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Frexalimab for Multiple Sclerosis
Study Summary
This trial is testing a new drug, SAR441344, to see if it can reduce the number of new active brain lesions in people with multiple sclerosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You tested positive for Hepatitis C within the last 3 months.I have had at least one relapse in the past year or a recent MRI showing active brain lesions.My weight is between 45 and 120 kg, and my BMI is between 18.0 and 35.0.I have a history or risk of blood clots, heart attack, stroke, or need blood thinner medication.My disability due to MS is severe, needing help to walk.I have been diagnosed with primary progressive or non-relapsing secondary progressive MS.I am between 18 and 55 years old.I have been diagnosed with RMS according to the 2017 McDonald criteria.My condition worsened in the last 30 days.My weight is between 45 to 120 kg and my BMI is between 18.0 to 35.0.You are allergic to humanized monoclonal antibodies or have had severe allergic reactions to any biological medication other than mild reactions at the injection site.I am able to understand and sign the consent form.Your lab test results are not normal.I have tested positive for Hepatitis B recently.If you are of reproductive age, you must use birth control methods that follow the local regulations for clinical trial participants.I have not taken any forbidden medications recently.You have HIV or have had HIV in the past.
- Group 1: Subcutaneous (SC) SAR441344
- Group 2: Intravenous (IV) SAR441344
- Group 3: IV Placebo
- Group 4: SC Placebo
- 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
Does this research study accept participants of all ages, including those under 65?
"The age boundary for this research is 18 to 55. For those younger than 18, there are 43 other trials they can join while 391 studies accept patients over 65 years of age."
For what kind of research participants is this trial most suited?
"This trial seeks 129 individuals with multiple sclerosis who are between 18 and 55 years of age. To be considered eligible, candidates must have a body weight in the range of 45 to 120 kilograms (inclusive) and a BMI ranging from 18.0 to 35.0 kg/m2 (inclusive). Furthermore, both men and women involved in this study ought to comply with local regulations regarding contraception methods while taking part in clinical studies."
Is enrollment in this experiment currently available?
"The clinicaltrials.gov page for this trial indicates that it is no longer recruiting patients; the original post date was June 7th 2021 and the last update occurred on October 10th 2022. However, there are currently 549 other trials that still need participants to join them in their research endeavours."
Is this medical experiment being undertaken in numerous health centers across North America?
"Seven sites are participating in the trial, including Milwaukee (8400003), Phoenix (8400007) and Gatineau (8400006). Additionally, there are four other recruitment locations."
Has SAR441344 SC been granted authorization from the FDA?
"Due to the lack of efficacy data, SAR441344 SC was given a safety score 2 on our scale. This assessment is based off the fact that this trial is currently in phase two, meaning there are some indications of safety but no evidence demonstrating effectiveness yet."
Who else is applying?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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