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Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)
NCT06700343 · Amgen
In plain English
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Official title
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
About this study
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 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 design
Enrollment target: 444 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-01-13
Estimated completion: 2027-12-17
Last updated: 2026-04-13
Interventions
Drug: Ocrelizumab (US)Drug: Ocrelizumab (EU)Drug: ABP 692
Primary outcomes
- • 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)
Sponsor
Amgen · industry
Contacts & investigators
ContactAmgen Call Center · contact · medinfo@amgen.com · 866-572-6436
InvestigatorMD · study_director, Amgen
All locations (107)
University of South AlabamaRecruiting
Mobile, Alabama, United States
Clinical Endpoints, LLCRecruiting
Scottsdale, Arizona, United States
Profound Research - Neurology Center of Southern CaliforniaRecruiting
Carlsbad, California, United States
Mountain Neurological Research CenterRecruiting
Basalt, Colorado, United States
Advanced Neurosciences Research, LlcRecruiting
Fort Collins, Colorado, United States
Hasbani NeurologyRecruiting
New Haven, Connecticut, United States
Neurology Offices of South FloridaRecruiting
Boca Raton, Florida, United States
Aqualane Clinical ResearchRecruiting
Naples, Florida, United States
Knight NeurologyRecruiting
Rockledge, Florida, United States
Premiere Research Institute Palm BeachRecruiting
West Palm Beach, Florida, United States
Hawaii Pacific NeuroscienceRecruiting
Honolulu, Hawaii, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Henry Ford HealthRecruiting
Detroit, Michigan, United States
Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington HillsRecruiting
Farmington, Michigan, United States
JFK Medical CenterRecruiting
Edison, New Jersey, United States
Hackensack Meridian HealthRecruiting
Paramus, New Jersey, United States
University of NM/Mind Imaging centerRecruiting
Albuquerque, New Mexico, United States
Triad Neurological AssociatesRecruiting
Winston-Salem, North Carolina, United States
Singlepoint Healthcare Opco, LLCRecruiting
Columbus, Ohio, United States
NDx Clinical Research, IncRecruiting
Dayton, Ohio, United States
Premier Neurology, PCRecruiting
Greenville, South Carolina, United States
Hope NeurologyRecruiting
Knoxville, Tennessee, United States
Vanderbilt University Medical Center (VUMC)Recruiting
Nashville, Tennessee, United States
Lone Star NeurologyRecruiting
Frisco, Texas, United States
Froedtert Hospital-Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Algemeen Ziekenhuis DeltaRecruiting
Roeselare, West-Vlaanderen, Belgium
MS-Netwerk Limburg - Revalidatie & MS CentrumRecruiting
Overpelt, Belgium
Diagnostic Consultative Center Convex LtdRecruiting
Sofia, Sofiiska, Bulgaria
UMHAT Dr.Georgi Stranski EADRecruiting
Pleven, Bulgaria
University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan RilskiRecruiting
Sofia, Bulgaria
Medical Center Hera EOODRecruiting
Sofia, Bulgaria
UMHATEM N.I. PirogovRecruiting
Sofia, Bulgaria
Foothills Medical CentreRecruiting
Calgary, Alberta, Canada
The Ottawa Hospital Research InstituteRecruiting
Ottawa, Ontario, Canada
Sestre milosrdnice University Hospital CenterRecruiting
Zagreb, Croatia
University Hospital Centre ZagrebRecruiting
Zagreb, Croatia
Fakultni nemocnice u sv. Anny v BrneRecruiting
Brno, Czechia
Fakultni Nemocnice Hradec KraloveRecruiting
Hradec Králové, Czechia
Privatni ordinace neurologieRecruiting
Hradec Králové, Czechia
Regional Hospital JihlavaRecruiting
Jihlava, Czechia
Nemocnice TepliceRecruiting
Teplice, Czechia
Aarhus Universitetshospital, SkejbyRecruiting
Aarhus N, Central Jutland, Denmark
Sydvestjysk SygehusRecruiting
Esbjerg, Region Syddanmark, Denmark
Dansk Multipel Sklerose CenterRecruiting
Glostrup Municipality, Denmark
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire CaremeauRecruiting
Nîmes, France
LTD Pineo Medical EcosystemRecruiting
Tbilisi, Georgia
Jo Ann University HospitalRecruiting
Tbilisi, Georgia
Zentrum fur klinische Forschung Dr.SchollRecruiting
Bad Homburg, Germany
Studienzentrum Dr. Bischof GmbHRecruiting
Böblingen, Germany
University Hospital Carl Gustav CarusRecruiting
Dresden, Germany
Curiositas-ad-Sanum GmbHRecruiting
Ebersberg, Germany
Universitaetsklinikum EssenRecruiting
Essen, Germany
Klinische Forschung Hamburg GmbHRecruiting
Hamburg, Germany
Multipel Studies Institut fuer klinische Studien GbRRecruiting
Hamburg, Germany
Universitaetsklinikum HeidelbergRecruiting
Heidelberg, Germany
Universitaetsklinikum LeipzigRecruiting
Leipzig, Germany
Praxisgemeinschaft fuer Neurologie, Psychiatrie und Psychotherapie - RegensburgCompleted
Regensburg, Germany
ZNS Siegen GmbHRecruiting
Siegen, Germany
Neuropraxis Munchen Sud - UnterhachingRecruiting
Unterhaching, Germany
Bellaria-Maggiore Hospital-Azienda USL BolognaRecruiting
Bologna, Italy
Casa di Cura Privata del Policlinico Igea S.p.ARecruiting
Milan, Italy
Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia II - Centro Sclerosi MulRecruiting
Naples, Italy
Ospedale Sant'Andrea HospitalRecruiting
Rome, Italy
Hospital of Lithuanian University of Health Sciences KaunasRecruiting
Kaunas, Lithuania
Klaipedas University HospitalRecruiting
Klaipėda, Lithuania
Vitamed Galaj i Cichomski sp.j.Recruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
MA-LEK Clinical Sp. z o.o.Recruiting
Katowice, Silesian Voivodeship, Poland
Neuro-CareRecruiting
Katowice, Silesian Voivodeship, Poland
Neurocentrum BydgoszczRecruiting
Bydgoszcz, Poland
Neuro Medic ClinicRecruiting
Katowice, Poland
Resmedica Sp. z o.o.Recruiting
Kielce, Poland
Krakowska Akademia NeurologiiRecruiting
Krakow, Poland
Centrum Neurologii Krzysztof SelmajRecruiting
Lodz, Poland
NZOZ Neuromed M. i M. Nastaj Sp.PRecruiting
Lublin, Poland
Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska LekarzyRecruiting
Poznan, Poland
Centrum Medyczne NeuroprotectRecruiting
Warsaw, Poland
MTZ Clinical Research Powered by PratiaRecruiting
Warsaw, Poland
ARENSIA ClinicsRecruiting
Bucharest, Romania
ARENSIA Exploratory Medicine at County Hospital Cluj-NapocaRecruiting
Cluj-Napoca, Romania
Clinical Hospital Center ZvezdaraRecruiting
Belgrade, Serbia
University Clinical Centre of KragujevacRecruiting
Kragujevac, Serbia
Clinic of Neurology, University Clinical Center NisRecruiting
Niš, Serbia
Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB)Recruiting
Bratislava, Slovakia
Neurologicka ambulancia Empathy, s.r.o.Recruiting
Bratislava, Slovakia
Fakultna Nemocnica TrnavaRecruiting
Trnava, Slovakia
University Medical Centre Ljubljana-UKCLRecruiting
Ljubljana, Slovenia
Hospital Universitario Fundacion AlcorconRecruiting
Alcorcón, Spain
Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)Recruiting
Barcelona, Spain
Hospital Vithas Nisa SevillaRecruiting
Castilleja de la Cuesta, Spain
Hospital de Denia Marina SaludRecruiting
Dénia, Spain
Hospital General Universitario Gregorio Maranon (HGUGM)Recruiting
Madrid, Spain
Vithas Hospital Parque San AntonioRecruiting
Malag, Spain
Hospital Regional Universitario de MalagaRecruiting
Málaga, Spain
Hospital Santa CaterinaRecruiting
Salt, Spain
Universidad de Sevilla - Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
Hospital Universitario de TorrejonRecruiting
Torrejón de Ardoz, Spain
Hospital Universitario Doctor PesetRecruiting
Valencia, Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe BulevRecruiting
Valencia, Spain
Hospital Alvaro CunqueiroRecruiting
Vigo, Spain
MS Center Research Unit, Sahlgrenska University HospitalRecruiting
Gothenburg, Sweden
Academic Specialist CenterCompleted
Stockholm, Sweden
Universitaetsspital Bern - InselspitalRecruiting
Bern, Switzerland
Ospedale Regionale di Lugano, Sede CivicoRecruiting
Lugano, Switzerland
Yeditepe University Kosuyolu HospitalRecruiting
Kadıköy, Istanbul, Turkey (Türkiye)
Uludag University Medical FacultyRecruiting
Bursa, Turkey (Türkiye)
Ondokuz Mayis University Health Practice and Research HospitalRecruiting
Samsun, Turkey (Türkiye)
Arencia Exploratory MedicineRecruiting
Kyiv, Ukraine