Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)

PHASE3CompletedINTERVENTIONAL
Enrollment

899

Participants

Timeline

Start Date

June 11, 2020

Primary Completion Date

July 16, 2024

Study Completion Date

July 16, 2024

Conditions
Relapsing Multiple Sclerosis
Interventions
DRUG

Tolebrutinib

"Pharmaceutical form: Tablet~Route of administration: Oral"

DRUG

Teriflunomide HMR1726

"Pharmaceutical form: Tablet~Route of administration: Oral"

DRUG

Placebo to match Tolebrutinib

"Pharmaceutical form: Tablet~Route of administration: Oral"

DRUG

Placebo to match Teriflunomide

"Pharmaceutical form: Tablet~Route of administration: Oral"

Trial Locations (186)

1012

Investigational Site Number :0320002, Capital Federal

1135

Investigational Site Number :3480105, Budapest

1145

Investigational Site Number :3480102, Budapest

2000

Investigational Site Number :0320003, Rosario

2800

Investigational Site Number :3480103, Tatabánya

3010

Investigational Site Number :7560002, Bern

3900

Investigational Site Number :0560001, Overpelt

5001

Investigational Site Number :7560003, Aarau

6903

Investigational Site Number :7560004, Lugano

7000

Investigational Site Number :0560002, Mons

7400

Investigational Site Number :3480106, Kaposvár

7800

Investigational Site Number :5780002, Namsos

9000

Investigational Site Number :0560004, Ghent

10000

Investigational Site Number :1910001, Zagreb

Investigational Site Number :1910002, Zagreb

Investigational Site Number :1910003, Zagreb

10034

Investigational Site Number :2030008, Prague

10408

Investigational Site Number :4100001, Goyang-si

10713

Investigational Site Number :2760015, Berlin

11000

Investigational Site Number :6880001, Belgrade

Investigational Site Number :6880003, Belgrade

Investigational Site Number :6880006, Belgrade

11535

Investigational Site Number :3000006, Athens

11772

South Shore Neurologic Associates-Site Number:8400100, Patchogue

12099

Investigational Site Number :2760014, Berlin

12462

Investigational Site Number :3000002, Athens

13100

Investigational Site Number :3760004, Safed

14029

Investigational Site Number :8040020, Chernihiv

15006

Investigational Site Number :2030005, Praha 5 - Motol

Investigational Site Number :7240008, A Coruña

15125

Investigational Site Number :3000007, Athens

17190

Investigational Site Number :7240004, Salt

18000

Investigational Site Number :6880004, Niš

19107

Jefferson Neurology Associates-Site Number:8400016, Philadelphia

21000

Investigational Site Number :6880005, Novi Sad

21050

Investigational Site Number :8040003, Vinnytsia

21093

International Neurorehabilitation Institute-Site Number:8400034, Lutherville-Timonium

23229

Neurological Associates-Site Number:8400097, Richmond

25000

Investigational Site Number :2500019, Besançon

25198

Investigational Site Number :7240005, Lleida

27607

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

28007

Investigational Site Number :7240003, Madrid

28034

Investigational Site Number :7240001, Madrid

28040

Investigational Site Number :7240002, Madrid

28210

Novant Health Multiple Sclerosis Care Center - South Park-Site Number:8400120, Charlotte

28223

Investigational Site Number :7240012, Pozuelo de Alarcón

29010

Investigational Site Number :7240010, Málaga

29650

Premier Neurology-Site Number:8400069, Greer

30029

Investigational Site Number :2500017, Nîmes

31096

Investigational Site Number :3760003, Haifa

31406

Meridian Clinical Research-Site Number:8400003, Savannah

32608

University of Florida Health-Site Number:8400159, Gainesville

32761

Neurology Associates, PA-Site Number:8400004, Maitland

33136

University of Miami-Site Number:8400063, Miami

33351

Infinity Clinical Research-Site Number:8400008, Sunrise

33487

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

33612

University of South Florida-Site Number:8400006, Tampa

34000

Investigational Site Number :6880002, Kragujevac

34295

Investigational Site Number :2500006, Montpellier

34896

Investigational Site Number :7920006, Istanbul

35010

Investigational Site Number :7240013, Las Palmas de Gran Canaria

35033

Investigational Site Number :2500003, Rennes

35058

North Central Neurology Associates, PC-Site Number:8400009, Cullman

37064

Advanced Neuroscience Center-Site Number:8400035, Franklin

37922

Sibyl Wray, MD, Neurology, PC-Site Number:8400007, Knoxville

40207

Norton Neurology MS Services-Site Number:8400127, Louisville

40509

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

40536

University of Kentucky-Site Number:8400106, Lexington

41009

Investigational Site Number :7240011, Seville

41110

Investigational Site Number :3000004, Larissa

43100

Investigational Site Number :7920004, Kuttahta

44093

Investigational Site Number :2500010, Nantes

44791

Investigational Site Number :2760020, Bochum

45147

Investigational Site Number :2760012, Essen

45459

Dayton Center for Neurological Disorders-Site Number:8400081, Centerville

46804

Fort Wayne Neurological Center-Site Number:8400039, Fort Wayne

48201

Wayne State University-Site Number:8400046, Detroit

48903

Investigational Site Number :7240009, Barakaldo

49005

Investigational Site Number :8040005, Dnipro

50005

Investigational Site Number :2030011, Hradec Králové

52621

Investigational Site Number :3760001, Tel Litwinsky

53215

Wheaton Franciscan Healthcare-Site Number:8400022, Milwaukee

55422

Minneapolis Clinic of Neurology-Site Number:8400051, Minneapolis

58000

Investigational Site Number :8040002, Chernivtsi

58023

Investigational Site Number :8040019, Chernivtsi

58103

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

58633

Investigational Site Number :2030001, Jihlava

60062

Consultants In Neurology-Site Number:8400011, Northbrook

61080

Investigational Site Number :7920003, Trabzon

61103

Investigational Site Number :8040022, Kharkiv

61166

Investigational Site Number :8040018, Kharkiv

62701

Prairie Education and Research Cooperative-Site Number:8400071, Springfield

63003

Investigational Site Number :2500005, Clermont-Ferrand

64111

Saint Luke's Hospital-Site Number:8400153, Kansas City

65691

Investigational Site Number :2030002, Brno

67098

Investigational Site Number :2500001, Strasbourg

68130

West Omaha Family Physicians-Site Number:8400139, Omaha

68198

University Of Nebraska-Site Number:8400129, Omaha

69500

Investigational Site Number :2500011, Bron

70810

The NeuroMedical Center-Site Number:8400057, Baton Rouge

75019

Investigational Site Number :2500007, Paris

75092

Texas Institute for Neuroogical Disorders-Sherman-Site Number:8400151, Sherman

76100

Investigational Site Number :3760006, Rehovot

77450

Mt Olympus Medical Research-Site Number:8400163, Katy

78258

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

78278

Investigational Site Number :3760002, Ashkelon

78300

Investigational Site Number :2500004, Poissy

79013

Investigational Site Number :8040006, Lviv

80528

Advanced Neurosciences Research-Site Number:8400025, Fort Collins

81621

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

82606

Investigational Site Number :7030001, Bratislava

84018

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

87131

University of New Mexico-Site Number:8400032, Albuquerque

90502

Harbor UCLA-Site Number:8400088, Torrance

91006

Arcadia Neurology Center-Site Number:8400070, Arcadia

92663

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

95445

Investigational Site Number :2760005, Bayreuth

97070

Investigational Site Number :2760003, Würzburg

110060

Investigational Site Number :3560002, New Delhi

117997

Investigational Site Number :6430007, Moscow

122001

Investigational Site Number :3560007, Gūrgaon

122002

Investigational Site Number :3560008, Gūrgaon

127015

Investigational Site Number :6430005, Moscow

160012

Investigational Site Number :3560005, Chandigarh

192242

Investigational Site Number :6430014, Saint Petersburg

197022

Investigational Site Number :6430004, Saint Petersburg

197110

Investigational Site Number :6430002, Saint Petersburg

241033

Investigational Site Number :6430013, Bryansk

420021

Investigational Site Number :6430001, Kazan'

430032

Investigational Site Number :6430011, Saransk

610998

Investigational Site Number :6430010, Kirov

620102

Investigational Site Number :6430012, Yekaterinburg

630087

Investigational Site Number :6430003, Novosibirsk

656024

Investigational Site Number :6430006, Barnaul

695004

Investigational Site Number :3560004, Thiruvananthapuram

5110683

Investigational Site Number :1520004, Valdivia

7650568

Investigational Site Number :1520002, Santiago

8380456

Investigational Site Number :1520001, Santiago

8431657

Investigational Site Number :1520003, Santiago

07601

Hackensack University Hospital-Site Number:8400047, Hackensack

C1023AAB

Investigational Site Number :0320004, CABA

C1061

Investigational Site Number :0320001, CABA

T4000AXL

Investigational Site Number :0320005, San Miguel de Tucumán

B-8000

Investigational Site Number :0560005, Bruges

90610-000

Investigational Site Number :0760001, Porto Alegre

81210-310

Investigational Site Number :0760002, Curitiba

01228-000

Investigational Site Number :0760007, São Paulo

T6G 2C8

Investigational Site Number :1240002, Edmonton

L8L 2X2

Investigational Site Number : 1240012, Hamilton

N6A 5A5

Investigational Site Number :1240014, London

J4V 2J2

Investigational Site Number :1240005, Greenfield Park

J8Y1W2

Investigational Site Number :1240006, Gatineau

G1W 4R4

Investigational Site Number :1240021, Québec

833-0024

Investigational Site Number :1520005, Santiago

Unknown

Investigational Site Number :1520006, Concepción

Investigational Site Number :2500018, Bordeaux

Investigational Site Number :3000009, Athens

Investigational Site Number :7920001, Samsun

06002

Investigational Site Number :2500002, Nice

115 28

Investigational Site Number :3000001, Athens

546 36

Investigational Site Number :3000003, Thessaloniki

LV-1002

Investigational Site Number :4280002, Riga

LV-1005

Investigational Site Number :4280003, Riga

1081 GN

Investigational Site Number :5280001, Amsterdam

0450

Investigational Site Number :5780001, Oslo

4710-243

Investigational Site Number :6200001, Braga

3000-075

Investigational Site Number :6200005, Coimbra

1162-050

Investigational Site Number :6200011, Lisbon

1649-035

Investigational Site Number :6200006, 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

00969

San Juan MS Center-Site Number:8400015, Guaynabo

03659

Investigational Site Number :7030002, Martin

950 01

Investigational Site Number :7030004, Nitra

03080

Investigational Site Number :4100003, Seoul

03722

Investigational Site Number :4100006, Seoul

06351

Investigational Site Number :4100002, Seoul

08036

Investigational Site Number :7240006, Barcelona

08907

Investigational Site Number :7240007, L'Hospitalet de Llobregat

06100

Investigational Site Number :7920002, Ankara

06500

Investigational Site Number :7920005, Besevler / Ankara

02091

Investigational Site Number :8040007, Kyiv

EX2 5DW

Investigational Site Number :8260003, Exeter

CT1 3NG

Investigational Site Number :8260016, Canterbury

BS10 5NB

Investigational Site Number :8260009, Bristol

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY