Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

Completed · Phase 3 · Has a placebo group

Conditions studied: Primary Progressive Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT04458051

Run by

Sanofi

People needed

767

Starts

2020-08-13

Expected to finish

2025-11-14

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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 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
• 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 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

Where it is running

• Collaborative Neuroscience Research Site Number : 8400045 — Los Alamitos, California, United States
• Multiple Sclerosis Center- Site Number : 8400143 — Los Angeles, California, United States
• Multiple Sclerosis Center of California Site Number : 8400135 — Newport Beach, California, United States
• SC3 Research - Pasadena Site Number : 8400070 — Pasadena, 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
• Advanced Neurosciences Research Site Number : 8400025 — Fort Collins, Colorado, United States
• South Florida Neurology Associates Site Number : 8400029 — Boca Raton, Florida, United States
• MS & Neuromuscular Center of Excellence Site Number : 8400172 — Clearwater, Florida, United States
• University of Florida, Fixel Center for Neurology Site Number : 8400159 — Gainesville, Florida, United States
• Neurology Associates, PA- Site Number : 8400004 — Maitland, Florida, United States
• University of South Florida Site Number : 8400006 — Tampa, Florida, United States
• Velocity Clinical Research Site Number : 8400003 — Savannah, Georgia, United States
• Hawaii Pacific Neuroscience Site Number : 8400103 — Honolulu, Hawaii, United States
• Consultants In Neurology- Site Number : 8400011 — Northbrook, Illinois, United States
• Methodist Hospital Site Number : 8400164 — Merrillville, Indiana, United States
• College Park Family Care Center Site Number : 8400044 — Overland Park, Kansas, United States
• University of Kentucky Site Number : 8400106 — Lexington, Kentucky, United States
• Ochsner Baptist Clinical Trials Unit (CTU)- Site Number : 8400107 — New Orleans, Louisiana, United States
• International Neurorehabilitation Institute Site Number : 8400034 — Lutherville, Maryland, United States
• Tufts Medical Center Site Number : 8400072 — Boston, Massachusetts, United States
• University of Massachusetts Site Number : 8400014 — Worcester, Massachusetts, United States
• Michigan Institute For Neurological Disorders Site Number : 8400058 — Farmington Hills, Michigan, United States
• UC San Diego ACTRI Site Number : 8400101 — La Jolla, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.