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 June 26, 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
Ioannina, , Greece
Haifa, , Israel
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Ankara, , Turkey
Ottawa, Ontario, Canada
Gatineau, Quebec, Canada
Santiago, Reg Metropolitana De Santiago, Chile
Istanbul, , Turkey
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Caba, Buenos Aires, Argentina
Buenos Aires, Ciudad De Buenos Aires, Argentina
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Córdoba, , Spain
Tampa, Florida, United States
Knoxville, Tennessee, United States
Braga, , Portugal
Caba, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Guangzhou, , China
Shanghai, , China
Matosinhos, , Portugal
Sevilla, Andalucia, Spain
Barcelona, Barcelona [Barcelona], Spain
Pozuelo De Alarcón, Madrid, Spain
Istanbul, , Turkey
Istanbul, , Turkey
West Hollywood, California, United States
Lutherville, Maryland, United States
Ozark, Missouri, United States
Columbus, Ohio, United States
Madrid, , Spain
Beijing, , China
Leipzig, , Germany
Scottsdale, Arizona, United States
Maitland, Florida, United States
Overland Park, Kansas, United States
Scottsdale, Arizona, United States
Raleigh, North Carolina, United States
Birmingham, Alabama, United States
Carlsbad, California, United States
Statesville, North Carolina, United States
Abington, Pennsylvania, United States
Levis, Quebec, Canada
Chengdu, , China
Charlotte, North Carolina, United States
Owosso, Michigan, United States
Quebec, , Canada
Altamonte Springs, Florida, United States
Merrillville, Indiana, United States
Albuquerque, New Mexico, United States
Centerville, Ohio, United States
Plano, Texas, United States
San Antonio, Texas, United States
Sherman, Texas, United States
Granby, Quebec, Canada
Guaynabo, , Puerto Rico
Canterbury, Kent, United Kingdom
Winston Salem, North Carolina, United States
Oklahoma City, Oklahoma, United States
West Palm Beach, Florida, United States
Evanston, Illinois, United States
Northbrook, Illinois, United States
Farmington Hills, Michigan, United States
Santiago De Chile, , Chile
Savannah, Georgia, United States
Springfield, Illinois, United States
Las Vegas, Nevada, United States
Cullman, Alabama, United States
Fort Collins, Colorado, United States
Saint Louis, Missouri, United States
Columbus, Ohio, United States
Salt Lake City, Utah, United States
Zefat, , Israel
Kocaeli, , Turkey
Mersin, , Turkey
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Irvine, California, United States
Iowa City, Iowa, United States
Saint Louis, Missouri, United States
San Antonio, Texas, United States
Vienna, Virginia, United States
Milwaukee, Wisconsin, United States
Kyoto Shi, Kyoto, Japan
Samsun, , Turkey
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Aurora, Colorado, United States
Stamford, Connecticut, United States
Iowa City, Iowa, United States
Plymouth, Minnesota, United States
Reno, Nevada, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
San Antonio, Texas, United States
Koriyama Shi, Fukushima, Japan
Morioka Shi, Iwate, Japan
Eskisehir, , Turkey
Kayseri, , Turkey
Konya, , Turkey
Shijiazhuang, , China
Birmingham, Alabama, United States
Cullman, Alabama, United States
Norwich, Connecticut, United States
Washington, District Of Columbia, United States
Tampa, Florida, United States
Louisville, Kentucky, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Beijing, , China
Changchun, , China
Chongqing, , China
Dongguan, , China
Jinan, , China
Shenyang, , China
Suzhou, , China
Taiyuan, , China
Wenzhou, , China
Wuhan, , China
Asahikawa, Hokkaido, Japan
Goyang Si, Gyeonggi Do, Korea, Republic Of
Seongnam, Gyeonggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Ankara, , Turkey
Bursa, , Turkey
Izmir, , Turkey
Van, , Turkey
London, London, City Of, United Kingdom
Orlando, Florida, United States
Laguna Hills, California, United States
Boca Raton, 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
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Beijing, , China
Changsha, , China
Fuzhou, , China
Guangzhou, , China
Tianjin, , China
Xi'an, , China
Yinchuan, , China
Asahikawa Shi, Hokkaido, Japan
Higashimatsuyama Shi, Saitama, Japan
Meguro Ku, Tokyo, Japan
Tachikawa Shi, Tokyo, Japan
Cape Town, , South Africa
Pretoria, , South Africa
Bern, , Switzerland
Izmir, , Turkey
Caba, Ciudad De Buenos Aires, Argentina
Ota Ku, Tokyo, Japan
Istanbul, , Turkey
Exeter, Devon, United Kingdom
New Brunswick, New Jersey, United States
Fargo, North Dakota, United States
Dayton, Ohio, United States
Caba, Ciudad De Buenos Aires, Argentina
Joinville, Santa Catarina, Brazil
Beijing, , China
Hangzhou, , China
Nanjing, , China
Pune, , India
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Boca Raton, Florida, United States
Pittsburgh, Pennsylvania, United States
Caba, Ciudad De Buenos Aires, Argentina
Pelt, , Belgium
Sao Paulo, São Paulo, Brazil
Hohhot, , China
Jihlava, , Czechia
Pardubice, , Czechia
Zlin, , Czechia
Shinjuku Ku, Tokyo, Japan
Las Palmas De Gran Canaria, Las Palmas, Spain
Pozuelo De Alarcon, Madrid, Spain
Madrid, , Spain
Málaga, , Spain
Istanbul, , Turkey
Birmingham, Alabama, United States
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
Laguna Hills, California, United States
West Hollywood, California, United States
Aurora, Colorado, United States
Fort Collins, Colorado, United States
Norwich, Connecticut, United States
Stamford, Connecticut, United States
Washington, District Of Columbia, United States
Altamonte Springs, Florida, United States
Boca Raton, Florida, United States
Boca Raton, Florida, United States
Maitland, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Savannah, Georgia, United States
Evanston, Illinois, United States
Northbrook, Illinois, United States
Springfield, Illinois, United States
Merrillville, Indiana, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Overland Park, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Lutherville, Maryland, United States
Boston, Massachusetts, United States
Foxboro, Massachusetts, United States
Detroit, Michigan, United States
Farmington Hills, Michigan, United States
Grand Rapids, Michigan, United States
Owosso, Michigan, United States
Plymouth, Minnesota, United States
Ozark, Missouri, United States
Saint Louis, Missouri, United States
Saint Louis, Missouri, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Lebanon, New Hampshire, United States
New Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Winston Salem, North Carolina, United States
Fargo, North Dakota, United States
Centerville, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Abington, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Greenville, South Carolina, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Sherman, Texas, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Vienna, Virginia, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Milwaukee, Wisconsin, United States
Gent, , Belgium
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Joinville, Santa Catarina, Brazil
Santo Andre, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Edmonton, Alberta, Canada
London, Ontario, Canada
Santiago De Chile, , Chile
Dongguan, , China
Brno, , Czechia
Thessaloniki, , Greece
Chieti, , Italy
Foggia, , Italy
Sapporo Shi, Hokkaido, Japan
Guaynabo, , Puerto Rico
Campulung Muscel, , Romania
Madrid, , Spain
Murcia, , Spain
Valladolid, , Spain
Kaohsiung, , Taiwan
Scottsdale, Arizona, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Ramat Gan, , Israel
Buenos Aires, , Argentina
Pleven, , Bulgaria
Santiago, Reg Metropolitana De Santiago, Chile
Nitra, , Slovakia
Izmit, , Turkey
Birmingham, Alabama, United States
Cullman, Alabama, United States
Phoenix, 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
Altamonte Springs, Florida, United States
Boca Raton, Florida, United States
Jacksonville, Florida, United States
Maitland, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Savannah, Georgia, United States
Evanston, Illinois, United States
Springfield, Illinois, United States
Iowa City, Iowa, United States
Kansas City, Kansas, 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
Saint Louis, Missouri, United States
Las Vegas, Nevada, United States
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
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Greer, South Carolina, 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
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Buenos Aires, Ciudad De Buenos Aires, Argentina
Overpelt, , Belgium
Porto Alegre, Rio Grande Do Sul, Brazil
Joinville, Santa Catarina, Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Sofia, , Bulgaria
Sofia, , Bulgaria
Edmonton, Alberta, Canada
Lévis, Quebec, Canada
Beijing, , China
Beijing, , China
Guangzhou, , China
Harbin, , China
Jiazhuang, , China
Jinan, , China
Wenzhou, , China
Xi An, , China
Brno, , Czechia
Hradec Kralove, , Czechia
Jihlava, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Zlín, , Czechia
Grenoble, , France
Nice, , France
Saint Herblain, , France
Larissa, , Greece
Thessaloniki, , Greece
Budapest, , Hungary
Budapest, , Hungary
Safed, , Israel
Florence, Firenze, Italy
Pozzilli, Isernia, Italy
Milan, Milano, Italy
Rome, Roma, Italy
Palermo, , Italy
Verona, , Italy
Koriyama, Fukushima, Japan
Asahikawa, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Morioka, Iwate, Japan
Sagamihara, Kanagawa, Japan
Higashimatsuyama, Saitama, Japan
Tachikawa, Tokyo, Japan
Kyoto, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Bydgoszcz, Kujawsko Pomorskie, Poland
Katowice, Slaskie, Poland
Zabrze, , Poland
Guimarã£Es, , Portugal
Câmpulung, , Romania
Pretoria, , South Africa
Seville, Andalucia, Spain
Barcelona, Barcelona [Barcelona], Spain
Pontevedra, , Spain
Akdeniz, , Turkey
Bursa, , Turkey
Eskişehir, , Turkey
Istanbul, , Turkey
Konya, , Turkey
Samsun, , Turkey
Brasília, Distrito Federal, Brazil
Vancouver, British Columbia, Canada
Laguna Hills, California, United States
Lancaster, California, United States
Orlando, Florida, United States
Alexandria, Louisiana, United States
Baton Rouge, Louisiana, United States
Foxboro, Massachusetts, United States
Albuquerque, New Mexico, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Winston Salem, North Carolina, United States
Dayton, Ohio, United States
Plano, Texas, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Innsbruck, , Austria
Goiânia, Goiás, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Santo André, São Paulo, Brazil
São Paulo, , Brazil
Blagoevgrad, , Bulgaria
Québec City, Quebec, Canada
Santiago, , Chile
Hradec Králové, , Czechia
Prague, , Czechia
Esbjerg, , Denmark
Bochum, , Germany
Athens, , Greece
Kaposvár, , Hungary
Pecs, , Hungary
Shimla, , India
Genoa, Genova, Italy
Rome, Roma, Italy
Rome, Roma, Italy
Foggia, , Italy
Pavia, , Italy
Kodaira, Tokyo, Japan
Fukuoka, , Japan
Guadalajara, Jalisco, Mexico
Tlalnepantla De Baz, , Mexico
Lodz, Lódzkie, Poland
Plewiska, Wielkopolskie, Poland
Katowice, , Poland
Katowice, , Poland
Zory, , Poland
Coimbra, , Portugal
Guimaraes, , Portugal
Lisbon, , Portugal
Constanta, , Romania
Martin, , Slovakia
Barakaldo, Bizkaia, Spain
Madrid, Madrid, Comunidad De, Spain
Valencia, , Spain
Valladolid, , Spain
Kaohsiung City, , Taiwan
Sultangazi, , Turkey
Chernivtsi, , Ukraine
Louisville, Kentucky, United States
Minneapolis, Minnesota, United States
Salvador, Bahia, Brazil
Düsseldorf, , Germany
Pécs, , Hungary
Orbassano, Torino, Italy
Catania, , Italy
Napoli, , Italy
Udine, , Italy
Kielce, , Poland
Guimarães, , Portugal
Menomonee Falls, Wisconsin, United States
Milan, Lombardia, Italy
Chiba, , Japan
Izmit, , Turkey
Ivano Frankivsk, , Ukraine
Lutsk, , Ukraine
Lviv, , Ukraine
Lancaster, California, United States
Baton Rouge, Louisiana, United States
Seattle, Washington, United States
Wien, , Austria
Belo Horizonte, Minas Gerais, Brazil
Panagyurishte, , Bulgaria
Pleven, , Bulgaria
Sofia, , Bulgaria
Vancouver, , Canada
Hohhot, , China
Brno, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Teplice, , Czechia
Caserta, , Italy
Ferrara, , Italy
Palermo, , Italy
Ravenna, , Italy
Vilnius, , Lithuania
Culiacan, Sinaloa, Mexico
Heerlen, , Netherlands
Guimaraes, , Portugal
Lisbon, , Portugal
Trnava, , Slovakia
Donostia San Sebastian, Gipuzkoa, Spain
Madrid, Madrid, Comunidad De, Spain
Chernivtsi, , Ukraine
Krykhivtsi, , Ukraine
Kyiv, , Ukraine
Vinnytsia, , Ukraine
Salford, , United Kingdom
Patchogue, New York, United States
Linz, , Austria
Glostrup, , Denmark
Münster, , Germany
Győr, , Hungary
Rome, Roma, Italy
Krakow, Malopolskie, Poland
Krakow, , Poland
Warszawa, , Poland
Bucharest, , Romania
Lviv, , Ukraine
Pazardzhik, , Bulgaria
Inverness, , United Kingdom
Fort Wayne, Indiana, United States
Rochester Hills, Michigan, United States
Columbus, Ohio, United States
Pittsburgh, Pennsylvania, United States
Fairfax, Virginia, United States
Milwaukee, Wisconsin, United States
Ciudad De Córdoba, Córdoba, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Vienna, , Austria
Belo Horizonte, Minas Gerais, Brazil
Sofia, , Bulgaria
Lévis, Quebec, Canada
Santiago, Reg Metropolitana De Santiago, Chile
La Tronche, , France
Lille, , France
Bielefeld, , Germany
Ulm, , Germany
Hyderabad, , India
Milan, Milano, Italy
Orbassano, Torino, Italy
Cuneo, , Italy
Firenze, , Italy
Foggia, , Italy
Napoli, , Italy
Palermo, , Italy
Parma, , Italy
Verona, , Italy
Katowice, Slaskie, Poland
Katowice, Slaskie, Poland
Zabrze, Slaskie, Poland
Zory, Slaskie, Poland
Kielce, Swietokrzyskie, Poland
Lublin, , Poland
Murcia, Almería, Spain
Barakaldo, Pais Vasco, Spain
Pontevedra, Pontevedra [Pontevedra], Spain
Seville, Sevilla, Spain
Madrid, , Spain
Madrid, , Spain
Bursa, , Turkey
Istanbul, , Turkey
London, England, United Kingdom
Salford, Manchester, United Kingdom
Changchun, , China
Denver, Colorado, United States
Roeland Park, Kansas, United States
St. Johns, Newfoundland And Labrador, Canada
Chengdu, , China
Pécs, , Hungary
Como, , Italy
Ferrara, , Italy
Modena, , Italy
Palermo, , Italy
Barcelona, , Spain
Boston, Massachusetts, United States
Pittsburgh, Pennsylvania, United States
Ciudad De Córdoba, , Argentina
Goiânia, , Brazil
Curitiba, , Brazil
Santo André, , Brazil
Shanghai, , China
Essen, , Germany
Jena, , Germany
Shimla, , India
Modena, , Italy
Lodz, , Poland
Bratislava, , Slovakia
Barcelona, , Spain
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported