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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to weeks 12, 24, 36 and 48
Awards & highlights
Study Summary
This trial will test a drug's effect on MS patients, looking at safety, tolerability & effectiveness. It will last 100 weeks.
Who is the study for?
Adults aged 18-60 with Multiple Sclerosis (RRMS, SPMS, or PPMS) can join this trial. They must be stable on approved treatments for at least 3 months or untreated, have an EDSS score up to 26, weigh at least 45 kg with a BMI of at least 18.0 kg/m^2. Participants should not have other neurological diseases besides MS and must agree to use contraception.Check my eligibility
What is being tested?
The study is testing SAR443820 against a placebo in people with Multiple Sclerosis over approximately two years. It includes initial double-blind treatment where neither participants nor researchers know who gets the real drug or placebo, followed by an open-label phase where everyone knows they're getting SAR443820.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions related to oral medications such as gastrointestinal discomfort, allergic reactions to ingredients in SAR443820, and any specific side effects that the investigational drug might cause.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (week 0) to weeks 12, 24, 36 and 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to weeks 12, 24, 36 and 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: Week 48 sNfL levels relative to baseline
Part B: Week 96 sNfL levels relative to baseline
Secondary outcome measures
Part A: Annualized relapse rate (ARR) of RMS population (relapsing SPMS and RRMS)
Part A: Change from baseline in EDSS Plus
Part A: Change from baseline in the intensity (T1) of SELs
+41 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SAR443820Experimental Treatment1 Intervention
Oral SAR443820
Group II: PlaceboPlacebo Group1 Intervention
Oral placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAR443820
2022
Completed Phase 1
~120
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Who is running the clinical trial?
SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,306 Total Patients Enrolled
40 Trials studying Multiple Sclerosis
14,089 Patients Enrolled for Multiple Sclerosis
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,125 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
11,417 Patients Enrolled for Multiple Sclerosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a serious infection in the last 4 weeks.I have a history of a neurological condition that is not multiple sclerosis.I am between 18 and 60 years old.I have an immune system disorder that requires me to take medicine to suppress my immune system.I have not received a live vaccine in the last 14 days.I have been diagnosed with a form of multiple sclerosis according to the latest criteria.I have a history of seizures or epilepsy.I haven't started treatment or have been stable on my current therapy for 3 months.My condition worsened within the last 8 weeks.I do not have severe heart, lung, liver, or kidney disease.I am not currently using any medications or treatments that are not allowed.I am currently taking medication that strongly affects liver enzyme CYP3A4.I weigh at least 45 kg and my BMI is at least 18.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: SAR443820
Awards:
This trial has 0 awards, including: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.
Is the age qualification for this research endeavor restricted to persons over 18 years of age?
"Based on the conditions for inclusion in this medical analysis, participants must be between 18 and 60 years old."
Answered by AI
Has SAR443820 been granted regulatory confirmation by the Food and Drug Administration?
"While SAR443820 is yet to be proven effective in clinical trials, there are some preliminary safety data points, thus it receives a score of 2."
Answered by AI
Who is eligible to join this medical experiment?
"In order to qualify for this clinical study, prospective participants must have a diagnosis of multiple sclerosis and fall within the age range of 18-60. The research team aims to enroll 168 individuals in total."
Answered by AI
Are there any current availabilities for individuals to participate in this trial?
"According to the information shared on clinicaltrials.gov, this experiment is actively recruiting patients. The trial was posted on December 27th 2022 and recently revised in January 31st 2023."
Answered by AI
Could you please provide an approximate number of participants in this research endeavor?
"Affirmative, the clinicaltrials.gov entry for this trial confirms it is actively enrolling participants. This study was first posted on December 27th 2022 and last updated January 31st 2023. Two sites are currently recruiting 168 patients in total."
Answered by AI
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