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

Investigation of an Investigational Medication for Delaying Disability in Non-Relapsing Secondary Progressive Multiple Sclerosis (nrSPMS)

Recruiting
18 years - 60 years
All
Phase 3
900 participants needed
1 Location

Study Overview

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 36 months double-blind 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 end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end.
  • The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Sclerosis
  • Age: 18 years - 60 years
  • Gender: All

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.
  • For patients eligible to be treated with siponimod: 1) does not tolerate it due to side effects or safety reasons, or 2) has failed siponimod treatment due to perceived lack of efficacy, or 3) has declined siponimod treatment.

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.

Updated on 04 Apr 2025. Study ID: NCT06141486

This study investigates the efficacy and safety of an investigational medication in delaying disability progression in individuals with non-relapsing secondary progressive multiple sclerosis (nrSPMS). nrSPMS is a stage of multiple sclerosis (MS) where symptoms worsen over time without periods of remission. Participants will be randomly assigned to receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.

Participants will undergo regular health assessments and monitoring. The study will include frequent visits initially, followed by less frequent visits. These visits will involve various tests and evaluations to monitor the participants' health and the effects of the medication. The safety and effectiveness of the investigational medication will be compared to the placebo over the course of the study.

  • Who can participate: Adults aged 18 to 60 years with non-relapsing secondary progressive multiple sclerosis (nrSPMS) who have shown disability progression in the past year and have not experienced clinical relapses for at least 24 months may participate.
  • Study details: Participants will receive either the investigational medication or a placebo and attend regular clinic visits for health assessments and monitoring.
  • Study Timelines and Visits: The study will last 43 months. The study requires up to 25 visits.

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