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ACTIVE NOT RECRUITING
NCT05147220
PHASE3

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)

Official title: A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

1001

Start Date

2021-12-16

Completion Date

2030-10-30

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

DRUG

Remibrutinib

tablet taken orally

DRUG

Teriflunomide

capsule taken orally

Locations (200)

AZ Integrated Neuro and Spine

Phoenix, Arizona, United States

Center for Neurosciences

Tucson, Arizona, United States

The Belinga Clinic

Fort Smith, Arkansas, United States

The Research and Education Inst. of Alta Bates Summit Med. Grp

Berkeley, California, United States

The Neuron Clinic

Chula Vista, California, United States

Glendale Adventist Medical Center

Glendale, California, United States

Hoag Health System

Newport Beach, California, United States

SC3 Research Pasadena

Pasadena, California, United States

Neuro Center

Pomona, California, United States

Alpine Clinical Research Center

Boulder, Colorado, United States

Christiana Care Health Services

Newark, Delaware, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Neurology of Central FL Res Ctr

Altamonte Springs, Florida, United States

Arrow Clinical Trials

Daytona Beach, Florida, United States

Homestead Assoc In Research Inc

Homestead, Florida, United States

Reliant Medical Research

Miami, Florida, United States

Neurological Services of Orlando PA

Orlando, Florida, United States

Orlando Health Clinical Trials

Orlando, Florida, United States

Comprehensive Neurology Clinic

Orlando, Florida, United States

Neurology Associates of Ormond Beach

Ormond Beach, Florida, United States

Neurostudies Inc

Port Charlotte, Florida, United States

Accel Research Sites St Pete-Largo

Seminole, Florida, United States

University Of South Florida

Tampa, Florida, United States

Conquest Research

Winter Park, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

IU Health Inc

Fort Wayne, Indiana, United States

College Park Family Care Center

Overland Park, Kansas, United States

Norton Neurology MS Services

Louisville, Kentucky, United States

American Oncology Partners PA Center for Cancer & Blood Disorders

Bethesda, Maryland, United States

Neurology Center of New England PC

Foxborough, Massachusetts, United States

Wayne State University Multiple Sclerosis Clinic

Detroit, Michigan, United States

The MS Center for Innovation in Care

St Louis, Missouri, United States

SCL Health

Billings, Montana, United States

Jersey Shore University Medical Ctr

Neptune City, New Jersey, United States

Neurological Associates of Long Island PC

Lake Success, New York, United States

NYU Langone Med Center CV Research

New York, New York, United States

The Neurological Institute PA

Charlotte, North Carolina, United States

Velocity Clinical Research

Raleigh, North Carolina, United States

Columbus Neuroscience

Westerville, Ohio, United States

Multiple Sclerosis Center of Excellence of OMRF

Oklahoma City, Oklahoma, United States

Providence St Vincent Med Center

Portland, Oregon, United States

University Of Pittsburgh Medical Ctr Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Reading Hospital

Reading, Pennsylvania, United States

Palmetto Clinical Research

Summerville, South Carolina, United States

Texas Neurology

Dallas, Texas, United States

John Peter Smith Hospital

Fort Worth, Texas, United States

Neuro Eye Clinical Trials Inc

Houston, Texas, United States

DHR Health Institute

McAllen, Texas, United States

Saturn Research Solutions LLC

Plano, Texas, United States

MS Center of Greater Washington, P.C.

Vienna, Virginia, United States

University of Wisconsin Madison

Madison, Wisconsin, United States

Neuroscience Group

Neenah, Wisconsin, United States

Novartis Investigative Site

Capital Federal, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Caba, Argentina

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Capital Federal, Argentina

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Santiago del Estero, Argentina

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Linz, Upper Austria, Austria

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Linz, Austria

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Brussels, Brussels Capital, Belgium

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Bruges, Belgium

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Edegem, Belgium

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Melsbroek, Belgium

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Overpelt, Belgium

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Porto Alegre, Porto Alegre RS, Brazil

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Santo André, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Pleven, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Santiago, Santiago Metropolitan, Chile

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Santiago, Santiago Metropolitan, Chile

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Guangzhou, Guangdong, China

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Zhengzhou, Henan, China

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Changsha, Hunan, China

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Baotou, Inner Mongolia, China

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Hohhot, Inner Mongolia, China

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Nanchang, Jiangxi, China

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Changchun, Jilin, China

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Beijing, China

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Beijing, China

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Chongqing, China

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Tianjin, China

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Puerto Colombia, Atlántico, Colombia

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Cali, Valle del Cauca Department, Colombia

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Cali, Valle del Cauca Department, Colombia

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Bogotá, Colombia

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Medellín, Colombia

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Medellín, Colombia

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Osijek, Croatia

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Rijeka, Croatia

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Zagreb, Croatia

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Slagelse, Denmark

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Tbilisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Guatemala City, Guatemala

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Shatin, Hong Kong

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Mangalore, Karnataka, India

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Mangalore, Karnataka, India

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Mumbai, Maharashtra, India

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Nashik, Maharashtra, India

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New Delhi, National Capital Territory of Delhi, India

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Chandigarh, Punjab, India

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Ludhiana, Punjab, India

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Lucknow, Uttar Pradesh, India

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Dehradun, Uttarakhand, India

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Dublin, Ireland

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Dublin, Ireland

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Ashkelon, Israel

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Hadera, Israel

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Haifa, Israel

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Jerusalem, Israel

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Sefad, Israel

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Milan, MI, Italy

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Roma, RM, Italy

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Roma, RM, Italy

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Roma, RM, Italy

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Verona, VR, Italy

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Novara, Italy

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Amman, Jordan

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Riga, LV, Latvia

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Riga, Latvia

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El Chouf, LBN, Lebanon

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Beirut, Lebanon

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Tripoli, Lebanon

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Šiauliai, LTU, Lithuania

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Klaipėda, Lithuania

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Kuala Lumpur, Kuala Lumpur, Malaysia

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Seberang Jaya, Pulau Pinang, Malaysia

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Kuching, Sarawak, Malaysia

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Kuala Terengganu, Terengganu, Malaysia

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Guadalajara, Jalisco, Mexico

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San Pedro G G, Mexico

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Veracruz, Mexico

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Rotterdam, South Holland, Netherlands

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Wroclaw, Lower Silesian Voivodeship, Poland

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Bydgoszcz, Woj Kujawsko Pomorskie, Poland

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Kielce, Poland

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Lodz, Poland

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Lodz, Poland

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Lublin, Poland

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Piotrkow Trybunalski, Poland

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Poznan, Poland

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Rzeszów, Poland

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Szczecin, Poland

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Jeddah, Saudi Arabia

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Jeddah, Saudi Arabia

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Riyadh, Saudi Arabia

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Bratislava, Slovakia

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Košice, Slovakia

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Nitra, Slovakia

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Trnava, Slovakia

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Cadiz, Andalusia, Spain

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Seville, Andalusia, Spain

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Sant Joan Despí, Barcelona, Spain

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Salt, Girona, Spain

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Alcorcón, Madrid, Spain

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Getafe, Madrid, Spain

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Majadahonda, Madrid, Spain

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El Palmar, Murcia, Spain

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Vigo, Pontevedra, Spain

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Castilleja de la Cuesta, Sevilla, Spain

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A Coruña, Spain

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Barcelona, Spain

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Córdoba, Spain

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Las Palmas GC, Spain

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León, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Málaga, Spain

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Valladolid, Spain

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Basel, Switzerland

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Bern, Switzerland

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Kaohsiung City, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Ankara, Bilkent-Cankaya, Turkey (Türkiye)

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Izmir, Karsiyaka, Turkey (Türkiye)

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Istanbul, Sultangazi, Turkey (Türkiye)

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Ankara, Yenimahalle, Turkey (Türkiye)

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Mersin, Yenisehir, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Abu Dhabi, United Arab Emirates

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Dubai, United Arab Emirates

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Westbruy on Trym, Bristol, United Kingdom

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Winchester, Hampshire, United Kingdom

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Glasgow, Scotland, United Kingdom