Spots Global Cancer Trial Database for Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
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Trial Identification
Brief Title: Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
Official Title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
Study ID: NCT04411641
Conditions
Study Description
Brief Summary: Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS Secondary Objective: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168
Detailed Description: Study duration will vary per participant in this event driven trial with a treatment duration of approximately 24 to 48 months. Participants completing the treatment period will be proposed to enroll in a separate long term safety study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama MS Center-Site Number:8400013, Birmingham, Alabama, United States
Center for Neurology and Spine-Site Number:8400089, Phoenix, Arizona, United States
Arcadia Neurology Center-Site Number:8400070, Arcadia, California, United States
UC San Diego ACTRI-Site Number:8400101, La Jolla, California, United States
Collaborative Neuroscience Research-Site Number:8400045, Long Beach, California, United States
Multiple Sclerosis Center-Site Number:8400143, Los Angeles, California, United States
University of San Francisco, Sandler Neurosciences Center-Site Number:8400137, San Francisco, California, United States
Harbor UCLA-Site Number:8400088, Torrance, California, United States
Regina Berkovich, MD, PhD-Site Number:8400059, West Hollywood, California, United States
Mountain Neurological Research Center, Inc.-Site Number:8400128, Basalt, Colorado, United States
University of Colorado-Site Number:8400012, Denver, Colorado, United States
Advanced Neurosciences Research-Site Number:8400025, Fort Collins, Colorado, United States
South Florida Neurology Associates-Site Number:8400029, Boca Raton, Florida, United States
Neurology Associates, PA-Site Number:8400004, Maitland, Florida, United States
Aqualane Clinical Research-Site Number:8400027, Naples, Florida, United States
Axiom Clinical Research of Florida-Site Number:8400001, Tampa, Florida, United States
University of South Florida-Site Number:8400006, Tampa, Florida, United States
Meridian Clinical Research-Site Number:8400003, Savannah, Georgia, United States
Consultants In Neurology-Site Number:8400011, Northbrook, Illinois, United States
University of Kansas Medical Center-Site Number:8400023, Kansas City, Kansas, United States
CHI Saint Joseph Medical Group Neurology-Site Number:8400110, Lexington, Kentucky, United States
Tufts Medical Center-Site Number:8400072, Boston, Massachusetts, United States
University of Massachusetts-Site Number:8400014, Worcester, Massachusetts, United States
Wayne State University-Site Number:8400046, Detroit, Michigan, United States
The Memorial Hospital-Site Number:8400033, Owosso, Michigan, United States
Minneapolis Clinic of Neurology-Site Number:8400051, Minneapolis, Minnesota, United States
Mayo Clinic-Site Number:8400111, Rochester, Minnesota, United States
Missouri Baptist Medical Center-Site Number:8400019, Saint Louis, Missouri, United States
Lou Ruvo Center for Brain Health-Site Number:8400117, Las Vegas, Nevada, United States
Holy Name Hospital-Site Number:8400104, Teaneck, New Jersey, United States
University of New Mexico-Site Number:8400032, Albuquerque, New Mexico, United States
Icahn School of Medicine at Mount Sinai (Department of Endoc-Site Number:8400038, New York, New York, United States
Neurology Associates of Stony Brook-Site Number:8400042, Stony Brook, New York, United States
Meridian Clinical Research, LLC-Site Number:8400005, Raleigh, North Carolina, United States
Sanford Brain & Spine Center-Site Number:8400126, Fargo, North Dakota, United States
University Hospitals CMC-Site Number:8400083, Cleveland, Ohio, United States
Cleveland Clinic-Site Number:8400125, Cleveland, Ohio, United States
Optimed Research, LTD-Site Number:8400147, Columbus, Ohio, United States
Neurology Specialists-Site Number:8400002, Dayton, Ohio, United States
Columbus Neuroscience-Site Number:8400010, Westerville, Ohio, United States
Providence Multiple Sclerosis Center-Site Number:8400020, Portland, Oregon, United States
Perelman Center for Advanced Medicine-Site Number:8400142, Philadelphia, Pennsylvania, United States
Jefferson Neurology Associates-Site Number:8400016, Philadelphia, Pennsylvania, United States
Premier Neurology-Site Number:8400069, Greer, South Carolina, United States
Mountain View Clinical Research-Site Number:8400024, Greer, South Carolina, United States
Neurology Clinic, PC-Site Number:8400087, Cordova, Tennessee, United States
Advanced Neuroscience Center-Site Number:8400035, Franklin, Tennessee, United States
Baylor College of Medicine-Site Number:8400136, Houston, Texas, United States
Neurology Center of San Antonio-Site Number:8400036, San Antonio, Texas, United States
University Of Vermont College Of Medicine-Site Number:8400130, Burlington, Vermont, United States
Medical College of Wisconsin-Site Number:8400028, Milwaukee, Wisconsin, United States
Investigational Site Number :0320002, Capital Federal, Buenos Aires, Argentina
Investigational Site Number :0320001, Caba, Ciudad De Buenos Aires, Argentina
Investigational Site Number :0320007, Buenos Aires, , Argentina
Investigational Site Number :0320006, Córdoba, , Argentina
Investigational Site Number :0320005, San Miguel de Tucuman, , Argentina
Investigational Site Number :0360003, Woolloongabba, Queensland, Australia
Investigational Site Number :0360002, Kent Town, South Australia, Australia
Investigational Site Number :0360004, Hobart, Tasmania, Australia
Investigational Site Number :0360001, Fitzroy, Victoria, Australia
Investigational Site Number :0360006, Heidelberg West, Victoria, Australia
Investigational Site Number :0400003, Innsbruck, , Austria
Investigational Site Number :0400001, Linz, , Austria
Investigational Site Number :0400004, Linz, , Austria
Investigational Site Number :0400002, Wien, , Austria
Investigational Site Number :1120004, Vitebsk, , Belarus
Investigational Site Number :1120005, Vitebsk, , Belarus
Investigational Site Number :0560007, Bruxelles, , Belgium
Investigational Site Number :0560003, Edegem, , Belgium
Investigational Site Number :0560006, Leuven, , Belgium
Investigational Site Number :0560008, Liège, , Belgium
Investigational Site Number :0560002, Mons, , Belgium
Investigational Site Number :0560001, Pelt, , Belgium
Investigational Site Number :1000002, Pleven, , Bulgaria
Investigational Site Number :1000005, Plovdiv, , Bulgaria
Investigational Site Number :1000004, Sofia, , Bulgaria
Investigational Site Number :1000008, Sofia, , Bulgaria
Investigational Site Number :1000001, Sofia, , Bulgaria
Investigational Site Number :1000006, Sofia, , Bulgaria
Investigational Site Number :1000009, Sofia, , Bulgaria
Investigational Site Number :1240017, Burnaby, British Columbia, Canada
Investigational Site Number :1240011, Halifax, Nova Scotia, Canada
Investigational Site Number :1240003, Ottawa, Ontario, Canada
Investigational Site Number :1240008, Toronto, Ontario, Canada
Investigational Site Number :1240006, Gatineau, Quebec, Canada
Investigational Site Number :1240005, Greenfield Park, Quebec, Canada
Investigational Site Number :1240004, Montreal, Quebec, Canada
Investigational Site Number :1240015, Montreal, Quebec, Canada
Investigational Site Number :1240007, Sherbrooke, Quebec, Canada
Investigational Site Number :1240021, Quebec, , Canada
Investigational Site Number :1560006, Beijing, , China
Investigational Site Number :1560012, Beijing, , China
Investigational Site Number :1560021, Beijing, , China
Investigational Site Number :1560003, Beijing, , China
Investigational Site Number :1560009, Beijing, , China
Investigational Site Number :1560004, Changchun, , China
Investigational Site Number :1560015, Changsha, , China
Investigational Site Number :1560005, Chengdu, , China
Investigational Site Number :1560019, Chongqing, , China
Investigational Site Number :1560035, Fuzhou, , China
Investigational Site Number :1560001, Guangzhou, , China
Investigational Site Number :1560007, Hangzhou, , China
Investigational Site Number :1560014, Shijiazhuang, , China
Investigational Site Number :1560008, Taiyuan, , China
Investigational Site Number :1560017, Xi'an, , China
Investigational Site Number :2030002, Brno, , Czechia
Investigational Site Number :2030004, Hradec Kralove, , Czechia
Investigational Site Number :2030001, Jihlava, , Czechia
Investigational Site Number :2030010, Ostrava - Poruba, , Czechia
Investigational Site Number :2030005, Praha 2, , Czechia
Investigational Site Number :2030003, Teplice, , Czechia
Investigational Site Number :2080001, Esbjerg, , Denmark
Investigational Site Number :2080005, Holstebro, , Denmark
Investigational Site Number :2080004, Odense, , Denmark
Investigational Site Number :2460003, Helsinki, , Finland
Investigational Site Number :2460001, Tampere, , Finland
Investigational Site Number :2460002, Turku, , Finland
Investigational Site Number :2500011, Bron, , France
Investigational Site Number :2500005, Clermont Ferrand, , France
Investigational Site Number :2500015, Gonesse, , France
Investigational Site Number :2500009, Lille, , France
Investigational Site Number :2500006, Montpellier, , France
Investigational Site Number :2500008, Nancy, , France
Investigational Site Number :2500010, Nantes, , France
Investigational Site Number :2500017, Nimes, , France
Investigational Site Number :2500016, Paris, , France
Investigational Site Number :2500014, Paris, , France
Investigational Site Number :2500007, Paris, , France
Investigational Site Number :2500003, Rennes, , France
Investigational Site Number :2500001, Strasbourg, , France
Investigational Site Number :2500012, Toulouse, , France
Investigational Site Number :2760005, Bayreuth, , Germany
Investigational Site Number :2760009, Berlin, , Germany
Investigational Site Number :2760001, Dresden, , Germany
Investigational Site Number :2760012, Essen, , Germany
Investigational Site Number :2760002, Gießen, , Germany
Investigational Site Number :2760010, Halle (Saale), , Germany
Investigational Site Number :2760006, Hannover, , Germany
Investigational Site Number :2760008, Münster, , Germany
Investigational Site Number :2760004, Rostock, , Germany
Investigational Site Number :2760011, Ulm, , Germany
Investigational Site Number :3000001, Athens, , Greece
Investigational Site Number :3000006, Athens, , Greece
Investigational Site Number :3000002, Athens, , Greece
Investigational Site Number :3000007, Athens, , Greece
Investigational Site Number :3000004, Larissa, , Greece
Investigational Site Number :3000003, Thessaloniki, , Greece
Investigational Site Number :3000005, Thessaloniki, , Greece
Investigational Site Number :3480008, Budapest, , Hungary
Investigational Site Number :3480004, Budapest, , Hungary
Investigational Site Number :3480007, Budapest, , Hungary
Investigational Site Number :3480002, Pécs, , Hungary
Investigational Site Number :3480001, Szeged, , Hungary
Investigational Site Number :3480006, Tatabánya, , Hungary
Investigational Site Number :3560007, Gurgaon, , India
Investigational Site Number :3560003, Gurgaon, , India
Investigational Site Number :3560005, India, , India
Investigational Site Number :3560004, Mangaluru, , India
Investigational Site Number :3560006, New Delhi, , India
Investigational Site Number :3560002, New Delhi, , India
Investigational Site Number :3760002, Ashkelon, , Israel
Investigational Site Number :3760003, Haifa, , Israel
Investigational Site Number :3760008, Jerusalem, , Israel
Investigational Site Number :3760001, Tel HaShomer, , Israel
Investigational Site Number :3760004, Zefat, , Israel
Investigational Site Number :3800011, Bergamo, , Italy
Investigational Site Number :3800007, Cagliari, , Italy
Investigational Site Number :3800012, Firenze, , Italy
Investigational Site Number :3800016, Firenze, , Italy
Investigational Site Number :3800014, Genova, , Italy
Investigational Site Number :3800013, L'Aquila, , Italy
Investigational Site Number :3800004, Milano, , Italy
Investigational Site Number :3800001, Milano, , Italy
Investigational Site Number :3800010, Milano, , Italy
Investigational Site Number :3800008, Pavia, , Italy
Investigational Site Number :3800005, Roma, , Italy
Investigational Site Number :3800009, Roma, , Italy
Investigational Site Number :3920016, Chiba-shi, Chiba, Japan
Investigational Site Number :3920022, Morioka-shi, Iwate, Japan
Investigational Site Number :3920011, Kyoto-shi, Kyoto, Japan
Investigational Site Number :3920020, Sendai-shi, Miyagi, Japan
Investigational Site Number :3920005, Niigata-shi, Niigata, Japan
Investigational Site Number :3920004, Moriguchi-shi, Osaka, Japan
Investigational Site Number :3920001, Osaka-shi, Osaka, Japan
Investigational Site Number :3920018, Kawagoe-shi, Saitama, Japan
Investigational Site Number :3920003, Kodaira-shi, Tokyo, Japan
Investigational Site Number :3920010, Ota-ku, Tokyo, Japan
Investigational Site Number :3920009, Ube-shi, Yamaguchi, Japan
Investigational Site Number :3920023, Sagamihara-shi, , Japan
Investigational Site Number :4400003, Kaunas, , Lithuania
Investigational Site Number :4400002, Klaipeda, , Lithuania
Investigational Site Number :4400001, Vilnius, , Lithuania
Investigational Site Number :5280001, Amsterdam, , Netherlands
Investigational Site Number :5280003, Breda, , Netherlands
Investigational Site Number :5280006, Groningen, , Netherlands
Investigational Site Number :5280002, Sittard-Geleen, , Netherlands
Investigational Site Number :5780003, Bergen, , Norway
Investigational Site Number :5780002, Namsos, , Norway
Investigational Site Number :5780001, Oslo, , Norway
Investigational Site Number :6160003, Bydgoszcz, Kujawsko-pomorskie, Poland
Investigational Site Number :6160005, Warszawa, Mazowieckie, Poland
Investigational Site Number :6160006, Warszawa, Mazowieckie, Poland
Investigational Site Number :6160002, Katowice, Slaskie, Poland
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Investigational Site Number :6160004, Katowice, Slaskie, Poland
Investigational Site Number :6160008, Plewiska, Wielkopolskie, Poland
Investigational Site Number :6160001, Lodz, , Poland
Investigational Site Number :6160012, Lublin, , Poland
Investigational Site Number :6160011, Zabrze, , Poland
Investigational Site Number :6200001, Braga, , Portugal
Investigational Site Number :6200011, Lisboa, , Portugal
Investigational Site Number :6200007, Lisboa, , Portugal
Investigational Site Number :6200006, Lisboa, , Portugal
Investigational Site Number :6200002, Matosinhos, , Portugal
Investigational Site Number :6200010, Porto, , Portugal
Investigational Site Number :6420008, Bucuresti, , Romania
Investigational Site Number :6420004, Campulung, , Romania
Investigational Site Number :6420006, Cluj-Napoca, , Romania
Investigational Site Number :6420003, Constanta, , Romania
Investigational Site Number :6420013, Oradea, , Romania
Investigational Site Number :6420005, Sibiu, , Romania
Investigational Site Number :6420001, Targu Mures, , Romania
Investigational Site Number :6420002, Timisoara, , Romania
Investigational Site Number :6430018, Barnaul, , Russian Federation
Investigational Site Number :6430023, Ekaterinburg, , Russian Federation
Investigational Site Number :6430025, Kaliningrad, , Russian Federation
Investigational Site Number :6430003, Kazan, , Russian Federation
Investigational Site Number :6430022, Kemerovo, , Russian Federation
Investigational Site Number :6430017, Kirov, , Russian Federation
Investigational Site Number :6430024, Krasnoyarsk, , Russian Federation
Investigational Site Number :6430020, Moscow, , Russian Federation
Investigational Site Number :6430002, Moscow, , Russian Federation
Investigational Site Number :6430013, Moscow, , Russian Federation
Investigational Site Number :6430001, Moscow, , Russian Federation
Investigational Site Number :6430008, Moscow, , Russian Federation
Investigational Site Number :6430021, Nizhny Novgorod, , Russian Federation
Investigational Site Number :6430006, Nizhny Novgorod, , Russian Federation
Investigational Site Number :6430005, Novosibirsk, , Russian Federation
Investigational Site Number :6430026, Perm, , Russian Federation
Investigational Site Number :6430007, Pyatigorsk, , Russian Federation
Investigational Site Number :6430016, Rostov-on-Don, , Russian Federation
Investigational Site Number :6430004, Saint-Petersburg, , Russian Federation
Investigational Site Number :6430009, Samara, , Russian Federation
Investigational Site Number :6430019, Saransk, , Russian Federation
Investigational Site Number :6430014, Smolensk, , Russian Federation
Investigational Site Number :6430011, St-Petersburg, , Russian Federation
Investigational Site Number :6430012, Tyumen, , Russian Federation
Investigational Site Number :6430010, Ufa, , Russian Federation
Investigational Site Number :7240007, Sevilla, Andalucia, Spain
Investigational Site Number :7240013, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240016, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240014, Salt, Girona [Gerona], Spain
Investigational Site Number :7240017, Las Palmas de Gran Canaria, Las Palmas, Spain
Investigational Site Number :7240004, Majadahonda, Madrid, Spain
Investigational Site Number :7240001, Pozuelo De Alarcón, Madrid, Spain
Investigational Site Number :7240012, Donostia, Pais Vasco, Spain
Investigational Site Number :7240008, Córdoba, , Spain
Investigational Site Number :7240015, Lleida, , Spain
Investigational Site Number :7240005, Madrid, , Spain
Investigational Site Number :7240002, Madrid, , Spain
Investigational Site Number :7240003, Madrid, , Spain
Investigational Site Number :7240010, Murcia, , Spain
Investigational Site Number :7240009, Málaga, , Spain
Investigational Site Number :7240011, Valencia, , Spain
Investigational Site Number :7920005, Eskisehir, , Turkey
Investigational Site Number :7920010, Hatay, , Turkey
Investigational Site Number :7920002, Istanbul, , Turkey
Investigational Site Number :7920009, Istanbul, , Turkey
Investigational Site Number :7920007, Istanbul, , Turkey
Investigational Site Number :7920006, Istanbul, , Turkey
Investigational Site Number :7920003, Istanbul, , Turkey
Investigational Site Number :7920013, Izmir, , Turkey
Investigational Site Number :7920001, Izmit, , Turkey
Investigational Site Number :7920011, Kütahya, , Turkey
Investigational Site Number :7920012, Mersin, , Turkey
Investigational Site Number :7920008, Trabzon, , Turkey
Investigational Site Number :8040008, Chernivtsi, , Ukraine
Investigational Site Number :8040016, Chernivtsi, , Ukraine
Investigational Site Number :8040003, Dnipro, , Ukraine
Investigational Site Number :8040010, Ivano-Frankivsk, , Ukraine
Investigational Site Number :8040007, Kharkiv, , Ukraine
Investigational Site Number :8040011, Kharkiv, , Ukraine
Investigational Site Number :8040012, Kharkiv, , Ukraine
Investigational Site Number :8040013, Kyiv, , Ukraine
Investigational Site Number :8040005, Lutsk, , Ukraine
Investigational Site Number :8040009, Lviv, , Ukraine
Investigational Site Number :8040004, Lviv, , Ukraine
Investigational Site Number :8040002, Odesa, , Ukraine
Investigational Site Number :8040006, Vinnytsia, , Ukraine
Investigational Site Number :8040014, Zhytomyr, , Ukraine
Investigational Site Number :8260003, Exeter, Devon, United Kingdom
Investigational Site Number :8260008, Plymouth, Devon, United Kingdom
Investigational Site Number :8260010, Swansea, Neath Port Talbot, United Kingdom
Investigational Site Number :8260012, Nottingham, Nottinghamshire, United Kingdom
Investigational Site Number :8260013, Oxford, Oxfordshire, United Kingdom
Investigational Site Number :8260009, Bristol, , United Kingdom
Investigational Site Number :8260001, Cardiff, , United Kingdom
Investigational Site Number :8260005, London, , United Kingdom
Investigational Site Number :8260018, London, , United Kingdom
Investigational Site Number :8260014, Newcastle Upon Tyne, , United Kingdom
Investigational Site Number :8260019, Salford, , United Kingdom
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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