Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
Launched by SANOFI · Nov 15, 2023
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness and safety of a medication called frexalimab (also known as SAR441344) for adults who have relapsing forms of multiple sclerosis (MS). The goal is to see how well frexalimab works in preventing MS relapses compared to another medication called teriflunomide. To participate, individuals must be between 18 and 55 years old and have been diagnosed with relapsing MS, showing signs of recent relapses or specific MRI findings.
Participants in the trial will have regular visits to monitor their health, starting with visits every four weeks for the first six months, and then every three months thereafter. The entire study duration varies but will last approximately 20 to 40 months, depending on when they join. It’s important to note that certain health conditions or recent relapses may prevent someone from participating. This study is currently recruiting participants, and anyone interested should check with their healthcare provider to see if they qualify.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.
- • History or current hypogammaglobulinemia defined by values below the lower limit of normal (LLN).
- • 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 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.
About Sanofi
Sanofi is a global healthcare leader dedicated to empowering life through innovation in pharmaceuticals and vaccines. With a strong commitment to research and development, Sanofi focuses on addressing complex health challenges across various therapeutic areas, including diabetes, oncology, immunology, and rare diseases. The company leverages advanced science and technology to develop transformative therapies that improve patient outcomes. Through collaborative partnerships and a patient-centric approach, Sanofi strives to enhance global health and deliver sustainable solutions that meet the evolving needs of healthcare systems and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Fairfax, Virginia, United States
Milwaukee, Wisconsin, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Tianjin, , China
Birmingham, Alabama, United States
Carlsbad, California, United States
Statesville, North Carolina, United States
Scottsdale, Arizona, United States
Irvine, California, United States
Savannah, Georgia, United States
Iowa City, Iowa, United States
Verona, , Italy
Katowice, Slaskie, Poland
Katowice, Slaskie, Poland
Zabrze, Slaskie, Poland
Kielce, Swietokrzyskie, Poland
Lublin, , Poland
Buenos Aires, , Argentina
Yinchuan, , China
Québec City, Quebec, Canada
Nashik, , India
Thiruvananthapuram, , India
Rome, Roma, Italy
Goiânia, Goiás, Brazil
Laguna Hills, California, United States
Alexandria, Louisiana, United States
Baton Rouge, Louisiana, United States
Albuquerque, New Mexico, United States
Charlotte, North Carolina, United States
Dayton, Ohio, United States
Seattle, Washington, United States
Tacoma, Washington, United States
São Paulo, , Brazil
Prague, , Czechia
Bochum, , Germany
Athens, , Greece
Pecs, , Hungary
Genoa, Genova, Italy
Rome, Roma, Italy
Rome, Roma, Italy
Foggia, , Italy
Pavia, , Italy
Kodaira, Tokyo, Japan
Fukuoka, , Japan
Lodz, Lódzkie, Poland
Plewiska, Wielkopolskie, Poland
Zory, , Poland
Guimaraes, , Portugal
Lisbon, , Portugal
Constanta, , Romania
Valencia, , Spain
Sultangazi, , Turkey
Tlalnepantla De Baz, , Mexico
Martin, , Slovakia
Homewood, Alabama, United States
Kaposvár, , Hungary
Zory, Slaskie, Poland
Brasília, Distrito Federal, Brazil
Guadalajara, Jalisco, Mexico
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Scottsdale, Arizona, United States
West Hollywood, California, United States
Aurora, Colorado, United States
Fort Collins, Colorado, United States
Norwich, Connecticut, United States
Tampa, Florida, United States
Northbrook, Illinois, United States
Springfield, Illinois, United States
Merrillville, Indiana, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
New Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
Fargo, North Dakota, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Knoxville, Tennessee, United States
San Antonio, Texas, United States
Sherman, Texas, United States
Vienna, Virginia, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Paulo, São Paulo, Brazil
Edmonton, Alberta, Canada
Dongguan, , China
Brno, , Czechia
Sapporo Shi, Hokkaido, Japan
Matosinhos, , Portugal
Campulung Muscel, , Romania
Sevilla, Andalucia, Spain
Valladolid, , Spain
Delhi, , India
Abington, Pennsylvania, United States
Santiago, , Chile
Irvine, California, United States
Orlando, Florida, United States
Saint Louis, Missouri, United States
Portland, Oregon, United States
Greenville, South Carolina, United States
Fairfax, Virginia, United States
Tacoma, Washington, United States
Joinville, Santa Catarina, Brazil
Sao Paulo, São Paulo, Brazil
Santiago De Chile, , Chile
Murcia, , Spain
Innsbruck, , Austria
Leipzig, , Germany
Boca Raton, Florida, United States
Charlotte, North Carolina, United States
Plano, Texas, United States
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Katowice, , Poland
Katowice, , Poland
Scottsdale, Arizona, United States
Santo André, São Paulo, Brazil
Overland Park, Kansas, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Chieti, , Italy
Aurora, Colorado, United States
Stamford, Connecticut, United States
Morioka Shi, Iwate, Japan
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Eskisehir, , Turkey
Iowa City, Iowa, United States
Plymouth, Minnesota, United States
Konya, , Turkey
Chiba, , Japan
Madrid, Madrid, Comunidad De, Spain
Kyiv, , Ukraine
Guimaraes, , Portugal
Lutsk, , Ukraine
Philadelphia, Pennsylvania, United States
Vilnius, , Lithuania
Lancaster, California, United States
Baton Rouge, Louisiana, United States
Seattle, Washington, United States
Menomonee Falls, Wisconsin, United States
Panagyurishte, , Bulgaria
Pleven, , Bulgaria
Brno, , Czechia
Milan, Lombardia, Italy
Caserta, , Italy
Ferrara, , Italy
Palermo, , Italy
Culiacan, Sinaloa, Mexico
Lisbon, , Portugal
Izmit, , Turkey
Vinnytsia, , Ukraine
Salford, , United Kingdom
West Palm Beach, Florida, United States
Evanston, Illinois, United States
Owosso, Michigan, United States
Winston Salem, North Carolina, United States
Oklahoma City, Oklahoma, United States
San Antonio, Texas, United States
Santiago De Chile, , Chile
Haifa, , Israel
Phoenix, Arizona, United States
Belo Horizonte, Minas Gerais, Brazil
Vancouver, , Canada
Hohhot, , China
Ravenna, , Italy
Orlando, Florida, United States
Reno, Nevada, United States
Raleigh, North Carolina, United States
Northbrook, Illinois, United States
Knoxville, Tennessee, United States
Altamonte Springs, Florida, United States
Merrillville, Indiana, United States
Centerville, Ohio, United States
Guaynabo, , Puerto Rico
Canterbury, Kent, United Kingdom
Plano, Texas, United States
Sherman, Texas, United States
Granby, Quebec, Canada
San Antonio, Texas, United States
Farmington Hills, Michigan, United States
Denver, Colorado, United States
Roeland Park, Kansas, United States
St. Johns, Newfoundland And Labrador, Canada
Como, , Italy
Modena, , Italy
Palermo, , Italy
Ferrara, , Italy
Lancaster, California, United States
Charlotte, North Carolina, United States
Levis, Quebec, Canada
Pécs, , Hungary
Phoenix, Arizona, United States
Laguna Hills, California, United States
Altamonte Springs, Florida, United States
Maitland, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Savannah, Georgia, United States
Farmington Hills, Michigan, United States
Saint Louis, Missouri, United States
Las Vegas, Nevada, United States
Lebanon, New Hampshire, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Dallas, Texas, United States
Plano, Texas, United States
London, Ontario, Canada
Thessaloniki, , Greece
Koriyama Shi, Fukushima, Japan
Guaynabo, , Puerto Rico
Boston, Massachusetts, United States
Ciudad De Córdoba, Córdoba, Argentina
Changchun, , China
Chengdu, , China
Ivano Frankivsk, , Ukraine
Kaohsiung, , Taiwan
Foxboro, Massachusetts, United States
Plymouth, Minnesota, United States
Chernivtsi, , Ukraine
Madrid, , Spain
Cullman, Alabama, United States
Scottsdale, Arizona, United States
Carlsbad, California, United States
Stamford, Connecticut, United States
Washington, District Of Columbia, United States
Boca Raton, Florida, United States
Evanston, Illinois, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Lutherville, Maryland, United States
Foxboro, Massachusetts, United States
Ozark, Missouri, United States
Reno, Nevada, United States
Winston Salem, North Carolina, United States
Centerville, Ohio, United States
Oklahoma City, Oklahoma, United States
Abington, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Salt Lake City, Utah, United States
Gent, , Belgium
Porto Alegre, Rio Grande Do Sul, Brazil
Santo Andre, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Foggia, , Italy
Madrid, , Spain
New Brunswick, New Jersey, United States
Dayton, Ohio, United States
Caba, Buenos Aires, Argentina
Caba, Ciudad De Buenos Aires, Argentina
Caba, Ciudad De Buenos Aires, Argentina
Joinville, Santa Catarina, Brazil
Beijing, , China
Hangzhou, , China
Nanjing, , China
Pune, , India
Ota Ku, Tokyo, Japan
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Istanbul, , Turkey
Exeter, Devon, United Kingdom
Birmingham, Alabama, United States
Cullman, Alabama, United States
Norwich, Connecticut, United States
Washington, District Of Columbia, United States
Albuquerque, New Mexico, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Chengdu, , China
Chongqing, , China
Wenzhou, , China
Wuhan, , China
Bursa, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Van, , Turkey
Blagoevgrad, , Bulgaria
Sofia, , Bulgaria
Hradec Králové, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Teplice, , Czechia
Esbjerg, , Denmark
Shimla, , India
Asahikawa, Hokkaido, Japan
Goyang Si, Gyeonggi Do, Korea, Republic Of
Heerlen, , Netherlands
Braga, , Portugal
Coimbra, , Portugal
Nitra, , Slovakia
Trnava, , Slovakia
Barakaldo, Bizkaia, Spain
Donostia San Sebastian, Gipuzkoa, Spain
Madrid, Madrid, Comunidad De, Spain
Kaohsiung City, , Taiwan
Krykhivtsi, , Ukraine
Louisville, Kentucky, United States
Minneapolis, Minnesota, United States
Rosario, Santa Fe, Argentina
Salvador, Bahia, Brazil
Catania, , Italy
Napoli, , Italy
Udine, , Italy
Kielce, , Poland
Guimarães, , Portugal
Tampa, Florida, United States
Louisville, Kentucky, United States
Dongguan, , China
Jinan, , China
Shenyang, , China
Shijiazhuang, , China
Suzhou, , China
Seongnam, Gyeonggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Ankara, , Turkey
London, London, City Of, United Kingdom
Taiyuan, , China
Gatineau, Quebec, Canada
Owosso, Michigan, United States
Patchogue, New York, United States
Linz, , Austria
Ottawa, Ontario, Canada
Glostrup, , Denmark
Münster, , Germany
Győr, , Hungary
Rome, Roma, Italy
Krakow, Malopolskie, Poland
Krakow, , Poland
Warszawa, , Poland
Bucharest, , Romania
Ankara, , Turkey
West Hollywood, California, United States
Lutherville, Maryland, United States
Ozark, Missouri, United States
Cullman, Alabama, United States
Fort Collins, Colorado, United States
Tampa, Florida, United States
Lviv, , Ukraine
Lviv, , Ukraine
Vienna, Virginia, United States
Milwaukee, Wisconsin, United States
Quebec, , Canada
Shanghai, , China
Kyoto Shi, Kyoto, Japan
Samsun, , Turkey
San Antonio, Texas, United States
Saint Louis, Missouri, United States
Springfield, Illinois, United States
Saint Louis, Missouri, United States
Las Vegas, Nevada, United States
Columbus, Ohio, United States
Salt Lake City, Utah, United States
Santiago, Reg Metropolitana De Santiago, Chile
Beijing, , China
Changchun, , China
Zefat, , Israel
Kocaeli, , Turkey
Mersin, , Turkey
Birmingham, Alabama, United States
Cullman, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Carlsbad, California, United States
Irvine, California, United States
West Hollywood, California, United States
Aurora, Colorado, United States
Fort Collins, Colorado, United States
Washington, District Of Columbia, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Savannah, Georgia, United States
Evanston, Illinois, United States
Overland Park, Kansas, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
Rochester Hills, Michigan, United States
Columbus, Ohio, United States
Buenos Aires, , Argentina
Overpelt, , Belgium
Porto Alegre, Rio Grande Do Sul, Brazil
Jiazhuang, , China
Jinan, , China
Wenzhou, , China
Xi An, , China
Brno, , Czechia
Hradec Kralove, , Czechia
Nice, , France
Saint Herblain, , France
Ioannina, , Greece
Larissa, , Greece
Thessaloniki, , Greece
Koriyama, Fukushima, Japan
Asahikawa, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Morioka, Iwate, Japan
Sagamihara, Kanagawa, Japan
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Bydgoszcz, Kujawsko Pomorskie, Poland
Katowice, Slaskie, Poland
Zabrze, , Poland
Guimarã£Es, , Portugal
Câmpulung, , Romania
Samsun, , Turkey
Scottsdale, Arizona, United States
Maitland, Florida, United States
Overland Park, Kansas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Sherman, Texas, United States
Salt Lake City, Utah, United States
Vienna, Virginia, United States
Philadelphia, Pennsylvania, United States
Springfield, Illinois, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Buenos Aires, Ciudad De Buenos Aires, Argentina
Buenos Aires, Ciudad De Buenos Aires, Argentina
Grenoble, , France
Florence, Firenze, Italy
Sofia, , Bulgaria
Prague, , Czechia
Safed, , Israel
Tachikawa, Tokyo, Japan
Boston, Massachusetts, United States
Las Vegas, Nevada, United States
Bronx, New York, United States
Dayton, Ohio, United States
Hershey, Pennsylvania, United States
Greer, South Carolina, United States
Buenos Aires, , Argentina
Salvador, Bahia, Brazil
Joinville, Santa Catarina, Brazil
São Paulo, , Brazil
Pleven, , Bulgaria
Sha Tin, , Hong Kong
Budapest, , Hungary
Novara, , Italy
Higashimatsuyama, Saitama, Japan
Reno, Nevada, United States
Lebanon, New Hampshire, United States
New Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
Raleigh, North Carolina, United States
Winston Salem, North Carolina, United States
Fargo, North Dakota, United States
Columbus, Ohio, United States
Sofia, , Bulgaria
Edmonton, Alberta, Canada
Lévis, Quebec, Canada
Guangzhou, , China
Harbin, , China
Pozzilli, Isernia, Italy
Milan, Milano, Italy
Rome, Roma, Italy
Palermo, , Italy
Verona, , Italy
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Seville, Andalucia, Spain
Barcelona, Barcelona [Barcelona], Spain
Pozuelo De Alarcón, Madrid, Spain
Pontevedra, , Spain
Akdeniz, , Turkey
Istanbul, , Turkey
Izmit, , Turkey
Konya, , Turkey
Santiago, Reg Metropolitana De Santiago, Chile
Beijing, , China
Beijing, , China
Cincinnati, Ohio, United States
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Kayseri, , Turkey
Fargo, North Dakota, United States
Columbus, Ohio, United States
Caba, Buenos Aires, Argentina
Bursa, , Turkey
Eskişehir, , Turkey
Istanbul, , Turkey
Pittsburgh, Pennsylvania, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Düsseldorf, , Germany
Pécs, , Hungary
Orbassano, Torino, Italy
Laguna Hills, California, United States
Boca Raton, Florida, United States
Orlando, Florida, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Lebanon, New Hampshire, United States
Greenville, South Carolina, United States
Dallas, Texas, United States
Sao Paulo, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Guangzhou, , China
Xi'an, , China
Asahikawa Shi, Hokkaido, Japan
Higashimatsuyama Shi, Saitama, Japan
Meguro Ku, Tokyo, Japan
Tachikawa Shi, Tokyo, Japan
Pretoria, , South Africa
Istanbul, , Turkey
Beijing, , China
Quebec City, Quebec, Canada
Santiago, Reg Metropolitana De Santiago, Chile
Changsha, , China
Istanbul, , Turkey
Izmir, , Turkey
Boca Raton, Florida, United States
Pittsburgh, Pennsylvania, United States
Caba, Ciudad De Buenos Aires, Argentina
Pelt, , Belgium
Sao Paulo, São Paulo, Brazil
Beijing, , China
Hohhot, , China
Jihlava, , Czechia
Pardubice, , Czechia
Zlin, , Czechia
Shinjuku Ku, Tokyo, Japan
Barcelona, Barcelona [Barcelona], Spain
Las Palmas De Gran Canaria, Las Palmas, Spain
Pozuelo De Alarcon, Madrid, Spain
Córdoba, , Spain
Madrid, , Spain
Málaga, , Spain
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Fuzhou, , China
Guangzhou, , China
Cape Town, , South Africa
Bern, , Switzerland
Boca Raton, Florida, United States
Maitland, Florida, United States
Wien, , Austria
Valladolid, , Spain
Chernivtsi, , Ukraine
Altamonte Springs, Florida, United States
Jacksonville, Florida, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
Winston Salem, North Carolina, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Ciudad De Córdoba, , Argentina
Vienna, , Austria
Goiânia, , Brazil
Belo Horizonte, Minas Gerais, Brazil
Curitiba, , Brazil
Santo André, , Brazil
São Paulo, , Brazil
Zlín, , Czechia
Ramat Gan, , Israel
Modena, , Italy
Kyoto, , Japan
Lodz, , Poland
Barcelona, , Spain
Fort Wayne, Indiana, United States
Rochester Hills, Michigan, United States
Columbus, Ohio, United States
Pittsburgh, Pennsylvania, United States
Milan, Milano, Italy
Orbassano, Torino, Italy
Cuneo, , Italy
Firenze, , Italy
Foggia, , Italy
Napoli, , Italy
Palermo, , Italy
Parma, , Italy
Murcia, Almería, Spain
Pazardzhik, , Bulgaria
Sofia, , Bulgaria
Vancouver, British Columbia, Canada
Lévis, Quebec, Canada
Santiago, Reg Metropolitana De Santiago, Chile
Shanghai, , China
Jihlava, , Czechia
Pardubice, , Czechia
La Tronche, , France
Shimla, , India
Pontevedra, Pontevedra [Pontevedra], Spain
Madrid, , Spain
Madrid, , Spain
Bursa, , Turkey
Istanbul, , Turkey
London, England, United Kingdom
Salford, Manchester, United Kingdom
Inverness, , United Kingdom
Lille, , France
Bielefeld, , Germany
Essen, , Germany
Jena, , Germany
Ulm, , Germany
Budapest, , Hungary
Hyderabad, , India
Barakaldo, Pais Vasco, Spain
Seville, Sevilla, Spain
Bratislava, , Slovakia
Pretoria, , South Africa
Barcelona, , Spain
Newport Beach, California, United States
Miami Lakes, Florida, United States
Springfield, Oregon, United States
El Paso, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salvador, Bahia, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sã£O Paulo, , Brazil
Berlin, , Germany
Dresden, , Germany
Erbach, , Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported