A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.

February 12, 2026 updated by: Sanofi

An Interventional, Phase 3 Extension Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis, or Nonrelapsing Secondary Progressive Multiple Sclerosis

This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]).

SUBSTUDY: ToleDYNAMIC substudy

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants with relapsing MS from the Phase 2b LTS16004 parent study will continue open-label (OL) tolebrutinib.

All participants from the Phase 3 parent studies (EFC16033, EFC16034, EFC16645, and EFC16035) will learn which treatment they received in the parent study:

If from one of the Phase 3 relapsing MS studies and on teriflunomide, an accelerated elimination procedure or a 3-month washout period is required prior to starting OL tolebrutinib. If on teriflunomide, and benefiting and recommended by the Investigator, the participant may opt to continue teriflunomide outside of the LTS17043 study, if clinically appropriate. If on tolebrutinib, the participant will continue tolebrutinib.
All participants from one of the Phase 3 progressive MS studies will start OL tolebrutinib.
If a participant already started OL tolebrutinib in the Phase 3 parent study this will be continued.
RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment as per their randomization from the parent study.

The treatment duration per participant will be approximately 3 years of OL tolebrutinib.

Study Type

Interventional

Enrollment (Estimated)

2500

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Córdoba, Argentina, 5000
    - Investigational Site Number : 0320006
  - San Miguel de Tucumán, Argentina, 4000
    - Investigational Site Number : 0320005
- Buenos Aires
  - CABA, Buenos Aires, Argentina, C1012AAR
    - Investigational Site Number : 0320002
  - CABA, Buenos Aires, Argentina, C1023AAB
    - Investigational Site Number : 0320004
- Buenos Aires F.D.
  - CABA, Buenos Aires F.D., Argentina, C1021
    - Investigational Site Number : 0320007
  - CABA, Buenos Aires F.D., Argentina, C1424
    - Investigational Site Number : 0320001
  - CABA, Buenos Aires F.D., Argentina, C1425 BKU
    - Investigational Site Number : 0329901
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, 2000
    - Investigational Site Number : 0320003
Australia
- New South Wales
  - St Leonards, New South Wales, Australia, 2065
    - Investigational Site Number : 0360001
- South Australia
  - Kent Town, South Australia, Australia, 5067
    - Investigational Site Number : 0360006
- Victoria
  - Melbourne, Victoria, Australia, 3065
    - Investigational Site Number : 0360007
Austria
- - Innsbruck, Austria, 6020
    - Investigational Site Number : 0400003
  - Linz, Austria, 4020
    - Investigational Site Number : 0400004
  - Vienna, Austria, 1090
    - Investigational Site Number : 0400002
Belgium
- - Bruges, Belgium, 8000
    - Investigational Site Number : 0560005
  - Brussels, Belgium, 1070
    - Investigational Site Number : 0560009
  - Ghent, Belgium, 9000
    - Investigational Site Number : 0560004
  - Leuven, Belgium, 3000
    - Investigational Site Number : 0560006
  - Liège, Belgium, 4000
    - Investigational Site Number : 0560008
  - Overpelt, Belgium, 3900
    - Investigational Site Number : 0560001
  - Woluwe-Saint-Lambert, Belgium, 1200
    - Investigational Site Number : 0560007
Brazil
- Goiás
  - Goiânia, Goiás, Brazil, 74605-020
    - HC UFG - Hospital Das Clinicas de Goias- Site Number : 0760003
- Paraná
  - Curitiba, Paraná, Brazil, 81210-310
    - Instituto de Neurologia de Curitiba- Site Number : 0760002
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
    - Hospital Sao Lucas da PUCRS- Site Number : 0760001
- São Paulo
  - São Paulo, São Paulo, Brazil, 01228-000
    - CPQuali Pesquisa Clinica- Site Number : 0760007
Bulgaria
- - Pleven, Bulgaria, 5809
    - Investigational Site Number : 1000002
  - Plovdiv, Bulgaria, 4002
    - Investigational Site Number : 1000005
  - 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
  - Sofia, Bulgaria, 1431
    - Investigational Site Number : 1000006
  - Sofia, Bulgaria, 1680
    - Investigational Site Number : 1000009
Canada
- - Québec, Canada, G1J 1Z4
    - Investigational Site Number : 1240001
- Alberta
  - Edmonton, Alberta, Canada, T6G 2C8
    - Investigational Site Number : 1240002
- British Columbia
  - Burnaby, British Columbia, Canada, V5G 2X6
    - Investigational Site Number : 1240017
  - Vancouver, British Columbia, Canada, V6T 2B5
    - Investigational Site Number : 1249901
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H4K4
    - Investigational Site Number : 1240011
- Ontario
  - Hamilton, Ontario, Canada, L8L 2X2
    - Investigational Site Number : 1240012
  - Ottawa, Ontario, Canada, K1H 8L6
    - Investigational Site Number : 1240003
  - Toronto, Ontario, Canada, M4N 3M5
    - Investigational Site Number : 1240008
  - Toronto, Ontario, Canada, M5B 1W8
    - Investigational Site Number : 1240013
- Quebec
  - Gatineau, Quebec, Canada, J8Y 1W2
    - Investigational Site Number : 1240006
  - Lévis, Quebec, Canada, G6W0M5
    - Investigational Site Number : 1240021
  - 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
- - Santiago, Chile, 8431657
    - Investigational Site Number : 1520003
- 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
  - Santiago, Reg Metropolitana de Santiago, Chile, 833-0024
    - Investigational Site Number : 1520005
China
- - Beijing, China, 100730
    - Investigational Site Number : 1560009
  - Beijing, China, 100730
    - Investigational Site Number : 1560025
  - Beijing, China, 100034
    - Investigational Site Number : 1560006
  - Beijing, China, 100191
    - Investigational Site Number : 1560023
  - Changchun, China, 130021
    - Investigational Site Number : 1560004
  - Changsha, China, 410008
    - Investigational Site Number : 1560015
  - Chengdu, China, 610041
    - Investigational Site Number : 1560005
  - Chongqing, China, 400016
    - Investigational Site Number : 1560019
  - Fuzhou, China, 350005
    - Investigational Site Number : 1560035
  - Guangzhou, China, 510630
    - Investigational Site Number : 1569903
  - Hohhot, China, 010020
    - Investigational Site Number : 1560027
  - Nanjing, China, 210008
    - Investigational Site Number : 1560044
  - Nanjing, China, 210029
    - Investigational Site Number : 1560042
  - Shanghai, China, 200040
    - Investigational Site Number : 1569901
  - Shenyang, China, 110004
    - Investigational Site Number : 1560018
  - Shijiazhuang, China, 050000
    - Investigational Site Number : 1560014
  - Taiyuan, China, 030001
    - Investigational Site Number : 1560008
  - Tianjin, China, 300052
    - Investigational Site Number : 1560020
  - Wenzhou, China, 325000
    - Investigational Site Number : 1560026
  - Wuhan, China, 430030
    - Investigational Site Number : 1560011
  - Xi'an, China, 710038
    - Investigational Site Number : 1560017
Colombia
- - Bogotá, Colombia, K1K 4L2
    - 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
  - Brno, Czechia, 62500
    - Investigational Site Number : 2039907
  - Hradec Králové, Czechia, 50005
    - Investigational Site Number : 2039903
  - Jihlava, Czechia, 58633
    - Investigational Site Number : 2039901
  - Ostrava - Poruba, Czechia, 70852
    - Investigational Site Number : 2039902
  - Pardubice, Czechia, 53203
    - Investigational Site Number : 2039904
  - Prague, Czechia, 10034
    - Investigational Site Number : 2030008
  - Prague, Czechia, 12808
    - Investigational Site Number : 2039906
  - Praha 5 - Motol, Czechia, 15000
    - Investigational Site Number : 2039905
  - Teplice, Czechia, 41501
    - Investigational Site Number : 2030003
  - Zlín, Czechia, 76275
    - Investigational Site Number : 2030007
Denmark
- - Esbjerg, Denmark, 6700
    - Investigational Site Number : 2080001
  - Holstebro, Denmark, 7500
    - Investigational Site Number : 2080005
  - Odense, Denmark, 5000
    - Investigational Site Number : 2080004
Estonia
- - Tallinn, Estonia, 11315
    - Investigational Site Number : 2330001
Finland
- - Tampere, Finland, 33520
    - Investigational Site Number : 2460001
  - Turku, Finland, 20520
    - Investigational Site Number : 2460002
France
- - Besançon, France, 25030
    - Investigational Site Number : 2500019
  - Bron, France, 69500
    - Investigational Site Number : 2500011
  - Clermont-Ferrand, France, 63000
    - 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
  - Nantes, France, 44093
    - Investigational Site Number : 2500010
  - Nice, France, 06001
    - Investigational Site Number : 2500002
  - 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, 67091
    - Investigational Site Number : 2500001
  - Toulouse, France, 31059
    - Investigational Site Number : 2500012
Georgia
- - Tbilisi, Georgia, 0159
    - Investigational Site Number : 2680009
  - Tbilisi, Georgia, 0160
    - Investigational Site Number : 2680003
  - Tbilisi, Georgia, 0101
    - 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
  - Berlin, Germany, 12099
    - Investigational Site Number : 2760014
  - Bochum, Germany, 44791
    - Investigational Site Number : 2760020
  - Dresden, Germany, 01307
    - Investigational Site Number : 2760001
  - Düsseldorf, Germany, 40225
    - Investigational Site Number : 2769901
  - Essen, Germany, 45147
    - Investigational Site Number : 2760012
  - Giessen, Germany, 35392
    - Investigational Site Number : 2760002
  - Hamburg, Germany, 22179
    - Investigational Site Number : 2760016
  - München, Germany, 81377
    - Investigational Site Number : 2760018
  - Münster, Germany, 48149
    - Investigational Site Number : 2760008
  - Ulm, Germany, 89081
    - Investigational Site Number : 2760011
  - Würzburg, Germany, 97074
    - Investigational Site Number : 2760003
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, 55236
    - Investigational Site Number : 3000009
  - Thessaloniki, Greece, 54636
    - Investigational Site Number : 3000003
Hong Kong
- - Shatin, NT, Hong Kong, 000
    - Investigational Site Number : 3440001
Hungary
- - Budapest, Hungary, 1033
    - Investigational Site Number : 3489901
  - Budapest, Hungary, 1138
    - Investigational Site Number : 3489903
  - Budapest, Hungary, 1152
    - Investigational Site Number : 3480007
  - Pécs, Hungary, 7623
    - Investigational Site Number : 3480002
India
- - Bengaluru, India, 560001
    - Investigational Site Number : 3560014
  - Chandigarh, India, 160015
    - Investigational Site Number : 3569904
  - Delhi, India, 110060
    - Investigational Site Number : 3560002
  - Gūrgaon, India, 122001
    - Investigational Site Number : 3560007
  - Gūrgaon, India, 122002
    - Investigational Site Number : 3569903
  - Mangaluru, India, 575018
    - Investigational Site Number : 3569901
  - Nagpur, India, 440012
    - Investigational Site Number : 3560009
  - New Delhi, India, 110029
    - Investigational Site Number : 3569902
  - Thiruvananthapuram, India, 695011
    - Investigational Site Number : 3560004
Israel
- - Haifa, Israel, 31096
    - Investigational Site Number : 3760003
  - Rehovot, Israel, 76100
    - Investigational Site Number : 3760006
  - Safed, Israel, 13100
    - Investigational Site Number : 3760004
  - Tel Litwinsky, Israel, 52621
    - Investigational Site Number : 3760001
Italy
- - Bergamo, Italy, 24127
    - Investigational Site Number : 3800011
  - 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
  - Genova, Italy, 16132
    - Investigational Site Number : 3800014
  - Napoli, Italy, 80138
    - Investigational Site Number : 3800006
  - Pavia, Italy, 27100
    - Investigational Site Number : 3800008
  - Roma, Italy, 00189
    - Investigational Site Number : 3800013
  - Roma, Italy, 00152
    - Investigational Site Number : 3800005
  - Roma, Italy, 00168
    - Investigational Site Number : 3800009
- Isernia
  - Pozzilli, Isernia, Italy, 86077
    - Investigational Site Number : 3800002
- Lombardy
  - Milan, Lombardy, Italy, 20133
    - Investigational Site Number : 3800010
- Milano
  - Milan, Milano, Italy, 20132
    - Investigational Site Number : 3800001
- Roma
  - Rome, Roma, Italy, 00168
    - Investigational Site Number : 3800009
- Tuscany
  - Florence, Tuscany, Italy, 50134
    - Investigational Site Number : 3800012
Japan
- Chiba
  - Chiba, Chiba, Japan, 260-8677
    - Investigational Site Number : 3920016
- 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
- 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
  - 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
  - Riga, Latvia, LV-1005
    - Investigational Site Number : 4280003
Lithuania
- - Kaunas, Lithuania, 50161
    - Investigational Site Number : 4400003
  - Vilnius, Lithuania, 08661
    - Investigational Site Number : 4400001
  - Šiauliai, Lithuania, LT-76231
    - Investigational Site Number : 4400004
Mexico
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44670
    - Investigational Site Number : 4840004
- Mexico City
  - Benito Juárez, Mexico City, Mexico, 03100
    - Investigational Site Number : 4840002
  - Mexico City, Mexico City, Mexico, 06700
    - Investigational Site Number : 4840001
- Veracruz
  - Veracruz. Mexico City, Veracruz, Mexico, 91900
    - Investigational Site Number : 4840003
Netherlands
- - Amsterdam, Netherlands, 1081 HV
    - Investigational Site Number : 5280001
  - Breda, Netherlands, 4818 CK
    - Investigational Site Number : 5280003
  - Groningen, Netherlands, 9728NT
    - Investigational Site Number : 5280006
  - Heerlen, Netherlands, 6419 PC
    - Investigational Site Number : 5280002
Norway
- - Bergen, Norway, 5021
    - Investigational Site Number : 5780003
  - Oslo, Norway, 0450
    - Investigational Site Number : 5780001
Poland
- Greater Poland Voivodeship
  - Plewiska, Greater Poland Voivodeship, Poland, 62-064
    - Investigational Site Number : 6160008
- Kuyavian-Pomeranian Voivodeship
  - Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
    - Investigational Site Number : 6160003
- Lublin Voivodeship
  - Lublin, Lublin Voivodeship, Poland, 20-410
    - Investigational Site Number : 6160012
- 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
- Podkarpackie Voivodeship
  - Glogow Mlp., Podkarpackie Voivodeship, Poland, 36-060
    - Investigational Site Number : 6160009
- Silesian Voivodeship
  - Katowice, Silesian Voivodeship, Poland, 40-686
    - Investigational Site Number : 6160004
  - Katowice, Silesian Voivodeship, Poland, 40571
    - Investigational Site Number : 6160002
  - Zabrze, Silesian Voivodeship, Poland, 41-800
    - Investigational Site Number : 6160011
Portugal
- - Braga, Portugal, 4710-243
    - Investigational Site Number : 6200001
  - Coimbra, Portugal, 3000-075
    - Investigational Site Number : 6200005
  - Lisbon, Portugal, 1649-035
    - Investigational Site Number : 6200006
  - Lisbon, Portugal, 1349-019
    - Investigational Site Number : 6200007
  - Lisbon, Portugal, 1500-650
    - Investigational Site Number : 6200012
  - Lisbon, Portugal, 1169-050
    - Investigational Site Number : 6200011
  - Matosinhos Municipality, Portugal, 4464-513
    - Investigational Site Number : 6200002
  - Santa Maria da Feira, Portugal, 4520-211
    - Investigational Site Number : 6200004
Puerto Rico
- - Guaynabo, Puerto Rico, 00969
    - San Juan MS Center- Site Number : 8400015
Romania
- - Brasov, Romania, 500283
    - Investigational Site Number : 6420015
  - Bucharest, Romania, 022328
    - Investigational Site Number : 6420008
  - Campulung Muscel, Romania, 115100
    - Investigational Site Number : 6420004
  - Cluj-Napoca, Romania, 400012
    - Investigational Site Number : 6420006
  - Constanța, Romania, 900123
    - Investigational Site Number : 6420003
  - Oradea, Romania, 410154
    - Investigational Site Number : 6420013
  - Sibiu, Romania, 550052
    - Investigational Site Number : 6420005
  - Timișoara, Romania, 300723
    - Investigational Site Number : 6420002
Serbia
- - Belgrade, Serbia, 11000
    - Investigational Site Number : 6880001
  - Belgrade, Serbia, 11000
    - Investigational Site Number : 6880006
  - Belgrade, Serbia, 11000
    - Investigational Site Number : 6880003
  - Kragujevac, Serbia, 34000
    - Investigational Site Number : 6880002
  - Novi Sad, Serbia, 21000
    - Investigational Site Number : 6880005
Slovakia
- - Bratislava, Slovakia, 821 01
    - Investigational Site Number : 7030001
  - Martin, Slovakia, 03659
    - Investigational Site Number : 7030002
  - Nitra, Slovakia, 949 01
    - Investigational Site Number : 7030004
South Africa
- - Pretoria, South Africa, 0041
    - Investigational Site Number : 7100001
South Korea
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, South Korea, 10408
    - Investigational Site Number : 4100001
- Seoul-teukbyeolsi
  - Seoul, Seoul-teukbyeolsi, South Korea, 03080
    - Investigational Site Number : 4100003
  - Seoul, Seoul-teukbyeolsi, South Korea, 03722
    - Investigational Site Number : 4100006
  - Seoul, Seoul-teukbyeolsi, South Korea, 135-710
    - Investigational Site Number : 4100002
Spain
- - Córdoba, Spain, 14004
    - Investigational Site Number : 7249914
  - Madrid, Spain, 28034
    - Investigational Site Number : 7249903
  - Madrid, Spain, 28040
    - Investigational Site Number : 7249910
  - Murcia, Spain, 30120
    - Investigational Site Number : 7249916
  - Málaga, Spain, 29010
    - Investigational Site Number : 7249915
  - Palma de Mallorca, Spain, 07120
    - Investigational Site Number : 7249920
  - Valencia, Spain, 46026
    - Investigational Site Number : 7249917
- A Coruña [La Coruña]
  - A Coruña, A Coruña [La Coruña], Spain, 15006
    - Investigational Site Number : 7249908
- Andalusia
  - Seville, Andalusia, Spain, 41009
    - Investigational Site Number : 7249907
- Barcelona [Barcelona]
  - Barcelona, Barcelona [Barcelona], Spain, 08035
    - Investigational Site Number : 7249906
  - Barcelona, Barcelona [Barcelona], Spain, 08036
    - Investigational Site Number : 7249912
  - L'Hospitalet de Llobregat, Barcelona [Barcelona], Spain, 08907
    - Investigational Site Number : 7249919
- Bizkaia
  - Barakaldo, Bizkaia, Spain, 48903
    - Investigational Site Number : 7249913
- Galicia [Galicia]
  - Santiago de Compostela, Galicia [Galicia], Spain, 15706
    - Investigational Site Number : 7249921
- Gipuzkoa
  - Donostia / San Sebastian, Gipuzkoa, Spain, 20014
    - Investigational Site Number : 7249918
- Girona [Gerona]
  - Salt, Girona [Gerona], Spain, 17190
    - Investigational Site Number : 7249911
- Las Palmas
  - Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
    - Investigational Site Number : 7249904
- Lleida [Lérida]
  - Lleida / Lleida, Lleida [Lérida], Spain, 25198
    - Investigational Site Number : 7249902
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Investigational Site Number : 7249901
  - Pozuelo de Alarcón, Madrid, Spain, 28223
    - Investigational Site Number : 7249905
- Madrid, Comunidad de
  - Madrid / Madrid, Madrid, Comunidad de, Spain, 28007
    - Investigational Site Number : 7249909
Sweden
- - Gothenburg, Sweden, 41346
    - Investigational Site Number : 7520001
  - Stockholm, Sweden, 113 65
    - Investigational Site Number : 7520002
Switzerland
- - Bern, Switzerland, 3010
    - Investigational Site Number : 7560002
Taiwan
- - Hsinchu, Taiwan, 30059
    - Investigational Site Number : 1580007
  - Taipei, Taiwan, 112
    - Investigational Site Number : 1580002
Thailand
- - Bangkok Noi, Thailand, 10700
    - Investigational Site Number : 7640001
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06100
    - Investigational Site Number : 7920006
  - Eskişehir, Turkey (Türkiye), 26040
    - Investigational Site Number : 7920005
  - Istanbul, Turkey (Türkiye), 34303
    - Investigational Site Number : 7920002
  - Istanbul, Turkey (Türkiye), 34785
    - Investigational Site Number : 7920007
  - Istanbul, Turkey (Türkiye), 34096
    - Investigational Site Number : 7920003
  - Istanbul, Turkey (Türkiye), 34668
    - Investigational Site Number : 7920009
  - Izmir, Turkey (Türkiye), 35340
    - Investigational Site Number : 7920014
  - Izmir, Turkey (Türkiye), 35360
    - Investigational Site Number : 7920010
  - Kocaeli, Turkey (Türkiye), 41380
    - Investigational Site Number : 7920001
  - Konya, Turkey (Türkiye), 42080
    - Investigational Site Number : 7920017
  - Kütahya, Turkey (Türkiye), 43100
    - Investigational Site Number : 7929901
  - Mersin, Turkey (Türkiye), 33070
    - Investigational Site Number : 7929902
  - Samsun, Turkey (Türkiye), 55200
    - Investigational Site Number : 7929903
Ukraine
- - Chernivtsi, Ukraine, 14029
    - Investigational Site Number : 8040020
  - Chernivtsi, Ukraine, 58000
    - Investigational Site Number : 8049912
  - Chernivtsi, Ukraine, 58023
    - Investigational Site Number : 8049904
  - Dnipro, Ukraine, 49089
    - Investigational Site Number : 8049905
  - Ivano-Frankivsk, Ukraine, 76493
    - Investigational Site Number : 8049908
  - Kharkiv, Ukraine, 61058
    - Investigational Site Number : 8040025
  - Kharkiv, Ukraine, 61068
    - Investigational Site Number : 8049903
  - Kharkiv, Ukraine, 61166
    - Investigational Site Number : 8040018
  - Kyiv, Ukraine, 01135
    - Investigational Site Number : 8049902
  - Kyiv, Ukraine, 02091
    - Investigational Site Number : 8049911
  - Kyiv, Ukraine, 03115
    - Investigational Site Number : 8049901
  - Lutsk, Ukraine, 43005
    - Investigational Site Number : 8049914
  - Lviv, Ukraine, 79010
    - Investigational Site Number : 8049909
  - Lviv, Ukraine, 79029
    - Investigational Site Number : 8049906
  - Odesa, Ukraine, 65025
    - Investigational Site Number : 8049913
  - Vinnytsia, Ukraine, 21001
    - Investigational Site Number : 8049910
  - Vinnytsia, Ukraine, 21009
    - Investigational Site Number : 8040024
United Kingdom
- - Bristol, United Kingdom, BS161LE
    - Investigational Site Number : 8260009
  - Newcastle upon Tyne, United Kingdom, NE1 4LP
    - Investigational Site Number : 8260014
  - Salford, United Kingdom, M6 8HD
    - Investigational Site Number : 8260019
- Devon
  - Exeter, Devon, United Kingdom, EX2 5DW
    - Investigational Site Number : 8260003
- Kent
  - Kent, 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 0RE
    - 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 4XN
    - Investigational Site Number : 8260001
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - The University of Alabama at Birmingham- Site Number : 8400013
  - Cullman, Alabama, United States, 35058
    - ~North Central Neurology Associates, PC- Site Number : 8400009
- Arizona
  - Phoenix, Arizona, United States, 85018
    - Center for Neurology and Spine- Site Number : 8400089
- California
  - Los Alamitos, California, United States, 90720
    - Collaborative Neuroscience Research- Site Number : 8400045
  - Los Angeles, California, United States, 90033
    - USC- Site Number : 8400143
  - San Diego, California, United States, 92037-0943
    - University of California San Diego Medical Center- Site Number : 8400101
  - West Hollywood, California, United States, 90048
    - Regina Berkovich, MD, PhD- Site Number : 8400059
- Colorado
  - Denver, Colorado, United States, 80262
    - University of Colorado- Site Number : 8400012
  - Fort Collins, Colorado, United States, 80528
    - Advanced Neurosciences Research- Site Number : 8400025
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - Georgetown University Medical Center- Site Number : 8400119
- Florida
  - Boca Raton, Florida, United States, 33487
    - SFM Clinical Research, LLC- Site Number : 8400029
  - Gainesville, Florida, United States, 32608
    - University of Florida Health- Site Number : 8400159
  - Maitland, Florida, United States, 32751
    - Neurology Associates- Site Number : 8409902
  - Miami, Florida, United States, 33136
    - University of Miami- Site Number : 8400063
  - Naples, Florida, United States, 34105
    - Aqualane Clinical Research- Site Number : 8400027
  - Tampa, Florida, United States, 33609-4052
    - Axiom Clinical Research of Florida- Site Number : 8400001
  - Tampa, Florida, United States, 33612
    - University of South Florida- Site Number : 8409905
- Georgia
  - Savannah, Georgia, United States, 31406
    - Velocity Clinical Research- Site Number : 8409903
- Illinois
  - Northbrook, Illinois, United States, 60062
    - Consultants In Neurology- Site Number : 8409906
  - Springfield, Illinois, United States, 62702
    - Springfield Clinic, LLP- Site Number : 8400071
- Indiana
  - Fort Wayne, Indiana, United States, 46815
    - Indiana University Health, Inc- Site Number : 8400039
- Kansas
  - Kansas City, Kansas, United States, 66160-7321
    - University of Kansas Medical Center- Site Number : 8400023
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky- Site Number : 8400106
  - Louisville, Kentucky, United States, 40207
    - Norton Neurology MS Services- Site Number : 8400127
- Louisiana
  - Baton Rouge, Louisiana, United States, 70810
    - The NeuroMedical Center- Site Number : 8400057
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Clinic Foundation- Site Number : 8400107
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center- Site Number : 8400072
  - Worcester, Massachusetts, United States, 01655
    - University of Massachusetts- Site Number : 8400014
- Michigan
  - Detroit, Michigan, United States, 48201
    - Wayne State University- Site Number : 8400046
  - Farmington Hills, Michigan, United States, 48334
    - Michigan Institute Neuro Disorders- Site Number : 8400058
  - Owosso, Michigan, United States, 48867
    - Memorial Healthcare Institute for Neuroscience- Site Number : 8400033
- Minnesota
  - Golden Valley, Minnesota, United States, 55422
    - Minneapolis Clinic of Neurology- Site Number : 8400051
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic- Site Number : 8400111
- Missouri
  - Ozark, Missouri, United States, 65721
    - Sharlin Health & Neurology- Site Number : 8400093
  - St Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center- Site Number : 8400019
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Lou Ruvo Center for Brain Health- Site Number : 8400117
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - University of New Mexico- Site Number : 8400032
- New York
  - New York, New York, United States, 10021
    - Mount Sinai Medical Center- Site Number : 8400038
  - Patchogue, New York, United States, 11772
    - NYU Langone South Shore Neurologic Associates- Site Number : 8400100
  - Stony Brook, New York, United States, 11794
    - Neurology Associates of Stony Brook- Site Number : 8400042
- North Carolina
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Baptist Medical Center- Site Number : 8400116
- Ohio
  - Centerville, Ohio, United States, 45459
    - Dayton Center for Neurological Disorders- Site Number : 8400081
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation-Mellen Center for MS- Site Number : 8400125
  - Columbus, Ohio, United States, 43221
    - The Ohio State University Wexner Medical Center- Site Number : 8400150
  - Columbus, Ohio, United States, 43235
    - The Boster Center for Multiple Sclerosis- Site Number : 8400147
  - Dayton, Ohio, United States, 45417
    - UC Health, LLC- Site Number : 8409901
- Oregon
  - Portland, Oregon, United States, 97225
    - Providence Multiple Sclerosis Center- Site Number : 8400020
- South Carolina
  - Greenville, South Carolina, United States, 29605
    - Premier Neurology- Site Number : 8400069
- Tennessee
  - Knoxville, Tennessee, United States, 37922
    - HOPE Neurology- Site Number : 8409904
- Texas
  - San Antonio, Texas, United States, 78258
    - Lone Star Neurology of San Antonio- Site Number : 8400036
- Vermont
  - Burlington, Vermont, United States, 05405
    - University of Vermont - Larner College of Medicine- Site Number : 8400130
- Virginia
  - Richmond, Virginia, United States, 23229
    - Neurological Associates- Site Number : 8400097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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.

- 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tolebrutinib Participants will receive OL tolebrunitib 60 mg once daily. RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment as per their randomization from the parent study.	Drug: Tolebrutinib Pharmaceutical form:Tablet-Route of administration:oral Other Names: SAR442168 Drug: Placebo Pharmaceutical form:Tablet-Route of administration:oral
Active Comparator: Teriflunomide participants will receive teriflunomide 14 mg daily RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment (either tolebrutinib or teriflunomide) as per their randomization from the parent study. If unblinded to teriflunomide parent study treatment assignment, these RMS participants will continue teriflunomide in the LTS17043 study.	Drug: Placebo Pharmaceutical form:Tablet-Route of administration:oral Drug: Teriflunomide Pharmaceutical form:Tablet-Route of administration:oral Other Names: Aubagio

Participant Group / Arm

Intervention / Treatment

Experimental: Tolebrutinib

Participants will receive OL tolebrunitib 60 mg once daily.
RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment as per their randomization from the parent study.

Drug: Tolebrutinib

Pharmaceutical form:Tablet-Route of administration:oral

Other Names:

SAR442168

Drug: Placebo

Pharmaceutical form:Tablet-Route of administration:oral

Active Comparator: Teriflunomide

participants will receive teriflunomide 14 mg daily
RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment (either tolebrutinib or teriflunomide) as per their randomization from the parent study. If unblinded to teriflunomide parent study treatment assignment, these RMS participants will continue teriflunomide in the LTS17043 study.

Drug: Placebo

Pharmaceutical form:Tablet-Route of administration:oral

Drug: Teriflunomide

Pharmaceutical form:Tablet-Route of administration:oral

Other Names:

Aubagio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation Time Frame: From baseline until the End of study approximately 3 years per participant		From baseline until the End of study approximately 3 years per participant
Number of Participants with Potentially clinically significant abnormalities (PCSAs) Time Frame: From baseline until the End of study approximately 3 years per participant	Potentially clinically significant abnormalities (PCSAs) determined by laboratory tests, electrocardiogram (ECG), or vital signs and safety findings on MRI during the study period.	From baseline until the End of study approximately 3 years per participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies Time Frame: From baseline until the End of study approximately 3 years per participant	Time to onset is defined as a sustained increase from baseline EDSS (pivotal trial) of: RMS: ≥1.5 points when the baseline score is 0, ≥1.0 point when the baseline score is 0.5 to ≤5.5 or ≥0.5 point when the baseline score is >5.5 PPMS: ≥1.0 point when the baseline score is ≤5.5 or ≥0.5 point when the baseline score is >5.5 NRSPMS: ≥1.0 point when the baseline score is ≤5.0 or ≥0.5 point when the baseline score is >5.0	From baseline until the End of study approximately 3 years per participant
Annualized Relapse Rate (ARR) for RMS only Time Frame: From baseline until the End of study approximately 3 years per participant	ARR during the OL treatment period assessed by confirmed protocol-defined relapses	From baseline until the End of study approximately 3 years per participant
Number of new and/or enlarging T2-hyperintense lesions per year Time Frame: From baseline until the End of study approximately 3 years per participant		From baseline until the End of study approximately 3 years per participant
Change from baseline in total volume of T2-hyperintense lesions Time Frame: From baseline until the End of study approximately 3 years per participant		From baseline until the End of study approximately 3 years per participant
ToleDYNAMIC substudy Change from baseline in biomarkers Time Frame: From baseline until 12 months per participant		From baseline until 12 months per participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

LTS17043 Plain Language Results Summary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2024

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2029

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

LTS17043
2023-503631-18 (Registry Identifier: CTIS)
U1111-1287-6797 (Registry Identifier: ICTRP)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on Tolebrutinib

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