Phase
Condition
Multiple Sclerosis
Neurologic Disorders
Scar Tissue
Treatment
Teriflunomide
Placebo (match to Teriflunomide)
Evobrutinib
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 beforeScreening with either: a. one relapse which occurred within the last year prior torandomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesionwithin 6 months prior to randomization
Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 atScreening and Baseline (Day 1). Participants with an EDSS score less than or equalto [<=] 2 at Screening and Baseline (Day 1) are only eligible for participation iftheir disease duration (time since onset of symptoms) is no more than 10 years
Participants are neurologically stable for >= 30 days prior to both screening andbaseline (Day 1)
Female participants must be neither pregnant nor breast-feeding or must lackchild-bearing potential (as defined by either: post-menopausal or surgicallysterile), or use an effective method of contraception for the duration of the studyand at least 2 years after study intervention due to the long elimination period forteriflunomide of 2 years, unless the participant undergoes an acceleratedelimination procedure
Male participants must refrain from donating sperm and/or abstain from intercoursewith women of child-bearing potential or use an effective method of contraceptionfor the duration of the study and at least 2 years after study intervention due tothe long elimination period for teriflunomide of 2 years, unless the participantundergoes an accelerated elimination procedure
Participants have given written informed consent prior to any study-relatedprocedure
Other protocol defined inclusion criteria could apply.
Exclusion
Exclusion Criteria:
Participants diagnosed with Progressive MS, in accordance with the 2017 RevisedMcDonald 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 atscreening and Baseline (Day 1)
Immunologic disorder other than MS, or any other condition requiring oral,intravenous (IV), intramuscular, or intra-articular corticosteroid therapy, with theexception of well-controlled Type 2 diabetes mellitus or well controlled thyroiddisease
Other protocol defined exclusion criteria could apply.
Study Design
Connect with a study center
Research Site 144
Gomel,
BelarusSite Not Available
Research Site 143
Grodno,
BelarusSite Not Available
Research Site 142
Minsk,
BelarusSite Not Available
Research Site 141
Vitebsk,
BelarusSite Not Available
Research Site 145
Vitebsk,
BelarusSite Not Available
Research Site 603
Belo Horizonte,
BrazilSite Not Available
Research Site 599
Curitiba,
BrazilSite Not Available
Research Site 604
Goiânia,
BrazilSite Not Available
Research Site 600
Joinville,
BrazilSite Not Available
Research Site 614
Passo Fundo,
BrazilSite Not Available
Research Site 591
Porto Alegre,
BrazilSite Not Available
Research Site 594
Porto Alegre,
BrazilSite Not Available
Research Site 596
Porto Alegre,
BrazilSite Not Available
Research Site 609
Vitória,
BrazilSite Not Available
Research Site 155
Blagoevgrad,
BulgariaSite Not Available
Research Site 156
Dupnitsa,
BulgariaSite Not Available
Research Site 157
Pleven,
BulgariaSite Not Available
Research Site 801
Pleven,
BulgariaSite Not Available
Research Site 804
Pleven,
BulgariaSite Not Available
Research Site 805
Plovdiv,
BulgariaSite Not Available
Research Site 151
Sofia,
BulgariaSite Not Available
Research Site 152
Sofia,
BulgariaSite Not Available
Research Site 153
Sofia,
BulgariaSite Not Available
Research Site 158
Sofia,
BulgariaSite Not Available
Research Site 159
Sofia,
BulgariaSite Not Available
Research Site 160
Sofia,
BulgariaSite Not Available
Research Site 802
Sofia,
BulgariaSite Not Available
Research Site 803
Sofia,
BulgariaSite Not Available
Research Site 808
Sofia,
BulgariaSite Not Available
Research Site 154
Veliko Tarnovo,
BulgariaSite Not Available
Research Site 106
Burnaby,
CanadaSite Not Available
Research Site 107
London,
CanadaSite Not Available
Research Site 105
Montreal,
CanadaSite Not Available
Research Site 101
Ottawa,
CanadaSite Not Available
Research Site 455
Bordeaux Cedex,
FranceSite Not Available
Research Site 459
Brest cedex 2,
FranceSite Not Available
Reserach Site 451
Clermont Ferrand Cedex,
FranceSite Not Available
Research Site 458
Limoges cedex,
FranceSite Not Available
Research Site 456
Nimes,
FranceSite Not Available
Research Site 453
Paris,
FranceSite Not Available
Research Site 457
Pringy cedex,
FranceSite Not Available
Research Site 452
Strasbourg cedex,
FranceSite Not Available
Research Site 454
Tours cedex 9,
FranceSite Not Available
Research Site 172
Augsburg,
GermanySite Not Available
Research Site 177
Berlin,
GermanySite Not Available
Research Site 180
Berlin,
GermanySite Not Available
Research Site 178
Bonn,
GermanySite Not Available
Please Contact the Communication Center
Darmstadt, 64293
GermanySite Not Available
Research Site 184
Dresden,
GermanySite Not Available
Research Site 174
Hamburg,
GermanySite Not Available
Research Site 182
Heidelberg,
GermanySite Not Available
Research Site 179
Koeln,
GermanySite Not Available
Research Site 181
Leipzig,
GermanySite Not Available
Research Site 173
Mainz,
GermanySite Not Available
Research Site 176
Minden,
GermanySite Not Available
Research Site 171
Regensburg,
GermanySite Not Available
Research Site 183
Rostock,
GermanySite Not Available
Research Site 175
Tuebingen,
GermanySite Not Available
Research Site 194
Athens,
GreeceSite Not Available
Research Site 196
Athens,
GreeceSite Not Available
Research Site 197
Athens,
GreeceSite Not Available
Research Site 201
Athens,
GreeceSite Not Available
Research Site 202
Athens,
GreeceSite Not Available
Research Site 205
Athens,
GreeceSite Not Available
Research Site 207
Athens,
GreeceSite Not Available
Reserach Site 206
Athens,
GreeceSite Not Available
Research Site 198
Heraklion,
GreeceSite Not Available
Research Site 204
Ioannina,
GreeceSite Not Available
Research Site 192
Larissa,
GreeceSite Not Available
Research Site 199
Marousi,
GreeceSite Not Available
Research Site 203
Patra,
GreeceSite Not Available
Research Site 191
Patras,
GreeceSite Not Available
Research Site 195
Thessaloniki,
GreeceSite Not Available
Research Site 445
Ahmedabad,
IndiaSite Not Available
Research Site 444
Bangalore,
IndiaSite Not Available
Research Site 443
Mangalore,
IndiaSite Not Available
Research Site 442
New Delhi,
IndiaSite Not Available
Research Site 218
Bari,
ItalySite Not Available
Research Site 216
Catania,
ItalySite Not Available
Research Site 214
Cefalù,
ItalySite Not Available
Research Site 219
Firenze,
ItalySite Not Available
Research Site 221
Milano,
ItalySite Not Available
Research Site 211
Napoli,
ItalySite Not Available
Research Site 215
Napoli,
ItalySite Not Available
Research Site 220
Orbassano,
ItalySite Not Available
Research Site 217
Palermo,
ItalySite Not Available
Research Site 212
Pozzilli,
ItalySite Not Available
Research Site 213
Roma,
ItalySite Not Available
Research Site 222
Roma,
ItalySite Not Available
Research Site 231
Riga,
LatviaSite Not Available
Research Site 232
Riga,
LatviaSite Not Available
Research Site 233
Riga,
LatviaSite Not Available
Research site 241
Kaunas,
LithuaniaSite Not Available
Research site 244
Klaipeda,
LithuaniaSite Not Available
Research site 243
Siauliai,
LithuaniaSite Not Available
Research site 242
Vilnius,
LithuaniaSite Not Available
Research Site 551
Kuala Lumpur,
MalaysiaSite Not Available
Research Site 554
Kuala Lumpur,
MalaysiaSite Not Available
Research Site 556
Kuala Lumpur,
MalaysiaSite Not Available
Research Site 552
Kuching,
MalaysiaSite Not Available
Research Site 553
Seberang Jaya,
MalaysiaSite Not Available
Research Site 555
Selangor,
MalaysiaSite Not Available
Research Site 251
Chisinau,
Moldova, Republic ofSite Not Available
Research Site 252
Chisinau,
Moldova, Republic ofSite Not Available
Research Site 481
Bergen,
NorwaySite Not Available
Research site 483
Drammen,
NorwaySite Not Available
Research Site 482
Namsos,
NorwaySite Not Available
Research Site 562
Baguio City,
PhilippinesSite Not Available
Research Site 561
Cebu City,
PhilippinesSite Not Available
Reserach Site 267
Bydgoszcz,
PolandSite Not Available
Reserach Site 268
Bydgoszcz,
PolandSite Not Available
Research Site 273
Katowice,
PolandSite Not Available
Research site 846
Katowice,
PolandSite Not Available
Research site 274
Katowice-Ochojec,
PolandSite Not Available
Research Site 276
Krakow,
PolandSite Not Available
Research Site 263
Lodz,
PolandSite Not Available
Research Site 266
Nowa Sol,
PolandSite Not Available
Research Site 270
Poznan,
PolandSite Not Available
Research Site 262
Rzeszow,
PolandSite Not Available
Research Site 265
Siemianowice,
PolandSite Not Available
Research Site 271
Szczecin,
PolandSite Not Available
Research Site 264
Warszawa,
PolandSite Not Available
Research Site 277
Warszawa,
PolandSite Not Available
Reserach Site 275
Warszawa,
PolandSite Not Available
Research Site 269
Wroclaw,
PolandSite Not Available
Research Site 261
Zabrze,
PolandSite Not Available
Research Site 278
Zamosc,
PolandSite Not Available
Research Site 272
Łódź,
PolandSite Not Available
Research Site 293
Aveiro,
PortugalSite Not Available
Research Site 282
Braga,
PortugalSite Not Available
Research Site 289
Coimbra,
PortugalSite Not Available
Research Site 281
Lisboa,
PortugalSite Not Available
Research Site 283
Lisboa,
PortugalSite Not Available
Research Site 287
Lisboa,
PortugalSite Not Available
Research SIte 284
Matosinhos,
PortugalSite Not Available
Research Site 292
Porto,
PortugalSite Not Available
Research Site 288
Pragal,
PortugalSite Not Available
Research Site 291
Santa Maria da Feira,
PortugalSite Not Available
Research Site 286
Torres Vedras,
PortugalSite Not Available
Research Site 791
Guaynabo,
Puerto RicoSite Not Available
Research Site 314
Brasov,
RomaniaSite Not Available
Research Site 307
București,
RomaniaSite Not Available
Research Site 309
Caracal,
RomaniaSite Not Available
Research Site 302
Targu Mures,
RomaniaSite Not Available
Research Site 325
Kazan,
Russian FederationSite Not Available
Research Site 329
Kazan,
Russian FederationSite Not Available
Research Site 323
Kemerovo,
Russian FederationSite Not Available
Research Site 344
Kirov,
Russian FederationSite Not Available
Research Site 340
Krasnodar,
Russian FederationSite Not Available
Research Site 334
Krasnoyarsk,
Russian FederationSite Not Available
Research Site 341
Moscow,
Russian FederationSite Not Available
Research Site 343
Moscow,
Russian FederationSite Not Available
Research Site 345
Moscow,
Russian FederationSite Not Available
Research Site 332
Nizhniy Novgorod,
Russian FederationSite Not Available
Research Site 327
Novosibirsk,
Russian FederationSite Not Available
Research Site 330
Novosibirsk,
Russian FederationSite Not Available
Research Site 331
Novosibirsk,
Russian FederationSite Not Available
Research Site 335
Novosibirsk,
Russian FederationSite Not Available
Research Site 328
Rostov-on-Don,
Russian FederationSite Not Available
Research Site 346
Saint Petersburg,
Russian FederationSite Not Available
Research Site 324
Saint-Petersburg,
Russian FederationSite Not Available
Research Site 338
Saint-Petersburg,
Russian FederationSite Not Available
Research Site 339
Saint-Petersburg,
Russian FederationSite Not Available
Research Site 342
Saint-Petersburg,
Russian FederationSite Not Available
Research Site 326
Saransk,
Russian FederationSite Not Available
Research Site 321
Sestroretsk,
Russian FederationSite Not Available
Research Site 337
Tyumen,
Russian FederationSite Not Available
Research Site 493
Riyadh,
Saudi ArabiaSite Not Available
Research Site 571
Singapore,
SingaporeSite Not Available
Research site 572
Singapore,
SingaporeSite Not Available
Research Site 351
Banska Bystrica,
SlovakiaSite Not Available
Research Site 352
Bratislava,
SlovakiaSite Not Available
Research Site 353
Bratislava,
SlovakiaSite Not Available
Research Site 354
Bratislava,
SlovakiaSite Not Available
Research Site 356
Bratislava,
SlovakiaSite Not Available
Research Site 359
Dubnica nad Vahom,
SlovakiaSite Not Available
Research Site 358
Trencin,
SlovakiaSite Not Available
Research Site 357
Trnava,
SlovakiaSite Not Available
Research Site 373
Celje,
SloveniaSite Not Available
Research Site 372
Ljubljana,
SloveniaSite Not Available
Research Site 371
Maribor,
SloveniaSite Not Available
Research Site 501
Cape Town,
South AfricaSite Not Available
Research Site 502
Cape Town,
South AfricaSite Not Available
Research Site 503
Cape Town,
South AfricaSite Not Available
Research Site 504
Pretoria,
South AfricaSite Not Available
Research Site 384
Alcoron, Madrid 28992
SpainSite Not Available
Research Site 384
Alcorcon,
SpainSite Not Available
Research Site 391
Barakaldo,
SpainSite Not Available
Research Site 390
Barcelona,
SpainSite Not Available
Research Site 382
Cordoba,
SpainSite Not Available
Research Site 389
El Palmar,
SpainSite Not Available
Research Site 388
Madrid,
SpainSite Not Available
Research Site 392
Majadahonda,
SpainSite Not Available
Research Site 383
Malaga,
SpainSite Not Available
Research Site 387
Sevilla,
SpainSite Not Available
Research Site 385
Valencia,
SpainSite Not Available
Research Site 386
Valencia,
SpainSite Not Available
Research Site 381
Vigo,
SpainSite Not Available
Research Site 512
Göteborg,
SwedenSite Not Available
Research site 514
Malmö,
SwedenSite Not Available
Research Site 511
Stockholm,
SwedenSite Not Available
Research Site 513
Uppsala,
SwedenSite Not Available
Research Site 404
Aarau,
SwitzerlandSite Not Available
Research Site 402
Bern,
SwitzerlandSite Not Available
Research Site 403
Lugano,
SwitzerlandSite Not Available
Research Site 583
Bangkoknoi,
ThailandSite Not Available
Research Site 582
Muang,
ThailandSite Not Available
Research Site 538
Ankara,
TurkeySite Not Available
Research Site 544
Ankara,
TurkeySite Not Available
Research Site 531
Istanbul,
TurkeySite Not Available
Research Site 534
Istanbul,
TurkeySite Not Available
Research Site 536
Istanbul,
TurkeySite Not Available
Research Site 541
Istanbul,
TurkeySite Not Available
Research Site 543
Istanbul,
TurkeySite Not Available
Research Site 539
Izmir,
TurkeySite Not Available
Research Site 533
Kocaeli,
TurkeySite Not Available
Research Site 537
Konya,
TurkeySite Not Available
Research Site 540
Mersin,
TurkeySite Not Available
Research Site 535
Samsun,
TurkeySite Not Available
Research Site 532
Trabzon,
TurkeySite Not Available
Research Site 415
Chernihiv,
UkraineSite Not Available
Research Site 417
Chernihiv,
UkraineSite Not Available
Research Site 414
Dnipro,
UkraineSite Not Available
Research Site 416
Dnipro,
UkraineSite Not Available
Research Site 420
Dnipro,
UkraineSite Not Available
Research Site 413
Ivano-Frankivsk,
UkraineSite Not Available
Research Site 624
Kharkiv,
UkraineSite Not Available
Research Site 632
Kharkiv,
UkraineSite Not Available
Research Site 633
Kharkiv,
UkraineSite Not Available
Research Site 419
Kherson,
UkraineSite Not Available
Research Site 411
Kyiv,
UkraineSite Not Available
Research Site 418
Kyiv,
UkraineSite Not Available
Research Site 629
Lutsk,
UkraineSite Not Available
Research Site 627
Lviv,
UkraineSite Not Available
Research Site 622
Poltava,
UkraineSite Not Available
Research Site 625
Rivne,
UkraineSite Not Available
Research Site 628
Ternopil,
UkraineSite Not Available
Research Site 630
Uzhgorod,
UkraineSite Not Available
Research Site 623
Vinnytsia,
UkraineSite Not Available
Research Site 412
Zaporizhzhia,
UkraineSite Not Available
Research Site 621
Zaporizhzhia,
UkraineSite Not Available
Research Site 631
Zaporizhzhia,
UkraineSite Not Available
Research Site 626
Zhytomyr,
UkraineSite Not Available
Research Site 752
Cullman, Alabama 35058
United StatesSite Not Available
Research Site 741
Scottsdale, Arizona 85258
United StatesSite Not Available
Research Site 704
Tucson, Arizona 85710
United StatesSite Not Available
Research Site 751
Hanford, California 93230
United StatesSite Not Available
Research Site 737
West Hollywood, California 90048
United StatesSite Not Available
Research Site 759
Colorado Springs, Colorado 80907
United StatesSite Not Available
Research Site 725
Fort Collins, Colorado 80528
United StatesSite Not Available
Research Site 746
Altamonte Springs, Florida 32714
United StatesSite Not Available
Research Site 718
Jacksonville, Florida 32209
United StatesSite Not Available
Research Site 702
Naples, Florida 34105
United StatesSite Not Available
Research Site 740
Orlando, Florida 32806
United StatesSite Not Available
Research Site 726
Port Charlotte, Florida 33952
United StatesSite Not Available
Research Site 719
Sarasota, Florida 34243
United StatesSite Not Available
Research Site 707
Tampa, Florida 33634
United StatesSite Not Available
Research Site 743
Tampa, Florida 33612
United StatesSite Not Available
Research Site 732
Vero Beach, Florida 32960
United StatesSite Not Available
Research Site 705
Weeki Wachee, Florida 34607
United StatesSite Not Available
Research Site 753
West Palm Beach, Florida 33407
United StatesSite Not Available
Research Site 742
Honolulu, Hawaii 96817
United StatesSite Not Available
Research Site 715
Evanston, Illinois 60201
United StatesSite Not Available
Research Site 714
Fort Wayne, Indiana 46804
United StatesSite Not Available
Research Site 744
Lafayette, Indiana 47904
United StatesSite Not Available
Research Site 717
Overland Park, Kansas 66212
United StatesSite Not Available
Research Site 735
Nicholasville, Kentucky 40356
United StatesSite Not Available
Research Site 706
Scarborough, Maine 04074
United StatesSite Not Available
Please Contact U.S. Medical Information
Rockland, Massachusetts 02370
United StatesSite Not Available
Research Site 738
Detroit, Michigan 48202
United StatesSite Not Available
Research Site 723
Saint Louis, Missouri 63128
United StatesSite Not Available
Research Site 724
Amherst, New York 14226
United StatesSite Not Available
Research Site 736
Asheville, North Carolina 28006
United StatesSite Not Available
Research Site 712
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Research Site 730
Raleigh, North Carolina 27607
United StatesSite Not Available
Research Site 728
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Research Site 711
Canton, Ohio 44735
United StatesSite Not Available
Research Site 757
Columbus, Ohio 43214
United StatesSite Not Available
Research Site 734
Dayton, Ohio 45459
United StatesSite Not Available
Research Site 748
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Research Site 703
San Antonio, Texas 78258
United StatesSite Not Available
Research Site 721
Norfolk, Virginia 23502
United StatesSite Not Available
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