Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive 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 a new medication called frexalimab to see if it can help adults with a type of multiple sclerosis known as non-relapsing secondary progressive multiple sclerosis (nrSPMS). The goal is to find out if this treatment can delay the progression of disability in participants aged 18 to 60 years. The trial is designed so that neither the participants nor the researchers know who is receiving the medication and who is receiving a placebo (a dummy treatment). Participants will be expected to attend up to 27 visits over a period that could last between 27 to 51 months.
To be eligible for the trial, participants must have a confirmed diagnosis of multiple sclerosis and have shown recent disability progression. They should not have had any relapses in the last two years and must meet certain health criteria, like having a specific score on a disability scale. Participants should also be able to use contraception if required. It’s important to note that individuals with certain health issues or who have taken frexalimab before will not be eligible for this study. Overall, this trial aims to assess how well frexalimab works and how safe it is for patients with this condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion 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 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.
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
Woolloongabba, Queensland, Australia
Pleven, , Bulgaria
Ioannina, , Greece
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Valencia, , Spain
Ankara, , Turkey
Ottawa, Ontario, Canada
Gatineau, Quebec, Canada
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Nice, , France
Istanbul, , Turkey
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Samsun, , Turkey
Krakow, Malopolskie, Poland
Kyiv, , Ukraine
Budapest, , Hungary
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
Sofia, , Bulgaria
Guangzhou, , China
Shanghai, , China
Bron, , France
Lille, , France
Paris, , France
Rennes, , France
Matosinhos, , Portugal
Barcelona, Barcelona [Barcelona], Spain
Pozuelo De Alarcón, Madrid, Spain
Eskisehir, , Turkey
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
Lviv, , Ukraine
Maitland, Florida, United States
Overland Park, Kansas, United States
Vinnytsia, , Ukraine
Wellesley, Massachusetts, United States
Amherst, New York, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Birmingham, Alabama, United States
Carlsbad, California, United States
Statesville, North Carolina, United States
Clearwater, Florida, United States
Levis, Quebec, Canada
Chengdu, , China
Charlotte, North Carolina, United States
Marburg, , Germany
Owosso, Michigan, United States
Kogarah, New South Wales, Australia
Heidelberg, Victoria, Australia
Quebec, , Canada
Merrillville, Indiana, United States
Sherman, Texas, United States
West Palm Beach, Florida, United States
Winston Salem, North Carolina, United States
Oklahoma City, Oklahoma, United States
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Guaynabo, , Puerto Rico
Kent, , United Kingdom
Farmington Hills, Michigan, United States
Scottsdale, Arizona, United States
Savannah, Georgia, United States
Northbrook, Illinois, United States
Springfield, Illinois, United States
Las Vegas, Nevada, United States
New York, New York, United States
Columbus, Ohio, United States
Newport News, Virginia, United States
Kocaeli, , Turkey
Mersin, , Turkey
Kocaeli, , Turkey
Iowa City, Iowa, United States
Saint Louis, Missouri, United States
Milwaukee, Wisconsin, United States
Kyoto Shi, Kyoto, Japan
Scottsdale, Arizona, United States
Newport Beach, California, United States
East Setauket, New York, United States
Montreal, Quebec, Canada
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Samsun, , Turkey
Majadahonda, Madrid, Spain
Stamford, Connecticut, United States
Iowa City, Iowa, United States
Plymouth, Minnesota, United States
Reno, Nevada, United States
Philadelphia, Pennsylvania, United States
San Antonio, Texas, United States
Koriyama Shi, Fukushima, Japan
Konya, , Turkey
Berkeley, California, United States
Teaneck, New Jersey, United States
Cincinnati, Ohio, United States
Greenville, South Carolina, United States
Burnaby, British Columbia, Canada
Shijiazhuang, , China
Kayseri, , Turkey
Washington, District Of Columbia, United States
Tampa, Florida, United States
Portland, Oregon, United States
Beijing, , China
Changchun, , China
Taiyuan, , China
Wuhan, , China
Goyang Si, Gyeonggi Do, Korea, Republic Of
Seongnam, Gyeonggi Do, Korea, Republic Of
Van, , Turkey
London, London, City Of, United Kingdom
Los Angeles, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Norwich, Connecticut, United States
Altamonte Springs, Florida, United States
Orlando, Florida, United States
Chicago, Illinois, United States
Detroit, Michigan, United States
Nashville, Tennessee, United States
Burlington, Vermont, United States
Morgantown, West Virginia, United States
Joinville, Santa Catarina, Brazil
Sao Paulo, São Paulo, Brazil
Vancouver, British Columbia, Canada
Ankara, , Turkey
Bursa, , Turkey
Izmir, , Turkey
Swansea, Neath Port Talbot, United Kingdom
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Changsha, , China
Tianjin, , China
Xi'an, , China
Asahikawa Shi, Hokkaido, Japan
Higashimatsuyama Shi, Saitama, Japan
Izmir, , Turkey
Scottsdale, Arizona, United States
La Jolla, California, United States
Fort Collins, Colorado, United States
Gainesville, Florida, United States
Peoria, Illinois, United States
Albuquerque, New Mexico, United States
Nashville, Tennessee, United States
Vienna, Virginia, United States
Brasília, Distrito Federal, Brazil
Sao Paulo, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Calgary, Alberta, Canada
Cardiff, Vale Of Glamorgan, The, United Kingdom
Worcester, Massachusetts, United States
Lebanon, New Hampshire, United States
New Brunswick, New Jersey, United States
Stony Brook, New York, United States
Fargo, North Dakota, United States
Caba, Ciudad De Buenos Aires, Argentina
Himeji, Hyogo, Japan
Ota Ku, Tokyo, Japan
Istanbul, , Turkey
Exeter, Devon, United Kingdom
Beijing, , China
Dayton, Ohio, United States
Zhengzhou, , China
Fazakerley, Liverpool, United Kingdom
Oxford, Oxfordshire, United Kingdom
Newcastle Upon Tyne, , United Kingdom
Newport, , United Kingdom
Pavia, , Italy
Shinjuku Ku, Tokyo, Japan
Las Palmas De Gran Canaria, Las Palmas, Spain
Málaga, , Spain
Nashville, Tennessee, United States
Istanbul, , Turkey
Birmingham, Alabama, United States
Carlsbad, California, United States
West Hollywood, California, United States
Stamford, Connecticut, United States
Washington, District Of Columbia, United States
Maitland, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, 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
New Orleans, Louisiana, United States
Lutherville, Maryland, 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
Las Vegas, Nevada, United States
Reno, Nevada, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Winston Salem, North Carolina, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Knoxville, Tennessee, United States
San Antonio, Texas, United States
Sherman, Texas, United States
Milwaukee, Wisconsin, United States
Thessaloniki, , Greece
Chieti, , Italy
Madrid, , Spain
Murcia, , Spain
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Berkeley, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Aurora, Colorado, United States
Fort Collins, Colorado, United States
New Haven, Connecticut, United States
Norwich, Connecticut, United States
Altamonte Springs, Florida, United States
Clearwater, Florida, United States
Gainesville, Florida, United States
West Palm Beach, Florida, United States
Chicago, Illinois, United States
Northbrook, Illinois, United States
Peoria, Illinois, United States
Foxboro, Massachusetts, United States
Wellesley, Massachusetts, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Lebanon, New Hampshire, United States
New Brunswick, New Jersey, United States
Teaneck, New Jersey, United States
Albuquerque, New Mexico, United States
Amherst, New York, United States
New York, New York, United States
New York, New York, United States
Stony Brook, New York, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Greenville, South Carolina, United States
Burlington, Vermont, United States
Fairfax, Virginia, United States
Newport News, Virginia, United States
Vienna, Virginia, United States
Morgantown, West Virginia, United States
Caba, Ciudad De Buenos Aires, Argentina
Brasília, Distrito Federal, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Joinville, Santa Catarina, Brazil
Sao Paulo, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Guaynabo, , Puerto Rico
Athens, , Greece
Rotterdam, , Netherlands
Prague, , Czechia
Buenos Aires, , Argentina
Buenos Aires, Ciudad De Buenos Aires, Argentina
Buenos Aires, , Argentina
Pleven, , Bulgaria
Santiago, Reg Metropolitana De Santiago, Chile
Paris, , France
Saint Herblain, , France
Strasbourg, , France
Lisbon, , Portugal
Lisbon, , Portugal
Gothenburg, , Sweden
Stockholm, , Sweden
Eskişehir, , Turkey
Istanbul, , Turkey
Izmit, , Turkey
Carlsbad, California, United States
West Hollywood, California, United States
Washington, District Of Columbia, United States
Maitland, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Springfield, Illinois, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Overland Park, Kansas, United States
New Orleans, Louisiana, United States
Saint Louis, Missouri, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Lebanon, New Hampshire, United States
Raleigh, North Carolina, United States
Winston Salem, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Sherman, Texas, United States
Milwaukee, Wisconsin, United States
Overpelt, , Belgium
Sofia, , Bulgaria
Sofia, , Bulgaria
Lévis, Quebec, Canada
Beijing, , China
Beijing, , China
Harbin, , China
Jiazhuang, , China
Xi An, , China
Brno, , Czechia
Hradec Kralove, , Czechia
Jihlava, , Czechia
Zlín, , Czechia
Florence, Firenze, Italy
Pozzilli, Isernia, Italy
Milan, Milano, Italy
Rome, Roma, Italy
Palermo, , Italy
Koriyama, Fukushima, Japan
Asahikawa, Hokkaido, Japan
Sagamihara, Kanagawa, Japan
Higashimatsuyama, Saitama, Japan
Kyoto, , Japan
Tokyo, , Japan
Tokyo, , Japan
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Seville, Andalucia, Spain
Konya, , Turkey
Phoenix, Arizona, United States
Berkeley, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Palo Alto, California, United States
Aurora, Colorado, United States
Fort Collins, Colorado, United States
New Haven, Connecticut, United States
Altamonte Springs, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Oldsmar, Florida, United States
West Palm Beach, Florida, United States
Peoria, Illinois, United States
Wellesley, Massachusetts, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
New Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
Amherst, New York, United States
New York, New York, United States
New York, New York, United States
Stony Brook, New York, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Greer, South Carolina, United States
Nashville, Tennessee, United States
Burlington, Vermont, United States
Newport News, Virginia, United States
Vienna, Virginia, United States
Morgantown, West Virginia, United States
Melbourne, Victoria, Australia
Brasília, Distrito Federal, Brazil
Joinville, Santa Catarina, Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Montreal, Quebec, Canada
Pointe Claire, Quebec, Canada
Zhengzhou, , China
Akdeniz, , Turkey
Bursa, , Turkey
Canterbury, Kent, United Kingdom
Swansea, Neath Port Talbot, United Kingdom
Gwent, , United Kingdom
Newcastle Upon Tyne, , United Kingdom
Orlando, Florida, United States
Charlotte, North Carolina, United States
Winston Salem, North Carolina, United States
Blagoevgrad, , Bulgaria
Québec City, Quebec, Canada
Hradec Králové, , Czechia
Bochum, , Germany
Rome, Roma, Italy
Rome, Roma, Italy
Foggia, , Italy
Kodaira, Tokyo, Japan
Plewiska, Wielkopolskie, Poland
Sultangazi, , Turkey
Alexandria, Louisiana, United States
Baton Rouge, Louisiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Foxboro, Massachusetts, United States
New York, New York, United States
Plano, Texas, United States
Saint Leonards, New South Wales, Australia
Kortrijk, , Belgium
Goiânia, Goiás, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
São Paulo, , Brazil
Toronto, Ontario, Canada
Prague, , Czechia
Teplice, , Czechia
Budapest, , Hungary
Shimla, , India
Sittard Geleen, , Netherlands
Barakaldo, Bizkaia, Spain
Istanbul, , Turkey
New Haven, Connecticut, United States
Albuquerque, New Mexico, United States
Columbus, Ohio, United States
Melsbroek, , Belgium
Prague, , Czechia
Grenoble, , France
Barcelona, Barcelona [Barcelona], Spain
Pontevedra, , Spain
Chernivtsi, , Ukraine
Krykhivtsi, , Ukraine
Düsseldorf, , Germany
Boca Raton, Florida, United States
Baton Rouge, Louisiana, United States
Baltimore, Maryland, United States
Rochester Hills, Michigan, United States
Menomonee Falls, Wisconsin, United States
Brussels, , Belgium
Brno, , Czechia
Créteil, , France
Montpellier, , France
Genoa, Genova, Italy
Milan, Lombardia, Italy
Gallarate, Varese, Italy
Augusta, , Italy
Chiba, , Japan
Katowice, , Poland
Poznan, , Poland
L'hospitalet De Llobregat, Barcelona [Barcelona], Spain
Lleida, Lleida [Lérida], Spain
Izmit, , Turkey
Ivano Frankivsk, , Ukraine
Lutsk, , Ukraine
Lviv, , Ukraine
Salford, , United Kingdom
Phoenix, Arizona, United States
Milwaukee, Wisconsin, United States
Ravenna, , Italy
Katowice, , Poland
Donostia San Sebastian, Gipuzkoa, Spain
Vancouver, , Canada
Golden Valley, Minnesota, United States
Belo Horizonte, Minas Gerais, Brazil
Sofia, , Bulgaria
Ostrava, , Czechia
Budapest, , Hungary
Gyor, , Hungary
Cefalù, Palermo, Italy
Bologna, , Italy
Caserta, , Italy
Ferrara, , Italy
Rzeszow, , Poland
Huddinge, , Sweden
Malmö, , Sweden
Irvine, California, United States
Seattle, Washington, United States
Belo Horizonte, Minas Gerais, Brazil
Panagyurishte, , Bulgaria
Pazardzhik, , Bulgaria
Larissa, , Greece
Inverness, , United Kingdom
Milwaukee, Wisconsin, United States
Lévis, Quebec, Canada
Ulm, , Germany
Milan, Milano, Italy
Murcia, Almería, Spain
Seville, Sevilla, Spain
London, England, United Kingdom
Denver, Colorado, United States
Boca Raton, Florida, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Rochester Hills, Michigan, United States
Minneapolis, Minnesota, United States
New York, New York, United States
Fairfax, Virginia, United States
Buenos Aires, , Argentina
Belo Horizonte, Minas Gerais, Brazil
North York, Ontario, Canada
Changchun, , China
La Tronche, , France
Bielefeld, , Germany
Münster, , Germany
Athens, , Greece
Hyderabad, , India
Naples, Napoli, Italy
Rome, Roma, Italy
Parma, , Italy
Rzeszow, Podkarpackie, Poland
Katowice, Slaskie, Poland
Katowice, Slaskie, Poland
Poznan, Wielkopolskie, Poland
Lisbon, , Portugal
L'hospitalet De Llobregat, Catalunya [Cataluña], Spain
Barakaldo, Pais Vasco, Spain
Pontevedra, Pontevedra [Pontevedra], Spain
Bursa, , Turkey
Gwent, Blaenau Gwent, United Kingdom
Newcastle Upon Tyne, England, United Kingdom
Salford, Manchester, United Kingdom
Swansea, Swansea [Abertawe Gb Ata], United Kingdom
Liverpool, , United Kingdom
Fort Myers, Florida, United States
Cardiff, Cardiff [Caerdydd Gb Crd], United Kingdom
Barcelona, , Spain
Los Angeles, California, United States
Goiânia, , Brazil
Jena, , Germany
Shimla, , India
Barcelona, , Spain
L'hospitalet De Llobregat, , Spain
Lleida, , Spain
Cardiff, , United Kingdom
Swansea, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported