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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

767

Participants

Timeline

Start Date

August 13, 2020

Primary Completion Date

November 14, 2025

Study Completion Date

November 14, 2025

Conditions
Primary Progressive Multiple Sclerosis
Interventions
DRUG

Tolebrutinib

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

DRUG

Placebo

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

Trial Locations (277)

1033

Investigational Site Number : 3480206, Budapest

1070

Investigational Site Number : 0560009, Brussels

1083

Investigational Site Number : 3480202, Budapest

1090

Investigational Site Number : 0400002, Vienna

1113

Investigational Site Number : 1000004, Sofia

1138

Investigational Site Number : 3480203, Budapest

1200

Investigational Site Number : 0560007, Woluwe-Saint-Lambert

1407

Investigational Site Number : 1000008, Sofia

1431

Investigational Site Number : 1000001, Sofia

1606

Investigational Site Number : 1000011, Sofia

2000

Investigational Site Number : 0320003, Rosario

2065

Investigational Site Number : 0360006, St Leonards

2139

Investigational Site Number : 0360005, Concord

3900

Investigational Site Number : 0560001, Overpelt

4000

Investigational Site Number : 0560008, Liège

4021

Investigational Site Number : 0400004, Linz

5021

Investigational Site Number : 5780003, Bergen

5809

Investigational Site Number : 1000002, Pleven

6700

Investigational Site Number : 2080001, Esbjerg

7001

Investigational Site Number : 0360003, Hobart

7500

Investigational Site Number : 2080005, Holstebro

9000

Investigational Site Number : 0560004, Ghent

9038

Investigational Site Number : 5780005, Tromsø

10000

Investigational Site Number : 1910001, Zagreb

Investigational Site Number : 1910002, Zagreb

10117

Investigational Site Number : 2760009, Berlin

10700

Investigational Site Number : 7640001, Bangkok

10713

Investigational Site Number : 2760015, Berlin

11000

Investigational Site Number : 6880001, Belgrade

11315

Investigational Site Number : 2330001, Tallinn

11525

Investigational Site Number : 3000006, Athens

11794

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

12462

Investigational Site Number : 3000002, Athens

13100

Investigational Site Number : 3760004, Safed

14004

Investigational Site Number : 7240004, Córdoba

14050

Investigational Site Number : 4840005, Mexico City

15006

Investigational Site Number : 7240012, A Coruña

15084

Investigational Site Number : 6040004, Lima

15125

Investigational Site Number : 3000007, Marousi

15706

Investigational Site Number : 7240015, Santiago de Compostela

17190

Investigational Site Number : 7240011, Salt

18055

Investigational Site Number : 2760004, Rostock

19107

Jefferson Neurology Associates Site Number : 8400016, Philadelphia

20132

Investigational Site Number : 3800001, Milan

21001

Investigational Site Number : 8040024, Vinnytsia

21093

International Neurorehabilitation Institute Site Number : 8400034, Lutherville

26040

Investigational Site Number : 7920005, Eskişehir

27103

Atrium Health Wake Forest Baptist Site Number : 8400116, Winston-Salem

27607

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

27710

Duke Neurological Disorders Clinic- Site Number : 8400098, Durham

28007

Investigational Site Number : 7240003, Madrid

28222

Investigational Site Number : 7240002, Majadahonda

28223

Investigational Site Number : 7240001, Pozuelo de Alarcón

29010

Investigational Site Number : 7240005, Málaga

30029

Investigational Site Number : 2500017, Nîmes

30120

Investigational Site Number : 7240006, Murcia

30625

Investigational Site Number : 2760006, Hanover

31059

Investigational Site Number : 2500012, Toulouse

31406

Velocity Clinical Research Site Number : 8400003, Savannah

32601

University of Florida, Fixel Center for Neurology Site Number : 8400159, Gainesville

32761

Neurology Associates, PA- Site Number : 8400004, Maitland

33070

Investigational Site Number : 7920012, Mersin

33487

South Florida Neurology Associates Site Number : 8400029, Boca Raton

33612

University of South Florida Site Number : 8400006, Tampa

33761

MS & Neuromuscular Center of Excellence Site Number : 8400172, Clearwater

34000

Investigational Site Number : 6880002, Kragujevac

34093

Investigational Site Number : 7920016, Istanbul

34265

Investigational Site Number : 7920003, Istanbul

34295

Investigational Site Number : 2500006, Montpellier

34303

Investigational Site Number : 7920002, Istanbul

34785

Investigational Site Number : 7920007, Istanbul

35010

Investigational Site Number : 7240016, Las Palmas de Gran Canaria

35033

Investigational Site Number : 2500003, Rennes

35100

Investigational Site Number : 7920015, Izmir

35340

Investigational Site Number : 7920018, Izmir

35385

Investigational Site Number : 2760002, Giessen

40225

Investigational Site Number : 2760021, Düsseldorf

40536

University of Kentucky Site Number : 8400106, Lexington

41009

Investigational Site Number : 7240007, Seville

41110

Investigational Site Number : 3000004, Larissa

41380

Investigational Site Number : 7920001, İzmit

42080

Investigational Site Number : 7920017, Konya

43005

Investigational Site Number : 8040011, Lutsk

43100

Investigational Site Number : 7920011, Kütahya

43221

The Ohio State University Wexner Medical Center- Site Number : 8400150, Columbus

43235

The Boster Center for Multiple Sclerosis Site Number : 8400147, Columbus

44195

Cleveland Clinic Site Number : 8400125, Cleveland

44670

Investigational Site Number : 4840004, Guadalajara

44791

Investigational Site Number : 2760020, Bochum

45147

Investigational Site Number : 2760012, Essen

45212

Riverhills Neuroscience - Norwood Site Number : 8400167, Cincinnati

46026

Investigational Site Number : 7240008, Valencia

46410

Methodist Hospital Site Number : 8400164, Merrillville

48013

Investigational Site Number : 7240013, Bilbao

48149

Investigational Site Number : 2760008, Münster

48334

Michigan Institute For Neurological Disorders Site Number : 8400058, Farmington Hills

48867

The Memorial Hospital- Site Number : 8400033, Owosso

50005

Investigational Site Number : 2030004, Hradec Králové

50134

Investigational Site Number : 3800016, Florence

54035

Investigational Site Number : 2500008, Nancy

54055

Investigational Site Number : 4840007, Tlalnepantla

55236

Investigational Site Number : 3000009, Thessaloniki

55905

Mayo Clinic Site Number : 8400111, Rochester

58023

Investigational Site Number : 8040020, Chernivtsi

58633

Investigational Site Number : 2030001, Jihlava

59037

Investigational Site Number : 2500009, Lille

60062

Consultants In Neurology- Site Number : 8400011, Northbrook

61068

Investigational Site Number : 8040017, Kharkiv

Investigational Site Number : 8040025, Kharkiv

61103

Investigational Site Number : 8040023, Kharkiv

63003

Investigational Site Number : 2500005, Clermont-Ferrand

65025

Investigational Site Number : 8040010, Odesa

65691

Investigational Site Number : 2030002, Brno

65721

Sharlin Health & Neurology Site Number : 8400093, Ozark

66100

Investigational Site Number : 3800018, Chieti

66210

College Park Family Care Center Site Number : 8400044, Overland Park

67098

Investigational Site Number : 2500001, Strasbourg

68198

University Of Nebraska- Site Number : 8400129, Omaha

69500

Investigational Site Number : 2500011, Bron

70121

Ochsner Baptist Clinical Trials Unit (CTU)- Site Number : 8400107, New Orleans

75013

Investigational Site Number : 2500014, Paris

75019

Investigational Site Number : 2500007, Paris

76493

Investigational Site Number : 8040012, Ivano-Frankivsk

77450

Mt Olympus Medical Research Site Number : 8400163, Katy

78258

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

78300

Investigational Site Number : 2500004, Poissy

79010

Investigational Site Number : 8040002, Lviv

79013

Investigational Site Number : 8040007, Lviv

80131

Investigational Site Number : 3800003, Napoli

80138

Investigational Site Number : 3800006, Napoli

80528

Advanced Neurosciences Research Site Number : 8400025, Fort Collins

81377

Investigational Site Number : 2760018, München

86077

Investigational Site Number : 3800002, Pozzilli

87131

University of New Mexico Site Number : 8400032, Albuquerque

89081

Investigational Site Number : 2760011, Ulm

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

90720

Collaborative Neuroscience Research Site Number : 8400045, Los Alamitos

91105

SC3 Research - Pasadena Site Number : 8400070, Pasadena

91120

Investigational Site Number : 3760008, Jerusalem

91910

Investigational Site Number : 4840003, Veracruz

92037

UC San Diego ACTRI Site Number : 8400101, La Jolla

92663

Multiple Sclerosis Center of California Site Number : 8400135, Newport Beach

94158

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

95123

Investigational Site Number : 3800015, Catania

95445

Investigational Site Number : 2760005, Bayreuth

95500

Investigational Site Number : 2500015, Gonesse

96817

Hawaii Pacific Neuroscience Site Number : 8400103, Honolulu

97225

Providence Multiple Sclerosis Center Site Number : 8400020, Portland

100032

Investigational Site Number : 1560003, Beijing

100053

Investigational Site Number : 1560012, Beijing

100730

Investigational Site Number : 1560009, Beijing

Investigational Site Number : 1560025, Beijing

110029

Investigational Site Number : 3560005, New Delhi

111321

Investigational Site Number : 1700003, Bogotá

115100

Investigational Site Number : 6420004, Campulung Muscel

117997

Investigational Site Number : 6430013, Moscow

129128

Investigational Site Number : 6430011, Moscow

130021

Investigational Site Number : 1560004, Changchun

197376

Investigational Site Number : 6430017, Saint Petersburg

200040

Investigational Site Number : 1560001, Shanghai

210009

Investigational Site Number : 1120004, Vitebsk

210037

Investigational Site Number : 1120005, Vitebsk

236035

Investigational Site Number : 6430023, Kaliningrad

300736

Investigational Site Number : 6420002, Timișoara

325000

Investigational Site Number : 1560026, Wenzhou

344022

Investigational Site Number : 6430015, Rostov-on-Don

350005

Investigational Site Number : 1560035, Fuzhou

357538

Investigational Site Number : 6430008, Pyatigorsk

410008

Investigational Site Number : 1560015, Changsha

410154

Investigational Site Number : 6420013, Oradea

420032

Investigational Site Number : 6430004, Kazan'

430032

Investigational Site Number : 6430020, Saransk

443095

Investigational Site Number : 6430009, Samara

450005

Investigational Site Number : 6430006, Ufa

510630

Investigational Site Number : 1560002, Guangzhou

540136

Investigational Site Number : 6420001, Târgu Mureş

560001

Investigational Site Number : 3560014, Bengaluru

575018

Investigational Site Number : 3560004, Mangaluru

603137

Investigational Site Number : 6430014, Nizhny Novgorod

610041

Investigational Site Number : 1560005, Chengdu

620102

Investigational Site Number : 6430022, Yekaterinburg

625000

Investigational Site Number : 6430007, Tyumen

656043

Investigational Site Number : 6430018, Barnaul

660029

Investigational Site Number : 6430021, Krasnoyarsk

900123

Investigational Site Number : 6420003, Constanța

5266202

Investigational Site Number : 3760001, Ramat Gan

7650568

Investigational Site Number : 1520002, Santiago

8380456

Investigational Site Number : 1520001, Santiago

02111

Tufts Medical Center Site Number : 8400072, Boston

01655

University of Massachusetts Site Number : 8400014, Worcester

07601

Hackensack University Hospital Site Number : 8400047, Hackensack

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

C1012AAR

Investigational Site Number : 0320002, CABA

81210-310

Instituto de Neurologia de Curitiba Site Number : 0760002, Curitiba

01228-000

CPQuali Pesquisa Clinica Site Number : 0760007, São Paulo

T6G 2C8

Investigational Site Number : 1240002, Edmonton

V6T 2B5

Investigational Site Number : 1240016, Vancouver

L8L 2X2

Investigational Site Number : 1240012, Hamilton

K1H 8L6

Investigational Site Number : 1240003, Ottawa

M5B 1W8

Investigational Site Number : 1240013, Toronto

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

010050

Investigational Site Number : 1560027, Hohhot

030001

Investigational Site Number : 1560008, Taiyuan

Unknown

Investigational Site Number : 1700001, Bogotá

Investigational Site Number : 7920010, Hatay

Investigational Site Number : 7920013, Samsun

415 29

Investigational Site Number : 2030003, Teplice

0114

Investigational Site Number : 2680005, Tbilisi

0159

Investigational Site Number : 2680009, Tbilisi

0160

Investigational Site Number : 2680003, Tbilisi

0172

Investigational Site Number : 2680004, Tbilisi

01307

Investigational Site Number : 2760001, Dresden

115 28

Investigational Site Number : 3000001, Athens

546 36

Investigational Site Number : 3000003, Thessaloniki

09126

Investigational Site Number : 3800007, Cagliari

00189

Investigational Site Number : 3800013, Roma

260-8677

Investigational Site Number : 3920016, Chiba

963-8052

Investigational Site Number : 3920008, Koriyama-shi

020-8505

Investigational Site Number : 3920022, Morioka

252-0392

Investigational Site Number : 3920023, Sagamihara-shi

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

113-8431

Investigational Site Number : 3920014, Bunkyo-ku

187-8551

Investigational Site Number : 3920003, Kodaira-shi

146-0065

Investigational Site Number : 3920010, Ōta-ku

160-8582

Investigational Site Number : 3920017, Shinjuku-ku

930-0194

Investigational Site Number : 3920015, Toyama

LV-1002

Investigational Site Number : 4280002, Riga

06700

Investigational Site Number : 4840001, Mexico City

4818 CK

Investigational Site Number : 5280003, Breda

9728NT

Investigational Site Number : 5280006, Groningen

6162 BG

Investigational Site Number : 5280002, Sittard-Geleen

85-796

Investigational Site Number : 6160003, Bydgoszcz

90-549

Investigational Site Number : 6160001, Lodz

01-211

Investigational Site Number : 6160005, Warsaw

01-684

Investigational Site Number : 6160006, Warsaw

40-684

Investigational Site Number : 6160007, Katowice

40-686

Investigational Site Number : 6160004, Katowice

4710-243

Investigational Site Number : 6200001, Braga

1349-019

Investigational Site Number : 6200007, Lisbon

1500-650

Investigational Site Number : 6200012, Lisbon

4464-513

Investigational Site Number : 6200002, Matosinhos Municipality

4099-001

Investigational Site Number : 6200010, Porto

4520-211

Investigational Site Number : 6200004, Santa Maria da Feira

022328

Investigational Site Number : 6420008, Bucharest

0041

Investigational Site Number : 7100001, Pretoria

08035

Investigational Site Number : 7240010, Barcelona

07120

Investigational Site Number : 7240014, Palma de Mallorca

413 45

Investigational Site Number : 7520001, Gothenburg

591 85

Investigational Site Number : 7520005, Motala

06100

Investigational Site Number : 7920009, Ankara

06500

Investigational Site Number : 7920014, Ankara

01135

Investigational Site Number : 8040014, Kyiv

02091

Investigational Site Number : 8040013, Kyiv

03115

Investigational Site Number : 8040015, Kyiv

EX2 5DW

Investigational Site Number : 8260003, Exeter

CT1 3NG

Investigational Site Number : 8260016, Canterbury

EC1M 6BQ

Investigational Site Number : 8260006, London

SW17 0QT

Investigational Site Number : 8260005, London

SA6 6NL

Investigational Site Number : 8260010, Swansea

NG7 2UH

Investigational Site Number : 8260012, Nottingham

OX3 9DU

Investigational Site Number : 8260013, Oxford

CF4 4XY

Investigational Site Number : 8260001, Cardiff

BS10 5NB

Investigational Site Number : 8260009, Bristol

M6 8HD

Investigational Site Number : 8260019, Salford

S5 7AU

Investigational Site Number : 8260007, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY