Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS) (PERSEUS)

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)

Primary Objective:

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS)

Secondary Objectives:

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 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168

Study Overview

• Status: Completed
• Conditions: Primary Progressive Multiple Sclerosis
• Intervention / Treatment: Drug: Tolebrutinib; Drug: Placebo

Detailed Description

Study duration will vary per participant in this event driven trial with a treatment duration of approximately 12 to 60 months.

• Study Type: Interventional
• Enrollment (Actual): 767
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1012AAR
      • Investigational Site Number : 0320002
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Investigational Site Number : 0320003
• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Investigational Site Number : 0360005
    • St Leonards, New South Wales, Australia, 2065
      • Investigational Site Number : 0360006
  • Tasmania
    • Hobart, Tasmania, Australia, 7001
      • Investigational Site Number : 0360003
• Austria
  • Linz, Austria, 4021
    • Investigational Site Number : 0400004
  • Vienna, Austria, 1090
    • Investigational Site Number : 0400002
• Belarus
  • Vitebsk, Belarus, 210009
    • Investigational Site Number : 1120004
  • Vitebsk, Belarus, 210037
    • Investigational Site Number : 1120005
• Belgium
  • Brussels, Belgium, 1070
    • Investigational Site Number : 0560009
  • Ghent, Belgium, 9000
    • Investigational Site Number : 0560004
  • Liège, Belgium, 4000
    • Investigational Site Number : 0560008
  • Overpelt, Belgium, 3900
    • Investigational Site Number : 0560001
  • Woluwe-Saint-Lambert, Belgium, 1200
    • Investigational Site Number : 0560007
• Brazil
  • Paraná
    • Curitiba, Paraná, Brazil, 81210-310
      • Instituto de Neurologia de Curitiba Site Number : 0760002
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01228-000
      • CPQuali Pesquisa Clinica Site Number : 0760007
• Bulgaria
  • Pleven, Bulgaria, 5809
    • Investigational Site Number : 1000002
  • Sofia, Bulgaria, 1113
    • Investigational Site Number : 1000004
  • Sofia, Bulgaria, 1407
    • Investigational Site Number : 1000008
  • Sofia, Bulgaria, 1431
    • Investigational Site Number : 1000001
  • Sofia, Bulgaria, 1606
    • Investigational Site Number : 1000011
• Canada
  • Québec, Canada, G1J 1Z4
    • Investigational Site Number : 1240001
  • Québec, Canada, G1W 4R4
    • Investigational Site Number : 1240021
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2C8
      • Investigational Site Number : 1240002
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 2B5
      • Investigational Site Number : 1240016
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Investigational Site Number : 1240012
    • Ottawa, Ontario, Canada, K1H 8L6
      • Investigational Site Number : 1240003
    • Toronto, Ontario, Canada, M5B 1W8
      • Investigational Site Number : 1240013
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Investigational Site Number : 1240004
    • Montreal, Quebec, Canada, H3A 2B4
      • Investigational Site Number : 1240015
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Investigational Site Number : 1240007
• Chile
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 8380456
      • Investigational Site Number : 1520001
    • Santiago, Reg Metropolitana de Santiago, Chile, 7650568
      • Investigational Site Number : 1520002
• China
  • Beijing, China, 100032
    • Investigational Site Number : 1560003
  • Beijing, China, 100053
    • Investigational Site Number : 1560012
  • Beijing, China, 100730
    • Investigational Site Number : 1560009
  • Beijing, China, 100730
    • Investigational Site Number : 1560025
  • Changchun, China, 130021
    • Investigational Site Number : 1560004
  • Changsha, China, 410008
    • Investigational Site Number : 1560015
  • Chengdu, China, 610041
    • Investigational Site Number : 1560005
  • Fuzhou, China, 350005
    • Investigational Site Number : 1560035
  • Guangzhou, China, 510630
    • Investigational Site Number : 1560002
  • Hohhot, China, 010050
    • Investigational Site Number : 1560027
  • Shanghai, China, 200040
    • Investigational Site Number : 1560001
  • Taiyuan, China, 030001
    • Investigational Site Number : 1560008
  • Wenzhou, China, 325000
    • Investigational Site Number : 1560026
• Colombia
  • Bogotá, Colombia, 111321
    • Investigational Site Number : 1700003
  • Bogotá, Colombia
    • Investigational Site Number : 1700001
• Croatia
  • Zagreb, Croatia, 10000
    • Investigational Site Number : 1910001
  • Zagreb, Croatia, 10000
    • Investigational Site Number : 1910002
• Czechia
  • Brno, Czechia, 65691
    • Investigational Site Number : 2030002
  • Hradec Králové, Czechia, 50005
    • Investigational Site Number : 2030004
  • Jihlava, Czechia, 58633
    • Investigational Site Number : 2030001
  • Teplice, Czechia, 415 29
    • Investigational Site Number : 2030003
• Denmark
  • Esbjerg, Denmark, 6700
    • Investigational Site Number : 2080001
  • Holstebro, Denmark, 7500
    • Investigational Site Number : 2080005
• Estonia
  • Tallinn, Estonia, 11315
    • Investigational Site Number : 2330001
• France
  • Bron, France, 69500
    • Investigational Site Number : 2500011
  • Clermont-Ferrand, France, 63003
    • Investigational Site Number : 2500005
  • Gonesse, France, 95500
    • Investigational Site Number : 2500015
  • Lille, France, 59037
    • Investigational Site Number : 2500009
  • Montpellier, France, 34295
    • Investigational Site Number : 2500006
  • Nancy, France, 54035
    • Investigational Site Number : 2500008
  • Nîmes, France, 30029
    • Investigational Site Number : 2500017
  • Paris, France, 75013
    • Investigational Site Number : 2500014
  • Paris, France, 75019
    • Investigational Site Number : 2500007
  • Poissy, France, 78300
    • Investigational Site Number : 2500004
  • Rennes, France, 35033
    • Investigational Site Number : 2500003
  • Strasbourg, France, 67098
    • Investigational Site Number : 2500001
  • Toulouse, France, 31059
    • Investigational Site Number : 2500012
• Georgia
  • Tbilisi, Georgia, 0114
    • Investigational Site Number : 2680005
  • Tbilisi, Georgia, 0159
    • Investigational Site Number : 2680009
  • Tbilisi, Georgia, 0160
    • Investigational Site Number : 2680003
  • Tbilisi, Georgia, 0172
    • Investigational Site Number : 2680004
• Germany
  • Bayreuth, Germany, 95445
    • Investigational Site Number : 2760005
  • Berlin, Germany, 10117
    • Investigational Site Number : 2760009
  • Berlin, Germany, 10713
    • Investigational Site Number : 2760015
  • Bochum, Germany, 44791
    • Investigational Site Number : 2760020
  • Dresden, Germany, 01307
    • Investigational Site Number : 2760001
  • Düsseldorf, Germany, 40225
    • Investigational Site Number : 2760021
  • Essen, Germany, 45147
    • Investigational Site Number : 2760012
  • Giessen, Germany, 35385
    • Investigational Site Number : 2760002
  • Hanover, Germany, 30625
    • Investigational Site Number : 2760006
  • München, Germany, 81377
    • Investigational Site Number : 2760018
  • Münster, Germany, 48149
    • Investigational Site Number : 2760008
  • Rostock, Germany, 18055
    • Investigational Site Number : 2760004
  • Ulm, Germany, 89081
    • Investigational Site Number : 2760011
• Greece
  • Athens, Greece, 115 28
    • Investigational Site Number : 3000001
  • Athens, Greece, 11525
    • Investigational Site Number : 3000006
  • Athens, Greece, 12462
    • Investigational Site Number : 3000002
  • Larissa, Greece, 41110
    • Investigational Site Number : 3000004
  • Marousi, Greece, 15125
    • Investigational Site Number : 3000007
  • Thessaloniki, Greece, 546 36
    • Investigational Site Number : 3000003
  • Thessaloniki, Greece, 55236
    • Investigational Site Number : 3000009
• Hungary
  • Budapest, Hungary, 1033
    • Investigational Site Number : 3480206
  • Budapest, Hungary, 1083
    • Investigational Site Number : 3480202
  • Budapest, Hungary, 1138
    • Investigational Site Number : 3480203
• India
  • Bengaluru, India, 560001
    • Investigational Site Number : 3560014
  • Mangaluru, India, 575018
    • Investigational Site Number : 3560004
  • New Delhi, India, 110029
    • Investigational Site Number : 3560005
• Israel
  • Jerusalem, Israel, 91120
    • Investigational Site Number : 3760008
  • Ramat Gan, Israel, 5266202
    • Investigational Site Number : 3760001
  • Safed, Israel, 13100
    • Investigational Site Number : 3760004
• Italy
  • Cagliari, Italy, 09126
    • Investigational Site Number : 3800007
  • Catania, Italy, 95123
    • Investigational Site Number : 3800015
  • Chieti, Italy, 66100
    • Investigational Site Number : 3800018
  • Florence, Italy, 50134
    • Investigational Site Number : 3800016
  • Milan, Italy, 20132
    • Investigational Site Number : 3800001
  • Napoli, Italy, 80131
    • Investigational Site Number : 3800003
  • Napoli, Italy, 80138
    • Investigational Site Number : 3800006
  • Roma, Italy, 00189
    • Investigational Site Number : 3800013
  • Isernia
    • Pozzilli, Isernia, Italy, 86077
      • Investigational Site Number : 3800002
• Japan
  • Chiba
    • Chiba, Chiba, Japan, 260-8677
      • Investigational Site Number : 3920016
  • Fukushima
    • Koriyama-shi, Fukushima, Japan, 963-8052
      • Investigational Site Number : 3920008
  • Iwate
    • Morioka, Iwate, Japan, 020-8505
      • Investigational Site Number : 3920022
  • Kanagawa
    • Sagamihara-shi, Kanagawa, Japan, 252-0392
      • Investigational Site Number : 3920023
  • Kyoto
    • Kyoto, Kyoto, Japan, 616-8255
      • Investigational Site Number : 3920011
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Investigational Site Number : 3920020
  • Niigata
    • Niigata, Niigata, Japan, 951-8520
      • Investigational Site Number : 3920005
  • Osaka
    • Moriguchi-shi, Osaka, Japan, 570-8507
      • Investigational Site Number : 3920004
    • Osaka, Osaka, Japan, 556-0016
      • Investigational Site Number : 3920001
  • Saitama
    • Kawagoe-shi, Saitama, Japan, 350-8550
      • Investigational Site Number : 3920018
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Investigational Site Number : 3920014
    • Kodaira-shi, Tokyo, Japan, 187-8551
      • Investigational Site Number : 3920003
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Investigational Site Number : 3920017
    • Ōta-ku, Tokyo, Japan, 146-0065
      • Investigational Site Number : 3920010
  • Toyama
    • Toyama, Toyama, Japan, 930-0194
      • Investigational Site Number : 3920015
• Latvia
  • Riga, Latvia, LV-1002
    • Investigational Site Number : 4280002
• Mexico
  • Mexico City, Mexico, 14050
    • Investigational Site Number : 4840005
  • Tlalnepantla, Mexico, 54055
    • Investigational Site Number : 4840007
  • Veracruz, Mexico, 91910
    • Investigational Site Number : 4840003
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44670
      • Investigational Site Number : 4840004
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06700
      • Investigational Site Number : 4840001
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Investigational Site Number : 5280003
  • Groningen, Netherlands, 9728NT
    • Investigational Site Number : 5280006
  • Sittard-Geleen, Netherlands, 6162 BG
    • Investigational Site Number : 5280002
• Norway
  • Bergen, Norway, 5021
    • Investigational Site Number : 5780003
  • Tromsø, Norway, 9038
    • Investigational Site Number : 5780005
• Peru
  • Lima, Peru, 15084
    • Investigational Site Number : 6040004
• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
      • Investigational Site Number : 6160003
  • Lódzkie
    • Lodz, Lódzkie, Poland, 90-549
      • Investigational Site Number : 6160001
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 01-211
      • Investigational Site Number : 6160005
    • Warsaw, Masovian Voivodeship, Poland, 01-684
      • Investigational Site Number : 6160006
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-684
      • Investigational Site Number : 6160007
    • Katowice, Silesian Voivodeship, Poland, 40-686
      • Investigational Site Number : 6160004
• Portugal
  • Braga, Portugal, 4710-243
    • Investigational Site Number : 6200001
  • Lisbon, Portugal, 1349-019
    • Investigational Site Number : 6200007
  • Lisbon, Portugal, 1500-650
    • Investigational Site Number : 6200012
  • Matosinhos Municipality, Portugal, 4464-513
    • Investigational Site Number : 6200002
  • Porto, Portugal, 4099-001
    • Investigational Site Number : 6200010
  • Santa Maria da Feira, Portugal, 4520-211
    • Investigational Site Number : 6200004
• Romania
  • Bucharest, Romania, 022328
    • Investigational Site Number : 6420008
  • Campulung Muscel, Romania, 115100
    • Investigational Site Number : 6420004
  • Constanța, Romania, 900123
    • Investigational Site Number : 6420003
  • Oradea, Romania, 410154
    • Investigational Site Number : 6420013
  • Timișoara, Romania, 300736
    • Investigational Site Number : 6420002
  • Târgu Mureş, Romania, 540136
    • Investigational Site Number : 6420001
• Russia
  • Barnaul, Russia, 656043
    • Investigational Site Number : 6430018
  • Kaliningrad, Russia, 236035
    • Investigational Site Number : 6430023
  • Kazan', Russia, 420032
    • Investigational Site Number : 6430004
  • Krasnoyarsk, Russia, 660029
    • Investigational Site Number : 6430021
  • Moscow, Russia, 117997
    • Investigational Site Number : 6430013
  • Moscow, Russia, 129128
    • Investigational Site Number : 6430011
  • Nizhny Novgorod, Russia, 603137
    • Investigational Site Number : 6430014
  • Pyatigorsk, Russia, 357538
    • Investigational Site Number : 6430008
  • Rostov-on-Don, Russia, 344022
    • Investigational Site Number : 6430015
  • Saint Petersburg, Russia, 197376
    • Investigational Site Number : 6430017
  • Samara, Russia, 443095
    • Investigational Site Number : 6430009
  • Saransk, Russia, 430032
    • Investigational Site Number : 6430020
  • Tyumen, Russia, 625000
    • Investigational Site Number : 6430007
  • Ufa, Russia, 450005
    • Investigational Site Number : 6430006
  • Yekaterinburg, Russia, 620102
    • Investigational Site Number : 6430022
• Serbia
  • Belgrade, Serbia, 11000
    • Investigational Site Number : 6880001
  • Kragujevac, Serbia, 34000
    • Investigational Site Number : 6880002
• South Africa
  • Pretoria, South Africa, 0041
    • Investigational Site Number : 7100001
• Spain
  • Córdoba, Spain, 14004
    • Investigational Site Number : 7240004
  • Madrid, Spain, 28007
    • Investigational Site Number : 7240003
  • Murcia, Spain, 30120
    • Investigational Site Number : 7240006
  • Málaga, Spain, 29010
    • Investigational Site Number : 7240005
  • Palma de Mallorca, Spain, 07120
    • Investigational Site Number : 7240014
  • Valencia, Spain, 46026
    • Investigational Site Number : 7240008
  • A Coruña [La Coruña]
    • A Coruña, A Coruña [La Coruña], Spain, 15006
      • Investigational Site Number : 7240012
    • Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
      • Investigational Site Number : 7240015
  • Andalusia
    • Seville, Andalusia, Spain, 41009
      • Investigational Site Number : 7240007
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08035
      • Investigational Site Number : 7240010
  • Bizkaia
    • Bilbao, Bizkaia, Spain, 48013
      • Investigational Site Number : 7240013
  • Girona [Gerona]
    • Salt, Girona [Gerona], Spain, 17190
      • Investigational Site Number : 7240011
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
      • Investigational Site Number : 7240016
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Investigational Site Number : 7240002
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Investigational Site Number : 7240001
• Sweden
  • Gothenburg, Sweden, 413 45
    • Investigational Site Number : 7520001
  • Motala, Sweden, 591 85
    • Investigational Site Number : 7520005
• Thailand
  • Bangkok, Thailand, 10700
    • Investigational Site Number : 7640001
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06100
    • Investigational Site Number : 7920009
  • Ankara, Turkey (Türkiye), 06500
    • Investigational Site Number : 7920014
  • Eskişehir, Turkey (Türkiye), 26040
    • Investigational Site Number : 7920005
  • Hatay, Turkey (Türkiye)
    • Investigational Site Number : 7920010
  • Istanbul, Turkey (Türkiye), 34265
    • Investigational Site Number : 7920003
  • Istanbul, Turkey (Türkiye), 34093
    • Investigational Site Number : 7920016
  • Istanbul, Turkey (Türkiye), 34303
    • Investigational Site Number : 7920002
  • Istanbul, Turkey (Türkiye), 34785
    • Investigational Site Number : 7920007
  • Izmir, Turkey (Türkiye), 35100
    • Investigational Site Number : 7920015
  • Izmir, Turkey (Türkiye), 35340
    • Investigational Site Number : 7920018
  • Konya, Turkey (Türkiye), 42080
    • Investigational Site Number : 7920017
  • Kütahya, Turkey (Türkiye), 43100
    • Investigational Site Number : 7920011
  • Mersin, Turkey (Türkiye), 33070
    • Investigational Site Number : 7920012
  • Samsun, Turkey (Türkiye)
    • Investigational Site Number : 7920013
  • İzmit, Turkey (Türkiye), 41380
    • Investigational Site Number : 7920001
• Ukraine
  • Chernivtsi, Ukraine, 58023
    • Investigational Site Number : 8040020
  • Ivano-Frankivsk, Ukraine, 76493
    • Investigational Site Number : 8040012
  • Kharkiv, Ukraine, 61068
    • Investigational Site Number : 8040017
  • Kharkiv, Ukraine, 61068
    • Investigational Site Number : 8040025
  • Kharkiv, Ukraine, 61103
    • Investigational Site Number : 8040023
  • Kyiv, Ukraine, 01135
    • Investigational Site Number : 8040014
  • Kyiv, Ukraine, 02091
    • Investigational Site Number : 8040013
  • Kyiv, Ukraine, 03115
    • Investigational Site Number : 8040015
  • Lutsk, Ukraine, 43005
    • Investigational Site Number : 8040011
  • Lviv, Ukraine, 79010
    • Investigational Site Number : 8040002
  • Lviv, Ukraine, 79013
    • Investigational Site Number : 8040007
  • Odesa, Ukraine, 65025
    • Investigational Site Number : 8040010
  • Vinnytsia, Ukraine, 21001
    • Investigational Site Number : 8040024
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • Investigational Site Number : 8260009
  • Salford, United Kingdom, M6 8HD
    • Investigational Site Number : 8260019
  • Sheffield, United Kingdom, S5 7AU
    • Investigational Site Number : 8260007
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Investigational Site Number : 8260003
  • Kent
    • Canterbury, Kent, United Kingdom, CT1 3NG
      • Investigational Site Number : 8260016
  • London, City of
    • London, London, City of, United Kingdom, EC1M 6BQ
      • Investigational Site Number : 8260006
    • London, London, City of, United Kingdom, SW17 0QT
      • Investigational Site Number : 8260005
  • Neath Port Talbot
    • Swansea, Neath Port Talbot, United Kingdom, SA6 6NL
      • Investigational Site Number : 8260010
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • Investigational Site Number : 8260012
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Investigational Site Number : 8260013
  • Vale of Glamorgan, the
    • Cardiff, Vale of Glamorgan, the, United Kingdom, CF4 4XY
      • Investigational Site Number : 8260001
• United States
  • California
    • La Jolla, California, United States, 92037
      • UC San Diego ACTRI Site Number : 8400101
    • Los Alamitos, California, United States, 90720
      • Collaborative Neuroscience Research Site Number : 8400045
    • Los Angeles, California, United States, 90033
      • Multiple Sclerosis Center- Site Number : 8400143
    • Newport Beach, California, United States, 92663
      • Multiple Sclerosis Center of California Site Number : 8400135
    • Pasadena, California, United States, 91105
      • SC3 Research - Pasadena Site Number : 8400070
    • San Francisco, California, United States, 94158
      • University of San Francisco, Sandler Neurosciences Center- Site Number : 8400137
    • Torrance, California, United States, 90502
      • Harbor UCLA Site Number : 8400088
    • West Hollywood, California, United States, 90048
      • Regina Berkovich, MD, PhD Site Number : 8400059
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Advanced Neurosciences Research Site Number : 8400025
  • Florida
    • Boca Raton, Florida, United States, 33487
      • South Florida Neurology Associates Site Number : 8400029
    • Clearwater, Florida, United States, 33761
      • MS & Neuromuscular Center of Excellence Site Number : 8400172
    • Gainesville, Florida, United States, 32601
      • University of Florida, Fixel Center for Neurology Site Number : 8400159
    • Maitland, Florida, United States, 32761
      • Neurology Associates, PA- Site Number : 8400004
    • Tampa, Florida, United States, 33612
      • University of South Florida Site Number : 8400006
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Velocity Clinical Research Site Number : 8400003
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Pacific Neuroscience Site Number : 8400103
  • Illinois
    • Northbrook, Illinois, United States, 60062
      • Consultants In Neurology- Site Number : 8400011
  • Indiana
    • Merrillville, Indiana, United States, 46410
      • Methodist Hospital Site Number : 8400164
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • College Park Family Care Center Site Number : 8400044
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Site Number : 8400106
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Baptist Clinical Trials Unit (CTU)- Site Number : 8400107
  • Maryland
    • Lutherville, Maryland, United States, 21093
      • International Neurorehabilitation Institute Site Number : 8400034
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center Site Number : 8400072
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Site Number : 8400014
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Michigan Institute For Neurological Disorders Site Number : 8400058
    • Owosso, Michigan, United States, 48867
      • The Memorial Hospital- Site Number : 8400033
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Site Number : 8400111
  • Missouri
    • Ozark, Missouri, United States, 65721
      • Sharlin Health & Neurology Site Number : 8400093
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University Of Nebraska- Site Number : 8400129
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Hospital Site Number : 8400047
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Site Number : 8400032
  • New York
    • New York, New York, United States, 10029-6501
      • Icahn School of Medicine at Mount Sinai (Department of Endoc Site Number : 8400038
    • Stony Brook, New York, United States, 11794
      • Neurology Associates of Stony Brook Site Number : 8400042
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Neurological Disorders Clinic- Site Number : 8400098
    • Raleigh, North Carolina, United States, 27607
      • Meridian Clinical Research, LLC- Site Number : 8400005
    • Winston-Salem, North Carolina, United States, 27103
      • Atrium Health Wake Forest Baptist Site Number : 8400116
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Riverhills Neuroscience - Norwood Site Number : 8400167
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Site Number : 8400125
    • Columbus, Ohio, United States, 43235
      • The Boster Center for Multiple Sclerosis Site Number : 8400147
    • Columbus, Ohio, United States, 43221
      • The Ohio State University Wexner Medical Center- Site Number : 8400150
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Multiple Sclerosis Center Site Number : 8400020
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Neurology Associates Site Number : 8400016
  • South Carolina
    • Greer, South Carolina, United States, 29651-1817
      • Mountain View Clinical Research Site Number : 8400024
  • Texas
    • Katy, Texas, United States, 77450
      • Mt Olympus Medical Research Site Number : 8400163
    • San Antonio, Texas, United States, 78258
      • Neurology Center of San Antonio Site Number : 8400036

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 to 55 years of age inclusive
• Diagnosis of PPMS according to the 2017 McDonald criteria
• Expanded disability status scale (EDSS) score between 2.0 to 6.5 points, at screening inclusive
• Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG) index either during screening or documented previous history.
• Contraceptive use consistent with local regulations for individuals participating in clinical studies
• Participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Is not a woman of childbearing potential (WOCBP) or is a WOCBP and agrees to use an acceptable contraceptive method
• the participant must not have access to ocrelizumab (eg, ocrelizumab not available on the national market or not reimbursed for the approved indication).
• the participant must have access to and be eligible to be treated with ocrelizumab but: 1) does not tolerate it due to side effects or safety reasons; and/or 2) has failed ocrelizumab treatment due to perceived lack of efficacy

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• Participant has conditions that would adversely affect study participation such as short life expectancy.
• Evidence of infection with human immunodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection that would adversely affect study participation.
• Persistent chronic or active or recurring system infection that may adversely affect participation or IMP administration in this study as judged by the investigator
• History of malignancy within 5 years prior to screening.
• History of alcohol or drug abuse within 1 year prior to Screening.
• Hospitalized for psychiatric disease within 2 years prior to Screening.
• Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.
• A bleeding disorder or known platelet dysfunction at any time prior to the screening visit.
• A platelet count <150 000/μL at the screening visit.
• A history of significant bleeding event within 6 months prior to screening, according to the Investigator's judgment such as, but not limited to cerebral or gastrointestinal
• Lymphocyte count below the lower limit of normal at Screening.
• Recent live (attenuated) vaccine within 2 months before the first treatment visit.
• Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study.
• The participant has received medications/treatments for MS within a specified time frame.
• Receiving potent and moderate inducers of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes.
• Receiving anticoagulant or antiplatelet therapy (such as aspirin >81mg/day, clopidogrel, warfarin).
• Contraindications to magnetic resonance imaging (MRI).

NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAR442168; Dose 1 of oral SAR442168 once daily	Drug: Tolebrutinib; Pharmaceutical form: Film-coated Tablet Route of administration: Oral; Other Names: SAR442168
Placebo Comparator: Placebo; Placebo to match the SAR442168 once daily	Drug: Placebo; Pharmaceutical form: Film-coated Tablet Route of administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-month composite Confirmed Disability Progression (cCDP)	Time to onset of 6-month cCDP defined as follows: Increase over at least 6 months of ≥1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is ≤5.5, or ≥0.5 points when the baseline EDSS score is >5.5, or ≥20% from the baseline T25-FW, or ≥20% from the baseline 9-HPT	Up to approximately 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Population pharmacokinetics	Plasma concentration of SAR442168 (population PK assessment) at Months 6, 9, and 12	Months 6, 9 and 12
6-month Confirmed Disability Progression (CDP)	Time to onset of 6-month CDP as assessed by EDSS score	Up to approximately 60 months
Change in T2 hyperintense lesions by MRI	Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI after baseline up to and including the end of study (EOS)	From screening MRI to approximately 60 months
Time to onset of confirmed disability improvement (CDI)	Time to onset of CDI defined as ≥1.0-point decrease on the EDSS score from baseline confirmed over at least 6 months	Up to approximately 60 months
Percent change in Brain volume (BV)	Percent change in brain volume (BV) as detected by brain MRI at the EOS compared to month 6	From 6 months up to approximately 60 months
Change in cognitive function as assessed by SDMT	Change in cognitive function at the EOS compared to baseline as assessed by the Symbol Digit Modalities Test (SDMT)	From Baseline up to approximately 60 months
Change in cognitive function as assessed by CVLT-II	Change in cognitive function at the EOS compared to baseline as assessed by the California Verbal Learning Test II (CVLT-II) where available	From Baseline up to approximately 60 months
Change in Multiple Sclerosis Quality of Life	Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) at the EOS compared to baseline	From Baseline up to approximately 60 months
Safety and Tolerability	Number of participants with adverse events (AEs), Serious AEs, AEs leading to permanent study intervention discontinuation, and adverse events of special interest (AESI)	From screening up to approximately 60 months
Change in plasma neurofilament light chain (NfL)	Change in NfL levels from at the EOS compared to baseline	From Baseline up to approximately 60 months
Change in lymphocyte phenotype subsets	Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline in a subset of participants	From Baseline up to approximately 60 months
Changes in serum Immunoglobulin level	Changes in serum Immunoglobulin level at the EOS compared to baseline	From Baseline up to approximately 60 months
Change in serum chitinase-3 like protein 1 (Chi3L1)	Change in serum Chi3L1 at EOS compared to baseline	From Baseline up to approximately 60 months
3-month composite Confirmed Disability Progression (cCDP)	Time to onset of 3-month cCDP	Up to approximately 60 months

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

Helpful Links

• EFC16035 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2020
• Primary Completion (Actual): November 14, 2025
• Study Completion (Actual): November 14, 2025

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Pathological Conditions, Signs and Symptoms; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive
• Other Study ID Numbers: EFC16035; U1111-1238-1318 (Registry Identifier: ICTRP); 2020-000645-14 (EudraCT Number); 2024-514495-41 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No