New hope for slowing debilitating MS progression

NCT ID NCT04458051

Completed Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

Summary

This Phase 3 trial tested whether the drug SAR442168 could slow disability progression in people with primary progressive multiple sclerosis (PPMS). 767 participants were randomly assigned to receive either the drug or a placebo for 12 to 60 months. Researchers measured changes in walking, hand function, brain scans, and overall quality of life to see if the treatment was effective and safe.

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes NO responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Locations

Advanced Neurosciences Research Site Number : 8400025

Fort Collins, Colorado, 80528, United States
Atrium Health Wake Forest Baptist Site Number : 8400116

Winston-Salem, North Carolina, 27103, United States
CPQuali Pesquisa Clinica Site Number : 0760007

São Paulo, São Paulo, 01228-000, Brazil
Cleveland Clinic Site Number : 8400125

Cleveland, Ohio, 44195, United States
Collaborative Neuroscience Research Site Number : 8400045

Los Alamitos, California, 90720, United States
College Park Family Care Center Site Number : 8400044

Overland Park, Kansas, 66210, United States
Consultants In Neurology- Site Number : 8400011

Northbrook, Illinois, 60062, United States
Duke Neurological Disorders Clinic- Site Number : 8400098

Durham, North Carolina, 27710, United States
Hackensack University Hospital Site Number : 8400047

Hackensack, New Jersey, 07601, United States
Harbor UCLA Site Number : 8400088

Torrance, California, 90502, United States
Hawaii Pacific Neuroscience Site Number : 8400103

Honolulu, Hawaii, 96817, United States
Icahn School of Medicine at Mount Sinai (Department of Endoc Site Number : 8400038

New York, New York, 10029-6501, United States
Instituto de Neurologia de Curitiba Site Number : 0760002

Curitiba, Paraná, 81210-310, Brazil
International Neurorehabilitation Institute Site Number : 8400034

Lutherville, Maryland, 21093, United States
Investigational Site Number : 0320002

CABA, Buenos Aires, C1012AAR, Argentina
Investigational Site Number : 0320003

Rosario, Santa Fe Province, 2000, Argentina
Investigational Site Number : 0360003

Hobart, Tasmania, 7001, Australia
Investigational Site Number : 0360005

Concord, New South Wales, 2139, Australia
Investigational Site Number : 0360006

St Leonards, New South Wales, 2065, Australia
Investigational Site Number : 0400002

Vienna, 1090, Austria
Investigational Site Number : 0400004

Linz, 4021, Austria
Investigational Site Number : 0560001

Overpelt, 3900, Belgium
Investigational Site Number : 0560004

Ghent, 9000, Belgium
Investigational Site Number : 0560007

Woluwe-Saint-Lambert, 1200, Belgium
Investigational Site Number : 0560008

Liège, 4000, Belgium
Investigational Site Number : 0560009

Brussels, 1070, Belgium
Investigational Site Number : 1000001

Sofia, 1431, Bulgaria
Investigational Site Number : 1000002

Pleven, 5809, Bulgaria
Investigational Site Number : 1000004

Sofia, 1113, Bulgaria
Investigational Site Number : 1000008

Sofia, 1407, Bulgaria
Investigational Site Number : 1000011

Sofia, 1606, Bulgaria
Investigational Site Number : 1120004

Vitebsk, 210009, Belarus
Investigational Site Number : 1120005

Vitebsk, 210037, Belarus
Investigational Site Number : 1240001

Québec, G1J 1Z4, Canada
Investigational Site Number : 1240002

Edmonton, Alberta, T6G 2C8, Canada
Investigational Site Number : 1240003

Ottawa, Ontario, K1H 8L6, Canada
Investigational Site Number : 1240004

Montreal, Quebec, H2X 0A9, Canada
Investigational Site Number : 1240007

Sherbrooke, Quebec, J1H 5N4, Canada
Investigational Site Number : 1240012

Hamilton, Ontario, L8L 2X2, Canada
Investigational Site Number : 1240013

Toronto, Ontario, M5B 1W8, Canada
Investigational Site Number : 1240015

Montreal, Quebec, H3A 2B4, Canada
Investigational Site Number : 1240016

Vancouver, British Columbia, V6T 2B5, Canada
Investigational Site Number : 1240021

Québec, G1W 4R4, Canada
Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 8380456, Chile
Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 7650568, Chile
Investigational Site Number : 1560001

Shanghai, 200040, China
Investigational Site Number : 1560002

Guangzhou, 510630, China
Investigational Site Number : 1560003

Beijing, 100032, China
Investigational Site Number : 1560004

Changchun, 130021, China
Investigational Site Number : 1560005

Chengdu, 610041, China
Investigational Site Number : 1560008

Taiyuan, 030001, China
Investigational Site Number : 1560009

Beijing, 100730, China
Investigational Site Number : 1560012

Beijing, 100053, China
Investigational Site Number : 1560015

Changsha, 410008, China
Investigational Site Number : 1560025

Beijing, 100730, China
Investigational Site Number : 1560026

Wenzhou, 325000, China
Investigational Site Number : 1560027

Hohhot, 010050, China
Investigational Site Number : 1560035

Fuzhou, 350005, China
Investigational Site Number : 1700001

Bogotá, Colombia
Investigational Site Number : 1700003

Bogotá, 111321, Colombia
Investigational Site Number : 1910001

Zagreb, 10000, Croatia
Investigational Site Number : 1910002

Zagreb, 10000, Croatia
Investigational Site Number : 2030001

Jihlava, 58633, Czechia
Investigational Site Number : 2030002

Brno, 65691, Czechia
Investigational Site Number : 2030003

Teplice, 415 29, Czechia
Investigational Site Number : 2030004

Hradec Králové, 50005, Czechia
Investigational Site Number : 2080001

Esbjerg, 6700, Denmark
Investigational Site Number : 2080005

Holstebro, 7500, Denmark
Investigational Site Number : 2330001

Tallinn, 11315, Estonia
Investigational Site Number : 2500001

Strasbourg, 67098, France
Investigational Site Number : 2500003

Rennes, 35033, France
Investigational Site Number : 2500004

Poissy, 78300, France
Investigational Site Number : 2500005

Clermont-Ferrand, 63003, France
Investigational Site Number : 2500006

Montpellier, 34295, France
Investigational Site Number : 2500007

Paris, 75019, France
Investigational Site Number : 2500008

Nancy, 54035, France
Investigational Site Number : 2500009

Lille, 59037, France
Investigational Site Number : 2500011

Bron, 69500, France
Investigational Site Number : 2500012

Toulouse, 31059, France
Investigational Site Number : 2500014

Paris, 75013, France
Investigational Site Number : 2500015

Gonesse, 95500, France
Investigational Site Number : 2500017

Nîmes, 30029, France
Investigational Site Number : 2680003

Tbilisi, 0160, Georgia
Investigational Site Number : 2680004

Tbilisi, 0172, Georgia
Investigational Site Number : 2680005

Tbilisi, 0114, Georgia
Investigational Site Number : 2680009

Tbilisi, 0159, Georgia
Investigational Site Number : 2760001

Dresden, 01307, Germany
Investigational Site Number : 2760002

Giessen, 35385, Germany
Investigational Site Number : 2760004

Rostock, 18055, Germany
Investigational Site Number : 2760005

Bayreuth, 95445, Germany
Investigational Site Number : 2760006

Hanover, 30625, Germany
Investigational Site Number : 2760008

Münster, 48149, Germany
Investigational Site Number : 2760009

Berlin, 10117, Germany
Investigational Site Number : 2760011

Ulm, 89081, Germany
Investigational Site Number : 2760012

Essen, 45147, Germany
Investigational Site Number : 2760015

Berlin, 10713, Germany
Investigational Site Number : 2760018

München, 81377, Germany
Investigational Site Number : 2760020

Bochum, 44791, Germany
Investigational Site Number : 2760021

Düsseldorf, 40225, Germany
Investigational Site Number : 3000001

Athens, 115 28, Greece
Investigational Site Number : 3000002

Athens, 12462, Greece
Investigational Site Number : 3000003

Thessaloniki, 546 36, Greece
Investigational Site Number : 3000004

Larissa, 41110, Greece
Investigational Site Number : 3000006

Athens, 11525, Greece
Investigational Site Number : 3000007

Marousi, 15125, Greece
Investigational Site Number : 3000009

Thessaloniki, 55236, Greece
Investigational Site Number : 3480202

Budapest, 1083, Hungary
Investigational Site Number : 3480203

Budapest, 1138, Hungary
Investigational Site Number : 3480206

Budapest, 1033, Hungary
Investigational Site Number : 3560004

Mangaluru, 575018, India
Investigational Site Number : 3560005

New Delhi, 110029, India
Investigational Site Number : 3560014

Bengaluru, 560001, India
Investigational Site Number : 3760001

Ramat Gan, 5266202, Israel
Investigational Site Number : 3760004

Safed, 13100, Israel
Investigational Site Number : 3760008

Jerusalem, 91120, Israel
Investigational Site Number : 3800001

Milan, 20132, Italy
Investigational Site Number : 3800002

Pozzilli, Isernia, 86077, Italy
Investigational Site Number : 3800003

Napoli, 80131, Italy
Investigational Site Number : 3800006

Napoli, 80138, Italy
Investigational Site Number : 3800007

Cagliari, 09126, Italy
Investigational Site Number : 3800013

Roma, 00189, Italy
Investigational Site Number : 3800015

Catania, 95123, Italy
Investigational Site Number : 3800016

Florence, 50134, Italy
Investigational Site Number : 3800018

Chieti, 66100, Italy
Investigational Site Number : 3920001

Osaka, Osaka, 556-0016, Japan
Investigational Site Number : 3920003

Kodaira-shi, Tokyo, 187-8551, Japan
Investigational Site Number : 3920004

Moriguchi-shi, Osaka, 570-8507, Japan
Investigational Site Number : 3920005

Niigata, Niigata, 951-8520, Japan
Investigational Site Number : 3920008

Koriyama-shi, Fukushima, 963-8052, Japan
Investigational Site Number : 3920010

Ōta-ku, Tokyo, 146-0065, Japan
Investigational Site Number : 3920011

Kyoto, Kyoto, 616-8255, Japan
Investigational Site Number : 3920014

Bunkyo-ku, Tokyo, 113-8431, Japan
Investigational Site Number : 3920015

Toyama, Toyama, 930-0194, Japan
Investigational Site Number : 3920016

Chiba, Chiba, 260-8677, Japan
Investigational Site Number : 3920017

Shinjuku-ku, Tokyo, 160-8582, Japan
Investigational Site Number : 3920018

Kawagoe-shi, Saitama, 350-8550, Japan
Investigational Site Number : 3920020

Sendai, Miyagi, 980-8574, Japan
Investigational Site Number : 3920022

Morioka, Iwate, 020-8505, Japan
Investigational Site Number : 3920023

Sagamihara-shi, Kanagawa, 252-0392, Japan
Investigational Site Number : 4280002

Riga, LV-1002, Latvia
Investigational Site Number : 4840001

Mexico City, Mexico City, 06700, Mexico
Investigational Site Number : 4840003

Veracruz, 91910, Mexico
Investigational Site Number : 4840004

Guadalajara, Jalisco, 44670, Mexico
Investigational Site Number : 4840005

Mexico City, 14050, Mexico
Investigational Site Number : 4840007

Tlalnepantla, 54055, Mexico
Investigational Site Number : 5280002

Sittard-Geleen, 6162 BG, Netherlands
Investigational Site Number : 5280003

Breda, 4818 CK, Netherlands
Investigational Site Number : 5280006

Groningen, 9728NT, Netherlands
Investigational Site Number : 5780003

Bergen, 5021, Norway
Investigational Site Number : 5780005

Tromsø, 9038, Norway
Investigational Site Number : 6040004

Lima, 15084, Peru
Investigational Site Number : 6160001

Lodz, Lódzkie, 90-549, Poland
Investigational Site Number : 6160003

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Investigational Site Number : 6160004

Katowice, Silesian Voivodeship, 40-686, Poland
Investigational Site Number : 6160005

Warsaw, Masovian Voivodeship, 01-211, Poland
Investigational Site Number : 6160006

Warsaw, Masovian Voivodeship, 01-684, Poland
Investigational Site Number : 6160007

Katowice, Silesian Voivodeship, 40-684, Poland
Investigational Site Number : 6200001

Braga, 4710-243, Portugal
Investigational Site Number : 6200002

Matosinhos Municipality, 4464-513, Portugal
Investigational Site Number : 6200004

Santa Maria da Feira, 4520-211, Portugal
Investigational Site Number : 6200007

Lisbon, 1349-019, Portugal
Investigational Site Number : 6200010

Porto, 4099-001, Portugal
Investigational Site Number : 6200012

Lisbon, 1500-650, Portugal
Investigational Site Number : 6420001

Târgu Mureş, 540136, Romania
Investigational Site Number : 6420002

Timișoara, 300736, Romania
Investigational Site Number : 6420003

Constanța, 900123, Romania
Investigational Site Number : 6420004

Campulung Muscel, 115100, Romania
Investigational Site Number : 6420008

Bucharest, 022328, Romania
Investigational Site Number : 6420013

Oradea, 410154, Romania
Investigational Site Number : 6430004

Kazan', 420032, Russia
Investigational Site Number : 6430006

Ufa, 450005, Russia
Investigational Site Number : 6430007

Tyumen, 625000, Russia
Investigational Site Number : 6430008

Pyatigorsk, 357538, Russia
Investigational Site Number : 6430009

Samara, 443095, Russia
Investigational Site Number : 6430011

Moscow, 129128, Russia
Investigational Site Number : 6430013

Moscow, 117997, Russia
Investigational Site Number : 6430014

Nizhny Novgorod, 603137, Russia
Investigational Site Number : 6430015

Rostov-on-Don, 344022, Russia
Investigational Site Number : 6430017

Saint Petersburg, 197376, Russia
Investigational Site Number : 6430018

Barnaul, 656043, Russia
Investigational Site Number : 6430020

Saransk, 430032, Russia
Investigational Site Number : 6430021

Krasnoyarsk, 660029, Russia
Investigational Site Number : 6430022

Yekaterinburg, 620102, Russia
Investigational Site Number : 6430023

Kaliningrad, 236035, Russia
Investigational Site Number : 6880001

Belgrade, 11000, Serbia
Investigational Site Number : 6880002

Kragujevac, 34000, Serbia
Investigational Site Number : 7100001

Pretoria, 0041, South Africa
Investigational Site Number : 7240001

Pozuelo de Alarcón, Madrid, 28223, Spain
Investigational Site Number : 7240002

Majadahonda, Madrid, 28222, Spain
Investigational Site Number : 7240003

Madrid, 28007, Spain
Investigational Site Number : 7240004

Córdoba, 14004, Spain
Investigational Site Number : 7240005

Málaga, 29010, Spain
Investigational Site Number : 7240006

Murcia, 30120, Spain
Investigational Site Number : 7240007

Seville, Andalusia, 41009, Spain
Investigational Site Number : 7240008

Valencia, 46026, Spain
Investigational Site Number : 7240010

Barcelona, Barcelona [Barcelona], 08035, Spain
Investigational Site Number : 7240011

Salt, Girona [Gerona], 17190, Spain
Investigational Site Number : 7240012

A Coruña, A Coruña [La Coruña], 15006, Spain
Investigational Site Number : 7240013

Bilbao, Bizkaia, 48013, Spain
Investigational Site Number : 7240014

Palma de Mallorca, 07120, Spain
Investigational Site Number : 7240015

Santiago de Compostela, A Coruña [La Coruña], 15706, Spain
Investigational Site Number : 7240016

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Investigational Site Number : 7520001

Gothenburg, 413 45, Sweden
Investigational Site Number : 7520005

Motala, 591 85, Sweden
Investigational Site Number : 7640001

Bangkok, 10700, Thailand
Investigational Site Number : 7920001

İzmit, 41380, Turkey (Türkiye)
Investigational Site Number : 7920002

Istanbul, 34303, Turkey (Türkiye)
Investigational Site Number : 7920003

Istanbul, 34265, Turkey (Türkiye)
Investigational Site Number : 7920005

Eskişehir, 26040, Turkey (Türkiye)
Investigational Site Number : 7920007

Istanbul, 34785, Turkey (Türkiye)
Investigational Site Number : 7920009

Ankara, 06100, Turkey (Türkiye)
Investigational Site Number : 7920010

Hatay, Turkey (Türkiye)
Investigational Site Number : 7920011

Kütahya, 43100, Turkey (Türkiye)
Investigational Site Number : 7920012

Mersin, 33070, Turkey (Türkiye)
Investigational Site Number : 7920013

Samsun, Turkey (Türkiye)
Investigational Site Number : 7920014

Ankara, 06500, Turkey (Türkiye)
Investigational Site Number : 7920015

Izmir, 35100, Turkey (Türkiye)
Investigational Site Number : 7920016

Istanbul, 34093, Turkey (Türkiye)
Investigational Site Number : 7920017

Konya, 42080, Turkey (Türkiye)
Investigational Site Number : 7920018

Izmir, 35340, Turkey (Türkiye)
Investigational Site Number : 8040002

Lviv, 79010, Ukraine
Investigational Site Number : 8040007

Lviv, 79013, Ukraine
Investigational Site Number : 8040010

Odesa, 65025, Ukraine
Investigational Site Number : 8040011

Lutsk, 43005, Ukraine
Investigational Site Number : 8040012

Ivano-Frankivsk, 76493, Ukraine
Investigational Site Number : 8040013

Kyiv, 02091, Ukraine
Investigational Site Number : 8040014

Kyiv, 01135, Ukraine
Investigational Site Number : 8040015

Kyiv, 03115, Ukraine
Investigational Site Number : 8040017

Kharkiv, 61068, Ukraine
Investigational Site Number : 8040020

Chernivtsi, 58023, Ukraine
Investigational Site Number : 8040023

Kharkiv, 61103, Ukraine
Investigational Site Number : 8040024

Vinnytsia, 21001, Ukraine
Investigational Site Number : 8040025

Kharkiv, 61068, Ukraine
Investigational Site Number : 8260001

Cardiff, Vale of Glamorgan, the, CF4 4XY, United Kingdom
Investigational Site Number : 8260003

Exeter, Devon, EX2 5DW, United Kingdom
Investigational Site Number : 8260005

London, London, City of, SW17 0QT, United Kingdom
Investigational Site Number : 8260006

London, London, City of, EC1M 6BQ, United Kingdom
Investigational Site Number : 8260007

Sheffield, S5 7AU, United Kingdom
Investigational Site Number : 8260009

Bristol, BS10 5NB, United Kingdom
Investigational Site Number : 8260010

Swansea, Neath Port Talbot, SA6 6NL, United Kingdom
Investigational Site Number : 8260012

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
Investigational Site Number : 8260013

Oxford, Oxfordshire, OX3 9DU, United Kingdom
Investigational Site Number : 8260016

Canterbury, Kent, CT1 3NG, United Kingdom
Investigational Site Number : 8260019

Salford, M6 8HD, United Kingdom
Jefferson Neurology Associates Site Number : 8400016

Philadelphia, Pennsylvania, 19107, United States
MS & Neuromuscular Center of Excellence Site Number : 8400172

Clearwater, Florida, 33761, United States
Mayo Clinic Site Number : 8400111

Rochester, Minnesota, 55905, United States
Meridian Clinical Research, LLC- Site Number : 8400005

Raleigh, North Carolina, 27607, United States
Methodist Hospital Site Number : 8400164

Merrillville, Indiana, 46410, United States
Michigan Institute For Neurological Disorders Site Number : 8400058

Farmington Hills, Michigan, 48334, United States
Mountain View Clinical Research Site Number : 8400024

Greer, South Carolina, 29651-1817, United States
Mt Olympus Medical Research Site Number : 8400163

Katy, Texas, 77450, United States
Multiple Sclerosis Center of California Site Number : 8400135

Newport Beach, California, 92663, United States
Multiple Sclerosis Center- Site Number : 8400143

Los Angeles, California, 90033, United States
Neurology Associates of Stony Brook Site Number : 8400042

Stony Brook, New York, 11794, United States
Neurology Associates, PA- Site Number : 8400004

Maitland, Florida, 32761, United States
Neurology Center of San Antonio Site Number : 8400036

San Antonio, Texas, 78258, United States
Ochsner Baptist Clinical Trials Unit (CTU)- Site Number : 8400107

New Orleans, Louisiana, 70121, United States
Providence Multiple Sclerosis Center Site Number : 8400020

Portland, Oregon, 97225, United States
Regina Berkovich, MD, PhD Site Number : 8400059

West Hollywood, California, 90048, United States
Riverhills Neuroscience - Norwood Site Number : 8400167

Cincinnati, Ohio, 45212, United States
SC3 Research - Pasadena Site Number : 8400070

Pasadena, California, 91105, United States
Sharlin Health & Neurology Site Number : 8400093

Ozark, Missouri, 65721, United States
South Florida Neurology Associates Site Number : 8400029

Boca Raton, Florida, 33487, United States
The Boster Center for Multiple Sclerosis Site Number : 8400147

Columbus, Ohio, 43235, United States
The Memorial Hospital- Site Number : 8400033

Owosso, Michigan, 48867, United States
The Ohio State University Wexner Medical Center- Site Number : 8400150

Columbus, Ohio, 43221, United States
Tufts Medical Center Site Number : 8400072

Boston, Massachusetts, 02111, United States
UC San Diego ACTRI Site Number : 8400101

La Jolla, California, 92037, United States
University Of Nebraska- Site Number : 8400129

Omaha, Nebraska, 68198, United States
University of Florida, Fixel Center for Neurology Site Number : 8400159

Gainesville, Florida, 32601, United States
University of Kentucky Site Number : 8400106

Lexington, Kentucky, 40536, United States
University of Massachusetts Site Number : 8400014

Worcester, Massachusetts, 01655, United States
University of New Mexico Site Number : 8400032

Albuquerque, New Mexico, 87131, United States
University of San Francisco, Sandler Neurosciences Center- Site Number : 8400137

San Francisco, California, 94158, United States
University of South Florida Site Number : 8400006

Tampa, Florida, 33612, United States
Velocity Clinical Research Site Number : 8400003

Savannah, Georgia, 31406, United States

Conditions

Explore the condition pages connected to this study.

PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS