Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)

NCT ID: NCT04411641

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-24
• Study Completion Date: 2024-08-29

Brief Summary

Primary Objective:

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS

Secondary Objective:

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 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168

Detailed Description

This was an event-driven (6-month CDP) trial with a variable treatment duration (end-of-study [EOS] duration: up to approximately 47months).

Participants with 6-month confirmed disability progression (CDP) had an option to receive tolebrutinib in the open-label (OL).

Conditions

Non-relapsing Secondary Progressive Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SAR442168

60 mg of oral SAR442168 once daily

Group Type: EXPERIMENTAL

Tolebrutinib

Intervention Type: DRUG

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

Placebo

Placebo tablet to match SAR442168 once daily

Group Type: PLACEBO_COMPARATOR

Placebo to match Tolebrutinib

Intervention Type: DRUG

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

Interventions

Tolebrutinib

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

Intervention Type: DRUG

Placebo to match Tolebrutinib

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

Intervention Type: DRUG

Other Intervention Names

SAR442168

Eligibility Criteria

Inclusion Criteria

• 18 to 60 years of age inclusive
• Diagnosis of nonrelapsing secondary progressive multiple sclerosis according to the 2017 McDonald criteria
• Expanded disability status scale (EDSS) between 3.0 to 6.5 points inclusive, at screening
• The participant must have documented evidence of disability progression observed during the 12 months before screening
• Absence of clinical relapses for at least 24 months
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Is not a WOCBP OR
• Is a WOCBP and agrees to use an acceptable contraceptive method

Exclusion Criteria

• The participant has conditions that would adversely affect study participation such as short life expectancy.
• Evidence of infection with human immuodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infections 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.
• Hospitalized for psychiatric disease within 2 years prior to screening.
• Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at screening
• Bleeding disorder, known platelet dysfunctionat 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 bleeding.
• 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 or inhibitors 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).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

University of Alabama MS Center-Site Number:8400013

Birmingham, Alabama, United States

Center for Neurology and Spine-Site Number:8400089

Phoenix, Arizona, United States

Arcadia Neurology Center-Site Number:8400070

Arcadia, California, United States

UC San Diego ACTRI-Site Number:8400101

La Jolla, California, United States

Collaborative Neuroscience Research-Site Number:8400045

Long Beach, California, United States

Multiple Sclerosis Center-Site Number:8400143

Los Angeles, California, United States

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

San Francisco, California, United States

Harbor UCLA-Site Number:8400088

Torrance, California, United States

Regina Berkovich, MD, PhD-Site Number:8400059

West Hollywood, California, United States

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

Basalt, Colorado, United States

University of Colorado-Site Number:8400012

Denver, Colorado, United States

Advanced Neurosciences Research-Site Number:8400025

Fort Collins, Colorado, United States

South Florida Neurology Associates-Site Number:8400029

Boca Raton, Florida, United States

Neurology Associates, PA-Site Number:8400004

Maitland, Florida, United States

Aqualane Clinical Research-Site Number:8400027

Naples, Florida, United States

Axiom Clinical Research of Florida-Site Number:8400001

Tampa, Florida, United States

University of South Florida-Site Number:8400006

Tampa, Florida, United States

Meridian Clinical Research-Site Number:8400003

Savannah, Georgia, United States

Consultants In Neurology-Site Number:8400011

Northbrook, Illinois, United States

University of Kansas Medical Center-Site Number:8400023

Kansas City, Kansas, United States

CHI Saint Joseph Medical Group Neurology-Site Number:8400110

Lexington, Kentucky, United States

Tufts Medical Center-Site Number:8400072

Boston, Massachusetts, United States

University of Massachusetts-Site Number:8400014

Worcester, Massachusetts, United States

Wayne State University-Site Number:8400046

Detroit, Michigan, United States

The Memorial Hospital-Site Number:8400033

Owosso, Michigan, United States

Minneapolis Clinic of Neurology-Site Number:8400051

Minneapolis, Minnesota, United States

Mayo Clinic-Site Number:8400111

Rochester, Minnesota, United States

Missouri Baptist Medical Center-Site Number:8400019

St Louis, Missouri, United States

Lou Ruvo Center for Brain Health-Site Number:8400117

Las Vegas, Nevada, United States

Holy Name Hospital-Site Number:8400104

Teaneck, New Jersey, United States

University of New Mexico-Site Number:8400032

Albuquerque, New Mexico, United States

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

New York, New York, United States

Neurology Associates of Stony Brook-Site Number:8400042

Stony Brook, New York, United States

Meridian Clinical Research, LLC-Site Number:8400005

Raleigh, North Carolina, United States

Sanford Brain & Spine Center-Site Number:8400126

Fargo, North Dakota, United States

University Hospitals CMC-Site Number:8400083

Cleveland, Ohio, United States

Cleveland Clinic-Site Number:8400125

Cleveland, Ohio, United States

Optimed Research, LTD-Site Number:8400147

Columbus, Ohio, United States

Neurology Specialists-Site Number:8400002

Dayton, Ohio, United States

Columbus Neuroscience-Site Number:8400010

Westerville, Ohio, United States

Providence Multiple Sclerosis Center-Site Number:8400020

Portland, Oregon, United States

Perelman Center for Advanced Medicine-Site Number:8400142

Philadelphia, Pennsylvania, United States

Jefferson Neurology Associates-Site Number:8400016

Philadelphia, Pennsylvania, United States

Premier Neurology-Site Number:8400069

Greer, South Carolina, United States

Mountain View Clinical Research-Site Number:8400024

Greer, South Carolina, United States

Neurology Clinic, PC-Site Number:8400087

Cordova, Tennessee, United States

Advanced Neuroscience Center-Site Number:8400035

Franklin, Tennessee, United States

Baylor College of Medicine-Site Number:8400136

Houston, Texas, United States

Neurology Center of San Antonio-Site Number:8400036

San Antonio, Texas, United States

University Of Vermont College Of Medicine-Site Number:8400130

Burlington, Vermont, United States

Medical College of Wisconsin-Site Number:8400028

Milwaukee, Wisconsin, United States

Investigational Site Number :0320002

Capital Federal, Buenos Aires, Argentina

Investigational Site Number :0320001

CABA, Buenos Aires F.D., Argentina

Investigational Site Number :0320007

Buenos Aires, , Argentina

Investigational Site Number :0320006

Córdoba, , Argentina

Investigational Site Number :0320005

San Miguel de Tucumán, , Argentina

Investigational Site Number : 0360007

St Leonards, New South Wales, Australia

Investigational Site Number :0360003

Woolloongabba, Queensland, Australia

Investigational Site Number :0360002

Kent Town, South Australia, Australia

Investigational Site Number :0360004

Hobart, Tasmania, Australia

Investigational Site Number :0360001

Fitzroy, Victoria, Australia

Investigational Site Number :0360006

Heidelberg West, Victoria, Australia

Investigational Site Number :0400003

Innsbruck, , Austria

Investigational Site Number :0400001

Linz, , Austria

Investigational Site Number :0400004

Linz, , Austria

Investigational Site Number :0400002

Vienna, , Austria

Investigational Site Number :1120004

Vitebsk, , Belarus

Investigational Site Number :1120005

Vitebsk, , Belarus

Investigational Site Number : 0560009

Brussels, , Belgium

Investigational Site Number :0560007

Brussels, , Belgium

Investigational Site Number :0560003

Edegem, , Belgium

Investigational Site Number : 0560004

Ghent, , Belgium

Investigational Site Number :0560006

Leuven, , Belgium

Investigational Site Number :0560008

Liège, , Belgium

Investigational Site Number :0560002

Mons, , Belgium

Investigational Site Number :0560001

Overpelt, , Belgium

Investigational Site Number :1000002

Pleven, , Bulgaria

Investigational Site Number :1000005

Plovdiv, , Bulgaria

Investigational Site Number :1000004

Sofia, , Bulgaria

Investigational Site Number :1000008

Sofia, , Bulgaria

Investigational Site Number :1000001

Sofia, , Bulgaria

Investigational Site Number :1000006

Sofia, , Bulgaria

Investigational Site Number :1000009

Sofia, , Bulgaria

Investigational Site Number :1240017

Burnaby, British Columbia, Canada

Investigational Site Number :1240011

Halifax, Nova Scotia, Canada

Investigational Site Number :1240003

Ottawa, Ontario, Canada

Investigational Site Number :1240008

Toronto, Ontario, Canada

Investigational Site Number :1240006

Gatineau, Quebec, Canada

Investigational Site Number :1240005

Greenfield Park, Quebec, Canada

Investigational Site Number :1240004

Montreal, Quebec, Canada

Investigational Site Number :1240015

Montreal, Quebec, Canada

Investigational Site Number :1240007

Sherbrooke, Quebec, Canada

Investigational Site Number : 1240001

Québec, , Canada

Investigational Site Number :1240021

Québec, , Canada

Investigational Site Number :1560006

Beijing, , China

Investigational Site Number :1560012

Beijing, , China

Investigational Site Number :1560021

Beijing, , China

Investigational Site Number :1560003

Beijing, , China

Investigational Site Number :1560009

Beijing, , China

Investigational Site Number :1560004

Changchun, , China

Investigational Site Number :1560015

Changsha, , China

Investigational Site Number :1560005

Chengdu, , China

Investigational Site Number :1560019

Chongqing, , China

Investigational Site Number :1560035

Fuzhou, , China

Investigational Site Number :1560001

Guangzhou, , China

Investigational Site Number :1560007

Hangzhou, , China

Investigational Site Number :1560014

Shijiazhuang, , China

Investigational Site Number :1560008

Taiyuan, , China

Investigational Site Number :1560017

Xi'an, , China

Investigational Site Number :2030002

Brno, , Czechia

Investigational Site Number :2030004

Hradec Králové, , Czechia

Investigational Site Number :2030001

Jihlava, , Czechia

Investigational Site Number :2030010

Ostrava - Poruba, , Czechia

Investigational Site Number :2030005

Prague, , Czechia

Investigational Site Number :2030003

Teplice, , Czechia

Investigational Site Number :2080001

Esbjerg, , Denmark

Investigational Site Number :2080005

Holstebro, , Denmark

Investigational Site Number :2080004

Odense, , Denmark

Investigational Site Number :2460003

Helsinki, , Finland

Investigational Site Number :2460001

Tampere, , Finland

Investigational Site Number :2460002

Turku, , Finland

Investigational Site Number :2500011

Bron, , France

Investigational Site Number :2500005

Clermont-Ferrand, , France

Investigational Site Number :2500015

Gonesse, , France

Investigational Site Number :2500009

Lille, , France

Investigational Site Number :2500006

Montpellier, , France

Investigational Site Number :2500008

Nancy, , France

Investigational Site Number :2500010

Nantes, , France

Investigational Site Number :2500017

Nîmes, , France

Investigational Site Number :2500016

Paris, , France

Investigational Site Number :2500014

Paris, , France

Investigational Site Number :2500007

Paris, , France

Investigational Site Number :2500003

Rennes, , France

Investigational Site Number :2500001

Strasbourg, , France

Investigational Site Number :2500012

Toulouse, , France

Investigational Site Number :2760005

Bayreuth, , Germany

Investigational Site Number :2760009

Berlin, , Germany

Investigational Site Number :2760001

Dresden, , Germany

Investigational Site Number :2760012

Essen, , Germany

Investigational Site Number :2760002

Giessen, , Germany

Investigational Site Number :2760010

Halle, , Germany

Investigational Site Number :2760006

Hanover, , Germany

Investigational Site Number :2760008

Münster, , Germany

Investigational Site Number :2760004

Rostock, , Germany

Investigational Site Number :2760011

Ulm, , Germany

Investigational Site Number :3000001

Athens, , Greece

Investigational Site Number :3000006

Athens, , Greece

Investigational Site Number :3000002

Athens, , Greece

Investigational Site Number :3000007

Athens, , Greece

Investigational Site Number :3000004

Larissa, , Greece

Investigational Site Number :3000003

Thessaloniki, , Greece

Investigational Site Number :3000005

Thessaloniki, , Greece

Investigational Site Number :3480008

Budapest, , Hungary

Investigational Site Number :3480004

Budapest, , Hungary

Investigational Site Number :3480007

Budapest, , Hungary

Investigational Site Number :3480002

Pécs, , Hungary

Investigational Site Number :3480001

Szeged, , Hungary

Investigational Site Number :3480006

Tatabánya, , Hungary

Investigational Site Number :3560007

Gurgaon, , India

Investigational Site Number :3560003

Gurgaon, , India

Investigational Site Number :3560005

India, , India

Investigational Site Number :3560004

Mangaluru, , India

Investigational Site Number : 3560009

Nagpur, , India

Investigational Site Number :3560006

New Delhi, , India

Investigational Site Number :3560002

New Delhi, , India

Investigational Site Number :3760002

Ashkelon, , Israel

Investigational Site Number :3760003

Haifa, , Israel

Investigational Site Number :3760008

Jerusalem, , Israel

Investigational Site Number :3760004

Safed, , Israel

Investigational Site Number :3760001

Tel Litwinsky, , Israel

Investigational Site Number :3800011

Bergamo, , Italy

Investigational Site Number :3800007

Cagliari, , Italy

Investigational Site Number :3800012

Florence, , Italy

Investigational Site Number :3800016

Florence, , Italy

Investigational Site Number :3800014

Genova, , Italy

Investigational Site Number :3800013

L’Aquila, , Italy

Investigational Site Number :3800004

Milan, , Italy

Investigational Site Number :3800001

Milan, , Italy

Investigational Site Number :3800010

Milan, , Italy

Investigational Site Number :3800008

Pavia, , Italy

Investigational Site Number :3800005

Roma, , Italy

Investigational Site Number :3800009

Roma, , Italy

Investigational Site Number :3920016

Chiba, Chiba, Japan

Investigational Site Number :3920022

Morioka, Iwate, Japan

Investigational Site Number :3920011

Kyoto, Kyoto, Japan

Investigational Site Number :3920020

Sendai, Miyagi, Japan

Investigational Site Number :3920005

Niigata, Niigata, Japan

Investigational Site Number :3920004

Moriguchi-shi, Osaka, Japan

Investigational Site Number :3920001

Osaka, Osaka, Japan

Investigational Site Number :3920018

Kawagoe-shi, Saitama, Japan

Investigational Site Number :3920003

Kodaira-shi, Tokyo, Japan

Investigational Site Number :3920010

Ōta-ku, Tokyo, Japan

Investigational Site Number :3920009

Ube-shi, Yamaguchi, Japan

Investigational Site Number :3920023

Sagamihara-shi, , Japan

Investigational Site Number :4400003

Kaunas, , Lithuania

Investigational Site Number :4400002

Klaipėda, , Lithuania

Investigational Site Number :4400001

Vilnius, , Lithuania

Investigational Site Number :5280001

Amsterdam, , Netherlands

Investigational Site Number :5280003

Breda, , Netherlands

Investigational Site Number :5280006

Groningen, , Netherlands

Investigational Site Number :5280002

Sittard-Geleen, , Netherlands

Investigational Site Number :5780003

Bergen, , Norway

Investigational Site Number :5780002

Namsos, , Norway

Investigational Site Number :5780001

Oslo, , Norway

Investigational Site Number :6160008

Plewiska, Greater Poland Voivodeship, Poland

Investigational Site Number :6160003

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Investigational Site Number :6160005

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number :6160006

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number :6160002

Katowice, Silesian Voivodeship, Poland

Investigational Site Number :6160007

Katowice, Silesian Voivodeship, Poland

Investigational Site Number :6160004

Katowice, Silesian Voivodeship, Poland

Investigational Site Number :6160001

Lodz, , Poland

Investigational Site Number :6160012

Lublin, , Poland

Investigational Site Number :6160011

Zabrze, , Poland

Investigational Site Number :6200001

Braga, , Portugal

Investigational Site Number :6200011

Lisbon, , Portugal

Investigational Site Number :6200007

Lisbon, , Portugal

Investigational Site Number :6200006

Lisbon, , Portugal

Investigational Site Number :6200002

Matosinhos Municipality, , Portugal

Investigational Site Number :6200010

Porto, , Portugal

Investigational Site Number :6420008

Bucharest, , Romania

Investigational Site Number :6420004

Campulung Muscel, , Romania

Investigational Site Number :6420006

Cluj-Napoca, , Romania

Investigational Site Number :6420003

Constanța, , Romania

Investigational Site Number :6420013

Oradea, , Romania

Investigational Site Number :6420005

Sibiu, , Romania

Investigational Site Number :6420001

Târgu Mureş, , Romania

Investigational Site Number :6420002

Timișoara, , Romania

Investigational Site Number :6430018

Barnaul, , Russia

Investigational Site Number :6430025

Kaliningrad, , Russia

Investigational Site Number :6430003

Kazan', , Russia

Investigational Site Number :6430022

Kemerovo, , Russia

Investigational Site Number :6430017

Kirov, , Russia

Investigational Site Number :6430024

Krasnoyarsk, , Russia

Investigational Site Number :6430020

Moscow, , Russia

Investigational Site Number :6430002

Moscow, , Russia

Investigational Site Number :6430013

Moscow, , Russia

Investigational Site Number :6430001

Moscow, , Russia

Investigational Site Number :6430008

Moscow, , Russia

Investigational Site Number :6430021

Nizhny Novgorod, , Russia

Investigational Site Number :6430006

Nizhny Novgorod, , Russia

Investigational Site Number :6430005

Novosibirsk, , Russia

Investigational Site Number :6430026

Perm, , Russia

Investigational Site Number :6430007

Pyatigorsk, , Russia

Investigational Site Number :6430016

Rostov-on-Don, , Russia

Investigational Site Number :6430011

Saint Petersburg, , Russia

Investigational Site Number :6430004

Saint Petersburg, , Russia

Investigational Site Number :6430009

Samara, , Russia

Investigational Site Number :6430019

Saransk, , Russia

Investigational Site Number :6430014

Smolensk, , Russia

Investigational Site Number :6430012

Tyumen, , Russia

Investigational Site Number :6430010

Ufa, , Russia

Investigational Site Number :6430023

Yekaterinburg, , Russia

Investigational Site Number :7240007

Seville, Andalusia, Spain

Investigational Site Number :7240013

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number :7240016

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number :7240012

Donostia / San Sebastian, Basque Country, Spain

Investigational Site Number :7240014

Salt, Girona [Gerona], Spain

Investigational Site Number :7240017

Las Palmas de Gran Canaria, Las Palmas, Spain

Investigational Site Number :7240004

Majadahonda, Madrid, Spain

Investigational Site Number :7240001

Pozuelo de Alarcón, Madrid, Spain

Investigational Site Number :7240008

Córdoba, , Spain

Investigational Site Number :7240015

Lleida, , Spain

Investigational Site Number :7240005

Madrid, , Spain

Investigational Site Number :7240002

Madrid, , Spain

Investigational Site Number :7240003

Madrid, , Spain

Investigational Site Number :7240009

Málaga, , Spain

Investigational Site Number :7240010

Murcia, , Spain

Investigational Site Number :7240011

Valencia, , Spain

Investigational Site Number :7920005

Eskişehir, , Turkey (Türkiye)

Investigational Site Number :7920010

Hatay, , Turkey (Türkiye)

Investigational Site Number :7920002

Istanbul, , Turkey (Türkiye)

Investigational Site Number :7920009

Istanbul, , Turkey (Türkiye)

Investigational Site Number :7920007

Istanbul, , Turkey (Türkiye)

Investigational Site Number :7920006

Istanbul, , Turkey (Türkiye)

Investigational Site Number :7920003

Istanbul, , Turkey (Türkiye)

Investigational Site Number :7920013

Izmir, , Turkey (Türkiye)

Investigational Site Number :7920001

İzmit, , Turkey (Türkiye)

Investigational Site Number :7920011

Kütahya, , Turkey (Türkiye)

Investigational Site Number :7920012

Mersin, , Turkey (Türkiye)

Investigational Site Number :7920008

Trabzon, , Turkey (Türkiye)

Investigational Site Number :8040008

Chernivtsi, , Ukraine

Investigational Site Number :8040016

Chernivtsi, , Ukraine

Investigational Site Number :8040003

Dnipro, , Ukraine

Investigational Site Number :8040010

Ivano-Frankivsk, , Ukraine

Investigational Site Number :8040007

Kharkiv, , Ukraine

Investigational Site Number :8040011

Kharkiv, , Ukraine

Investigational Site Number :8040012

Kharkiv, , Ukraine

Investigational Site Number :8040013

Kyiv, , Ukraine

Investigational Site Number :8040005

Lutsk, , Ukraine

Investigational Site Number :8040009

Lviv, , Ukraine

Investigational Site Number :8040004

Lviv, , Ukraine

Investigational Site Number :8040002

Odesa, , Ukraine

Investigational Site Number :8040006

Vinnytsia, , Ukraine

Investigational Site Number :8040014

Zhytomyr, , Ukraine

Investigational Site Number :8260003

Exeter, Devon, United Kingdom

Investigational Site Number :8260008

Plymouth, Devon, United Kingdom

Investigational Site Number :8260010

Swansea, Neath Port Talbot, United Kingdom

Investigational Site Number :8260012

Nottingham, Nottinghamshire, United Kingdom

Investigational Site Number :8260013

Oxford, Oxfordshire, United Kingdom

Investigational Site Number :8260009

Bristol, , United Kingdom

Investigational Site Number :8260001

Cardiff, , United Kingdom

Investigational Site Number :8260005

London, , United Kingdom

Investigational Site Number :8260018

London, , United Kingdom

Investigational Site Number :8260014

Newcastle upon Tyne, , United Kingdom

Investigational Site Number :8260019

Salford, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belarus; Belgium; Bulgaria; Canada; China; Czechia; Denmark; Finland; France; Germany; Greece; Hungary; India; Israel; Italy; Japan; Lithuania; Netherlands; Norway; Poland; Portugal; Romania; Russia; Spain; Turkey (Türkiye); Ukraine; United Kingdom

References

Fox RJ, Bar-Or A, Traboulsee A, Oreja-Guevara C, Giovannoni G, Vermersch P, Syed S, Li Y, Vargas WS, Turner TJ, Wallstroem E, Reich DS; HERCULES Trial Group. Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis. N Engl J Med. 2025 May 15;392(19):1883-1892. doi: 10.1056/NEJMoa2415988. Epub 2025 Apr 8.

Reference Type: DERIVED

PMID: 40202696 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://sanofi.trialsummaries.com/Study/StudyDetails?id=25250&tenant=MT_SNY_9011

EFC16645 Plain language Results Summary

Other Identifiers

U1111-1246-7768

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-000647-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC16645

Identifier Type: -

Identifier Source: org_study_id