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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06141486
Recruitment Status : Recruiting
First Posted : November 21, 2023
Last Update Posted : April 10, 2024
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief Summary:

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 approximately 51 months 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 have variable duration ranging from approximately 27 to 51 months.
  • The study intervention duration will vary ranging from approximately 27 to 51 months.
  • The number of scheduled visits will be up to 27 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Frexalimab Drug: Placebo Drug: MRI contrast-enhancing agents Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 858 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 27, 2023
Estimated Primary Completion Date : December 23, 2026
Estimated Study Completion Date : March 24, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Frexalimab
Frexalimab IV administration
 Drug: Frexalimab
SAR441344 Solution for IV infusion

Drug: MRI contrast-enhancing agents
IV, as per respective label
Placebo Comparator: Placebo
Matching placebo
 Drug: Placebo
Solution for IV infusion

Drug: MRI contrast-enhancing agents
IV, as per respective label


Outcome Measures
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Primary Outcome Measures :
  1. Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months [ Time Frame: Until Week 204 ]
    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 Outcome Measures :
  1. Time to onset of composite cCDP confirmed over 3 months [ Time Frame: Until Week 204 ]
  2. Time to onset of individual components of the composite, confirmed over 3-months or 6-months [ Time Frame: Until Week 204 ]
  3. Time to onset of confirmed disability improvement (CDI) [ Time Frame: Until Week 204 ]
    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 month [ Time Frame: Until Week 204 ]
  5. Percent change in brain volume loss as detected by MRI scans at the end of study (EOS) compared to Month 6 [ Time Frame: From Week 24 to Week 204 ]
  6. Change in cognitive function at the EOS compared to baseline as assessed by symbol digit modalities test (SDMT) [ Time Frame: Baseline, Until Week 204 ]
  7. Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time [ Time Frame: Baseline, Until Week 204 ]
  8. Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue multiple sclerosis (MS)-8a over time [ Time Frame: Baseline, Until Week 204 ]
  9. Annualized relapse rate during the study period assessed by protocol defined adjudicated relapses [ Time Frame: Until Week 204 ]
  10. Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation and AE of special interests (AESIs) [ Time Frame: Until Week 204 ]
  11. Number of participants with potentially clinically significant abnormalities (PCSAs) in laboratory tests, ECG, and vital signs during the study period [ Time Frame: Until Week 204 ]
    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: Until Week 204 ]
  13. Change from baseline in serum Ig levels over time [ Time Frame: Until Week 204 ]
  14. Change from baseline in plasma neurofilament light chain (NfL) levels over time [ Time Frame: Until Week 204 ]
  15. Frexalimab plasma concentration over time [ Time Frame: Until Week 204 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 frexalimab.

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06141486


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 contact-us@sanofi.com

Locations
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Sponsors and Collaborators
Sanofi
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT06141486    
Other Study ID Numbers: EFC17504
U1111-1280-7114 ( Registry Identifier: ICTRP )
2023-504359-29 ( Registry Identifier: CTIS )
First Posted: November 21, 2023    Key Record Dates
Last Update Posted: April 10, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Chronic Disease
Disease Attributes