Multiple Sclerosis Clinical Trial
Study of Evobrutinib in Participants With RMS (evolutionRMS 2)
Summary
The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants completing the Double-blind Treatment Period prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.
Eligibility Criteria
Inclusion Criteria:
Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018)
Participants with one or more documented relapses within the 2 years before Screening with either: a. one relapse which occurred within the last year prior to randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization
Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening and Baseline (Day 1). Participants with an EDSS score <= 2 at Screening and Baseline (Day 1) are only eligible for participation if their disease duration (time since onset of symptoms) is no more than 10 years
Participants are neurologically stable for >= 30 days prior to both screening and baseline (Day 1)
Female participants must be neither pregnant nor breast-feeding or must lack child-bearing potential (as defined by either: post-menopausal or surgically sterile), or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
Male participants must refrain from donating sperm and/or abstain from intercourse with women of child-bearing potential or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
Participants have given written informed consent prior to any study-related procedure
Other protocol defined inclusion criteria could apply.
Exclusion Criteria:
Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b) Participants with secondary progressive MS without evidence of relapse
Disease duration more than (>) 10 years in participants with an EDSS =< 2.0 at screening and Baseline (Day 1)
Immunologic disorder other than MS, or any other condition requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease
Other protocol defined exclusion criteria could apply.
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There are 37 Locations for this study
Cullman Alabama, 35058, United States
Scottsdale Arizona, 85258, United States
Tucson Arizona, 85710, United States
Hanford California, 93230, United States
West Hollywood California, 90048, United States
Colorado Springs Colorado, 80907, United States
Fort Collins Colorado, 80528, United States
Altamonte Springs Florida, 32714, United States
Jacksonville Florida, 32209, United States
Naples Florida, 34105, United States
Orlando Florida, 32806, United States
Port Charlotte Florida, 33952, United States
Sarasota Florida, 34243, United States
Tampa Florida, 33612, United States
Tampa Florida, 33634, United States
Vero Beach Florida, 32960, United States
Weeki Wachee Florida, 34607, United States
West Palm Beach Florida, 33407, United States
Honolulu Hawaii, 96817, United States
Evanston Illinois, 60201, United States
Fort Wayne Indiana, 46804, United States
Lafayette Indiana, 47904, United States
Overland Park Kansas, 66212, United States
Nicholasville Kentucky, 40356, United States
Scarborough Maine, 04074, United States
Detroit Michigan, 48202, United States
Saint Louis Missouri, 63128, United States
Amherst New York, 14226, United States
Asheville North Carolina, 28006, United States
Chapel Hill North Carolina, 27599, United States
Winston-Salem North Carolina, 27157, United States
Canton Ohio, 44735, United States
Columbus Ohio, 43214, United States
Dayton Ohio, 45459, United States
Philadelphia Pennsylvania, 19107, United States
San Antonio Texas, 78258, United States
Norfolk Virginia, 23502, United States
Gomel , , Belarus
Grodno , , Belarus
Minsk , , Belarus
Vitebsk , , Belarus
Vitebsk , , Belarus
Belo Horizonte , , Brazil
Curitiba , , Brazil
Goiânia , , Brazil
Joinville , , Brazil
Passo Fundo , , Brazil
Porto Alegre , , Brazil
Porto Alegre , , Brazil
Porto Alegre , , Brazil
Vitória , , Brazil
Blagoevgrad , , Bulgaria
Dupnitsa , , Bulgaria
Pleven , , Bulgaria
Pleven , , Bulgaria
Pleven , , Bulgaria
Plovdiv , , Bulgaria
Sofia , , Bulgaria
Sofia , , Bulgaria
Sofia , , Bulgaria
Sofia , , Bulgaria
Sofia , , Bulgaria
Sofia , , Bulgaria
Sofia , , Bulgaria
Sofia , , Bulgaria
Sofia , , Bulgaria
Veliko Tarnovo , , Bulgaria
Burnaby , , Canada
London , , Canada
Montreal , , Canada
Ottawa , , Canada
Bordeaux Cedex , , France
Brest cedex 2 , , France
Clermont Ferrand Cedex , , France
Limoges cedex , , France
Nimes , , France
Paris , , France
Pringy cedex , , France
Strasbourg cedex , , France
Tours cedex 9 , , France
Augsburg , , Germany
Berlin , , Germany
Berlin , , Germany
Bonn , , Germany
Dresden , , Germany
Hamburg , , Germany
Heidelberg , , Germany
Koeln , , Germany
Leipzig , , Germany
Mainz , , Germany
Minden , , Germany
Regensburg , , Germany
Rostock , , Germany
Tuebingen , , Germany
Athens , , Greece
Athens , , Greece
Athens , , Greece
Athens , , Greece
Athens , , Greece
Athens , , Greece
Athens , , Greece
Athens , , Greece
Heraklion , , Greece
Ioannina , , Greece
Larissa , , Greece
Marousi , , Greece
Patras , , Greece
Patra , , Greece
Thessaloniki , , Greece
Ahmedabad , , India
Bangalore , , India
Mangalore , , India
New Delhi , , India
Bari , , Italy
Catania , , Italy
Cefalù , , Italy
Firenze , , Italy
Milano , , Italy
Napoli , , Italy
Napoli , , Italy
Orbassano , , Italy
Palermo , , Italy
Pozzilli , , Italy
Roma , , Italy
Roma , , Italy
Riga , , Latvia
Riga , , Latvia
Riga , , Latvia
Kaunas , , Lithuania
Klaipeda , , Lithuania
Siauliai , , Lithuania
Vilnius , , Lithuania
Kuala Lumpur , , Malaysia
Kuala Lumpur , , Malaysia
Kuala Lumpur , , Malaysia
Kuching , , Malaysia
Seberang Jaya , , Malaysia
Chisinau , , Moldova, Republic of
Chisinau , , Moldova, Republic of
Bergen , , Norway
Drammen , , Norway
Namsos , , Norway
Baguio City , , Philippines
Cebu City , , Philippines
Bydgoszcz , , Poland
Bydgoszcz , , Poland
Katowice-Ochojec , , Poland
Katowice , , Poland
Katowice , , Poland
Krakow , , Poland
Lodz , , Poland
Nowa Sol , , Poland
Poznan , , Poland
Rzeszow , , Poland
Siemianowice , , Poland
Szczecin , , Poland
Warszawa , , Poland
Warszawa , , Poland
Warszawa , , Poland
Zabrze , , Poland
Zamosc , , Poland
Łódź , , Poland
Aveiro , , Portugal
Braga , , Portugal
Coimbra , , Portugal
Lisboa , , Portugal
Lisboa , , Portugal
Lisboa , , Portugal
Matosinhos , , Portugal
Porto , , Portugal
Pragal , , Portugal
Santa Maria da Feira , , Portugal
Torres Vedras , , Portugal
Guaynabo , , Puerto Rico
Brasov , , Romania
București , , Romania
Caracal , , Romania
Targu Mures , , Romania
Kazan , , Russian Federation
Kazan , , Russian Federation
Kemerovo , , Russian Federation
Kirov , , Russian Federation
Krasnodar , , Russian Federation
Krasnoyarsk , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Nizhniy Novgorod , , Russian Federation
Novosibirsk , , Russian Federation
Novosibirsk , , Russian Federation
Novosibirsk , , Russian Federation
Novosibirsk , , Russian Federation
Rostov-on-Don , , Russian Federation
Saint Petersburg , , Russian Federation
Saint-Petersburg , , Russian Federation
Saint-Petersburg , , Russian Federation
Saint-Petersburg , , Russian Federation
Saint-Petersburg , , Russian Federation
Saransk , , Russian Federation
Sestroretsk , , Russian Federation
Tyumen , , Russian Federation
Riyadh , , Saudi Arabia
Singapore , , Singapore
Singapore , , Singapore
Banska Bystrica , , Slovakia
Bratislava , , Slovakia
Bratislava , , Slovakia
Bratislava , , Slovakia
Bratislava , , Slovakia
Dubnica nad Vahom , , Slovakia
Trencin , , Slovakia
Trnava , , Slovakia
Celje , , Slovenia
Ljubljana , , Slovenia
Maribor , , Slovenia
Cape Town , , South Africa
Cape Town , , South Africa
Cape Town , , South Africa
Pretoria , , South Africa
Alcorcon , , Spain
Barakaldo , , Spain
Barcelona , , Spain
Cordoba , , Spain
El Palmar , , Spain
Madrid , , Spain
Majadahonda , , Spain
Malaga , , Spain
Sevilla , , Spain
Valencia , , Spain
Valencia , , Spain
Vigo , , Spain
Göteborg , , Sweden
Malmö , , Sweden
Stockholm , , Sweden
Uppsala , , Sweden
Aarau , , Switzerland
Bern , , Switzerland
Lugano , , Switzerland
Bangkoknoi , , Thailand
Muang , , Thailand
Ankara , , Turkey
Ankara , , Turkey
Istanbul , , Turkey
Istanbul , , Turkey
Istanbul , , Turkey
Istanbul , , Turkey
Istanbul , , Turkey
Izmir , , Turkey
Kocaeli , , Turkey
Konya , , Turkey
Mersin , , Turkey
Samsun , , Turkey
Trabzon , , Turkey
Chernihiv , , Ukraine
Chernihiv , , Ukraine
Dnipro , , Ukraine
Dnipro , , Ukraine
Dnipro , , Ukraine
Ivano-Frankivsk , , Ukraine
Kharkiv , , Ukraine
Kharkiv , , Ukraine
Kharkiv , , Ukraine
Kherson , , Ukraine
Kyiv , , Ukraine
Kyiv , , Ukraine
Lutsk , , Ukraine
Lviv , , Ukraine
Poltava , , Ukraine
Rivne , , Ukraine
Ternopil , , Ukraine
Uzhgorod , , Ukraine
Vinnytsia , , Ukraine
Zaporizhzhia , , Ukraine
Zaporizhzhia , , Ukraine
Zaporizhzhia , , Ukraine
Zhytomyr , , Ukraine
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