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.

View Eligibility Criteria

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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1124

Study ID:

NCT04338061

Recruitment Status:

Terminated

Sponsor:

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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There are 37 Locations for this study

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Research Site 752
Cullman Alabama, 35058, United States
Research Site 741
Scottsdale Arizona, 85258, United States
Research Site 704
Tucson Arizona, 85710, United States
Research Site 751
Hanford California, 93230, United States
Research Site 737
West Hollywood California, 90048, United States
Research Site 759
Colorado Springs Colorado, 80907, United States
Research Site 725
Fort Collins Colorado, 80528, United States
Research Site 746
Altamonte Springs Florida, 32714, United States
Research Site 718
Jacksonville Florida, 32209, United States
Research Site 702
Naples Florida, 34105, United States
Research Site 740
Orlando Florida, 32806, United States
Research Site 726
Port Charlotte Florida, 33952, United States
Research Site 719
Sarasota Florida, 34243, United States
Research Site 743
Tampa Florida, 33612, United States
Research Site 707
Tampa Florida, 33634, United States
Research Site 732
Vero Beach Florida, 32960, United States
Research Site 705
Weeki Wachee Florida, 34607, United States
Research Site 753
West Palm Beach Florida, 33407, United States
Research Site 742
Honolulu Hawaii, 96817, United States
Research Site 715
Evanston Illinois, 60201, United States
Research Site 714
Fort Wayne Indiana, 46804, United States
Research Site 744
Lafayette Indiana, 47904, United States
Research Site 717
Overland Park Kansas, 66212, United States
Research Site 735
Nicholasville Kentucky, 40356, United States
Research Site 706
Scarborough Maine, 04074, United States
Research Site 738
Detroit Michigan, 48202, United States
Research Site 723
Saint Louis Missouri, 63128, United States
Research Site 724
Amherst New York, 14226, United States
Research Site 736
Asheville North Carolina, 28006, United States
Research Site 712
Chapel Hill North Carolina, 27599, United States
Research Site 728
Winston-Salem North Carolina, 27157, United States
Research Site 711
Canton Ohio, 44735, United States
Research Site 757
Columbus Ohio, 43214, United States
Research Site 734
Dayton Ohio, 45459, United States
Research Site 748
Philadelphia Pennsylvania, 19107, United States
Research Site 703
San Antonio Texas, 78258, United States
Research Site 721
Norfolk Virginia, 23502, United States
Research Site 144
Gomel , , Belarus
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Grodno , , Belarus
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Minsk , , Belarus
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Vitebsk , , Belarus
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Vitebsk , , Belarus
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Belo Horizonte , , Brazil
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Curitiba , , Brazil
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Goiânia , , Brazil
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Joinville , , Brazil
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Passo Fundo , , Brazil
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Porto Alegre , , Brazil
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Porto Alegre , , Brazil
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Porto Alegre , , Brazil
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Vitória , , Brazil
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Blagoevgrad , , Bulgaria
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Dupnitsa , , Bulgaria
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Pleven , , Bulgaria
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Pleven , , Bulgaria
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Pleven , , Bulgaria
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Plovdiv , , Bulgaria
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Sofia , , Bulgaria
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Sofia , , Bulgaria
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Sofia , , Bulgaria
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Sofia , , Bulgaria
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Sofia , , Bulgaria
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Sofia , , Bulgaria
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Sofia , , Bulgaria
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Sofia , , Bulgaria
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Sofia , , Bulgaria
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Veliko Tarnovo , , Bulgaria
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Burnaby , , Canada
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London , , Canada
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Montreal , , Canada
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Ottawa , , Canada
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Bordeaux Cedex , , France
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Brest cedex 2 , , France
Reserach Site 451
Clermont Ferrand Cedex , , France
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Limoges cedex , , France
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Nimes , , France
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Paris , , France
Research Site 457
Pringy cedex , , France
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Strasbourg cedex , , France
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Tours cedex 9 , , France
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Augsburg , , Germany
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Berlin , , Germany
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Berlin , , Germany
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Bonn , , Germany
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Dresden , , Germany
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Hamburg , , Germany
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Heidelberg , , Germany
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Koeln , , Germany
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Leipzig , , Germany
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Mainz , , Germany
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Minden , , Germany
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Regensburg , , Germany
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Rostock , , Germany
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Tuebingen , , Germany
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Athens , , Greece
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Athens , , Greece
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Athens , , Greece
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Athens , , Greece
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Athens , , Greece
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Athens , , Greece
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Athens , , Greece
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Athens , , Greece
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Heraklion , , Greece
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Ioannina , , Greece
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Larissa , , Greece
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Marousi , , Greece
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Patras , , Greece
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Patra , , Greece
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Thessaloniki , , Greece
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Ahmedabad , , India
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Bangalore , , India
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Mangalore , , India
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New Delhi , , India
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Bari , , Italy
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Catania , , Italy
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Cefalù , , Italy
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Firenze , , Italy
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Milano , , Italy
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Napoli , , Italy
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Napoli , , Italy
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Orbassano , , Italy
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Palermo , , Italy
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Pozzilli , , Italy
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Roma , , Italy
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Roma , , Italy
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Riga , , Latvia
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Riga , , Latvia
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Riga , , Latvia
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Kaunas , , Lithuania
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Klaipeda , , Lithuania
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Siauliai , , Lithuania
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Vilnius , , Lithuania
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Kuala Lumpur , , Malaysia
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Kuala Lumpur , , Malaysia
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Kuala Lumpur , , Malaysia
Research Site 552
Kuching , , Malaysia
Research Site 553
Seberang Jaya , , Malaysia
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Chisinau , , Moldova, Republic of
Research Site 252
Chisinau , , Moldova, Republic of
Research Site 481
Bergen , , Norway
Research site 483
Drammen , , Norway
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Namsos , , Norway
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Baguio City , , Philippines
Research Site 561
Cebu City , , Philippines
Reserach Site 267
Bydgoszcz , , Poland
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Bydgoszcz , , Poland
Research site 274
Katowice-Ochojec , , Poland
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Katowice , , Poland
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Katowice , , Poland
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Krakow , , Poland
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Lodz , , Poland
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Nowa Sol , , Poland
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Poznan , , Poland
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Rzeszow , , Poland
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Siemianowice , , Poland
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Szczecin , , Poland
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Warszawa , , Poland
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Warszawa , , Poland
Reserach Site 275
Warszawa , , Poland
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Zabrze , , Poland
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Zamosc , , Poland
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Łódź , , Poland
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Aveiro , , Portugal
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Braga , , Portugal
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Coimbra , , Portugal
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Lisboa , , Portugal
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Lisboa , , Portugal
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Lisboa , , Portugal
Research SIte 284
Matosinhos , , Portugal
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Porto , , Portugal
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Pragal , , Portugal
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Santa Maria da Feira , , Portugal
Research Site 286
Torres Vedras , , Portugal
Research Site 791
Guaynabo , , Puerto Rico
Research Site 314
Brasov , , Romania
Research Site 307
București , , Romania
Research Site 309
Caracal , , Romania
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Targu Mures , , Romania
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Kazan , , Russian Federation
Research Site 329
Kazan , , Russian Federation
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Kemerovo , , Russian Federation
Research Site 344
Kirov , , Russian Federation
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Krasnodar , , Russian Federation
Research Site 334
Krasnoyarsk , , Russian Federation
Research Site 341
Moscow , , Russian Federation
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Moscow , , Russian Federation
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Moscow , , Russian Federation
Research Site 332
Nizhniy Novgorod , , Russian Federation
Research Site 327
Novosibirsk , , Russian Federation
Research Site 330
Novosibirsk , , Russian Federation
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Novosibirsk , , Russian Federation
Research Site 335
Novosibirsk , , Russian Federation
Research Site 328
Rostov-on-Don , , Russian Federation
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Saint Petersburg , , Russian Federation
Research Site 324
Saint-Petersburg , , Russian Federation
Research Site 338
Saint-Petersburg , , Russian Federation
Research Site 339
Saint-Petersburg , , Russian Federation
Research Site 342
Saint-Petersburg , , Russian Federation
Research Site 326
Saransk , , Russian Federation
Research Site 321
Sestroretsk , , Russian Federation
Research Site 337
Tyumen , , Russian Federation
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Riyadh , , Saudi Arabia
Research Site 571
Singapore , , Singapore
Research site 572
Singapore , , Singapore
Research Site 351
Banska Bystrica , , Slovakia
Research Site 352
Bratislava , , Slovakia
Research Site 353
Bratislava , , Slovakia
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Bratislava , , Slovakia
Research Site 356
Bratislava , , Slovakia
Research Site 359
Dubnica nad Vahom , , Slovakia
Research Site 358
Trencin , , Slovakia
Research Site 357
Trnava , , Slovakia
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Celje , , Slovenia
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Ljubljana , , Slovenia
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Maribor , , Slovenia
Research Site 501
Cape Town , , South Africa
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Cape Town , , South Africa
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Cape Town , , South Africa
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Pretoria , , South Africa
Research Site 384
Alcorcon , , Spain
Research Site 391
Barakaldo , , Spain
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Barcelona , , Spain
Research Site 382
Cordoba , , Spain
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El Palmar , , Spain
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Madrid , , Spain
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Majadahonda , , Spain
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Malaga , , Spain
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Sevilla , , Spain
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Valencia , , Spain
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Valencia , , Spain
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Vigo , , Spain
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Göteborg , , Sweden
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Malmö , , Sweden
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Stockholm , , Sweden
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Uppsala , , Sweden
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Aarau , , Switzerland
Research Site 402
Bern , , Switzerland
Research Site 403
Lugano , , Switzerland
Research Site 583
Bangkoknoi , , Thailand
Research Site 582
Muang , , Thailand
Research Site 538
Ankara , , Turkey
Research Site 544
Ankara , , Turkey
Research Site 531
Istanbul , , Turkey
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Istanbul , , Turkey
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Istanbul , , Turkey
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Istanbul , , Turkey
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Istanbul , , Turkey
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Izmir , , Turkey
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Kocaeli , , Turkey
Research Site 537
Konya , , Turkey
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Mersin , , Turkey
Research Site 535
Samsun , , Turkey
Research Site 532
Trabzon , , Turkey
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Chernihiv , , Ukraine
Research Site 417
Chernihiv , , Ukraine
Research Site 414
Dnipro , , Ukraine
Research Site 416
Dnipro , , Ukraine
Research Site 420
Dnipro , , Ukraine
Research Site 413
Ivano-Frankivsk , , Ukraine
Research Site 624
Kharkiv , , Ukraine
Research Site 632
Kharkiv , , Ukraine
Research Site 633
Kharkiv , , Ukraine
Research Site 419
Kherson , , Ukraine
Research Site 411
Kyiv , , Ukraine
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Kyiv , , Ukraine
Research Site 629
Lutsk , , Ukraine
Research Site 627
Lviv , , Ukraine
Research Site 622
Poltava , , Ukraine
Research Site 625
Rivne , , Ukraine
Research Site 628
Ternopil , , Ukraine
Research Site 630
Uzhgorod , , Ukraine
Research Site 623
Vinnytsia , , Ukraine
Research Site 412
Zaporizhzhia , , Ukraine
Research Site 621
Zaporizhzhia , , Ukraine
Research Site 631
Zaporizhzhia , , Ukraine
Research Site 626
Zhytomyr , , Ukraine

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1124

Study ID:

NCT04338061

Recruitment Status:

Terminated

Sponsor:


Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

How clear is this clinincal trial information?

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