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NCT Number: NCT06141486

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

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. * If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number : 0320003, Rosario, Santa Fe Province, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Current hypogammaglobulinemia defined by immunoglobulin levels (IgG and/or IgM) below the lower limits of normal (LLN) at Screening or a history of primary hypogammaglobulinemia. Patients with a history of secondary hypogammaglobulinemia induced by anti-C20 monoclonal antibodies (eg, ocrelizumab, ofatumumab, ublituximab, rituximab) may be considered for study inclusion provided their immunoglobulin levels are within the normal limits (WNL) at time of Screening.
  • 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.

Treatment and study plan

Frexalimab

Drug

SAR441344 Solution for IV infusion

Placebo

Drug

Solution for IV infusion

MRI contrast-enhancing agents

Drug

IV, as per respective label

Primary outcomes

  1. Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months in the double-blind treatment period

    Time frame: Up to 36 months

    Defined as Increase from the baseline expanded disability status scale (EDSS) score of ≥1.0 point when the baseline is <5.5, or ≥0.5 point when the baseline is ≥5.5, OR Increase of ≥20% from the baseline time in the 9 hole peg test (9HPT),OR Increase of ≥20% from the baseline time in the timed 25 foot walk (T25FW) test

Secondary outcomes

  1. Time to onset of composite cCDP confirmed over 3 months in the double-blind treatment period

    Time frame: Up to 36 months

  2. Time to onset of individual components of the composite, confirmed over 3-months or 6 months in the double-blind treatment period

    Time frame: Up to 36 months

    increase from the baseline EDSS score of ≥1.0 point when the baseline is <5.5, or ≥0.5 point when the baseline is ≥5.5

  3. Time to onset of confirmed disability improvement (CDI) in the double-blind treatment period

    Time frame: Up to 36 months

    defined as decrease from the baseline EDSS score of ≥1.0 or ≥ 0.5 points when baseline is ≤5.5 or >5.5 points, respectively, confirmed over 6 months.

  4. Number of new and/or enlarging T2hyperintense lesions per scan as detected by MRI, and number of new and/or enlarging T2-hyperintense lesions per scan as detected by MRI

    Time frame: Up to 36 months

    defined as the sum of the individual number of new and/or enlarging T2-hyperintense lesions at all scheduled visits starting after baseline up to the end of double-blind treatment period

  5. Percent change in brain volume loss as detected by MRI scans at the end of double-blind treatment period compared to Month 6

    Time frame: Up to 36 months

  6. Change in cognitive function at the end of double-blind treatment period compared to baseline as assessed by symbol digit modalities test (SDMT)

    Time frame: Baseline, Up to 36 months

  7. Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time in the double-blind treatment period

    Time frame: Baseline, Up to 36 months

  8. Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue multiple sclerosis (MS)-8a over time in the double-blind treatment period

    Time frame: Baseline, Up to 36 months

  9. Annualized relapse rate during the double-blind treatment period assessed by protocol defined adjudicated relapses

    Time frame: Up to 36 months

  10. Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation and AE of special interests (AESIs)

    Time frame: Up to 36 months

  11. Number of participants with potentially clinically significant abnormalities (PCSAs) in laboratory tests, ECG, and vital signs during the study period

    Time frame: Up to 36 months

    12-lead ECG (electrocardiogram) will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.

  12. Number of participants with antibody over time

    Time frame: Up to 36 months

  13. Change from baseline in serum Ig levels over time

    Time frame: Up to 36 months

  14. Change from baseline in plasma neurofilament light chain (NfL) levels over time in the double-blind treatment period

    Time frame: Up to 36 months

  15. Frexalimab plasma concentration over time in the double-blind treatment period

    Time frame: Up to 36 months

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis

Acronym: FREVIVA

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Nov 21, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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