A randomized, double-blind, Phase 3 study comparing efficacy and safety of SAR441344 to placebo in adult participants with non-relapsing secondary progressive multiple sclerosis (FREVIVA)

type of intervention

Interventional, Randomised controlled trial (interventional), Randomized

recruitment status

Recruiting

region

NSW, QLD, VIC

type of ms

Secondary progressive MS

Brief Summary

This is a Phase 3 clinical trial. Its aim is to demonstrate the efficacy and safety of an investigational drug compared to placebo in participants with Secondary Progressive MS. Globally, approximately 868 participants will be randomly assigned to the investigational drug or placebo. This is a double-blind study. This means the study doctor and participant will not know if they are receiving the investigational drug or placebo. Participants will receive an intravenous infusion once a month (every 4 weeks). The study is expected to last between 2.5 and 4.5 years.

Link to Website: www.sanofistudies.com/AU-nrSPMS

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.
  • 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 SAR441344.

The above information is not intended to contain all considerations relevant to a patient’s potential participation in a clinical trial.

Anticipated Start Date

Already started

Recruitment Contacts

NSW:

Principle Investigator: Raymond Schwartz at Southern Neurology.

Contact the clinical research coordinator at clinical.trials@southern-neurology.com.au

QLD:

Princess Alexandra Hospital

Principial Investigator: Stefan Blum

Site contact is Genevieve Skinner genevieve.skinner@health.qld.gov.au

Region

NSW, VIC, QLD
The trial is currently running in NSW with more sites to be added soon.

Ethics

Yes

Last Updated

17/06/2024

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