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

Purpose

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.

Condition

  • Multiple Sclerosis

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Alabama Neurology Associates- Site Number : 8400115
Birmingham, Alabama 35209

Dignity Health St. Joseph's Hospital and Medical Center- Site Number : 8400139
Phoenix, Arizona 85013

HonorHealth Neurology- Site Number : 8400074
Scottsdale, Arizona 85251

Perseverance Research Center- Site Number : 8400138
Scottsdale, Arizona 85254

Imaging EndPoints- Site Number : 8400050
Scottsdale, Arizona 85258

Sutter East Bay Medical Foundation- Site Number : 8400134
Berkeley, California 94705

The Research Center of Southern California, LLC- Site Number : 8400023
Carlsbad, California 92011

University of California, Irvine- Site Number : 8400143
Irvine, California 92697

University of California San Diego- Site Number : 8400095
La Jolla, California 92037

Southern California Permanente Medical Group- Site Number : 8400184
Los Angeles, California 90027

University of Southern California, Los Angeles- Site Number : 8400118
Los Angeles, California 90033

Hoag Memorial Hospital- Site Number : 8400031
Newport Beach, California 92663

Stanford Neuroscience Health Center- Site Number : 8400120
Palo Alto, California 94304

Regina Berkovich, MD, PhD- Site Number : 8400005
West Hollywood, California 90048

University of Colorado Health Science Center- Site Number : 8400001
Aurora, Colorado 80045

Advanced Neurosciences Research- Site Number : 8400148
Fort Collins, Colorado 80528

Yale University- Site Number : 8400081
New Haven, Connecticut 06519

Hartford Healthcare Medical Group- Site Number : 8400069
Norwich, Connecticut 06360

New England Institute for Clinical Research- Site Number : 8400114
Stamford, Connecticut 06905

Georgetown University Hospital- Site Number : 8400044
Washington D.C., District of Columbia 20007

Neurology of Central Florida Research Center, LLC- Site Number : 8400147
Altamonte Springs, Florida 32714

First Choice Neurology- Site Number : 8400169
Boca Raton, Florida 33428

MS & Neuromuscular Center of Excellence- Site Number : 8400015
Clearwater, Florida 33761

Beth Israel Deaconess Medical Center- Site Number : 8400041
Fort Myers, Florida 33919

University of Florida Health- Site Number : 8400054
Gainesville, Florida 32608

Mayo Clinic- Site Number : 8400093
Jacksonville, Florida 32224

Neurology Associates, PA- Site Number : 8400010
Maitland, Florida 32761

University of Miami- Site Number : 8400177
Miami, Florida 33136

Orlando Health Neuroscience Institute- Site Number : 8400060
Orlando, Florida 32806

Axiom Clinical Research of Florida- Site Number : 8400049
Tampa, Florida 33609-4052

University of South Florida- Site Number : 8400013
Tampa, Florida 33612

Premiere Research Institute at Palm Beach Neurology- Site Number : 8400105
West Palm Beach, Florida 33407

Savannah Neurology Specialists- Site Number : 8400061
Savannah, Georgia 31406

Joi Life Wellness Group LLC- Site Number : 8400192
Smyrna, Georgia 30080

Rush University Medical Center- Site Number : 8400102
Chicago, Illinois 60612

University of Chicago Biological Science/Neurology (The) University of Chicago Medical Center)- Site Number : 8400055
Chicago, Illinois 60637

Consultants In Neurology- Site Number : 8400020
Northbrook, Illinois 60062

Springfield Clinic, LLP- Site Number : 8400043
Springfield, Illinois 62702

Neuroscience Institute Center- Site Number : 8400053
Merrillville, Indiana 46410

University Of Iowa Hospitals And Clinics- Site Number : 8400029
Iowa City, Iowa 52242-1009

University of Kansas Medical Center- Site Number : 8400084
Kansas City, Kansas 66103

College Park Family Care Center- Site Number : 8400032
Overland Park, Kansas 66212

Baptist Health Lexington- Site Number : 8400149
Lexington, Kentucky 40503

Neuromedical Clinic of CENLA, LLC- Site Number : 8400159
Alexandria, Louisiana 71301

DelRicht Research- Site Number : 8400182
Baton Rouge, Louisiana 70810

Ochsner Clinic Foundation- Site Number : 8400027
New Orleans, Louisiana 70121

University of Maryland, Baltimore- Site Number : 8400185
Baltimore, Maryland 21201

Johns Hopkins University- Site Number : 8400080
Baltimore, Maryland 21287

International Neurorehabilitation Institute- Site Number : 8400089
Lutherville, Maryland 21093

Tufts Medical Center- Site Number : 8400003
Boston, Massachusetts 02111

Boston Clinical Trials- Site Number : 8400178
Boston, Massachusetts 02131

Neurology Center of New England PC- Site Number : 8400164
Foxborough, Massachusetts 02035

The Elliot Lewis Center for Multiple Sclerosis Care- Site Number : 8400033
Wellesley, Massachusetts 02481

University of Massachusetts- Site Number : 8400028
Worcester, Massachusetts 01655

Michigan Institute For Neurological Disorders- Site Number : 8400004
Farmington Hills, Michigan 48334

Trinity Health Grand Rapids- Site Number : 8400150
Grand Rapids, Michigan 49503

Memorial Healthcare Institute for Neuroscience- Site Number : 8400123
Owosso, Michigan 48867

Profound Research / Rochester Medical Group / Michigan Health Partners- Site Number : 8400172
Rochester Hills, Michigan 48307

Minneapolis Clinic of Neurology- Site Number : 8400077
Minneapolis, Minnesota 55422

University of Minnesota - Department of Neurology- Site Number : 8400056
Minneapolis, Minnesota 55455

Minnesota Center for Multiple Sclerosis- Site Number : 8400073
Plymouth, Minnesota 55446

Sharlin Health & Neurology- Site Number : 8400016
Ozark, Missouri 65721

Washington University School of Medicine- Site Number : 8400076
St Louis, Missouri 63110

Lou Ruvo Center for Brain Health- Site Number : 8400045
Las Vegas, Nevada 89106

Renown Institute for Neurosciences- Site Number : 8400066
Reno, Nevada 89502

Dartmouth Hitchcock Medical Center- Site Number : 8400098
Lebanon, New Hampshire 03756-0001

Rutgers University - Robert Wood Johnson Medical School- Site Number : 8400067
New Brunswick, New Jersey 08901

Holy Name Medical Center- Site Number : 8400101
Teaneck, New Jersey 07666

University of New Mexico- Site Number : 8400090
Albuquerque, New Mexico 87131

Dent Neurologic Institute- Site Number : 8400129
Amherst, New York 14226

Icahn School of Medicine at Mount Sinai.- Site Number : 8400011
New York, New York 10029-6504

Columbia University Medical Center- Site Number : 8400088
New York, New York 10032-3725

Neurology Associates of Stony Brook- Site Number : 8400094
Stony Brook, New York 11794

Piedmont Healthcare/Research- Site Number : 8400002
Charlotte, North Carolina 28210

Velocity Clinical Research, Inc- Site Number : 8400014
Raleigh, North Carolina 27607

Atrium Health Wake Forest Baptist- Site Number : 8400040
Winston-Salem, North Carolina 27103

Sanford Brain and Spine Center- Site Number : 8400085
Fargo, North Dakota 58103

Riverhills Neuroscience - Norwood- Site Number : 8400007
Cincinnati, Ohio 45212

University of Cincinnati Medical Center- Site Number : 8400117
Cincinnati, Ohio 45219

Ohio State University- Site Number : 8400009
Columbus, Ohio 43210

The Boster Center for Multiple Sclerosis- Site Number : 8400006
Columbus, Ohio 43235

University of Cincinnati- Site Number : 8400008
Dayton, Ohio 45417

Oklahoma Medical Research Foundation- Site Number : 8400039
Oklahoma City, Oklahoma 73104

Providence Multiple Sclerosis Center- Site Number : 8400052
Portland, Oregon 97225

Penn State Milton S. Hershey Medical Center- Site Number : 8400176
Hershey, Pennsylvania 17033

Comprehensive MS Center Thomas Jefferson University Hospital- Site Number : 8400035
Philadelphia, Pennsylvania 19107

Premier Neurology- Site Number : 8400047
Greenville, South Carolina 29605

HOPE Neurology- Site Number : 8400019
Knoxville, Tennessee 37922

Vanderbilt University Medical Center Vanderbilt Comprehensive Multiple Sclerosis Center- Site Number : 8400130
Nashville, Tennessee 37215

Neurology Consultants of Dallas- Site Number : 8400152
Dallas, Texas 75243

North Texas Institute of Neurology - Plano- Site Number : 8400083
Plano, Texas 75024

Lone Star Neurology of San Antonio- Site Number : 8400099
San Antonio, Texas 78258

Texas Institute for Neurological Disorders-Sherman- Site Number : 8400018
Sherman, Texas 75092

University Of Vermont- Site Number : 8400042
Burlington, Vermont 05401

INOVA Neurology- Site Number : 8400109
Fairfax, Virginia 22031

Riverside Hampton Roads Neurology- Site Number : 8400132
Newport News, Virginia 23666

MS Center of Greater Washington- Site Number : 8400128
Vienna, Virginia 22182

Sentara Neurological Associates- Site Number : 8400168
Virginia Beach, Virginia 23456

Swedish Medical Center- Site Number : 8400078
Seattle, Washington 98122

West Virginia University- Site Number : 8400131
Morgantown, West Virginia 26506

Wheaton Franciscan Healthcare- Site Number : 8400034
Milwaukee, Wisconsin 53215

Medical College of Wisconsin- Site Number : 8400038
Milwaukee, Wisconsin 53226

More Details

NCT ID
NCT06141486
Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free number for US & Canada)
800-633-1610
contact-us@sanofi.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center