Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,131

Participants

Timeline

Start Date

September 24, 2020

Primary Completion Date

August 29, 2024

Study Completion Date

August 29, 2024

Conditions
Non-relapsing Secondary Progressive Multiple Sclerosis
Interventions
DRUG

Tolebrutinib

Pharmaceutical form: Film-coated tablet Route of administration: Oral

DRUG

Placebo to match Tolebrutinib

Pharmaceutical form: Film-coated tablet Route of administration: Oral

Trial Locations (306)

1012

Investigational Site Number :0320002, Capital Federal

1070

Investigational Site Number : 0560009, Brussels

1090

Investigational Site Number :0400002, Vienna

1113

Investigational Site Number :1000004, Sofia

1135

Investigational Site Number :3480008, Budapest

1145

Investigational Site Number :3480004, Budapest

1152

Investigational Site Number :3480007, Budapest

1200

Investigational Site Number :0560007, Brussels

1407

Investigational Site Number :1000008, Sofia

1431

Investigational Site Number :1000001, Sofia

Investigational Site Number :1000006, Sofia

1680

Investigational Site Number :1000009, Sofia

1860

Investigational Site Number :0320007, Buenos Aires

2065

Investigational Site Number : 0360007, St Leonards

2800

Investigational Site Number :3480006, Tatabánya

3000

Investigational Site Number :0560006, Leuven

3065

Investigational Site Number :0360001, Fitzroy

3081

Investigational Site Number :0360006, Heidelberg West

3900

Investigational Site Number :0560001, Overpelt

4000

Investigational Site Number :0560008, Liège

Investigational Site Number :1000005, Plovdiv

4020

Investigational Site Number :0400001, Linz

4021

Investigational Site Number :0400004, Linz

4102

Investigational Site Number :0360003, Woolloongabba

5000

Investigational Site Number :0320006, Córdoba

Investigational Site Number :2080004, Odense

5021

Investigational Site Number :5780003, Bergen

5800

Investigational Site Number :1000002, Pleven

6020

Investigational Site Number :0400003, Innsbruck

6700

Investigational Site Number :2080001, Esbjerg

6725

Investigational Site Number :3480001, Szeged

7000

Investigational Site Number :0560002, Mons

7001

Investigational Site Number :0360004, Hobart

7500

Investigational Site Number :2080005, Holstebro

7623

Investigational Site Number :3480002, Pécs

7800

Investigational Site Number :5780002, Namsos

9000

Investigational Site Number : 0560004, Ghent

10002

Investigational Site Number :8040014, Zhytomyr

10117

Investigational Site Number :2760009, Berlin

11535

Investigational Site Number :3000006, Athens

11794

Neurology Associates of Stony Brook-Site Number:8400042, Stony Brook

12462

Investigational Site Number :3000002, Athens

12808

Investigational Site Number :2030005, Prague

13100

Investigational Site Number :3760004, Safed

14004

Investigational Site Number :7240008, Córdoba

15125

Investigational Site Number :3000007, Athens

16132

Investigational Site Number :3800014, Genova

17190

Investigational Site Number :7240014, Salt

18055

Investigational Site Number :2760004, Rostock

19104

Perelman Center for Advanced Medicine-Site Number:8400142, Philadelphia

19107

Jefferson Neurology Associates-Site Number:8400016, Philadelphia

20014

Investigational Site Number :7240012, Donostia / San Sebastian

20122

Investigational Site Number :3800004, Milan

20132

Investigational Site Number :3800001, Milan

20133

Investigational Site Number :3800010, Milan

20520

Investigational Site Number :2460002, Turku

21050

Investigational Site Number :8040006, Vinnytsia

24127

Investigational Site Number :3800011, Bergamo

25198

Investigational Site Number :7240015, Lleida

27100

Investigational Site Number :3800008, Pavia

27607

Meridian Clinical Research, LLC-Site Number:8400005, Raleigh

28007

Investigational Site Number :7240005, Madrid

28034

Investigational Site Number :7240002, Madrid

28040

Investigational Site Number :7240003, Madrid

28222

Investigational Site Number :7240004, Majadahonda

28223

Investigational Site Number :7240001, Pozuelo de Alarcón

29010

Investigational Site Number :7240009, Málaga

29650

Premier Neurology-Site Number:8400069, Greer

30029

Investigational Site Number :2500017, Nîmes

30120

Investigational Site Number :7240010, Murcia

30625

Investigational Site Number :2760006, Hanover

31059

Investigational Site Number :2500012, Toulouse

31096

Investigational Site Number :3760003, Haifa

31406

Meridian Clinical Research-Site Number:8400003, Savannah

32761

Neurology Associates, PA-Site Number:8400004, Maitland

33070

Investigational Site Number :7920012, Mersin

33487

South Florida Neurology Associates-Site Number:8400029, Boca Raton

33520

Investigational Site Number :2460001, Tampere

33612

University of South Florida-Site Number:8400006, Tampa

34098

Investigational Site Number :7920002, Istanbul

34105

Aqualane Clinical Research-Site Number:8400027, Naples

34295

Investigational Site Number :2500006, Montpellier

34688

Investigational Site Number :7920009, Istanbul

34785

Investigational Site Number :7920007, Istanbul

34896

Investigational Site Number :7920006, Istanbul

35010

Investigational Site Number :7240017, Las Palmas de Gran Canaria

35033

Investigational Site Number :2500003, Rennes

35100

Investigational Site Number :7920013, Izmir

35233

University of Alabama MS Center-Site Number:8400013, Birmingham

35385

Investigational Site Number :2760002, Giessen

37064

Advanced Neuroscience Center-Site Number:8400035, Franklin

38018

Neurology Clinic, PC-Site Number:8400087, Cordova

40382

Columbus Neuroscience-Site Number:8400010, Westerville

40509

CHI Saint Joseph Medical Group Neurology-Site Number:8400110, Lexington

41009

Investigational Site Number :7240007, Seville

41110

Investigational Site Number :3000004, Larissa

41380

Investigational Site Number :7920001, İzmit

43005

Investigational Site Number :8040005, Lutsk

43100

Investigational Site Number :7920011, Kütahya

43235

Optimed Research, LTD-Site Number:8400147, Columbus

44093

Investigational Site Number :2500010, Nantes

44106

University Hospitals CMC-Site Number:8400083, Cleveland

44195

Cleveland Clinic-Site Number:8400125, Cleveland

45147

Investigational Site Number :2760012, Essen

45417

Neurology Specialists-Site Number:8400002, Dayton

46026

Investigational Site Number :7240011, Valencia

48149

Investigational Site Number :2760008, Münster

48201

Wayne State University-Site Number:8400046, Detroit

48867

The Memorial Hospital-Site Number:8400033, Owosso

49005

Investigational Site Number :8040003, Dnipro

50005

Investigational Site Number :2030004, Hradec Králové

50134

Investigational Site Number :3800012, Florence

50141

Investigational Site Number :3800016, Florence

50161

Investigational Site Number :4400003, Kaunas

52621

Investigational Site Number :3760001, Tel Litwinsky

53226

Medical College of Wisconsin-Site Number:8400028, Milwaukee

54035

Investigational Site Number :2500008, Nancy

55422

Minneapolis Clinic of Neurology-Site Number:8400051, Minneapolis

55905

Mayo Clinic-Site Number:8400111, Rochester

57010

Investigational Site Number :3000005, Thessaloniki

58000

Investigational Site Number :8040008, Chernivtsi

58023

Investigational Site Number :8040016, Chernivtsi

58103

Sanford Brain & Spine Center-Site Number:8400126, Fargo

58633

Investigational Site Number :2030001, Jihlava

59037

Investigational Site Number :2500009, Lille

60062

Consultants In Neurology-Site Number:8400011, Northbrook

61068

Investigational Site Number :8040007, Kharkiv

61080

Investigational Site Number :7920008, Trabzon

61103

Investigational Site Number :8040011, Kharkiv

Investigational Site Number :8040012, Kharkiv

63003

Investigational Site Number :2500005, Clermont-Ferrand

63131

Missouri Baptist Medical Center-Site Number:8400019, St Louis

65025

Investigational Site Number :8040002, Odesa

65691

Investigational Site Number :2030002, Brno

67010

Investigational Site Number :3800013, L’Aquila

67098

Investigational Site Number :2500001, Strasbourg

69500

Investigational Site Number :2500011, Bron

70852

Investigational Site Number :2030010, Ostrava - Poruba

75012

Investigational Site Number :2500016, Paris

75013

Investigational Site Number :2500014, Paris

75019

Investigational Site Number :2500007, Paris

76018

Investigational Site Number :8040010, Ivano-Frankivsk

77030

Baylor College of Medicine-Site Number:8400136, Houston

78258

Neurology Center of San Antonio-Site Number:8400036, San Antonio

78278

Investigational Site Number :3760002, Ashkelon

79010

Investigational Site Number :8040009, Lviv

79013

Investigational Site Number :8040004, Lviv

80262

University of Colorado-Site Number:8400012, Denver

80528

Advanced Neurosciences Research-Site Number:8400025, Fort Collins

81621

Mountain Neurological Research Center, Inc.-Site Number:8400128, Basalt

84018

Center for Neurology and Spine-Site Number:8400089, Phoenix

87131

University of New Mexico-Site Number:8400032, Albuquerque

89081

Investigational Site Number :2760011, Ulm

89106

Lou Ruvo Center for Brain Health-Site Number:8400117, Las Vegas

90033

Multiple Sclerosis Center-Site Number:8400143, Los Angeles

90048

Regina Berkovich, MD, PhD-Site Number:8400059, West Hollywood

90502

Harbor UCLA-Site Number:8400088, Torrance

90806

Collaborative Neuroscience Research-Site Number:8400045, Long Beach

91006

Arcadia Neurology Center-Site Number:8400070, Arcadia

91120

Investigational Site Number :3760008, Jerusalem

92037

UC San Diego ACTRI-Site Number:8400101, La Jolla

92288

Investigational Site Number :4400002, Klaipėda

94158

University of San Francisco, Sandler Neurosciences Center-Site Number:8400137, San Francisco

95445

Investigational Site Number :2760005, Bayreuth

95500

Investigational Site Number :2500015, Gonesse

97225

Providence Multiple Sclerosis Center-Site Number:8400020, Portland

100034

Investigational Site Number :1560006, Beijing

100053

Investigational Site Number :1560012, Beijing

100700

Investigational Site Number :1560021, Beijing

100730

Investigational Site Number :1560003, Beijing

Investigational Site Number :1560009, Beijing

110029

Investigational Site Number :3560006, New Delhi

110060

Investigational Site Number :3560002, New Delhi

115100

Investigational Site Number :6420004, Campulung Muscel

117997

Investigational Site Number :6430020, Moscow

122001

Investigational Site Number :3560007, Gūrgaon

122002

Investigational Site Number :3560003, Gūrgaon

125367

Investigational Site Number :6430002, Moscow

127015

Investigational Site Number :6430013, Moscow

129110

Investigational Site Number :6430001, Moscow

129128

Investigational Site Number :6430008, Moscow

130021

Investigational Site Number :1560004, Changchun

197022

Investigational Site Number :6430011, Saint Petersburg

197110

Investigational Site Number :6430004, Saint Petersburg

210009

Investigational Site Number :1120004, Vitebsk

210037

Investigational Site Number :1120005, Vitebsk

214018

Investigational Site Number :6430014, Smolensk

236035

Investigational Site Number :6430025, Kaliningrad

300736

Investigational Site Number :6420002, Timișoara

310009

Investigational Site Number :1560007, Hangzhou

344022

Investigational Site Number :6430016, Rostov-on-Don

350005

Investigational Site Number :1560035, Fuzhou

357538

Investigational Site Number :6430007, Pyatigorsk

400012

Investigational Site Number :6420006, Cluj-Napoca

400016

Investigational Site Number :1560019, Chongqing

410008

Investigational Site Number :1560015, Changsha

410154

Investigational Site Number :6420013, Oradea

420021

Investigational Site Number :6430003, Kazan'

430032

Investigational Site Number :6430019, Saransk

440012

Investigational Site Number : 3560009, Nagpur

443095

Investigational Site Number :6430009, Samara

450005

Investigational Site Number :6430010, Ufa

510630

Investigational Site Number :1560001, Guangzhou

540136

Investigational Site Number :6420001, Târgu Mureş

550052

Investigational Site Number :6420005, Sibiu

575018

Investigational Site Number :3560004, Mangaluru

603137

Investigational Site Number :6430021, Nizhny Novgorod

603155

Investigational Site Number :6430006, Nizhny Novgorod

610041

Investigational Site Number :1560005, Chengdu

610998

Investigational Site Number :6430017, Kirov

614990

Investigational Site Number :6430026, Perm

620102

Investigational Site Number :6430023, Yekaterinburg

625000

Investigational Site Number :6430012, Tyumen

630087

Investigational Site Number :6430005, Novosibirsk

650099

Investigational Site Number :6430022, Kemerovo

656024

Investigational Site Number :6430018, Barnaul

660029

Investigational Site Number :6430024, Krasnoyarsk

710038

Investigational Site Number :1560017, Xi'an

900123

Investigational Site Number :6420003, Constanța

33609-4052

Axiom Clinical Research of Florida-Site Number:8400001, Tampa

66160-7321

University of Kansas Medical Center-Site Number:8400023, Kansas City

02111

Tufts Medical Center-Site Number:8400072, Boston

01655

University of Massachusetts-Site Number:8400014, Worcester

07666

Holy Name Hospital-Site Number:8400104, Teaneck

10029-6501

Icahn School of Medicine at Mount Sinai (Department of Endoc-Site Number:8400038, New York

29651-1817

Mountain View Clinical Research-Site Number:8400024, Greer

05401

University Of Vermont College Of Medicine-Site Number:8400130, Burlington

C1061

Investigational Site Number :0320001, CABA

T4000AXL

Investigational Site Number :0320005, San Miguel de Tucumán

Unknown

Investigational Site Number :0360002, Kent Town

Investigational Site Number :3560005, India

Investigational Site Number :7920005, Eskişehir

Investigational Site Number :7920010, Hatay

Investigational Site Number :7920003, Istanbul

B-2650

Investigational Site Number :0560003, Edegem

V5G 2X6

Investigational Site Number :1240017, Burnaby

B3H 1V7

Investigational Site Number :1240011, Halifax

K1H 8L6

Investigational Site Number :1240003, Ottawa

M4N 3M5

Investigational Site Number :1240008, Toronto

J8Y 1W2

Investigational Site Number :1240006, Gatineau

J4V 2J2

Investigational Site Number :1240005, Greenfield Park

H2X 0A9

Investigational Site Number :1240004, Montreal

H3A 2B4

Investigational Site Number :1240015, Montreal

J1H 5N4

Investigational Site Number :1240007, Sherbrooke

G1J 1Z4

Investigational Site Number : 1240001, Québec

G1W 4R4

Investigational Site Number :1240021, Québec

050000

Investigational Site Number :1560014, Shijiazhuang

030001

Investigational Site Number :1560008, Taiyuan

415 29

Investigational Site Number :2030003, Teplice

00180

Investigational Site Number :2460003, Helsinki

01307

Investigational Site Number :2760001, Dresden

06120

Investigational Site Number :2760010, Halle

115 28

Investigational Site Number :3000001, Athens

546 36

Investigational Site Number :3000003, Thessaloniki

09126

Investigational Site Number :3800007, Cagliari

00152

Investigational Site Number :3800005, Roma

00168

Investigational Site Number :3800009, Roma

260-8677

Investigational Site Number :3920016, Chiba

020-8505

Investigational Site Number :3920022, Morioka

616-8255

Investigational Site Number :3920011, Kyoto

980-8574

Investigational Site Number :3920020, Sendai

951-8520

Investigational Site Number :3920005, Niigata

570-8507

Investigational Site Number :3920004, Moriguchi-shi

556-0016

Investigational Site Number :3920001, Osaka

350-8550

Investigational Site Number :3920018, Kawagoe-shi

187-8551

Investigational Site Number :3920003, Kodaira-shi

146-0065

Investigational Site Number :3920010, Ōta-ku

755-8505

Investigational Site Number :3920009, Ube-shi

252-0392

Investigational Site Number :3920023, Sagamihara-shi

08661

Investigational Site Number :4400001, Vilnius

1081 GN

Investigational Site Number :5280001, Amsterdam

4818 CK

Investigational Site Number :5280003, Breda

9728 NZ

Investigational Site Number :5280006, Groningen

6162 BG

Investigational Site Number :5280002, Sittard-Geleen

0450

Investigational Site Number :5780001, Oslo

62-064

Investigational Site Number :6160008, Plewiska

85-796

Investigational Site Number :6160003, Bydgoszcz

01-211

Investigational Site Number :6160005, Warsaw

01-684

Investigational Site Number :6160006, Warsaw

40-571

Investigational Site Number :6160002, Katowice

40-684

Investigational Site Number :6160007, Katowice

40-686

Investigational Site Number :6160004, Katowice

90-549

Investigational Site Number :6160001, Lodz

20-016

Investigational Site Number :6160012, Lublin

41-800

Investigational Site Number :6160011, Zabrze

4710-243

Investigational Site Number :6200001, Braga

1162-050

Investigational Site Number :6200011, Lisbon

1349-019

Investigational Site Number :6200007, Lisbon

1649-035

Investigational Site Number :6200006, Lisbon

4464-513

Investigational Site Number :6200002, Matosinhos Municipality

4099-001

Investigational Site Number :6200010, Porto

022328

Investigational Site Number :6420008, Bucharest

08035

Investigational Site Number :7240013, Barcelona

08036

Investigational Site Number :7240016, Barcelona

03115

Investigational Site Number :8040013, Kyiv

EX2 5DW

Investigational Site Number :8260003, Exeter

PL6 8DH

Investigational Site Number :8260008, Plymouth

SA6 6NL

Investigational Site Number :8260010, Swansea

NG7 2UH

Investigational Site Number :8260012, Nottingham

OX3 9DZ

Investigational Site Number :8260013, Oxford

BS10 5NB

Investigational Site Number :8260009, Bristol

CF4 4XY

Investigational Site Number :8260001, Cardiff

SW17 0RE

Investigational Site Number :8260005, London

W6 8RF

Investigational Site Number :8260018, London

NE1 4LP

Investigational Site Number :8260014, Newcastle upon Tyne

M6 8HD

Investigational Site Number :8260019, Salford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT04411641 - Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES) | Biotech Hunter | Biotech Hunter