Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)

PHASE3CompletedINTERVENTIONAL
Enrollment

974

Participants

Timeline

Start Date

June 30, 2020

Primary Completion Date

July 15, 2024

Study Completion Date

July 15, 2024

Conditions
Relapsing Multiple Sclerosis
Interventions
DRUG

Tolebrutinib

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

DRUG

Teriflunomide

"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 (179)

112

Investigational Site Number :1580002, Taipei

333

Investigational Site Number :1580006, Taoyuang

402

Investigational Site Number :1580003, Taichung

833

Investigational Site Number :1580005, Kaohsiung City

1113

Investigational Site Number :1000004, Sofia

1407

Investigational Site Number :1000008, Sofia

1431

Investigational Site Number :1000001, Sofia

Investigational Site Number :1000006, Sofia

1680

Investigational Site Number :1000009, Sofia

4000

Investigational Site Number :1000005, Plovdiv

4021

Investigational Site Number :0400004, Linz

5800

Investigational Site Number :1000002, Pleven

6700

Investigational Site Number :2080001, Esbjerg

7500

Investigational Site Number :2080005, Holstebro

10043

Investigational Site Number :3800007, Orbassano

11315

Investigational Site Number :2330001, Tallinn

14004

Investigational Site Number :7240004, Córdoba

16132

Investigational Site Number :3800014, Genova

18055

Investigational Site Number :2760004, Rostock

20007

Georgetown University Medical Center-Site Number:8400119, Washington D.C.

20014

Investigational Site Number :7240008, Donostia / San Sebastian

20132

Investigational Site Number :3800001, Milan

20133

Investigational Site Number :3800010, Milan

20520

Investigational Site Number :2460002, Turku

22179

Investigational Site Number :2760016, Hamburg

24127

Investigational Site Number :3800011, Bergamo

27100

Investigational Site Number :3800008, Pavia

27157

Wake Forest University Baptist Medical Center-Site Number:8400116, Winston-Salem

27607

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

28223

Investigational Site Number :7240001, Pozuelo de Alarcón

29010

Investigational Site Number :7240005, Málaga

30059

Investigational Site Number :1580007, Hsinchu

30120

Investigational Site Number :7240006, Murcia

31406

Meridian Clinical Research-Site Number:8400003, Savannah

33070

Investigational Site Number :7920006, Mersin

33520

Investigational Site Number :2460001, Tampere

33612

University of South Florida-Site Number:8400006, Tampa

33919

Beth Israel Deaconess Medical Center-Site Number:8400064, Fort Myers

34098

Investigational Site Number :7920002, Istanbul

34688

Investigational Site Number :7920009, Istanbul

34785

Investigational Site Number :7920007, Istanbul

35100

Investigational Site Number :7920008, Izmir

35233

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

40225

Investigational Site Number :2760019, Düsseldorf

40382

Columbus Neuroscience-Site Number:8400010, Westerville

41009

Investigational Site Number :7240003, Seville

41380

Investigational Site Number :7920001, Kocaeli

43005

Investigational Site Number :8040010, Lutsk

43221

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

43235

Optimed Research, LTD-Site Number:8400147, Columbus

46026

Investigational Site Number :7240007, Valencia

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 :3800012, Florence

50161

Investigational Site Number :4400003, Kaunas

50406

Investigational Site Number :2330002, Tartu

53203

Investigational Site Number :2030009, Pardubice

60062

Consultants In Neurology-Site Number:8400011, Northbrook

61068

Investigational Site Number :8040016, Kharkiv

61103

Investigational Site Number :8040013, Kharkiv

63131

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

65025

Investigational Site Number :8040009, Odesa

65721

Sharlin Health & Neurology-Site Number:8400093, Ozark

73000

Investigational Site Number :8040008, Kherson

73104

Oklahoma Medical Research Foundation-Site Number:8400018, Oklahoma City

75390

University of Texas Southwestern Medical Center-Site Number:8400077, Dallas

76275

Investigational Site Number :2030007, Zlín

76493

Investigational Site Number :8040011, Ivano-Frankivsk

79010

Investigational Site Number :8040001, Lviv

80045

University of Colorado-Site Number:8400012, Aurora

80131

Investigational Site Number :3800003, Napoli

Investigational Site Number :3800006, Napoli

86077

Investigational Site Number :3800002, Pozzilli

89081

Investigational Site Number :2760011, Ulm

91910

Investigational Site Number :4840003, Veracruz

92288

Investigational Site Number :4400002, Klaipėda

94158

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

95123

Investigational Site Number :3800015, Catania

97225

Providence Multiple Sclerosis Center-Site Number:8400020, Portland

98122

Multiple Sclerosis Center, Swedish Neuroscience Institute-Site Number:8400121, Seattle

100034

Investigational Site Number :1560006, Beijing

100050

Investigational Site Number :1560010, Beijing

100053

Investigational Site Number :1560012, Beijing

100191

Investigational Site Number :1560023, Beijing

100730

Investigational Site Number :1560001, Beijing

Investigational Site Number :1560009, Beijing

Investigational Site Number :1560025, Beijing

100853

Investigational Site Number :1560021, Beijing

110004

Investigational Site Number :1560018, Shenyang

115100

Investigational Site Number :6420004, Campulung Muscel

125367

Investigational Site Number :6430002, Moscow

129128

Investigational Site Number :6430008, Moscow

130021

Investigational Site Number :1560004, Changchun

194044

Investigational Site Number :6430001, Saint Petersburg

200040

Investigational Site Number :1560003, Shanghai

210008

Investigational Site Number :1560044, Nanjing

210009

Investigational Site Number :1120005, Vitebsk

210029

Investigational Site Number :1560042, Nanjing

210037

Investigational Site Number :1120004, Vitebsk

214018

Investigational Site Number :6430009, Smolensk

300052

Investigational Site Number :1560020, Tianjin

300736

Investigational Site Number :6420002, Timișoara

344022

Investigational Site Number :6430012, Rostov-on-Don

350005

Investigational Site Number :1560035, Fuzhou

357538

Investigational Site Number :6430007, Pyatigorsk

400016

Investigational Site Number :1560019, Chongqing

410008

Investigational Site Number :1560015, Changsha

410169

Investigational Site Number :6420010, Oradea

430030

Investigational Site Number :1560011, Wuhan

443095

Investigational Site Number :6430005, Samara

450005

Investigational Site Number :6430004, Ufa

500283

Investigational Site Number :6420015, Brasov

510080

Investigational Site Number :1560016, Guangzhou

510515

Investigational Site Number :1560028, Guangzhou

510630

Investigational Site Number :1560002, Guangzhou

540136

Investigational Site Number :6420001, Târgu Mureş

550052

Investigational Site Number :6420005, Sibiu

603137

Investigational Site Number :6430011, Nizhny Novgorod

603155

Investigational Site Number :6430003, Nizhny Novgorod

610041

Investigational Site Number :1560005, Chengdu

625000

Investigational Site Number :6430006, Tyumen

660029

Investigational Site Number :6430014, Krasnoyarsk

710038

Investigational Site Number :1560017, Xi'an

750004

Investigational Site Number :1560033, Yinchuan

900123

Investigational Site Number :6420003, Constanța

33609-4052

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

02111

Tufts Medical Center-Site Number:8400072, Boston

V6T 2B5

Investigational Site Number :1240016, Vancouver

K1H 8L6

Investigational Site Number :1240003, Ottawa

M5B 1W8

Investigational Site Number :1240013, Toronto

J8Y 1W2

Investigational Site Number :1240006, Gatineau

014010

Investigational Site Number :1560022, Baotou

010050

Investigational Site Number :1560027, Hohhot

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

Unknown

Investigational Site Number : 3440001, Shatin, NT

Investigational Site Number :7920005, Eskişehir

Investigational Site Number :7920011, Hatay

Investigational Site Number :7920003, Istanbul

Investigational Site Number :7920010, Izmir

00152

Investigational Site Number :3800005, Roma

00168

Investigational Site Number :3800009, Roma

00189

Investigational Site Number :3800013, Roma

260-8677

Investigational Site Number :3920016, Chiba

963-8052

Investigational Site Number :3920008, Koriyama-shi

305-0005

Investigational Site Number :3920012, Tsukuba

020-8505

Investigational Site Number :3920022, Morioka

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

162-8666

Investigational Site Number :3920013, Shinjuku-ku

755-8505

Investigational Site Number :3920009, Ube-shi

252-0392

Investigational Site Number :3920023, Sagamihara-shi

LT-76231

Investigational Site Number :4400004, Šiauliai

08661

Investigational Site Number :4400001, Vilnius

03100

Investigational Site Number :4840002, México

06700

Investigational Site Number :4840001, México

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

36-060

Investigational Site Number :6160009, Glogow Mlp.

40-571

Investigational Site Number :6160002, Katowice

40-686

Investigational Site Number :6160004, Katowice

90-549

Investigational Site Number :6160001, Lodz

022328

Investigational Site Number :6420008, Bucharest

08035

Investigational Site Number :7240009, Barcelona

413 45

Investigational Site Number :7520001, Gothenburg

113 65

Investigational Site Number :7520002, Stockholm

03115

Investigational Site Number :8040014, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT04410978 - Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1) | Biotech Hunter | Biotech Hunter