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Tolebrutinib for Primary Progressive Multiple Sclerosis (PERSEUS Trial)
Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 6, 9 and 12
Awards & highlights
PERSEUS 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.Check my eligibility
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.See study design
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.
PERSEUS Trial 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.
Select...
My MS symptoms started less than 15 years ago if my disability is severe, or less than 10 years if it's mild.
Select...
My disability level is moderate, as measured on a specific scale.
Select...
I am between 18 and 55 years old.
PERSEUS Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
3-month composite Confirmed Disability Progression (cCDP)
Secondary outcome measures
6-month Confirmed Disability Progression (CDP)
6-month composite Confirmed Disability Progression (cCDP)
Change in Multiple Sclerosis Quality of Life
+11 morePERSEUS 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 1
~110
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,280 Total Patients Enrolled
41 Trials studying Multiple Sclerosis
16,063 Patients Enrolled for Multiple Sclerosis
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,138 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
10,891 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Where can I find a list of sites where this trial is taking place?
"To make participation as convenient as possible, this trial has 80 enrolment sites. These enrolment centres are situated in La Jolla, Newport Beach, Milwaukee as well as other towns and cities."
Answered by AI
How many test subjects are recruited for this clinical trial?
"To carry out this research project, 990 individuals who meet the eligibility standards are required. The pharmaceutical company sponsoring the trial, Sanofi, will administer the study from various locations, such as Investigational Site Number :8400101 in La Jolla, California and Investigational Site Number :8400135 in Newport Beach, Wisconsin."
Answered by AI
If I enroll in the trial, am I able to complete it?
"This trial is looking for 990 people, aged 18-55, who have primary progressive multiple sclerosis. Participants must also meet the following criteria:- Aged 18-55- EDSS score of 2.0-6.5 at screening- Not a WOCBP, or a WOCBP using acceptable contraception- Disease duration <15 years if EDSS >5.0, or <10 years if EDSS ≤5.0"
Answered by AI
Has Tolebrutinib received regulatory approval from the United States Food and Drug Administration?
"Tolebrutinib's safety is supported by multiple rounds of clinical data, leading our team to rate it a 3."
Answered by AI
Does this study require that participants be over the age of 30?
"This particular study only enrolls patients aged 18-55. However, there are 42 other trials for treatments targeting those under 18 and 403 for treatments targeting those 65 and older."
Answered by AI
Who else is applying?
What state do they live in?
Mississippi
How old are they?
18 - 65
What site did they apply to?
Investigational Site Number :8400107
What portion of applicants met pre-screening criteria?
Did not meet criteria
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