Search / Trial NCT04338022

Study of Evobrutinib in Participants With RMS (evolutionRMS 1)
Launched by MERCK HEALTHCARE KGAA, DARMSTADT, GERMANY, AN AFFILIATE OF MERCK KGAA, DARMSTADT, GERMANY · Apr 6, 2020

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Trial Information

Current as of May 07, 2025

Terminated

Keywords

Evobrutinib Teriflunomide Aubagio® Relapsing Multiple Sclerosis

ClinConnect Summary

No description provided

Gender

ALL

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.

About Merck Healthcare Kgaa, Darmstadt, Germany, An Affiliate Of Merck Kgaa, Darmstadt, Germany

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, is a leading global healthcare company dedicated to advancing medical research and innovation. With a strong commitment to improving patient outcomes, the organization focuses on developing cutting-edge therapies and solutions across various therapeutic areas, including oncology, neurology, and immunology. Leveraging its extensive expertise in pharmaceuticals and life sciences, Merck Healthcare aims to address unmet medical needs through rigorous clinical trials and collaborations, driving progress in healthcare and enhancing the quality of life for patients worldwide.

Locations

Mobile, Alabama, United States

Phoenix, Arizona, United States

Long Beach, California, United States

Pasadena, California, United States

San Diego, California, United States

Stamford, Connecticut, United States

Washington, District Of Columbia, United States

Boca Raton, Florida, United States

Maitland, Florida, United States

Miami, Florida, United States

Ormond Beach, Florida, United States

Saint Petersburg, Florida, United States

Tallahassee, Florida, United States

Elk Grove Village, Illinois, United States

Northbrook, Illinois, United States

Peoria, Illinois, United States

Rolling Meadows, Illinois, United States

Indianapolis, Indiana, United States

Kansas City, Kansas, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Foxboro, Massachusetts, United States

Lawrence, Massachusetts, United States

Worcester, Massachusetts, United States

Detroit, Michigan, United States

Farmington Hills, Michigan, United States

Saint Louis, Missouri, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Audubon, New Jersey, United States

Patchogue, New York, United States

Akron, Ohio, United States

Toledo, Ohio, United States

Oklahoma City, Oklahoma, United States

Springfield, Oregon, United States

Willow Grove, Pennsylvania, United States

Knoxville, Tennessee, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

Lubbock, Texas, United States

Round Rock, Texas, United States

Layton, Utah, United States

Alexandria, Virginia, United States

Virginia Beach, Virginia, United States

Milwaukee, Wisconsin, United States

Ciudad Autonoma Buenos Aires, , Argentina

Ciudad Autonoma De Buenos Aires, , Argentina

Cordoba, , Argentina

Godoy Cruz, , Argentina

Guaymallen, , 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

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

Plovdiv, , Bulgaria

Sofia, , Bulgaria

Greenfield Park, , Canada

Levis, , Canada

Moncton, , Canada

Montreal, , Canada

Toronto, , Canada

Barranquilla, , Colombia

Medellin, , Colombia

Osijek, , Croatia

Rijeka, , Croatia

Varazdin, , Croatia

Zagreb, , Croatia

Brno, , 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

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

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

Reggio Calabria, , Italy

Roma, , Italy

Salerno, , Italy

Verona, , Italy

Goyang Si, , Korea, Republic Of

Seoul, , Korea, Republic Of

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

Barnaul, , Russian Federation

Ekaterinburg, , Russian Federation

Kaluga, , Russian Federation

Kazan, , Russian Federation

Kirov, , Russian Federation

Krasnoyarsk, , 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

Kragujevac, , Serbia

Nis, , Serbia

Novi Sad, , Serbia

Uzice, , Serbia

Valjevo, , Serbia

Barcelona, , Spain

Cadiz, , Spain

Lleida, , Spain

Madrid, , Spain

Pozuelo De Alarcon, , Spain

Salt, , Spain

San Sebastian, , Spain

Sevilla, , Spain

Chernivtsi, , Ukraine

Kharkiv, , Ukraine

Kropyvnytskyi, , Ukraine

Kyiv, , Ukraine

Lviv, , Ukraine

Odesa, , Ukraine

Poltava, , Ukraine

Sumy, , Ukraine

Vinnytsia, , Ukraine

Zaporizhzhia, , Ukraine

Exeter, , United Kingdom

Glasgow, , United Kingdom

Newcastle, , United Kingdom

Swansea, , United Kingdom

Kaohsiung, , Taiwan

Taichung, , Taiwan

Taipei, , Taiwan

Aguascalientes, , Mexico

Culiacan, , Mexico

Patients applied

0 patients applied

Trial Officials

Medical Responsible

Study Director

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

Timeline

First submit

April 06, 2020

Trial launched

June 12, 2020

Trial updated

April 25, 2024

Estimated completion

Not reported

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Study of Evobrutinib in Participants With RMS (evolutionRMS 1) Launched by MERCK HEALTHCARE KGAA, DARMSTADT, GERMANY, AN AFFILIATE OF MERCK KGAA, DARMSTADT, GERMANY · Apr 6, 2020

Study of Evobrutinib in Participants With RMS (evolutionRMS 1)
Launched by MERCK HEALTHCARE KGAA, DARMSTADT, GERMANY, AN AFFILIATE OF MERCK KGAA, DARMSTADT, GERMANY · Apr 6, 2020