This study is in progress, not accepting new patients

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

a study on Multiple Sclerosis

Summary

Eligibility
for people ages 18-55 (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Michael Sy (uci)

Description

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 depending on the recruitment rate, the event rate, the study discontinuation rate and the 12-month minimum treatment duration. Different participants will have different study durations. The last participant randomized will have at least 12 months of study duration, and assuming a 28-month recruitment period, the first participant randomized will have 40 months or longer of study duration.
  • The study intervention duration will vary similarly as the study duration.
  • The scheduled visits will include monthly visits for the first 6 months and quarterly visits thereafter until the common end of study (EOS), or premature end of treatment (pEOT) after which 3 follow-up visits will be performed

Official Title

Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis

Keywords

Multiple Sclerosis, teriflunomide, Cholestyramine Resin, Charcoal, Frexalimab, MRI contrast-enhancing agents, Cholestyramine, Activated charcoal

Eligibility

You can join if…

Open to people ages 18-55

  • 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.

You CAN'T join if...

  • 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.
  • Current hypogammaglobulinemia defined by Ig levels below the LLN at Screening or a history of primary 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 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.

Locations

  • University of California Irvine - School of Medicine- Site Number : 8401143
    Irvine California 92697 United States
  • Private Practice - Dr. Regina Berkovich- Site Number : 8400005
    West Hollywood California 90048 United States
  • Hoag Memorial Hospital Presbyterian- Site Number : 8401031
    Newport Beach California 92663 United States
  • Multiple Sclerosis Center of California - Laguna Hills- Site Number : 8401122
    Laguna Hills California 92653 United States
  • The Neurology Center of Southern California - Carlsbad- Site Number : 8400023
    Carlsbad California 92011 United States

Lead Scientist at University of California Health

  • Michael Sy (uci)
    Associate Clinical Professor, Neurology, School of Medicine. Authored (or co-authored) 11 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
Links
EFC17919 Plain Language Results Summary
ID
NCT06141473
Phase
Phase 3 Multiple Sclerosis Research Study
Study Type
Interventional
Participants
About 1655 people participating
Last Updated