Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis (FREVIVA)

  • STATUS
    Recruiting
  • End date
    Mar 24, 2028
  • participants needed
    858
  • sponsor
    Sanofi
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Updated on 7 August 2024
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Summary

The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to approximately 51 months administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS 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 ranging from approximately 27 to 51 months.
  • The study intervention duration will vary ranging from approximately 12 to 51 months.
  • The number of scheduled visits will be up to 27 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.

Details
Condition Multiple Sclerosis
Age 18-60 years
Treatment Placebo, Frexalimab, MRI contrast-enhancing agents
Clinical Study IdentifierNCT06141486
SponsorSanofi
Last Modified on7 August 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria
Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee
Participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee
Absence of clinical relapses for at least 24 months
The participant must have an EDSS score at screening from 3.0 to 6.5 points, inclusive
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion 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 sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
The participant was previously exposed to frexalimab
The above information is not intended to contain all considerations relevant
to a patient's potential participation in a clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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