Multiple Sclerosis Clinical Trial
Study of Evobrutinib in Participants With RMS (evolutionRMS 1)
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 50 Locations for this study
Mobile Alabama, 36693, United States
Phoenix Arizona, 85013, United States
Phoenix Arizona, 85018, United States
Long Beach California, 90806, United States
Pasadena California, 91105, United States
San Diego California, 92121, United States
Stamford Connecticut, 06905, United States
Washington District of Columbia, 20007, United States
Boca Raton Florida, 33428, United States
Maitland Florida, 32751, United States
Miami Florida, 33136, United States
Ormond Beach Florida, 32174, United States
Saint Petersburg Florida, 33713, United States
Tallahassee Florida, 32308, United States
Elk Grove Village Illinois, 60007, United States
Northbrook Illinois, 60062, United States
Peoria Illinois, 61637, United States
Rolling Meadows Illinois, 60008, United States
Indianapolis Indiana, 46256, United States
Kansas City Kansas, 66160, United States
New Orleans Louisiana, 70115, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02114, United States
Foxboro Massachusetts, 02035, United States
Lawrence Massachusetts, 01843, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48201, United States
Farmington Hills Michigan, 48334, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63131, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89106, United States
Audubon New Jersey, 08106, United States
Patchogue New York, 11772, United States
Akron Ohio, 44320, United States
Toledo Ohio, 43614, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73104, United States
Springfield Oregon, 97477, United States
Willow Grove Pennsylvania, 19090, United States
Knoxville Tennessee, 37922, United States
Nashville Tennessee, 37205, United States
Nashville Tennessee, 37215, United States
Dallas Texas, 75214, United States
Houston Texas, 77030, United States
Lubbock Texas, 79410, United States
Round Rock Texas, 78681, United States
Layton Utah, 84041, United States
Alexandria Virginia, 22310, United States
Virginia Beach Virginia, 23456, United States
Milwaukee Wisconsin, 53226, United States
Ciudad Autonoma Buenos Aires , , Argentina
Ciudad Autonoma Buenos Aires , , Argentina
Ciudad Autonoma Buenos Aires , , Argentina
Ciudad Autonoma Buenos Aires , , Argentina
Ciudad Autonoma de Buenos Aires , , Argentina
Ciudad Autonoma de Buenos Aires , , Argentina
Ciudad Autonoma de Buenos Aires , , Argentina
Cordoba , , Argentina
Godoy Cruz , , Argentina
Guaymallen , , Argentina
Rosario , , Argentina
Rosario , , Argentina
Salta , , Argentina
San Juan , , Argentina
San Miguel de Tucuman , , Argentina
Auchenflower , , Australia
Concord , , Australia
Hobart , , Australia
Liverpool , , Australia
New Lambton Heights , , Australia
St Leonards , , Australia
Innsbruck , , Austria
Linz , , Austria
Salzburg , , Austria
Vienna , , Austria
Bruxelles , , Belgium
Bruxelles , , Belgium
Kortrijk , , Belgium
La Louvière , , Belgium
Liège , , Belgium
Overpelt , , Belgium
Roeselare , , Belgium
Bihac , , Bosnia and Herzegovina
Mostar , , Bosnia and Herzegovina
Sarajevo , , Bosnia and Herzegovina
Pleven , , Bulgaria
Pleven , , Bulgaria
Plovdiv , , Bulgaria
Plovdiv , , Bulgaria
Sofia , , Bulgaria
Sofia , , Bulgaria
Sofia , , Bulgaria
Sofia , , Bulgaria
Sofia , , Bulgaria
Sofia , , Bulgaria
Greenfield Park , , Canada
Levis , , Canada
Moncton , , Canada
Montreal , , Canada
Toronto , , Canada
Barranquilla , , Colombia
Barranquilla , , Colombia
Medellin , , Colombia
Medellin , , Colombia
Osijek , , Croatia
Rijeka , , Croatia
Varazdin , , Croatia
Zagreb , , Croatia
Zagreb , , Croatia
Brno , , Czechia
Brno , , Czechia
Hradec Kralove , , Czechia
Hradec Kralove , , Czechia
Jihlava , , Czechia
Ostrava , , Czechia
Pardubice , , Czechia
Plzen-Bory , , Czechia
Praha 10 , , Czechia
Praha 2 , , Czechia
Praha 4 - Krc , , Czechia
Praha 5 , , Czechia
Tallinn , , Estonia
Tartu , , Estonia
Turku , , Finland
Bron cedex , , France
Caen cedex 9 , , France
Grenoble cedex 09 , , France
Lille cedex , , France
Lille , , France
Montpellier , , France
Nantes cedex 1 , , France
Nice Cedex 1 , , France
Rennes cedex 09 , , France
Rouen Cedex , , France
Toulouse cedex 9 , , France
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Bamberg , , Germany
Bayreuth , , Germany
Berlin , , Germany
Bochum , , Germany
Bonn , , Germany
Erbach , , Germany
Essen , , Germany
Frankfurt , , Germany
Hannover , , Germany
Mannheim , , Germany
Muenchen , , Germany
Muenster , , Germany
Potsdam , , Germany
Siegen , , Germany
Ulm , , Germany
Hong Kong , , Hong Kong
Hongkong , , Hong Kong
Shatin , , Hong Kong
Budapest , , Hungary
Budapest , , Hungary
Budapest , , Hungary
Budapest , , Hungary
Budapest , , Hungary
Kistarcsa , , Hungary
Pecs , , Hungary
Tatabanya , , Hungary
Vac , , Hungary
Hyderabad , , India
Nashik , , India
New Delhi , , India
Ashkelon , , Israel
Jerusalem , , Israel
Petah Tikva , , Israel
Ramat Gan , , Israel
Rechovot , , Israel
Safed , , Israel
Bologna , , Italy
Chieti , , Italy
Genova , , Italy
Messina , , Italy
Milano , , Italy
Montichiari , , Italy
Napoli , , Italy
Napoli , , Italy
Reggio Calabria , , Italy
Roma , , Italy
Salerno , , Italy
Verona , , Italy
Goyang-si , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Aguascalientes , , Mexico
Culiacan , , Mexico
Hoorn , , Netherlands
Nieuwegein , , Netherlands
Rotterdam , , Netherlands
Sittard-Geleen , , Netherlands
Bydgoszcz , , Poland
Gdansk , , Poland
Katowice , , Poland
Knurow , , Poland
Lodz , , Poland
Lublin , , Poland
Oswiecim , , Poland
Rzeszów , , Poland
Warszawa , , Poland
Warszawa , , Poland
Barnaul , , Russian Federation
Ekaterinburg , , Russian Federation
Kaluga , , Russian Federation
Kazan , , Russian Federation
Kirov , , Russian Federation
Krasnoyarsk , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Nizhniy Novgorod , , Russian Federation
Perm , , Russian Federation
Pyatigorsk , , Russian Federation
Saint-Petersburg , , Russian Federation
Saratov , , Russian Federation
Smolensk , , Russian Federation
St.Petersburg , , Russian Federation
Tomsk , , Russian Federation
Ufa , , Russian Federation
Ulyanovsk , , Russian Federation
Yaroslavl , , Russian Federation
Belgrade , , Serbia
Belgrade , , Serbia
Belgrade , , Serbia
Kragujevac , , Serbia
Nis , , Serbia
Novi Sad , , Serbia
Uzice , , Serbia
Valjevo , , Serbia
Barcelona , , Spain
Barcelona , , Spain
Cadiz , , Spain
Lleida , , Spain
Madrid , , Spain
Madrid , , Spain
Madrid , , Spain
Pozuelo de Alarcon , , Spain
Salt , , Spain
San Sebastian , , Spain
Sevilla , , Spain
Kaohsiung , , Taiwan
Taichung , , Taiwan
Taipei , , Taiwan
Taipei , , Taiwan
Chernivtsi , , Ukraine
Kharkiv , , Ukraine
Kharkiv , , Ukraine
Kharkiv , , Ukraine
Kharkiv , , Ukraine
Kharkiv , , Ukraine
Kharkiv , , Ukraine
Kropyvnytskyi , , Ukraine
Kyiv , , Ukraine
Lviv , , Ukraine
Odesa , , Ukraine
Poltava , , Ukraine
Sumy , , Ukraine
Vinnytsia , , Ukraine
Zaporizhzhia , , Ukraine
Zaporizhzhia , , Ukraine
Exeter , , United Kingdom
Glasgow , , United Kingdom
Newcastle , , United Kingdom
Swansea , , United Kingdom
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