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
Status: Recruiting
Location: See all (89) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
University of South Alabama
RECRUITING
Mobile
Arizona
Clinical Endpoints, LLC
RECRUITING
Scottsdale
California
Profound Research - Neurology Center of Southern California
RECRUITING
Carlsbad
Colorado
Mountain Neurological Research Center
RECRUITING
Basalt
Advanced Neurosciences Research, Llc
RECRUITING
Fort Collins
Connecticut
Hasbani Neurology
RECRUITING
New Haven
Florida
Neurology Offices of South Florida
RECRUITING
Boca Raton
Aqualane Clinical Research
RECRUITING
Naples
Knight Neurology
RECRUITING
Rockledge
Premiere Research Institute Palm Beach
RECRUITING
West Palm Beach
Hawaii
Hawaii Pacific Neuroscience
RECRUITING
Honolulu
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Michigan
Henry Ford Health
RECRUITING
Detroit
Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington Hills
RECRUITING
Farmington
North Carolina
Triad Neurological Associates
RECRUITING
Winston-salem
New Jersey
Hackensack Meridian Health
RECRUITING
Paramus
New Mexico
University of NM/Mind Imaging center
RECRUITING
Albuquerque
Ohio
The Boster Center for Multiple Sclerosis
RECRUITING
Columbus
Neurology Diagnostics, Inc.
RECRUITING
Dayton
South Carolina
Premier Neurology, PC
RECRUITING
Greenville
Tennessee
Hope Neurology
RECRUITING
Knoxville
Vanderbilt University Medical Center (VUMC)
RECRUITING
Nashville
Texas
Lone Star Neurology
RECRUITING
Frisco
Wisconsin
Froedtert & Medical College of Wisconsin - Clinical Cancer Center - Froedtert Hospital - Courage Cli
RECRUITING
Milwaukee
Other Locations
Belgium
MS-Netwerk Limburg - Revalidatie & MS Centrum
RECRUITING
Overpelt
Algemeen Ziekenhuis Delta
RECRUITING
Roeselare
Bulgaria
UMHAT Dr.Georgi Stranski EAD
RECRUITING
Pleven
Diagnostic Consultative Center Convex Ltd
RECRUITING
Sofia
Medical Center Hera EOOD
RECRUITING
Sofia
UMHATEM N.I. Pirogov
RECRUITING
Sofia
Canada
Foothills Medical Centre
RECRUITING
Calgary
The Ottawa Hospital Research Institute
RECRUITING
Ottawa
Croatia
Sestre milosrdnice University Hospital Center
RECRUITING
Zagreb
University Hospital Centre Zagreb
RECRUITING
Zagreb
Denmark
Aarhus Universitetshospital, Skejby
RECRUITING
Aarhus N
Dansk Multipel Sklerose Center
RECRUITING
Glostrup Municipality
France
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
RECRUITING
Nîmes
Georgia
Jo Ann University Hospital
RECRUITING
Tbilisi
LTD Pineo Medical Ecosystem
RECRUITING
Tbilisi
Germany
Zentrum fur klinische Forschung Dr.Scholl
RECRUITING
Bad Homburg
Studienzentrum fur Neurologie und Psychiatrie Boblingen
RECRUITING
Böblingen
University Hospital Carl Gustav Carus
RECRUITING
Dresden
Klinische Forschung Hamburg GmbH
RECRUITING
Hamburg
Universitaet Heidelberg
RECRUITING
Heidelberg
Universitaetsklinikum Leipzig
RECRUITING
Leipzig
Praxisgemeinschaft fuer Neurologie, Psychiatrie und Psychotherapie - Regensburg
RECRUITING
Regensburg
Neurologische Praxis Siegen
RECRUITING
Siegen
Neuropraxis Munchen Sud - Unterhaching
RECRUITING
Unterhaching
Italy
Casa di Cura Privata del Policlinico Igea S.p.A
RECRUITING
Milan
Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia II - Centro Sclerosi Mul
RECRUITING
Naples
Ospedale Sant'Andrea Hospital
RECRUITING
Rome
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas
RECRUITING
Kaunas
Klaipedas University Hospital
RECRUITING
Klaipėda
Poland
Neurocentrum Bydgoszcz
RECRUITING
Bydgoszcz
Vitamed Galaj i Cichomski sp.j.
RECRUITING
Bydgoszcz
MA-LEK Clinical Sp. z o.o.
RECRUITING
Katowice
Neuro Medic Clinic
RECRUITING
Katowice
Neuro-Care
RECRUITING
Katowice
Resmedica Sp. z o.o.
RECRUITING
Kielce
Krakowska Akademia Neurologii
RECRUITING
Krakow
Centrum Neurologii Krzysztof Selmaj
RECRUITING
Lodz
NZOZ Neuromed M. i M. Nastaj Sp.P
RECRUITING
Lublin
Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy
RECRUITING
Poznan
Centrum Medyczne Neuroprotect
RECRUITING
Warsaw
MTZ Clinical Research Powered by Pratia
RECRUITING
Warsaw
Serbia
Clinical Hospital Center Zvezdara
RECRUITING
Belgrade
University Clinical Centre of Kragujevac
RECRUITING
Kragujevac
Clinic of Neurology, University Clinical Center Nis
RECRUITING
Niš
Slovakia
Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB)
RECRUITING
Bratislava
Neurologicka ambulancia Empathy, s.r.o.
RECRUITING
Bratislava
Fakultna Nemocnica Trnava
RECRUITING
Trnava
Spain
Hospital Universitario Fundacion Alcorcon
RECRUITING
Alcorcón
Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)
RECRUITING
Barcelona
Hospital Vithas Nisa Sevilla
RECRUITING
Castilleja De La Cuesta
Hospital de Denia Marina Salud
RECRUITING
Dã©nia
Vithas Hospital Parque San Antonio
RECRUITING
Malag
Hospital Regional Universitario de Malaga
RECRUITING
Málaga
Hospital Santa Caterina
RECRUITING
Salt
Universidad de Sevilla - Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitario Doctor Peset
RECRUITING
Valencia
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
RECRUITING
Valencia
Hospital Alvaro Cunqueiro
RECRUITING
Vigo
Sweden
MS Center Research Unit, Sahlgrenska University Hospital
RECRUITING
Gothenburg
Academic Specialist Center
COMPLETED
Stockholm
Switzerland
Universitaetsspital Bern - Inselspital
RECRUITING
Bern
Ospedale Regionale di Lugano, Sede Civico
RECRUITING
Lugano
Turkey
Uludag University Medical Faculty
RECRUITING
Bursa
Yeditepe University Kosuyolu Hospital
RECRUITING
Kadıköy
Ondokuz Mayis University Health Practice and Research Hospital
RECRUITING
Samsun
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2025-01-13
Estimated Completion Date: 2027-12-17
Participants
Target number of participants: 444
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Amgen