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NCT06141473RECRUITINGIRB Ready

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

(FREXALT)

Sponsored by Sanofi

Quick Self-Assessment

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๐Ÿ“Š
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0% interest

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.

Who Can Participate

Inclusion Criteria

The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria.
The participant has an EDSS score โ‰ค5.5 at the first visit (Screening Visit)
The participant must have at least 1 of the following prior to screening:
โ‰ฅ1 documented relapse within the previous year OR
โ‰ฅ2 documented relapses within the previous 2 years, OR
โ‰ฅ1 documented Gd enhancing lesion on an MRI scan within the previous year.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria

The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria
The participant has a history of infection or may be at risk for infection:
The presence of psychiatric disturbance or substance abuse.
History, clinical evidence, suspicion or significant risk for thromboe

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

1600 participants

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Age Range

18 Years - 55 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Sanofi

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Birmingham

Alabama

Location available
View Birmingham location page
RECRUITING

Cullman

Alabama

Location available
View Cullman location page
RECRUITING

Homewood

Alabama

Location available
View Homewood location page
RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

Scottsdale

Arizona

Location available
View Scottsdale location page
RECRUITING

Scottsdale

Arizona

Location available
View Scottsdale location page
RECRUITING

Carlsbad

California

Location available
View Carlsbad location page
RECRUITING

Irvine

California

Location available
View Irvine location page
RECRUITING

Laguna Hills

California

Location available
View Laguna Hills location page

๐Ÿ“ And 91 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Multiple Sclerosis Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Multiple Sclerosis Treatment Options in Birmingham, Alabama

If you're searching for Multiple Sclerosis treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Cullman, Homewood and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Multiple Sclerosis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 1600 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Multiple Sclerosis?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Multiple Sclerosis

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Multiple Sclerosis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06141473. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.