AzTrials
AzTrials

Primary Progressive Multiple SclerosisPhase 3PERSEUSNCT04458051

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

A Phase 3 study testing Tolebrutinib in people with Primary Progressive Multiple Sclerosis, run by Sanofi at 277 sites in 42 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Primary Progressive Multiple Sclerosis
What is being tested?
Tolebrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
767 participants
Where
277 sitesin 42 countries
Study dates
13 Aug 2020to 14 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 18 to 55 years of age inclusive
  • Diagnosis of PPMS according to the 2017 McDonald criteria
  • Expanded disability status scale (EDSS) score between 2.0 to 6.5 points, at screening inclusive
  • Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG) index either during screening or documented previous history.
  • Contraceptive use consistent with local regulations for individuals participating in clinical studies
  • Participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
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  • Is not a woman of childbearing potential (WOCBP) or is a WOCBP and agrees to use an acceptable contraceptive method
  • the participant must not have access to ocrelizumab (eg, ocrelizumab not available on the national market or not reimbursed for the approved indication).
  • the participant must have access to and be eligible to be treated with ocrelizumab but: 1) does not tolerate it due to side effects or safety reasons; and/or 2) has failed ocrelizumab treatment due to perceived lack of efficacy

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Participant has conditions that would adversely affect study participation such as short life expectancy.
  • Evidence of infection with human immunodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection that would adversely affect study participation.
  • Persistent chronic or active or recurring system infection that may adversely affect participation or IMP administration in this study as judged by the investigator
  • History of malignancy within 5 years prior to screening.
  • History of alcohol or drug abuse within 1 year prior to Screening.
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  • Hospitalized for psychiatric disease within 2 years prior to Screening.
  • Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.
  • A bleeding disorder or known platelet dysfunction at any time prior to the screening visit.
  • A platelet count <150 000/μL at the screening visit.
  • A history of significant bleeding event within 6 months prior to screening, according to the Investigator's judgment such as, but not limited to cerebral or gastrointestinal
  • Lymphocyte count below the lower limit of normal at Screening.
  • Recent live (attenuated) vaccine within 2 months before the first treatment visit.
  • Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study.
  • The participant has received medications/treatments for MS within a specified time frame.
  • Receiving potent and moderate inducers of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes.
  • Receiving anticoagulant or antiplatelet therapy (such as aspirin >81mg/day, clopidogrel, warfarin).
  • Contraindications to magnetic resonance imaging (MRI).
  • NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Trial locations and contacts

277 sites in 42 countries.

277 sites in 42 countries

United States45 sites

  • University of New Mexico Site Number : 8400032

    Albuquerque, New Mexico, 87131

  • South Florida Neurology Associates Site Number : 8400029

    Boca Raton, Florida, 33487

  • Tufts Medical Center Site Number : 8400072

    Boston, Massachusetts, 02111

  • Riverhills Neuroscience - Norwood Site Number : 8400167

    Cincinnati, Ohio, 45212

  • MS & Neuromuscular Center of Excellence Site Number : 8400172

    Clearwater, Florida, 33761

  • Cleveland Clinic Site Number : 8400125

    Cleveland, Ohio, 44195

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

    Columbus, Ohio, 43221

  • The Boster Center for Multiple Sclerosis Site Number : 8400147

    Columbus, Ohio, 43235

  • Duke Neurological Disorders Clinic- Site Number : 8400098

    Durham, North Carolina, 27710

  • Michigan Institute For Neurological Disorders Site Number : 8400058

    Farmington Hills, Michigan, 48334

  • Advanced Neurosciences Research Site Number : 8400025

    Fort Collins, Colorado, 80528

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

    Gainesville, Florida, 32601

  • Mountain View Clinical Research Site Number : 8400024

    Greer, South Carolina, 29651-1817

  • Hackensack University Hospital Site Number : 8400047

    Hackensack, New Jersey, 07601

  • Hawaii Pacific Neuroscience Site Number : 8400103

    Honolulu, Hawaii, 96817

  • Mt Olympus Medical Research Site Number : 8400163

    Katy, Texas, 77450

  • UC San Diego ACTRI Site Number : 8400101

    La Jolla, California, 92037

  • University of Kentucky Site Number : 8400106

    Lexington, Kentucky, 40536

  • Collaborative Neuroscience Research Site Number : 8400045

    Los Alamitos, California, 90720

  • Multiple Sclerosis Center- Site Number : 8400143

    Los Angeles, California, 90033

  • International Neurorehabilitation Institute Site Number : 8400034

    Lutherville, Maryland, 21093

  • Neurology Associates, PA- Site Number : 8400004

    Maitland, Florida, 32761

  • Methodist Hospital Site Number : 8400164

    Merrillville, Indiana, 46410

  • Ochsner Baptist Clinical Trials Unit (CTU)- Site Number : 8400107

    New Orleans, Louisiana, 70121

  • Icahn School of Medicine at Mount Sinai (Department of Endoc Site Number : 8400038

    New York, New York, 10029-6501

  • Multiple Sclerosis Center of California Site Number : 8400135

    Newport Beach, California, 92663

  • Consultants In Neurology- Site Number : 8400011

    Northbrook, Illinois, 60062

  • University Of Nebraska- Site Number : 8400129

    Omaha, Nebraska, 68198

  • College Park Family Care Center Site Number : 8400044

    Overland Park, Kansas, 66210

  • The Memorial Hospital- Site Number : 8400033

    Owosso, Michigan, 48867

  • Sharlin Health & Neurology Site Number : 8400093

    Ozark, Missouri, 65721

  • SC3 Research - Pasadena Site Number : 8400070

    Pasadena, California, 91105

  • Jefferson Neurology Associates Site Number : 8400016

    Philadelphia, Pennsylvania, 19107

  • Providence Multiple Sclerosis Center Site Number : 8400020

    Portland, Oregon, 97225

  • Meridian Clinical Research, LLC- Site Number : 8400005

    Raleigh, North Carolina, 27607

  • Mayo Clinic Site Number : 8400111

    Rochester, Minnesota, 55905

  • Neurology Center of San Antonio Site Number : 8400036

    San Antonio, Texas, 78258

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

    San Francisco, California, 94158

  • Velocity Clinical Research Site Number : 8400003

    Savannah, Georgia, 31406

  • Neurology Associates of Stony Brook Site Number : 8400042

    Stony Brook, New York, 11794

  • University of South Florida Site Number : 8400006

    Tampa, Florida, 33612

  • Harbor UCLA Site Number : 8400088

    Torrance, California, 90502

  • Regina Berkovich, MD, PhD Site Number : 8400059

    West Hollywood, California, 90048

  • Atrium Health Wake Forest Baptist Site Number : 8400116

    Winston-Salem, North Carolina, 27103

  • University of Massachusetts Site Number : 8400014

    Worcester, Massachusetts, 01655

Other trials in United States

Japan15 sites

  • Investigational Site Number : 3920014

    Bunkyo-ku, Tokyo, 113-8431

  • Investigational Site Number : 3920016

    Chiba, Chiba, 260-8677

  • Investigational Site Number : 3920018

    Kawagoe-shi, Saitama, 350-8550

  • Investigational Site Number : 3920003

    Kodaira-shi, Tokyo, 187-8551

  • Investigational Site Number : 3920008

    Koriyama-shi, Fukushima, 963-8052

  • Investigational Site Number : 3920011

    Kyoto, Kyoto, 616-8255

  • Investigational Site Number : 3920004

    Moriguchi-shi, Osaka, 570-8507

  • Investigational Site Number : 3920022

    Morioka, Iwate, 020-8505

  • Investigational Site Number : 3920005

    Niigata, Niigata, 951-8520

  • Investigational Site Number : 3920001

    Osaka, Osaka, 556-0016

  • Investigational Site Number : 3920010

    Ōta-ku, Tokyo, 146-0065

  • Investigational Site Number : 3920023

    Sagamihara-shi, Kanagawa, 252-0392

  • Investigational Site Number : 3920020

    Sendai, Miyagi, 980-8574

  • Investigational Site Number : 3920017

    Shinjuku-ku, Tokyo, 160-8582

  • Investigational Site Number : 3920015

    Toyama, Toyama, 930-0194

Other trials in Japan

Russia15 sites

  • Investigational Site Number : 6430018

    Barnaul, 656043

  • Investigational Site Number : 6430023

    Kaliningrad, 236035

  • Investigational Site Number : 6430004

    Kazan', 420032

  • Investigational Site Number : 6430021

    Krasnoyarsk, 660029

  • Investigational Site Number : 6430013

    Moscow, 117997

  • Investigational Site Number : 6430011

    Moscow, 129128

  • Investigational Site Number : 6430014

    Nizhny Novgorod, 603137

  • Investigational Site Number : 6430008

    Pyatigorsk, 357538

  • Investigational Site Number : 6430015

    Rostov-on-Don, 344022

  • Investigational Site Number : 6430017

    Saint Petersburg, 197376

  • Investigational Site Number : 6430009

    Samara, 443095

  • Investigational Site Number : 6430020

    Saransk, 430032

  • Investigational Site Number : 6430007

    Tyumen, 625000

  • Investigational Site Number : 6430006

    Ufa, 450005

  • Investigational Site Number : 6430022

    Yekaterinburg, 620102

Other trials in Russia

Spain15 sites

  • Investigational Site Number : 7240012

    A Coruña, A Coruña [La Coruña], 15006

  • Investigational Site Number : 7240010

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number : 7240013

    Bilbao, Bizkaia, 48013

  • Investigational Site Number : 7240004

    Córdoba, 14004

  • Investigational Site Number : 7240016

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Investigational Site Number : 7240003

    Madrid, 28007

  • Investigational Site Number : 7240002

    Majadahonda, Madrid, 28222

  • Investigational Site Number : 7240005

    Málaga, 29010

  • Investigational Site Number : 7240006

    Murcia, 30120

  • Investigational Site Number : 7240014

    Palma de Mallorca, 07120

  • Investigational Site Number : 7240001

    Pozuelo de Alarcón, Madrid, 28223

  • Investigational Site Number : 7240011

    Salt, Girona [Gerona], 17190

  • Investigational Site Number : 7240015

    Santiago de Compostela, A Coruña [La Coruña], 15706

  • Investigational Site Number : 7240007

    Seville, Andalusia, 41009

  • Investigational Site Number : 7240008

    Valencia, 46026

Other trials in Spain

Turkey (Türkiye)15 sites

  • Investigational Site Number : 7920009

    Ankara, 06100

  • Investigational Site Number : 7920014

    Ankara, 06500

  • Investigational Site Number : 7920005

    Eskişehir, 26040

  • Investigational Site Number : 7920010

    Hatay

  • Investigational Site Number : 7920016

    Istanbul, 34093

  • Investigational Site Number : 7920003

    Istanbul, 34265

  • Investigational Site Number : 7920002

    Istanbul, 34303

  • Investigational Site Number : 7920007

    Istanbul, 34785

  • Investigational Site Number : 7920015

    Izmir, 35100

  • Investigational Site Number : 7920018

    Izmir, 35340

  • Investigational Site Number : 7920001

    İzmit, 41380

  • Investigational Site Number : 7920017

    Konya, 42080

  • Investigational Site Number : 7920011

    Kütahya, 43100

  • Investigational Site Number : 7920012

    Mersin, 33070

  • Investigational Site Number : 7920013

    Samsun

Other trials in Turkey (Türkiye)

China13 sites

  • Investigational Site Number : 1560003

    Beijing, 100032

  • Investigational Site Number : 1560012

    Beijing, 100053

  • Investigational Site Number : 1560009

    Beijing, 100730

  • Investigational Site Number : 1560025

    Beijing, 100730

  • Investigational Site Number : 1560004

    Changchun, 130021

  • Investigational Site Number : 1560015

    Changsha, 410008

  • Investigational Site Number : 1560005

    Chengdu, 610041

  • Investigational Site Number : 1560035

    Fuzhou, 350005

  • Investigational Site Number : 1560002

    Guangzhou, 510630

  • Investigational Site Number : 1560027

    Hohhot, 010050

  • Investigational Site Number : 1560001

    Shanghai, 200040

  • Investigational Site Number : 1560008

    Taiyuan, 030001

  • Investigational Site Number : 1560026

    Wenzhou, 325000

Other trials in China

France13 sites

  • Investigational Site Number : 2500011

    Bron, 69500

  • Investigational Site Number : 2500005

    Clermont-Ferrand, 63003

  • Investigational Site Number : 2500015

    Gonesse, 95500

  • Investigational Site Number : 2500009

    Lille, 59037

  • Investigational Site Number : 2500006

    Montpellier, 34295

  • Investigational Site Number : 2500008

    Nancy, 54035

  • Investigational Site Number : 2500017

    Nîmes, 30029

  • Investigational Site Number : 2500014

    Paris, 75013

  • Investigational Site Number : 2500007

    Paris, 75019

  • Investigational Site Number : 2500004

    Poissy, 78300

  • Investigational Site Number : 2500003

    Rennes, 35033

  • Investigational Site Number : 2500001

    Strasbourg, 67098

  • Investigational Site Number : 2500012

    Toulouse, 31059

Other trials in France

Germany13 sites

  • Investigational Site Number : 2760005

    Bayreuth, 95445

  • Investigational Site Number : 2760009

    Berlin, 10117

  • Investigational Site Number : 2760015

    Berlin, 10713

  • Investigational Site Number : 2760020

    Bochum, 44791

  • Investigational Site Number : 2760001

    Dresden, 01307

  • Investigational Site Number : 2760021

    Düsseldorf, 40225

  • Investigational Site Number : 2760012

    Essen, 45147

  • Investigational Site Number : 2760002

    Giessen, 35385

  • Investigational Site Number : 2760006

    Hanover, 30625

  • Investigational Site Number : 2760018

    München, 81377

  • Investigational Site Number : 2760008

    Münster, 48149

  • Investigational Site Number : 2760004

    Rostock, 18055

  • Investigational Site Number : 2760011

    Ulm, 89081

Other trials in Germany

Ukraine13 sites

  • Investigational Site Number : 8040020

    Chernivtsi, 58023

  • Investigational Site Number : 8040012

    Ivano-Frankivsk, 76493

  • Investigational Site Number : 8040017

    Kharkiv, 61068

  • Investigational Site Number : 8040025

    Kharkiv, 61068

  • Investigational Site Number : 8040023

    Kharkiv, 61103

  • Investigational Site Number : 8040014

    Kyiv, 01135

  • Investigational Site Number : 8040013

    Kyiv, 02091

  • Investigational Site Number : 8040015

    Kyiv, 03115

  • Investigational Site Number : 8040011

    Lutsk, 43005

  • Investigational Site Number : 8040002

    Lviv, 79010

  • Investigational Site Number : 8040007

    Lviv, 79013

  • Investigational Site Number : 8040010

    Odesa, 65025

  • Investigational Site Number : 8040024

    Vinnytsia, 21001

Other trials in Ukraine

United Kingdom11 sites

  • Investigational Site Number : 8260009

    Bristol, BS10 5NB

  • Investigational Site Number : 8260016

    Canterbury, Kent, CT1 3NG

  • Investigational Site Number : 8260001

    Cardiff, Vale of Glamorgan, the, CF4 4XY

  • Investigational Site Number : 8260003

    Exeter, Devon, EX2 5DW

  • Investigational Site Number : 8260006

    London, London, City of, EC1M 6BQ

  • Investigational Site Number : 8260005

    London, London, City of, SW17 0QT

  • Investigational Site Number : 8260012

    Nottingham, Nottinghamshire, NG7 2UH

  • Investigational Site Number : 8260013

    Oxford, Oxfordshire, OX3 9DU

  • Investigational Site Number : 8260019

    Salford, M6 8HD

  • Investigational Site Number : 8260007

    Sheffield, S5 7AU

  • Investigational Site Number : 8260010

    Swansea, Neath Port Talbot, SA6 6NL

Other trials in United Kingdom

Canada10 sites

  • Investigational Site Number : 1240002

    Edmonton, Alberta, T6G 2C8

  • Investigational Site Number : 1240012

    Hamilton, Ontario, L8L 2X2

  • Investigational Site Number : 1240004

    Montreal, Quebec, H2X 0A9

  • Investigational Site Number : 1240015

    Montreal, Quebec, H3A 2B4

  • Investigational Site Number : 1240003

    Ottawa, Ontario, K1H 8L6

  • Investigational Site Number : 1240001

    Québec, G1J 1Z4

  • Investigational Site Number : 1240021

    Québec, G1W 4R4

  • Investigational Site Number : 1240007

    Sherbrooke, Quebec, J1H 5N4

  • Investigational Site Number : 1240013

    Toronto, Ontario, M5B 1W8

  • Investigational Site Number : 1240016

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

Italy9 sites

  • Investigational Site Number : 3800007

    Cagliari, 09126

  • Investigational Site Number : 3800015

    Catania, 95123

  • Investigational Site Number : 3800018

    Chieti, 66100

  • Investigational Site Number : 3800016

    Florence, 50134

  • Investigational Site Number : 3800001

    Milan, 20132

  • Investigational Site Number : 3800003

    Naples, 80131

  • Investigational Site Number : 3800006

    Naples, 80138

  • Investigational Site Number : 3800002

    Pozzilli, Isernia, 86077

  • Investigational Site Number : 3800013

    Roma, 00189

Other trials in Italy

Greece7 sites

  • Investigational Site Number : 3000001

    Athens, 115 28

  • Investigational Site Number : 3000006

    Athens, 11525

  • Investigational Site Number : 3000002

    Athens, 12462

  • Investigational Site Number : 3000004

    Larissa, 41110

  • Investigational Site Number : 3000007

    Marousi, 15125

  • Investigational Site Number : 3000003

    Thessaloniki, 546 36

  • Investigational Site Number : 3000009

    Thessaloniki, 55236

Other trials in Greece

Poland6 sites

  • Investigational Site Number : 6160003

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Investigational Site Number : 6160007

    Katowice, Silesian Voivodeship, 40-684

  • Investigational Site Number : 6160004

    Katowice, Silesian Voivodeship, 40-686

  • Investigational Site Number : 6160001

    Lodz, Lódzkie, 90-549

  • Investigational Site Number : 6160005

    Warsaw, Masovian Voivodeship, 01-211

  • Investigational Site Number : 6160006

    Warsaw, Masovian Voivodeship, 01-684

Other trials in Poland

Portugal6 sites

  • Investigational Site Number : 6200001

    Braga, 4710-243

  • Investigational Site Number : 6200007

    Lisbon, 1349-019

  • Investigational Site Number : 6200012

    Lisbon, 1500-650

  • Investigational Site Number : 6200002

    Matosinhos Municipality, 4464-513

  • Investigational Site Number : 6200010

    Porto, 4099-001

  • Investigational Site Number : 6200004

    Santa Maria da Feira, 4520-211

Other trials in Portugal

Romania6 sites

  • Investigational Site Number : 6420008

    Bucharest, 022328

  • Investigational Site Number : 6420004

    Campulung Muscel, 115100

  • Investigational Site Number : 6420003

    Constanța, 900123

  • Investigational Site Number : 6420013

    Oradea, 410154

  • Investigational Site Number : 6420001

    Târgu Mureş, 540136

  • Investigational Site Number : 6420002

    Timișoara, 300736

Other trials in Romania

Belgium5 sites

  • Investigational Site Number : 0560009

    Brussels, 1070

  • Investigational Site Number : 0560004

    Ghent, 9000

  • Investigational Site Number : 0560008

    Liège, 4000

  • Investigational Site Number : 0560001

    Overpelt, 3900

  • Investigational Site Number : 0560007

    Woluwe-Saint-Lambert, 1200

Other trials in Belgium

Bulgaria5 sites

  • Investigational Site Number : 1000002

    Pleven, 5809

  • Investigational Site Number : 1000004

    Sofia, 1113

  • Investigational Site Number : 1000008

    Sofia, 1407

  • Investigational Site Number : 1000001

    Sofia, 1431

  • Investigational Site Number : 1000011

    Sofia, 1606

Other trials in Bulgaria

Mexico5 sites

  • Investigational Site Number : 4840004

    Guadalajara, Jalisco, 44670

  • Investigational Site Number : 4840001

    Mexico City, Mexico City, 06700

  • Investigational Site Number : 4840005

    Mexico City, 14050

  • Investigational Site Number : 4840007

    Tlalnepantla, 54055

  • Investigational Site Number : 4840003

    Veracruz, 91910

Other trials in Mexico

Czechia4 sites

  • Investigational Site Number : 2030002

    Brno, 65691

  • Investigational Site Number : 2030004

    Hradec Králové, 50005

  • Investigational Site Number : 2030001

    Jihlava, 58633

  • Investigational Site Number : 2030003

    Teplice, 415 29

Other trials in Czechia

Georgia4 sites

  • Investigational Site Number : 2680005

    Tbilisi, 0114

  • Investigational Site Number : 2680009

    Tbilisi, 0159

  • Investigational Site Number : 2680003

    Tbilisi, 0160

  • Investigational Site Number : 2680004

    Tbilisi, 0172

Other trials in Georgia

Australia3 sites

  • Investigational Site Number : 0360005

    Concord, New South Wales, 2139

  • Investigational Site Number : 0360003

    Hobart, Tasmania, 7001

  • Investigational Site Number : 0360006

    St Leonards, New South Wales, 2065

Other trials in Australia

Hungary3 sites

  • Investigational Site Number : 3480206

    Budapest, 1033

  • Investigational Site Number : 3480202

    Budapest, 1083

  • Investigational Site Number : 3480203

    Budapest, 1138

Other trials in Hungary

India3 sites

  • Investigational Site Number : 3560014

    Bengaluru, 560001

  • Investigational Site Number : 3560004

    Mangaluru, 575018

  • Investigational Site Number : 3560005

    New Delhi, 110029

Other trials in India

Israel3 sites

  • Investigational Site Number : 3760008

    Jerusalem, 91120

  • Investigational Site Number : 3760001

    Ramat Gan, 5266202

  • Investigational Site Number : 3760004

    Safed, 13100

Other trials in Israel

Netherlands3 sites

  • Investigational Site Number : 5280003

    Breda, 4818 CK

  • Investigational Site Number : 5280006

    Groningen, 9728NT

  • Investigational Site Number : 5280002

    Sittard-Geleen, 6162 BG

Other trials in Netherlands

Argentina2 sites

  • Investigational Site Number : 0320002

    CABA, Buenos Aires, C1012AAR

  • Investigational Site Number : 0320003

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Austria2 sites

  • Investigational Site Number : 0400004

    Linz, 4021

  • Investigational Site Number : 0400002

    Vienna, 1090

Other trials in Austria

Belarus2 sites

  • Investigational Site Number : 1120004

    Vitebsk, 210009

  • Investigational Site Number : 1120005

    Vitebsk, 210037

Other trials in Belarus

Brazil2 sites

  • Instituto de Neurologia de Curitiba Site Number : 0760002

    Curitiba, Paraná, 81210-310

  • CPQuali Pesquisa Clinica Site Number : 0760007

    São Paulo, São Paulo, 01228-000

Other trials in Brazil

Chile2 sites

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7650568

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8380456

Other trials in Chile

Colombia2 sites

  • Investigational Site Number : 1700003

    Bogotá, 111321

  • Investigational Site Number : 1700001

    Bogotá

Other trials in Colombia

Croatia2 sites

  • Investigational Site Number : 1910001

    Zagreb, 10000

  • Investigational Site Number : 1910002

    Zagreb, 10000

Other trials in Croatia

Denmark2 sites

  • Investigational Site Number : 2080001

    Esbjerg, 6700

  • Investigational Site Number : 2080005

    Holstebro, 7500

Other trials in Denmark

Norway2 sites

  • Investigational Site Number : 5780003

    Bergen, 5021

  • Investigational Site Number : 5780005

    Tromsø, 9038

Other trials in Norway

Serbia2 sites

  • Investigational Site Number : 6880001

    Belgrade, 11000

  • Investigational Site Number : 6880002

    Kragujevac, 34000

Other trials in Serbia

Sweden2 sites

  • Investigational Site Number : 7520001

    Gothenburg, 413 45

  • Investigational Site Number : 7520005

    Motala, 591 85

Other trials in Sweden

Estonia1 site

  • Investigational Site Number : 2330001

    Tallinn, 11315

Other trials in Estonia

Latvia1 site

  • Investigational Site Number : 4280002

    Riga, LV-1002

Other trials in Latvia

Peru1 site

  • Investigational Site Number : 6040004

    Lima, 15084

Other trials in Peru

South Africa1 site

  • Investigational Site Number : 7100001

    Pretoria, 0041

Other trials in South Africa

Thailand1 site

  • Investigational Site Number : 7640001

    Bangkok, 10700

Other trials in Thailand

About this study

Official title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)

Primary Objective:

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS)

Secondary Objectives:

To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168

Read the detailed description

Study duration will vary per participant in this event driven trial with a treatment duration of approximately 12 to 60 months.

Being tested
Tolebrutinib, Placebo
Medical subject headings
Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TolebrutinibDrug

    Also called SAR442168

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

  • PlaceboDrug

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

Study groups in NCT04458051
Study groupRoleWhat they receive
SAR442168ExperimentalDose 1 of oral SAR442168 once daily
Receives: Drug: Tolebrutinib
PlaceboPlacebo comparatorPlacebo to match the SAR442168 once daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-month composite Confirmed Disability Progression (cCDP)

    Time to onset of 6-month cCDP defined as follows:

    Increase over at least 6 months of ≥1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is ≤5.5, or ≥0.5 points when the baseline EDSS score is >5.5, or ≥20% from the baseline T25-FW, or ≥20% from the baseline 9-HPT

    Measured: Up to approximately 60 months

Secondary outcomes (14)

  1. 6-month Confirmed Disability Progression (CDP)

    Time to onset of 6-month CDP as assessed by EDSS score

    Measured: Up to approximately 60 months

  2. 3-month composite Confirmed Disability Progression (cCDP)

    Time to onset of 3-month cCDP

    Measured: Up to approximately 60 months

  3. Change in T2 hyperintense lesions by MRI

    Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI after baseline up to and including the end of study (EOS)

    Measured: From screening MRI to approximately 60 months

  4. Time to onset of confirmed disability improvement (CDI)

    Time to onset of CDI defined as ≥1.0-point decrease on the EDSS score from baseline confirmed over at least 6 months

    Measured: Up to approximately 60 months

  5. Percent change in Brain volume (BV)

    Percent change in brain volume (BV) as detected by brain MRI at the EOS compared to month 6

    Measured: From 6 months up to approximately 60 months

  6. Change in cognitive function as assessed by SDMT

    Change in cognitive function at the EOS compared to baseline as assessed by the Symbol Digit Modalities Test (SDMT)

    Measured: From Baseline up to approximately 60 months

  7. Change in cognitive function as assessed by CVLT-II

    Change in cognitive function at the EOS compared to baseline as assessed by the California Verbal Learning Test II (CVLT-II) where available

    Measured: From Baseline up to approximately 60 months

  8. Change in Multiple Sclerosis Quality of Life

    Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) at the EOS compared to baseline

    Measured: From Baseline up to approximately 60 months

  9. Safety and Tolerability

    Number of participants with adverse events (AEs), Serious AEs, AEs leading to permanent study intervention discontinuation, and adverse events of special interest (AESI)

    Measured: From screening up to approximately 60 months

  10. Population pharmacokinetics

    Plasma concentration of SAR442168 (population PK assessment) at Months 6, 9, and 12

    Measured: Months 6, 9 and 12

  11. Change in plasma neurofilament light chain (NfL)

    Change in NfL levels from at the EOS compared to baseline

    Measured: From Baseline up to approximately 60 months

  12. Change in lymphocyte phenotype subsets

    Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline in a subset of participants

    Measured: From Baseline up to approximately 60 months

  13. Changes in serum Immunoglobulin level

    Changes in serum Immunoglobulin level at the EOS compared to baseline

    Measured: From Baseline up to approximately 60 months

  14. Change in serum chitinase-3 like protein 1 (Chi3L1)

    Change in serum Chi3L1 at EOS compared to baseline

    Measured: From Baseline up to approximately 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start13 Aug 2020
  3. Primary completion14 Nov 2025
  4. Study completion14 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
767 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04458051
Sponsor's protocol ID
EFC16035
Other IDs
U1111-1238-1318, 2024-514495-41, 2020-000645-14
Acronym
PERSEUS
Status last verified
Jan 2026
First submitted
1 Jul 2020
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Maxwell CR, Turner TJ, Wallstroem E, Patel S, Pappas SC, Lewis JH, Andrade RJ, Syed S. Tolebrutinib liver safety: A detailed overview. Mult Scler Relat Disord. 2026 Jul 23;113:107404. doi: 10.1016/j.msard.2026.107404. Online ahead of print.

    PubMed 42546561

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tolebrutinib in people with Primary Progressive Multiple Sclerosis, run by Sanofi at 277 sites in 42 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 277 sites in United States, Japan, Russia, Spain, Turkey (Türkiye) and 37 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month composite Confirmed Disability Progression (cCDP) (time frame: Up to approximately 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04458051, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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