for people ages 18-55 (full criteria)
at San Francisco, California and other locations
study started
completion around
Principal Investigator
by Bruce Cree
Headshot of Bruce Cree
Bruce Cree



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

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


Primary Progressive Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Sclerosis, Tolebrutinib


You can join if…

Open to people ages 18-55

  • 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: - 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

You CAN'T join if...

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. - 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


- 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


- The participant has received medications/treatments for MS within a specified time


- 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


  • University of San Francisco, Sandler Neurosciences Center Site Number : 8400137 in progress, not accepting new patients
    San Francisco California 94158 United States
  • SC3 Research - Pasadena Site Number : 8400070 accepting new patients
    Pasadena California 91105 United States
  • UC San Diego ACTRI Site Number : 8400101 accepting new patients
    La Jolla California 92037 United States

Lead Scientist at UCSF

  • Bruce Cree
    Bruce Cree, MD, PhD, MAS is a Professor of Clinical Neurology and is the George A. Zimmermann Endowed Professor in Multiple Sclerosis in the Department of Neurology at the University of California San Francisco. Dr. Cree completed his MD and PhD in Biochemistry at UCSF. His neurology residency training was at Columbia University.


accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
Phase 3 Multiple Sclerosis Research Study
Study Type
Expecting 700 study participants
Last Updated