AzTrials
AzTrials

Multiple SclerosisPhase 3FREXALTNCT06141473

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

A Phase 3 study testing Frexalimab, Teriflunomide and MRI contrast-enhancing agents in people with Multiple Sclerosis, run by Sanofi at 382 sites in 41 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Frexalimab, Teriflunomide and MRI contrast-enhancing agents
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,655 participants
Where
382 sitesin 41 countries
Study dates
13 Dec 2023to 6 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria.
  • The participant has an EDSS score ≤5.5 at the first visit (Screening Visit)
  • The participant must have at least 1 of the following prior to screening:
  • ≥1 documented relapse within the previous year OR
  • ≥2 documented relapses within the previous 2 years, OR
  • ≥1 documented Gd enhancing lesion on an MRI scan within the previous year.
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Who cannot join

  • The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria
  • The participant has a history of infection or may be at risk for infection:
  • The presence of psychiatric disturbance or substance abuse.
  • History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
  • Current hypogammaglobulinemia defined by Ig levels below the LLN at Screening or a history of primary hypogammaglobulinemia.
  • A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis.
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  • The participant has had a relapse in the 30 days prior to randomization.
  • The participant has contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

382 sites in 41 countries.

382 sites in 41 countries

United States99 sites

  • Abington Neurological Associates- Site Number : 8401065

    Abington, Pennsylvania, 19001

  • The University of New Mexico- Site Number : 8401090

    Albuquerque, New Mexico, 87106

  • NeuroMedical Clinic of Central Louisiana- Site Number : 8401159

    Alexandria, Louisiana, 71301

  • Neurology of Central Florida- Site Number : 8401147

    Altamonte Springs, Florida, 32714

  • University of Colorado - Anschutz Medical Campus- Site Number : 8401001

    Aurora, Colorado, 80045

  • The NeuroMedical Center- Site Number : 8401182

    Baton Rouge, Louisiana, 70810

  • University of Alabama at Birmingham- Site Number : 8401135

    Birmingham, Alabama, 35233

  • Neurology Offices of South Florida - Boca Raton- Site Number : 8401169

    Boca Raton, Florida, 33428

  • First Choice Neurology - Espinosa Neuroscience Institute- Site Number : 8401071

    Boca Raton, Florida, 33486

  • Boston Clinical Trials- Site Number : 8401178

    Boston, Massachusetts, 02131

  • Beth Israel Deaconess Medical Center - Boston- Site Number : 8401041

    Boston, Massachusetts, 02215

  • Nova Clinical Research - Bradenton- Site Number : 8400189

    Bradenton, Florida, 34209

  • The Neurology Center of Southern California - Carlsbad- Site Number : 8400023

    Carlsbad, California, 92011

  • Dayton Center for Neurological Disorders- Site Number : 8400079

    Centerville, Ohio, 45459

  • The Neurological Institute- Site Number : 8401166

    Charlotte, North Carolina, 28204

  • Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002

    Charlotte, North Carolina, 28210

  • University of Cincinnati Medical Center- Site Number : 8401117

    Cincinnati, Ohio, 45219

  • The Ohio State University- Site Number : 8401009

    Columbus, Ohio, 43210

  • OhioHealth Riverside Methodist Hospital- Site Number : 8401092

    Columbus, Ohio, 43214

  • The Boster Center for Multiple Sclerosis- Site Number : 8400006

    Columbus, Ohio, 43235

  • North Central Neurology Associates- Site Number : 8401100

    Cullman, Alabama, 35058

  • Neurology Consultants of Dallas - Lyndon B Johnson Freeway- Site Number : 8400152

    Dallas, Texas, 75243

  • UC Health - Elizabeth Place- Site Number : 8401008

    Dayton, Ohio, 45408

  • Henry Ford Hospital- Site Number : 8401091

    Detroit, Michigan, 48202

  • ANESC Research- Site Number : 8400187

    El Paso, Texas, 79912

  • NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8401111

    Evanston, Illinois, 60201

  • Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8401109

    Fairfax, Virginia, 22031

  • Sanford Brain And Spine Center- Site Number : 8401085

    Fargo, North Dakota, 58103

  • Michigan Institute for Neurological Disorders- Site Number : 8400004

    Farmington Hills, Michigan, 48334

  • Advanced Neurology of Colorado- Site Number : 8401148

    Fort Collins, Colorado, 80528

  • IU Health Physicians - Fort Wayne - Hope Drive- Site Number : 8400058

    Fort Wayne, Indiana, 46815

  • Neurology Center of New England- Site Number : 8401164

    Foxborough, Massachusetts, 02035

  • Premier Neurology- Site Number : 8401047

    Greer, South Carolina, 29650

  • Penn State Health Milton South Hershey Medical Center- Site Number : 8401176

    Hershey, Pennsylvania, 17033

  • Alabama Neurology Associates- Site Number : 8400115

    Homewood, Alabama, 35209

  • Baylor College of Medicine Medical Center- Site Number : 8401170

    Houston, Texas, 77030

  • University of Iowa- Site Number : 8400029

    Iowa City, Iowa, 52242

  • University of California Irvine - School of Medicine- Site Number : 8401143

    Irvine, California, 92697

  • Mayo Clinic in Florida- Site Number : 8401093

    Jacksonville, Florida, 32224

  • University of Kansas Medical Center- Site Number : 8400084

    Kansas City, Kansas, 66160

  • Hope Neurology- Site Number : 8400019

    Knoxville, Tennessee, 37922

  • Multiple Sclerosis Center of California - Laguna Hills- Site Number : 8401122

    Laguna Hills, California, 92653

  • Chemidox Clinical Trials- Site Number : 8401157

    Lancaster, California, 93534

  • Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400045

    Las Vegas, Nevada, 89106

  • Baptist Health Lexington- Site Number : 8401149

    Lexington, Kentucky, 40503

  • Norton Neurology Services- Site Number : 8401103

    Louisville, Kentucky, 40207

  • International Neurorehabilitation Institute- Site Number : 8400089

    Lutherville, Maryland, 21093

  • Neurology Associates - Maitland- Site Number : 8400010

    Maitland, Florida, 32751

  • Neuroscience Institute Center- Site Number : 8400053

    Merrillville, Indiana, 46410

  • University of Miami Hospital- Site Number : 8401177

    Miami, Florida, 33136

  • Design Neuroscience Center- Site Number : 8401191

    Miami Lakes, Florida, 33016

  • Wheaton Franciscan Healthcare - St Francis- Site Number : 8400034

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038

    Milwaukee, Wisconsin, 53226

  • M Health Fairview University of Minnesota Medical Center - East Bank- Site Number : 8400056

    Minneapolis, Minnesota, 55455

  • Rutgers University- Site Number : 8401067

    New Brunswick, New Jersey, 08903

  • Ochsner Medical Center - Jefferson Highway- Site Number : 8400027

    New Orleans, Louisiana, 70121

  • Hoag Memorial Hospital Presbyterian- Site Number : 8401031

    Newport Beach, California, 92663

  • Consultants in Neurology- Site Number : 8401020

    Northbrook, Illinois, 60062

  • Hartford Healthcare Medical Group- Site Number : 8401069

    Norwich, Connecticut, 06360

  • Oklahoma Medical Research Foundation- Site Number : 8400039

    Oklahoma City, Oklahoma, 73104

  • Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060

    Orlando, Florida, 32806

  • Memorial Healthcare Institute for Neuroscience- Site Number : 8400123

    Owosso, Michigan, 48867

  • Sharlin Health and Neurology- Site Number : 8400016

    Ozark, Missouri, 65721

  • South Shore Neurologic Associates - Patchogue- Site Number : 8400063

    Patchogue, New York, 11772

  • Thomas Jefferson University Hospital- Site Number : 8400035

    Philadelphia, Pennsylvania, 19107

  • St. Joseph's Hospital and Medical Center- Site Number : 8401139

    Phoenix, Arizona, 85013

  • Allegheny General Hospital- Site Number : 8401173

    Pittsburgh, Pennsylvania, 15212

  • UPMC Magee-Womens Hospital- Site Number : 8401133

    Pittsburgh, Pennsylvania, 15213

  • North Texas Institute of Neurology & Headache - Plano- Site Number : 8401083

    Plano, Texas, 75024

  • Minnesota Center for Multiple Sclerosis- Site Number : 8400073

    Plymouth, Minnesota, 55446

  • Providence St. Vincent's Medical Center- Site Number : 8400052

    Portland, Oregon, 97225

  • Raleigh Neurology Associates- Site Number : 8400014

    Raleigh, North Carolina, 27607

  • Renown Regional Medical Center- Site Number : 8400066

    Reno, Nevada, 89502

  • Rochester Medical Group- Site Number : 8401172

    Rochester Hills, Michigan, 48307

  • Kc Research Center- Site Number : 8400032

    Roeland Park, Kansas, 66205

  • UT Health - San Antonio- Site Number : 8401167

    San Antonio, Texas, 78229

  • Neurology Center of San Antonio- Site Number : 8400099

    San Antonio, Texas, 78258

  • Velocity Clinical Research - Savannah Neurology- Site Number : 8400061

    Savannah, Georgia, 31406

  • Perseverance Research Center- Site Number : 8401138

    Scottsdale, Arizona, 85253

  • Clinical Endpoints- Site Number : 8400050

    Scottsdale, Arizona, 85258

  • Swedish Medical Center - Seattle- Site Number : 8400078

    Seattle, Washington, 98104

  • University of Washington Medical Center - Northwest- Site Number : 8401146

    Seattle, Washington, 98133

  • Texas Institute for Neurological Disorders - Sherman- Site Number : 8400018

    Sherman, Texas, 75092

  • Joi Life Wellness Group LLC- Site Number : 8401192

    Smyrna, Georgia, 30080

  • Springfield Clinic 1st - 900 Building- Site Number : 8400043

    Springfield, Illinois, 62702

  • Oregon Neurology Associates- Site Number : 8400188

    Springfield, Oregon, 97477

  • Washington University- Site Number : 8400076

    St Louis, Missouri, 63110

  • The MS Center for Innovations in Care- Site Number : 8401141

    St Louis, Missouri, 63131

  • New England Institute for Clinical Research- Site Number : 8400114

    Stamford, Connecticut, 06905

  • MultiCare Tacoma General Hospital- Site Number : 8401140

    Tacoma, Washington, 98405

  • Axiom Clinical Research of Florida- Site Number : 8400049

    Tampa, Florida, 33609

  • University of South Florida- Site Number : 8400013

    Tampa, Florida, 33612

  • Montefiore Medical Center - Einstein Campus- Site Number : 8401145

    The Bronx, New York, 10461

  • Multiple Sclerosis Center of Greater Washington (MSCGW)- Site Number : 8401128

    Vienna, Virginia, 22182

  • Sentara Family Medicine Physicians - Virginia Beach - Glenn Mitchell Drive- Site Number : 8401168

    Virginia Beach, Virginia, 23456

  • MedStar Georgetown University Hospital- Site Number : 8400044

    Washington D.C., District of Columbia, 20007

  • Private Practice - Dr. Regina Berkovich- Site Number : 8400005

    West Hollywood, California, 90048

  • Palm Beach Neurology- Site Number : 8401105

    West Palm Beach, Florida, 33407

  • Atrium Health - Wake Forest Baptist - Shepherd- Site Number : 8400040

    Winston-Salem, North Carolina, 27103

Other trials in United States

China29 sites

  • Investigational Site Number : 1560007

    Beijing, 100005

  • Investigational Site Number : 1560005

    Beijing, 100034

  • Investigational Site Number : 1560008

    Beijing, 100050

  • Investigational Site Number : 1560003

    Changchun, 130021

  • Investigational Site Number : 1560011

    Changsha, 410008

  • Investigational Site Number : 1560004

    Chengdu, 610041

  • Investigational Site Number : 1561029

    Chengdu, 610072

  • Investigational Site Number : 1560015

    Chongqing, 400016

  • Investigational Site Number : 1560020

    Dongguan, 523000

  • Investigational Site Number : 1561028

    Fuzhou, 350001

  • Investigational Site Number : 1561026

    Guangzhou, 510180

  • Investigational Site Number : 1560002

    Guangzhou, 510630

  • Investigational Site Number : 1561023

    Hangzhou, 310003

  • Investigational Site Number : 1561027

    Harbin, 150001

  • Investigational Site Number : 1560019

    Hohhot, 010050

  • Investigational Site Number : 1560040

    Hohhot, 010070

  • Investigational Site Number : 1560010

    Jiazhuang, 050000

  • Investigational Site Number : 1561025

    Jinan, 250014

  • Investigational Site Number : 1560018

    Nanjing, 210008

  • Investigational Site Number : 1560001

    Shanghai, 200040

  • Investigational Site Number : 1560043

    Shanghai, 200127

  • Investigational Site Number : 1560014

    Shenyang, 110004

  • Investigational Site Number : 1560030

    Suzhou, 215006

  • Investigational Site Number : 1560006

    Taiyuan, 030001

  • Investigational Site Number : 1560012

    Tianjin, 300052

  • Investigational Site Number : 1560016

    Wenzhou, 325035

  • Investigational Site Number : 1560009

    Wuhan, 430030

  • Investigational Site Number : 1560013

    Xi'an, 710038

  • Investigational Site Number : 1560021

    Yinchuan, 750004

Other trials in China

Italy25 sites

  • Investigational Site Number : 3801012

    Catania, 95123

  • Investigational Site Number : 3800014

    Chieti, 66100

  • Investigational Site Number : 3800033

    Como, 22100

  • Investigational Site Number : 3801025

    Cona, Ferrara, 44124

  • Investigational Site Number : 3800004

    Florence, Firenze, 50134

  • Investigational Site Number : 3800019

    Foggia, 71100

  • Investigational Site Number : 3801011

    Genoa, Genova, 16132

  • Investigational Site Number : 3800002

    Milan, Milano, 20132

  • Investigational Site Number : 3800016

    Milan, Milano, 20133

  • Investigational Site Number : 3801028

    Modena, 41125

  • Investigational Site Number : 3800032

    Monza, Monza E Brianza, 20052

  • Investigational Site Number : 3801010

    Naples, Napoli, 80131

  • Investigational Site Number : 3801026

    Novara, 28100

  • Investigational Site Number : 3801024

    Orbassano, Torino, 10043

  • Investigational Site Number : 3800017

    Palermo, 90127

  • Investigational Site Number : 3801022

    Palermo, 90127

  • Investigational Site Number : 3801029

    Parma, 43100

  • Investigational Site Number : 3801005

    Pavia, 27100

  • Investigational Site Number : 3801030

    Ravenna, 48121

  • Investigational Site Number : 3800015

    Rome, Roma, 00133

  • Investigational Site Number : 3800001

    Rome, Roma, 00149

  • Investigational Site Number : 3801013

    Rome, Roma, 00161

  • Investigational Site Number : 3800021

    Rome, Roma, 00168

  • Investigational Site Number : 3801031

    Udine, 33100

  • Investigational Site Number : 3800020

    Verona, 37134

Other trials in Italy

Turkey (Türkiye)19 sites

  • Investigational Site Number : 7921018

    Ankara, 06010

  • Investigational Site Number : 7920011

    Ankara, 06800

  • Investigational Site Number : 7921020

    Bursa, 16059

  • Investigational Site Number : 7921013

    Bursa, 16310

  • Investigational Site Number : 7921005

    Eskişehir, 26480

  • Investigational Site Number : 7920012

    Istanbul, 34010

  • Investigational Site Number : 7920002

    Istanbul, 34098

  • Investigational Site Number : 7921016

    Istanbul, 34200

  • Investigational Site Number : 7921009

    Istanbul, 34668

  • Investigational Site Number : 7920007

    Istanbul, 34785

  • Investigational Site Number : 7921019

    Izmir, 35340

  • Investigational Site Number : 7920008

    Izmir, 35360

  • Investigational Site Number : 7920001

    İzmit, 41001

  • Investigational Site Number : 7921014

    Kayseri, 38039

  • Investigational Site Number : 7920015

    Konya, 42075

  • Investigational Site Number : 7921006

    Mersin, 33070

  • Investigational Site Number : 7921004

    Samsun, 55139

  • Investigational Site Number : 7920003

    Sultangazi, 34265

  • Investigational Site Number : 7920017

    Van, 65080

Other trials in Turkey (Türkiye)

Brazil17 sites

  • Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0761025

    Belo Horizonte, Minas Gerais, 30150-320

  • L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760003

    Brasília, Federal District, 70200-730

  • Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0761001

    Curitiba, Paraná, 81210-310

  • Universidade Federal de Goias- Site Number : 0761024

    Goiânia, Goiás, 74605-020

  • Clínica Neurológica- Site Number : 0761007

    Joinville, Santa Catarina, 89202-165

  • Hospital Moinhos de Vento- Site Number : 0761005

    Porto Alegre, Rio Grande do Sul, 90035-902

  • IMV Pesquisa Neurológica- Site Number : 0761031

    Porto Alegre, Rio Grande do Sul, 90110-000

  • Instituto Ceos- Site Number : 0761028

    Porto Alegre, Rio Grande do Sul, 90480-020

  • InsCer - Instituto do Cérebro da PUCRS- Site Number : 0761009

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Centro de Pesquisas da Clínica IBIS- Site Number : 0761030

    Salvador, Estado de Bahia, 41820-020

  • Clinica AMO- Site Number : 0761017

    Salvador, Estado de Bahia, 41823-010

  • Hospital E Maternidade Christovão Da Gama- Site Number : 0761022

    Santo André, São Paulo, 09030-010

  • CPHosp Medicina, Ensino e Pesquisa (CPQuali)- Site Number : 0761002

    São Paulo, 01228-000

  • Centro de Pesquisas Clínicas - São Paulo- Site Number : 0761027

    São Paulo, 01228-200

  • PSEG Centro de Pesquisa Clínica- Site Number : 0761021

    São Paulo, 04038-002

  • Jordy Sinapse- Site Number : 0761004

    São Paulo, 04515-000

  • Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0761029

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Japan16 sites

  • Investigational Site Number : 3920014

    Asahikawa, Hokkaido, 070-0901

  • Investigational Site Number : 3920006

    Asahikawa, Hokkaido, 070-8530

  • Investigational Site Number : 3920002

    Chiba, 260-8677

  • Investigational Site Number : 3920013

    Fukuoka, 812-8582

  • Investigational Site Number : 3920015

    Higashi-Matsuyama, Saitama, 355-0005

  • Investigational Site Number : 3800008

    Joyo-Shi, 610-0113

  • Investigational Site Number : 3920016

    Kodaira, Tokyo, 187-8551

  • Investigational Site Number : 3920003

    Kōriyama, Fukushima, 963-8052

  • Investigational Site Number : 3920001

    Kyoto, 616-8255

  • Investigational Site Number : 3920010

    Sagamihara, Kanagawa, 252-0315

  • Investigational Site Number : 3920017

    Sapporo, Hokkaido, 063-0005

  • Investigational Site Number : 3920009

    Tachikawa, Tokyo, 190-8531

  • Investigational Site Number : 3920011

    Tokyo, 145-0065

  • Investigational Site Number : 3920004

    Tokyo, 152-8902

  • Investigational Site Number : 3920012

    Tokyo, 160-8582

  • Investigational Site Number : 3920008

    Yahaba, Iwate, 028-3695

Other trials in Japan

Spain15 sites

  • Investigational Site Number : 7241009

    Barakaldo, Basque Country, 48903

  • Investigational Site Number : 7240010

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number : 7240004

    Córdoba, 14004

  • Investigational Site Number : 7240013

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Investigational Site Number : 7240006

    Madrid, 28006

  • Investigational Site Number : 7241023

    Madrid, 28007

  • Investigational Site Number : 7240002

    Madrid, 28034

  • Investigational Site Number : 7240003

    Madrid, 28040

  • Investigational Site Number : 7241022

    Madrid, 28040

  • Investigational Site Number : 7240005

    Málaga, 29010

  • Investigational Site Number : 7240018

    Murcia, Almería, 30120

  • Investigational Site Number : 7241014

    Pontevedra, Pontevedra [Pontevedra], 36312

  • Investigational Site Number : 7240001

    Pozuelo de Alarcón, Madrid, 28223

  • Investigational Site Number : 7240007

    Seville, Sevilla, 41009

  • Investigational Site Number : 7240011

    Valladolid, 47003

Other trials in Spain

Germany14 sites

  • Investigational Site Number : 2761009

    Bielefeld, 33647

  • Investigational Site Number : 2761016

    Böblingen, 71034

  • Investigational Site Number : 2760010

    Bochum, 44791

  • Investigational Site Number : 2760012

    Dresden, 01307

  • Investigational Site Number : 2760002

    Düsseldorf, 40225

  • Investigational Site Number : 2761013

    Erbach im Odenwald, 64711

  • Investigational Site Number : 2761011

    Essen, 45147

  • Investigational Site Number : 2761017

    Giessen, 35392

  • Investigational Site Number : 2761014

    Heidelberg, 69117

  • Investigational Site Number : 2761007

    Jena, 07747

  • Investigational Site Number : 2760003

    Leipzig, 04103

  • Investigational Site Number : 2761008

    Marburg, 35043

  • Investigational Site Number : 2761006

    Münster, 48149

  • Investigational Site Number : 2760001

    Ulm, 89073

Other trials in Germany

Poland14 sites

  • Investigational Site Number : 6160018

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Investigational Site Number : 6161010

    Katowice, Silesian Voivodeship, 40-081

  • Investigational Site Number : 6160019

    Katowice, Silesian Voivodeship, 40-686

  • Investigational Site Number : 6161011

    Katowice, 40571

  • Investigational Site Number : 6161015

    Kielce, Świętokrzyskie Voivodeship, 25-726

  • Investigational Site Number : 6161005

    Krakow, Lesser Poland Voivodeship, 31-501

  • Investigational Site Number : 6161014

    Krakow, 31-271

  • Investigational Site Number : 6161008

    Lodz, Lódzkie, 90-324

  • Investigational Site Number : 6161017

    Lublin, Lublin Voivodeship, 20-002

  • Investigational Site Number : 6160002

    Plewiska, Greater Poland Voivodeship, 62-064

  • Investigational Site Number : 6160006

    Rzeszów, Podkarpackie Voivodeship, 35-055

  • Investigational Site Number : 6161016

    Warsaw, Masovian Voivodeship, 02-172

  • Investigational Site Number : 6160004

    Zabrze, Silesian Voivodeship, 41-800

  • Investigational Site Number : 6160020

    Żory, Silesian Voivodeship, 44-240

Other trials in Poland

Czechia11 sites

  • Investigational Site Number : 2031011

    Brno, 625 00

  • Investigational Site Number : 2030005

    Brno, 656 91

  • Investigational Site Number : 2030002

    Hradec Králové, 500 05

  • Investigational Site Number : 2030006

    Jihlava, 586 01

  • Investigational Site Number : 2031007

    Ostrava, 708 52

  • Investigational Site Number : 2030010

    Pardubice, 532 03

  • Investigational Site Number : 2031003

    Prague, 100 34

  • Investigational Site Number : 2031004

    Prague, 128 08

  • Investigational Site Number : 2031008

    Prague, 150 06

  • Investigational Site Number : 2031009

    Teplice, 415 01

  • Investigational Site Number : 2030001

    Zlín, 762 75

Other trials in Czechia

Bulgaria10 sites

  • Investigational Site Number : 1000009

    Blagoevgrad, 2700

  • Investigational Site Number : 1001008

    Panagyurishte, 4500

  • Investigational Site Number : 1000007

    Pazardzhik, 4400

  • Investigational Site Number : 1000002

    Pleven, 5800

  • Investigational Site Number : 1001010

    Pleven, 5800

  • Investigational Site Number : 1000004

    Sofia, 1407

  • Investigational Site Number : 1001001

    Sofia, 1431

  • Investigational Site Number : 1001006

    Sofia, 1606

  • Investigational Site Number : 1000005

    Sofia, 1680

  • Investigational Site Number : 1000012

    Sofia, 1700

Other trials in Bulgaria

India9 sites

  • Investigational Site Number : 3560002

    Chandigarh, 160012

  • Investigational Site Number : 3561008

    Hyderabad, 500082

  • Investigational Site Number : 3560020

    Kochi, 682040

  • Investigational Site Number : 3560010

    Nagpur, 440012

  • Investigational Site Number : 3561005

    Nashik, 422005

  • Investigational Site Number : 3560017

    New Delhi, 110029

  • Investigational Site Number : 3561023

    New Delhi, 110060

  • Investigational Site Number : 3561006

    Shimla, 171001

  • Investigational Site Number : 3561004

    Thiruvananthapuram, 695011

Other trials in India

Ukraine9 sites

  • Investigational Site Number : 8040007

    Chernivtsi, 58000

  • Investigational Site Number : 8040001

    Chernivtsi, 58023

  • Investigational Site Number : 8040009

    Ivano-Frankivsk, 76019

  • Investigational Site Number : 8041003

    Krykhivtsi, 76493

  • Investigational Site Number : 8041006

    Kyiv, 02091

  • Investigational Site Number : 8040008

    Lutsk, 43005

  • Investigational Site Number : 8040004

    Lviv, 79010

  • Investigational Site Number : 8041002

    Lviv, 79029

  • Investigational Site Number : 8041005

    Vinnytsia, 21050

Other trials in Ukraine

Canada8 sites

  • Investigational Site Number : 1240017

    Edmonton, Alberta, T6G 2B7

  • Investigational Site Number : 1240001

    Gatineau, Quebec, J8Y 1W2

  • Investigational Site Number : 1240004

    Granby, Quebec, J2G 1T7

  • Investigational Site Number : 1240008

    Lévis, Quebec, G6W 0M5

  • Investigational Site Number : 1240014

    London, Ontario, N6a 4l6

  • Investigational Site Number : 1240002

    Ottawa, Ontario, K1H 8L6

  • Investigational Site Number : 1240003

    Québec, Quebec, G1J 1Z4

  • Investigational Site Number : 1240007

    St. John's, Newfoundland and Labrador, A1B 3V6

Other trials in Canada

Argentina7 sites

  • Investigational Site Number : 0320002

    Buenos Aires, 1012

  • Investigational Site Number : 0320008

    Buenos Aires, 1023

  • Investigational Site Number : 0321010

    Buenos Aires, 1055

  • Investigational Site Number : 0320009

    Buenos Aires, 1060

  • Investigational Site Number : 0320001

    Buenos Aires, 1425

  • Investigational Site Number : 0321011

    Córdoba, 5004

  • Investigational Site Number : 0320003

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Mexico7 sites

  • Investigational Site Number : 4841005

    Culiacán, Sinaloa, 80020

  • Investigational Site Number : 4841007

    Guadalajara, Jalisco, 44670

  • Investigational Site Number : 4840011

    Mérida, Yucatán, 97070

  • Investigational Site Number : 4841009

    Mexico City, 04700

  • Investigational Site Number : 4840002

    Monterrey, Nuevo León, 64460

  • Investigational Site Number : 4841003

    Tlalnepantla, 54055

  • Investigational Site Number : 4840001

    Veracruz, 91900

Other trials in Mexico

South Korea7 sites

  • Investigational Site Number : 4100001

    Goyang-si, Gyeonggi-do, 10408

  • Investigational Site Number : 4100007

    Seongnam-si, Gyeonggi-do, 13620

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi, 02841

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 06351

  • Investigational Site Number : 4100008

    Seoul, Seoul-teukbyeolsi, 06591

Other trials in South Korea

France6 sites

  • Investigational Site Number : 2501017

    Calais, 62107

  • Investigational Site Number : 2501018

    Colmar, 68024

  • Investigational Site Number : 2501006

    La Tronche, 38700

  • Investigational Site Number : 2501009

    Lille, 59037

  • Investigational Site Number : 2501002

    Nice, 06001

  • Investigational Site Number : 2501010

    Saint-Herblain, 44800

Other trials in France

Portugal6 sites

  • Investigational Site Number : 6200001

    Braga, 4710-243

  • Investigational Site Number : 6201005

    Coimbra, 3000-075

  • Investigational Site Number : 6200009

    Guimarães, 4800-055

  • Investigational Site Number : 6201011

    Lisbon, 1169-050

  • Investigational Site Number : 6201012

    Lisbon, 1500-650

  • Investigational Site Number : 6200002

    Matosinhos Municipality, 4464-513

Other trials in Portugal

Chile5 sites

  • Investigational Site Number : 1521005

    Las Condes, 7550000

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8320325

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 8330032

  • Investigational Site Number : 1521001

    Santiago, Reg Metropolitana de Santiago, 8380456

  • Investigational Site Number : 1521003

    Santiago, 8431657

Other trials in Chile

Greece5 sites

  • Investigational Site Number : 3001005

    Athens, 124 62

  • Investigational Site Number : 3000004

    Ioannina, 455 00

  • Investigational Site Number : 3001001

    Larissa, 411 10

  • Investigational Site Number : 3000002

    Thessaloniki, 546 36

  • Investigational Site Number : 3001006

    Thessaloniki, 552 36

Other trials in Greece

Hungary5 sites

  • Investigational Site Number : 3481003

    Budapest, 1033

  • Investigational Site Number : 3481004

    Budapest, 1138

  • Investigational Site Number : 3480002

    Győr, 9024

  • Investigational Site Number : 3480001

    Kaposvár, 7400

  • Investigational Site Number : 3481005

    Pécs, 7623

Other trials in Hungary

United Kingdom5 sites

  • Investigational Site Number : 8261003

    Canterbury, Kent, CT1 3NG

  • Investigational Site Number : 8260001

    Exeter, Devon, EX2 5DW

  • Investigational Site Number : 8260010

    Inverness, Highland, IV2 3UJ

  • Investigational Site Number : 8260013

    London, England, E11 1NR

  • Investigational Site Number : 8261008

    Salford, Manchester, M6 8HD

Other trials in United Kingdom

Slovakia4 sites

  • Investigational Site Number : 7031001

    Bratislava - Kramare, 831 01

  • Investigational Site Number : 7030007

    Martin, 036 01

  • Investigational Site Number : 7030004

    Nitra, 950 01

  • Investigational Site Number : 7030003

    Trnava, 917 75

Other trials in Slovakia

Austria3 sites

  • Investigational Site Number : 0400001

    Innsbruck, 6020

  • Investigational Site Number : 0401002

    Linz, 4020

  • Investigational Site Number : 0401003

    Vienna, 1180

Other trials in Austria

Israel3 sites

  • Investigational Site Number : 3760001

    Haifa, 3109601

  • Investigational Site Number : 3760003

    Ramat Gan, 5262100

  • Investigational Site Number : 3760002

    Safed, 1311001

Other trials in Israel

Romania3 sites

  • Investigational Site Number : 6421004

    Bucharest, 050098

  • Investigational Site Number : 6420002

    Campulung Muscel, 115100

  • Investigational Site Number : 6421001

    Constanța, 900123

Other trials in Romania

Thailand3 sites

  • Investigational Site Number : 7641002

    Bangkok, 10330

  • Investigational Site Number : 7641001

    Bangkok, 10700

  • Investigational Site Number : 7641004

    Khon Kaen, 40002

Other trials in Thailand

Belgium2 sites

  • Investigational Site Number : 0560006

    Ghent, 9000

  • Investigational Site Number : 0560005

    Overpelt, 3900

Other trials in Belgium

Denmark2 sites

  • Investigational Site Number : 2081002

    Esbjerg, 6700

  • Investigational Site Number : 2081001

    Glostrup Municipality, 2600

Other trials in Denmark

Saudi Arabia2 sites

  • Investigational Site Number : 6820001

    Riyadh, 11461

  • Investigational Site Number : 6820002

    Riyadh, 11525

Other trials in Saudi Arabia

South Africa2 sites

  • Investigational Site Number : 7101002

    Cape Town, 7405

  • Investigational Site Number : 7101001

    Pretoria, 0040

Other trials in South Africa

United Arab Emirates2 sites

  • Investigational Site Number : 7840002

    Abu Dhabi, 15258

  • Investigational Site Number : 7841002

    Abu Dhabi, 15258

Other trials in United Arab Emirates

Croatia1 site

  • Investigational Site Number : 1911001

    Zagreb, 10000

Other trials in Croatia

Hong Kong1 site

  • Investigational Site Number : 3441001

    Shatin, 999077

Other trials in Hong Kong

Lithuania1 site

  • Investigational Site Number : 4401001

    Vilnius, 08661

Other trials in Lithuania

Malaysia1 site

  • Investigational Site Number : 4581001

    Kuala Lumpur, 50586

Other trials in Malaysia

Puerto Rico1 site

  • San Juan MS Center- Site Number : 8401106

    Guaynabo, 00969

Other trials in Puerto Rico

Singapore1 site

  • Investigational Site Number : 7021001

    Singapore, 308433

Other trials in Singapore

Switzerland1 site

  • Investigational Site Number : 7561001

    Bern, 3010

Other trials in Switzerland

Taiwan1 site

  • Investigational Site Number : 1581001

    Kaohsiung City, 833

Other trials in Taiwan

About this study

Official title: Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis

The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.

Study details include:

  • This event-driven study will have variable duration depending on the recruitment rate, the event rate, the study discontinuation rate and the 12-month minimum treatment duration. Different participants will have different study durations. The last participant randomized will have at least 12 months of study duration, and assuming a 28-month recruitment period, the first participant randomized will have 40 months or longer of study duration.
  • The study intervention duration will vary similarly as the study duration.
  • The scheduled visits will include monthly visits for the first 6 months and quarterly visits thereafter until the common end of study (EOS), or premature end of treatment (pEOT) after which 3 follow-up visits will be performed
Being tested
Frexalimab, Teriflunomide, Placebo infusion, Placebo tablet, MRI contrast-enhancing agents
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FrexalimabDrug

    SAR441344 Solution for IV infusion

  • TeriflunomideDrug

    Aubagio oral tablet

  • Placebo infusionDrug

    Solution for IV infusion

  • Placebo tabletDrug

    Oral tablet

  • MRI contrast-enhancing agentsDrug

    IV, as per respective label

  • CholestyramineDrug

    oral, 8 g 3 times daily for 11 days for accelerated elimination procedure (4 g 3 times daily for 11 days in case of intolerance). The teriflunomide local label should be followed.

  • Activated charcoalDrug

    oral, 50 g every 12 hours for 11 days for accelerated elimination procedure. The teriflunomide local label should be followed.

Study groups in NCT06141473
Study groupRoleWhat they receive
FrexalimabExperimentalParticipants will receive Frexalimab infusion and placebo tablet.
Receives: Drug: Frexalimab; Drug: Placebo tablet; Drug: MRI contrast-enhancing agents; Drug: Cholestyramine; Drug: Activated charcoal
TeriflunomideActive comparatorParticipants will receive teriflunomide tablet and placebo infusion.
Receives: Drug: Teriflunomide; Drug: Placebo infusion; Drug: MRI contrast-enhancing agents; Drug: Cholestyramine; Drug: Activated charcoal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses

    ARR during the study period assessed by protocol-defined adjudicated relapses. This endpoint will be analyzed in the ITT population of each study using a negative binomial model with the total number of adjudicated relapses per participant occurring during the observation period as the response variable and with terms for treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (<4, ≥4), and geographical region (US, non-US).

    Measured: Until Week 156

Secondary outcomes (16)

  1. Time to onset of composite confirmed disability worsening (cCDW)

    confirmed over 6 months as assessed by the composite of:

    • increase from the baseline expanded disability status scale (EDSS) score of ≥1.5 points when the baseline is 0, or ≥1.0 point when the baseline is 0.5 to 5.0, or ≥0.5 point when the baseline is ≥5.5, OR
    • increase of ≥20% from the baseline time in the 9-hole peg test (9HPT), OR
    • increase of ≥20% from the baseline time in the Timed 25-foot walk (T25FW) test

    Measured: Until Week 156

  2. Time to onset of cCDW, confirmed over 3 months

    Measured: Until Week 156

  3. Time to onset of individual components of the composite, confirmed over 3-months or 6-months

    Measured: Until Week 156

  4. Time to onset of confirmed disability improvement (CDI)

    defined as decrease from baseline EDSS score of ≥1.0 or ≥ 0.5 points when the baseline is ≥2 to ≤5.5 or >5.5 points, respectively, confirmed over 6 months. No improvement possible for 0 to 1.5 points

    Measured: Until Week 156

  5. Progression independent of relapse activity defined as the time to onset of 6-month cCDW

    defined by either no prior relapse or an onset more than 90 days after the start date of the last adjudicated relapse

    Measured: Until Week 156

  6. Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI

    defined as the sum of the individual number of new and/or enlarging T2 lesions at all scheduled visits starting after baseline up to and including the EOS visit

    Measured: Until Week 156

  7. Total number of new Gd-enhancing T1hyperintense lesions per scan as detected by MRI

    defined as the sum of the individual number of new Gd enhancing T1-hyperintense lesions at all scheduled visits starting after baseline up to and including the EOS visit divided by the number of scans

    Measured: Until Week 156

  8. Percent change in brain volume loss as detected by brain MRI scans at the EOS compared to Month 6

    Measured: From Week 24 to Week 156

  9. Change in cognitive function at the EOS compared to baseline as assessed by the symbol digit modalities test (SDMT)

    Measured: From baseline to Week 156

  10. Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time

    Measured: From baseline to Week 156

  11. Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue MS-8 over time

    Measured: Until Week 156

  12. Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs and safety scales during the study period

    Measured: Until Week 168

  13. Number of participants with potentially clinically significant abnormality (PCSAs) in laboratory tests, ECG and vital signs during the study period

    12-lead ECG (electrocardiogram) will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.

    Measured: Until Week 168

  14. Number of participants with antidrug (ADAs) over time

    Measured: Until Week 156

  15. Change from baseline in plasma neurofilament light chain (NfL) levels over time

    Measured: Until Week 144

  16. Frexalimab plasma concentration over time

    Measured: Until Week 144

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2023
  2. Study start13 Dec 2023
  3. Primary completion6 May 2027 (estimated)
  4. Study completion6 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,655 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06141473
Sponsor's protocol ID
EFC17919
Other IDs
2023-504358-36, U1111-1290-9326, 2023
Acronym
FREXALT
Status last verified
Jul 2026
First submitted
9 Nov 2023
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available.

    PubMed 39899371

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Frexalimab, Teriflunomide and MRI contrast-enhancing agents in people with Multiple Sclerosis, run by Sanofi at 382 sites in 41 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 382 sites in United States, China, Italy, Turkey (Türkiye), Brazil and 36 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses (time frame: Until Week 156). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06141473, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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