Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
444 participants
INTERVENTIONAL
2025-01-13
2027-12-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
ABP 692
IV infusion
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.
Ocrelizumab (US)
IV infusion
ABP 692
IV infusion
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.
Ocrelizumab (EU)
IV infusion
Interventions
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Ocrelizumab (US)
IV infusion
Ocrelizumab (EU)
IV infusion
ABP 692
IV infusion
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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University of South Alabama
Mobile, Alabama, United States
Clinical Endpoints, LLC
Scottsdale, Arizona, United States
Profound Research - Neurology Center of Southern California
Carlsbad, California, United States
Mountain Neurological Research Center
Basalt, Colorado, United States
Advanced Neurosciences Research, Llc
Fort Collins, Colorado, United States
Hasbani Neurology
New Haven, Connecticut, United States
Neurology Offices of South Florida
Boca Raton, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Knight Neurology
Rockledge, Florida, United States
Premiere Research Institute Palm Beach
West Palm Beach, Florida, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Henry Ford Health
Detroit, Michigan, United States
Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington Hills
Farmington, Michigan, United States
Hackensack Meridian Health
Paramus, New Jersey, United States
University of NM/Mind Imaging center
Albuquerque, New Mexico, United States
Triad Neurological Associates
Winston-Salem, North Carolina, United States
The Boster Center for Multiple Sclerosis
Columbus, Ohio, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, United States
Premier Neurology, PC
Greenville, South Carolina, United States
Hope Neurology
Knoxville, Tennessee, United States
Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, United States
Lone Star Neurology
Frisco, Texas, United States
Froedtert & Medical College of Wisconsin - Clinical Cancer Center - Froedtert Hospital - Courage Cli
Milwaukee, Wisconsin, United States
Algemeen Ziekenhuis Delta
Roeselare, West-Vlaanderen, Belgium
MS-Netwerk Limburg - Revalidatie & MS Centrum
Overpelt, , Belgium
Diagnostic Consultative Center Convex Ltd
Sofia, Sofiiska, Bulgaria
UMHAT Dr.Georgi Stranski EAD
Pleven, , Bulgaria
Medical Center Hera EOOD
Sofia, , Bulgaria
UMHATEM N.I. Pirogov
Sofia, , Bulgaria
Foothills Medical Centre
Calgary, Alberta, Canada
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Sestre milosrdnice University Hospital Center
Zagreb, , Croatia
University Hospital Centre Zagreb
Zagreb, , Croatia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, , Czechia
Privatni ordinace neurologie
Hradec Králové, , Czechia
Regional Hospital Jihlava
Jihlava, , Czechia
Aarhus Universitetshospital, Skejby
Aarhus N, Central Jutland, Denmark
LTD Pineo Medical Ecosystem
Tbilisi, , Georgia
Jo Ann University Hospital
Tbilisi, , Georgia
Zentrum fur klinische Forschung Dr.Scholl
Bad Homburg, , Germany
Studienzentrum fur Neurologie und Psychiatrie Boblingen
Böblingen, , Germany
University Hospital Carl Gustav Carus
Dresden, , Germany
Klinische Forschung Hamburg GmbH
Hamburg, , Germany
Praxisgemeinschaft fuer Neurologie, Psychiatrie und Psychotherapie - Regensburg
Regensburg, , Germany
Neuropraxis Munchen Sud - Unterhaching
Unterhaching, , Germany
Casa di Cura Privata del Policlinico Igea S.p.A
Milan, , Italy
Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia II - Centro Sclerosi Mul
Naples, , Italy
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, , Lithuania
Klaipedas University Hospital
Klaipėda, , Lithuania
Vitamed Galaj i Cichomski sp.j.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
MA-LEK Clinical Sp. z o.o.
Katowice, Silesian Voivodeship, Poland
Neuro-Care
Katowice, Silesian Voivodeship, Poland
Neurocentrum Bydgoszcz
Bydgoszcz, , Poland
Neuro Medic Clinic
Katowice, , Poland
Resmedica Sp. z o.o.
Kielce, , Poland
Krakowska Akademia Neurologii
Krakow, , Poland
Centrum Neurologii Krzysztof Selmaj
Lodz, , Poland
NZOZ Neuromed M. i M. Nastaj Sp.P
Lublin, , Poland
Centrum Medyczne Neuroprotect
Warsaw, , Poland
MTZ Clinical Research Powered by Pratia
Warsaw, , Poland
Clinical Hospital Center Zvezdara
Belgrade, , Serbia
University Clinical Centre of Kragujevac
Kragujevac, , Serbia
Clinic of Neurology, University Clinical Center Nis
Niš, , Serbia
Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB)
Bratislava, , Slovakia
Neurologicka ambulancia Empathy, s.r.o.
Bratislava, , Slovakia
Hospital Universitario Fundacion Alcorcon
Alcorcón, , Spain
Hospital Vithas Nisa Sevilla
Castilleja de la Cuesta, , Spain
Hospital de Denia Marina Salud
Dénia, , Spain
Vithas Hospital Parque San Antonio
Malag, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Universidad de Sevilla - Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
Valencia, , Spain
Hospital Alvaro Cunqueiro
Vigo, , Spain
MS Center Research Unit, Sahlgrenska University Hospital
Gothenburg, , Sweden
Academic Specialist Center
Stockholm, , Sweden
Universitaetsspital Bern - Inselspital
Bern, , Switzerland
Ospedale Regionale di Lugano, Sede Civico
Lugano, , Switzerland
Yeditepe University Kosuyolu Hospital
Kadıköy, Istanbul, Turkey (Türkiye)
Uludag University Medical Faculty
Bursa, , Turkey (Türkiye)
Ondokuz Mayis University Health Practice and Research Hospital
Samsun, , Turkey (Türkiye)
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2024-512914-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20230309
Identifier Type: -
Identifier Source: org_study_id