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

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).

Study Overview

• Status: Recruiting
• Conditions: Relapsing-remitting Multiple Sclerosis (RRMS)
• Intervention / Treatment: Drug: ABP 692; Drug: Ocrelizumab (US); Drug: Ocrelizumab (EU)

• Study Type: Interventional
• Enrollment (Estimated): 444
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• Belgium
  • Overpelt, Belgium, 3900
    • Recruiting
    • MS-Netwerk Limburg - Revalidatie & MS Centrum
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • Recruiting
      • Algemeen Ziekenhuis Delta
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Recruiting
    • UMHAT Dr.Georgi Stranski EAD
  • Sofia, Bulgaria, 1510
    • Recruiting
    • Medical Center Hera Eood
  • Sofia, Bulgaria, 1431
    • Recruiting
    • University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski
  • Sofia, Bulgaria, 1606
    • Recruiting
    • UMHATEM N.I. Pirogov
  • Sofiiska
    • Sofia, Sofiiska, Bulgaria, 1680
      • Recruiting
      • Diagnostic Consultative Center Convex Ltd
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Recruiting
      • Foothills Medical Centre
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital Research Institute
• Croatia
  • Zagreb, Croatia, 10000
    • Recruiting
    • University Hospital Centre Zagreb
  • Zagreb, Croatia, 10000
    • Recruiting
    • Sestre milosrdnice University Hospital Center
• Czechia
  • Brno, Czechia, 656 91
    • Recruiting
    • Fakultni nemocnice u sv. Anny v Brne
  • Hradec Králové, Czechia, 500 05
    • Recruiting
    • Fakultni nemocnice Hradec Kralove
  • Hradec Králové, Czechia, 50003
    • Recruiting
    • Privatni ordinace neurologie
  • Jihlava, Czechia, 58601
    • Recruiting
    • Regional Hospital Jihlava
  • Teplice, Czechia, 415 01
    • Recruiting
    • Nemocnice Teplice
• Denmark
  • Glostrup Municipality, Denmark, 2600
    • Recruiting
    • Dansk Multipel Sklerose Center
  • Central Jutland
    • Aarhus N, Central Jutland, Denmark, 8200
      • Recruiting
      • Aarhus Universitetshospital, Skejby
  • Region Syddanmark
    • Esbjerg, Region Syddanmark, Denmark, 6700
      • Recruiting
      • Sydvestjysk Sygehus
• France
  • Nîmes, France, 30029
    • Recruiting
    • Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
• Georgia
  • Tbilisi, Georgia, 0114
    • Recruiting
    • Ltd Pineo Medical Ecosystem
  • Tbilisi, Georgia, 0159
    • Recruiting
    • Jo Ann University Hospital
• Germany
  • Bad Homburg, Germany, 61348
    • Recruiting
    • Zentrum fur klinische Forschung Dr.Scholl
  • Böblingen, Germany, 71034
    • Recruiting
    • Studienzentrum Dr. Bischof GmbH
  • Dresden, Germany, 01307
    • Recruiting
    • University Hospital Carl Gustav Carus
  • Ebersberg, Germany, 85560
    • Recruiting
    • Curiositas-ad-Sanum GmbH
  • Essen, Germany, 45147
    • Recruiting
    • Universitaetsklinikum Essen
  • Hamburg, Germany, 20253
    • Recruiting
    • Klinische Forschung Hamburg GmbH
  • Hamburg, Germany, 22179
    • Recruiting
    • Multipel Studies Institut fuer klinische Studien GbR
  • Heidelberg, Germany, 69120
    • Recruiting
    • Universitaetsklinikum Heidelberg
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitaetsklinikum Leipzig
  • Regensburg, Germany, 93059
    • Completed
    • Praxisgemeinschaft fuer Neurologie, Psychiatrie und Psychotherapie - Regensburg
  • Siegen, Germany, 57076
    • Recruiting
    • ZNS Siegen GmbH
  • Unterhaching, Germany, 82008
    • Recruiting
    • Neuropraxis Munchen Sud - Unterhaching
• Italy
  • Bologna, Italy, 40139
    • Recruiting
    • Bellaria-Maggiore Hospital-Azienda USL Bologna
  • Milan, Italy, 20144
    • Recruiting
    • Casa di Cura Privata del Policlinico Igea S.p.A
  • Naples, Italy, 80138
    • Recruiting
    • Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia II - Centro Sclerosi Mul
  • Rome, Italy, 00189
    • Recruiting
    • Ospedale Sant'Andrea Hospital
• Lithuania
  • Kaunas, Lithuania, 50161
    • Recruiting
    • Hospital of Lithuanian University of Health Sciences Kaunas
  • Klaipėda, Lithuania, LT-92288
    • Recruiting
    • Klaipedas University Hospital
• Poland
  • Bydgoszcz, Poland, 85-796
    • Recruiting
    • Neurocentrum Bydgoszcz
  • Katowice, Poland, 40-686
    • Recruiting
    • Neuro Medic Clinic
  • Kielce, Poland, 25-726
    • Recruiting
    • Resmedica Sp. z o.o.
  • Krakow, Poland, 31-505
    • Recruiting
    • Krakowska Akademia Neurologii
  • Lodz, Poland, 90-324
    • Recruiting
    • Centrum Neurologii Krzysztof Selmaj
  • Lublin, Poland, 20-064
    • Recruiting
    • NZOZ Neuromed M. i M. Nastaj Sp.P
  • Poznan, Poland, 61-853
    • Recruiting
    • Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy
  • Warsaw, Poland, 01-684
    • Recruiting
    • Centrum Medyczne NeuroProtect
  • Warsaw, Poland, 02-172
    • Recruiting
    • MTZ Clinical Research Powered by Pratia
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-079
      • Recruiting
      • Vitamed Galaj i Cichomski sp.j.
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-571
      • Recruiting
      • MA-LEK Clinical Sp. z o.o.
    • Katowice, Silesian Voivodeship, Poland, 40-749
      • Recruiting
      • Neuro-Care
• Romania
  • Bucharest, Romania, 011658
    • Recruiting
    • ARENSIA Clinics
  • Cluj-Napoca, Romania, 400006
    • Recruiting
    • ARENSIA Exploratory Medicine at County Hospital Cluj-Napoca
• Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • Clinical Hospital Center Zvezdara
  • Kragujevac, Serbia, 34000
    • Recruiting
    • University Clinical Centre of Kragujevac
  • Niš, Serbia, 18000
    • Recruiting
    • Clinic of Neurology, University Clinical Center Nis
• Slovakia
  • Bratislava, Slovakia, 82626
    • Recruiting
    • Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB)
  • Bratislava, Slovakia, 85101
    • Recruiting
    • Neurologicka ambulancia Empathy, s.r.o.
  • Trnava, Slovakia, 91775
    • Recruiting
    • Fakultna nemocnica Trnava
• Slovenia
  • Ljubljana, Slovenia, 1110
    • Recruiting
    • University Medical Centre Ljubljana-UKCL
• Spain
  • Alcorcón, Spain, 28922
    • Recruiting
    • Hospital Universitario Fundacion Alcorcon
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)
  • Castilleja de la Cuesta, Spain, 41950
    • Recruiting
    • Hospital Vithas Nisa Sevilla
  • Dénia, Spain, 03700
    • Recruiting
    • Hospital de Denia Marina Salud
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Maranon (HGUGM)
  • Malag, Spain, 29016
    • Recruiting
    • Vithas Hospital Parque San Antonio
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Regional Universitario de Málaga
  • Salt, Spain, 17190
    • Recruiting
    • Hospital Santa Caterina
  • Seville, Spain, 41009
    • Recruiting
    • Universidad de Sevilla - Hospital Universitario Virgen Macarena
  • Torrejón de Ardoz, Spain, 28850
    • Recruiting
    • Hospital Universitario de Torrejon
  • Valencia, Spain, 46017
    • Recruiting
    • Hospital Universitario Doctor Peset
  • Valencia, Spain, 46026
    • Recruiting
    • Universitat de Valencia - Hospital Universitari I Politecnic La Fe de Valencia (Hospital La Fe Bulev
  • Vigo, Spain, 36312
    • Recruiting
    • Hospital Álvaro Cunqueiro
• Sweden
  • Gothenburg, Sweden, 413 45
    • Recruiting
    • MS Center Research Unit, Sahlgrenska University Hospital
  • Stockholm, Sweden, SE113 65
    • Completed
    • Academic Specialist Center
• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Universitaetsspital Bern - Inselspital
  • Lugano, Switzerland, 6903
    • Recruiting
    • Ospedale Regionale di Lugano, Sede Civico
• Turkey (Türkiye)
  • Bursa, Turkey (Türkiye), 16059
    • Recruiting
    • Uludag University Medical Faculty
  • Samsun, Turkey (Türkiye), 55280
    • Recruiting
    • Ondokuz Mayis University Health Practice and Research Hospital
  • Istanbul
    • Kadıköy, Istanbul, Turkey (Türkiye), 34718
      • Recruiting
      • Yeditepe University Kosuyolu Hospital
• Ukraine
  • Kyiv, Ukraine, 01135
    • Recruiting
    • Arencia Exploratory Medicine
• United States
  • Alabama
    • Mobile, Alabama, United States, 36617
      • Recruiting
      • University of South Alabama
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Recruiting
      • Clinical Endpoints, LLC
  • California
    • Carlsbad, California, United States, 92011
      • Recruiting
      • Profound Research - Neurology Center of Southern California
  • Colorado
    • Basalt, Colorado, United States, 81621
      • Recruiting
      • Mountain Neurological Research Center
    • Fort Collins, Colorado, United States, 80528
      • Recruiting
      • Advanced Neurosciences Research, Llc
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Recruiting
      • Hasbani Neurology
  • Florida
    • Boca Raton, Florida, United States, 33428
      • Recruiting
      • Neurology Offices of South Florida
    • Naples, Florida, United States, 34105
      • Recruiting
      • Aqualane Clinical Research
    • Pensacola, Florida, United States, 32504
      • Recruiting
      • Emerald Coast Neurology/Synergy Clinical Research
    • Rockledge, Florida, United States, 32955
      • Recruiting
      • Knight Neurology
    • West Palm Beach, Florida, United States, 33407
      • Recruiting
      • Premiere Research Institute Palm Beach
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Recruiting
      • Hawaii Pacific Neuroscience
  • Illinois
    • Chicago, Illinois, United States, 60612-3841
      • Completed
      • Rush University Medical Center, Rush University Cancer Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health
    • Farmington, Michigan, United States, 48334-2979
      • Recruiting
      • Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington Hills
  • New Jersey
    • Edison, New Jersey, United States, 08820
      • Recruiting
      • JFK Medical Center
    • Paramus, New Jersey, United States, 07652
      • Recruiting
      • Hackensack Meridian Health
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Recruiting
      • University of NM/Mind Imaging center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Triad Neurological Associates
  • Ohio
    • Columbus, Ohio, United States, 43235
      • Recruiting
      • Singlepoint Healthcare Opco, LLC
    • Dayton, Ohio, United States, 45459
      • Recruiting
      • NDx Clinical Research, Inc
  • South Carolina
    • Greenville, South Carolina, United States, 29650
      • Recruiting
      • Premier Neurology, PC
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Recruiting
      • Hope Neurology
    • Nashville, Tennessee, United States, 37215
      • Recruiting
      • Vanderbilt University Medical Center (VUMC)
  • Texas
    • Frisco, Texas, United States, 75035
      • Recruiting
      • Lone Star Neurology
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert Hospital-Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: ABP 692; IV infusion
Experimental: 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.	Drug: ABP 692; IV infusion; Drug: Ocrelizumab (US); IV infusion
Experimental: 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.	Drug: Ocrelizumab (EU); IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time at Which Cmax, d15 (Tmax, d15) of IP is Observed		Day 15
Trough Concentration (Ctrough) of IP at Day 15		Day 15
Clearance (CL) of IP		Up to Week 48
Volume of Distribution (Vd) of IP		Up to week 48
Terminal Elimination Half-life (T1/2) of IP		Up to Week 48
Mean Residence Time (MRT) of IP		Up to Week 48
Total Number of New or Enlarging T2 Hyperintense Lesions per Brain MRI		Up to Week 24
Total Number of New or Enlarging T2 Hyperintense Lesions per Brain MRI at Week 48		Week 48
Total Number of GdE T1-weighted Lesions per Brain MRI		Up to Week 24
Total Number of GdE T1-weighted Lesions per Brain MRI at Week 48		Week 48
Total Number of Combined Unique Active (CUA) Lesions per Brain MRI		Up to Week 24
Total Number of CUA Lesions per Brain MRI at Week 48		Week 48
Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 24		Week 24
Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 24		Week 24
Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 48		Week 48
Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 48		Week 48
Percentage of Participants who are Relapse-free at Week 24		Week 24
Percentage of Participants who are Relapse-free at Week 48		Week 48
Percentage of Participants with Anti-drug Antibodies (ADAs)		Up to Week 48
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a treatment, combination product, medical device, or procedure. A TEAE is defined as an AE that starts or worsens on or after the first IP infusion up to the end of study visit.	Up to Week 96
Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAEs)		Up to Week 96
Number of Participants Experiencing Treatment-emergent Events of Interest (EOIs)		Up to Week 96

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): December 17, 2027

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Neuroscience; Neuroimmunology; Ocrelizumab; Neurology; Immunosuppressants; ABP 692
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Immunologic Factors; Physiological Effects of Drugs; ocrelizumab
• Other Study ID Numbers: 20230309; 2024-512914-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No