 61348, Germany

Location

Studienzentrum Dr. Bischof GmbH

Böblingen, 71034, Germany

Location

University Hospital Carl Gustav Carus

Dresden, 01307, Germany

Location

Curiositas-ad-Sanum GmbH

Ebersberg, 85560, Germany

Location

Universitaetsklinikum Essen

Essen, 45147, Germany

Location

Klinische Forschung Hamburg GmbH

Hamburg, 20253, Germany

Location

Multipel Studies Institut fuer klinische Studien GbR

Hamburg, 22179, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

Location

Praxisgemeinschaft fuer Neurologie, Psychiatrie und Psychotherapie - Regensburg

Regensburg, 93059, Germany

Location

ZNS Siegen GmbH

Siegen, 57076, Germany

Location

Neuropraxis Munchen Sud - Unterhaching

Unterhaching, 82008, Germany

Location

Bellaria-Maggiore Hospital-Azienda USL Bologna

Bologna, 40139, Italy

Location

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

Milan, 20144, Italy

Location

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

Naples, 80138, Italy

Location

Ospedale Sant'Andrea Hospital

Rome, 00189, Italy

Location

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, 50161, Lithuania

Location

Klaipedas University Hospital

Klaipėda, LT-92288, Lithuania

Location

Vitamed Galaj i Cichomski sp.j.

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

Location

MA-LEK Clinical Sp. z o.o.

Katowice, Silesian Voivodeship, 40-571, Poland

Location

Neuro-Care

Katowice, Silesian Voivodeship, 40-749, Poland

Location

Neurocentrum Bydgoszcz

Bydgoszcz, 85-796, Poland

Location

Neuro Medic Clinic

Katowice, 40-686, Poland

Location

Resmedica Sp. z o.o.

Kielce, 25-726, Poland

Location

Krakowska Akademia Neurologii

Krakow, 31-505, Poland

Location

Centrum Neurologii Krzysztof Selmaj

Lodz, 90-324, Poland

Location

NZOZ Neuromed M. i M. Nastaj Sp.P

Lublin, 20-064, Poland

Location

Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy

Poznan, 61-853, Poland

Location

Centrum Medyczne Neuroprotect

Warsaw, 01-684, Poland

Location

MTZ Clinical Research Powered by Pratia

Warsaw, 02-172, Poland

Location

ARENSIA Clinics

Bucharest, 011658, Romania

Location

ARENSIA Exploratory Medicine at County Hospital Cluj-Napoca

Cluj-Napoca, 400006, Romania

Location

Clinical Hospital Center Zvezdara

Belgrade, 11000, Serbia

Location

University Clinical Centre of Kragujevac

Kragujevac, 34000, Serbia

Location

Clinic of Neurology, University Clinical Center Nis

Niš, 18000, Serbia

Location

Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB)

Bratislava, 82626, Slovakia

Location

Neurologicka ambulancia Empathy, s.r.o.

Bratislava, 85101, Slovakia

Location

Fakultna Nemocnica Trnava

Trnava, 91775, Slovakia

Location

University Medical Centre Ljubljana-UKCL

Ljubljana, 1110, Slovenia

Location

Hospital Universitario Fundacion Alcorcon

Alcorcón, 28922, Spain

Location

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

Barcelona, 08036, Spain

Location

Hospital Vithas Nisa Sevilla

Castilleja de la Cuesta, 41950, Spain

Location

Hospital de Denia Marina Salud

Dénia, 03700, Spain

Location

Hospital General Universitario Gregorio Maranon (HGUGM)

Madrid, 28007, Spain

Location

Vithas Hospital Parque San Antonio

Malag, 29016, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

Location

Hospital Santa Caterina

Salt, 17190, Spain

Location

Universidad de Sevilla - Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario de Torrejon

Torrejón de Ardoz, 28850, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

Location

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

Valencia, 46026, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, 36312, Spain

Location

MS Center Research Unit, Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Academic Specialist Center

Stockholm, SE113 65, Sweden

Location

Universitaetsspital Bern - Inselspital

Bern, 3010, Switzerland

Location

Ospedale Regionale di Lugano, Sede Civico

Lugano, 6903, Switzerland

Location

Yeditepe University Kosuyolu Hospital

Kadıköy, Istanbul, 34718, Turkey (Türkiye)

Location

Uludag University Medical Faculty

Bursa, 16059, Turkey (Türkiye)

Location

Ondokuz Mayis University Health Practice and Research Hospital

Samsun, 55280, Turkey (Türkiye)

Location

Arencia Exploratory Medicine

Kyiv, 01135, Ukraine

Location

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

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): April 19, 2027
• Study Completion (Estimated): October 4, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

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

BE (2); IT (4); DE (12); CA (2); ES (13); UA (1); CR (2); PL (12); CH (2); SL (3); US (27); FR (1); RO (2); BU (5); CZ (5); LI (2); DK (3); SE (2); GE (2); TU (3)