Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)
HERCULES
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
3 other identifiers
interventional
1,131
29 countries
298
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2020
Typical duration for phase_3
298 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedStudy Start
First participant enrolled
September 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2024
CompletedResults Posted
Study results publicly available
June 18, 2025
CompletedJuly 2, 2025
June 1, 2025
3.9 years
May 28, 2020
June 3, 2025
July 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Onset of 6-Month Confirmed Disability Progression (CDP) as Assessed by Expanded Disability Status Scale (EDSS)
The EDSS is a disability scale that assesses the following 7 functional domains: visual, brainstem, pyramidal \[motor\], cerebellar \[coordination\], sensory, cerebral, and bowel/bladder. The total EDSS ranges from 0 (normal) to 10 (death due to multiple sclerosis \[MS\]) (0.5 increments from 1-10; next increase after 0 is 1). Higher scores indicated increased disability. Time to onset of 6-month CDP was defined as the time from randomization to the onset of a sustained increase from baseline in EDSS score of \>=1.0 point from the baseline EDSS score when the baseline score was \<=5.0 or of \>=0.5 points when the baseline EDSS score was \>5.0 confirmed after a minimum 6-month interval.
Baseline (Day 1) up to approximately 47 months
Secondary Outcomes (16)
Time to Onset of 3-month Confirmed Disability Progression as Assessed by Expanded Disability Status Scale
Baseline (Day 1) up to approximately 47 months
Mean Number of New and/or Enlarging T2-hyperintense Lesions Per Year
Baseline (Day 1) up to approximately 47 months
Time to Onset of Sustained 20% Increase in the 9-hole Peg Test (HPT) for at Least 3 Months
Baseline (Day 1) up to approximately 47 months
Time to Onset of Sustained 20% Increase in the Timed 25-foot Walk (T25-FW) for at Least 3 Months
Baseline (Day 1) up to approximately 47 months
Time to Onset of 6-month Confirmed Disability Improvement (CDI) as Assessed by Expanded Disability Status Scale
Baseline (Day 1) up to approximately 47 months
- +11 more secondary outcomes
Study Arms (2)
SAR442168
EXPERIMENTAL60 mg of oral SAR442168 once daily
Placebo
PLACEBO COMPARATORPlacebo tablet to match SAR442168 once daily
Interventions
Pharmaceutical form: Film-coated tablet Route of administration: Oral
Pharmaceutical form: Film-coated tablet Route of administration: Oral
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (306)
University of Alabama MS Center-Site Number:8400013
Birmingham, Alabama, 35233, United States
Center for Neurology and Spine-Site Number:8400089
Phoenix, Arizona, 84018, United States
Arcadia Neurology Center-Site Number:8400070
Arcadia, California, 91006, United States
UC San Diego ACTRI-Site Number:8400101
La Jolla, California, 92037, United States
Collaborative Neuroscience Research-Site Number:8400045
Long Beach, California, 90806, United States
Multiple Sclerosis Center-Site Number:8400143
Los Angeles, California, 90033, United States
University of San Francisco, Sandler Neurosciences Center-Site Number:8400137
San Francisco, California, 94158, United States
Harbor UCLA-Site Number:8400088
Torrance, California, 90502, United States
Regina Berkovich, MD, PhD-Site Number:8400059
West Hollywood, California, 90048, United States
Mountain Neurological Research Center, Inc.-Site Number:8400128
Basalt, Colorado, 81621, United States
University of Colorado-Site Number:8400012
Denver, Colorado, 80262, United States
Advanced Neurosciences Research-Site Number:8400025
Fort Collins, Colorado, 80528, United States
South Florida Neurology Associates-Site Number:8400029
Boca Raton, Florida, 33487, United States
Neurology Associates, PA-Site Number:8400004
Maitland, Florida, 32761, United States
Aqualane Clinical Research-Site Number:8400027
Naples, Florida, 34105, United States
Axiom Clinical Research of Florida-Site Number:8400001
Tampa, Florida, 33609-4052, United States
University of South Florida-Site Number:8400006
Tampa, Florida, 33612, United States
Meridian Clinical Research-Site Number:8400003
Savannah, Georgia, 31406, United States
Consultants In Neurology-Site Number:8400011
Northbrook, Illinois, 60062, United States
University of Kansas Medical Center-Site Number:8400023
Kansas City, Kansas, 66160-7321, United States
CHI Saint Joseph Medical Group Neurology-Site Number:8400110
Lexington, Kentucky, 40509, United States
Tufts Medical Center-Site Number:8400072
Boston, Massachusetts, 02111, United States
University of Massachusetts-Site Number:8400014
Worcester, Massachusetts, 01655, United States
Wayne State University-Site Number:8400046
Detroit, Michigan, 48201, United States
The Memorial Hospital-Site Number:8400033
Owosso, Michigan, 48867, United States
Minneapolis Clinic of Neurology-Site Number:8400051
Minneapolis, Minnesota, 55422, United States
Mayo Clinic-Site Number:8400111
Rochester, Minnesota, 55905, United States
Missouri Baptist Medical Center-Site Number:8400019
St Louis, Missouri, 63131, United States
Lou Ruvo Center for Brain Health-Site Number:8400117
Las Vegas, Nevada, 89106, United States
Holy Name Hospital-Site Number:8400104
Teaneck, New Jersey, 07666, United States
University of New Mexico-Site Number:8400032
Albuquerque, New Mexico, 87131, United States
Icahn School of Medicine at Mount Sinai (Department of Endoc-Site Number:8400038
New York, New York, 10029-6501, United States
Neurology Associates of Stony Brook-Site Number:8400042
Stony Brook, New York, 11794, United States
Meridian Clinical Research, LLC-Site Number:8400005
Raleigh, North Carolina, 27607, United States
Sanford Brain & Spine Center-Site Number:8400126
Fargo, North Dakota, 58103, United States
University Hospitals CMC-Site Number:8400083
Cleveland, Ohio, 44106, United States
Cleveland Clinic-Site Number:8400125
Cleveland, Ohio, 44195, United States
Optimed Research, LTD-Site Number:8400147
Columbus, Ohio, 43235, United States
Neurology Specialists-Site Number:8400002
Dayton, Ohio, 45417, United States
Columbus Neuroscience-Site Number:8400010
Westerville, Ohio, 40382, United States
Providence Multiple Sclerosis Center-Site Number:8400020
Portland, Oregon, 97225, United States
Perelman Center for Advanced Medicine-Site Number:8400142
Philadelphia, Pennsylvania, 19104, United States
Jefferson Neurology Associates-Site Number:8400016
Philadelphia, Pennsylvania, 19107, United States
Premier Neurology-Site Number:8400069
Greer, South Carolina, 29650, United States
Mountain View Clinical Research-Site Number:8400024
Greer, South Carolina, 29651-1817, United States
Neurology Clinic, PC-Site Number:8400087
Cordova, Tennessee, 38018, United States
Advanced Neuroscience Center-Site Number:8400035
Franklin, Tennessee, 37064, United States
Baylor College of Medicine-Site Number:8400136
Houston, Texas, 77030, United States
Neurology Center of San Antonio-Site Number:8400036
San Antonio, Texas, 78258, United States
University Of Vermont College Of Medicine-Site Number:8400130
Burlington, Vermont, 05401, United States
Medical College of Wisconsin-Site Number:8400028
Milwaukee, Wisconsin, 53226, United States
Investigational Site Number :0320002
Capital Federal, Buenos Aires, 1012, Argentina
Investigational Site Number :0320001
CABA, Buenos Aires F.D., C1061, Argentina
Investigational Site Number :0320007
Buenos Aires, 1860, Argentina
Investigational Site Number :0320006
Córdoba, 5000, Argentina
Investigational Site Number :0320005
San Miguel de Tucumán, T4000AXL, Argentina
Investigational Site Number : 0360007
St Leonards, New South Wales, 2065, Australia
Investigational Site Number :0360003
Woolloongabba, Queensland, 4102, Australia
Investigational Site Number :0360002
Kent Town, South Australia, Australia
Investigational Site Number :0360004
Hobart, Tasmania, 7001, Australia
Investigational Site Number :0360001
Fitzroy, Victoria, 3065, Australia
Investigational Site Number :0360006
Heidelberg West, Victoria, 3081, Australia
Investigational Site Number :0400003
Innsbruck, 6020, Austria
Investigational Site Number :0400001
Linz, 4020, Austria
Investigational Site Number :0400004
Linz, 4021, Austria
Investigational Site Number :0400002
Vienna, 1090, Austria
Investigational Site Number :1120004
Vitebsk, 210009, Belarus
Investigational Site Number :1120005
Vitebsk, 210037, Belarus
Investigational Site Number : 0560009
Brussels, 1070, Belgium
Investigational Site Number :0560007
Brussels, 1200, Belgium
Investigational Site Number :0560003
Edegem, B-2650, Belgium
Investigational Site Number : 0560004
Ghent, 9000, Belgium
Investigational Site Number :0560006
Leuven, 3000, Belgium
Investigational Site Number :0560008
Liège, 4000, Belgium
Investigational Site Number :0560002
Mons, 7000, Belgium
Investigational Site Number :0560001
Overpelt, 3900, Belgium
Investigational Site Number :1000002
Pleven, 5800, Bulgaria
Investigational Site Number :1000005
Plovdiv, 4000, Bulgaria
Investigational Site Number :1000004
Sofia, 1113, Bulgaria
Investigational Site Number :1000008
Sofia, 1407, Bulgaria
Investigational Site Number :1000001
Sofia, 1431, Bulgaria
Investigational Site Number :1000006
Sofia, 1431, Bulgaria
Investigational Site Number :1000009
Sofia, 1680, Bulgaria
Investigational Site Number :1240017
Burnaby, British Columbia, V5G 2X6, Canada
Investigational Site Number :1240011
Halifax, Nova Scotia, B3H 1V7, Canada
Investigational Site Number :1240003
Ottawa, Ontario, K1H 8L6, Canada
Investigational Site Number :1240008
Toronto, Ontario, M4N 3M5, Canada
Investigational Site Number :1240006
Gatineau, Quebec, J8Y 1W2, Canada
Investigational Site Number :1240005
Greenfield Park, Quebec, J4V 2J2, Canada
Investigational Site Number :1240004
Montreal, Quebec, H2X 0A9, Canada
Investigational Site Number :1240015
Montreal, Quebec, H3A 2B4, Canada
Investigational Site Number :1240007
Sherbrooke, Quebec, J1H 5N4, Canada
Investigational Site Number : 1240001
Québec, G1J 1Z4, Canada
Investigational Site Number :1240021
Québec, G1W 4R4, Canada
Investigational Site Number :1560006
Beijing, 100034, China
Investigational Site Number :1560012
Beijing, 100053, China
Investigational Site Number :1560021
Beijing, 100700, China
Investigational Site Number :1560003
Beijing, 100730, China
Investigational Site Number :1560009
Beijing, 100730, China
Investigational Site Number :1560004
Changchun, 130021, China
Investigational Site Number :1560015
Changsha, 410008, China
Investigational Site Number :1560005
Chengdu, 610041, China
Investigational Site Number :1560019
Chongqing, 400016, China
Investigational Site Number :1560035
Fuzhou, 350005, China
Investigational Site Number :1560001
Guangzhou, 510630, China
Investigational Site Number :1560007
Hangzhou, 310009, China
Investigational Site Number :1560014
Shijiazhuang, 050000, China
Investigational Site Number :1560008
Taiyuan, 030001, China
Investigational Site Number :1560017
Xi'an, 710038, China
Investigational Site Number :2030002
Brno, 65691, Czechia
Investigational Site Number :2030004
Hradec Králové, 50005, Czechia
Investigational Site Number :2030001
Jihlava, 58633, Czechia
Investigational Site Number :2030010
Ostrava - Poruba, 70852, Czechia
Investigational Site Number :2030005
Prague, 12808, Czechia
Investigational Site Number :2030003
Teplice, 415 29, Czechia
Investigational Site Number :2080001
Esbjerg, 6700, Denmark
Investigational Site Number :2080005
Holstebro, 7500, Denmark
Investigational Site Number :2080004
Odense, 5000, Denmark
Investigational Site Number :2460003
Helsinki, 00180, Finland
Investigational Site Number :2460001
Tampere, 33520, Finland
Investigational Site Number :2460002
Turku, 20520, Finland
Investigational Site Number :2500011
Bron, 69500, France
Investigational Site Number :2500005
Clermont-Ferrand, 63003, France
Investigational Site Number :2500015
Gonesse, 95500, France
Investigational Site Number :2500009
Lille, 59037, France
Investigational Site Number :2500006
Montpellier, 34295, France
Investigational Site Number :2500008
Nancy, 54035, France
Investigational Site Number :2500010
Nantes, 44093, France
Investigational Site Number :2500017
Nîmes, 30029, France
Investigational Site Number :2500016
Paris, 75012, France
Investigational Site Number :2500014
Paris, 75013, France
Investigational Site Number :2500007
Paris, 75019, France
Investigational Site Number :2500003
Rennes, 35033, France
Investigational Site Number :2500001
Strasbourg, 67098, France
Investigational Site Number :2500012
Toulouse, 31059, France
Investigational Site Number :2760005
Bayreuth, 95445, Germany
Investigational Site Number :2760009
Berlin, 10117, Germany
Investigational Site Number :2760001
Dresden, 01307, Germany
Investigational Site Number :2760012
Essen, 45147, Germany
Investigational Site Number :2760002
Giessen, 35385, Germany
Investigational Site Number :2760010
Halle, 06120, Germany
Investigational Site Number :2760006
Hanover, 30625, Germany
Investigational Site Number :2760008
Münster, 48149, Germany
Investigational Site Number :2760004
Rostock, 18055, Germany
Investigational Site Number :2760011
Ulm, 89081, Germany
Investigational Site Number :3000001
Athens, 115 28, Greece
Investigational Site Number :3000006
Athens, 11535, Greece
Investigational Site Number :3000002
Athens, 12462, Greece
Investigational Site Number :3000007
Athens, 15125, Greece
Investigational Site Number :3000004
Larissa, 41110, Greece
Investigational Site Number :3000003
Thessaloniki, 546 36, Greece
Investigational Site Number :3000005
Thessaloniki, 57010, Greece
Investigational Site Number :3480008
Budapest, 1135, Hungary
Investigational Site Number :3480004
Budapest, 1145, Hungary
Investigational Site Number :3480007
Budapest, 1152, Hungary
Investigational Site Number :3480002
Pécs, 7623, Hungary
Investigational Site Number :3480001
Szeged, 6725, Hungary
Investigational Site Number :3480006
Tatabánya, 2800, Hungary
Investigational Site Number :3560007
Gūrgaon, 122001, India
Investigational Site Number :3560003
Gūrgaon, 122002, India
Investigational Site Number :3560005
India, India
Investigational Site Number :3560004
Mangaluru, 575018, India
Investigational Site Number : 3560009
Nagpur, 440012, India
Investigational Site Number :3560006
New Delhi, 110029, India
Investigational Site Number :3560002
New Delhi, 110060, India
Investigational Site Number :3760002
Ashkelon, 78278, Israel
Investigational Site Number :3760003
Haifa, 31096, Israel
Investigational Site Number :3760008
Jerusalem, 91120, Israel
Investigational Site Number :3760004
Safed, 13100, Israel
Investigational Site Number :3760001
Tel Litwinsky, 52621, Israel
Investigational Site Number :3800011
Bergamo, 24127, Italy
Investigational Site Number :3800007
Cagliari, 09126, Italy
Investigational Site Number :3800012
Florence, 50134, Italy
Investigational Site Number :3800016
Florence, 50141, Italy
Investigational Site Number :3800014
Genova, 16132, Italy
Investigational Site Number :3800013
L’Aquila, 67010, Italy
Investigational Site Number :3800004
Milan, 20122, Italy
Investigational Site Number :3800001
Milan, 20132, Italy
Investigational Site Number :3800010
Milan, 20133, Italy
Investigational Site Number :3800008
Pavia, 27100, Italy
Investigational Site Number :3800005
Roma, 00152, Italy
Investigational Site Number :3800009
Roma, 00168, Italy
Investigational Site Number :3920016
Chiba, Chiba, 260-8677, Japan
Investigational Site Number :3920022
Morioka, Iwate, 020-8505, Japan
Investigational Site Number :3920011
Kyoto, Kyoto, 616-8255, Japan
Investigational Site Number :3920020
Sendai, Miyagi, 980-8574, Japan
Investigational Site Number :3920005
Niigata, Niigata, 951-8520, Japan
Investigational Site Number :3920004
Moriguchi-shi, Osaka, 570-8507, Japan
Investigational Site Number :3920001
Osaka, Osaka, 556-0016, Japan
Investigational Site Number :3920018
Kawagoe-shi, Saitama, 350-8550, Japan
Investigational Site Number :3920003
Kodaira-shi, Tokyo, 187-8551, Japan
Investigational Site Number :3920010
Ōta-ku, Tokyo, 146-0065, Japan
Investigational Site Number :3920009
Ube-shi, Yamaguchi, 755-8505, Japan
Investigational Site Number :3920023
Sagamihara-shi, 252-0392, Japan
Investigational Site Number :4400003
Kaunas, 50161, Lithuania
Investigational Site Number :4400002
Klaipėda, 92288, Lithuania
Investigational Site Number :4400001
Vilnius, 08661, Lithuania
Investigational Site Number :5280001
Amsterdam, 1081 GN, Netherlands
Investigational Site Number :5280003
Breda, 4818 CK, Netherlands
Investigational Site Number :5280006
Groningen, 9728 NZ, Netherlands
Investigational Site Number :5280002
Sittard-Geleen, 6162 BG, Netherlands
Investigational Site Number :5780003
Bergen, 5021, Norway
Investigational Site Number :5780002
Namsos, 7800, Norway
Investigational Site Number :5780001
Oslo, 0450, Norway
Investigational Site Number :6160008
Plewiska, Greater Poland Voivodeship, 62-064, Poland
Investigational Site Number :6160003
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Investigational Site Number :6160005
Warsaw, Masovian Voivodeship, 01-211, Poland
Investigational Site Number :6160006
Warsaw, Masovian Voivodeship, 01-684, Poland
Investigational Site Number :6160002
Katowice, Silesian Voivodeship, 40-571, Poland
Investigational Site Number :6160007
Katowice, Silesian Voivodeship, 40-684, Poland
Investigational Site Number :6160004
Katowice, Silesian Voivodeship, 40-686, Poland
Investigational Site Number :6160001
Lodz, 90-549, Poland
Investigational Site Number :6160012
Lublin, 20-016, Poland
Investigational Site Number :6160011
Zabrze, 41-800, Poland
Investigational Site Number :6200001
Braga, 4710-243, Portugal
Investigational Site Number :6200011
Lisbon, 1162-050, Portugal
Investigational Site Number :6200007
Lisbon, 1349-019, Portugal
Investigational Site Number :6200006
Lisbon, 1649-035, Portugal
Investigational Site Number :6200002
Matosinhos Municipality, 4464-513, Portugal
Investigational Site Number :6200010
Porto, 4099-001, Portugal
Investigational Site Number :6420008
Bucharest, 022328, Romania
Investigational Site Number :6420004
Campulung Muscel, 115100, Romania
Investigational Site Number :6420006
Cluj-Napoca, 400012, Romania
Investigational Site Number :6420003
Constanța, 900123, Romania
Investigational Site Number :6420013
Oradea, 410154, Romania
Investigational Site Number :6420005
Sibiu, 550052, Romania
Investigational Site Number :6420001
Târgu Mureş, 540136, Romania
Investigational Site Number :6420002
Timișoara, 300736, Romania
Investigational Site Number :6430018
Barnaul, 656024, Russia
Investigational Site Number :6430025
Kaliningrad, 236035, Russia
Investigational Site Number :6430003
Kazan', 420021, Russia
Investigational Site Number :6430022
Kemerovo, 650099, Russia
Investigational Site Number :6430017
Kirov, 610998, Russia
Investigational Site Number :6430024
Krasnoyarsk, 660029, Russia
Investigational Site Number :6430020
Moscow, 117997, Russia
Investigational Site Number :6430002
Moscow, 125367, Russia
Investigational Site Number :6430013
Moscow, 127015, Russia
Investigational Site Number :6430001
Moscow, 129110, Russia
Investigational Site Number :6430008
Moscow, 129128, Russia
Investigational Site Number :6430021
Nizhny Novgorod, 603137, Russia
Investigational Site Number :6430006
Nizhny Novgorod, 603155, Russia
Investigational Site Number :6430005
Novosibirsk, 630087, Russia
Investigational Site Number :6430026
Perm, 614990, Russia
Investigational Site Number :6430007
Pyatigorsk, 357538, Russia
Investigational Site Number :6430016
Rostov-on-Don, 344022, Russia
Investigational Site Number :6430011
Saint Petersburg, 197022, Russia
Investigational Site Number :6430004
Saint Petersburg, 197110, Russia
Investigational Site Number :6430009
Samara, 443095, Russia
Investigational Site Number :6430019
Saransk, 430032, Russia
Investigational Site Number :6430014
Smolensk, 214018, Russia
Investigational Site Number :6430012
Tyumen, 625000, Russia
Investigational Site Number :6430010
Ufa, 450005, Russia
Investigational Site Number :6430023
Yekaterinburg, 620102, Russia
Investigational Site Number :7240007
Seville, Andalusia, 41009, Spain
Investigational Site Number :7240013
Barcelona, Barcelona [Barcelona], 08035, Spain
Investigational Site Number :7240016
Barcelona, Barcelona [Barcelona], 08036, Spain
Investigational Site Number :7240012
Donostia / San Sebastian, Basque Country, 20014, Spain
Investigational Site Number :7240014
Salt, Girona [Gerona], 17190, Spain
Investigational Site Number :7240017
Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Investigational Site Number :7240004
Majadahonda, Madrid, 28222, Spain
Investigational Site Number :7240001
Pozuelo de Alarcón, Madrid, 28223, Spain
Investigational Site Number :7240008
Córdoba, 14004, Spain
Investigational Site Number :7240015
Lleida, 25198, Spain
Investigational Site Number :7240005
Madrid, 28007, Spain
Investigational Site Number :7240002
Madrid, 28034, Spain
Investigational Site Number :7240003
Madrid, 28040, Spain
Investigational Site Number :7240009
Málaga, 29010, Spain
Investigational Site Number :7240010
Murcia, 30120, Spain
Investigational Site Number :7240011
Valencia, 46026, Spain
Investigational Site Number :7920005
Eskişehir, Turkey (Türkiye)
Investigational Site Number :7920010
Hatay, Turkey (Türkiye)
Investigational Site Number :7920002
Istanbul, 34098, Turkey (Türkiye)
Investigational Site Number :7920009
Istanbul, 34688, Turkey (Türkiye)
Investigational Site Number :7920007
Istanbul, 34785, Turkey (Türkiye)
Investigational Site Number :7920006
Istanbul, 34896, Turkey (Türkiye)
Investigational Site Number :7920003
Istanbul, Turkey (Türkiye)
Investigational Site Number :7920013
Izmir, 35100, Turkey (Türkiye)
Investigational Site Number :7920001
İzmit, 41380, Turkey (Türkiye)
Investigational Site Number :7920011
Kütahya, 43100, Turkey (Türkiye)
Investigational Site Number :7920012
Mersin, 33070, Turkey (Türkiye)
Investigational Site Number :7920008
Trabzon, 61080, Turkey (Türkiye)
Investigational Site Number :8040008
Chernivtsi, 58000, Ukraine
Investigational Site Number :8040016
Chernivtsi, 58023, Ukraine
Investigational Site Number :8040003
Dnipro, 49005, Ukraine
Investigational Site Number :8040010
Ivano-Frankivsk, 76018, Ukraine
Investigational Site Number :8040007
Kharkiv, 61068, Ukraine
Investigational Site Number :8040011
Kharkiv, 61103, Ukraine
Investigational Site Number :8040012
Kharkiv, 61103, Ukraine
Investigational Site Number :8040013
Kyiv, 03115, Ukraine
Investigational Site Number :8040005
Lutsk, 43005, Ukraine
Investigational Site Number :8040009
Lviv, 79010, Ukraine
Investigational Site Number :8040004
Lviv, 79013, Ukraine
Investigational Site Number :8040002
Odesa, 65025, Ukraine
Investigational Site Number :8040006
Vinnytsia, 21050, Ukraine
Investigational Site Number :8040014
Zhytomyr, 10002, Ukraine
Investigational Site Number :8260003
Exeter, Devon, EX2 5DW, United Kingdom
Investigational Site Number :8260008
Plymouth, Devon, PL6 8DH, 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 9DZ, United Kingdom
Investigational Site Number :8260009
Bristol, BS10 5NB, United Kingdom
Investigational Site Number :8260001
Cardiff, CF4 4XY, United Kingdom
Investigational Site Number :8260005
London, SW17 0RE, United Kingdom
Investigational Site Number :8260018
London, W6 8RF, United Kingdom
Investigational Site Number :8260014
Newcastle upon Tyne, NE1 4LP, United Kingdom
Investigational Site Number :8260019
Salford, M6 8HD, United Kingdom
Related Publications (1)
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.
PMID: 40202696DERIVED
Related Links
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi aventis recherche & développement
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2020
First Posted
June 2, 2020
Study Start
September 24, 2020
Primary Completion
August 29, 2024
Study Completion
August 29, 2024
Last Updated
July 2, 2025
Results First Posted
June 18, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
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