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Tolebrutinib for Primary Progressive Multiple Sclerosis (PERSEUS Trial)

Phase 3
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease duration from the onset of MS symptoms of <15 years if screening EDSS score of >5.0 OR <10 years if screening EDSS score of ≤5.0.
Disease duration from the onset of MS symptoms of <15 years if screening EDSS score of >5.0 OR <10 years if screening EDSS score of ≤5.0
Must not have
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
Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 6, 9 and 12
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new drug to see if it can help people with primary progressive multiple sclerosis (PPMS) by delaying disability progression.

Who is the study for?
This trial is for adults aged 18-55 with Primary Progressive Multiple Sclerosis (PPMS) as per the McDonald criteria, an EDSS score of 2.0 to 6.5, and a disease duration less than 15 years if severely disabled or less than 10 years if not. Participants must use contraception and cannot be pregnant or breastfeeding.
What is being tested?
The study tests Tolebrutinib's effectiveness against a placebo in slowing down disability progression in PPMS patients. It also examines its impact on clinical outcomes, MRI lesions, cognitive function, physical ability, quality of life, safety/tolerability and how it moves through and acts in the body.
What are the potential side effects?
While specific side effects are not listed here, typical concerns may include potential reactions at the infusion site for Tolebrutinib (if applicable), general medication-related risks like nausea or headaches, and any unique issues identified during early phases of testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My MS symptoms started less than 15 years ago if my disability is severe, or less than 10 years if it's mild.
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My MS symptoms started less than 15 years ago if my disability is severe, or less than 10 years if it's mild.
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My disability level is moderate, as measured on a specific scale.
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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have HIV, hepatitis B or C, TB, or any serious infections.
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I haven't had major surgery in the last 4 weeks and don't plan any during the study.
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I am currently on blood thinners like aspirin (over 81mg/day), clopidogrel, or warfarin.
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I am not taking strong drugs that affect liver enzymes CYP3A or CYP2C8.
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I have a history of bleeding disorders or platelet dysfunction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 6, 9 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 6, 9 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
3-month composite Confirmed Disability Progression (cCDP)
Secondary study objectives
6-month Confirmed Disability Progression (CDP)
6-month composite Confirmed Disability Progression (cCDP)
Change in Multiple Sclerosis Quality of Life
+11 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SAR442168Experimental Treatment1 Intervention
Dose 1 of oral SAR442168 once daily
Group II: PlaceboPlacebo Group1 Intervention
Placebo to match the SAR442168 once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tolebrutinib
2020
Completed Phase 3
~3110

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,204 Previous Clinical Trials
4,036,012 Total Patients Enrolled
41 Trials studying Multiple Sclerosis
16,136 Patients Enrolled for Multiple Sclerosis
Clinical Sciences & OperationsStudy DirectorSanofi
873 Previous Clinical Trials
2,020,085 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
10,964 Patients Enrolled for Multiple Sclerosis

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04458051 — Phase 3
Multiple Sclerosis Research Study Groups: Placebo, SAR442168
Multiple Sclerosis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04458051 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04458051 — Phase 3
~104 spots leftby Jul 2025
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