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
Status: Recruiting
Location: See all (312) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• \- Participants with RMS, PPMS, or NRSPMS who completed the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 pivotal tolebrutinib trials (EFC16033, EFC16034, EFC16645, EFC16035) on IMP.
• OR
• \- The Phase 2b LTS (LTS16004) or Phase 3 tolebrutinib pivotal trial participants who temporarily discontinued IMP due to a national emergency and completed the trial visits.
• ToleDYNAMIC Substudy: Inclusion criteria are those of the main study
Locations
United States
Alabama
University of Alabama at Birmingham- Site Number : 8400013
RECRUITING
Birmingham
North Central Neurology Associates- Site Number : 8400009
RECRUITING
Cullman
Arizona
Center for Neurology and Spine - Phoenix - North 32nd Street- Site Number : 8400089
RECRUITING
Phoenix
California
Collaborative Neuroscience Research- Site Number : 8400045
RECRUITING
Los Alamitos
Keck School of Medicine of University of Southern California- Site Number : 8400143
RECRUITING
Los Angeles
University of California at San Diego- Site Number : 8400101
RECRUITING
San Diego
Private Practice - Dr. Regina Berkovich- Site Number : 8400059
RECRUITING
West Hollywood
Colorado
University of Colorado- Site Number : 8400012
RECRUITING
Denver
Advanced Neurology of Colorado- Site Number : 8400025
RECRUITING
Fort Collins
Washington, D.c.
MedStar Georgetown University Hospital- Site Number : 8400119
RECRUITING
Washington D.c.
Florida
SFM Clinical Research- Site Number : 8400029
RECRUITING
Boca Raton
Neurology Associates - Maitland- Site Number : 8409902
RECRUITING
Maitland
University of Miami- Site Number : 8400063
RECRUITING
Miami
Aqualane Clinical Research- Site Number : 8400027
RECRUITING
Naples
Axiom Clinical Research of Florida- Site Number : 8400001
RECRUITING
Tampa
University of South Florida- Site Number : 8409905
RECRUITING
Tampa
Georgia
Velocity Clinical Research - Savannah Neurology- Site Number : 8409903
RECRUITING
Savannah
Illinois
Consultants in Neurology- Site Number : 8409906
RECRUITING
Northbrook
Springfield Clinic 1st - 800 Building- Site Number : 8400071
RECRUITING
Springfield
Indiana
IU Health Physicians - Fort Wayne - Hope Drive- Site Number : 8400039
RECRUITING
Fort Wayne
Kansas
University of Kansas Medical Center- Site Number : 8400023
RECRUITING
Kansas City
Kentucky
Norton Neurology Services- Site Number : 8400127
RECRUITING
Louisville
Louisiana
The NeuroMedical Center- Site Number : 8400057
RECRUITING
Baton Rouge
Massachusetts
Tufts Medical Center- Site Number : 8400072
RECRUITING
Boston
Michigan
Harper University Hospital- Site Number : 8400046
RECRUITING
Detroit
Michigan Institute for Neurological Disorders- Site Number : 8400058
RECRUITING
Farmington Hills
Memorial Healthcare Institute for Neuroscience- Site Number : 8400033
RECRUITING
Owosso
Minnesota
Minneapolis Clinic of Neurology - Golden Valley- Site Number : 8400051
RECRUITING
Golden Valley
Missouri
Sharlin Health & Neurology- Site Number : 8400093
RECRUITING
Ozark
Missouri Baptist Medical Center- Site Number : 8400019
RECRUITING
St Louis
North Carolina
Atrium Health Wake Forest Baptist Medical Center - Winston-Salem - Medical Center Boulevard- Site Number : 8400116
RECRUITING
Winston-salem
New Mexico
University of New Mexico Comprehensive Cancer Center- Site Number : 8400032
RECRUITING
Albuquerque
Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400117
RECRUITING
Las Vegas
New York
Icahn School of Medicine at Mount Sinai- Site Number : 8400038
RECRUITING
New York
South Shore Neurologic Associates - Patchogue- Site Number : 8400100
RECRUITING
Patchogue
Stony Brook University- Site Number : 8400042
RECRUITING
Stony Brook
Ohio
Dayton Center for Neurological Disorders- Site Number : 8400081
RECRUITING
Centerville
Cleveland Clinic - Cleveland- Site Number : 8400125
RECRUITING
Cleveland
The Boster Center for Multiple Sclerosis- Site Number : 8400147
RECRUITING
Columbus
The Ohio State University Wexner Medical Center - Ohio State Outpatient Care Upper Arlington- Site Number : 8400150
RECRUITING
Columbus
UC Health - Elizabeth Place- Site Number : 8409901
RECRUITING
Dayton
Oregon
Providence St. Vincent's Medical Center- Site Number : 8400020
RECRUITING
Portland
South Carolina
Premier Neurology- Site Number : 8400069
RECRUITING
Greer
Tennessee
Hope Neurology- Site Number : 8409904
RECRUITING
Knoxville
Texas
Neurology Center of San Antonio- Site Number : 8400036
RECRUITING
San Antonio
Virginia
Neurological Associates - Richmond- Site Number : 8400097
RECRUITING
Richmond
Vermont
University of Vermont Medical Center- Site Number : 8400130
RECRUITING
Burlington
Other Locations
Argentina
Investigational Site Number : 0320001
ACTIVE_NOT_RECRUITING
Buenos Aires
Investigational Site Number : 0320002
RECRUITING
Buenos Aires
Investigational Site Number : 0320004
ACTIVE_NOT_RECRUITING
Buenos Aires
Investigational Site Number : 0320007
ACTIVE_NOT_RECRUITING
Buenos Aires
Investigational Site Number : 0329901
ACTIVE_NOT_RECRUITING
Buenos Aires
Investigational Site Number : 0320006
ACTIVE_NOT_RECRUITING
Córdoba
Investigational Site Number : 0320003
RECRUITING
Rosario
Investigational Site Number : 0320005
ACTIVE_NOT_RECRUITING
San Miguel De Tucumán
Investigational Site Number : 0320005
RECRUITING
San Miguel De Tucumán
Australia
Investigational Site Number : 0360006
ACTIVE_NOT_RECRUITING
Kent Town
Investigational Site Number : 0360007
ACTIVE_NOT_RECRUITING
Melbourne
Investigational Site Number : 0360001
ACTIVE_NOT_RECRUITING
Saint Leonards
Austria
Investigational Site Number : 0400003
RECRUITING
Innsbruck
Investigational Site Number : 0400004
RECRUITING
Linz
Investigational Site Number : 0400002
RECRUITING
Vienna
Belgium
Investigational Site Number : 0560005
ACTIVE_NOT_RECRUITING
Bruges
Investigational Site Number : 0560007
RECRUITING
Brussels
Investigational Site Number : 0560004
RECRUITING
Ghent
Investigational Site Number : 0560006
ACTIVE_NOT_RECRUITING
Leuven
Investigational Site Number : 0560008
RECRUITING
Liège
Investigational Site Number : 0560001
RECRUITING
Overpelt
Brazil
Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760002
ACTIVE_NOT_RECRUITING
Curitiba
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
ACTIVE_NOT_RECRUITING
Porto Alegre
CPQuali Pesquisa Clinica - São Paulo- Site Number : 0760007
RECRUITING
São Paulo
Bulgaria
Investigational Site Number : 1000002
RECRUITING
Pleven
Investigational Site Number : 1000005
ACTIVE_NOT_RECRUITING
Plovdiv
Investigational Site Number : 1000001
RECRUITING
Sofia
Investigational Site Number : 1000004
RECRUITING
Sofia
Investigational Site Number : 1000006
ACTIVE_NOT_RECRUITING
Sofia
Investigational Site Number : 1000008
RECRUITING
Sofia
Investigational Site Number : 1000009
ACTIVE_NOT_RECRUITING
Sofia
Canada
Investigational Site Number : 1240017
RECRUITING
Burnaby
Investigational Site Number : 1240002
RECRUITING
Edmonton
Investigational Site Number : 1240006
RECRUITING
Gatineau
Investigational Site Number : 1240011
RECRUITING
Halifax
Investigational Site Number : 1240012
RECRUITING
Hamilton
Investigational Site Number : 1240021
RECRUITING
Lévis
Investigational Site Number : 1240004
RECRUITING
Montreal
Investigational Site Number : 1240015
RECRUITING
Montreal
Investigational Site Number : 1240003
RECRUITING
Ottawa
Investigational Site Number : 1240001
RECRUITING
Québec
Investigational Site Number : 1240007
RECRUITING
Sherbrooke
Investigational Site Number : 1240008
RECRUITING
Toronto
Investigational Site Number : 1249901
RECRUITING
Vancouver
Chile
Investigational Site Number : 1520001
RECRUITING
Santiago
Investigational Site Number : 1520002
RECRUITING
Santiago
Investigational Site Number : 1520003
ACTIVE_NOT_RECRUITING
Santiago
Investigational Site Number : 1520005
ACTIVE_NOT_RECRUITING
Santiago
China
Investigational Site Number : 1560006
ACTIVE_NOT_RECRUITING
Beijing
Investigational Site Number : 1560009
RECRUITING
Beijing
Investigational Site Number : 1560023
ACTIVE_NOT_RECRUITING
Beijing
Investigational Site Number : 1560025
COMPLETED
Beijing
Investigational Site Number : 1560004
RECRUITING
Changchun
Investigational Site Number : 1560015
RECRUITING
Changsha
Investigational Site Number : 1560005
RECRUITING
Chengdu
Investigational Site Number : 1560019
ACTIVE_NOT_RECRUITING
Chongqing
Investigational Site Number : 1560035
COMPLETED
Fuzhou
Investigational Site Number : 1569903
RECRUITING
Guangzhou
Investigational Site Number : 1560027
RECRUITING
Hohhot
Investigational Site Number : 1560014
ACTIVE_NOT_RECRUITING
Jiazhuang
Investigational Site Number : 1560042
ACTIVE_NOT_RECRUITING
Nanjing
Investigational Site Number : 1560044
ACTIVE_NOT_RECRUITING
Nanjing
Investigational Site Number : 1569901
RECRUITING
Shanghai
Investigational Site Number : 1560018
RECRUITING
Shenyang
Investigational Site Number : 1560008
RECRUITING
Taiyuan
Investigational Site Number : 1560020
RECRUITING
Tianjin
Investigational Site Number : 1560026
RECRUITING
Wenzhou
Investigational Site Number : 1560011
ACTIVE_NOT_RECRUITING
Wuhan
Investigational Site Number : 1560017
RECRUITING
Xi'an
Croatia
Investigational Site Number : 1910001
RECRUITING
Zagreb
Investigational Site Number : 1910002
RECRUITING
Zagreb
Denmark
Investigational Site Number : 2080001
RECRUITING
Esbjerg
Investigational Site Number : 2080005
COMPLETED
Holstebro
Investigational Site Number : 2080004
RECRUITING
Odense
Estonia
Investigational Site Number : 2330001
RECRUITING
Tallinn
Finland
Investigational Site Number : 2460001
ACTIVE_NOT_RECRUITING
Tampere
Investigational Site Number : 2460002
ACTIVE_NOT_RECRUITING
Turku
France
Investigational Site Number : 2500019
RECRUITING
Besançon
Investigational Site Number : 2500011
RECRUITING
Bron
Investigational Site Number : 2500005
RECRUITING
Clermont-ferrand
Investigational Site Number : 2500015
RECRUITING
Gonesse
Investigational Site Number : 2500009
RECRUITING
Lille
Investigational Site Number : 2500006
RECRUITING
Montpellier
Investigational Site Number : 2500008
RECRUITING
Nancy
Investigational Site Number : 2500002
RECRUITING
Nice
Investigational Site Number : 2500017
RECRUITING
Nîmes
Investigational Site Number : 2500007
RECRUITING
Paris
Investigational Site Number : 2500014
RECRUITING
Paris
Investigational Site Number : 2500004
RECRUITING
Poissy
Investigational Site Number : 2500003
RECRUITING
Rennes
Investigational Site Number : 2500010
ACTIVE_NOT_RECRUITING
Saint-herblain
Investigational Site Number : 2500001
RECRUITING
Strasbourg
Investigational Site Number : 2500012
RECRUITING
Toulouse
Georgia
Investigational Site Number : 2680003
RECRUITING
Tbilisi
Investigational Site Number : 2680004
RECRUITING
Tbilisi
Investigational Site Number : 2680009
RECRUITING
Tbilisi
Germany
Investigational Site Number : 2760005
RECRUITING
Bayreuth
Investigational Site Number : 2760009
RECRUITING
Berlin
Investigational Site Number : 2760014
RECRUITING
Berlin
Investigational Site Number : 2760015
RECRUITING
Berlin
Investigational Site Number : 2760020
ACTIVE_NOT_RECRUITING
Bochum
Investigational Site Number : 2760001
RECRUITING
Dresden
Investigational Site Number : 2769901
RECRUITING
Düsseldorf
Investigational Site Number : 2760012
RECRUITING
Essen
Investigational Site Number : 2760002
RECRUITING
Giessen
Investigational Site Number : 2760016
RECRUITING
Hamburg
Investigational Site Number : 2760008
RECRUITING
Münster
Investigational Site Number : 2760011
RECRUITING
Ulm
Investigational Site Number : 2760003
RECRUITING
Würzburg
Greece
Investigational Site Number : 3000001
RECRUITING
Athens
Investigational Site Number : 3000002
RECRUITING
Athens
Investigational Site Number : 3000006
ACTIVE_NOT_RECRUITING
Athens
Investigational Site Number : 3000007
ACTIVE_NOT_RECRUITING
Athens
Investigational Site Number : 3000004
RECRUITING
Larissa
Investigational Site Number : 3000003
RECRUITING
Thessaloniki
Investigational Site Number : 3000009
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Investigational Site Number : 3440001
ACTIVE_NOT_RECRUITING
Shatin
Hungary
Investigational Site Number : 3480007
ACTIVE_NOT_RECRUITING
Budapest
Investigational Site Number : 3489901
RECRUITING
Budapest
Investigational Site Number : 3489903
RECRUITING
Budapest
Investigational Site Number : 3480002
ACTIVE_NOT_RECRUITING
Pécs
India
Investigational Site Number : 3569904
ACTIVE_NOT_RECRUITING
Chandigarh
Investigational Site Number : 3560007
COMPLETED
Gurugram
Investigational Site Number : 3569903
ACTIVE_NOT_RECRUITING
Gurugram
Investigational Site Number : 3569901
ACTIVE_NOT_RECRUITING
Mangaluru
Investigational Site Number : 3560009
ACTIVE_NOT_RECRUITING
Nagpur
Investigational Site Number : 3560002
ACTIVE_NOT_RECRUITING
New Delhi
Investigational Site Number : 3569902
ACTIVE_NOT_RECRUITING
New Delhi
Investigational Site Number : 3569902
RECRUITING
New Delhi
Investigational Site Number : 3560004
ACTIVE_NOT_RECRUITING
Thiruvananthapuram
Israel
Investigational Site Number : 3760003
ACTIVE_NOT_RECRUITING
Haifa
Investigational Site Number : 3760001
RECRUITING
Ramat Gan
Investigational Site Number : 3760006
ACTIVE_NOT_RECRUITING
Rehovot
Investigational Site Number : 3760004
ACTIVE_NOT_RECRUITING
Safed
Italy
Investigational Site Number : 3800011
ACTIVE_NOT_RECRUITING
Bergamo
Investigational Site Number : 3800007
RECRUITING
Cagliari
Investigational Site Number : 3800015
RECRUITING
Catania
Investigational Site Number : 3800018
RECRUITING
Chieti
Investigational Site Number : 3800012
ACTIVE_NOT_RECRUITING
Florence
Investigational Site Number : 3800016
RECRUITING
Florence
Investigational Site Number : 3800014
ACTIVE_NOT_RECRUITING
Genoa
Investigational Site Number : 3800001
RECRUITING
Milan
Investigational Site Number : 3800010
ACTIVE_NOT_RECRUITING
Milan
Investigational Site Number : 3800006
RECRUITING
Naples
Investigational Site Number : 3800008
ACTIVE_NOT_RECRUITING
Pavia
Investigational Site Number : 3800002
RECRUITING
Pozzilli
Investigational Site Number : 3800009
RECRUITING
Roma
Investigational Site Number : 3800005
ACTIVE_NOT_RECRUITING
Rome
Investigational Site Number : 3800009
ACTIVE_NOT_RECRUITING
Rome
Investigational Site Number : 3800013
RECRUITING
Rome
Japan
Investigational Site Number : 3920018
ACTIVE_NOT_RECRUITING
Kawagoe
Investigational Site Number : 3920011
RECRUITING
Kyoto
Investigational Site Number : 3920022
RECRUITING
Morioka
Investigational Site Number : 3920001
ACTIVE_NOT_RECRUITING
Osaka
Investigational Site Number : 3920004
RECRUITING
Osaka
Investigational Site Number : 3920023
RECRUITING
Sagamihara
Investigational Site Number : 3920010
RECRUITING
Tokyo
Latvia
Investigational Site Number : 4280002
ACTIVE_NOT_RECRUITING
Riga
Investigational Site Number : 4280003
ACTIVE_NOT_RECRUITING
Riga
Lithuania
Investigational Site Number : 4400003
ACTIVE_NOT_RECRUITING
Kaunas
Investigational Site Number : 4400004
ACTIVE_NOT_RECRUITING
Šiauliai
Investigational Site Number : 4400001
ACTIVE_NOT_RECRUITING
Vilnius
Mexico
Investigational Site Number : 4840001
RECRUITING
Mexico City
Investigational Site Number : 4840002
RECRUITING
Mexico City
Investigational Site Number : 4840003
RECRUITING
Veracruz
Netherlands
Investigational Site Number : 5280001
ACTIVE_NOT_RECRUITING
Amsterdam
Investigational Site Number : 5280002
RECRUITING
Heerlen
Norway
Investigational Site Number : 5780003
RECRUITING
Bergen
Investigational Site Number : 5780001
RECRUITING
Oslo
Poland
Investigational Site Number : 6160003
RECRUITING
Bydgoszcz
Investigational Site Number : 6160009
ACTIVE_NOT_RECRUITING
Głogów Małopolski
Investigational Site Number : 6160002
ACTIVE_NOT_RECRUITING
Katowice
Investigational Site Number : 6160004
RECRUITING
Katowice
Investigational Site Number : 6160001
RECRUITING
Lodz
Investigational Site Number : 6160012
RECRUITING
Lublin
Investigational Site Number : 6160008
ACTIVE_NOT_RECRUITING
Plewiska
Investigational Site Number : 6160005
RECRUITING
Warsaw
Investigational Site Number : 6160006
ACTIVE_NOT_RECRUITING
Warsaw
Investigational Site Number : 6160011
ACTIVE_NOT_RECRUITING
Zabrze
Portugal
Investigational Site Number : 6200001
RECRUITING
Braga
Investigational Site Number : 6200005
RECRUITING
Coimbra
Investigational Site Number : 6200006
ACTIVE_NOT_RECRUITING
Lisbon
Investigational Site Number : 6200011
RECRUITING
Lisbon
Investigational Site Number : 6200004
ACTIVE_NOT_RECRUITING
Santa Maria Da Feira
Puerto Rico
San Juan MS Center- Site Number : 8400015
RECRUITING
Guaynabo
Republic of Korea
Investigational Site Number : 4100001
ACTIVE_NOT_RECRUITING
Goyang-si
Investigational Site Number : 4100002
ACTIVE_NOT_RECRUITING
Seoul
Investigational Site Number : 4100003
ACTIVE_NOT_RECRUITING
Seoul
Investigational Site Number : 4100006
ACTIVE_NOT_RECRUITING
Seoul
Romania
Investigational Site Number : 6420015
ACTIVE_NOT_RECRUITING
Brasov
Investigational Site Number : 6420008
RECRUITING
Bucharest
Investigational Site Number : 6420004
RECRUITING
Campulung Muscel
Investigational Site Number : 6420006
RECRUITING
Cluj-napoca
Investigational Site Number : 6420003
RECRUITING
Constanța
Investigational Site Number : 6420013
RECRUITING
Oradea
Investigational Site Number : 6420005
RECRUITING
Sibiu
Investigational Site Number : 6420002
ACTIVE_NOT_RECRUITING
Timișoara
Serbia
Investigational Site Number : 6880001
RECRUITING
Belgrade
Investigational Site Number : 6880003
ACTIVE_NOT_RECRUITING
Belgrade
Investigational Site Number : 6880006
ACTIVE_NOT_RECRUITING
Belgrade
Investigational Site Number : 6880002
RECRUITING
Kragujevac
Investigational Site Number : 6880005
ACTIVE_NOT_RECRUITING
Novi Sad
Slovakia
Investigational Site Number : 7030001
ACTIVE_NOT_RECRUITING
Bratislava
Investigational Site Number : 7030002
ACTIVE_NOT_RECRUITING
Martin
Investigational Site Number : 7030004
ACTIVE_NOT_RECRUITING
Nitra
Spain
Investigational Site Number : 7249908
RECRUITING
A Coruña
Investigational Site Number : 7249913
ACTIVE_NOT_RECRUITING
Barakaldo
Investigational Site Number : 7249906
RECRUITING
Barcelona
Investigational Site Number : 7249912
RECRUITING
Barcelona
Investigational Site Number : 7249914
ACTIVE_NOT_RECRUITING
Córdoba
Investigational Site Number : 7249918
ACTIVE_NOT_RECRUITING
Donostia / San Sebastian
Investigational Site Number : 7249911
ACTIVE_NOT_RECRUITING
Girona
Investigational Site Number : 7249919
ACTIVE_NOT_RECRUITING
L'hospitalet De Llobregat
Investigational Site Number : 7249904
RECRUITING
Las Palmas De Gran Canaria
Investigational Site Number : 7249902
ACTIVE_NOT_RECRUITING
Lleida
Investigational Site Number : 7249903
ACTIVE_NOT_RECRUITING
Madrid
Investigational Site Number : 7249909
RECRUITING
Madrid
Investigational Site Number : 7249910
ACTIVE_NOT_RECRUITING
Madrid
Investigational Site Number : 7249901
RECRUITING
Majadahonda
Investigational Site Number : 7249915
RECRUITING
Málaga
Investigational Site Number : 7249916
RECRUITING
Murcia
Investigational Site Number : 7249905
RECRUITING
Pozuelo De Alarcón
Investigational Site Number : 7249921
RECRUITING
Santiago De Compostela
Investigational Site Number : 7249907
RECRUITING
Seville
Investigational Site Number : 7249917
RECRUITING
Valencia
Sweden
Investigational Site Number : 7520001
RECRUITING
Gothenburg
Investigational Site Number : 7520002
RECRUITING
Stockholm
Switzerland
Investigational Site Number : 7560002
ACTIVE_NOT_RECRUITING
Bern
Taiwan
Investigational Site Number : 1580007
ACTIVE_NOT_RECRUITING
Hsinchu
Investigational Site Number : 1580002
ACTIVE_NOT_RECRUITING
Taipei
Turkey
Investigational Site Number : 7920006
RECRUITING
Ankara
Investigational Site Number : 7920005
RECRUITING
Eskişehir
Investigational Site Number : 7920002
RECRUITING
Istanbul
Investigational Site Number : 7920003
ACTIVE_NOT_RECRUITING
Istanbul
Investigational Site Number : 7920007
ACTIVE_NOT_RECRUITING
Istanbul
Investigational Site Number : 7920009
ACTIVE_NOT_RECRUITING
Istanbul
Investigational Site Number : 7920010
RECRUITING
Izmir
Investigational Site Number : 7920001
ACTIVE_NOT_RECRUITING
İzmit
Investigational Site Number : 7929901
ACTIVE_NOT_RECRUITING
Kütahya
Investigational Site Number : 7929902
RECRUITING
Mersin
Investigational Site Number : 7929903
RECRUITING
Samsun
Ukraine
Investigational Site Number : 8040020
ACTIVE_NOT_RECRUITING
Chernivtsi
Investigational Site Number : 8049904
RECRUITING
Chernivtsi
Investigational Site Number : 8049912
ACTIVE_NOT_RECRUITING
Chernivtsi
Investigational Site Number : 8049905
ACTIVE_NOT_RECRUITING
Dnipro
Investigational Site Number : 8040018
ACTIVE_NOT_RECRUITING
Kharkiv
Investigational Site Number : 8040025
RECRUITING
Kharkiv
Investigational Site Number : 8049903
RECRUITING
Kharkiv
Investigational Site Number : 8049908
RECRUITING
Krykhivtsi
Investigational Site Number : 8049901
RECRUITING
Kyiv
Investigational Site Number : 8049902
RECRUITING
Kyiv
Investigational Site Number : 8049911
ACTIVE_NOT_RECRUITING
Kyiv
Investigational Site Number : 8049914
RECRUITING
Lutsk
Investigational Site Number : 8049906
RECRUITING
Lviv
Investigational Site Number : 8049909
RECRUITING
Lviv
Investigational Site Number : 8049913
RECRUITING
Odesa
Investigational Site Number : 8040024
RECRUITING
Vinnytsia
Investigational Site Number : 8049910
ACTIVE_NOT_RECRUITING
Vinnytsia
United Kingdom
Investigational Site Number : 8260009
RECRUITING
Bristol
Investigational Site Number : 8260016
ACTIVE_NOT_RECRUITING
Canterbury
Investigational Site Number : 8260003
RECRUITING
Exeter
Investigational Site Number : 8260005
ACTIVE_NOT_RECRUITING
London
Investigational Site Number : 8260014
ACTIVE_NOT_RECRUITING
Newcastle Upon Tyne
Investigational Site Number : 8260013
RECRUITING
Oxford
Investigational Site Number : 8260019
ACTIVE_NOT_RECRUITING
Salford
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-04-16
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 2500
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Sanofi