AzTrials
AzTrials

Multiple SclerosisPhase 3FREVIVANCT06141486

Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

A Phase 3 study testing Frexalimab and MRI contrast-enhancing agents in people with Multiple Sclerosis, run by Sanofi at 311 sites in 27 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 this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Frexalimab and MRI contrast-enhancing agents
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
943 participants
Where
311 sitesin 27 countries
Study dates
27 Dec 2023to 24 Mar 2028
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria.
  • Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee.
  • Participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee.
  • Absence of clinical relapses for at least 24 months.
  • The participant must have an EDSS score at screening from 3.0 to 6.5 points, inclusive.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • For patients eligible to be treated with siponimod: 1) does not tolerate it due to side effects or safety reasons, or 2) has failed siponimod treatment due to perceived lack of efficacy, or 3) has declined siponimod treatment.

Who cannot join

  • 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 immunoglobulin levels (IgG and/or IgM) below the lower limits of normal (LLN) at Screening or a history of primary hypogammaglobulinemia. Patients with a history of secondary hypogammaglobulinemia induced by anti-C20 monoclonal antibodies (eg, ocrelizumab, ofatumumab, ublituximab, rituximab) may be considered for study inclusion provided their immunoglobulin levels are within the normal limits (WNL) at time of Screening.
  • 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.
  • The participant has sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
  • The participant was previously exposed to frexalimab.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

311 sites in 27 countries.

311 sites in 27 countries

United States79 sites

  • The University of New Mexico- Site Number : 8400090

    Albuquerque, New Mexico, 87106

  • NeuroMedical Clinic of Central Louisiana- Site Number : 8400159

    Alexandria, Louisiana, 71301

  • Neurology of Central Florida- Site Number : 8400147

    Altamonte Springs, Florida, 32714

  • Dent Neurologic Institute - Amherst- Site Number : 8400129

    Amherst, New York, 14226

  • University of Colorado - Anschutz Medical Campus- Site Number : 8400001

    Aurora, Colorado, 80045

  • University of Maryland School of Medicine - Baltimore- Site Number : 8400185

    Baltimore, Maryland, 21201

  • Johns Hopkins Hospital- Site Number : 8400080

    Baltimore, Maryland, 21287

  • Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134

    Berkeley, California, 94705

  • Tufts Medical Center- Site Number : 8400003

    Boston, Massachusetts, 02111

  • Boston Clinical Trials- Site Number : 8400178

    Boston, Massachusetts, 02131

  • University of Vermont Medical Center- Site Number : 8400042

    Burlington, Vermont, 05401

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

    Charlotte, North Carolina, 28210

  • Rush University Medical Center- Site Number : 8400102

    Chicago, Illinois, 60612

  • University of Chicago Medical Center- Site Number : 8400055

    Chicago, Illinois, 60637

  • Riverhills Neuroscience- Site Number : 8400007

    Cincinnati, Ohio, 45212

  • University of Cincinnati Medical Center- Site Number : 8400117

    Cincinnati, Ohio, 45219

  • MS & Neuromuscular Center of Excellence- Site Number : 8400015

    Clearwater, Florida, 33761

  • The Ohio State University- Site Number : 8400009

    Columbus, Ohio, 43210

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

    Columbus, Ohio, 43235

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

    Dallas, Texas, 75243

  • UC Health - Elizabeth Place- Site Number : 8400008

    Dayton, Ohio, 45408

  • Henry Ford Hospital- Site Number : 8400091

    Detroit, Michigan, 48202

  • Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8400109

    Fairfax, Virginia, 22031

  • Sanford Brain and Spine Center- Site Number : 8400085

    Fargo, North Dakota, 58103

  • Michigan Institute for Neurological Disorders- Site Number : 8400004

    Farmington Hills, Michigan, 48334

  • Advanced Neurology of Colorado- Site Number : 8400148

    Fort Collins, Colorado, 80528

  • Neurology Center of New England- Site Number : 8400164

    Foxborough, Massachusetts, 02035

  • Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054

    Gainesville, Florida, 32608

  • Minneapolis Clinic of Neurology - Golden Valley- Site Number : 8400077

    Golden Valley, Minnesota, 55422

  • Trinity Health Grand Rapids- Site Number : 8400150

    Grand Rapids, Michigan, 49503

  • Premier Neurology- Site Number : 8400047

    Greer, South Carolina, 29650

  • Penn State Health Milton South Hershey Medical Center- Site Number : 8400176

    Hershey, Pennsylvania, 17033

  • Alabama Neurology Associates- Site Number : 8400115

    Homewood, Alabama, 35209

  • University of Iowa- Site Number : 8400029

    Iowa City, Iowa, 52242-1009

  • University of California Irvine - School of Medicine- Site Number : 8400143

    Irvine, California, 92697

  • University of Kansas Medical Center- Site Number : 8400084

    Kansas City, Kansas, 66103

  • University of California San Diego - La Jolla- Site Number : 8400095

    La Jolla, California, 92037

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

    Las Vegas, Nevada, 89106

  • Baptist Health Lexington- Site Number : 8400149

    Lexington, Kentucky, 40503

  • Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400184

    Los Angeles, California, 90027

  • Neurology Associates - Maitland- Site Number : 8400010

    Maitland, Florida, 32751

  • Neuroscience Institute Center- Site Number : 8400053

    Merrillville, Indiana, 46410

  • 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

  • Vanderbilt Multiple Sclerosis Center- Site Number : 8400130

    Nashville, Tennessee, 37215

  • Yale University School of Medicine- Site Number : 8400081

    New Haven, Connecticut, 06510

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

    New Orleans, Louisiana, 70121

  • Icahn School of Medicine at Mount Sinai- Site Number : 8400011

    New York, New York, 10029

  • Columbia University Irving Medical Center- Site Number : 8400088

    New York, New York, 10032

  • Hoag Memorial Hospital Presbyterian- Site Number : 8400031

    Newport Beach, California, 92663

  • Consultants in Neurology- Site Number : 8400020

    Northbrook, Illinois, 60062

  • Hartford Healthcare Medical Group- Site Number : 8400069

    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

  • Stanford Neuroscience Health Center- Site Number : 8400120

    Palo Alto, California, 94304

  • North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083

    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 : 8400172

    Rochester Hills, Michigan, 48307

  • Neurology Center of San Antonio- Site Number : 8400099

    San Antonio, Texas, 78258

  • Perseverance Research Center- Site Number : 8400138

    Scottsdale, Arizona, 85253

  • Imaging Endpoints- Site Number : 8400050

    Scottsdale, Arizona, 85258

  • Swedish Medical Center - Seattle- Site Number : 8400078

    Seattle, Washington, 98104

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

    Sherman, Texas, 75092

  • Joi Life Wellness Group LLC- Site Number : 8400192

    Smyrna, Georgia, 30080

  • Washington University- Site Number : 8400076

    St Louis, Missouri, 63110

  • Axiom Clinical Research of Florida- Site Number : 8400049

    Tampa, Florida, 33609

  • University of South Florida- Site Number : 8400013

    Tampa, Florida, 33612

  • Holy Name Medical Center- Site Number : 8400101

    Teaneck, New Jersey, 07666

  • MedStar Georgetown University Hospital- Site Number : 8400044

    Washington D.C., District of Columbia, 20007

  • The Elliot Lewis Center- Site Number : 8400033

    Wellesley, Massachusetts, 02481

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

    West Hollywood, California, 90048

  • Palm Beach Neurology- Site Number : 8400105

    West Palm Beach, Florida, 33407

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

    Winston-Salem, North Carolina, 27103

  • UMass Memorial Medical Center - University Campus- Site Number : 8400028

    Worcester, Massachusetts, 01655

Other trials in United States

Spain22 sites

  • Investigational Site Number : 7240009

    Barakaldo, Basque Country, 48903

  • Investigational Site Number : 7240016

    Barcelona, Barcelona [Barcelona], 08003

  • Investigational Site Number : 7240010

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number : 7240004

    Córdoba, 14004

  • Investigational Site Number : 7240012

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Investigational Site Number : 7240024

    Girona, Girona [Gerona], 17190

  • Investigational Site Number : 7240011

    L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907

  • Investigational Site Number : 7240013

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Investigational Site Number : 7240015

    Lleida, Lleida [Lérida], 25198

  • Investigational Site Number : 7240006

    Madrid, 28006

  • Investigational Site Number : 7240023

    Madrid, 28007

  • Investigational Site Number : 7240002

    Madrid, 28034

  • Investigational Site Number : 7240003

    Madrid, 28040

  • Investigational Site Number : 7240022

    Madrid, 28040

  • Investigational Site Number : 7240017

    Majadahonda, Madrid, 28222

  • Investigational Site Number : 7240005

    Málaga, 29010

  • Investigational Site Number : 7240018

    Murcia, Almería, 30120

  • Investigational Site Number : 7240014

    Pontevedra, Pontevedra [Pontevedra], 36312

  • Investigational Site Number : 7240001

    Pozuelo de Alarcón, Madrid, 28223

  • Investigational Site Number : 7240007

    Seville, Sevilla, 41009

  • Investigational Site Number : 7240008

    Valencia, 46026

  • Investigational Site Number : 7240025

    Zaragoza, 50009

Other trials in Spain

Italy21 sites

  • Investigational Site Number : 3800034

    Augusta, Catania, 96011

  • Investigational Site Number : 3800009

    Bologna, 40139

  • Investigational Site Number : 3800006

    Cefalù, Palermo, 90015

  • Investigational Site Number : 3800014

    Chieti, 66100

  • Investigational Site Number : 3800025

    Cona, Ferrara, 44124

  • Investigational Site Number : 3800004

    Florence, Firenze, 50134

  • Investigational Site Number : 3800019

    Foggia, 71100

  • Investigational Site Number : 3800035

    Gallarate, Varese, 21013

  • Investigational Site Number : 3800011

    Genoa, Genova, 16132

  • Investigational Site Number : 3800002

    Milan, Milano, 20132

  • Investigational Site Number : 3800016

    Milan, Milano, 20133

  • Investigational Site Number : 3800010

    Naples, Napoli, 80131

  • Investigational Site Number : 3800026

    Novara, 28100

  • Investigational Site Number : 3800017

    Palermo, 90127

  • Investigational Site Number : 3800029

    Parma, 43100

  • Investigational Site Number : 3800005

    Pavia, 27100

  • Investigational Site Number : 3800003

    Perugia, 06156

  • Investigational Site Number : 3800030

    Ravenna, 48121

  • Investigational Site Number : 3800001

    Rome, Roma, 00149

  • Investigational Site Number : 3800013

    Rome, Roma, 00161

  • Investigational Site Number : 3800021

    Rome, Roma, 00168

Other trials in Italy

Turkey (Türkiye)19 sites

  • Investigational Site Number : 7920018

    Ankara, 06010

  • Investigational Site Number : 7920011

    Ankara, 06800

  • Investigational Site Number : 7920020

    Bursa, 16059

  • Investigational Site Number : 7920013

    Bursa, 16310

  • Investigational Site Number : 7920005

    Eskişehir, 26480

  • Investigational Site Number : 7920012

    Istanbul, 34010

  • Investigational Site Number : 7920002

    Istanbul, 34098

  • Investigational Site Number : 7920016

    Istanbul, 34200

  • Investigational Site Number : 7920009

    Istanbul, 34668

  • Investigational Site Number : 7920007

    Istanbul, 34785

  • Investigational Site Number : 7920019

    Izmir, 35340

  • Investigational Site Number : 7920008

    Izmir, 35360

  • Investigational Site Number : 7920001

    İzmit, 41001

  • Investigational Site Number : 7920014

    Kayseri, 38039

  • Investigational Site Number : 7920015

    Konya, 42075

  • Investigational Site Number : 7920006

    Mersin, 33070

  • Investigational Site Number : 7920004

    Samsun, 55139

  • Investigational Site Number : 7920003

    Sultangazi, 34265

  • Investigational Site Number : 7920017

    Van, 65080

Other trials in Turkey (Türkiye)

China16 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 : 1560045

    Fuzhou, 350005

  • Investigational Site Number : 1560002

    Guangzhou, 510630

  • Investigational Site Number : 1561027

    Harbin, 150001

  • Investigational Site Number : 1560010

    Jiazhuang, 050000

  • Investigational Site Number : 1560001

    Shanghai, 200040

  • Investigational Site Number : 1560006

    Taiyuan, 030001

  • Investigational Site Number : 1560012

    Tianjin, 300121

  • Investigational Site Number : 1560009

    Wuhan, 430030

  • Investigational Site Number : 1560013

    Xi'an, 710038

  • Investigational Site Number : 1560034

    Zhengzhou, 450052

Other trials in China

Brazil15 sites

  • Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0760025

    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 : 0760001

    Curitiba, Paraná, 81210-310

  • Universidade Federal de Goias- Site Number : 0760024

    Goiânia, Goiás, 74605-020

  • Clínica Neurológica- Site Number : 0760007

    Joinville, Santa Catarina, 89202-165

  • Hospital Moinhos de Vento- Site Number : 0760005

    Porto Alegre, Rio Grande do Sul, 90035-902

  • IMV Pesquisa Neurológica- Site Number : 0760031

    Porto Alegre, Rio Grande do Sul, 90110-000

  • Instituto Ceos- Site Number : 0760028

    Porto Alegre, Rio Grande do Sul, 90480-020

  • Centro de Pesquisas da Clínica IBIS- Site Number : 0760030

    Salvador, Estado de Bahia, 41820-020

  • Prognosis Centro de Pesquisa- Site Number : 0760032

    Santo André, São Paulo, 09040-010

  • CPHosp Medicina, Ensino e Pesquisa (CPQuali)- Site Number : 0760002

    São Paulo, 01228-000

  • PSEG Centro de Pesquisa Clínica- Site Number : 0760021

    São Paulo, 04038-002

  • Jordy Sinapse- Site Number : 0760004

    São Paulo, 04515-000

  • Hospital Israelita Albert Einstein- Site Number : 0760026

    São Paulo, 05651-901

  • Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760029

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Canada13 sites

  • Investigational Site Number : 1240005

    Burnaby, British Columbia, V5G 2X6

  • Investigational Site Number : 1240011

    Calgary, Alberta, T2N 2T9

  • Investigational Site Number : 1240001

    Gatineau, Quebec, J8Y 1W2

  • Investigational Site Number : 1240008

    Lévis, Quebec, G6W 0M5

  • Investigational Site Number : 1240014

    London, Ontario, N6A 5A5

  • Investigational Site Number : 1240018

    Moncton, New Brunswick, E1C 2Z3

  • Investigational Site Number : 1240009

    Montreal, Quebec, H2X 3E4

  • Investigational Site Number : 1240002

    Ottawa, Ontario, K1H 8L6

  • Investigational Site Number : 1240003

    Québec, Quebec, G1J 1Z4

  • Investigational Site Number : 1240006

    Sherbrooke, Quebec, J1H 5N4

  • Investigational Site Number : 1240015

    Toronto, Ontario, M4N 3M5

  • Investigational Site Number : 1240012

    Toronto, Ontario, M5B 1W8

  • Investigational Site Number : 1240010

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

Japan13 sites

  • Investigational Site Number : 3920014

    Asahikawa, Hokkaido, 070-0901

  • 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 : 3920007

    Himeji, Hyōgo, 670-8560

  • 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 : 3920011

    Tokyo, 145-0065

  • Investigational Site Number : 3920012

    Tokyo, 160-8582

  • Investigational Site Number : 2500015

    Toyama, 939-2716

Other trials in Japan

France12 sites

  • Investigational Site Number : 2500005

    Créteil, 94010

  • Investigational Site Number : 2500017

    Gonesse, 95500

  • Investigational Site Number : 2500006

    La Tronche, 38700

  • Investigational Site Number : 2500009

    Lille, 59037

  • Investigational Site Number : 2500016

    Nancy, 54035

  • Investigational Site Number : 2500002

    Nice, 06001

  • Investigational Site Number : 2500018

    Orsay, 91400

  • Investigational Site Number : 2500007

    Paris, 75019

  • Investigational Site Number : 2500014

    Paris, 75651

  • Investigational Site Number : 2500003

    Rennes, 35033

  • Investigational Site Number : 2500010

    Saint-Herblain, 44800

  • Investigational Site Number : 2500001

    Strasbourg, 67200

Other trials in France

Germany12 sites

  • Investigational Site Number : 2760009

    Bielefeld, 33647

  • Investigational Site Number : 2760010

    Bochum, 44791

  • Investigational Site Number : 2760012

    Dresden, 01307

  • Investigational Site Number : 2760002

    Düsseldorf, 40225

  • Investigational Site Number : 2760013

    Erbach im Odenwald, 64711

  • Investigational Site Number : 2760011

    Essen, 45147

  • Investigational Site Number : 2760014

    Heidelberg, 69117

  • Investigational Site Number : 2760007

    Jena, 07747

  • Investigational Site Number : 2760003

    Leipzig, 04103

  • Investigational Site Number : 2760008

    Marburg, 35043

  • Investigational Site Number : 2760006

    Münster, 48149

  • Investigational Site Number : 2760001

    Ulm, 89073

Other trials in Germany

United Kingdom11 sites

  • Investigational Site Number : 8260003

    Canterbury, Kent, CT1 3NG

  • Investigational Site Number : 8260007

    Cardiff, Cardiff [Caerdydd Gb-crd], CF14 4XW

  • Investigational Site Number : 8260001

    Exeter, Devon, EX2 5DW

  • Investigational Site Number : 8260011

    Gwent, Blaenau Gwent, NP20 2UB

  • Investigational Site Number : 8260010

    Inverness, Highland, IV2 3UJ

  • Investigational Site Number : 8260009

    Liverpool, L97LJ

  • Investigational Site Number : 8260013

    London, England, E11 1NR

  • Investigational Site Number : 8260006

    Newcastle upon Tyne, England, NE2 4HH

  • Investigational Site Number : 8260004

    Oxford, Oxfordshire, OX3 9DU

  • Investigational Site Number : 8260008

    Salford, Manchester, M6 8HD

  • Investigational Site Number : 8260005

    Swansea, Swansea [Abertawe Gb-ata], SA6 6SG

Other trials in United Kingdom

Bulgaria9 sites

  • Investigational Site Number : 1000009

    Blagoevgrad, 2700

  • Investigational Site Number : 1000008

    Panagyurishte, 4500

  • Investigational Site Number : 1000007

    Pazardzhik, 4400

  • Investigational Site Number : 1000002

    Pleven, 5800

  • Investigational Site Number : 1000010

    Pleven, 5800

  • Investigational Site Number : 1000004

    Sofia, 1407

  • Investigational Site Number : 1000001

    Sofia, 1431

  • Investigational Site Number : 1000006

    Sofia, 1606

  • Investigational Site Number : 1000005

    Sofia, 1680

Other trials in Bulgaria

Czechia8 sites

  • Investigational Site Number : 2030011

    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 : 2030007

    Ostrava, 708 52

  • Investigational Site Number : 2030008

    Prague, 150 06

  • Investigational Site Number : 2030009

    Teplice, 415 01

  • Investigational Site Number : 2030001

    Zlín, 762 75

Other trials in Czechia

Poland8 sites

  • Investigational Site Number : 6160007

    Bialystok, Podlaskie Voivodeship, 15-276

  • Investigational Site Number : 6160018

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Investigational Site Number : 6160010

    Katowice, Silesian Voivodeship, 40-081

  • Investigational Site Number : 6160011

    Katowice, 40571

  • Investigational Site Number : 6160005

    Krakow, Lesser Poland Voivodeship, 31-501

  • Investigational Site Number : 6160012

    Poznan, Greater Poland Voivodeship, 60-309

  • Investigational Site Number : 6160006

    Rzeszów, Podkarpackie Voivodeship, 35-055

  • Investigational Site Number : 6160004

    Zabrze, Silesian Voivodeship, 41-800

Other trials in Poland

Ukraine8 sites

  • Investigational Site Number : 8040001

    Chernivtsi, 58023

  • Investigational Site Number : 8040009

    Ivano-Frankivsk, 76019

  • Investigational Site Number : 8040003

    Krykhivtsi, 76493

  • Investigational Site Number : 8040006

    Kyiv, 02091

  • Investigational Site Number : 8040008

    Lutsk, 43005

  • Investigational Site Number : 8040004

    Lviv, 79010

  • Investigational Site Number : 8040002

    Lviv, 79029

  • Investigational Site Number : 8040005

    Vinnytsia, 21050

Other trials in Ukraine

Belgium6 sites

  • Investigational Site Number : 0560001

    Bruges, 8000

  • Investigational Site Number : 0560008

    Brussels, 1200

  • Investigational Site Number : 0560006

    Ghent, 9000

  • Investigational Site Number : 0560007

    Kortrijk, 8500

  • Investigational Site Number : 0560003

    Melsbroek, 1820

  • Investigational Site Number : 0560005

    Overpelt, 3900

Other trials in Belgium

Argentina5 sites

  • Investigational Site Number : 0320002

    Buenos Aires, 1012

  • Investigational Site Number : 0321010

    Buenos Aires, 1055

  • Investigational Site Number : 0320007

    Buenos Aires, 1060

  • Investigational Site Number : 0320001

    Buenos Aires, 1425

  • Investigational Site Number : 0320003

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Greece5 sites

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About this study

Official title: A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis

The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS 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 end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end.
  • The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.
  • If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months.
Being tested
Frexalimab, Placebo, 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

  • PlaceboDrug

    Solution for IV infusion

  • MRI contrast-enhancing agentsDrug

    IV, as per respective label

Study groups in NCT06141486
Study groupRoleWhat they receive
FrexalimabExperimentalFrexalimab IV administration
Receives: Drug: Frexalimab; Drug: MRI contrast-enhancing agents
PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Placebo; Drug: MRI contrast-enhancing agents

What is being measured

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

  1. Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months in the double-blind treatment period

    Defined as Increase from the baseline expanded disability status scale (EDSS) score of ≥1.0 point when the baseline is <5.5, 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: Up to 36 months

Secondary outcomes (15)

  1. Time to onset of composite cCDP confirmed over 3 months in the double-blind treatment period

    Measured: Up to 36 months

  2. Time to onset of individual components of the composite, confirmed over 3-months or 6 months in the double-blind treatment period

    increase from the baseline EDSS score of ≥1.0 point when the baseline is <5.5, or ≥0.5 point when the baseline is ≥5.5

    Measured: Up to 36 months

  3. Time to onset of confirmed disability improvement (CDI) in the double-blind treatment period

    defined as decrease from the baseline EDSS score of ≥1.0 or ≥ 0.5 points when baseline is ≤5.5 or >5.5 points, respectively, confirmed over 6 months.

    Measured: Up to 36 months

  4. Number of new and/or enlarging T2hyperintense lesions per scan as detected by MRI, and number of new and/or enlarging T2-hyperintense lesions per scan as detected by MRI

    defined as the sum of the individual number of new and/or enlarging T2-hyperintense lesions at all scheduled visits starting after baseline up to the end of double-blind treatment period

    Measured: Up to 36 months

  5. Percent change in brain volume loss as detected by MRI scans at the end of double-blind treatment period compared to Month 6

    Measured: Up to 36 months

  6. Change in cognitive function at the end of double-blind treatment period compared to baseline as assessed by symbol digit modalities test (SDMT)

    Measured: Baseline, Up to 36 months

  7. Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time in the double-blind treatment period

    Measured: Baseline, Up to 36 months

  8. Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue multiple sclerosis (MS)-8a over time in the double-blind treatment period

    Measured: Baseline, Up to 36 months

  9. Annualized relapse rate during the double-blind treatment period assessed by protocol defined adjudicated relapses

    Measured: Up to 36 months

  10. Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation and AE of special interests (AESIs)

    Measured: Up to 36 months

  11. Number of participants with potentially clinically significant abnormalities (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: Up to 36 months

  12. Number of participants with antibody over time

    Measured: Up to 36 months

  13. Change from baseline in serum Ig levels over time

    Measured: Up to 36 months

  14. Change from baseline in plasma neurofilament light chain (NfL) levels over time in the double-blind treatment period

    Measured: Up to 36 months

  15. Frexalimab plasma concentration over time in the double-blind treatment period

    Measured: Up to 36 months

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 start27 Dec 2023
  3. Primary completion24 Mar 2028 (estimated)
  4. Study completion24 Mar 2028 (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
943 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06141486
Sponsor's protocol ID
EFC17504
Other IDs
U1111-1280-7114, 2023-504359-29, 2023
Acronym
FREVIVA
Status last verified
May 2026
First submitted
9 Nov 2023
Last updated
14 May 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Frexalimab and MRI contrast-enhancing agents in people with Multiple Sclerosis, run by Sanofi at 311 sites in 27 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 8 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 311 sites in United States, Spain, Italy, Turkey (Türkiye), China and 22 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. Some participants in this study may receive a placebo. 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?

Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months in the double-blind treatment period (time frame: Up to 36 months). 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 NCT06141486.

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 14 May 2026.

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