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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-512914-16 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Ocrelizumab (US)/ABP 692 | Experimental | 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 (EU) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab (US) | Drug | IV infusion |
| |
| Ocrelizumab (EU) |
| Measure | Description | 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36617 | United States | ||
| Clinical Endpoints, LLC |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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.
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.
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| Drug |
IV infusion |
|
| ABP 692 | Drug | IV infusion |
|
| 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 |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Profound Research - Neurology Center of Southern California | Carlsbad | California | 92011 | United States |
| Mountain Neurological Research Center | Basalt | Colorado | 81621 | United States |
| Advanced Neurosciences Research, Llc | Fort Collins | Colorado | 80528 | United States |
| Hasbani Neurology | New Haven | Connecticut | 06511 | United States |
| Neurology Offices of South Florida | Boca Raton | Florida | 33428 | United States |
| Aqualane Clinical Research | Naples | Florida | 34105 | United States |
| Emerald Coast Neurology/Synergy Clinical Research | Pensacola | Florida | 32504 | United States |
| Knight Neurology | Rockledge | Florida | 32955 | United States |
| Premiere Research Institute Palm Beach | West Palm Beach | Florida | 33407 | United States |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | United States |
| Rush University Medical Center, Rush University Cancer Center | Chicago | Illinois | 60612-3841 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Henry Ford Health | Detroit | Michigan | 48202 | United States |
| Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington Hills | Farmington | Michigan | 48334-2979 | United States |
| JFK Medical Center | Edison | New Jersey | 08820 | United States |
| Hackensack Meridian Health | Paramus | New Jersey | 07652 | United States |
| University of NM/Mind Imaging center | Albuquerque | New Mexico | 87131 | United States |
| Triad Neurological Associates | Winston-Salem | North Carolina | 27103 | United States |
| Singlepoint Healthcare Opco, LLC | Columbus | Ohio | 43235 | United States |
| NDx Clinical Research, Inc | Dayton | Ohio | 45459 | United States |
| Premier Neurology, PC | Greenville | South Carolina | 29650 | United States |
| Hope Neurology | Knoxville | Tennessee | 37922 | United States |
| Vanderbilt University Medical Center (VUMC) | Nashville | Tennessee | 37215 | United States |
| Lone Star Neurology | Frisco | Texas | 75035 | United States |
| Froedtert Hospital-Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Algemeen Ziekenhuis Delta | Roeselare | West-Vlaanderen | 8800 | Belgium |
| MS-Netwerk Limburg - Revalidatie & MS Centrum | Overpelt | 3900 | Belgium |
| Diagnostic Consultative Center Convex Ltd | Sofia | Sofiiska | 1680 | Bulgaria |
| UMHAT Dr.Georgi Stranski EAD | Pleven | 5800 | Bulgaria |
| University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski | Sofia | 1431 | Bulgaria |
| Medical Center Hera EOOD | Sofia | 1510 | Bulgaria |
| UMHATEM N.I. Pirogov | Sofia | 1606 | Bulgaria |
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada |
| The Ottawa Hospital Research Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| Sestre milosrdnice University Hospital Center | Zagreb | 10000 | Croatia |
| University Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
| Fakultni nemocnice u sv. Anny v Brne | Brno | 656 91 | Czechia |
| Fakultni Nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Privatni ordinace neurologie | Hradec Králové | 50003 | Czechia |
| Regional Hospital Jihlava | Jihlava | 58601 | Czechia |
| Nemocnice Teplice | Teplice | 415 01 | Czechia |
| Aarhus Universitetshospital, Skejby | Aarhus N | Central Jutland | 8200 | Denmark |
| Sydvestjysk Sygehus | Esbjerg | Region Syddanmark | 6700 | Denmark |
| Dansk Multipel Sklerose Center | Glostrup Municipality | 2600 | Denmark |
| Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau | Nîmes | 30029 | France |
| LTD Pineo Medical Ecosystem | Tbilisi | 0114 | Georgia |
| Jo Ann University Hospital | Tbilisi | 0159 | Georgia |
| Zentrum fur klinische Forschung Dr.Scholl | Bad Homburg | 61348 | Germany |
| Studienzentrum Dr. Bischof GmbH | Böblingen | 71034 | Germany |
| University Hospital Carl Gustav Carus | Dresden | 01307 | Germany |
| Curiositas-ad-Sanum GmbH | Ebersberg | 85560 | Germany |
| Universitaetsklinikum Essen | Essen | 45147 | Germany |
| Klinische Forschung Hamburg GmbH | Hamburg | 20253 | Germany |
| Multipel Studies Institut fuer klinische Studien GbR | Hamburg | 22179 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitaetsklinikum Leipzig | Leipzig | 04103 | Germany |
| Praxisgemeinschaft fuer Neurologie, Psychiatrie und Psychotherapie - Regensburg | Regensburg | 93059 | Germany |
| ZNS Siegen GmbH | Siegen | 57076 | Germany |
| Neuropraxis Munchen Sud - Unterhaching | Unterhaching | 82008 | Germany |
| Bellaria-Maggiore Hospital-Azienda USL Bologna | Bologna | 40139 | Italy |
| Casa di Cura Privata del Policlinico Igea S.p.A | Milan | 20144 | Italy |
| Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia II - Centro Sclerosi Mul | Naples | 80138 | Italy |
| Ospedale Sant'Andrea Hospital | Rome | 00189 | Italy |
| Hospital of Lithuanian University of Health Sciences Kaunas | Kaunas | 50161 | Lithuania |
| Klaipedas University Hospital | Klaipėda | LT-92288 | Lithuania |
| Vitamed Galaj i Cichomski sp.j. | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-079 | Poland |
| MA-LEK Clinical Sp. z o.o. | Katowice | Silesian Voivodeship | 40-571 | Poland |
| Neuro-Care | Katowice | Silesian Voivodeship | 40-749 | Poland |
| Neurocentrum Bydgoszcz | Bydgoszcz | 85-796 | Poland |
| Neuro Medic Clinic | Katowice | 40-686 | Poland |
| Resmedica Sp. z o.o. | Kielce | 25-726 | Poland |
| Krakowska Akademia Neurologii | Krakow | 31-505 | Poland |
| Centrum Neurologii Krzysztof Selmaj | Lodz | 90-324 | Poland |
| NZOZ Neuromed M. i M. Nastaj Sp.P | Lublin | 20-064 | Poland |
| Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy | Poznan | 61-853 | Poland |
| Centrum Medyczne Neuroprotect | Warsaw | 01-684 | Poland |
| MTZ Clinical Research Powered by Pratia | Warsaw | 02-172 | Poland |
| ARENSIA Clinics | Bucharest | 011658 | Romania |
| ARENSIA Exploratory Medicine at County Hospital Cluj-Napoca | Cluj-Napoca | 400006 | Romania |
| Clinical Hospital Center Zvezdara | Belgrade | 11000 | Serbia |
| University Clinical Centre of Kragujevac | Kragujevac | 34000 | Serbia |
| Clinic of Neurology, University Clinical Center Nis | Niš | 18000 | Serbia |
| Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB) | Bratislava | 82626 | Slovakia |
| Neurologicka ambulancia Empathy, s.r.o. | Bratislava | 85101 | Slovakia |
| Fakultna Nemocnica Trnava | Trnava | 91775 | Slovakia |
| University Medical Centre Ljubljana-UKCL | Ljubljana | 1110 | Slovenia |
| Hospital Universitario Fundacion Alcorcon | Alcorcón | 28922 | Spain |
| Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO) | Barcelona | 08036 | Spain |
| Hospital Vithas Nisa Sevilla | Castilleja de la Cuesta | 41950 | Spain |
| Hospital de Denia Marina Salud | Dénia | 03700 | Spain |
| Hospital General Universitario Gregorio Maranon (HGUGM) | Madrid | 28007 | Spain |
| Vithas Hospital Parque San Antonio | Malag | 29016 | Spain |
| Hospital Regional Universitario de Malaga | Málaga | 29010 | Spain |
| Hospital Santa Caterina | Salt | 17190 | Spain |
| Universidad de Sevilla - Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario de Torrejon | Torrejón de Ardoz | 28850 | Spain |
| Hospital Universitario Doctor Peset | Valencia | 46017 | Spain |
| Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev | Valencia | 46026 | Spain |
| Hospital Alvaro Cunqueiro | Vigo | 36312 | Spain |
| MS Center Research Unit, Sahlgrenska University Hospital | Gothenburg | 413 45 | Sweden |
| Academic Specialist Center | Stockholm | SE113 65 | Sweden |
| Universitaetsspital Bern - Inselspital | Bern | 3010 | Switzerland |
| Ospedale Regionale di Lugano, Sede Civico | Lugano | 6903 | Switzerland |
| Yeditepe University Kosuyolu Hospital | Kadıköy | Istanbul | 34718 | Turkey (Türkiye) |
| Uludag University Medical Faculty | Bursa | 16059 | Turkey (Türkiye) |
| Ondokuz Mayis University Health Practice and Research Hospital | Samsun | 55280 | Turkey (Türkiye) |
| Arencia Exploratory Medicine | Kyiv | 01135 | Ukraine |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C533411 | ocrelizumab |
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