RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 depending on the recruitment rate, the event rate, the study discontinuation rate and the 12-month minimum treatment duration. Different participants will have different study durations. The last participant randomized will have at least 12 months of study duration, and assuming a 28-month recruitment period, the first participant randomized will have 40 months or longer of study duration. * The study intervention duration will vary similarly as the study duration. * 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.

Official Title

Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis

Quick Facts

Study Start:2023-12-13
Study Completion:2027-05-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06141473

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria.
  2. * The participant has an EDSS score ≤5.5 at the first visit (Screening Visit)
  3. * The participant must have at least 1 of the following prior to screening:
  4. * ≥1 documented relapse within the previous year OR
  5. * ≥2 documented relapses within the previous 2 years, OR
  6. * ≥1 documented Gd enhancing lesion on an MRI scan within the previous year.
  7. * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  1. * The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria
  2. * The participant has a history of infection or may be at risk for infection:
  3. * The presence of psychiatric disturbance or substance abuse.
  4. * 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.
  5. * Current hypogammaglobulinemia defined by Ig levels below the LLN at Screening or a history of primary hypogammaglobulinemia.
  6. * 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.
  7. * The participant has had a relapse in the 30 days prior to randomization.
  8. * 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.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

University of Alabama at Birmingham- Site Number : 8401135
Birmingham, Alabama, 35233
United States
North Central Neurology Associates- Site Number : 8401100
Cullman, Alabama, 35058
United States
Alabama Neurology Associates- Site Number : 8400115
Homewood, Alabama, 35209
United States
St. Joseph's Hospital and Medical Center- Site Number : 8401139
Phoenix, Arizona, 85013
United States
Perseverance Research Center- Site Number : 8401138
Scottsdale, Arizona, 85254
United States
Clinical Endpoints- Site Number : 8400050
Scottsdale, Arizona, 85258
United States
The Neurology Center of Southern California - Carlsbad- Site Number : 8400023
Carlsbad, California, 92011
United States
UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8401143
Irvine, California, 92697
United States
Multiple Sclerosis Center of California - Laguna Hills- Site Number : 8401122
Laguna Hills, California, 92653
United States
Chemidox Clinical Trials- Site Number : 8401157
Lancaster, California, 93534
United States
Hoag Memorial Hospital Presbyterian- Site Number : 8401031
Newport Beach, California, 92663
United States
Private Practice - Dr. Regina Berkovich- Site Number : 8400005
West Hollywood, California, 90048
United States
University of Colorado- Site Number : 8401001
Denver, Colorado, 80262
United States
Advanced Neurology of Colorado- Site Number : 8401148
Fort Collins, Colorado, 80528
United States
Hartford Healthcare Medical Group- Site Number : 8401069
Norwich, Connecticut, 06360
United States
New England Institute for Clinical Research- Site Number : 8400114
Stamford, Connecticut, 06905
United States
MedStar Georgetown University Hospital- Site Number : 8400044
Washington D.C., District of Columbia, 20007
United States
Neurology of Central Florida- Site Number : 8401147
Altamonte Springs, Florida, 32714
United States
Neurology Offices of South Florida - Boca Raton- Site Number : 8401169
Boca Raton, Florida, 33428
United States
First Choice Neurology - Espinosa Neuroscience Institute- Site Number : 8401071
Boca Raton, Florida, 33486
United States
Mayo Clinic Hospital Jacksonville- Site Number : 8401093
Jacksonville, Florida, 32224
United States
Neurology Associates - Maitland- Site Number : 8400010
Maitland, Florida, 32751
United States
Research by Design, LLC- Site Number : 8401191
Miami Lakes, Florida, 33016
United States
Orlando Health Neuroscience Institute- Site Number : 8400060
Orlando, Florida, 32806
United States
Axiom Clinical Research of Florida- Site Number : 8400049
Tampa, Florida, 33609
United States
University of South Florida- Site Number : 8400013
Tampa, Florida, 33612
United States
Palm Beach Medical Group- Site Number : 8401105
West Palm Beach, Florida, 33407
United States
Velocity Clinical Research - Savannah Neurology- Site Number : 8400061
Savannah, Georgia, 31406
United States
NorthShore Medical Group - Evanston- Site Number : 8401111
Evanston, Illinois, 60201
United States
Consultants in Neurology- Site Number : 8401020
Northbrook, Illinois, 60062
United States
Springfield Clinic 1st - 800 Building- Site Number : 8400043
Springfield, Illinois, 62702
United States
IU Health Physicians - Fort Wayne - Hope Drive- Site Number : 8400058
Fort Wayne, Indiana, 46815
United States
Neuroscience Institute Center- Site Number : 8400053
Merrillville, Indiana, 46410
United States
University of Iowa- Site Number : 8400029
Iowa City, Iowa, 52242
United States
University of Kansas Medical Center- Site Number : 8400084
Kansas City, Kansas, 66160
United States
KC Research Center- Site Number : 8400032
Roeland Park, Kansas, 66205
United States
Baptist Health Lexington- Site Number : 8401149
Lexington, Kentucky, 40503
United States
Norton Neurology Services- Site Number : 8401103
Louisville, Kentucky, 40207
United States
NeuroMedical Clinic of Central Louisiana- Site Number : 8401159
Alexandria, Louisiana, 71301
United States
The NeuroMedical Center- Site Number : 8401182
Baton Rouge, Louisiana, 70810
United States
Ochsner Medical Center - Jefferson Highway- Site Number : 8400027
New Orleans, Louisiana, 70121
United States
International Neurorehabilitation Institute- Site Number : 8400089
Lutherville, Maryland, 21093
United States
Boston Clinical Trials- Site Number : 8401178
Boston, Massachusetts, 02131
United States
Beth Israel Deaconess Medical Center- Site Number : 8401041
Boston, Massachusetts, 02215
United States
Neurology Center of New England- Site Number : 8401164
Foxborough, Massachusetts, 02035
United States
Henry Ford Hospital- Site Number : 8401091
Detroit, Michigan, 48202
United States
Michigan Institute for Neurological Disorders- Site Number : 8400004
Farmington Hills, Michigan, 48334
United States
Trinity Health Grand Rapids- Site Number : 8400150
Grand Rapids, Michigan, 49503
United States
Memorial Healthcare Institute for Neuroscience- Site Number : 8400123
Owosso, Michigan, 48867
United States
Rochester Medical Group- Site Number : 8401172
Rochester Hills, Michigan, 48307
United States
M Health Fairview University of Minnesota Medical Center - East Bank- Site Number : 8400056
Minneapolis, Minnesota, 55455
United States
Minnesota Center for Multiple Sclerosis- Site Number : 8400073
Plymouth, Minnesota, 55446
United States
Sharlin Health & Neurology- Site Number : 8400016
Ozark, Missouri, 65721
United States
Washington University School of Medicine- Site Number : 8400076
St Louis, Missouri, 63110
United States
The MS Center for Innovations in Care- Site Number : 8401141
St Louis, Missouri, 63131
United States
Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400045
Las Vegas, Nevada, 89106
United States
Renown Regional Medical Center- Site Number : 8400066
Reno, Nevada, 89502
United States
Rutgers University- Site Number : 8401067
New Brunswick, New Jersey, 08903
United States
University of New Mexico Comprehensive Cancer Center- Site Number : 8401090
Albuquerque, New Mexico, 87102
United States
South Shore Neurologic Associates - Patchogue- Site Number : 8400063
Patchogue, New York, 11772
United States
Montefiore Hutchinson Campus- Site Number : 8401145
The Bronx, New York, 10461
United States
The Neurological Institute- Site Number : 8401166
Charlotte, North Carolina, 28204
United States
Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002
Charlotte, North Carolina, 28210
United States
Raleigh Neurology Associates- Site Number : 8400014
Raleigh, North Carolina, 27607
United States
Wake Forest Baptist Health- Site Number : 8400040
Winston-Salem, North Carolina, 27103
United States
Sanford Neuroscience Clinic- Site Number : 8401085
Fargo, North Dakota, 58103
United States
Dayton Center for Neurological Disorders- Site Number : 8400079
Centerville, Ohio, 45459
United States
University of Cincinnati - Internal Medicine- Site Number : 8401117
Cincinnati, Ohio, 45267
United States
The Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute- Site Number : 8401009
Columbus, Ohio, 43210
United States
OhioHealth Riverside Methodist Hospital- Site Number : 8401092
Columbus, Ohio, 43214
United States
The Boster Center for Multiple Sclerosis- Site Number : 8400006
Columbus, Ohio, 43235
United States
UC Health - Elizabeth Place- Site Number : 8401008
Dayton, Ohio, 45417
United States
Oklahoma Medical Research Foundation- Site Number : 8400039
Oklahoma City, Oklahoma, 73104
United States
Providence St. Vincent's Medical Center- Site Number : 8400052
Portland, Oregon, 97225
United States
Oregon Neurology- Site Number : 8400188
Springfield, Oregon, 97477
United States
Abington Neurological Associates- Site Number : 8401065
Abington, Pennsylvania, 19001
United States
Penn State Health Milton South Hershey Medical Center- Site Number : 8401176
Hershey, Pennsylvania, 17033
United States
Thomas Jefferson University Hospital- Site Number : 8400035
Philadelphia, Pennsylvania, 19107
United States
Allegheny General Hospital- Site Number : 8401173
Pittsburgh, Pennsylvania, 15212
United States
UPMC Magee-Womens Hospital- Site Number : 8401133
Pittsburgh, Pennsylvania, 15213
United States
Premier Neurology- Site Number : 8401047
Greer, South Carolina, 29650
United States
Hope Neurology- Site Number : 8400019
Knoxville, Tennessee, 37922
United States
Neurology Consultants of Dallas - Lyndon B Johnson Freeway- Site Number : 8400152
Dallas, Texas, 75243
United States
ANESC Research- Site Number : 8400187
El Paso, Texas, 79912
United States
Baylor College of Medicine Medical Center- Site Number : 8401170
Houston, Texas, 77030
United States
North Texas Institute of Neurology & Headache - Plano- Site Number : 8401083
Plano, Texas, 75024
United States
UT Health - San Antonio- Site Number : 8401167
San Antonio, Texas, 78229
United States
Neurology Center of San Antonio- Site Number : 8400099
San Antonio, Texas, 78258
United States
Texas Institute for Neurological Disorders - Sherman- Site Number : 8400018
Sherman, Texas, 75092
United States
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8401109
Fairfax, Virginia, 22031
United States
Multiple Sclerosis Center of Greater Washington (MSCGW)- Site Number : 8401128
Vienna, Virginia, 22182
United States
Swedish Medical Center - Seattle- Site Number : 8400078
Seattle, Washington, 98104
United States
University of Washington Medical Center - Northwest- Site Number : 8401146
Seattle, Washington, 98133
United States
MultiCare Institute for Research & Innovation- Site Number : 8401140
Tacoma, Washington, 98405
United States
Wheaton Franciscan Healthcare - St Francis- Site Number : 8400034
Milwaukee, Wisconsin, 53215
United States
Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-13
Study Completion Date2027-05-06

Study Record Updates

Study Start Date2023-12-13
Study Completion Date2027-05-06

Terms related to this study

Additional Relevant MeSH Terms

  • Multiple Sclerosis