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

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Sanofi

Status and phase

Enrolling
Phase 3

Conditions

Multiple Sclerosis

Treatments

Drug: Activated charcoal
Drug: Cholestyramine
Drug: MRI contrast-enhancing agents
Drug: Placebo tablet
Drug: Frexalimab
Drug: Placebo infusion
Drug: Teriflunomide

Study type

Interventional

Funder types

Industry

Identifiers

NCT06141473
2023-504358-36 (Other Identifier)
U1111-1290-9326 (Registry Identifier)
EFC17919

Details and patient eligibility

About

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 20 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.

Enrollment

1,400 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,400 participants in 2 patient groups

Frexalimab
Experimental group
Description:
Participants will receive Frexalimab infusion and placebo tablet.
Treatment:
Drug: Frexalimab
Drug: Placebo tablet
Drug: Cholestyramine
Drug: MRI contrast-enhancing agents
Drug: Activated charcoal
Teriflunomide
Active Comparator group
Description:
Participants will receive teriflunomide tablet and placebo infusion.
Treatment:
Drug: Teriflunomide
Drug: Placebo infusion
Drug: Cholestyramine
Drug: MRI contrast-enhancing agents
Drug: Activated charcoal

Trial contacts and locations

83

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Central trial contact

Trial Transparency email recommended (Toll free number for US & Canada)

Data sourced from clinicaltrials.gov

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