ClinicalTrials.gov record
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
ClinicalTrials.gov ID: NCT04458051
Public ClinicalTrials.gov record NCT04458051. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)
Study identification
- NCT ID
- NCT04458051
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Sanofi
- Industry
- Enrollment
- 767 participants
Conditions and interventions
Conditions
Interventions
- Tolebrutinib Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 12, 2020
- Primary completion
- Nov 13, 2025
- Completion
- Nov 13, 2025
- Last update posted
- Jan 6, 2026
2020 – 2025
United States locations
- U.S. sites
- 45
- U.S. states
- 25
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC San Diego ACTRI Site Number : 8400101 | La Jolla | California | 92037 | — |
| Collaborative Neuroscience Research Site Number : 8400045 | Los Alamitos | California | 90720 | — |
| Multiple Sclerosis Center- Site Number : 8400143 | Los Angeles | California | 90033 | — |
| Multiple Sclerosis Center of California Site Number : 8400135 | Newport Beach | California | 92663 | — |
| SC3 Research - Pasadena Site Number : 8400070 | Pasadena | California | 91105 | — |
| University of San Francisco, Sandler Neurosciences Center- Site Number : 8400137 | San Francisco | California | 94158 | — |
| Harbor UCLA Site Number : 8400088 | Torrance | California | 90502 | — |
| Regina Berkovich, MD, PhD Site Number : 8400059 | West Hollywood | California | 90048 | — |
| Advanced Neurosciences Research Site Number : 8400025 | Fort Collins | Colorado | 80528 | — |
| South Florida Neurology Associates Site Number : 8400029 | Boca Raton | Florida | 33487 | — |
| MS & Neuromuscular Center of Excellence Site Number : 8400172 | Clearwater | Florida | 33761 | — |
| University of Florida, Fixel Center for Neurology Site Number : 8400159 | Gainesville | Florida | 32601 | — |
| Neurology Associates, PA- Site Number : 8400004 | Maitland | Florida | 32761 | — |
| University of South Florida Site Number : 8400006 | Tampa | Florida | 33612 | — |
| Velocity Clinical Research Site Number : 8400003 | Savannah | Georgia | 31406 | — |
| Hawaii Pacific Neuroscience Site Number : 8400103 | Honolulu | Hawaii | 96817 | — |
| Consultants In Neurology- Site Number : 8400011 | Northbrook | Illinois | 60062 | — |
| Methodist Hospital Site Number : 8400164 | Merrillville | Indiana | 46410 | — |
| College Park Family Care Center Site Number : 8400044 | Overland Park | Kansas | 66210 | — |
| University of Kentucky Site Number : 8400106 | Lexington | Kentucky | 40536 | — |
| Ochsner Baptist Clinical Trials Unit (CTU)- Site Number : 8400107 | New Orleans | Louisiana | 70121 | — |
| International Neurorehabilitation Institute Site Number : 8400034 | Lutherville | Maryland | 21093 | — |
| Tufts Medical Center Site Number : 8400072 | Boston | Massachusetts | 02111 | — |
| University of Massachusetts Site Number : 8400014 | Worcester | Massachusetts | 01655 | — |
| Michigan Institute For Neurological Disorders Site Number : 8400058 | Farmington Hills | Michigan | 48334 | — |
| The Memorial Hospital- Site Number : 8400033 | Owosso | Michigan | 48867 | — |
| Mayo Clinic Site Number : 8400111 | Rochester | Minnesota | 55905 | — |
| Sharlin Health & Neurology Site Number : 8400093 | Ozark | Missouri | 65721 | — |
| University Of Nebraska- Site Number : 8400129 | Omaha | Nebraska | 68198 | — |
| Hackensack University Hospital Site Number : 8400047 | Hackensack | New Jersey | 07601 | — |
| University of New Mexico Site Number : 8400032 | Albuquerque | New Mexico | 87131 | — |
| Icahn School of Medicine at Mount Sinai (Department of Endoc Site Number : 8400038 | New York | New York | 10029-6501 | — |
| Neurology Associates of Stony Brook Site Number : 8400042 | Stony Brook | New York | 11794 | — |
| Duke Neurological Disorders Clinic- Site Number : 8400098 | Durham | North Carolina | 27710 | — |
| Meridian Clinical Research, LLC- Site Number : 8400005 | Raleigh | North Carolina | 27607 | — |
| Atrium Health Wake Forest Baptist Site Number : 8400116 | Winston-Salem | North Carolina | 27103 | — |
| Riverhills Neuroscience - Norwood Site Number : 8400167 | Cincinnati | Ohio | 45212 | — |
| 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 | — |
| Providence Multiple Sclerosis Center Site Number : 8400020 | Portland | Oregon | 97225 | — |
| Jefferson Neurology Associates Site Number : 8400016 | Philadelphia | Pennsylvania | 19107 | — |
| Mountain View Clinical Research Site Number : 8400024 | Greer | South Carolina | 29651-1817 | — |
| Mt Olympus Medical Research Site Number : 8400163 | Katy | Texas | 77450 | — |
| Neurology Center of San Antonio Site Number : 8400036 | San Antonio | Texas | 78258 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 232 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04458051, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 6, 2026 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04458051 live on ClinicalTrials.gov.