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

  • STATUS
    Recruiting
  • End date
    May 4, 2027
  • participants needed
    1400
  • sponsor
    Sanofi
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Updated on 2 September 2024
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Summary

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.
Study details include:
  • This event-driven study will have variable duration of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized.
  • The study intervention duration will vary ranging from approximately 12 to 40 months.
  • The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months.

Description

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Details
Condition Multiple Sclerosis
Age 18years - 55years
Treatment placebo infusion, TERIFLUNOMIDE, Frexalimab, MRI contrast-enhancing agents, Placebo tablet, Cholestyramine, Activated charcoal
Clinical Study IdentifierNCT06141473
SponsorSanofi
Last Modified on2 September 2024

Eligibility

 Yes No Not Sure

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 ≤5.5 at the first visit (Screening Visit)
The participant must have at least 1 of the following prior to screening
≥1 documented relapse within the previous year OR
≥2 documented relapses within the previous 2 years, OR
≥1 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 thromboembolic events, as well as myocardial infarction, stroke, and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment
History or current hypogammaglobulinemia defined by values below the lower limit of normal (LLN)
A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis
The participant has had a relapse in the 30 days prior to randomization
The participant has contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans
The above information is not intended to contain all considerations relevant
to a participant's potential participation in a clinical trial
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