A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
Launched by SANOFI · Apr 15, 2024
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the long-term safety and tolerability of a medication called tolebrutinib for adults with different types of Multiple Sclerosis (MS), including relapsing forms and progressive forms. The study is currently recruiting participants who have previously taken tolebrutinib in earlier studies. To be eligible, you need to be at least 18 years old and have completed a previous tolebrutinib trial, or have temporarily stopped due to a national emergency but still completed the trial visits.
If you join the trial, you can expect to receive ongoing monitoring and support regarding your health while taking tolebrutinib. The study will help researchers understand how safe and well-tolerated the medication is over a longer period. However, there are certain health conditions that could prevent you from participating, such as having active infections, liver disease, or a history of substance abuse, among others. Overall, this study aims to gather important information that could benefit future patients with Multiple Sclerosis.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • - Participants with RMS, PPMS, or NRSPMS who completed the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 pivotal tolebrutinib trials (EFC16033, EFC16034, EFC16645, EFC16035) on IMP.
- • OR
- • - The Phase 2b LTS (LTS16004) or Phase 3 tolebrutinib pivotal trial participants who temporarily discontinued IMP due to a national emergency and completed the trial visits.
- • ToleDYNAMIC Substudy: Inclusion criteria are those of the main study
- Exclusion Criteria:
- * Participants are excluded from the study if any of the following criteria apply:
- • The participant is at risk for or has a persistent chronic, active (including fever higher than 38°C and clinically unstable), or recurring systemic infection, as judged by the Investigator
- • For participants initiating OL tolebrutinib in the LTS17043 study: Participants at risk of developing or having reactivation of hepatitis, ie, results at the unblinding visit (RMS) or opt-in visit (PMS) for serological markers for hepatitis B and C viruses indicating acute or chronic infection
- • Active alcohol use disorder or a history of alcohol or drug abuse within 1 year prior to the opt-in visit
- • Current alcohol intake equal to or exceeding the following at the opt-in visit: more than 2 drinks per day for men and more than 1 drink per day for women
- • Abnormal ECG during the opt-in visit considered in the Investigator's judgment to be clinically significant, such as QTcF \>500 msec, in the context of this study.
- • A bleeding disorder, known platelet dysfunction, abnormal platelet count (\<100,000/microliter), history of significant bleeding event or other conditions and planned procedures that may predispose the participant to excessive bleeding during the study, as judged by the Investigator.
- • For participants initiating OL tolebrutinib in the LTS17043 study: Confirmed unblinding visit (RMS) or opt-in visit (PMS) alanine aminotransferase (ALT) more than 1.5 × upper limit of normal (ULN) OR aspartate aminotransferase (AST) more than 1.5 × ULN OR alkaline phosphatase more than 2 × ULN (unless caused by non-liver-related disorder or explained by a stable chronic liver disorder) OR total bilirubin more than 1.5 × ULN (unless due to Gilbert syndrome or non-liver-related disorder).
- • Acute liver disease, cirrhosis, chronic liver disease (unless considered stable for more than 6 months).
- • Participants who developed clinically relevant cardiovascular, hepatic, endocrine, neuropsychiatric or other major systemic disease making implementation of the protocol or interpretation of the trial results difficult or that would put the patient at risk by participating in the trial, as judged by the Investigator.
- • The participant is receiving treatment during the study period with drugs not permitted by the study protocol, including potent and moderate inducers of cytochrome P450 (CYP) 3A or potent inhibitors of CYP2C8 hepatic enzymes.
- • NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
- • ToleDYNAMIC Substudy: Exclusion criteria are those of the main study
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
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Santiago, Reg Metropolitana De Santiago, Chile
Nice, , France
Oslo, , Norway
Gent, , Belgium
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Amsterdam, , Netherlands
Sofia, , Bulgaria
Nagpur, , India
Toronto, Ontario, Canada
Quebec, , Canada
Riga, , Latvia
Braga, , Portugal
Rosario, Santa Fe, Argentina
Linz, , Austria
Leuven, , Belgium
Liège, , Belgium
Sofia, , Bulgaria
Sofia, , Bulgaria
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Beijing, , China
Changchun, , China
Changsha, , China
Chengdu, , China
Fuzhou, , China
Taiyuan, , China
Tianjin, , China
Zagreb, , Croatia
Zagreb, , Croatia
Esbjerg, , Denmark
Holstebro, , Denmark
Tallinn, , Estonia
Bron, , France
Gonesse, , France
Lille, , France
Montpellier, , France
Nancy, , France
Paris, , France
Rennes, , France
Toulouse, , France
Bayreuth, , Germany
Berlin, , Germany
Berlin, , Germany
Bochum, , Germany
Dresden, , Germany
Essen, , Germany
Münster, , Germany
Ulm, , Germany
Athens, , Greece
Thessaloniki, , Greece
New Delhi, , India
Pozzilli, Isernia, Italy
Cagliari, , Italy
Catania, , Italy
Bergen, , Norway
Bydgoszcz, Kujawsko Pomorskie, Poland
Lodz, Lódzkie, Poland
Warszawa, Mazowieckie, Poland
Santa Maria Da Feira, , Portugal
Constanta, , Romania
Belgrade, , Serbia
Kragujevac, , Serbia
Eskisehir, , Turkey
Istanbul, , Turkey
Canterbury, Kent, United Kingdom
London, London, City Of, United Kingdom
Oxford, Oxfordshire, United Kingdom
Bristol, , United Kingdom
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Ramat Gan, , Israel
Linz, , Austria
Belgrade, , Serbia
Brugge, , Belgium
Knoxville, Tennessee, United States
Beijing, , China
Chongqing, , China
Shanghai, , China
Wuhan, , China
Xi'an, , China
Kyiv, , Ukraine
Kyiv, , Ukraine
Goyang Si, Gyeonggi Do, Korea, Republic Of
Timisoara, , Romania
Exeter, Devon, United Kingdom
San Miguel De Tucumán, , Argentina
Odense, , Denmark
Istanbul, , Turkey
Larissa, , Greece
Birmingham, Alabama, United States
Cullman, Alabama, United States
Phoenix, Arizona, United States
La Jolla, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
West Hollywood, California, United States
Denver, Colorado, United States
Fort Collins, Colorado, United States
Washington, District Of Columbia, United States
Boca Raton, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Northbrook, Illinois, United States
Springfield, Illinois, United States
Fort Wayne, Indiana, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Detroit, Michigan, United States
Farmington Hills, Michigan, United States
Owosso, Michigan, United States
Golden Valley, Minnesota, United States
Ozark, Missouri, United States
Saint Louis, Missouri, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Patchogue, New York, United States
Stony Brook, New York, United States
Winston Salem, North Carolina, United States
Centerville, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Portland, Oregon, United States
Greer, South Carolina, United States
Knoxville, Tennessee, United States
San Antonio, Texas, United States
Sherman, Texas, United States
Burlington, Vermont, United States
Richmond, Virginia, United States
Buenos Aires, Ciudad De Buenos Aires, Argentina
Caba, Ciudad De Buenos Aires, Argentina
Caba, Ciudad De Buenos Aires, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Córdoba, , Argentina
San Miguel De Tucuman, , Argentina
Saint Leonards, New South Wales, Australia
Kent Town, South Australia, Australia
Melbourne, Victoria, Australia
Innsbruck, , Austria
Vienna, , Austria
Bruges, , Belgium
Brussels, , Belgium
Overpelt, , Belgium
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
São Paulo, , Brazil
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Edmonton, Alberta, Canada
Burnaby, British Columbia, Canada
Vancouver, British Columbia, Canada
Gatineau, Quebec, Canada
Lévis, Quebec, Canada
Montreal, Quebec, Canada
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, , Chile
Beijing, , China
Beijing, , China
Guangzhou, , China
Hohhot, , China
Jiazhuang, , China
Nanjing, , China
Nanjing, , China
Shenyang, , China
Xi An, , China
Brno, , Czechia
Brno, , Czechia
Hradec Kralove, , Czechia
Jihlava, , Czechia
Ostrava, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Teplice, , Czechia
Zlín, , Czechia
Tampere, , Finland
Turku, , Finland
Besançon, , France
Clermont Ferrand, , France
Nîmes, , France
Paris, , France
Poissy, , France
Saint Herblain, , France
Strasbourg, , France
Berlin, , Germany
Düsseldorf, , Germany
Giessen, , Germany
Hamburg, , Germany
Wã¼rzburg, , Germany
Athens, , Greece
Athens, , Greece
Athens, , Greece
Sha Tin, , Hong Kong
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Pã©Cs, , Hungary
Chandigarh, , India
Gurugram, , India
Gurugram, , India
Mangaluru, , India
New Delhi, , India
Thiruvananthapuram, , India
Haifa, , Israel
Rehovot, , Israel
Safed, , Israel
Florence, Firenze, Italy
Milan, Lombardia, Italy
Rome, Roma, Italy
Rome, Roma, Italy
Florence, Toscana, Italy
Bergamo, , Italy
Genoa, , Italy
Milan, , Italy
Naples, , Italy
Pavia, , Italy
Pozzilli, , Italy
Roma, , Italy
Rome, , Italy
Morioka, Iwate, Japan
Sagamihara, Kanagawa, Japan
Kawagoe, Saitama, Japan
Kyoto, , Japan
Osaka, , Japan
Osaka, , Japan
Tokyo, , Japan
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Riga, , Latvia
Kaunas, , Lithuania
Siauliai, , Lithuania
Vilnius, , Lithuania
Mexico City, Ciudad De Mexico, Mexico
Mexico City, Ciudad De Mexico, Mexico
Veracruz. Mexico City, Veracruz, Mexico
Heerlen, , Netherlands
Warsaw, Mazowieckie, Poland
Glogow, Podkarpackie, Poland
Katowice, Slaskie, Poland
Plewiska, Wielkopolskie, Poland
Katowice, , Poland
Lublin, , Poland
Zabrze, , Poland
Coimbra, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Guaynabo, , Puerto Rico
Brașov, , Romania
Bucharest, , Romania
Cluj Napoca, , Romania
Câmpulung, , Romania
Oradea, , Romania
Sibiu, , Romania
Belgrade, , Serbia
Novi Sad, , Serbia
Bratislava, , Slovakia
Martin, , Slovakia
Nitra, , Slovakia
A Coruña, A Coruña [La Coruña], Spain
Seville, Andalucia, Spain
Barcelona, Barcelona [Barcelona], Spain
Barcelona, Barcelona [Barcelona], Spain
Hospitalet De Llobregat, Barcelona [Barcelona], Spain
Barakaldo, Bizkaia, Spain
Donostia San Sebastian, Gipuzkoa, Spain
Girona, Girona [Gerona], Spain
Las Palmas De Gran Canaria, Las Palmas, Spain
Lleida, Lleida [Lérida], Spain
Madrid, Madrid, Comunidad De, Spain
Majadahonda, Madrid, Spain
Pozuelo De Alarcón, Madrid, Spain
Córdoba, , Spain
Madrid, , Spain
Madrid, , Spain
Murcia, , Spain
Málaga, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Stockholm, , Sweden
Bern, , Switzerland
Hsinchu, , Taiwan
Taipei City, , Taiwan
Akdeniz, , Turkey
Ankara, , Turkey
Eskişehir, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Izmit, , Turkey
Kütahya, , Turkey
Samsun, , Turkey
Chernivtsi, , Ukraine
Chernivtsi, , Ukraine
Chernivtsi, , Ukraine
Dnipro, , Ukraine
Ivano Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Lutsk, , Ukraine
Lviv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Vinnytsia, , Ukraine
Vinnytsia, , Ukraine
Salford, Manchester, United Kingdom
Newcastle Upon Tyne, , United Kingdom
Milan, Milano, Italy
Phoenix, Arizona, United States
Aurora, Colorado, United States
Fort Wayne, Indiana, United States
Detroit, Michigan, United States
Albuquerque, New Mexico, United States
Columbus, Ohio, United States
Buenos Aires, Ciudad De Buenos Aires, Argentina
Halifax, Nova Scotia, Canada
Quebec, , Canada
Hradec Králové, , Czechia
Veracruz, , Mexico
Warsaw, Mazowieckie, Poland
Timișoara, , Romania
L'hospitalet De Llobregat, Barcelona [Barcelona], Spain
Krykhivtsi, , Ukraine
Lviv, , Ukraine
Izmit, , Turkey
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Halifax, Nova Scotia, Canada
Pécs, , Hungary
Buenos Aires, , Argentina
Lodz, , Poland
London, , United Kingdom
Curitiba, , Brazil
A Coruña, , Spain
Barcelona, , Spain
Barcelona, , Spain
L'hospitalet De Llobregat, , Spain
Girona, , Spain
Lleida, , Spain
Madrid, , Spain
Fort Wayne, Indiana, United States
Winston Salem, North Carolina, United States
Buenos Aires, , Argentina
Lévis, Quebec, Canada
Changchun, , China
Wenzhou, , China
Pécs, , Hungary
Florence, Firenze, Italy
Genoa, Genova, Italy
Milan, Milano, Italy
Naples, Napoli, Italy
Rome, Roma, Italy
Lublin, Lubelskie, Poland
Katowice, Slaskie, Poland
Zabrze, Slaskie, Poland
Bucharest, , Romania
Barakaldo, Pais Vasco, Spain
Seville, Sevilla, Spain
Mersin, , Turkey
London, England, United Kingdom
Newcastle Upon Tyne, England, United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported