Study of Evobrutinib in Participants With RMS (evolutionRMS 2)
NCT ID: NCT04338061
Last Updated: 2025-03-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1166 participants
INTERVENTIONAL
2020-07-02
2024-03-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Teriflunomide
Teriflunomide
Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.
Evobrutinib
Evobrutinib
Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.
Interventions
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Teriflunomide
Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.
Evobrutinib
Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 less than or equal to \[\<=\] 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
Exclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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EMD Serono Research & Development Institute, Inc.
INDUSTRY
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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Research Site 752
Cullman, Alabama, United States
Research Site 741
Scottsdale, Arizona, United States
Research Site 704
Tucson, Arizona, United States
Research Site 751
Hanford, California, United States
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West Hollywood, California, United States
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Colorado Springs, Colorado, United States
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Fort Collins, Colorado, United States
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Altamonte Springs, Florida, United States
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Jacksonville, Florida, United States
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Naples, Florida, United States
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Orlando, Florida, United States
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Port Charlotte, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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Weeki Wachee, Florida, United States
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West Palm Beach, Florida, United States
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Honolulu, Hawaii, United States
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Evanston, Illinois, United States
Research Site 714
Fort Wayne, Indiana, United States
Research Site 744
Lafayette, Indiana, United States
Research Site 717
Overland Park, Kansas, United States
Research Site 735
Nicholasville, Kentucky, United States
Research Site 706
Scarborough, Maine, United States
Research Site 738
Detroit, Michigan, United States
Research Site 723
St Louis, Missouri, United States
Research Site 724
Amherst, New York, United States
Research Site 736
Asheville, North Carolina, United States
Research Site 712
Chapel Hill, North Carolina, United States
Research Site 730
Raleigh, North Carolina, United States
Research Site 728
Winston-Salem, North Carolina, United States
Research Site 711
Canton, Ohio, United States
Research Site 757
Columbus, Ohio, United States
Research Site 734
Dayton, Ohio, United States
Research Site 748
Philadelphia, Pennsylvania, United States
Research Site 703
San Antonio, Texas, United States
Research Site 721
Norfolk, Virginia, United States
Research Site 143
Grodno, , Belarus
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Homyel, , 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, , France
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Brest, , France
Reserach Site 451
Clermont-Ferrand, , France
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Limoges, , France
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Nîmes, , France
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Paris, , France
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Pringy, , France
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Strasbourg, , France
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Tours, , 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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Cologne, , Germany
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Dresden, , Germany
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Hamburg, , Germany
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Heidelberg, , 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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Tübingen, , 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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Pátrai, , Greece
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Pátrai, , 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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Florence, , Italy
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Milan, , 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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Klaipėda, , Lithuania
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Šiauliai, , 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
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Kuching, , Malaysia
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Seberang Jaya, , Malaysia
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Chisinau, , Moldova
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Chisinau, , Moldova
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Bergen, , Norway
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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
Reserach Site 268
Bydgoszcz, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Katowice-Ochojec, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Nowa Sól, , Poland
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Poznan, , Poland
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Rzeszów, , Poland
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Siemianowice Śląskie, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Zamość, , Poland
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Aveiro, , Portugal
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Braga, , Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
Research SIte 284
Matosinhos Municipality, , Portugal
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Porto, , Portugal
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Pragal, , Portugal
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Santa Maria da Feira, , Portugal
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Torres Vedras, , Portugal
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Guaynabo, , Puerto Rico
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Brasov, , Romania
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Bucharest, , Romania
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Caracal, , Romania
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Târgu Mureş, , Romania
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Kazan', , Russia
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Kazan', , Russia
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Kemerovo, , Russia
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Kirov, , Russia
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Krasnodar, , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Novosibirsk, , Russia
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Novosibirsk, , Russia
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Novosibirsk, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
Research Site 338
Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saransk, , Russia
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Sestroretsk, , Russia
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Tyumen, , Russia
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Riyadh, , Saudi Arabia
Research Site 571
Singapore, , Singapore
Research site 572
Singapore, , Singapore
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Dubnica nad Váhom, , Slovakia
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Trenčín, , Slovakia
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Trnava, , Slovakia
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Celje, , Slovenia
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Ljubljana, , Slovenia
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Maribor, , Slovenia
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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
Alcorcón, , Spain
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Barakaldo, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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El Palmar, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Málaga, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Vigo, , Spain
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Gothenburg, , Sweden
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Malmo, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Aarau, , Switzerland
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Bern, , Switzerland
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Lugano, , Switzerland
Research Site 583
Bangkoknoi, , Thailand
Research Site 582
Muang, , Thailand
Research Site 538
Ankara, , Turkey (Türkiye)
Research Site 544
Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
Research Site 539
Izmir, , Turkey (Türkiye)
Research Site 533
Kocaeli, , Turkey (Türkiye)
Research Site 537
Konya, , Turkey (Türkiye)
Research Site 540
Mersin, , Turkey (Türkiye)
Research Site 535
Samsun, , Turkey (Türkiye)
Research Site 532
Trabzon, , Turkey (Türkiye)
Research Site 415
Chernihiv, , Ukraine
Research Site 417
Chernihiv, , Ukraine
Research Site 414
Dnipro, , Ukraine
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Dnipro, , Ukraine
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Dnipro, , Ukraine
Research Site 413
Ivano-Frankivsk, , Ukraine
Research Site 624
Kharkiv, , Ukraine
Research Site 632
Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kherson, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Lviv, , Ukraine
Research Site 622
Poltava, , Ukraine
Research Site 625
Rivne, , Ukraine
Research Site 628
Ternopil, , Ukraine
Research Site 630
Uzhhorod, , 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
Countries
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References
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Montalban X, Vermersch P, Arnold DL, Bar-Or A, Cree BAC, Cross AH, Kubala Havrdova E, Kappos L, Stuve O, Wiendl H, Wolinsky JS, Dahlke F, Le Bolay C, Shen Loo L, Gopalakrishnan S, Hyvert Y, Javor A, Guehring H, Tenenbaum N, Tomic D; evolutionRMS investigators. Safety and efficacy of evobrutinib in relapsing multiple sclerosis (evolutionRMS1 and evolutionRMS2): two multicentre, randomised, double-blind, active-controlled, phase 3 trials. Lancet Neurol. 2024 Nov;23(11):1119-1132. doi: 10.1016/S1474-4422(24)00328-4. Epub 2024 Sep 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
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2019-004980-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS200527_0082
Identifier Type: -
Identifier Source: org_study_id
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