Multiple Sclerosis Clinical Trial
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Summary
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.
Eligibility Criteria
Inclusion Criteria:
Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.
A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.
Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in < 240 seconds.
Ability to perform the Timed 25-Foot Walk Test (T25FWT) in <150 seconds.
For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs.
For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.
Exclusion Criteria:
Disease duration of > 10 years from the onset of symptoms and an EDSS score at screening < 2.0.
Female participants who are pregnant or breastfeeding, or intending to become pregnant.
Male participants who intend to father a child during the study.
A diagnosis of primary progressive MS (PPMS) or non-active secondary progressive MS (SPMS).
Any known or suspected active infection at screening, including but not limited to a positive screening test for Hepatitis B and C, an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML).
History of cancer including hematologic malignancy and solid tumors within 10 years of screening.
Known presence of other neurological disorders, that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study and clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease.
Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
Hypoproteinemia.
Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's Syndrome.
Participants with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia.
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
History of alcohol or other drug abuse within 12 months prior to screening.
History of or currently active primary or secondary (non-drug-related) immunodeficiency, including known history of human immunodeficiency virus (HIV) infection.
Inability to complete an MRI scan.
Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening (inhaled and topical corticosteroids are allowed).
Receipt of a live-attenuated vaccine within 6 weeks prior to randomization.
Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.
OLE Inclusion Criteria:
Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib.
Participants randomized to the teriflunomide treatment arm during the DBT phase must undergo the accelerated teriflunomide elimination procedure (ATEP) prior to the first administration of open-label fenebrutinib.
For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs.
For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.
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There are 186 Locations for this study
Birmingham Alabama, 35233, United States
Homewood Alabama, 35209, United States
Phoenix Arizona, 85032, United States
Tucson Arizona, 85718, United States
Carlsbad California, 92011, United States
Irvine California, 92697, United States
Pasadena California, 91105, United States
Aurora Colorado, 80045, United States
Basalt Colorado, 81621, United States
Denver Colorado, 80209, United States
Fort Collins Colorado, 80528, United States
Maitland Florida, 32751, United States
Miami Florida, 33144, United States
Tampa Florida, 33609, United States
Highland Park Illinois, 60035, United States
Fort Wayne Indiana, 46805, United States
Baton Rouge Louisiana, 70810, United States
Shreveport Louisiana, 71103, United States
Baltimore Maryland, 21287, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48202, United States
Saint Louis Missouri, 63110, United States
Newark New Jersey, 07103, United States
Teaneck New Jersey, 07666, United States
Albuquerque New Mexico, 87131, United States
Canton New York, 13617, United States
Centerville Ohio, 45459, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43235, United States
Westerville Ohio, 43082, United States
Oklahoma City Oklahoma, 73104, United States
Bethlehem Pennsylvania, 18015, United States
Greenville South Carolina, 29605, United States
Cordova Tennessee, 38018, United States
Knoxville Tennessee, 37920, United States
Plano Texas, 75024, United States
Sherman Texas, 75092, United States
Christiansburg Virginia, 24073, United States
Vienna Virginia, 22182, United States
Kirkland Washington, 98034, United States
Tacoma Washington, 98405, United States
Milwaukee Wisconsin, 53215, United States
Buenos Aires , C1122, Argentina
Buenos Aires , C1424, Argentina
Ciudad Autonoma Buenos Aires , C1405, Argentina
Ciudad Autonoma de Buenos Aires , C1012, Argentina
Rosario , S2000, Argentina
San Juan , J5400, Argentina
San Miguel , T4000, Argentina
Beijing City , 10003, China
Beijing City , 10005, China
Changchun , 13002, China
Changsha City , 41000, China
Chengdu , 61004, China
Chongqing , 40001, China
Guangzhou City , 51008, China
Guangzhou City , 51026, China
Guiyang , , China
Hohhot City , 01000, China
Kunming City , 65002, China
Lanzhou , 73003, China
Nanjing City , 21000, China
Shanghai , 20012, China
Shijiazhuang , 05000, China
Suzhou City , 21503, China
Taiyuan City , 03000, China
Tianjin , 30005, China
Wuhan City , 43003, China
Xi'an City , 71003, China
Santiago de los Caballeros , 51000, Dominican Republic
Santo Domingo , 10210, Dominican Republic
Helsinki , 00290, Finland
Oulu , 90100, Finland
Tbilisi , 0114, Georgia
Tbilisi , 0114, Georgia
Tbilisi , 0159, Georgia
Tbilisi , 0160, Georgia
Tbilisi , 0179, Georgia
Berlin , 13347, Germany
Böblingen , 71034, Germany
Dresden , 01307, Germany
Gießen , 35392, Germany
Kiel , 24105, Germany
Münster , 48149, Germany
Sande , 26452, Germany
Stuttgart , 70174, Germany
Tübingen , 72076, Germany
Ulm , 89081, Germany
Westerstede , 26655, Germany
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Shatin, New Territories , , Hong Kong
Budapest , 1033, Hungary
Budapest , 1138, Hungary
Eger , 3300, Hungary
Kistarcsa , 2143, Hungary
Szeged , 6725, Hungary
L'Aquila Abruzzo, 67100, Italy
Napoli Campania, 80131, Italy
Napoli Campania, 80138, Italy
Parma Emilia-Romagna, 43126, Italy
Roma Lazio, 00133, Italy
Roma Lazio, 00185, Italy
Roma Lazio, 00189, Italy
Bergamo Lombardia, 24127, Italy
Gallarate Lombardia, 21013, Italy
Milano Lombardia, 20132, Italy
Torrette - Ancona Marche, 60100, Italy
Mondovì (CN) Piemonte, 12084, Italy
Foggia Puglia, 71100, Italy
Catania Sicilia, 95123, Italy
Firenze Toscana, 50134, Italy
Siena Toscana, 53100, Italy
Padova Veneto, 35128, Italy
Nairobi , 00100, Kenya
Saltillo Coahuila, 25050, Mexico
Cdmx Mexico CITY (federal District), 03100, Mexico
Mexico City Mexico CITY (federal District), 03100, Mexico
Culiacán Sinaloa, 80020, Mexico
Mexico Tlaxcala, 06726, Mexico
FES , 30000, Morocco
Marrakech , 40080, Morocco
Oujda , , Morocco
Rabat , 10100, Morocco
Rabat , 10100, Morocco
Sittard-Geleen , 6162 , Netherlands
Skopje , 1000, North Macedonia
Skopje , 1000, North Macedonia
Stip , 2000, North Macedonia
Bellavista , Calla, Peru
La Victoria, Lima , Lima , Peru
Lima , 15003, Peru
LIma , Lima , Peru
Lima , Lima , Peru
Miraflores , 15046, Peru
Pueblo Libre , Lima , Peru
?ory , 44-24, Poland
Bydgoszcz , 85-79, Poland
Bydgoszcz , 85-79, Poland
Katowice , 40-56, Poland
Krosno , 38-40, Poland
Lodz , 90-32, Poland
Lublin , 20-49, Poland
Opole , 45-22, Poland
Plewiska , 62-06, Poland
Pozna? , 61-73, Poland
Poznan , 60-69, Poland
Szczecin , 71-25, Poland
Warszawa , 02-95, Poland
Zabrze , 41-80, Poland
Braga , 4710-, Portugal
Coimbra , 3000-, Portugal
Lisboa , 1169-, Portugal
Lisboa , 1500-, Portugal
Lisboa , 1649-, Portugal
Loures , 2674-, Portugal
Porto , 4099-, Portugal
Porto , 4200-, Portugal
Santa Maria Da Feira , 4520-, Portugal
Barnaul Altaj, 65602, Russian Federation
UFA Baskortostan, 45000, Russian Federation
Sankt-petersburg Sankt Petersburg, 19737, Russian Federation
St Petersburg Sankt Petersburg, 19429, Russian Federation
St Petersburg Sankt Petersburg, 19702, Russian Federation
Yekaterinburg Sverdlovsk, 62010, Russian Federation
Ulyanovsk Uljanovsk, 43206, Russian Federation
Kirov , 61000, Russian Federation
Novosibirsk , 63000, Russian Federation
Belgrade , 11000, Serbia
L'Hospitalet de Llobregat Barcelona, 08907, Spain
Pozuelo de Alarcon Madrid, 28223, Spain
EL Palmar (EL Palmar) Murcia, 30120, Spain
Vigo Pontevedra, , Spain
Barcelona , 08035, Spain
Madrid , 28006, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Malaga , 29010, Spain
Sevilla , 41009, Spain
Bern , 3010, Switzerland
Lugano , 6903, Switzerland
North Dist. , 40447, Taiwan
Taipei , 100, Taiwan
Taoyuan , 333, Taiwan
Mannouba , 2010, Tunisia
Monastir , 5000, Tunisia
Sfax , 3029, Tunisia
Kyiv Chernihiv Governorate, 02123, Ukraine
Lviv Chernihiv Governorate, 79007, Ukraine
Zaporizhzhia Katerynoslav Governorate, 69600, Ukraine
Zaporizhzhye Katerynoslav Governorate, 69063, Ukraine
Dnipro Kharkiv Governorate, 49038, Ukraine
Dnipro KIEV Governorate, 49027, Ukraine
Kyiv KIEV Governorate, 03037, Ukraine
Vinnytsia KIEV Governorate, 21050, Ukraine
Vinnytsia Podolia Governorate, 21009, Ukraine
Kharkov , 61068, Ukraine
Lviv , 79010, Ukraine
Odesa , 65117, Ukraine
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