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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 6, 9 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 6, 9 and 12
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 moreAwards & 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
2,215 Previous Clinical Trials
4,046,321 Total Patients Enrolled
41 Trials studying Multiple Sclerosis
16,136 Patients Enrolled for Multiple Sclerosis
Clinical Sciences & OperationsStudy DirectorSanofi
876 Previous Clinical Trials
2,020,904 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
10,964 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with primary progressive multiple sclerosis using specific criteria from 2017.My MS symptoms started less than 15 years ago if my disability is severe, or less than 10 years if it's mild.You have a history of alcohol or drug abuse within the last year before the screening.I have not been hospitalized for a psychiatric condition in the last 2 years.You have important abnormal results from blood tests or heart tests done before the study.I have taken medication for MS recently.You cannot have a magnetic resonance imaging (MRI) for medical reasons.I do not have HIV, hepatitis B or C, TB, or any serious infections.I have had cancer within the last 5 years.I haven't had major surgery in the last 4 weeks and don't plan any during the study.I am currently on blood thinners like aspirin (over 81mg/day), clopidogrel, or warfarin.You had a major bleeding event, like in your brain or stomach, within the past 6 months.I have not received a live vaccine in the last 2 months.Your lymphocyte count is lower than what is considered normal.I am not taking strong drugs that affect liver enzymes CYP3A or CYP2C8.I do not have any ongoing infections that could interfere with the study treatment.I have a history of bleeding disorders or platelet dysfunction.You are not able to get pregnant, or if you can get pregnant, you agree to use a reliable birth control method during the study.My MS symptoms started less than 15 years ago if my disability is severe, or less than 10 years if it's mild.Your blood platelet count is less than 150,000 per microliter at the screening visit.You have abnormal levels of certain substances in your spinal fluid or a history of this condition.My disability level is moderate, as measured on a specific scale.I am between 18 and 55 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: SAR442168
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.